into duct ion to iso 90012008 25.4.12
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W h a t i s I S O ?
ISO is the international
organization for
standardization based in
Geneva, Switzerland. It is thelargest standards organization
in the world and it develops
standards for use of companies
and organizations worldwide.
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ISO is a non governmental organization
and its membership comprises of
standardization bodies of the majorcountries of the world including India.
Bureau of Indian Standards representsIndia in ISO.
Continued.
What is ISO ?
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STANDARDSSTANDARDIZATION
SPECIFICATION
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Specification:Requirements for a product, service or system interms of dimension, tolerances, functions andperformance.
StandardizationStandardization is the process through which wearrive at an agreed and common performance
parameters or specification for a product, processor a system
Standard
A standard documents the specificationor therequirements for a product, process or a systemarrived through the standardization process. Itdefines the requirements in measurable terms.
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Quality management system is a set of policies,procedures and processes required for planning
and execution of the business activities of an
organization.
The activities of the quality management system is
designed to drive the organization to continuallyimprove the effectiveness and efficiency of itsperformance.
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PolicyProcedureProcess
PolicyAn organizations business
goals and objectives
Procedure
Specifies how a job has tobe done
ProcessA series of interlinked
activities aimed toproduce a planned result
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SYSTEM
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Driving system Computer operating system
Management system Design system
Can you name some other systems?
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Customerrequirements
QMS Regulatory & Legalrequirements
Continualimprovement
Process & proceduremanagementCustomer
satisfaction
WHY QMS IS REQUIRED
QMS is the framework for development of a qualitypolicy that drives the organization to continual
improvement and customer satisfaction, and alsoensure compliance to legal and regulatory requirements
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All these activities are directed towards implementation ofthe quality policy of the organization.
A set of procedures and processes are required to direct andcontrol the activities of the organization and improve its
effectiveness.
Quality management systems consistof,
quality planning,
quality assurance,
quality control, and
quality improvement.
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Quality plan is a framework of procedures and
processes that establish the objectives for quality,
and application of quality system elements.
It translates quality policy into measurable objectives
and requirements and lays down a sequence of steps
for realizing them within a specified timeframe.
It documents activity plans , resources required ,
responsibilities and all other requirements required
for the relevant project.
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Quality control is a technical function that includes all thescientific precautions, such as calibrations andduplications, that are needed to acquire data of knownand adequate quality.
Quality assurance is a management function; it deals withsetting policy and running an administrative system of
management controls that cover planning, implementation,and review of data collection activities and the use of datain decision making.
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Quality improvement is a planned andstructured approach to improve
performance through,1. systematic analysis of the activities,
2. measurement of performance,
3. prevention of errors,4. setting targets, and
5. identifying and applying improved methods to
achieve the targetted improvements.
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Quality
STATEDREQUIREMENT
HIGHQUALITY
LOWQUALITY
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ISO 9001:2008
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3
2
ISO 9001 is a quality management
system standard
The standard was issued in 1987,
revised in 1994, 2000 & 2008.
The standard ensures that quality
products are produced consistently.
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I S O 9 0 0 1 : 2 0 0 8 ISO 9001:2008 is the current version of the quality management
system standard issued by ISO. It provides a set of generic
requirements for all type of business activities.
The requirements
Apply to the processes that create and control the products and
services of an organization.
Prescribes systematic control of activities to ensure that the needs and
expectations of customers are met.
Is designed and intended to apply to virtually any product or service,
made by any process anywhere in the world.
It is a standard against which an organization can be certified.
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C e r t i f i c a t i o n
1. Certification is the formal recognition that an organization has the
proficiency to meet the specified requirements of a recognizedquality system standard.
2. Certification is given by an accredited body such as DNV, Bureau
Veritas, BIS etc. after assessment of the organization through audits,
and then issuing a certificate to show that the organization abides by
the principles set out in the standard (viz.ISO 9001),following
industry best practices
3. Certification communicates to the world that the company has
established a recognized quality system.
