awarness iso 9001

8/7/2019 Awarness ISO 9001

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Introduction of the Resource PersonIntroduction of the Resource Person

Engr. Bilal Haider Engr. Bilal Haider

Lecturer Lecturer

Institute of Chemical Engg. & Tech.Institute of Chemical Engg. & Tech.

University of the Punjab, LahoreUniversity of the Punjab, Lahore

Qualification:Qualification: B.Sc. Engg. (Chem.), MS (TQM), Lead Assessor ISO 17025, 9000B.Sc. Engg. (Chem.), MS (TQM), Lead Assessor ISO 17025, 9000

Professional Affiliations:Professional Affiliations: PNAC & NAPNAC & NA

Professional Trainings:Professional Trainings:

ISO/IEC 17025 Assessor Course, Norwegian Accreditation (Norway)ISO/IEC 17025 Assessor Course, Norwegian Accreditation (Norway)

IRCA Qualified ISO 9000 Auditor IRCA Qualified ISO 9000 Auditor

National Quality Award Assessor (NQAA) Course organized by Asian ProductivityNational Quality Award Assessor (NQAA) Course organized by Asian ProductivityOrganization (APO), Japan.Organization (APO), Japan.

Evaluation of Measurement Uncertainty, Norwegian Accreditation (Norway)Evaluation of Measurement Uncertainty, Norwegian Accreditation (Norway)

ISO 17020 ³General criteria for the operation of various types of bodies performingISO 17020 ³General criteria for the operation of various types of bodies performinginspection´ organized by PNACinspection´ organized by PNAC



Discussion TopicsDiscussion Topics

Introduction to Quality and StandardizationIntroduction to Quality and Standardization

Evolution of Quality Management SystemEvolution of Quality Management System(ISO 9000)(ISO 9000)

Quality Management SystemQuality Management System -- RequirementsRequirements(ISO 9001:2008)(ISO 9001:2008)



Introduction to Quality and

Standardization



What is Quality after all?What is Quality after all?



Quality«!Quality«!

µFitness for use¶µFitness for use¶ ± ± JuranJuran

µConformance to requirements¶µConformance to requirements¶ ± ± CrosbyCrosby

µCustomer satisfaction/delight¶µCustomer satisfaction/delight¶ ± ± DemingDeming

µDegree to which a set of inherent characteristicsµDegree to which a set of inherent characteristics

fulfils requirements¶fulfils requirements¶ -- ISO 9000:2000ISO 9000:2000



Customer SatisfactionCustomer Satisfaction

³³ DegreeDegree toto whichwhich thethe customer¶scustomer¶s requirementsrequirements havehave beenbeenfulfilledfulfilled ´́

Performance < 1Performance < 1 -- DissatisfactionDissatisfaction

Satisfaction = = 1Satisfaction = = 1 -- SatisfactionSatisfaction

Expectation > 1Expectation > 1 -- DelightDelight



StandardizationStandardization

The process of developing and agreeing upon Standards.



Aims of Standardization Aims of Standardization

F itness for purpose

Interchangeability

Variety reduction

Compatibility

Guarding against factors that affect thehealth and safety of consumers

Environmental protection

Better utilization of resources

Better communication and

understanding Better communication and

understanding

Removal of trade barriers



Standard?

Standards are documented agreements

containing technical specifications or precise

criteria to be used consistently as aguideline of characteristics, to ensure that

materials, products, processes and services

are fit for their intended purpose.



TYPES OF STANDARDSVocabulary standards:

Glossaries, signs and symbols; A few examples are Paper Vocabulary, Listof Equivalent Terms Used in the Plastic Industry, Vocabulary for the RefractoryIndustry and Vocabulary of Information Processing.

Measurement standards:

Material measure or physical property that defines or reproduces the unit of measurement of a base or derived quantity. Such as units of measures; Theseven basic units of the SI system e.g. meter, Kg, Ampere etc.

Product standards:

Cover specifications for dimensions, performance, health, safety,environmental protection and documentation; Standards for inspection, test

methods and analysis.

Management Standards:

Standards that focus on organization, such as for logistics, maintenance,inventory management, quality management, project management andproduction management such as ISO 9000, ISO 14000, ISO 17025, S A 8000,H ACCP etc.



Attributes of a standard

A standard generally has three attributes:

1. Level : such as at the company, national or international level.

2. Subject : such as engineering, food, textile or management.

3. Aspect : such as specification, testing and analysis, packaging andlabeling (more than one aspect may be covered in a single standard: astandard may include specification of items such as the product, itssampling and inspection, related tests and analysis, packaging andlabeling).

For example the term ³Pakistan Standard Specification of Biscuits´,means that the standard is a national standard (level), in the food area(subject), and provides specifications (aspect) for the biscuits.



Infrastructure for Standardization in Pakistan

Standards InstitutePSQCA

Legal framework in Pakistan

LABORATORIES

Microbe Chemical Textile

TESTING SERVICES

Systemcertifiers..

