9001 quality manual

8/13/2019 9001 Quality Manual

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Quality Manual

Document Number AD-QM

Date 24-Apr-12

Revision No 1

Page 1 of 26

Company Internal

ISO 9001:2008 Quality Manual

Revision 1.0

Prepared by

Reviewed by

Approved by

XYZ Company

Address:

The contents of this Manual and the related documentation are confidential to the company and should not

be reproduced or copied, either in part or full nor issued to third party without prior approval of the XYZ

Company


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Quality Manual Amendment Sheet

Sl. No DatePage

Number

Revision StatusAmendment Details

Sign of

MROld New

List of Controlled Copy Holders

Copy Holder Copy No

Management Representative --

Library Copy 01

Certifying Body 02


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Table of Contents

INTRODUCTION ............................................................................................................. 5

QUALITY ........................................................................................................................ 5

SCOPE ............................................................................................................................ 6

Exclusions: ......................................................................................................................... 6

QUALITY MANAGEMENT SYSTEM .............................................................................. 7

General requirement ........................................................................................................ 7

Documentation requirements .......................................................................................... 7

MANAGEMENT RESPONSIBILITY ............................................................................. 10

Management Commitment ............................................................................................ 10

Customer focus ................................................................................................................ 10

Planning ........................................................................................................................... 10

Quality management system planning .................................................................. 10

Quality objectives ................................................................................................. 11

Responsibility, Authority and communication ............................................................ 12

Responsibility Matrix ..................................................................................................... 14

Management Representative ................................................................................. 16

Internal Communication ....................................................................................... 16

Management Review ....................................................................................................... 17

RESOURCE MANAGEMENT ....................................................................................... 18

Provision of resources ..................................................................................................... 18

Human Resources ........................................................................................................... 18


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PRODUCT REALIZATION ........................................................................................... 20

Planning of PRODUCT realization ............................................................................... 20

Customer Related Process .............................................................................................. 20

Procurement .................................................................................................................... 21

PRODUCTION & SERVICE PROVISION ................................................................ 22

MEASUREMENT, ANALYSIS AND IMPROVEMENT .................................................. 24

General ............................................................................................................................. 24

Monitoring and measurement ....................................................................................... 24

Control of Non-Conformities ......................................................................................... 25

Analysis of Data............................................................................................................... 25

Improvement ................................................................................................................... 26


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INTRODUCTION

QUALITY

Date:

Place:

XYZ Company is committed to deliveringenhanced value to customers, through

continual improvement of processes and

systems by way of innovation, technology and

knowledge management.

Authorized Signatory


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SCOPE

EXCLUSIONS:

DESIGN AND DEVELOPMENT

Design and development has been excluded as Organization does not conduct any design

activities.

Exclusions of the above clauses do not affect the organizations ability and responsibility to

provide products that meets customer, statutory and regulatory requirements.


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QUALITY MANAGEMENT SYSTEM

GENERAL REQUIREMENT

The Organization has established documented, implemented, maintained and would

continually improve the Quality Management system in accordance with the requirements of

ISO 9001:2008 International standard.

The Organization has determined the processes for Quality Management System and their

application throughout the organization.

The Organization has determined the sequence and interaction of these processes with the

criteria and methods required to ensure the effective operation and control of these processes.

The Organization has ensured the availability of resources and information necessary for the

process and measures monitors and analyzes these processes and implements action necessary

to achieve planned results and continual improvements.

DOCUMENTATION REQUIREMENTS

GENERAL

The Quality System is organized into the following elements.

Quality Policy

A Quality Statement prefaces the Quality Manual. This outlines the objectives of the Quality

System and the companys commitment to Quality.

The QMS Manual by the company is documented in the following levels of Documentation.

Level 1: QMS Manual.

This addresses the requirements stated in the ISO 9001:2008 Standards as applicable to theprocess followed in the ABC Company.

Level 2: Quality System Procedures as required by the organization and standards


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Master List of System related Procedures are as mentioned here below.

