qms essentials v 0.2

Advance Innovation Group

2013

QMS Essentials v 0.2ISO 9001Pranay, Shishir

QMS Essentials v 0.2

Classification: AIG – Internal of 78

Document Revision History

Date Document VersionDocumentRevisionComments

Prepared By Approved By

12 April 0.1 Draft Only Shishir Singh Under Review

12 November 0.2 Shishir Singh Pranay Kumar

Distribution ListDocument Sent To Purpose

All QMS Students For Information

ReferencesReference Document Name Description Page No.

N/A N/A N/A

DisclaimerThis document is prepared, reviewed and approved by the AIG Principal Consultant. All changes to thisDocument shall be reviewed and approved by AIG Principal Consultant.



Contents

1.0 PURPOSE______________________________________________________________________________5

2.0 AUDIENCE_____________________________________________________________________________5

3.0 GLOSSARY_____________________________________________________________________________5

4.0 HISTORY ______________________________________________________________________________54.1 Introduction _____________________________________________________________ 54.2 A Brief History of ISO_______________________________________________________ 64.3 The ISO Standardization Process _____________________________________________ 6

5.0 The eight principles of quality management _________________________________________________75.1 Customer focus ___________________________________________________________ 75.2 Leadership_______________________________________________________________ 75.3 Involvement of people _____________________________________________________ 85.4 Process approach _________________________________________________________ 85.5 System approach to management ____________________________________________ 85.6 Continual improvement ____________________________________________________ 85.7 Factual approach to decision making __________________________________________ 95.8 Mutually beneficial supplier relationships ______________________________________ 9

6.0 ISO 9000 Family of Documents ____________________________________________________________96.1 ISO 9000:2005, Quality management systems - Fundamentals and vocabulary _________ 96.2 ISO 9001:2008, Quality management systems - Requirements _____________________ 106.3 ISO 9004:2009, Managing for the sustained success of an organisation – A qualitymanagement approach__________________________________________________________ 106.4 ISO 19011, Guidelines on Quality and/or Environmental Management Systems Auditing(currently under development) ___________________________________________________ 10

7.0 Non conformity _______________________________________________________________________107.1 Types of Non conformity __________________________________________________ 107.2 Major Non conformity ____________________________________________________ 117.3 Minor Non Conformity ____________________________________________________ 117.4 Observation_____________________________________________________________ 11

8.0 QMS Essentials________________________________________________________________________118.1 Guidance on Clause 4.2 of ISO 9001:2008 _____________________________________ 12

Documented statements of a quality policy and objectives________________________ 12 Quality Manual __________________________________________________________ 12 Documented procedures __________________________________________________ 12 Documents needed by the organization to ensure the effective planning, operation andcontrol of its processes ________________________________________________________ 13 Records ________________________________________________________________ 13

8.2 Records required by ISO 9001:2008 __________________________________________ 148.3 Process Design Methodology _______________________________________________ 148.4 Another model saying the same thing ________________________________________ 158.5 Typical Quality Pyramid in Organizations ______________________________________ 168.6 Ensuring Process Maturity – Model Example ___________________________________ 168.7 Salient Feature of a sound Quality Management System _________________________ 17

Management Commitment ________________________________________________ 17 Internal Audit & Independence of Internal Auditors _____________________________ 18



Corrective & Preventive Action______________________________________________ 18 Continual Improvement ___________________________________________________ 18 Documented Process _____________________________________________________ 18 Test of Design ___________________________________________________________ 18 Awareness Program:______________________________________________________ 18 Implementation & Test of its Effectiveness ____________________________________ 18 Management Involvement in Audit and Audit outcome __________________________ 19 Documentation Hierarchy__________________________________________________ 19

8.8 Service Performance Metrics _______________________________________________ 19 Understand customer requirement & determine the measure of success ____________ 19 Define the operational definition& the defect definition__________________________ 20 Prepare Data Collection Plan _______________________________________________ 20 Validate the data_________________________________________________________ 20 Report Out _____________________________________________________________ 20

9.0 Audit Process _________________________________________________________________________219.1 Sample Nonconformance Report ____________________________________________ 249.2 Sample Audit Checklist ____________________________________________________ 25

10.0 Best Practices for Implementing and Utilizing a Standards-based QMS __________________________2610.1 Why implement a Quality Management System ________________________________ 2610.2 Effective Utilization of a QMS _______________________________________________ 2710.3 Management Responsibility ________________________________________________ 2710.4 Resource Management____________________________________________________ 2710.5 Product Realization_______________________________________________________ 2810.6 Measurement, Analysis, and Improvement ____________________________________ 28

11.0 Frequently Asked Questions (FAQ's) ______________________________________________________2911.1 ISO ____________________________________________________________________ 3011.2 ISO 9000 Family of standards _______________________________________________ 3011.3 ISO 9001:2008___________________________________________________________ 40



1.0 PURPOSEThe purpose of this document is to serve as a reading material for all students of Advance Innovation Group.This document intends to be a quick reference guide to all students @AIG in their pursuit to QMSImplementation.

2.0 AUDIENCEThe QMS Essential Doc is intended for all the students of Advance Innovation Group.

3.0 GLOSSARYTerms / Acronyms / Abbreviations Description

4.0 HISTORY

4.1 Introduction

The ISO 14000 series of environmental management standards are intended to assist organizations managethe environmental effect of their business practices. The ISO 14000 series is similar to the ISO 9000 seriespublished in 1987. The purpose of the ISO 9000 series is to encourage organizations to institute qualityassurance management programs. Although ISO 9000 deals with the overall management of an organizationand ISO 14000 deals with the management of the environmental effects of an organization, both standards areconcerned with processes, and there is talk of combining the two series into one.

Both series of standards were published by ISO, the International Organization for Standardization. Thepurpose of ISO is to facilitate international trade and cooperation in commercial, intellectual, scientific andeconomic endeavors by developing international standards. ISO originally focused on industrial andmechanical engineering standards. Now, it has ventured into setting standards for an organization's processes,policies, and practices.

Both series of standards stemmed from concerns about international trade. One of the issues of the 1986GATT negotiations in Uruguay was the removal of non-tariff trade barriers. Standards fall into this category.The ISO 9000 standard was published about a year after the Uruguay GATT negotiations. The ISO 14000standards are a response to both the GATT negotiations and to the growing global concern for theenvironment as evidenced by the 1992 Rio Conference on the environment.

Both the ISO 9000 and the ISO 14000 series have critics and proponents. The critics of the standards point outthat quality management policies proposed by ISO 9000 do not necessarily result in quality products. Critics



also project that the environmental management policies of ISO 14000 will not guarantee that an organizationis not damaging the environment. Both series require third-party certification, and the certification business isbooming, thanks in part to these two standards. Questions have risen regarding the fairness of the certificationprocess. Both series are heavy in their documentation requirements and demand a significant amount of timeand personnel.

The proponents of the series point to the economic benefits that can be gained by putting the standards intopractice. These benefits include the opening of new markets and the development of streamlined procedures,which can lead to increased profits. There are also non-tangible benefits of ISO 14000 certification, such asimproved employee morale, improved corporate image, and the feeling of "doing the right thing".

Because of the strong similarities between the two standards, it is almost impossible to discuss ISO 14000without including a discussion of ISO 9000 and the ISO standards-setting process. In addition, the experiencesthat organizations have had with the ISO 9000 series have raised questions that many people want resolvedbefore they wholeheartedly embrace the ISO 14000 series. The reader will gain the most information from thispaper by reading the following sections in the order in which they are listed below:

4.2 A Brief History of ISOStandards are important in international trade because incongruent standards can be barriers to trade, givingsome organizations advantages in certain areas of the world. Standards provide clear identifiable referencesthat are recognized internationally and encourage fair competition in free-market economies. Standardsfacilitate trade through enhanced product quality and reliability, greater interoperability and compatibility,greater ease of maintenance and reduced costs. ISO covers a wide variety of standards with the exception ofelectrical and electronic engineering standards covered by the International Electrotechnical Commission (IEC),telecommunication standards covered by the International Telegraph Union (ITU) and information technologycov ered by JTC 1 (a joint committee between ISO and IEC).

The organization which today is known as ISO began in 1926 as the International Federation of the NationalStandardizing Associations (ISA). This organization focused heavily on mechanical engineering. It wasdisbanded in 1942 during the second World War but was re-organized under the current name, ISO, in 1946.

Even the name of the organization is standardized. The name, "ISO" is not an acronym but was derived fromthe Greek word "isos" meaning "equal". (The relation to standards is that if two objects meet the samestandard, they should be equal.) This name eliminates any confusion that could result from the translation of"International Organization For Standardization" into different languages which would lead to differentacronyms.

ISO is a voluntary organization whose members are recognized standard authorities, each one representingone country. The bulk of the work of ISO is done by the 2700 technical committees, subcommittees andworking groups. Each committee and subcommittee is headed by a Secretariat from one of the memberorganizations. The American National Standards Institute (ANSI) is the United States representative to ISO. TheANSI ASC Z-1/ASQ Standards Group coordinates the United States representation in the ISO TechnicalCommittees 176 and 207 which are concerned with the ISO 9000 and ISO 14000 standards respectively.

4.3 The ISO Standardization ProcessEach member body who has an interest in the work of a committee is entitled to be a member of thatcommittee. Standards are reached by consensus with each member organization representing the interests ofthe vendors, manufacturers, consumers, profession als, and government of it's country.



Each standard goes through a six stage process before being published as an ISO standard. The first stage is theproposal stage in which a need for a standard is determined and members are identified who are willing towork on it. The standards then ent ers the preparatory stage where a working draft of the standard isdeveloped. When the working draft is completed, it enters the committee stage and is sent out for commentsuntil a consensus is reached. The output of this stage is the Draft Internation al Standard (DIS). The DIS thenenters the enquiry stage where it is circulated among all member bodies and then voted upon. If a DIS doesnot receive 75% of the vote, it returns to lower stages and work on it continues. If it passes the enquiry stage ,it becomes a Final Draft International Standard and enters the approval stage. During this stage it will againcirculate through all member bodies for a final vote and again it must pass this stage with 75% of the vote. Ifthe standard passes this sta ge, it enters the publication stage and is sent to the ISO Central Secretariat forpublication.

Because certain technologies are changing so rapidly, ISO has instituted a Fast Track procedure that allows astandard which has been proven in the market to enter the approval process at the enquiry stage.

5.0 The eight principles of quality management

Quality - That is the quality of processes and results – is and will continue to be an essential competitivefactor, if not the most decisive one. When it comes to achieving one’s own objectives as well as fulfillingcustomer requirements, a reliable quality management system is indispensable.

The eight principles of quality management reflect the experience of leading top managers. They provideassistance in focusing on objec-tives, on systematic leadership and on the con-tinual improvement ofperformance.

5.1 Customer focus

Consistent customer focus is the single most essential factor of every business success. Being “Best inClass” means predicting and exceeding customer expectations. The whole company organisation needs tobe aligned accordingly.

Your customers‘needs are understood throughout the company. Your internal company is directly linked to customer expectations. You improve your company‘s ability to fulfill customer needs in day-to-day activities. You ensure that your employees have the necessary knowledge and skills to satisfy your customers.

5.2 Leadership

The degree to which the purpose, focus and internal environment of an organization fit together is aquestion of leadership. Managers create the internal environment in which people develop their skills andapply them for the benefit of the entire organization. Important tools to achieve this are management byexample, the consider-ation of involved stakeholders inside and outside the organization and thedevelopment of a clear vision of the organization’s future.

You develop and communicate a clear vision of your organization’s future. You translate your vision into measurable goals for the organization. You involve your employees in the realization of your company goals. You have a motivated, competent and stable staff.



5.3 Involvement of people

Every organization is only as good as its employ-ees. To allow them to apply their abilities and release theirpotential, it is necessary to involve them in the decision-making process. Doing that requires promotingcommitment and problem-solving skills on all levels and to encourage the employees to take the initiative inseeking op-portunities for improvement.

Your employees contribute actively to the improvement of your business strategy. Your employees adopt the organization‘s goals as their own goals. Your employees are involved in decision-making and the improvement of processes. Your employees are more satisfied with their work and devote their individual development potential to

the service of your organization.

5.4 Process approach

Results can be achieved more efficiently if necessary activities and resources are bundled and managed asa process. For this purpose, individual process steps need to be defined, inputs and outputs determinedand the interfaces with the organization‘s function identified. Finally, in order to ensure the smoothrunning of orga-nizational processes, possible error causes need to be identified and responsibilitiesdetermined.

Your processes ensure achievement of planned results and efficient use of resources. You take advantage of improvement potentials because you are aware of the essential success factors. Consistent emphasis on process orientation helps you to reduce costs and prevent errors. You take advantage of improvement potential because you are familiar with the essential success factors.

5.5 System approach to management

Each organization is a complex entity; that is why it is important to identify, manage and understandindividual pro-cesses and their interactions within the organizational workflow. This is the only way fororganizations to establish objec-tives effectively and efficiently.

You develop extensive and ambitious business plans, which combine functional and processaspects.

Sub-goals of individual processes become aligned with the main goals of your organization. Monitoring the effectiveness of individual processes allows you to better identify error causes and

improvement potential. You coordinate competencies and responsibilities for superordinate goals, avoid any overlapping of

competencies and stimulate teamwork.

5.6 Continual improvement

“If you cease to improve, you cease to be good.“ Behind this simple statement lies the realization thatcompetence and quality are not static, but dynamic values; that applies to organizations as well as to thepeople working there. That is why it is important for the success of an organization that continuousimprovement of products and systems becomes the ultimate goal of each employee.



You combine continuous improvement and strategic planning for more competitive business plans. You set realistic, measurable and ambitious goals for improve-ment and provide any necessary resources. Your employees become involved in the process of continual improvement. All employees of your organization are capable of improving products, processes and systems

5.7 Factual approach to decision making

Efficient decisions are based on the analysis of data and information. Ap-propriate decisions, based onexperi-ence and entrepreneurial intuition, can only be reached when these data and information arereviewed and verified continuously.

You develop your company strategies based on facts and information.

Taking into account relevant comparative data, you pursue more realistic and more ambitious goals.

You make use of recognized methods for data analysis, making results available where appropriate. Youoptimize your company’s processes and system performance, taking into account data and information,manage improvement processes and prevent future problems.

5.8 Mutually beneficial supplier relationships

All things are interdependent; organizations particularly depend on good business relationships with theirsuppliers. This is the only way for both parties to make the maximum contribution to the creation ofmutual value. Indispensable to that end is transparent communication, agreement on com-mon goalswhile taking account of the customer‘s interests, and cooperation in the development and improvementof products.