Systemauditors

Systemconsultants

LaboratoryaccreditationISO 17025

Accreditation BoardPNAC

Legalmetrology

ISO

OIML

BIPM

ENTERPRISES

Factorymetrology

lab

Tradetransaction

ILAC

IAF

NPSL

HACCP ISO14000 ISO 9000

An institution for training and monitoring Auditors



Renowned Standardization BodiesRenowned Standardization Bodies

ISOISO InternationalInternational OrganizationOrganization for for StandardizationStandardization

ASTMASTM AmericanAmerican SocietySociety for for TestingTesting andand MaterialsMaterials

DINDIN DeutschesDeutsches InstitutInstitut für für Normung Normung

ENEN EuropeanEuropean Norms Norms

IECIEC InternationalInternational ElectrotechnicalElectrotechnical CommissionCommission

BSIBSI BritishBritish StandardsStandards InstituteInstitute



CertificationCertification

1.1. MeansMeans ComplianceCompliance with a standard or with a standard or

specification (e.g. Systems or Productspecification (e.g. Systems or Product

Standards).Standards).

2.2. May beMay be general in the scopegeneral in the scope of of

recognitionrecognition

3.3. Considers total business .Considers total business .



Accreditation Accreditation

1.1. It meansIt means recognition of competencerecognition of competence in ain a

specific area and scope.specific area and scope.

2.2. Its scope is highlyIts scope is highly specificspecific..3.3. Evaluates people, skills and knowledge.Evaluates people, skills and knowledge.



Evolution of Quality ManagementEvolution of Quality Management

SystemSystem ± ± ISO 9001:2008ISO 9001:2008

19871987 First PublishedFirst Published ± ± ISO 9001, 9002 & 9003ISO 9001, 9002 & 9003

19941994 First revisionFirst revision ± ± ISO 9001, 9002 & 9003ISO 9001, 9002 & 9003

20002000 Second revisionSecond revision -- ISO 9001ISO 9001

20082008 Third revisionThird revision ± ± ISO 9001ISO 9001



Quality Management SystemQuality Management System

Management System to direct & control an organizationManagement System to direct & control an organization

with regard to quality.with regard to quality.



Quality management PrinciplesQuality management Principles

1. Customer focus1. Customer focus

2.2. LeadershipLeadership

3.3. Involvement of peopleInvolvement of people

4.4. Process ApproachProcess Approach

5.5. System approach to managementSystem approach to management

6.6. Continuous ImprovementContinuous Improvement

7.7. Factual approach to decision makingFactual approach to decision making8.8. Mutually beneficial supplier Mutually beneficial supplier

relationshipsrelationships



Quality Management Principle No.1Quality Management Principle No.1

Customer FocusCustomer Focus

Organizations depend on their customersOrganizations depend on their customers

and therefore should understand current andand therefore should understand current and

future customer needs, should meetfuture customer needs, should meet

customer requirements and strive to exceedcustomer requirements and strive to exceedcustomer expectations.customer expectations.

Application of this principle is reflected inApplication of this principle is reflected in

ISO 9001:2008 clauses 5.2, 7.2.3 and 8.2.1ISO 9001:2008 clauses 5.2, 7.2.3 and 8.2.1



Customer Focus...Customer Focus...

ApplicationApplication of of thisthis principleprinciple involvesinvolves ::

ResearchingResearching andand understandingunderstanding customer customer needsneedsandand expectationsexpectations..

EnsuringEnsuring thatthat thethe objectivesobjectives of of thethe organizationorganization arearelinkedlinked toto customer customer needsneeds andand expectationsexpectations..

CommunicatingCommunicating customer customer needsneeds andand expectationsexpectationsthroughoutthroughout thethe organizationorganization..

MeasuringMeasuring customer customer satisfactionsatisfaction andand actingacting onon thetheresultsresults

SystematicallySystematically managingmanaging customer customer relationshipsrelationships..EnsuringEnsuring aa balancedbalanced approachapproach betweenbetween satisfyingsatisfyingcustomerscustomers andand other other interestedinterested partiesparties (such(such asasowners,owners, employees,employees, suppliers,suppliers, financiers,financiers, locallocalcommunitiescommunities andand societysociety asas aa whole)whole)



Quality Management Principle No.2Quality Management Principle No.2

LeadershipLeadership

Leaders establish unity of purpose andLeaders establish unity of purpose anddirection of the organization. Theydirection of the organization. Theyshould create and maintain the internalshould create and maintain the internal

environment in which people canenvironment in which people canbecome fully involved in achieving thebecome fully involved in achieving theorganization¶s objectives.organization¶s objectives.

This principle is reflected in ISOThis principle is reflected in ISO9001:2008 clauses 5.3, 5.4, 5.5, 6.1, 6.29001:2008 clauses 5.3, 5.4, 5.5, 6.1, 6.2



Leadership...Leadership...