Procedure for Control of Documents AD-QSP1

Procedure for Control of Records AD-QSP2

Procedure for Internal Quality Audit AD-QSP3

Procedure for Control of Non Conforming Product AD-QSP4

Procedure for Corrective / Preventive Action AD-QSP5

Level 3: Process related Documents like Drawings, Forms and registers as required by ISO

9001:2008 and suitable for effective planning, operation and control of its processes

Level 4: Records required by the standard and the process

QUALITY MANUAL

The Organization has established and maintained Quality Manual that includes

Scope of the QMS including details of exclusion and its justification Documented procedures established for the or reference to them Description of the Interaction between the process and QMS.

CONTROL OF DOCUMENTS

The process for controlling the documents and amendment within the organization is explained

in the Procedure for Control of Documents.

Details of Amendments in Quality Manual, System procedures and any other documents are

recorded in the Document Amendment list. Current Revision status of all Documents starts

from 1 and subsequent changes will be 2, 3 and so on.

Current Issue status of Quality Manual is 1.0.

If the current status of the manual is x.y, minor changes will lead to increment in y and majorchanges will lead to increment in x. After 10 continuous minor changes or after 2 years of no

major changes, the revision will have a mandatory increment in x.

All documents are ensured that they are legible and easily identifiable. The Quality Manual is

identified as AD-QM and the page numbering is done at the header of each page.


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The Organization has ensured that Documents of External origin necessary for the planning and

operation of the quality management system are identified and their distribution controlled.

Reference: Procedure for Control of Documents AD-QSP1

CONTROL OF QUALITY RECORDS

The Organization has established the records required for the Quality management system,

which has been controlled.

All records are maintained to provide evidence of conformance and of effective operation of

the Quality management system. Records are maintained in either Hard copies or soft copies.

Procedure has been established for the identification, storage, protection, retrieval time,

retention time and disposition of quality records.

Records are maintained legibly, identifiable and retrievable

Reference: Procedure for Control of Records AD-QSP2


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MANAGEMENT RESPONSIBILITY

MANAGEMENT COMMITMENT

The Quality Management System has been implemented and its effectiveness is controlled by

continual improvement and by

Communicating to the organization the importance of meeting customer as well asstatutory & regulatory requirements.

Establishing the quality policy. Establishing Quality Objectives. Conducting Management Review meeting. Ensuring availability of necessary resources

CUSTOMER FOCUS

The Organization ensures that customer needs and expectations are determined through

interactions and feedbacks. The requirements of customers are fulfilled with the aim of

achieving customer satisfaction.

PLANNING

QUALITY MANAGEMENT SYSTEM PLANNING

The Organization has ensured that the planning of the Quality Management system is carried

out to meet all requirements as well as Quality objectives and integrity of the quality

management system is maintained when changes to the quality management system areplanned and implemented.


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QUALITY OBJECTIVES

The Quality Objectives has been established at relevant departmental level within the

Organization. This is tangible and consistent with Quality Policy.

S No Department Objectives

1.2.3.4.5.6.7.8.9.10.11.12.13.14.15.16.17.18.19.20.


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RESPONSIBILITY, AUTHORITY AND COMMUNICATION

The Responsibility & authorities are defined below. In addition to this Job Responsibilities are

issued to all the persons.

Responsibilities of Designation

1. Monitoring the Resource requirements2. Ensuring that the company meets all statutory and regulatory requirements.3. Chairing Management review meeting.4. In-charge of Marketing activities5. Handling customer enquiries and complaints6. Reviewing the requirements of customer.7. Sending Quotations to enquiries received8. Overall operations of the company.9. Implementing QMS in the company.10.Member of the Management Review.11.Identifying Training Needs and requirement of Resources.12.Recruitment of New Employees.13.Conducting Internal Quality Audits at regular intervals14.Responsible for Document and record control.15.Coordinating with the vendors16.Coordinating with the vendors for replacement of any faulty item found.17.Vendor Selection and Annual Re-Evaluation.18.Raising Purchase orders from the Approved Suppliers List and subsequent approval

from Director.