4. Certification provides evidence that the organization has
implemented an effective business management system, and that
they are serious about quality and ensuring that the customer'sexpectations are met.
5. It gives buyers confidence that the organization would be able to
supply quality products consistently.
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An organization to survive and grow must satisfy its customers.
Customers are satisfied when products
and services meet their expectations.
ISO 9001: 2008 provides the framework
of process models that turn out products
to satisfy customer expectations.
ISO 9001:2008 being a QMS standard, its implementation
enables an organization to ensure that its business processes
interact efficiently and effectively to produce qualitygoods and
services.
Why an organization should implement
ISO 9001: 2008?
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ISO 9001:2008 requires a documented qualitymanagement system.
The standard allows flexibility to an organization todecide as to what documentation they will include intheir quality management system.
The objective of the quality management system is to
support development and implementation of effectivebusiness processes. As such, documents not requiredfor the business should not be included in the qualitysystem.
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Documented statements of a quality policy andquality objectives.
A quality manual.
Documented procedures required by the standard. Documents needed by the organization to ensure the
effective planning, operation and control of itsprocesses.
Records required by the standard. 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.
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An organizations policy is a statement that enunciates
the organizations business goals and objectives andbroadly outlines the means to achieve them. It may alsoinclude a plan of action to gain competitive advantage.
A quality policy related to the overall corporate policy,defines the organizations commitment to quality. It sets
up quality plans through which it aspires to achieve
business leadership.
A quality policy is a framework of quality objectives andaction plans to drive continual performanceimprovement throughout the organization.
Q u a l i t y p o l i c y
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The quality policy should be aligned to the organizationsbusiness needs.
The quality policy should include a commitment to comply tothe requirements of the quality management systemrequirements.
The effectiveness of the quality management system shall becontinually improved.
Quality policy should provide aframeworkfor establishingand reviewing of quality objectives.
The quality policy shall be communicated at all levels withinthe organization and it shall be reviewed for continuingsuitability.
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ISO 9000:2005 defines quality objective as a qualityoriented goal - something to aim for or try to achieve.
To understand quality objective we must understandthe difference between a Goal and Objective.
A goal generally implies an intention, something thatwe would like to achieve.
Objective goes a step further. It is a goal withmeasurable target, that is achievable within aspecified timeframe. Quality objective converts a goalto an effective action plan.
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Quality objectives to be measurable and
consistent with the quality policy.
The clause also requires quality objectivesto be established at all relevant functionsand levels.
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Q alit Objecti es
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1. In practice quality objectives are selected from the day
to day work functions of an organization with the
intention of carrying out a specific targetedimprovement which is measurable.
2. Quality objectives must be reviewed and tracked to
ensure that there is progress towards the targeted
improvement.
3. While quality objectives should be consistent with thequality policy, from the business perspective they can
relate to the strategic business needs of the
organization.
4. Since quality policy itself relates to the strategic
business objectives of an organization, there is unlikely
to be any conflict with quality policy when quality
objectives are derived from thestrategic needs.
Quality Objectives
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Strategy guides the nature and direction of an
organization. It is about gaining business advantage
over the competitors by differentiating and increasing
the value of its products and services in the eyes of the
customer. Strategy can be expressed in three differentforms,
1. General Strategy2. Corporate Strategy, and
3. Competitive Strategy
St t
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1. General strategy is concerned with courses of action, the relationship
between ends and means.
2. Corporate strategy is concerned with choices and commitments
regarding markets, business and the very nature of the company itself.
3. Competitive strategy is concerned with competitors and competition
Cost, Differentiaton and Focus, as also Operating excellence, Customer
intimacy and Product leadership.
Strategy
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An organization having a well defined strategy, the salient points of
which has been communicated to its employees will be in an
advantageous position in terms of competition in the market place.
A well understood statement of the company strategy aligns employee
behaviour with the business requirements.