Application of this principle involvesApplication of this principle involves::

ConsideringConsidering thethe needsneeds of of allall interestedinterested partiesparties includingincludingcustomers,customers, owners,owners, employees,employees, suppliers,suppliers, financiers,financiers,locallocal communitiescommunities andand societysociety asas aa wholewhole..

EstablishingEstablishing aa clear clear visionvision of of thethe organization¶sorganization¶s futurefuture..SettingSetting challengingchallenging goalsgoals andand targetstargets..

CreatingCreating andand sustainingsustaining sharedshared values,values, fairnessfairness andandethicalethical rolerole modelsmodels atat allall levelslevels of of thethe organizationorganization..

EstablishingEstablishing trusttrust andand eliminatingeliminating fear fear..

ProvidingProviding peoplepeople withwith thethe requiredrequired resources,resources, trainingtrainingandand freedomfreedom toto actact withwith responsibilityresponsibility andand accountabilityaccountability..

Inspiring,Inspiring, encouragingencouraging andand recognizingrecognizing people¶speople¶scontributionscontributions..



PeoplePeople atat allall levelslevels areare essenceessence of of anan organizationorganization

andand their their fullfull involvementinvolvement enablesenables their their abilitiesabilities toto bebeusedused for for thethe organization¶sorganization¶s benefitbenefit.. ThisThis principleprinciple isis

reflectedreflected inin ISOISO 90019001::20082008 clausesclauses 55..33(d)(d) andand 66..22..

Quality Management Principle No.3

Involvement of people



Involvement of people...Involvement of people...

Application of this principle involves:Application of this principle involves:

People understanding the importance of their People understanding the importance of their

contribution and role in the organization.contribution and role in the organization.

People identifying constraints to their performance.People identifying constraints to their performance.

People accepting ownership of processes andPeople accepting ownership of processes and

problems and their responsibility for solving them.problems and their responsibility for solving them.



Involvement of people...Involvement of people...

People evaluating their performance against their People evaluating their performance against their

personal goals and objectives.personal goals and objectives.

People actively seeking opportunities to enhance their People actively seeking opportunities to enhance their competence, knowledge and experience.competence, knowledge and experience.

People freely sharing knowledge and experience.People freely sharing knowledge and experience.

People openly discussing problems and issues.People openly discussing problems and issues.



AA desireddesired resultresult isis achievedachieved moremore efficientlyefficiently whenwhen

activitiesactivities andand relatedrelated resourcesresources areare managedmanaged asas aa

processprocess..

ThisThis principleprinciple isis reflectedreflected inin almostalmost allall clausesclauses of of

ISOISO 90019001


Process Approach



ApplicationApplication of of thisthis principleprinciple involvesinvolves::

SystematicallySystematically definingdefining thethe activitiesactivities necessarynecessary toto

obtainobtain aa desireddesired resultresult..

EstablishingEstablishing clear clear responsibilityresponsibility andand accountabilityaccountability for for

managingmanaging keykey activitiesactivities..

Analyzing Analyzing andand measuringmeasuring of of thethe capabilitycapability of of keykeyactivitiesactivities..

Process Approach...



IdentifyingIdentifying thethe interfacesinterfaces of of keykey activitiesactivities withinwithin andand

betweenbetween thethe functionsfunctions of of thethe organizationorganization..

FocusingFocusing onon thethe factorsfactors -- suchsuch asas resources,resources,

methods,methods, andand materialsmaterials -- thatthat willwill improveimprove keykey

activitiesactivities of of thethe organizationorganization..

EvaluatingEvaluating risks,risks, consequencesconsequences andand impactsimpacts of of

activitiesactivities onon customers,customers, supplierssuppliers andand other other

interestedinterested partiesparties..

Process Approach...



Identifying,Identifying, understandingunderstanding andand managingmanaging inter inter--relatedrelated

processesprocesses asas aa systemsystem contributescontributes toto thethe

organization¶sorganization¶s effectivenesseffectiveness andand efficiencyefficiency inin

achievingachieving itsits objectivesobjectives.. ThisThis principleprinciple isis reflectedreflected inin

ISOISO 90019001::20082008clausesclauses 44..11&& 44..22..


System approach to management



System approach to management...System approach to management...


StructuringStructuring aa systemsystem toto achieveachieve thethe organization¶sorganization¶s

objectivesobjectives inin thethe mostmost effectiveeffective andand efficientefficient wayway.. UnderstandingUnderstanding thethe inter inter--dependenciesdependencies betweenbetween thethe

processesprocesses of of thethe systemsystem..

StructuredStructured approachesapproaches thatthat harmonizeharmonize andand integrateintegrate

processesprocesses..



System approach to management...System approach to management...