You increase your competitive advantage through the develop-ment of strategic partnerships withsuppliers.

You develop more ambitious goals by including your suppliers in your planning at an early stage. Through improved relationships with suppliers, you ensure reliability, punctuality and error free

compliance of incoming goods. You develop and strengthen the performance capability of your suppliers through training activities and

joint efforts towards continuous improvement.

6.0 ISO 9000 Family of Documents

6.1 ISO 9000:2005, Quality management systems - Fundamentals andvocabulary

Establishes a starting point for understanding the standards and defines the fundamentalterms and definitions used in the ISO 9000 family which you need to avoid misunderstandings in their

use.



6.2 ISO 9001:2008, Quality management systems - Requirements

This is the requirement standard you use to assess your ability to meet customer and applicableregulatory requirements and thereby address customer satisfaction.

It is now the only standard in the ISO 9000 family against which third-party certification can becarried.

6.3 ISO 9004:2009, Managing for the sustained success of anorganisation – A quality management approach

ISO 9004 now gives guidance to the management of an organization on how to achieve sustainedsuccess by use of a quality management approach. It helps an organization to move its management systembeyond the basic requirements of ISO 9001, to meet the needs and expectations of its all relevant interestedparties, and guides management in assessing their organization’s strengths and weaknesses.

ISO 9004:2009 gives guidance to an organization on the steps it should take for improving its qualitymaturity beyond that achieved from the implementation of an ISO 9001 based QMS. Taken together, thestandards form a “consistent pair” of standards, as both are based on the 8 quality management principles andthe “Process approach” model.

6.4 ISO 19011, Guidelines on Quality and/or EnvironmentalManagement Systems Auditing (currently under development)

Provides you with guidelines for verifying the system's ability to achieve defined quality objectives.You can use this standard internally or for auditing your suppliers.

7.0 Non conformity

• Nonconformity refers to a failure to comply with requirements. A requirement is a need, expectation,or obligation. It can be stated or implied by an organization, its customers, or other interested parties.

• There are many types of requirements. Some of these include quality requirements, customerrequirements, management requirements, product requirements, and legal requirements. Wheneveryour organization fails to meet one of these requirements, non-conformity occurs. ISO 9001lists quality management system requirements. When your organization deviates from theserequirements, nonconformity occurs.

7.1 Types of Non conformity

Major Non conformity Minor Non Conformity Observation



7.2 Major Non conformity

The absence or total breakdown of a system to meet the ISO 9000 requirement. A number of minor nonconformities against one requirement can represent a total breakdown of the

system and thus be considered a major nonconformity. Any noncompliance that would result in the probable shipment of nonconforming product. A condition that may result in the failure or materially reduce the usability of the products or services

for their intended purpose. A noncompliance that judgment and experience indicate is likely either to result in the failure of the

quality system or to materially reduce its ability to assure controlled processes or products

7.3 Minor Non Conformity

• An ISO 9000 nonconformance to that judgment and experience indicate is not likely to result in thefailure of the quality system or reduce its ability to assure controlled processes or products.

• A failure in some part of the supplier's documented quality system relative to ISO 9000, or• A single observed lapse in following one item of the company's quality system.

7.4 Observation

• An observation is essentially an OPINION.• Some say you can ignore it while others expect the Observation to be addressed in some manner -

such as through the corrective action system

8.0 QMS Essentials

ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document,implement, and maintain a quality management system and continually improve its effectiveness inaccordance with the requirements of this International Standard”

Clause 4.2.1 General explains that the quality management system documentation shall include:

Documented statements of a quality policy and quality objectives; A quality manual Documented procedures required by this International Standard Documents needed by the organization to ensure the effective planning, operation and control of its

processes, and Records required by this International Standard;

The notes after Clause 4.2 make it clear that where the standard specifically requires a “documentedprocedure”, the procedure has to be established, documented, implemented and maintained. It alsoemphasizes that the extent of the QMS documentation may differ from one organization to another due to:



The size of organization and type of activities; The complexity of processes and their interactions, and The competence of personnel.

All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO9001:2008, or, for the particular case of records, according to clause 4.2.4.

8.1 Guidance on Clause 4.2 of ISO 9001:2008

The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of thegeneral documentation requirements of the International Standard.

Documented statements of a quality policy and objectives

Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documentedquality policy has to be controlled according to the requirements of clause 4.2.3.

Note: Organizations that are revising their quality policy for the first time, or in order to meet the amendedrequirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).

Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documentedquality objectives are also subject to the document control requirements of clause 4.2.3.

Quality Manual

Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format andstructure of the manual is a decision for each organization, and will depend on the organization’s size,culture and complexity. Some organizations may choose to use the quality manual for other purposesbesides that of simply documenting the QMS.

A small organization may find it appropriate to include the description of its entire QMS within asingle manual, including all the documented procedures required by the standard.

Large, multi-national organizations may need several manuals at the global, national or regional level,and a more complex hierarchy of documentation.

The quality manual is a document that has to be controlled in accordance with the requirements ofclause 4.2.3.

Documented procedures

ISO 9001:2008 specifically requires the organization to have “documented procedures” for thefollowing six activities: 4.2.3 Control of documents 4.2.4 Control of records 8.2.2 Internal audit 8.3 Control of nonconforming product 8.5.2 Corrective action 8.5.3 Preventive action



These documented procedures have to be controlled in accordance with the requirements of clause4.2.3

Some organizations may find it convenient to combine the procedure for several activities into asingle documented procedure (for example, corrective action and preventive action). Others maychoose to document a given activity by using more than one documented procedure (for example,internal audits). Both are acceptable.

Some organizations (particularly larger organizations, or those with more complex processes) mayrequire additional documented procedures (particularly those relating to product realizationprocesses) to implement an effective QMS.

Other organizations may require additional procedures, but the size and/or culture of theorganization could enable these to be effectively implemented without necessarily beingdocumented. However, in order to demonstrate compliance with ISO 9001:2008, the organization hasto be able to provide objective evidence (not necessarily documented) that its QMS has beeneffectively implemented.

Documents needed by the organization to ensure the effective planning,operation and control of its processes

In order for an organization to demonstrate the effective implementation of its QMS, it may benecessary to develop documents other than documented procedures. However, the only documentsspecifically mentioned in ISO 9001:2008 are:

- Quality policy (clause 4.2.1.a)- Quality objectives (clause 4.2.1.a)- Quality manual (clause 4.2.1.b)

There are several requirements of ISO 9001:2008 where an organization could add value to its QMSand demonstrate conformity by the preparation of other documents, even though the standard doesnot specifically require them. Examples may include:- Process maps, process flow charts and/or process descriptions- Organization charts- Specifications- Work and/or test instructions- Documents containing internal communications- Production schedules- Approved supplier lists- Test and inspection plans- Quality plans

All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or4.2.4, as applicable

Records

To see examples of records specifically required by ISO 9001:2008, Organizations are free to develop other records that may be needed to demonstrate conformity of

their processes, products and quality management system. Requirements for the control of records are different from those for other documents, and all records

have to be controlled according to those of clause 4.2.4 of ISO 9001:2008.



8.2 Records required by ISO 9001:2008Clause Record required5.6.1 Management reviews

6.2.2 e) Education, training, skills and experience

7.1 d) Evidence that the realization processes and resulting product fulfill requirements

7.2.2 Results of the review of requirements related to the product and actions arising from the review

7.3.2 Design and development inputs relating to product requirements

7.3.4 Results of design and development reviews and any necessary actions

7.3.5 Results of design and development verification and any necessary actions

7.3.6 Results of design and development validation and any necessary actions

7.3.7 Results of the review of design and development changes and any necessary actions

7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations

7.5.2 d)As required by the organization to demonstrate the validation of processes where the resultingoutput cannot be verified by subsequent monitoring or measurement

7.5.3 The unique identification of the product, where traceability is a requirement

7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use

7.6 a)Basis used for calibration or verification of measuring equipment where no international or nationalmeasurement standards exist

7.6Validity of the previous measuring results when the measuring equipment is found not to conform torequirements

7.6 Results of calibration and verification of measuring equipment

8.2.2 Internal audit results and follow-up actions

8.2.4 Indication of the person(s) authorizing release of product.

8.3Nature of the product nonconformities and any subsequent actions taken, including concessionsobtained

8.5.2 e) Results of corrective action

8.5.3 d) Results of preventive action

8.3 Process Design Methodology



8.4 Another model saying the same thing



8.5 Typical Quality Pyramid in Organizations

8.6 Ensuring Process Maturity – Model Example



8.7 Salient Feature of a sound Quality Management System

Management Commitment

At every step of QMS development & implementation the management of the organization shouldbe actively involved.



Internal Audit & Independence of Internal Auditors

To ensure that the QMS remains effective and the documented processes are being adhered to,quarterly audits are being performed by independent auditors. (The periodicity may differ from organizationto organization depending on the organizational maturity etc. One should keep in mind that audit is a costhence overdoing audit is never advisable unless it is a new system, and /or it is critical to organizationalsuccess or customer satisfaction).

Organization should ensure independence of the Internal Audit process by getting the qualityfunction to report to the highest office of the organization.

Corrective & Preventive Action

For all process or product non conformities, the process of RCA should be in place and for all nonconformities a formally documented Corrective Action Plan is mandatory.

Continual Improvement

Organization should aim at continual improvement of processes as part of our endeavor foroperational excellence. As an auditor, one should spend time with the process owners to understand whatendeavors have been made to improve the system.

Documented Process

All processes in the organization are formally documented and communicated to all employees. Theyshould be adequately version controlled, review process defined and availability, integrity & confidentiality ofinformation be ensured. Organization may choose to have central repository that ensures availability of thedocuments on a need to know basis, while ensuring suitable controls of availability, integrity & confidentialityof information.

Test of Design

All processes created should be tested for their design intent (if they meet all the CTQ thathave been identified, all process handshakes provisioned for etc.). While auditing or implementingprocesses one should do due diligence to understand the needs of various stakeholders and processbottlenecks.

Awareness Program:

There should be an awareness program mandated for all processes with defined set of audience.To monitor the design and effectiveness of these programs there should be a well defined audit processin place.

Implementation & Test of its Effectiveness

All processes implemented should be verified through internal & external audit process for theireffectiveness.

Periodicity of Audits and their scope should be pre-defined.



Management Involvement in Audit and Audit outcome

Management and the leadership team of the organization is actively involved at every step of theprocess design ,review, review of the review of the audit results, non-conformities and their closure resultingout of corrective & preventive actions.

Documentation Hierarchy

The Organization should have a 3 tier process documentation approach.

Level 1 Constitutes of the Organizational Quality Policy, Manual and organizational objectives.Level 2 Documents are specific to departments and constitutes of department manuals, department

objectives, SOP, Work Instructions, standards and guidelines etc.Level 3 Should constitute of the templates, checklist etc. The diagrammatic representation of the same is

given above (See Typical Quality Pyramid in Organizations)

8.8 Service Performance Metrics

At XXXX we should make adequate provisions to establish an organization driven by numbers. Metrics play akey role in our decision making process and understanding of the areas of improvement. Metrics should formthe basis of our process of measuring success to anything that we do.There should be a defined way of creating metrics at the company. Essentially all such endeavor starts with thecustomer and his definition of the measure of success.

Understand customer requirement & determine the measure of success

Your initiative of metrics creation should always start with understanding the customerrequirement. Determine the measure of success based on the customer requirement.



Measure of success determined is validated by the customer to avoid expectation mismatch at alater stage.

Define the operational definition& the defect definition

Operational definition and defect definition are defined in advance to ensure that all the peopleinvolved have the common understanding of the process.

Prepare Data Collection Plan

Data collection plan should be prepared to establish framework for data collection. Individuals areidentified within the organization and assigned roles and responsibilities to collect data.

The entire data collection process should be designed in an organized manner to identifybottlenecks if any, and put effective controls to efficiently collect data. Data collection plan helps us identifywhat data needs to be collected and from where.

P.S. Data Validity is an important concern for the customer.

Validate the data

Once the data is collected, the same is validated by review process to ensure its completeness andcorrectness.

Report Out

Timely report should be sent to all stakeholders to ensure effective monitoring. It helps to know thecurrent state of affairs, identify areas of improvement, if any; take corrective and preventive steps foreradication of defects and continual improvement.



9.0 Audit Process

Y

N

Require a sign offfrom GE GDC

Program Office

Define Audit Methodology(including Sampling techniques)

Conduct internal audit basedon TOD/TOE

A

Audit Reporting(Comply with the reportingguidelines published by GE GDCProgram.)

Submit the action plan forclosure of audit findings.

On quarterlybasis covering atleast 3 quarters

Conducted annually by GE approvedExternal Auditors

(Audit will be based in TOD/TOE)Any

Exception tothis schedule

Publish scheduleon the first

quarter of theyear

Internal External

CnS Audit

START

END



Audit Process Flow – 2Sample Audit Flow Chart

Prepare and publish Internal AuditPlan

Prepare and publish Internal AuditSchedule

Identify Audit Methodology

Conduct Internal Audits

Audit Reporting

CAPA Logging

Follow-up Audit

Any open NC

Audit Process Closed

Yes

START

END

ManagementReview



END

CAPA Closing

Audit Reporting(Comply with the reportingguidelines published by GE GDCProgram.)

A

CAPAReporting

Any OpenNC

ManagementReviewMeeting

Follow UpAudit



9.1 Sample Nonconformance Report

.



9.2 Sample Audit Checklist

Section ISO Guide Line Sub-section Sub-Guideline Count of Shall Documentation Required Records Required

4.1 General Requirement 5

4.2 Documentationrequirement

4.2.1 General 1

4.2.2 Quality Manual 1

4.2.3 Control Of Document 3 Yes

4.2.4 Control Of Records 2 Yes

5.1ManagementCommitment 1

5.2 Customer focus 1

5.3 Quality Policy 1

5.4 Planning5.4.1 Quality Objective 2

5.4.2 QMS Planning 1

5.5 Responsibility, Athorityand Communication

5.5.1 Responsibility & Authority 1

5.5.2 Management Representative 2

5.5.3 Internal Communication 1

5.6 Management Review

5.6.1 General 1 Yes

5.6.2 Review Input 1

5.6.3 Review Output 1

6.1 Provisions of resources 1

6.2 Human Resources6.2.1 General 1

6.2.2Competence awareness and

training 1 Yes

6.3 Infrastructure 1

6.4 Work Environment 1

7.1Planning of Product

Realization 3 Yes

7.2 Customer relatedProcesses

7.2.1Determination of requirements

related to the product 1

7.2.2Review of Requirements related to

the product 6 Yes

7.2.3 Customer Communication 1

7.3 Design & Devolpment

7.3.1 Design and devolopment planning 4

7.3.2 Design and devolopment inputs 4 Yes

7.3.3 Design and devolopment outputs 3

7.3.4 Design and devolopment review 3 Yes



10.0 Best Practices for Implementing and Utilizing a Standards-based QMS

As industries grow increasingly competitive, it is important for companies, large and small, tocertify to certain quality standards, such as ISO 9001 or sector-specific standards. As companies considerregistering to these standards, the challenge becomes how to best implement and utilize a qualitymanagement system.