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Authority of Designation

1 Approval of all QMS related Documents2 Approval of Purchase Orders for capital equipments.3 Approval of Deliverables4 Deciding on the disposition of non conforming products during delivery process and

customer returns

5 Approval of new contracts.


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RESPONSIBILITY MATRIX

ISO 9001 : 2008 Reference Designation Designation Designation Designation Designation Designation Designation

Document & Record Control

QMS PlanningQuality Policy and Objectives

MR Functions

Management Review Meeting

Resource Requirements

Human Resources

Maintenance

Marketing

Purchasing

Verification of Purchased ProductProduction

Service, Installation

Identification & Traceability

Customer Property

Packing and Stores

Calibration

Continual Improvement


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Customer Satisfaction

Internal Auditing.

Process Measurement and Controls

Product Measurement

Control of Non Conforming Product

Data Analysis.

Corrective and Preventive Actions

PPrimary Responsibility; SSecondary Responsibility; A - Authority


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MANAGEMENT REPRESENTATIVE

Management has appointedName of the membera member of the organization as the

Management Representative who irrespective of other responsibilities and authorities has to

Ensure that processes needed for the QMS are established, implemented andmaintained by frequent internal audits and Management Review.

Ensuring the promotion of awareness of customer requirements throughout theorganization.

Liaison with external bodies regarding QMS. Appraisal on the performance of QMS and any need for improvement to the

Management.

INTERNAL COMMUNICATION

The M.R has ensured that communication between its various levels and functions regarding

the process of the Quality Management System are effectively carried out and effectiveness is

checked through management review meetings.

Internal Communication is done by means of review meetings, Information display on theNotice Board and e-mail notifications.


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MANAGEMENT REVIEW

GENERAL

Top management reviews Quality Management system every 6 Months. This is conducted to

ensure the continuing suitability, adequacy and effectiveness of QMS.

Opportunities are also identified during these meeting for improvement and need for any

changes in the QMS including the Quality Policy, Quality objectives and customer complaints

and feedbacks.

REVIEW INPUT

Review Inputs includes current performance and improvements opportunities related to:

Results of audits. Customer feedback. Process performance and product conformance. Status of preventive and corrective action. Change that could affect the quality management system. Follow up action from previous management review. Recommendations for improvement.

Agenda is prepared by MR and circulated to all the attendees before MRM.

Reference:Agenda of Management Review Meeting

REVIEW OUTPUT

Review Output includes, actions related to

Improvements of the quality management system and its process Improvement of product related to customer requirements Resource needs

Review outputs are recorded in the minutes of management review meetings and copies

circulated to all members.

Reference: Minutes of the Management Review Meeting


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RESOURCE MANAGEMENT

PROVISION OF RESOURCES

The resources needed are determined and provided in timely manner to:

Implement and improve the process of the quality management system Address customer satisfaction.

HUMAN RESOURCES

GENERAL

The Organization has ensured that personnel who are assigned responsibility defined in the

QMS are competent on the basis of applicable education, training, skills and experience.

COMPETENCY, TRAINING AND AWARENESS

The organization identifies the competency needs for personnel performing activities

affecting quality by means of Skill Matrix. Based on Skill Matrix and training needs Training

Calendar is prepared for the year.

Providing training to satisfy these needs and evaluate the effectiveness of trainingprovided.

Maintain appropriate records of education, training, skills and experience. The Organization also ensures that personnel are aware of their job description and

their contribution to the achievement of Quality Objectives.

INFRASTRUCTURE

The company activities are carried out in a spacious building. Computers with Local AreaNetwork, Internet connection, phone and Fax are available.

List of assets is prepared and all the assets are maintained by respective personnel.


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WORK ENVIRONMENT

The Organization has provided a work environment as per statutory requirements. Inaddition to physical factors, other factors like temperature, humidity, noise and human

element is crucial as regards to the company is concerned and hence a good layout

which enable safety; proper illumination, Exhaust fans, First Aid Box, Fire Extinguishers,

Smoke detectors are provided.