ProvingProving aa better better understandingunderstanding of of thethe rolesroles andand responsibilitiesresponsibilities

necessarynecessary for for achievingachieving commoncommon objectivesobjectives andand therebythereby reducingreducing crosscross--

functionalfunctional barriersbarriers.. UnderstandingUnderstanding organizationalorganizational capabilitiescapabilities andand establishingestablishing resourceresource

constraintsconstraints prior prior toto actionaction..

TargetingTargeting andand definingdefining howhow specificspecific activitiesactivities withinwithin aa systemsystem shouldshould

operateoperate..

ContinuallyContinually improvingimproving thethe systemsystem throughthrough measurementmeasurement andand evaluationevaluation..



ContinualContinual improvementimprovement of of thethe organization¶sorganization¶s overalloverall

performanceperformance shouldshould bebe aa permanentpermanent objectiveobjective of of thetheorganizationorganization..

ThisThis principleprinciple isis reflectedreflected inin ISOISO 90019001 clauseclause 88..55..


Continual Improvement



Continual Improvement...Continual Improvement...


EmployingEmploying aa consistentconsistent organizationorganization--widewide approachapproachtoto continualcontinual improvementimprovement of of thethe organization¶sorganization¶s

performanceperformance..

ProvidingProviding peoplepeople withwith trainingtraining inin thethe methodsmethods andand

toolstools of of continualcontinual improvementimprovement..



MakingMaking continualcontinual improvementimprovement of of products,products,

processesprocesses andand systemssystems anan objectiveobjective for for everyevery

individualindividual inin thethe organizationorganization..

EstablishingEstablishing goalsgoals toto guide,guide, andand measuresmeasures toto track,track,

continualcontinual improvementimprovement..

RecognizingRecognizing andand acknowledgingacknowledging improvementsimprovements..

Continual Improvement...Continual Improvement...



Effective decisions are based on the analysis of Effective decisions are based on the analysis of data and information.data and information.

This principle is reflected in ISO 9001:2008This principle is reflected in ISO 9001:2008

clauses 5.4.1, 5.6.2, 7.3 and 8.4clauses 5.4.1, 5.6.2, 7.3 and 8.4


Factual approach to decision making



Factual approach to decision makingFactual approach to decision making

Application of this principle involves:Application of this principle involves:

Ensuring that data and information are sufficientlyEnsuring that data and information are sufficiently

accurate and reliable.accurate and reliable.

Making data accessible to those who need it.Making data accessible to those who need it.

Analyzing data and information using valid methods. Analyzing data and information using valid methods.

Making decisions and taking action based on actualMaking decisions and taking action based on actual

analysis, balanced with experience and intuitionanalysis, balanced with experience and intuition



An An organizationorganization andand itsits supplierssuppliers areare inter inter--

dependentdependent andand aa mutuallymutually beneficialbeneficialrelationshiprelationship enhancesenhances thethe abilityability of of bothboth toto

createcreate valuevalue..

ThisThis principleprinciple isis reflectedreflected inin ISOISO 90019001::20082008

clauseclause 77..44


Mutually beneficial supplier relationships




EstablishingEstablishing relationshipsrelationships thatthat balancebalance shortshort--termtermgainsgains withwith longlong--termterm considerationsconsiderations..

PoolingPooling of of expertiseexpertise andand resourcesresources withwith partnerspartners..

IdentifyingIdentifying andand selectingselecting keykey supplierssuppliers..

Clear Clear andand openopen communicationcommunication..

Mutually beneficial supplier relationships



SharingSharing informationinformation andand futurefuture plansplans..

EstablishingEstablishing joint joint developmentdevelopment andand improvementimprovement

activitiesactivities..

Inspiring,Inspiring, encouragingencouraging andand recognizingrecognizing improvementsimprovements

andand achievementsachievements byby supplierssuppliers..

Mutually beneficial supplier relationshipsMutually beneficial supplier relationships



ISO 9000 standardsISO 9000 standards

ThreeThree importantimportant standardsstandards inin thethe familyfamily of of ISOISO 90009000InternationalInternational StandardStandard areare::

ISO 9000:ISO 9000: Concepts, Principles, Fundamentals andConcepts, Principles, Fundamentals and

VocabularyVocabulary

ISO 9001:ISO 9001: Sets the QMS Requirements to be metSets the QMS Requirements to be met

ISO 9004:ISO 9004: Provides guidance for Continual improvement of Provides guidance for Continual improvement of organization¶s overall performanceorganization¶s overall performance



ISO 9001:2008ISO 9001:2008

Internationally accepted management standard thatInternationally accepted management standard thathas become a world benchmark for goodhas become a world benchmark for goodmanagement practicemanagement practice

Generic standard i.e. any industry sector viz.Generic standard i.e. any industry sector viz.manufacturing or service (education, hospitals,manufacturing or service (education, hospitals,hotels, banks, transport, accountancy, etc.) can usehotels, banks, transport, accountancy, etc.) can useit.it.