Think of a business as a collection of 1000 iron filings,
each filing representing an employee. If you pick up the
filings and drop them onto a piece of paper, they will lie
spread out all pointing in different directions. This will besomething like 1000 employees working hard with
different objectives in mind. If you now bring a magnet
over the filings, they change their positions and line up
in the same direction
The concept of strategy has been borrowed from the military and
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The concept of strategy has been borrowed from the military andadapted for use in business.
In the military, troops are maneuvered into positions before the
actual engagement takes place.
How the troops have to be deployed prior to engagement withthe enemy is a matter strategy.
During actual battle various type of actions are involveddepending on the progress and situation of the battle.
These actions which could keep on changing are termed tactics.
Together, strategy and tactics bridge the gap between ends andmeans.
Many businesses have adopted the techniques of strategy andtactics to gain competitive advantage in the market place.
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As a competitive strategy an organization can think of three core
values that it can deliver.
They are, Operational excellence (the lowest price), Productleadership (the best product), or Customer intimacy (the best
solution & service).
Of the three above the organization may have to decide which
value proposition they are best equipped to offer.
Mission&
Strategy
BusinessObjectives
QualityPolicy
QualityObjectives
Quality objectives are part of the continual
improvement activities within the organization.
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A quality manualdocuments an organization's qualitymanagement system . Clause 4.2.2 of ISO 9001:2008 definesthe minimum content of the quality manual as follows,
Scope of the QMS
Exclusions with their justifications
Interaction of the QMS processes
Quality procedures or reference to them
The format and structure of the manual is a decision for eachorganization, and will depend on the organizations size,culture and complexity.
The quality manual has to be controlled in accordance withthe requirements of clause 4.2.3.
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Establish, document, implement and maintain a quality management system
and continually improve its effectiveness.
a. Identify theprocesses required for the quality management system
b. Determine and document the sequence and interaction between the processesc. Identify and establish appropriate criteria and methods needed to operate and control
them.
d. Ensure that resources and supporting information are provided for process operation
e. Monitor, measure where applicable, and analyze the processes
f. Implement actions to achieve planned results and continual process improvement
These processes shall be managed by the organization in accordance with ISO
9001 . Organization should control outsourced processed. Type and extent
control on outsourced processes should be defined.
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A series of
interlinked activities
that use resources to transform
inputs into outputs.
ACTIVITY 3ACTIVITY 1 ACTIVITY 2 OUTPUTINPUT
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Processes must be planned and controlledto achieve the desired results.
Process planning requires control of inputs,resources and activities, and ensuring thatthe activities are arranged in the rightsequence.
Since the activities are also processes, theymust also be controlled.
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PROCESS
OUTPUT
RESOURCEPROCESS
CONTROL
INPUT
A process has to be
controlled to ensure
that the output
achieved is the
desired one
ACTIVITIES
A1 A2 A3
EACH PROCESS HAS A
SPECIFIC PURPOSE
PROCESS
A process requires
certain resources to
be able to function.
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As one of the measurements of theperformance of the quality management
system, the organization shall monitorinformation relating to customer perceptionas to whether the organization has metcustomer requirements.
The methods for obtaining and using thisinformation shall be determined.
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Continuous Continual
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Continual improvement is a set of activities that anorganization routinely carries out in order to improve itsability to meet requirements.
Continual improvement is achieved by carrying out internalaudits, performing management reviews, analyzing data,and implementing corrective and preventive actions.
Continual Improvement is a process ofincremental
improvement (step by step improvement) and is appliedcompany wide so that both managers and workmen areinvolved in this process of improvement.
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Breakthrough improvement is a majorimprovement that is achieved all at once.
Such improvements can be achieved throughinnovative changes of the process ortechnology, new advanced equipment or
complete overhaul of the working methodsto achieve a large jump in improvement.
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As opposed to continual improvement inwhich both managers and workmen are
involved and work together,
Breakthrough improvement is in the preserveof managers alone as this require technical
knowledge and out of the box thinking(innovation).