A few general questions need to be asked when undertaking what could be a complex, andsomewhat costly, effort. Why does a company need to implement a quality standard?

How will this standard fit that company’s particular business? What type of return oninvestment can be expected?

10.1 Why implement a Quality Management System

Most often, a company needs to implement a quality management system (QMS) based on arecognized standard, such as ISO 9001, because customers have begun to require it or have asked about acompany’s plan to implement such a standard. To become a preferred supplier, or even bid on contracts, manycompanies are required to be certified to ISO 9001 or similar standards. In these situations, the business casefor a QMS is straight forward. Rather than lose the business of a valuable customer, the better choice often isto determine how the standard applies to overall business operations and implement it.

Benefits go beyond retaining existing customers or qualifying for new contracts.Implementing a quality management system that is ISO 9001 compliant also provides discipline, improvesprocesses and increases the productivity and effectiveness of a company’s operations. Consistent, reliable,well-documented management systems result in reduced scrap and waste, less human errors, and as a result,increased profitability and customer satisfaction.

One way to determine the value of a quality management system is to learn from those thathave successfully implemented and certified their own systems. Over 20,000 companies have gone throughthe process and will openly discuss the results with suppliers and customers, as well as in user forums.Similarly, companies that are certified can answer important questions regarding measurable benefits, costs,timing, and challenges. In support of quality management systems, those that have undergone the processoften will point out the following:

• QMS certification demonstrates a commitment to customers and stakeholders by top management.

• It increases customer satisfaction through improved responsiveness and product/service reliability.

• QMS certification forms a strong, recognized foundation for meeting regulatory requirements.

• It enhances the image of an organization through proactive quality-focused leadership andinternational credentials.

• It reduces operating costs through error prevention, clear work instructions, consistent practices, andlower overall liability.



• QMS certification improves communications between employees, customers, and suppliers.

• QMS certification identifies opportunities for improvement through best practices process metrics,and customer feedback.

10.2 Effective Utilization of a QMS

How a company implements a management system should be consistent with the company’sexisting objectives, business operations, and tasks performed, which ISO 9000 refers to as ‘processes’.Companies have found that particular processes they have defined, or built the company around, are part oftheir competitive advantage, whether a manufacturing or service delivery process. ISO 9000 does notprescribe how a company operates but instead, identifies four processes (listed below) that all companiesmust perform. The standard instructs, “Document what you do, and do what you document.” Often,companies have implemented requirements but have not associated those requirements with the particularrequirements of a standard, such as ISO 9001:2008. The level of success and return for companies thatimplement and certify QMS comes from how well they do the following four clauses identified by ISO 9001.

10.3 Management Responsibility

Every business needs to know how it is performing in order to stay in business and preemptany problems with operations or customer dissatisfaction. Whether analyzing financial information, piececounts, yield data, shipment and return information, labor hours, machine hours, prompt payment, repeatedservice request, warranty claims, customer interviews, surveys, or other forms of customer feedback,measures will need to be set and monitored as to whether or not they are satisfactory or unsatisfactory. Themonitoring may be referred to as management review under ISO 9000. In most cases, the unsatisfactoryaspects will need to be fixed through some form of corrective action and likewise, the satisfactory aspectsimproved upon through some form of continual improvement procedure or program. Preventative action alsowill need to be taken to avoid the satisfactory from becoming unsatisfactory.

10.4 Resource Management

When managing its resources, a company must identify each of its business operations andplace it in one of the following categories:

• Key processes (a task directly related to satisfying the customer)• Support processes (necessary to operate key processes)• Management processes (used to help manage, measure, or report about the key Process).

Organizing existing information under these processes will facilitate an understanding of and ideally,the implementation of the process approach. Many companies find it extremely beneficial to form a team andhave each team member read the standard several times. This will ensure an overall understanding of theintent of the standard and the process approach.

After a company identifies its processes, it must take a general look at its business operationsby mapping the processes in the logical sequence in which they occur. Processes that rely on an input andoutput from one operation to another must be connected in sequence, relating the processes to key supportand management processes previously identified. It also is important to show how each of your existing



records, procedures, work instructions and documents relate to one another. This will help to ensure each ofthe processes is followed and the company is meeting the requirements of the chosen standard.

Once operations have been mapped, the system must be tested by completing audits in theprocess approach. Interview those implementing the requirements and observe each process andrequirement. Revisit, revise, improve or supplement those processes that do not meet the standard and thosethat are not flexible, fluent, feasible or efficient, given the nature of the particular business.

10.5 Product Realization

A major part of implementing and maintaining a successful quality management system isproduct realization, or the process by which products are developed, designed, produced, marketed, anddisposed. This will require a close look at the customer’s needs as they relate to the strategies and productsof the certifying company.

Prior to accepting an order from a customer, a review of what the customer has ordered willneed to be performed, deciding such factors as whether or not the product can be manufactured or theservice provided as expected, what the terms of the offer will be, and what are the associated costs. This is atypical customer-related process per ISO 9001:2008.

In conjunction with this customer-related process, a company also will select a supplier ofmaterial or other commodity, train employees, and discover the best methods to administer and implementthe process in order to obtain the desired results. Along this path, companies maintain records of customerorders, invoices, purchases, and schedules.

These activities may meet ISO 9001:2008 requirements, when formalized, for competence,awareness and training, control of records, and purchasing information. Following receipt of a customerorder, the realization of the product must be planned. In other words, plan the design of the product, thepurchasing of materials or other commodities, and verify that the item meets what has been ordered. Otherpoints to consider include the manufacture of material, component, or part to specific criteria andrequirements that will provide a product acceptable to the customer, including identifying, tracking,preserving, packaging, measuring, testing, delivering and orrecting any work in progress.

10.6 Measurement, Analysis, and Improvement

What is the Return on Investment (ROI)? This is a question that should always be asked bySenior Management, where resources, cost and/or capital are involved. The first and most obviousmeasurement of ROI is the retention and hit rate with customers who have required or inquired about acompany’s ISO 9001 or ISO/TS 16949 certified or compliant quality management system.

Objectives and targets should be set for other ROI measures, such as levels of scrap, rework, andcustomer rejects (spills in automotive). The objectives and targets should be reviewed periodically foradequacy, suitability, and effectiveness. Adjustments, redefinition and changes should be made where thetargets or overall objectives are not consistent with the business environment. Likewise, corrective andpreventive actions should be taken where expectations are not met or do not progress at a pace that meetsthe schedule for achievement.

Once targets are met and progress is satisfactory, continual improvement of the process shouldbegin. The objectives and targets may need to be redefined or moved and additional objectives and targets



identified. In the overall picture, a company’s ROI should be consistent and correlate with the effect of qualitymanagement on its financial performance, and internal and external customer satisfaction levels.

Success is a matter of discovering where a company’s policies, requirements, and processesbest fit the clauses of the standard. Defining, monitoring, measuring, redefining, adjusting and changing theprocesses will lead to achievement of the financial goals of the business.

11.0 Frequently Asked Questions (FAQ's)



This list of Frequently Asked Questions (FAQs) has been prepared by ISO/TC 176/SC 2 to supportthe publication of ISO 9001:2008 and of ISO 9004:2009. Input has been obtained from expertsand users of the ISO 9000 standards, expressed during seminars and presentations around theworld.

The list will be reviewed and updated on a regular basis to maintain its accuracy, and to includenew questions where appropriate. It is intended that this list will also provide a good source ofinformation for new users of the standards.

The FAQs given below have been categorized as follows:

1. ISO2. ISO 9000 Family of standards3. ISO 90014. ISO 9004

11.1 ISO

What is ISO?

The International Organization for Standardization (ISO) was established in 1947 and is(currently) an association of approximately 160 National Standards Bodies, which eachrepresent their own country. ISO employs a system of Technical Committees, Sub-committeesand Working Groups to develop International Standards. Besides the National Standards Bodies,ISO permits other international organizations that develop standards to participate in its work,by accepting them as Liaison members. ISO works in accordance with an agreed set of rules ofprocedure, the ISO/IEC Directives, which also include requirements on the presentation ofstandards.

Who are the National Standards Bodies, and who represents my country atISO?

Please use the link on ISO's web site that gives details, including contact information, of theNational Standards Bodies:

www.iso.org/iso/about/iso_members.htm

Is there any way I can participate in the development of standards?

Yes. If you are interested you should contact your National Standards Body for further details.

11.2 ISO 9000 Family of standards

What are the ISO 9000 standards ?

The ISO 9000 standards are a collection of formal International Standards, TechnicalSpecifications, Technical Reports, Handbooks and web based documents on QualityManagement. There are approximately 25 documents in the collection altogether, with new or



revised documents being developed on an ongoing basis.

(It should be noted that many of the International Standards in the ISO 9000 family arenumbered in the ISO 10000 range.)

Who is responsible for developing the ISO 9000 standards?

ISO Technical Committee (TC) number 176 (ISO/TC 176), and its Sub-committees, areresponsible for the development of the standards. The work is conducted on the basis of"consensus" among quality and industry experts nominated by the National Standards Bodies,representing a wide range of interested parties.

Where can copies of the standards be obtained?

Copies of the standards may be purchased from your National Standards Body, or from ISOitself. Many National Standards Bodies have them available in local-language versions.

Where can copies of the supporting ISO 9000 guidance notes or otherdocuments be found ?

Copies of the ISO 9000 Introduction and Support Package modules:

- Guidance on ISO 9001:2008 Sub-clause 1.2 'Application'- Guidance on the Documentation requirements of ISO 9001:2008- Guidance on the Terminology used in ISO 9001 and ISO 9004- Guidance on the Concept and Use of the Process Approach for management systems- Guidance on 'Outsourced Processes'

Where can information be obtained on the ISO 9000 standards?

There are a number of sources of information on the ISO 9000 quality management systemstandards, including ISO's web site (www.iso.org), which carry information on the standards.Your National Standards Body should be able to provide copies of the standards, andregistrars/certification bodies will be able to provide guidance on registration arrangements.

Why are standards revised?

ISO’s formal review process:

Requires continual review to keep standards up to date. Must be initiated within 3 years ofpublication of a standard.

User inputs from:

o Global user questionnaires/surveyso Market Justification Studieso Suggestions arising from the interpretation processo Opportunities for increased compatibility with ISO 14001



o The need for greater clarity, ease of use, and improved translation

Current trends:o Keeping up with recent developments in management system practices.

Who is responsible for revising ISO 9001 and ISO 9004?

The revision process is the responsibility of ISO Technical Committee no.176, Sub-committeeno.2 (ISO/TC 176/SC 2) and is conducted on the basis of consensus among quality and industryexperts nominated by ISO Member bodies, and representing all interested parties.

Where can I obtain information on the standards?

ISO maintains a web site at http://www.iso.org/ that carries general information on thestandards. Your National Standards Body can give you additional information about nationalversions.

Are the standards available in my national language?

The active participation of experts from around the world in the preparation of the newstandards facilitates their translation into many different languages.

ISO itself publishes standards in English and French.

You should contact your National Standards Body to see if they have your national languagetranslations of the standards.

Where can my organization go if it needs additional clarification orinterpretation of the standards?

The starting point for any individual request for an interpretation should be with the enquirer'sNational Standards Body. ISO Central Secretariat and ISO/TC 176/SC 2 cannot accept directrequests from individuals for interpretations of the ISO 9000 standards. ISO/TC 176 has aWorking Group that only accepts formal requests for interpretations from the NationalStandards Bodies.

Do the standards address financial issues?

Financial issues are not addressed in ISO 9001:2008, which is a requirements standard.

The ISO 10014:2006 and ISO 9004:2009 guidance standards emphasize the financial resourcesneeded for the implementation and improvement of a quality management system.

What are the benefits of ISO 9001:2008 and ISO 9004:2009?For ISO 9001:2008 the major benefits are:

- Simple to use



- Clear in language- Readily translatable and easily understandable- Compatibility with other management systems such as ISO 14001.

For ISO 9004:- Facilitates improvement in users’ quality management systems.- Provides guidance to an organization for the creation of a quality management system

that:o creates value for its customers, via the products it provideso creates value for all other interested partieso balances all interested-party viewpoints.

- Provides guidance for managers on leading their organization towards sustained success.- Forward compatibility to allow organizations to build on existing quality management

systems.

What are the main benefits to be derived from implementing an ISO 9000quality management system?

The ISO 9000 standards give organizations an opportunity to increase value to their activitiesand to improve their performance continually, by focusing on their major processes. Thestandards place great emphasis on making quality management systems closer to the processesof organizations and on continual improvement. As a result, they direct users to theachievement of business results, including the satisfaction of customers and other interestedparties.

The management of an organization should be able to view the adoption of the qualitymanagement system standards as a profitable business investment, not just as a requiredcertification issue.

Among the perceived benefits of using the standards are:- The connection of quality management systems to organizational processes- The encouragement of a natural progression towards improved organizationalperformance, via:

o the use of the Quality Management Principleso the adoption of a "process approach"o emphasis of the role of top managemento requirements for the establishment of measurable objectives at relevant functions

and levelso being orientated toward "continual improvement" and "customer satisfaction",

including the monitoring of information on "customer satisfaction" as a measure ofsystem performance.

o measurement of the quality management system, processes, and producto consideration of statutory and regulatory requirements.o attention to resource availability

Are the standards compatible with national quality award criteria?

The standards are based on 8 Quality Management Principles, which are aligned with the



philosophy and objectives of most quality award programs.

These principles are

- Customer focus,- Leadership,- Involvement of people,- Process approach,- System approach to management,- Continual improvement,- Factual approach to decision making, and- Mutually beneficial supplier relationships.

ISO 9004 recommends that organizations perform self-assessments as part of theirmanagement of systems and processes, and includes an annex giving guidance on thisapproach. This is similar to many quality awards programmes.

Why is the monitoring of "customer satisfaction" included in the standards?