Any type (private, public, government enterprise, Any type (private, public, government enterprise,etc) and any size of enterprise can use it (big, smalletc) and any size of enterprise can use it (big, smallor tiny)or tiny)



PDC A MethodologyPDC A Methodology

Plan

Do

check

Act



Model of Process based Quality Management SystemModel of Process based Quality Management System

Continual Improvement of the qualitymanagement system

Product

Product

realization

Managementresponsibility

Resource

management

Measurement,

analysis &

improvement

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ME

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C

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ISO 9001:2008ISO 9001:2008Quality Management SystemQuality Management System -- RequirementsRequirements

11..00 ScopeScope

22..00 NormativeNormative ReferencesReferences

33..00 TermsTerms andand DefinitionsDefinitions

44..00 QualityQuality ManagementManagement SystemSystem RequirementsRequirements

55..00 ManagementManagement ResponsibilityResponsibility

66..00 ResourceResource ManagementManagement

77..00 ProductProduct RealizationRealization

88..00 Measurement,Measurement, Analysis Analysis && ImprovementImprovement



4.1 General Requirements4.1 General Requirements

a)a) Identification of the processes for the QMSIdentification of the processes for the QMS

b)b) Determine the sequence of these processesDetermine the sequence of these processes

c)c) Determine criteria for effective operation &Determine criteria for effective operation &

control of these processescontrol of these processesd)d) Ensure the availability of resourcesEnsure the availability of resources

e)e) Monitor, measure (where applicable) andMonitor, measure (where applicable) and

analyze these processesanalyze these processes

f)f) Implement actions necessary for achievingImplement actions necessary for achievingplanned results and continual improvementplanned results and continual improvement

Quality Management System - 1

Q S



4.2.1 General

The QMS Documentation shall include:The QMS Documentation shall include:

a)a) Quality Policy & Quality ObjectivesQuality Policy & Quality Objectives

b)b) Quality ManualQuality Manualc)c) Documented procedures and records requiredDocumented procedures and records required

by this Standardby this Standard

d)d) Documents needed for planning, operation andDocuments needed for planning, operation and

control of processescontrol of processes

e)e) Records required by this StandardRecords required by this Standard

4.2 Documentation Requirements - 14.24.2 Documentation RequirementsDocumentation Requirements -- 11


Q lit M t S t 3



4.2.2 Quality Manual

a)a) Scope of QMS / Justification of the ExclusionsScope of QMS / Justification of the Exclusions

b)b) Documented procedures or reference to themDocumented procedures or reference to them

c)c) Description of interaction between the processesDescription of interaction between the processesof the QMSof the QMS

4.24.2 Documentation RequirementsDocumentation Requirements -- 22


Q lit M t S t 4



4.2.3 Control of documentsEstablishEstablish documented proceduredocumented procedure to define method to:to define method to:

a)a) Approve documents Approve documents

b)b) Review, update and reReview, update and re--approve documentsapprove documents

c)c) Identify the revision status / changesIdentify the revision status / changes

d)d) Ensure availability of relevant versions at point of Ensure availability of relevant versions at point of

useuse

e)e) Ensure documents are legible and readilyEnsure documents are legible and readilyidentifiableidentifiable

f)f) Identification and Control the external documentsIdentification and Control the external documents

g)g) Identification and Control of obsolete documentsIdentification and Control of obsolete documents



Q lit M t S t 5



4.2.4 Control of records

a) Establish / Maintain records to demonstrate

conformity to this International Standard

b) Keep records legible, readily identifiable andretrievable

c) Establish documented procedure for

identification, storage, protection, retrieval,

specify retention time and their disposition



D t ti R i t



DocumentsDocumentsQuality manual

Flow chart of major processes and their

interaction

Document control procedureRecord control procedure.

Description of out sourced services and their

control procedure.

RecordsRecordsDocument updating records

Disposal of quality records

C lause 4C lause 4

Documentation Requirements

M t R ibilit 1



a) Communication to the organization theimportance of meeting customer, statutory

and regularity requirements

b) Establish Quality Policy & Quality Objectives

c) Conducting Management Reviews

d) Ensuring the availability of resources

5.1 Management Commitment5.1 Management Commitment

Management Responsibility - 1

5.2 Customer Focus5.2 Customer Focus

Determine and meet the customer requirements

for enhancing customer satisfaction

M t R ibilit 2



a) Is appropriate to the purpose of the

organization

b) Includes a commitment to comply with and

continually improve the QMSc) Provides framework of establishing and

reviewing Quality Objectives

d) Is communicated and understood within

organization

e) Is reviewed for continuing suitability

5.3 Quality Policy5.3 Quality Policy


M t R ibilit 3



5.4.1 Quality Objectives

a) Needed to meet the requirements of the

product are established at relevant functions

within the organization

b) Are measurable and consistent with the

Quality Policy

5.45.4 PlanningPlanning -- 11


Management Responsibility 4



Specific

Measurable

AchievableResults orientated

Time bound

SMART ObjectivesSMART Objectives





5.4.2 Quality Management System Planning

Top Management shall ensure that

a) Planning is done for meeting the requirements

of this standard (4.1) and Quality Objectivesb) Integrity of the QMS is maintained when