The work place is well illuminated and also has Generator to take care of the powershutdown.


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SERVICE REALIZATION

PLANNING OF PRODUCT REALIZATION

The Organization has determined the planning process for realization of product:

Determined the Quality Objectives and requirements of the product. Establish processes and documentation and provide resource and facilities specific to

the product.

Establish process for verification and validation, monitoring, inspection activities and thecriteria for acceptability.

Records necessary to provide evidence of conformity of the process and the resultingproduct meets customer requirements.

CUSTOMER RELATED PROCESS

DETERMINATION OF THE REQUIREMENTS RELATED TO THE PRODUCT

The Organization has implemented systems to determine that the customer requirements

including

Product requirements specified by the customer, including the requirements foravailability, delivery and support.

Product requirements not specified by the customer but necessary for intended use orspecifics.

Obligations related to product, including statutory, regulatory and any otherrequirements.

Reference:Customer Enquiry Register


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REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT

The Business Development department reviews the requirements of the Customerrelated to the product.

This review is done after receiving an order. The review would cover all Technical andCommercial Aspects.

In case of change in product requirements, the organization ensures that relevantdocuments are amended and relevant personnel informed.

As the Order is confirmed the Business Development department initiates the orderprocessing.

Reference: Contract Review

CUSTOMER COMMUNICATIONS

The Organization has implemented effective arrangements for communicating with the

customer through different Medias such as Telephone, Fax, website and email; Courier / Postal

Product with regards to Enquiry, Product Information, Contracts, Amendment, Customer

Feedback and Complaints.

PROCUREMENT

PROCUREMENT PROCESS

An Indent is raised by the required Dept. based on the needs the Managing Director defines the

procurement and ensures that it conforms to the requirements.

Indent is raised by relevant department HODs. Analysis is carried out as per the need. A List is maintained with details of suppliers and service providers including

Subcontractors.

Evaluation of all suppliers is carried out before empanelling them Re-evaluation of suppliers is done every year.

Reference: Approved Supplier List F23, Supplier Re-evaluation F24


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PROCUREMENT INFORMATION

Any procurement is conveyed to the Managing Director in the Indent in line with the Billof Material.

Purchasing information is communicated to the supplier through Purchase Order,wherein the requirements for the materials/services, delivery and commercial terms are

clearly defined.

The Purchasing Dept. prepares the Purchase order. Amendments if any are subsequently informed to the supplier with amendment details

mentioned in the Purchase Order.

Reference: Purchase Order

VERIFICATION OF PROCURED PRODUCT/SERVICES

All products/services procured are checked for Quantum by Admin department andrecorded in the Register.

The Admin department inspects all incoming materials in line with the orderedspecification,

Admin Department will also preserve all warranty certificates of these equipments.

PRODUCTION & SERVICE PROVISION

CONTROL OF PRODUCTION & SERVICE PROVISION

The Organization has provided information related to product in the form of schematics,and work instructions, required for carrying out the sourcing, interviewing and staffing

process.

Quality check activity is carried out by Business Heads at each & every step of productdelivery.

VALIDATION OF PROCESS FOR PRODCUTION & SERVICE PROVISION


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The Organization has established validation process to review and approve processesand procedures with respect to equipments, Operators and other personnel involved inthe activities that affect Quality of the product, generate relevant records and re-

validate annually.

IDENTIFICATION AND TRACEABILITY

Items in the work place are kept as per pre-designated places earmarked and Items inthe stores are kept in appropriate bins / Racks with identification.

Products are identified by Product numbers & details related to that Product ispreserved in relevant files.

Reference: List of Products

CUSTOMER PROPERTY

The Organization receives inputs and specifications for reference and provision of solutions

with respect to physical security.

All care is taken to ensure that the items and information under the custody of the organization

are secured against theft or damage during internal processing. If any item is found to be

damaged or lost during the processing the same is informed to the customer.