"Customer satisfaction" is recognized as one of the driving criteria for any organization. In orderto evaluate if a product meets customer needs and expectations, it is necessary to monitor theextent of customer satisfaction. Improvements can be made by taking action to address anyidentified issues and concerns.

Can the standards improve "customer satisfaction"?

The quality management system details that are described in the standards are based onQuality Management Principles that include the "process approach" and "customer focus". Theadoption of these principles should provide customers with a higher level of confidence thatproducts will meet their needs and increase their satisfaction.

What is meant by "continual improvement"?

Continual improvement is the process focused on continually increasing the effectivenessand/or efficiency of the organization to fulfil its policies and objectives. Continual improvement(where "continual" highlights that an improvement process requires progressive consolidationsteps) responds to the growing needs and expectations of the customers and ensures adynamic evolution of the quality management system.

What is a process?

Any activity or operation, which receives inputs and converts them to outputs, can beconsidered as a process. Almost all activities and operations involved in generating a product orproviding a service are processes.

For organizations to function, they have to define and manage numerous inter-linkedprocesses. Often the output from one process will directly form the input into the next process.The systematic identification and management of the various processes employed within anorganization, and particularly the interactions between such processes, may be referred to as



the ‘process approach’ to management.

What is the "process approach"?

The "process approach" is a way of obtaining a desired result, by managing activities andrelated resources as a process. The "process approach" is a key element of the ISO 9000standards. For further guidance, please refer to the ISO 9000 Introduction and Support Packagemodule: Guidance on the Concept and Use of the Process Approach for management systems.

Can the "process approach" be applied to other management systems?

Yes. The "process approach" is a generic management principle, which can enhance anorganization’s effectiveness and efficiency in achieving defined objectives.

How can the PDCA cycle be used in the "process approach"?

The PDCA cycle is an established, logical, method that can be used to improve a process.

This requires:- (P) planning (what to do and how to do it),- (D) executing the plan (do what was planned),- (C) checking the results (did things happened according to plan) and- (A) act to improve the process (how to improve next time).

The PDCA cycle can be applied within an individual process, or across a group of processes.

Can any organization apply the "process approach"?

Yes. Many organizations already apply a "process approach" without recognizing it. They couldachieve additional benefits by understanding and controlling it.

Why should an organization apply the "process approach"?

By applying the "process approach" an organization should be able to obtain the following typesof benefits:

The integration and alignment of its processes to enable the achievement of its plannedresults.

An ability to focus effort on process effectiveness and efficiency. An increase in the confidence of customers and other interested parties as to the

consistent performance of the organization. Transparency of operations within the organization. Lower costs and shorter cycle times through effective and efficient use of resources. Improved, consistent and predictable results. The identification of opportunities for focused and prioritized improvement initiatives. The encouragement and involvement of people, and the clarification of their

responsibilities. The elimination of barriers between different functional units and the unification of their

focus to the objectives of the organization.



Improved management of process interfaces.

What is meant by the “sequence” of processes and their "interactions"?

The "sequence" of processes shows how the processes follow, or link, to each other to result ina final output.

For example, the output from one process may become the input of the next process orprocesses.

The "interactions" show how each process affects or influences one or more of the otherprocesses. For example, the monitoring or controlling of a process may be established in aseparate process.

How can the processes in an organization be determined?

Identify the organization's intended outputs, and the processes needed for achieving them.These will need to include processes for Management, Resources, Realization andMeasurement and Improvement.

- Identify all process inputs and outputs, along with the suppliers and customers, who maybe internal or external.

- Identify the sequence and interactions of the processes.

Should an organization define and document all its processes?

The main purpose of documentation is to enable the consistent and stable operation of anorganization's processes.

Although statutory, standards' or customer requirements may require certain documentation,there is no defined “catalogue”, or list of processes that has to be documented in ISO 9001,apart from the 6 indicated ones.

The organization should determine which processes are to be documented on the basis of:

- The size of the organization and type of its activities,

- The complexity of its processes and their interactions,

- The criticality of the processes and

- Availability of competent personnel.

A number of different methods can be used to document processes, such as graphicalrepresentations, written instructions, checklists, flow charts, visual media, or electronicmethods.

How much detail is required in process documentation?



The extent of detail is likely to depend upon factors such as:

- the size of an organisation and its types of activities,- the complexity of its processes and their interactions, and- the competence (level of education, training, skills and experience) of its personnel.

Is there a standard way of describing a process?

No, there is no standard way to describe a process. It depends on the culture, managementstyle, staff literacy, personal attributes and their interactions.

A process may be described using a flow chart, block diagram, responsibility matrix, writtenprocedures or pictures.

Process flowcharts or block diagrams can show how policies, objectives, influential factors, jobfunctions, activities, material, equipment, resources, information, people and decision makinginteract and/or interrelate in a logical order.

What should an organization do to adopt the "process approach"?

To adopt the "process approach" an organization should apply the following steps:

- Identify the processes of the organization,- Plan the processes,- Implement and measure the processes,- Analyse the processes,- Improve the processes.

What is a "process owner"?

A person who is given the responsibility and authority for managing a particular process issometimes referred to as the "process owner".

It may be useful for an organization's Management to appoint individual "process owners" andto define their roles and responsibilities; these should include the responsibility for ensuring theimplementation, maintenance and improvement of their specific process and its interactions.

It should be noted, however, that ISO 9001:2008 does not specifically require the appointmentof "process owners".

How can a process be measured?

There are various methods of measuring process controls and process performance, rangingfrom simple monitoring systems up to sophisticated statistically based systems (e.g. statisticalprocess control, or SPC, systems). The selection and use of any particular method will bedependent on the nature and complexity of an organization's processes and products. Theeffectiveness of an individual process may be measured by the conformity of its output or



product to customer requirements. Its efficiency may be measured from its use of resources. Inall cases the measurement of the process determines if its (measurable) objectives have beenachieved. Sometimes it only requires monitoring to confirm process operations.

Typical factors that are useful to consider when identifying measures of process control andprocess performance include:

- Conformity with requirements,

- Customer satisfaction,

- Supplier performance,

- On time delivery,

- Lead times,

- Failure rates,

- Waste,

- Process costs.

- Incident frequency

What is the difference between a "process" and a "procedure"?

A "process" may be explained as a set of interacting or interrelated activities, which areemployed to add value. A "procedure" is a method of describing the way or How in which all orpart of that process activities shall/should be performed.

ISO 9000:2005 defines a procedure as a "specified way to carry out an activity or a process",which does not necessarily have to be documented.

An organization has a well-established set of procedures. Can theseprocedures be used to help describe its processes?

Yes, if the procedures describe inputs and outputs, appropriate responsibilities, controls andresources needed to satisfy customer requirements.

Which standard are organizations registered/certified to?

Organizations have their quality management system registered/certified to ISO 9001:2008. Thescope of registration/ certification will need to reflect precisely and clearly the activitiescovered by the organization's quality management system; any exclusion to non-applicablerequirements of the standard (permitted through ISO 9001 clause 1.2 "Application") will needto be documented and justified in the quality manual (see also the ISO/TC 176/SC2 ISO 9000Introduction and Support Package module Guidance on ISO 9001:2008 clause 1.2 'Application').

Can an organization be certified/registered to ISO 9004?

ISO 9004 is a guidance standard, which is not intended to be used for third partyregistration/certification purposes. A key element of ISO 9004 is the ability to perform self-assessments. Third party quality management system certifications/ registrations are



performed to ISO 9001:2008.

What is happening to the other standards and documents in the ISO 9000family?

The four primary standards of the current ISO 9000 family are ISO 9000:2005, ISO 9001:2008,ISO 9004:2009 and ISO 19011:2002.

ISO 19011:2002 is currently being revised, with a new version expected in 2011.The other standards and documents are being reviewed and updated as necessary

What has happened to the ISO handbook “ISO 9001 for Small Businesses”?

A new edition was published in June 2010, to reflect the changes in ISO 9001:2008.

How are the standards applicable to organizations that provide services. ?

The standards are applicable to all types of organizations, operating in all types of sectors,including service providers.

(Note: the definition of the term 'product' in ISO 9000:2005 also includes 'services'. ISO9001:2008 and ISO 9004:2009 have been written to reflect this definition.)

What do quality management practitioners (consultant, auditor, or trainer)need to know about the standards?

As a minimum, quality management practitioners should familiarize themselves with therequirements of ISO 9001:2008, and also with the content and philosophies of ISO 9000:2005,ISO 9004 and the Quality Management Principles.

Practitioners whoa are already familiar with ISO 9001:2000 should become aware of theclarifications introduced in ISO 9001:2008, and their implications, prior to conducting audits tothat standard, or giving training and consultancy.

They should understand their client’s activities and processes, before providing appropriateinterpretations of the requirements of the standards, to add value to the client's operations.

ISO/TC 176 has developed the standard ISO 10019 Guidelines for the selection of qualitymanagement system consultants and use of their services, which may be useful to refer to forfurther guidance.

How should regulatory bodies use the standards?

Regulatory bodies should review their regulations currently in effect (or under development)and identify points where reference to the quality management system standards would beappropriate, before making recommendations to the legislative body.

What do auditors need to know about the standards?



Auditors, whether external or internal, should be able to demonstrate their competence on thestructure, content and terminology of the standards, and also on the underlying QualityManagement Principles.

The standards require that auditors are able to understand the organization's activities andprocesses and appropriately audit against the requirements of the ISO 9001 in relation to theorganization's objectives. According to joint advice from the International Accreditation Forum(IAF), ISO's Policy Committee for Conformity Assessment (ISO-CASCO) and ISO TC 176, auditorsshould be able to demonstrate competency in:

- The requirements of the ISO 9001:2008.

- The concepts and terminology of the ISO 9000:2005.

- The eight Quality Management Principles

- A general understanding of ISO 9004

- Familiarity with the auditing guidance standard ISO 19011.

11.3 ISO 9001:2008

How much is the implementation of ISO 9001:2008 going to cost?

It is not possible to give a definitive cost for implementing a QMS that meets the requirementsof ISO 9001.

The implementation costs, and associated certification costs, will be dependent on factors suchas:

the size of the organization (a few employees versus many) its organizational structure (a single division versus multiple ones) its geographical locations (a single site, versus multiple ones in many countries) the maturity of its existing QMS (is there an existing functional QMS in the organization

that just needs amending to meet the standard, or does the organization have to start onefrom scratch)

the complexity of its products (simple manufacturing or service delivery processes versuscomplex ones requiring statistical process controls)

One of the goals of ISO/TC 176/SC 2 is to produce standards that will minimize anypotential costs during a smooth implementation. Any additional costs may be considered as avalue-adding investment. A key factor in the development of ISO 9001:2008 was to limit theimpact of changes on users.

What are the main changes in ISO 9001:2008 as compared to ISO 9001:2000?



ISO 9001:2008 has been developed in order to introduce clarifications to the existingrequirements of ISO 9001:2000 and changes that are intended to improve compatibility withISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it changethe intent of the ISO 9001:2000 standard.

Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO9001:2000 should be afforded the same status as those who have already received a newcertificate to ISO 9001:2008. However, all organizations are expected to have made themigration to using ISO 9001:2008 by November 2010.

All changes between ISO 9001:2000 and ISO 9001:2008 are detailed in Annex B to ISO9001:2008.

How will the implementation of ISO 9001:2008 help my organization toimprove its efficiency?

ISO 9001:2008 aims at guaranteeing the effectiveness (but not necessarily the efficiency) of theorganization. For improved organizational efficiency, however, the best results can be obtainedby using ISO 9004:2009 in addition to ISO 9001:2008. The guiding quality managementprinciples are intended to assist an organization in continual improvement, which should leadto efficiencies throughout the organization.

Is an organization's ISO 9001 certificate applicable to all of its products ?

When an organization seeks to have its quality management system registered/certified to ISO9001:2008, it is required to agree a "scope of certification" with its registrar/certification body.This will define the products to which the organization's quality management system isapplicable, and against which it will be assessed. An organization is not obliged to include withinits "scope of certification" all the products that it provides (note that the ISO 9000:2005definition of "Product" includes "services"), but may be selective about those that are included.All applicable requirements of ISO 9001:2008 will need to be addressed by the organization'squality management system that covers those products that are included in the "scope ofcertification".

Customers should ensure that a potential supplier's "scope of certification" covers the productsthat they wish to order. Caveat Emptor!

What can an organization do if it is not able to comply with all of therequirements of ISO 9001?

ISO 9001 allows for the exclusion of some of its requirements (via clause 1.2 “Application”), butonly if it can be shown that these requirements are not applicable to the organization.

Exclusions are limited to the requirements given in Section 7 ("Product Realization"), whereindividual requirements may only be excluded if it can be shown that they do not affect theorganization's ability to provide product that meets customer and applicable statutory orregulatory requirements. Justification for such exclusions is also required to be detailed withinthe organization's quality manual.



For example, if design activities are not required by an organization to demonstrate itscapability to meet customer and applicable statutory /regulatory requirements, or if its productis provided on the basis of established design, then it may be able to exclude some of the"design" requirements but still be able to be registered/certified to ISO 9001:2008.

For further guidance, see the ISO 9000 Introduction and Support Package module: Guidance onISO 9001:2008 clause 1.2 'Application'.

How will a small organization be able to adapt the requirements of ISO 9001?What flexibility will be allowed?

The requirements of the amended ISO 9001:2008 remain applicable to small, medium, andlarge organizations alike, and such organizations should acquaint themselves with theclarifications in ISO 9001:2008. ISO/TC 176 has published a handbook “ISO 9001 for SmallBusinesses – What to do ?” giving specific advice to small businesses.

The requirements of ISO 9001 are applicable to small, medium, and large organizations alike.ISO 9001:2008 provides some flexibility, through clause 1.2 “Application”, on the exclusion ofcertain requirements for specific processes that may not be performed by the organization.

If, for example, the nature of your products does not require you to perform design activities, orif your product is provided on the basis of established design, you could discuss and justify theexclusion of these requirements with your certification/registration body (see also the ISO 9000Introduction and Support Package module Guidance on ISO 9001:2008 clause 1.2 'Application').However, individual organizations will still need to be able demonstrate their capability to meetcustomer and applicable statutory or regulatory requirements for their products, and will needto consider this when determining the complexity of their quality management systems.

Further guidance for small businesses may be found in the ISO handbook: ISO 9001 for SmallBusinesses – What to do, Advice from ISO/TC 176

What’s the relationship between the revised ISO 9001 and ISO 14001?