changes to QMS are planned and implemented


5.45.4 PlanningPlanning -- 22




5.5.1 Responsibility and AuthorityAre defined and communicated

5.5.2 Management Representative

The Management Shall appoint a Management

Representative responsible to :a) Ensure that processes for QMS are established,

implemented and maintained

b) Reporting to top management on performance of QMS

and any need for improvementc) Ensure the promotion of awareness of customer

requirements throughout the organization

5.5 Responsibility, Authority and Communication5.5 Responsibility, Authority and Communication -- 11





5.5.3 Internal Communication

Top management shall ensure that

appropriate communication processes are

established within the organization and thatcommunication takes place regarding the

effectiveness of quality management system.


5.5 Responsibility, Authority and Communication5.5 Responsibility, Authority and Communication -- 22




5.6.1 GeneralThe management shall review the QMS atplanned intervals to ensure it¶s continuedsuitability, adequacy and effectiveness

The review shall include :a) Assessing opportunities for improvement

and need for changes to the QMS

b) Review of the Quality Policy and Quality

ObjectivesRecords of the reviews must be kept

5.65.6 Management ReviewManagement Review -- 11





5.6.2 Review InputsThe Inputs shall include information on:

a) Results of audits

b) Customer feedback

c) Process performance and product conformity

d) Status of preventive and corrective action

e) Follow-up actions from previousmanagement review

f) Changes which could affect the QMS

g) Recommendations for improvement






5.6.3 Review OutputsThe Outputs shall include any decisions and

actions on:

a) Improvement of the effectiveness of quality

management system and processes,

b) Improvement of product related to customer

requirements

c) Resources needs






DocumentsDocuments

Quality objectives at organizational and

functional level.

Organization structure and responsibilities of

management representative and keyfunctionaries whose job affects product

quality.

Description of internal communication channel. (

This could be specified in quality manual)Procedure for management review

RecordsRecords

Evidence of quality planning

Record of management review

C lause 5 C lause 5


Resource Management - 1



The Organization shall determine and provideresources needed to :

a) Implement and maintain the QMS and

continually improve its effectiveness

b) Enhance customer satisfaction by meeting

customer requirements.


6.16.1 Provision of ResourcesProvision of Resources




6.2.1 GeneralCompetent persons should perform work effecting quality

6.2.2 Competence, awareness and training

a) Determine the necessary competence for the

personnel performing work effecting qualityb) Provide training and take action to satisfy these

needs

c) Evaluate the effectiveness of the action taken

d) Ensure that its personnel are aware of relevance andimportance of their activities and how they contribute

to the achievement of the quality objectives

e) Maintain appropriate records of education, training,

skills and experience

6.26.2 Human ResourcesHuman Resources





The organization shall determine, provide andmaintain the infrastructure needed to achieve

product conformity, it includes:

a) Building, workplace and associated utilities

b) Process equipment (both hardware and

software)

c) Supporting services(such as transport or communication)

6.36.3 InfrastructureInfrastructure





The organization shall determine and manage

the work environment needed to achieve

conformity to product requirements

6.46.4 Work EnvironmentWork Environment





DocumentsDocuments

Specific requirement of qualification and

competence of personnel

Procedure for identifying training needs and

yearly training plan

List of special facilities or work environments

affecting quality

Procedure for maintenance of buildings

equipment and facilitiesRecordRecord

Record of training and experience of personnel

Maintenance record

C lause 6 C lause 6


Product Realization - 1



Organization shall plan and develop the processesneeded for product realization, while considering theFollowing factors as appropriate:

a) Quality objective and requirements for the product

b) Need to establish processes, documents, andprovide resources specific to the product

c) Required verification, validation, monitoring,

inspection and test activities specific to the product

and the criteria for product acceptanced) Records needed to provide evidence that the

realization processes and resulting product meet

requirements (see 4.2.4)

7.17.1 Planning of Product RealizationPlanning of Product Realization

Product Realization 1




7.2.1 Determination of requirements related to the productThe organization shall determine:

a) Requirements specified by customer including

(delivery conditions & post Delivery activities)

b) Requirements not stated but necessary for the

intended use, where known

c) Statutory & regulatory requirements related to

productd) Any additional requirement determined by the

organization

7.27.2 Customer Related ProcessesCustomer Related Processes -- 11





7.2.2 Review of Requirements Related to the ProductReview following before the acceptance of contract :

a) Product requirements are defined

b) Contract or order requirements differing from those

previously expressed are resolved

c) The organization has the ability to meet the defined

requirements.