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To conduct internal audits at planned intervals to verify, conformance ofthe quality management system to the planned arrangements, and itseffective implementation and maintenance. The organization must:
a. Plan audit programs taking into consideration the status andimportance of the processes, areas and results of previous audits.
b. Define the audit criteria, scope, frequency, and methodsc. Select and use impartial and objective auditors, andd. Ensure that auditors do not audit areas of their own work, and
establish a documented procedure to define the responsibilitiesand requirements for,I. Planning and conducting audits.
II. Recording, reporting and maintenance of audit results.III. Ensuring that corrective actions are taken without delay toeliminate detected nonconformities and their causes.
IV. Following up of implementation of the correwctive actionsand reporting on the results of the corrective actions taken.
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An Audit is a fact finding mission. The
purpose is verification of compliance tospecified requirements. Internal audits are self auditing. Organizations audit themselves to verify that
operations, activities and processes are beingcarried out as per planned requirements.
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Internal audits must be conducted at plannedintervals to ensure compliance to requirements.
A documented procedure should define,1. How audits are to be planned including itsfrequency.
2. How they are to be recorded,and reported.3. For what periods audit records shall be
maintained.4. Ensuring timely corrective actions, and5. Verification of the results of corrective
actions.
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Internal audits verify, the effectiveness of the quality management system and its
implementation
Implementation and communicationof quality policy. Establishment, review and follow up of quality objectives. Implementation of continual improvement targets. Identification, implementation and improvements of processes
and procedures.
Achievement of customer satisfaction. Implementation of training requirements. Implementation of corrective anf preventive actions.
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The organization shall take corrective actions to eliminatenon conformities and their root causes to prevent theirrecurrence.
A documented procedure shall define requirements for:
a) reviewing non conformities and customer complaints,b) determining the causes of such nonconformities and
complaints,c) evaluating the need for action to ensure that non
conformities and complaints do not recur;
d) determining and implementing action needed;e) records of the results of action taken (see 4.2.4), andf) reviewing the effectiveness of the corrective action taken.
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A correction is an action taken to rectify a defective material throughre-working, reprocessing, assigning the defectives to some other usewhere they are acceptable; or totally destroying the defectives.
Corrections may not address the root cause of the problem.
Corrective actions address the root cause of the problem sothat the possibility of recurrence of the problem is eliminated.
Corrective action is a problem solving process, where theproblem is analyzed to identify the causes and then eliminatethem.
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Determine the actions to eliminate the causes of potentialnonconformities in order to prevent their occurrence.Ensure that preventive actions are appropriate to the
anticipated effects of the potential problem.
Establish a documented procedure to define the requirementsfor preventive action to:
Determine the potential nonconformities and their causes.
Evaluate the need for actions to prevent occurrence.
Determine and implement the needed actions .
Maintain records of the results of the actions taken., and
Review the effectiveness of preventive actions taken.
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Preventive actions are steps that are taken to removethe causes of potential nonconformitiessomething that
hasnt as yet occurred.
Preventive action is a risk analysis process.
While corrective actions prevent recurrence,preventive actions try to prevent future occurrences.
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QUALITYPOLICY
(5.3)
VERIFICATION
OF SYSTEM
INTERNALAUDIT(8.2.2)
QUALITY
OBJECTIVES
(5.4.1)
QUALITY
MANAGEMENTSYSTEM
(ISO 9001)
CUSTOMER
SATISFACTION
(8.2.1)
CONTINUAL
IMPROVEMENT
(8.5.1)
STARTING POINT
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Creation of an efficient and effective organization.
Well defined documented procedures and processes.
Consistent product quality.
Increased customer satisfaction.
Retention of customers.
Improved quality image, increased marketshare and profits.
Improved employee motivation, and awareness.
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1959
1972
1979
1987
1994
2000
2008
MIL-Q-9858: US defence qlty system standard
BS 4891: Quality Assurance Standard
BS 5750: Quality System Standard MIL-Q-9858ISO 9001: International Quality SystemStandard
Second revision: ISO 9001
First revision: ISO 9001
Current Version Of ISO 9001