Compatibility with ISO 14001:2004 has been maintained and enhanced. “Compatibility” meansthat common elements of the standards can be implemented by organizations in a sharedmanner, in whole or in part, without unnecessary duplication or the imposition of conflictingrequirements.

Are there any guidelines covering joint implementation of ISO 9001 and ISO14001?

The two standards are compatible. It is not expected that an ISO guideline will be prepared onthis subject at the present time. If the need for such a document arises, ISO will consider therequest as a new project. However, both ISO 9001 and ISO 14001 include an annex to show thecorrespondence between the two standards.

Is there a common guideline standard for auditing QMS and EMS according toISO 9001 and 14001?



Yes, ISO 19011:2002 provides guidelines for quality and/or environmental managementsystems auditing. Note that a project to revise ISO 19011 was started in 2008, to make itapplicable to all of ISO’s management system standards, and is expected to be completed in2011.

My organization provides services. Is ISO 9001:2008 applicable to us?

ISO 9001 is equally appropriate to all sectors, including service providers. The standard isapplicable to all types of organizations.

How does ISO 9001:2008 relate to the needs of specific business sectors?

ISO 9001:2008 is compatible with the existing management systems standards for specificbusiness sectors such as ISO/TS 16949, AS 9000/EN 9100 and TL 9000.

Users of a specific sector scheme are recommended to refer to the organization that isresponsible for that sector scheme, e.g. for:

- ISO/TS 16 949 refer to the IATF,- TL 9000 refer to the QuEST Forum- For AS 9000/EN 9100 refer to the IAQG

What documentation is required by ISO 9001?

ISO 9001:2008 refers specifically to only 6 documented procedures; however, otherdocumentation (including more documented procedures not specifically mentioned in ISO9001:2008) may be required by an organization, in order to manage the processes that arenecessary for the effective operation of the quality management system. This will varydepending on the size of the organization, the kind of activities in which it is involved and theircomplexity. For further guidance, please also refer to the ISO 9000 Introduction and SupportPackage module "Guidance on the Documentation Requirements of ISO 9001:2008"

What does an organization need to do to comply with ISO 9001?

When initially starting to use ISO 9001, an organization should familiarize its personnel with theQuality Management Principles, analyze the standards (especially ISO 9000 and ISO 9004), andconsider how their guidance and requirements may affect your activities and related processes.If it then wishes to proceed to registration/certification, it should perform a gap analysis againstthe requirements of ISO 9001 to determine where its current quality management system doesnot address the applicable ISO 9001:2008 requirements, before developing and implementingadditional processes to ensure that compliance will be achieved.

ISO 9004

What benefits are there to an organization implementing ISO 9004 ?

If a quality management system is appropriately implemented, utilizing the eight Quality



Management Principles, and in accordance with ISO 9004, all of an organization's interestedparties should benefit. For example:

Customers and users will benefit by receiving the products (see ISO 9000:2005) that are:- Conforming to the requirements- Dependable and reliable- Available when needed- Maintainable

People in the organization will benefit by:- Better working conditions- Increased job satisfaction- Improved health and safety- Improved morale- Improved stability of employment

Owners and investors will benefit by:- Increased return on investment- Improved operational results- Increased market share- Increased profits

Suppliers and partners will benefit by:- Stability- Growth- Partnership and mutual understanding

Society will benefit by:- Fulfilment of legal and regulatory requirements- Improved health and safety- Reduced environmental impact- Increased security

What was the need to update ISO 9004:2000?

The standards have to be kept up to date and they are regularly reviewed (at least every fiveyears under ISO’s rules) and revised as necessary. Also the feedback from users showed thatsome changes and improvements were needed.

If a product is not meeting its requirements or the expectations of its users, then it should bewithdrawn, changed or improved. ISO/TC 176/SC2 received information which indicated thatISO 9004:2000 was not meeting expectations, so decided to take action to change and improvethe product.

How was ISO 9004:2009 specified and developed?

In 2004 ISO/TC 176/SC2 conducted a formal review of ISO 9004:2000, in parallel with one forISO 9001:2000; this review led to a decision to revise the standard (and to amend ISO 9001).Next followed the development and approval of a “Design Specification” in 2005, followed by



the start of the drafting process. The drafting of an ISO standard involves the achievement ofseveral different successive levels of drafts; at all but the last stage, verification processes wereemployed to check the drafts against the Design Specification, and during the last but onestage, a validation process involving external reviews by potential users was employed. Most ofthe drafts were circulated for ballot amongst ISO’s member national standards bodies, leadingto their approval, and ultimately to publication of the revised standard.

What are the most important changes in ISO 9004:2009?

a) It has a new direction, giving advice on how to manage an organization for “sustainedsuccess”. It includes guidance on the development and deployment of an organization’sstrategy, as well as emphasizing innovation and learning.

b) It introduces two new, user-friendly, self-assessment tools; these describe possible situationsin the organization and give comparisons against each element of the standard, before ratingthese by 5 different levels of maturity.

What are the differences between ISO 9004:2000 and this new version?

ISO 9004:2000 was based closely on ISO 9001:2000. The new 2009 edition of ISO 9004 has aseparate focus on the sustained success of an organization over the long term.

There is much greater emphasis on: balancing the needs of all relevant interested parties; long-term planning; strategic issues; resources; risks; innovation; learning; and the use of self-assessment tools.

“Sustained success” – what does it mean?

The sustained success of an organization refers to its ability to consistently meet the needs andexpectations of its customers and other interested parties (e.g. shareholders, regulators,employees or society), in a balanced way, in order to remain a viable entity over the long term.

What are the main “features” of ISO 9004:2009?

Guidance to managers on processes for an organization to create and follow its own pathtowards sustained success, including two powerful self-assessment tools (one on strategicissues and the other on operational issues).

What are the main benefits to users of ISO 9004:2009?

It will help them to ensure the success of their organization over the long term, by achievinghigher levels of effectiveness and efficiency in their organization’s processes, in turn resulting inhigher satisfaction levels for all of its relevant interested parties.

Is ISO 9004:2009 useful for Small and Medium Enterprises (SMEs) or only forlarge organizations?

ISO 9004:2009 is applicable to any organization, regardless of its size, type and activity. ISO



9004:2009 is particularly suitable for SMEs, because of the strategy related aspects covered init.

We have a QMS based on ISO 9001. Why should we apply ISO 9004:2009?

ISO 9004 will help you to take your organization forward to its next stage of quality maturity, byenhancing its effectiveness and efficiency, and by re-orienting the organization to focus on allits relevant interested parties, with the aim of achieving high levels of satisfaction of their needsand expectations.

What organizations can use ISO 9004:2009?

All organizations can use ISO 9004, regardless of their size, products, activities, or type (profit,not-for-profit, governmental body etc.).

When should ISO 9004:2009 be applied?

In all situations where improvement is needed, or when important changes occur, such as:

To improve customer satisfaction; To reduce costs or to increase profits; In case of an acquisition or a merger; In case of changes in the management of an organization; To improve relations with suppliers; To increase the speed of processes.

Could we get our quality management system certified against ISO9004:2009?

This new standard is a guideline standard, not a requirement standard; it is not suitable, orintended, for certification purposes.

Why has the title of ISO 9004 changed?

ISO 9004:2009 now gives guidance on how to remain successful in the future, so the title had tobe changed to reflect this new direction. In turbulent and constantly changing situations,organizations can no longer just rely on better performance against their current businessmodels to survive and be successful; instead they have to anticipate, be proactive and monitor,predict, and react to the ever changing needs and expectations of their interested parties, inorder to remain successful in the future.

What is the scope of ISO 9004:2009?

This standard provides guidance to organizations to support the achievement of sustainedsuccess by a quality management approach. It is applicable to any organization, regardless of itssize, type, products or activity.



What is the purpose of ISO 9004:2009?

ISO 9004 now gives guidance to the management of an organization on how to achievesustained success by use of a quality management approach. It helps an organization to moveits management system beyond the basic requirements of ISO 9001, to meet the needs andexpectations of its all relevant interested parties, and guides management in assessing theirorganization’s strengths and weaknesses.

What are the changes in the structure of ISO 9004:2009?

ISO 9004 no longer has the same clause by clause structure as ISO 9001 (which was the case forISO 9004:2000). Instead the standard now starts with a clause on managing an organizationtowards sustained success, followed by clauses on:

strategy, resources, processes, monitoring, measurement, analysis and review; and closing with, improvement, innovation and learning.

Why has the structure been changed?

The new structure is related to the question: How do you manage an organization for success inthe long term? The previous edition was more related to the question: How do you extend thequality management system to incorporate all interested parties and support the achievementof higher performance?

In ISO 9004:2009 the term “partner” is used. How do “partners” differ from“suppliers”?

“Partners” can be either “suppliers”, or other types of bodies. “Partners” can be selectedsuppliers that an organization chooses to have a strategic relationship with, or which arestrategically important, for its future success. “Partners” can also be other types of bodies otherthan suppliers, e.g. some of its customers, universities/academic institutions or researchorganizations, or even in some cases competitors (e.g. when there is a need to agree tostandardize products or technologies).

What are the differences between the “process approach” model used in ISO9001 and the one used in ISO 9004?

ISO 9004 contains a more extensive process model than the one given in ISO 9001. While itcovers all of the elements of the ISO 9001 model, it also addresses some of the additional issuesfrom ISO 9004 itself, such as the needs of interested parties, strategy and policy, resourcemanagement (extended), process management, innovation and learning.

What is the meaning of “innovation” in ISO 9004, and what should be“innovated”?



Innovation refers to the development of new products, processes, organizational structures,interfaces and strategy, in contrast to the improvement of the existing ones.

What is the meaning of “learning” in ISO 9004, and what should be covered bylearning?

Learning refers to an organization implementing processes to capture the results of experiencesand lessons learned by people, both individually and collectively, and to then apply thatknowledge to new situations, to achieve beneficial results. The learning processes should coverelements such as: products, processes and their interfaces, organizational structures,management systems, human aspects and culture, infrastructure, work environment,technology, and relationships with relevant interested parties.

What should be the main steps to take when implementing ISO 9004:2009?

These will depend on the organization’s current situation, its ambitions, its present level ofmaturity, and its “organization’s environment” (i.e. its “business” environment, but relating to“not-for-profit” type businesses, governmental bodies etc.). In general, the mains steps shouldbe:

a review of the organization’s strategy, conducting a self-assessment at a strategic (key elements) level, refinement of its strategy (as a result of the self-assessment), conducting a self-assessment at an operational (detailed) level, to identify improvement

opportunities developing a management agenda and action plans for the medium term horizon (e.g. for

the next 2 to 3 years) deployment and translation of the action plans into requirements for the organization’s

processes, interfaces and resources (especially human resources), execution of any improvements or change programmes, evaluating and reviewing what has been achieved, going back to the first step (above) to adapt and improve the whole approach (i.e. closing

one cycle of a P-D-C-A loop and starting the next one).

What should be the first steps to take when implementing ISO 9004:2009?

If the organization has a clear strategy in place, the first step should be a strategic (key element)level self-assessment, to enable the organization to develop a management agenda and actionplans for the medium term horizon (e.g. for the next 2 - 3 years). If the strategy is not availableor is not up-to-date, the first step should be a review of the organization’s strategy, policies andassociated objectives, and to use these as an input to self-assessments that should beconducted at both a strategic (key elements) and operational (detailed) levels.

What should be the role of top management during the implementation ofISO 9004:2009?

The top management of an organization should take the role of the most important supporterand sponsor of such an implementation program. Implementing ISO 9004 will change the wayan organization thinks and behaves, and how it communicates both internally and externally.



What should be the path towards ”sustained success”, when starting with anISO 9001 based QMS?

Such a path will develop in two main directions:

a) extending the coverage of the processes in the organization towards all aspects of itsactivities and towards all relevant interested parties, and

b) improving each individual process with respect to its effectiveness and its efficiency, forlasting improvement in its performance.

The rate at which an organization should extend its process coverage, and the rate at which itshould improve its processes, will be dependent on its own ambitions and its competitiveposition.

What could be the costs of an improvement project or programme?

It is impossible to give an indication of the exact costs, as these will be specific to anorganization and its current situation; however, a well known “rule of the thumb” is that thecosts of waste reduction are often between 10% and 20% of the value of that waste. Anotherwell known figure is that waste in industrial organizations is on average between 7% and 15% ofturnover, and in service industries is between 15% and 30%.

What should be done differently when applying ISO 9004 in a “not-for-profit”organization?

About the only difference for a “not-for-profit” organization when compared to a “for-profit”organization is the terminology that is sometimes used for management issues, while the issuesremain the same for both. However, it is recognized that “not-for-profit” organizations oftenhave more complex patterns of dealing with, and influencing, their interested parties, than theusual contractual approach of “for-profit” organizations.

What are the most critical risks for failure when applying ISO 9004 :2009?

The most critical risk is people aspects. This includes the behaviour of top management as a keycomponent.

What is the relationship between ISO 9004:2009 and the ISO 26000 “Socialresponsibility” standard?

It is frequently said that the three key pillars of “sustainability” are sustainedeconomic/business (including “not-for-profit” business) success, environmental protection andsocial responsibility, and that an organization has to find the right balance between each ofthese pillars in order to survive. ISO 9004:2009 (as well as the other standards in the ISO 9000family) relates to the first of these, the ISO 14000 series of standards to the second, and ISO26000 to the third. For organizations that are familiar with the quality management standards,but not yet familiar with the issues relating to social responsibility, then implementing ISO9004:2009 could be a useful step in helping an organization towards its adaptation of ISO



26000, through its recommendations on balancing the needs and expectations of interestedparties.

What is the relationship between ISO 9004:2009 and the Excellence / Awardmodels such as EFQM and Deming Award Prize?

It is not competing with them but gives complementary guidance on the path towardsexcellence. ISO 9004:2009 is compatible with the main international and nationalExcellence/Award models.

What is the relationship between ISO 9004:2009 and the ISO 14000 series ofstandards?

ISO 9004:2009 refers to ISO 14001 under the clauses 6.5. Infrastructure, 6.8 Natural resourcesand 8.3.3 Internal audit. ISO 9004:2009 all but demands the use of the ISO 14000 series ofstandards, especially when an organization is aiming to satisfy all of its relevant interestedparties. This is particularly the case in the areas of strategy and policies, resources, processes,products (and their life-cycles), innovation and learning. Overall the relation between thesestandards is extremely important.

What is the relationship between ISO 9004:2009 and ISO 9001:2008?

ISO 9004:2009 gives guidance to an organization on the steps it should take for improving itsquality maturity beyond that achieved from the implementation of an ISO 9001 based QMS.Taken together, the standards form a “consistent pair” of standards, as both are based on the 8quality management principles and the “Process approach” model.