Results of the reviews must be maintained

Any change in requirements is communicated to all






7.2.2 Customer Communication

The organization shall define and implement

Effective arrangements for communicating with

customers in relation to :a) Product information

b) Enquiries, contracts or order handling,

including amendments, and

c) Customer feedback, including customer

complaints






7.3.1 Design and Development Planning

Organization shall determine the

a) Design and development stages,

b) Review, verification and validation that areappropriate to each design and developmentstage, and

c) Responsibilities and authorities for design

and development Planning output shall beupdated, as appropriate, as the design anddevelopment progresses

7.37.3 Design and DevelopmentDesign and Development -- 11





7.3.2 Design and Development Inputs

Inputs related to product requirements including following

shall be determined,

a) Functional and performance requirements,

b) Applicable statutory and regulatory requirements,

c) Where applicable, information derived from previoussimilar design, and

d) Other requirements essential for design anddevelopment

The requirements must be complete, unambiguous andnot in conflict in each other

The requirements must be reviewed for adequacy and

records must be maintained






7.3.3 Design and Development Outputs

The design and development outputs shall:

a) Meet the input requirements for design anddevelopment

b) Provide appropriate information for purchasing, production and for servicesprovision

c) Contain or reference product acceptancecriteria

d) Specify the characteristics of the productthat are essential for its safe and proper use






7.3.4 Design and Development Review

Reviews by representatives of the functions

concerned shall be performed in accordance with

planned arrangements (see 7.3.1) to :

a) Evaluate the ability of the results of design

and development to meet requirements, and

b) Identify any problems and propose

necessary actions.

Records of reviews and any necessary actions

shall be maintained


oduct ea at o 8




7.3.5 Design and development verification

Verification shall be performed in accordance

with planned arrangements (7.3.1) to ensure

that design and development outputs have

met the design and development input

requirements.

Records of the results and any actions shallbe maintained.





7.3.6 Design and development validationValidation shall be performed in accordance

with planned arrangements (7.3.1) to ensure

that Resulting product is capable of meeting

requirements for intended use, where known.

Where practicable, validation shall be

completed prior to the delivery or

implementation of the productRecords of the results and any actions shall

be maintained.





7.3.7 Control of design and development changes

The changes will be reviewed, verified and

validated as appropriate and approved before

implementation.

The review for change shall include evaluation

of the effects of the change on constituent

parts and product already delivered.

Records of the changes and any actions shallbe maintained.





7.4.1 Purchasing Process

The organization shall ensure that

purchased product conforms to specified

purchase requirements

The type and extent of control applied shall

be dependent upon the effect on the final

product

7.47.4 PurchasingPurchasing -- 11




7.4.2 Purchasing Information

Purchasing information shall describe the

purchased product, including where appropriate:

a) Requirement for approval of product,

procedures, process and equipment

b) Requirement for qualification of personnel

c) Quality management system requirements





7.4.3 Verification of the Purchased Product

Establish and implement the inspection

activities necessary for ensuring

conformance of purchased product topurchase information.

Where verification at the supplier¶s premises

is required by organization / customer, itshall be indicated so in the purchase

information.





7.5.1Control of Production and Service ProvisionProduction and service provision shall be carried out

under controlled conditions, as applicable:

a) Availability of information that describes the

characteristics of the product,

b) Availability of work instructions, as necessary,

c) Use of suitable equipment,

d) Availability and use of monitoring and measuring

devices,

e) Implementation of monitoring and measurement, and

f) Implementation of release, delivery and post-delivery

activities.

7.57.5 Production and Service ProvisionProduction and Service Provision -- 11




7.5.2Validation of processes for production and service

provisionValidation of process shall be done where the resultingoutput cannot be verified by subsequent monitoring or measurement, the following shall be addressed:

a) Defined criteria for review and approval of theprocesses

b) Approval of equipment and qualification of personnel

c) Use of specific methods and procedures

d) Requirements for recordse) Revalidation





7.5.3Identification and Traceability

Identification of product by suitable means

throughout product realization

Identification of the product status with

respect to the monitoring and measurement

requirements

Where traceability is required the

organization shall control and record the

unique identification of the product





7.5.4Customer Property

The organization shall

a) Identify, verify, protect and safeguard

customer propertyb) In case of loss, damage or unsuitable for use

customer must be informed

c) Records must be maintained





7.5.5Preservation of Product

The organization shall preserve the

conformity of product during internal

processing and delivery to the intendeddestination.

This preservation shall include identification,

handling, packing, storage and protection.