PRESERVATION OF PRODUCT

The organization preserves the conformity of product throughout the process cycle.

All Customer information are suitably identified, handled, stored and protected against

damage.

CONTROL OF MONITORING AND MEASURING EQUIPMENT

The Organization has determined and undertaken monitoring & measuring of equipments

needed to provide evidence of conformity & has ensured in a manner that it is consistent with

monitoring & measuring requirements of products to determine requirements.

All measuring equipments are calibrated and verified periodically prior to use againstmeasurement standards traceable to international or national measurement standards,

where no such standard exist the basis for calibration or verification is recorded.

All equipments have identification in order to trace its calibration status.


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Is safe guarded from adjustments that would invalidate the measurement result andprotect it from damage and deterioration during handling, maintenance & storage.

MEASUREMENT, ANALYSIS AND IMPROVEMENT

GENERAL

The Organization has planned and implemented the monitoring, measurement analysis and

improvement process needed to

Demonstrate conformity of the product. Ensure conformity of the QMS Continually improve the effectiveness of the QMS. Determine and implement statistical techniques for Data Analysis.

MONITORING AND MEASUREMENT

CUSTOMER SATISFACTION

The Organization has obtained information about the customers perception as towhether the company has met the requirements after delivery.

The feedback includes parameters on Quality, Delivery, and service. Information derivedfrom this has been reviewed and discussed in the Management Review Meeting

Customer feedback is collected from major customers at a frequency of 1 year.Feedbacks collected are reviewed and action initiated.

The customer feedback is reviewed on receipt and the index is calculated. The Sales department resolves customer Complaints requiring immediate attention.

Reference: Feedback Form

INTERNAL AUDIT

The Organization has established methods for conducting internal quality audits at every six

months to determine whether the quality management system conforms to the planned

arrangements to the requirements of the ISO 9001:2008 standard and to the quality


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management systems established by the organization and is effectively implemented and

maintained.

Reference: Procedure for Internal audit

MONITORING AND MEASUREMENT OF PROCESSES.

The Organization adopts methods for monitoring the QMS processes. These processesdemonstrate the ability of the processes to achieve planned results.

When planned results are not achieved, appropriate corrections and corrective actionsare initiated, to ensure conformity of process and product.

MONITORING AND MEASUREMENT OF SERVICE

Regular checks are carried out delivery team. Regular feed backsare recorded from the customer.

Reference: Project Sign-off Record

CONTROL OF NON-CONFORMITIES

The Organization has taken care to ensure that Nonconformance in the service is reduced or

eliminated.

Disposition of Nonconformities is carried out by the delivery team in-charge in liaison with

Production Manager.

Reference: Procedure for Control of Non-Conforming Product

ANALYSIS OF DATA

The Organization collects data, analyze and display appropriately in order to meet the Quality

Objectives and demonstrate the suitability and effectiveness of Quality Management System.

Data Analysis is directed towards

Enhancing Customer Satisfaction. Increasing the Quantum of Service Conformity to Service Requirements. Suppliers


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Characteristics of Processes and products including opportunities for Preventive action.All this data would be in the form of visual display like Bar chart, Graph or Pie chart.

IMPROVEMENT

CONTINUAL IMPROVEMENT

The Organization continually improves the effectiveness of the QMS through the declared

documents of Quality policy and Quality objectives, Audit Results, Data Analysis, Corrective and

Preventive Action and Management Review.

CORRECTIVE ACTION

The Organization has established methods to take action to eliminate the causes of Non -

Conformities in order to prevent recurrence. The corrective actions are appropriate to the

effects of the Non-Conformities encountered. Effectiveness of the Corrective action initiated is

reviewed

Reference: Procedure for Corrective and Preventive Action

PREVENTIVE ACTION

The Organization has established methods to determine actions to eliminate the causes of

potential non-conformities in order to prevent their occurrence and recurrence. Preventive

actions are appropriate to the effects of the potential problems. Effectiveness of the preventive

action initiated is reviewed.

Reference: Procedure for Corrective and Preventive Action