What is the relationship between ISO 9004:2009 and other ISO standards?

ISO 9004:2009 is compatible with many other management system standards. It makesreference to some of the ISO 14000 standards (environmental management); ISO 31000 (riskmanagement) and ISO 10000 series of standards (belonging to the ISO 9000 family ofstandards).

What is ISO 9004:2009 NOT for?

ISO 9004 is not a guideline for implementing a quality management system based on ISO 9001.

ISO 9004 is not a competitor to the business excellence awards

ISO 9004 is not for certification.



12.0 Sample Documents

12.1 Quality Manual

XYZ SOLUTIONS LTD

Quality Manual

QUALITY MANAGEMENT SYSTEM

DOC. NO: XYZ-QM-01

Issued By: MR Approved By: CEOIssue Date: 01/04/2008 Approved Date:



CHAPTER TITLE PAGE

00

TABLE OF CONTENT Total Pages -7Organization Profile (1.1) 2 of 7XYZ & its services(1.2) 2 of 7Scope of ISO 9001:2000 & Exclusion(1.3) 4 of 7Manual Distribution Control(1.4) 4 of 7Amendment Sheet(1.5) 5 of 7Organization Chart(1.6) 6 of 7Definition & Abbreviation(1.7) 7 of 7

1

QUALITY MANAGEMENT SYSTEM (4.0) Total Pages-5General requirements (4.1) 2 of 5Documentation requirements (4.2) 2 of 5General (4.2.1) 3 of 5Quality Manual (4.2.2) 3 of 5Structure of Manual(4.2.2.1) 3 of 5Method of Issue(4.2.2.2) 4 of 5Revision Updating and Amendment Procedure(4.2.2.3) 4 of 5Amendment Sheet(4.2.2.4) 5 of 5Distribution List(4.2.2.5) 5 of 5Control of Document(4.2.3) 5 of 5Control of Record(4.2.4) 5 of 5

2

MANAGEMENT RESPONSIBILITY(5.0) Total Pages-6Management Commitment(5.1) 2 of 6Customer Focus(5.2) 2 of 6Customer Relationship Development(5.2.1) 2 of 6Customer Communication Method(5.2.2) 2 of 6Customer Input(5.2.3) 3 of 6Supplier Input(5.2.4) 3 of 6Quality Policy(5.3) 3 of 6Planning(5.4) 3 of 6Quality Objective(5.4.1) 3 of 6Quality Management System Planning(5.4.2) 3 of 6Responsibility Authority & Communication(5.5) 4 of 6Responsibility & Authority(5.5.1) 4 of 6Management Representative(5.5.2) 4 of 6Internal Communication(5.5.3) 5 of 6Management Review(5.6) 5 of 6General(5.6.1) 5 of 6Review Input(5.6.2) 6 of 6Review Output(5.6.3) 6 of 6

3

RESOURCE MANAGEMENMT(6.0) Total Pages 2Provision of Resource(6.1) 2 of 2Human Resource(6.2) 2 of 2General(6.2.1) 2 of 2Competence Awareness & Training(6.2.2) 2 of 2Infrastructure(6.3) 2 of 2Work Environment(6.4) 2 of 2

4

PRODUCT REALIZATION (7.0) Total Pages 6Planning For Product Realization(7.1) 2 of 6Customer Related Process(7.2) 2 of 6Requirement related to Product(7.2.1) 2 of 6Review of requirement related to product(7.2.2) 2 of 6



Customer Communication(7.2.3) 2 of 6Design & Development(7.3) 2 of 6Design & Development planning(7.3.1) 3 of 6Design & Development Input(7.3.2) 3 of 6Design & Development Output(7.3.3) 3 of 6Design & Development Review(7.3.4) 3 of 6Design & Development Verification(7.3.5) 3 of 6Design & Development Validation(7.3.6) 3 of 6Design & Development changes(7.3.7) 4 of 6Purchasing(7.4) 4 of 6Purchasing process(7.4.1) 4 of 6Purchasing Information(7.4.2) 4 of 6Verification of purchased product(7.4.3) 4 of 6Production & Service provision(7.5) 5 of 6Control of production & Service provision(7.5.1) 5 of 6Validation of processes for production & service provision(7.5.2) 5 of 6Identification & traceability(7.5.3) 5 of 6Customer property(7.5.4) 5 of 6Preservation of product(7.5.5) 6 of 6Control of monitoring & measuring device(7.6) 6 of 6

5

MEASUREMENT ANALYSIS AND IMPROVEMENT Total Pages 5General(8.1) 2 of 5Monitoring & Measurement(8.2) 2 of 5Customer Satisfaction (8.2.1) 2 of 5Internal Audit(8.2.2) 2 of 5Monitoring & Measurement of Process(8.2.3) 3 of 5Monitoring & Measurement of Product(8.2.4) 3 of 5Control of Non -conforming product(8.3) 3 of 5Analysis of data(8.4) 3 of 5Trend Analysis of Nonconforming product(8.4.1) 4 of 5Service performance data(8.4.2) 4 of 5Improvement(8.5) 4 of 5Continual improvement(8.5.1) 4 of 5Corrective Action & Preventive Action (8.5.2& 8.5.3) 4 of 5 & 5 of 5

Annexure1 Interaction of Key Processes 2 of 2



CHAPTER ZERO

TABLE OF CONTENT



1.1 Organization profile:

XYZ is a next-generation end-to-end enabler of mobile value added services for mobile operators, mediacompanies, content providers enterprises and others.

A subsidiary of the US$ 500 million Escorts Group and a leading provider for mobile connectivity, applications,solutions, content and services.

XYZ was established in year 2000-01 and works with all major Telecom Operators and Large Enterprises likeAirtel, Idea, Reliance, American Express, LIC, UTI Bank, ICICI Bank, Citibank enabling all the players in the valuechain to deploy value added services quickly and cost effectively.

XYZ has expertise across Telecom Connectivity bearers like SMS, IVR, MMS, and GPRS and has available rangeof mobile applications, mobile services, content aggregation etc to be deployed on such bearers.

Established : Year 2000-2001

Customer Base : Enterprises & Telecom Operator

1.2 XYZ and its Service:

India based XYZ Solutions LTD. is a dynamic and forward thinking Company providing Value Added Services onthe mobility domain, focused on increasing revenues across all areas of mobile data value chain. With theproduct repertoire customized for Operators, Enterprises and Consumers, XYZ translates market needs andrequirements into innovative wireless solutions Striving towards unlocking the true potential of Mobile VAS inIndia, XYZ aims to cut across barriers to ensure development of solutions and products to cater to allsegments, greater rationality in revenue sharing between Telco’s & content developers and also develophigher quality content

Service Platform:

XYZ has a very array of technology platform and software for the mobile VAS market. The key strength of thecompany is that its own technology platform, software across the value chain from the various messagingplatform and gateway to content management and billing system to device based application.

This allows for quick deployment, integration and in this very fast moving market and ability to makeimmediate change and updates gives customers an edge on innovation. A holistic approach is taken to ensurethat all products developed and Marketed by XYZ will encompass not just current requirement but futurerequirement also dependable and lasting relationship.

Challenges are addressed through innovative software architectures, best in class software engineeringprocesses, innovative and fair business models and 24x7 customer support.

Value offerings:

1. Time to Market: The major part of the application is already developed, tested and is in operation. Theclient is only required to plug into a proven platform, saving time spent in gathering, software development,testing and deployment.

2. Low cost for the Client: The client does not have to invest in basic infrastructure like hardware andbandwidth. The client also does not have to invest in setting up an infrastructure for operational activities suchas people, data structure, power back up, security, 24x7 monitoring & support and much more.

Our Service Lines:



1. Messaging

Cellpush: It allows high volume outgoing messages.

Cellxpress short code platform: It captures incoming messages on short access numbers and mobilecontent sale. This also covers managing operator’s STK services including DP5/ DP6.

GME: It also captures incoming messages and focuses on providing low cost access numbers to theend users.

2. IVR:

IVR premium content services platform on short access numbers for mobile content sale

3. Celldial:

It enables large number of automated out dial calls for enterprises.

4. Mobile Commerce:

Mobile commerce refers to transactions using a wireless device and data connection that result in the transferof value in exchange for information, services, or goods. Mobile commerce, facilitated generally by mobilephones, includes services such as banking, payment, and ticketing.XYZ provides a set of integrated product suite for supporting companies in following categories to mobileoperators, banks and merchants. Also XYZ supports Commerce over SMS, IVR, and handset applicationconnected over GPRS or SMS.

5. Mobile Authentication:

A platform for banks and cash card operators for securely authenticating the account holder in interaction withhim over mobile.

6. Merchant M-Commerce:

Enables merchants to securely accept payment for goods and services for their customers over mobile. It alsofacilitates the merchant to showcase their merchandise (tickets, bill payments, card recharge and much more).

7. Cellworld Mobile Mall:

It allows user to access, search and discover commodities offered by merchants in a convenient and secureGUI format.

8. Multimedia over Media:

Cellpaper: Cellpaper is an MMS based platform that provides a new idea to publish rich content onmobile. The subscribers of these services receive a packaged Multimedia Message (MMS) withpresentation that includes Text, Audio, Images and Video with presentation.

Media Center: This platform delivers rich audio and video content over mobile such as full lengthsongs, music albums & videos, TV serials, news capsules and much more.

9. Enterprise Business Processes:

Celltrust, product authentication and mobile CRM platform: A new unique product authenticationservice from XYZ, targeted to consumer facing industry such as FMCG, Pharmaceuticals, automotives& spare parts, industrial commodities (bearings, welding rods, consumables etc.)



Cellmonitor: An application that allows monitoring of critical information processes using wirelessphones.

Mobile sales tracker: It supports logistics of retail distribution.

1.3 Scope of ISO 9001:2008 & Exclusion:

Scope of ISO-9001: 2008:-

The scope of ISO 9001:2008 Quality Management System is “PROVIDING MOBILE VALUE ADDEDSERVICES & MOBILE DATA SERVICES.”

Exclusions:-

There are no exclusions from the ISO 9001:2000 Quality Management System of XYZ Solutions Ltd.

1.4 Manual Distribution Control:

ISSUE NO. 01

IS THIS A CONTROLLED COPY? YES □ NO □

COPY NO. 01

Distribution list:

COPY NO. DISTRIBUTED TO01 (Master Copy) Management Representative02 Chief Executive Officer03 Employees of XYZ04 Certification Body

COPY APPROVED BY Signature Date

COPY ISSUED BY Signature Date

1.5 Amendment Sheet:

Sr.No. Section Page

No. Amendment details Rev. No. Rev. Date



1.6 Organization Chart:

1.7 Definitions and Abbreviation:

S.No Description Acronym1 International Organization for Standardization ISO2 Quality Management System QMS3 Procedure P4 Quality Objective QO5 Chief Executive Officer CEO6 Project Manager PM7 Head Sales & Marketing HEAD S&M8 Change Request Form CRF9 Purchase Order PO

10 Customer Feedback Form CFF11 Customer Support Center CSC12 Release Note RN13 Minutes Of Meeting MOM14 Audit Summary Report ASR15 Technical Change Request Form TCR16 Purchase Requisition Form PRF17 Quality Check Report QCR18 Visual Source Safe VSS19 Management Representative MR20 Management Review Meeting MRM21 Internal Quality Auditor IQA22 Human Resources HR23 Network Operation NOP24 Sales & Marketing S&M25 Data Management Group DMG26 Requirement Document RD27 Installation Document ID28 Estimation Document ED29 Test Plan TP30 Test Case TC31 Audit Report AR32 Configuration Management Policy CMP33 Roles &Responsibility R&R34 Order Processing & Billing Advice OPBA35 Business Development Executive BDE36 Program Manager PM37 Work Instruction W38 Quality Policy QP39 Testing TES40 Service Level Agreement SLA41 Operation Level Agreement OLA41 Problem Detail Form PDF



CHAPTER ONE

QUALITY MANAGEMENT SYSTEM

4 Quality Management Systems:

4.1 General Requirements:

The company has established and implemented a documented Quality System conforming to the requirementsof the International Quality System Standard ISO-9001: 2000 to ensure that all the services provided meet orexceed customer’s requirement. The Quality System show that the company operations are in accordance withthe company’s Quality Policy and organizational structure The Quality System is documented Structure, givenbelow.

Level I: Quality Manual

Level II: Procedures

Level III: W.I

Level IV: FormatsAnd Record

Level - I: Quality Manual (QM):

This Document outlines our policies regarding the requirements of ISO 9001:2000 define the scope andexclusions, This Quality Manuals defines the manner in which the company has implemented a QMS in orderto provide assurance of the high standards of Quality that we strive to achieve.

Level - II: Procedure (P):

Procedure are documented to the adequate level i.e. (Process-I to Process- X) for ease of implementation ofthe policies stated in QM

Process I - Customer Support CenterProcess II – Network OperationsProcess III –EngineeringProcess IV –Sales & MarketingProcess V - Data Management GroupProcess VI- Administration & PurchaseProcess VII- Human ResourceProcess IX- Quality AssuranceProcess X- Testing



Level - III: Work Instructions (W):

Work Instructions, required at the operational level are documented to ensure that the activities are done asper the requirements. These Work Instructions are based on the applicable codes / contract / standardpractices / specifications / product quality requirements.

Level - IV: Formats and Records:

Forms/templates are used in Different areas for recording information regarding action to be taken/resultsobtained. Records provided evidence of conformity to requirements and effective operation of the QMS.

The Department Head of various departments are responsible to implement the QMS in Respectivedepartment.

4.2. Documentation Requirements:

4.2.1 General:

XYZ Solutions Limited has identified the documentation requirements for each activity at variousstages which is given below:

The QMS is a four level of documentation structure consisting of: Quality Manual, Quality StandardProcedures, Work Instructions and Formats & Records.

QM is prepared, controlled and issued by MR. It is approved and authorized for issue by CEO.

4.2.2 Quality Manual: 3

This Quality Manual describes the Quality Management System adopted by XYZ SOLUTIONS LTD. The manuallists down Resources, Processes, Procedures, Monitoring and Measurement System for the QualityManagement System that has been formulated on the basis of ISO-9001: 2000 that is primarily of Plan, Do,Check & Act [PDCA] Cycle.

The Manual and the information incorporated herein is the property of XYZ SOLUTIONS LTD., it must not be re-produced in any form in whole or in part or otherwise without prior consent in writing from CELLENXTSOLUTIONS LTD. This quality manual has been effective from April 01, 2008.

4.2.2.1 Structure of the Manual:

This Quality Manual is structured as shown in the contents page of the Manual and follows the sequence ofQuality Management System elements according to ISO 9001:2000.

Each page of Quality Manual contains the Revision number of the Manual the Revision number "00" has beengiven to the first issue of the section. Only the front page of the manual bears the signatures of the ChiefExecutive Officer (Approving Authority of Manual) and the Management Representative (Issuing Authority ofManual).

In case of a controlled copy manual in the physical / paper form, each page of the manual is stamped“CONTROLLED COPY” at specified location on each page. The Obsolete Copy of the Manual of previous issuesare identified and stamped as “OBSOLETE COPY” is to be kept in archives along with records of amendments.Manual without “CONTROLLED COPY” stamp is considered as uncontrolled.

In case of a controlled copy manual in the soft / electronic form, the manual is converted into a PDF file andwatermarked as “CONTROLLED COPY”. The obsolete copies of the manual are kept in a separate folder namedas “Obsolete Documents”. Manuals in the non PDF version (Except the one with Management Representativewhich will be in word format) are considered as uncontrolled manuals.

4.2.2.2 Method of Issue:



The Management Representative is authorized by the CEO to carry out the activities of preparing, issuing,maintaining and updation of this Quality Manual. The distribution of the Manual and the amendment(s) arecontrolled and are carried out by the Management Representative. The controlled copies issued to copyholders bear a rubber stamp "CONTROLLED COPY" on each page at specified location if the manual is inphysical / paper copy. Controlled Soft / Electronic copies are issued after converting the manual in the PDFform.

Any additional copies of the Manual, required for external agencies, are issued by the ManagementRepresentative and such copies of the Manual issued are stamped "UNCONTROLLED' or issued in the nonPDF form. These uncontrolled copies do not come under the purview of document amendment procedureand they are not updated and are not used within the Organization.

A distribution list of the Quality Manual has been provided in all controlled copies. This list is used asreference for updation of the respective controlled copies.

The Management Representative maintains a Master copy of the manual.

4.2.2.3 Revision, Updating and Amendment Procedure:

The Quality Manual is reviewed periodically by the Management Representative in consultation with therelated personnel. No revision is implemented unless it has been approved by the CEO / Quality Head andformally issued. Each revision is introduced formally by the Management Representative by issue of revisedpage for each of the copy as per the Distribution list.

When revisions take place, the revisions will be indicated by the revision number and recorded in theamendment sheet available in the controlled copies of the Manual and indicated at 4.2.2.4 below. If there aremore than 20 amendments in the manual the complete manual is revised and Issue number is changed on thefront page of the manual.

The insertion of the additional / amended section(s) and the removal of the old section(s) in the individualcontrolled copies as per the distribution list of the Manual is the responsibility of the person holding theindividual copy. All old section(s) so removed are stamped as "OBSOLETE” and returned to the ManagementRepresentative who ensures that the same are destroyed to avoid inadvertent or misuse of document. In caseof manual in electronic format, the obsolete manual is deleted from the computer of the user and new manualis stored. Management Representative will preserve the copy of the manual in OBSOLETE DOCUMENT FOLDER.

Obsolete master copy of will be retained by Management Representative for a minimum period of three yearsfrom the date of their super session due to revision.

4.2.2.4 Amendment Sheet:

To ensure that each controlled copy of Quality Manual contains a complete record of revision, this amendmentsheet is updated and issued with each set of revised/new chapter(s) of the Quality Management SystemManual. An acknowledgement slip will be included along with for the signature and returned by all holders ofthe controlled copies. Amendment sheet is available at the beginning of this manual in section 00

4.2.2.5 Distribution List:

Distribution List is available at the beginning of this manual in Chapter 1

4.2.3 Control of Documents:

The Management Representative is responsible for coordination and enforcing the document control relatedactivities in accordance with procedure SYS-P-01.All the documents are developed & controlled in accordance with Process documentation.



The Unique document Identification for all types of documents in XYZ shall be structured manner which isdefined in procedure for Control of Documentation (Refer SYS-P-01)

4.2.4 Control of Records:

Record has been established and is maintained to provide evidence of conformity to requirement and to theeffective operation of the Quality Management system. Record shall remain legible readlly identifiable andretrievable a documented procedure is which is defining identifiable storage protection retrievable retentiontime and disposition of record (Refer to Procedure control of Record SYS-P-02).The MR is overall responsible for maintaining the record Matrix.



CHAPTER TWO

MANAGEMENT RESPONSIBILITY

5 Management Responsibility:

The Top Management shall be overall responsible for making Management Review effective. MR shall assistthe Top Management in carrying out Management Review.

5.1 Management Commitment:

The top management is committed to the development and implementation of the Quality ManagementSystem and continually improving its effectiveness through.

Communicating to the organization the importance of meeting customer as well as statutory and regulatoryrequirements,Establishing the quality policy,Ensuring that quality objectives are established,Conducting management reviews.Ensuring the availability of resources.

The top management drives Organization wide Quality Initiatives through Quality Management System,Process Audit, and Customer Satisfaction Surveys & Deployment of breakthrough process initiatives.

5.2 Customer Focus:

The top management shall ensure that customer requirements are determined and are met with the aim ofenhancing customer satisfaction. This is defined in the Customer Satisfaction Index. This metric will bemeasured once in every six months

CEO and all departmental heads shall ensure that the Organization remains focused on Customer byunderstanding;

a] The Market / Industry / Social / Economy Conditions and requirements.

b] The Present and future Customer needs.

c] Identifying the requirements of the customers and fulfilling them with the aim of enhancing CustomerSatisfaction.

d] Global technological advancement in the field of Telecom Value Added Services.

For further details refer Section 7.2.1. and 8.2.1.

5.2.1 Customer Relationship Development:

Customer Relationship development & Management at XYZ Solutions Limited happens at multiple levels.Top Management ensures that the customer requirement are either converted in to Services or Quality Systeminputs as appropriate. These requirement may also be used as an input for New Development.

5.2.2 Customer Communication Method:

Customer communication is a two way process at XYZ Solutions Limited customer can share his issues throughKey Account Manager & helpdesk. Organization ensures that suitable action such as new Quality improvementinitiatives is taken against these requirements which helping developing long-term relation with thecustomers.



5.2.3. Customer Input:

Customer inputs are taken through requirements given to sales Key Accounts Manager by the customer,customer feed back forms & input provided to the helpdesk through mail/phone call. These inputs areconsidered for all business activities

5.2.4 Supplier Input:

Supplier/Partner Inputs are taken during review meetings with the supplier/Partners and these are furthertaken into consideration while planning the business plan.

5.3 Quality Policy:

The Quality policy of XYZ Solutions Limited is:

“XYZ Solutions Limited is committed to delight customers by providing Superior & innovative services in thefield of mobile & data service”

This we shall achieve by:

1. Ensuring continual improvements in our processes & operations2. Providing growth oriented work environment to the Employees.3. Establishing & maintaining symbiotic relationship with the stakeholders.

CEO ensures that the quality Policy is made to understand at all levels of the organization by means ofdisplaying the Quality policy at various locations, setting Quality Objectives in line with the Quality Policy.

5.4 Planning:

5.4.1 Quality Objective:

Top management shall ensure that Quality objectives includes those needed to meet requirement forproduct are established at relevant function and levels within the organization the Quality objectives shallbe measurable and consistent with the Quality Policy.(Refer to List of Quality objectives of different Departments)

5.4.2 Quality Management System Planning:

Quality Head is overall responsible for effective planning, implementation and maintenance of QualityManagement System.

The following criteria will be considered as input to the planning: Quality policy and objectives. Customer Feedback. Need and expectation of the customer. Standards and requirements of the industry. Global economy and industry growth Technological advancement and innovations Customer suggestion Perceived opportunities and threats by doing a SWOT analysis if required. Necessary assessments, measurements, monitoring and analysis Any changes affecting QMS.

Based on above, the management works on the following parameters:



Further skill set, training and expertise needed. Budgetary and personnel needs. Measurements of progress. Any additional resource needs. Need for process improvement if any. Need for documentation and records.

5.5 Responsibility, Authority and Communication:

5.5.1 Responsibility, and authority:

Management of the company is directed by the managing director and assisted by various functional Heads.The company’s organization structure showing inter office relationship of various functional Heads is definedin Organization chart.Responsibilities & Authorities of Key personnel who manage, perform and verify work affecting Quality aredefined in (Roles & Responsibility Matrix).

These Personnel have authority to: Initiate action to prevent reoccurrence of non-conference relating to the product, process & Quality

system. Identify and record any problem relating to the product, process and Quality system Initiate recommended or provided solution through designated Channels Verify implementation of the solution Control further processing delivery or installation of nonconforming product until required corrective

action is taken.

5.5.2 Management Representative:

The Managing Director has appointed MR in addition to his normal responsibilities, as ManagementRepresentative who has responsibilities and authority to as defined in Roles & responsibility in detail.Important responsibilities are given below:

Monitor the establishment, implementation and functioning of the Quality Management System bymonitoring the implementation of the QMS on a day-to-day basis and organizing internal Qualityaudits and management review meetings.

Report to the CEO about the status of Quality Management System.

Conduct internal audits, Identify and Analyze non-conformities and results of internal audits andreport to management for review.

Monitor correct implementation of corrective and preventive actions as per quality procedures andverify effectiveness.

Responsible for the distribution of all controlled documentation.

Promotion of customer requirement throughout the organization.

Ensuring effectiveness of the Q.M.S. in the organization and to implement modifications required inthe documentation from time to time as requested by the user or self identification.

.

5.5.3 Internal Communication:



The internal Communication will be ensured between various departments and levels, regarding the process ofthe Quality Management System and their effectiveness by the following means of Meeting.Top to Bottom Communication is carried out by the way of informal meeting with the concerned employeeand the Process Owner. Formal top to bottom communication is carried out by the way of scheduled meetingof the employees with top management at a regular interval.Bottom to Top communication is carried out on specific request of the employee to the management.Peer-to-Peer communication is carried out through informal discussions, formal notices, email, chat softwareetc.

Internal communication is mainly carried out mainly by one to one communication, phone and emails.Effectiveness of QMS is communicated through internal quality audit reports and minutes of managementreview meetings.

5.6 Management Review:

5.6.1 General:

The management review is done through management review meetings which are chaired by CEO. The M.R.organizes the management review meetings for reviewing the effectiveness of existing quality systems andimprovements at least once in three months. Management review findings and recommendations arerecorded in minutes of meeting and circulated to all concerned persons by M.R.

The meetings also reviews customer complaints, trends in achieving quality objectives, review training needs,training imparted, its effectiveness, resources planning, and internal audit report, supplier performance,customer complaints and feedback, Process performance, corrective and preventive action taken.

The Quality Management System adopted to satisfy the requirements of the International Standard ISO9001:2000 are reviewed once in three months by the company to ensure its continuing suitability andeffectiveness.

The following people are member of the Management Review Meeting:

Chief Executive officer (CEO) Head Customer Support Management Representative (MR) All Process Owners Quality-In-charge

Time, date, venue and agenda for Management Review Meeting is prepared and circulated by mail to allconcerned members by the MR in consultation with the Top Manager at least a week before the scheduleddate of the meeting.During these meeting various aspects of QMS (Audits review of process performance) are discussed and actionplan is done minutes of meeting are maintained by the Management representative.

5.6.2 Review input:The points for discussion during the Management Review Meeting shall as a minimum, include the following:

Results of Audits and status of various non-conformities. Achievement Status of Quality Policy and Quality Objectives. Customer Feedback / Complaint, Process performance and Product Conformity, Status of Preventive and Corrective Actions, Follow-up actions from previous Management Reviews, Changes that could affect the Quality Management System and Recommendations for further improvement.



5.6.3 Review output:

The output of review shall be recorded in the form of Minutes of Meeting, which shall detail the action plan.After Management review meeting, the following points must be as output of MRM;

Improvement of the effectiveness of the quality management System and its process, Improvement of product related to customer requirements, and Resource need



CHAPTER THREE

RESOURCE MANAGEMENT

6 Resource Management:

6.1 Provision of resources:

The organization shall determine and provide the resources like competent personnel, proper workingenvironment and adequate infrastructure needed to implement and maintain Quality Management Systemand continually improve its effectiveness to enhance customer satisfaction by meeting customerrequirements.

6.2 Human Resource (Refer to HR Manual):

6.2.1 General:

Human Resources are the biggest assets of any organization and that has to be taken care by any organization.HRD is the major contributor for this activity. XYZ Solutions Limited has laid down a detailed process to providemanpower to each department. Depending upon their requirements. Individual departments give theirrequirements to HRD and the same has been processed (Refer HR Requirement & Training Procedure)

6.2.2 Competence, Awareness and Training:

Performance is a combination for knowledge, skill, experience, attitude and environment. The requisite levelof performance has to be maintained &constantly improved, which determines the need for training & thetype of training, which is to be givenThe organization always ensures to provide the required training to all its employees, whose performance mayaffect repair quality or effectiveness of the Quality System, whenever required.Training needs are identified depending on the established procedures and are provided accordingly. (ForDetail Refer to HR & Training Procedure).

6.3 Infrastructure:

The management shall ensure that the employees are provided with the necessary resources to perform theirduties without hindering the product conformity. Based on the project/product all the software and hardwareresources to build the same shall be provided. Transportation for delivery of the product for testing purposesetc shall also be made available.All the departments are having their own responsibility defined in their detailed process to control andmonitor the availability of all the required Equipments

(Refer to Infrastructure Assessment and Provision SYS-F-12)

6.4 Work Environment:

A suitable working environment to the extent possible is maintained, where the absence will result in productquality. The maintenance of work environment is taken care by Admin Department (Refer to Admin ManualCSL-AM-01)



CHAPTER FOUR

PRODUCT REALIZATION

7 Product Realizations:

7.1 Planning of Product /Service Realization:

Top management plans processes needed for product / service realization.The processes required for product realization are described in 4.1 of this Manual.

On the basis of business received from the customer, current load and distribution of work to various andavailability of the in-house resources, planning for delivery of the service is done. On the basis of planning thecustomer is informed the proposed Project Start date and also resource management and mobilizationactivities are initiated if required for the particular order.

Planning for product / service realization is carried out by Operations Head in consultation with Training Headdepending upon the customer’s requirement and existing work load

7.2 Customer related Process:

In certain cases the customer may require XYZ to implement their processes to drive the Project Execution. Insuch cases the same shall be followed.

7.2.1 Requirement related to Product:

It is ensured that the product / service requirements are adequately defined, documented and checkedwhether feasible and required.Accuracy level, formatting style and other specifications related to the service delivery are obtained from thecustomer in writing either through email or in paper form. In case customer quotes the same verbally thesame is to be confirmed with the customer by sending a confirmation email or suitable communication.Statutory and regulatory requirements for providing Telecom value added services to the client are addressedproperly and are met with and required license are obtained where ever required

7.2.2 Review of Requirement Related to Product:

Any differences in the offering of the organization and expectations of the customers are suitably reviewedand are resolved/amended/attended on a case to case basis and it is made sure that no work order is acceptedbefore detailed discussions with technical and commercial employees are carried out about economical andtechnical feasibility of the requirements.

7.2.3 Customer Communication:

Marketing team or respective Process owners or quality head or operations head communicate with thecustomers on any operational issues through email or telephone or direct meeting as and when necessary.

Customer Feedback, Customer Complaint etc. are the methodology for reverse customer communication. i.e.from customer to the organization.(Refer to Customer Feedback form S&M-F-18)

7.3 Design and development:

The extend of design and development application to the organization’s overall processes is limited. It islimited to the in-house development or up gradation of platforms or Applications used for providing TelecomValue Added Services. Overall responsibility for design and development is with the Engineering Head.

(Refer to New Application Development Process S&M-P-02)7.3.1 Design and Development Planning:



Program Manager will ensure that before starting of any project, design and development plan is preparedcontaining the following information.

Inputs specifications required for each of the stages Responsibility for each of the stages along with scheduled and actual Design and Development

Output. Review to see the match between design and development input and output. Proper verifications at various stages is carried out so as to ensure That product is developed as per the project objective. Validation of the project before installation to ensure it’s error free and complete functional as per

the requirement of the organization or the process.

7.3.2 Design and Development Input:

Program Manager ensures that the following details are available depending on the basis of nature of theproject. (Refer to Engineering Procedure ENG-P-01)

All kind of functional and performance requirements/specifications for a project. Complete operational details that the project/software that it is supposed to deliver should be must

be clearly defined considering applicable statutory and regulatory requirements along with drawings,formats, work flow etc. wherever required and possible.

Past experience from the similar projects should also be used as an input whenever possible.

7.3.3 Design and Development Output:

Project Manager/ Program Manager / Team Leader will ensure that design and development output is in theform of a programming code or software application.Records of design and development output is maintained by the organization for all kind of projects.

7.3.4 Design and development Review:

Engineering Head ensures for suitability and adequacy of design and development input for the design anddevelopment output. The review information is documented.

7.3.5 Design and development verification:

Project Manager / Project Member carry out frequent verifications at various stages of the experiment ofdevelopment process so as to ensure desired result and performance of the final product / softwareapplication / code. Result of the verifications is documented.

7.3.6 Design and development validation:

Engineering Head / Project Leader is responsible for validation of the final product / developed application /generated code before it is installed and made live. Validation is carried out against project requirements,functionality and performance parameters as mentioned in the specifications.

Result of the validation is documented.

7.3.7 Design and development changes:

Any changes in the design and development process are documented.(Refer to change request_ Enhancement in existing application ENG-F-05)

7.4 Purchasing:All purchases are carried out by admin in-charge as per requirements and requests received from variousdepartments through Purchase Requisition form.



Purchase covers everything that is required to process the input to generate output.

(Refer Purchase Procedure PUR-P-01)(Refer Purchase requisition Form PUR-F-06

7.4.1 Purchasing Process:

Purchases are made from the approved suppliers who are registered before purchasing.A List of approved supplier is prepared.

(Refer List of Approved Supplier PUR-F-03)

7.4.2 Purchasing Information:

Purchasing information clearly states the precise identification of the requirements, specifications and deliverydates.

The record of approved suppliers is maintained and is continuously updated based on the evaluation of theperformance of suppliers.

The orders are reviewed for adequacy of specified requirements prior to release.

7.4.3 Verification of Purchased Product:

Incoming material / HW/SW / service are inspected by the concerned employee of the organization against thepre-defined deliverables in order to ensure the highest quality of products / services.(Refer Quality Check Report PUR-F-04)

Admin Head evaluates performance of the suppliers, to asses their suitability on a continuous basis andmonitors regularly performance of the suppliers.

Records are maintained as detailed in the procedures.

Refer To Given Documents:Procedure for Purchase PUR-P-01Supplier Registration Form PUR-F-01Supplier evaluation form PUR-F-02List of approved suppliers PUR-F-03

7.5 Production and service provision:

7.5.1 Control of Production & Service Provision:

The Overall responsibility for implementation of the procedure lies with Operations Head and Quality Head.The organization has planned service provision activities under controlled conditions.(Refer to Procedure of Network Operation NOP-P-01)

(Refer to Procedure for Incident _Bug Fixing (CSC-P-02)

7.5.2 Validation of processes for production and service provision:

For validation of content uploading we check the alert on registered SIMs so that 2-3 SIMs are registered forevery service.

After sending messages Alerts received on mobile (on testing sim or on in house no. which are alreadyregistered against the keywords). To cross check the efficiency of the task done.



7.5.3 Identification and Traceability:

The overall responsibility for implementation of this clause lies with the Customer Support Head.

All the cases for processing are given a unique identification number and assign to an employee for processing.

The processing can be traced back for date and time at any point of time because it is identified by a uniquecase number and is processed by an employee whose job allocation details are documented. In case of anycomplaints of the customers, the cases can be easily traced back to its origin and with all the relevant data

Reference: Support Center tool

7.5.4 Customer Property:

The organization deals with data that are highly critical in nature. The data processed by the organization arebackup of logs for various clients.

In order to ensure that the customer data are protected and not misused by anybody in the organization, astrict control is exercised.

Access control is in place to ensure only authorized person access to restricted areas.

No USB ports or email or floppy or CD drive are made available on any of the computer systems of the agents.

In order to further augment the organization’s commitment towards protection of property of the customer,ISO 27001 ISMS is being planned by the organization.

Refer to List of Customer Property (NOP-F-26)

7.5.5 Preservation of product:

The input files and processed files are stored on the central servers with adequate data back-up mechanism.

Local data during processing are also backed up to ensure that they are safe in case of any system failure.

7.6 Control of Monitoring & Measuring Device:

For monitoring of services provided by XYZ Solutions Limited we used gateways if the gateway is hanged ordown, the customer support person (CSC person) has to restart the gateway properly. In case, gateway isworking properly and still not received the message, inform Netops immediately and log the case on CRM forthe same.

Further, Netops can check the technical issue to resolve the problem. As soon as, the problem is solved,Netops contacts the CSC and the content person will send a message only on test SIM to cross check theservice.

The software used for monitoring and measuring of job allocation and process monitoring is calibrated everysix months by using a known sample and validating the software for output. Responsibility of this calibration iswith the Network Operation Head that use this software.Refer to OP Manager ToolRefer to Work Instruction for Monitoring of Gateway (CSC-W-12)



CHAPTER FIVE

MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.0 Measurement, Analysis and Improvement:

8.1 General:

Measurement, analysis and improvement processes are implemented as a means of demonstrating thatproducts/ services conform to the requirements. Each area of management responsibility defines and records,measure accordingly to their importance and the results of data analysis, together with improvements areused as inputs to the management review process.

8.2 Monitoring and Measurement:

8.2.1 Customer Satisfaction:

XYZ Solutions Limited. Collects feedback from the immediate customer at regular intervals. From theimmediate customer feedback is collected minimum once every three months. The feedback addresses Qualityof service.

The records of the customer feedback are maintained.

(Refer to Customer feedback form (S&M-F-18)

The following parameters are measured for customer satisfaction: -

Sl. No Parameters Measured for Customer Satisfaction1. Understanding of the requirements2. Adherence to schedule3. Quality of documentation4. Promptness5. Effectiveness of support6. Internal Audits

8.2.2. Internal Audit:

Management Representative is responsible for ensuring the implementation of this procedure. He is alsoresponsible for overall coordination of matters related to Internal Audits.

The company has established a procedure for carrying out "Internal Audit". The Internal Quality Audits areplanned and coordinated in such a manner that the entire Quality Management System of the company isaudited at least once in three months by trained auditors independent of their activities.The Audit Planning carried out by Management Representative, by preparing schedules for audits based on thestatus and importance of the activity. Internal audit can also be conducted by external auditors if required.The procedure requires audit reports to be documented. The reports of the audits form the basis for suitableand timely corrective actions by the respective sections.

All corrective actions agreed upon as an outcome of the Internal Quality Audits are verified, Implementationand effectiveness of corrective actions taken are recorded.The audit findings that need attention of the managing director or top management team are brought to theirattention by Management Representative through Management Review.

In case any significant changes are observed in the system i.e. change in process or in case of specialassignment / Order, then unscheduled audits may be carried out.The Management Representative maintains the records of the Internal Quality Audits.



(Refer to Procedure of Internal Audit SYS-P-03)

8.2.3 Monitoring and Measurement of Process:

XYZ Solutions Limited monitors and measures the processes to achieve planned results by:

Internal Audit Number of customer complaints. Number of non-conformity arising during product / service realization. Customer feed backs and supplier performance. Through SLA & Cases Analysis

The data collected are used to take relevant corrective and preventive action and to enhance the process andproduct realization process.

8.2.4 Monitoring and Measurement of Product:

In order to monitor and measure the characteristics of the final output to be uploaded on the server, the sameis monitored for accuracy level at Network Operation. The same is verified again through UAT.

8.3 Control of Non-conforming Product:

The overall responsibility for implementation lies with MR. The responsibility for disposition/rectification ofnon-conformities also lies with the MR.

The non-conformity control involves identification, evaluation, segregation of documentation and dispositionof the non-conforming products found in purchased items, during service provision and other QualityManagement System areas. A documented procedure has been developed to deal with the non-conformingproducts.

Records pertaining to control of non-conforming products are maintained as detailed in the relevantprocedures.

(Reference: SYS-P-04 Control of Non-conforming Product)

8.4 Analysis of Data:

Relevant and reliable data is collected and is to be reviewed and analyzed for the continual improvement ofthe Quality Management System. The data is collected from relevant management information systemsincluding internal audits, corrective and preventive action, non-conforming product/service, customersatisfaction reports etc.

Analysis of the data provides information on:

Effectiveness of the Quality Management System Customer Satisfaction Suppliers evaluation Customer Complaints Process performance

The analysis of data is done in a graphical form wherever possible for clear representation of the results and isappropriate to the various objectives set by the organization.

8.4.1 Trend Analysis of Nonconforming Product:

The Nonconforming product data is collected by Testing Team & also through Customer complaints. The datais analyzed and is presented in review meeting of management for necessary action by respective teams,



8.4.2 Service performance data:

Service performance parameter like SLA, OLA have been tracked on weekly basis to timely resolve thecustomer complaints

8.5 Improvement:

8.5.1 Continual Improvement:

Top Management is responsible for implementation and taking decision towards continual management. It is aprocess that is undertaken throughout the organization.

The following will be used at the time of Management Review Meeting for continually improving the QualityManagement System and the business of the organization.

Quality Policy Quality Objectives Internal Audit Results Customer Feedback Analysis of Data relating to i] Corrective Action

ii] Preventive Action

8.5.2 & 8.5.3 Corrective and Preventive Actions:

M.R. is over all responsible for implementation of this procedure.A procedure has been established for initiating corrective and preventive actions with respect to non-conformity. Through this procedure, it is ensured that

The actual cause of non-conformity relating to product, process and quality system is investigated. Potential causes of non-conformity are identified through customer complaints, analysis of work /

operations, quality records, audit results etc. Determining the need of suitable action. Identifying and implementing the action. Record the action taken. Review the effectiveness of action taken to prevent recurrence and or occurrence of any known

nonconformities.

The company gives utmost importance to the customer complaints and suggestions. The corrective andpreventive actions are attended urgently depending upon the gravity of customer complaint, in the presenceof concerned departmental head, Quality Head, Management Representative and other personnel.

However, the review and analysis of the Corrective and Preventive Action requests, internal audit reports,customer complaints, production quality related data and supplier related information are carried out inManagement Review Meetings. The concerned functions are then advised on further course of action requiredto prevent recurrence of non-conformities and elimination of potential causes of non-conformities.

Reference:

SYS-P-05 Procedure for Corrective and Preventive ActionList of identified preventive actions



ANNEXURE- 1

INTERACTION OF KEY BUSINESS PROCESS

Interaction of Key Business Process of XYZ Solutions Limited



Annexure A

Term ISO 9000:2005 Clause Definition

Document 3.7.2 information and its supporting medium

Procedure 3.4.5specified way to carry out an activity or

a process (Note: Procedures can bedocumented or not)

Quality Manual 3.7.4document specifying the quality

management system of an organization

Quality Plan 3.7.5

document specifying which proceduresand associated resources shall be

applied by whom and when to a specificproject, product, process or contract

Record 3.7.6document stating results achieved or

providing evidence of activitiesperformed

Specification 3.7.3 document stating requirements



Annexure B

Clause Record required

5.6.1 Management reviews6.2.2 e) Education, training, skills and experience7.1 d) Evidence that the realization processes and resulting product fulfil requirements

7.2.2Results of the review of requirements related to the product and actions arising

from the review7.3.2 Design and development inputs relating to product requirements7.3.4 Results of design and development reviews and any necessary actions7.3.5 Results of design and development verification and any necessary actions7.3.6 Results of design and development validation and any necessary actions

7.3.7 Results of the review of design and development changes and any necessary actions

7.4.1Results of supplier evaluations and any necessary actions arising from the

evaluations

7.5.2 d)As required by the organization to demonstrate the validation of processes wherethe resulting output cannot be verified by subsequent monitoring or measurement

7.5.3 The unique identification of the product, where traceability is a requirement

7.5.4Customer property that is lost, damaged or otherwise found to be unsuitable for

use

7.6 a)Basis used for calibration or verification of measuring equipment where no

international or national measurement standards exist

7.6Validity of the previous measuring results when the measuring equipment is found

not to conform to requirements7.6 Results of calibration and verification of measuring equipment

8.2.2 Internal audit results and follow-up actions8.2.4 Indication of the person(s) authorizing release of product.

8.3Nature of the product nonconformities and any subsequent actions taken, including

concessions obtained8.5.2 e) Results of corrective action8.5.3 d) Results of preventive action

qms essentials v 0.2

Documents

iso standardization

brief history of iso

aig internal page

process approach

shishirqms essentials

qualitymanagement approach

factual approach

system approach