Preservation shall also apply to the

constituent parts of product





The equipments Shall be:

a) Calibrated or verified at specific intervals, or prior to use,

against measurement standards traceable to international

or national measurement standards, where no such

standards exist, the basis used for calibration or verification

shall be recorded

b) Adjusted or re-adjusted as necessary

c) Identified to enable the calibration status to be determined

d) Safeguarded from adjustments that would invalidate the

measurement result

e) Protected from damage and deterioration during handling,

maintenance and storage

f) Records shall be maintained

7.67.6 Control of Monitoring and Measuring EquipmentsControl of Monitoring and Measuring Equipments




DocumentsDocuments

Quality plan or other documents showing how

quality is planned in products/projects

Method of capturing customer requirements

Review of orders or contracts to assess

capability to meet customer¶s requirements

Specifications for company¶s products

Procedure for design and development

Specifications for purchased materials

C lause 7 C lause 7




DocumentsDocuments

Procedure for selection and approval of

suppliers

Procedure for review of suppliers performance

Procedure for verification of purchased products

and dealing with non conforming supplies.

Procedures or work instruction for critical

processes.

Procedure for assessing process capability and

approval of processes.

Qualification of operators and processes where

quality cannot be verified after work is

finished.

C lause 7 contnd..C lause 7 contnd..




DocumentsDocuments

Procedure for maintenance of critical equipment.

Procedure for identification and traceability of

materials (where required).

Inspection and testing plans/instructions.

Procedure for showing inspection/test status of

materials/equipment.

Procedure for calibration measuring devices.

Procedure for handling customer property.

Procedure for preservation, packaging and

storage of product.

C lause 7 contd«C lause 7 contd«




RecordsRecords

Contract review of major contracts

Design review record

Results of design verification/validation

Inspection results of purchased materials.

Record of qualification of operators and

processes where output cannot be assessed

for non conformity.

Inspection and testing records

Record of rework and rejection

Calibration record of measuring devices.

Record of damaged or lost customer property

(where applicable).

C lause 7 C lause 7

Measurement, Analysis and Improvement - 1



Organization must plan and implement themonitoringmeasurement, analysis and improvement

processesneeded to :

a) Demonstrate conformity of the product

b) Ensure conformity of the QMS

c) Continually improve the effectiveness of QMS

Determine applicable method including Statistical

Techniques and extent of their use

8.18.1 GeneralGeneral




8.2.1 Customer Satisfaction

Establish a method for obtaining and using

the information about customer perception

as to whether the organization has met

customer requirements

8.28.2 Monitoring & MeasurementMonitoring & Measurement -- 11




8.2.2 Internal AuditDocumented procedures Shall be established andinternal audits shall be conducted at regular intervalsto determine whether the QMS :

a) Conforms to standard and other requirements

determined by organizationb) Is effectively implemented and maintained

Audit shall be:

1. Planned, Criteria / Scope / Frequency and method bedefined.

2. Selection / conduct of audit shall ensure impartiality

3. Follow-up activities shall be performed

4. Records shall be maintained





8.2.3 Monitoring and measurement of processes

Apply methods for monitoring and where

applicable measurement of QMS processes.

Methods shall demonstrate the ability of theprocesses to achieve the planned results.

In case planned results are not obtained

Corrective / Preventive actions must be takento ensure the conformity to the product.





8.2.4 Monitoring and measurement of productMonitor the characteristics of the product at

appropriate stages in accordance with

planned arrangements (see 7.1)

Evidence of conformity and acceptancecriteria must be defined.

No product or service delivery shall not

proceed until the planed arrangement aresatisfactorily completed and approved by

authorized person.

Records shall also be maintained.





The nonconforming products must be

identified and controlled to prevent unintended

use or delivery.

Documented procedure stating responsibilityand authority to deal with nonconforming

products shall be defined.

8.3 Control of Nonconforming Product8.3 Control of Nonconforming Product -- 11




The organization shall deal with nonconforming productsby :

a) Taking action to eliminate the detected non

conformityb) Authorizing its use, release / acceptance under

concession by relevant authority if allowed bycustomer.

c) Take action to prevent its original intended use

Records and actions taken shall be recorded.

Incase of rework product shall be re-verified

Incase the product has been delivered appropriateactions shall be taken

8.3 Control of Nonconforming Product8.3 Control of Nonconforming Product -- 22




Determine, collect and analyze appropriate datato demonstrate the suitability and effectivenessof the QMS and to evaluate where continualimprovement of the QMS can be made.

Analysis of data shall provide informationrelating to:

a) Customer Satisfaction (see 8.2.1)

b) Conformity of product requirements (see 7.2.1)

c) Characteristics and trends of processes and

and products including opportunities of

Corrective action

d) Suppliers

8.48.4 Analysis of DataAnalysis of Data




8.5.1 Continual ImprovementThe organization shall continually improve the

effectiveness of QMS through the use of :

Quality Policy

Quality Objectives,

Audit Results

Analysis of data,

Corrective and Preventive Actions

Management Review

8.58.5 ImprovementImprovement -- 11





8.5.2 Corrective Action

Corrective actions shall be taken to eliminatecauses

of nonconformities to prevent their recurrence.

Documented procedure shall be established todefine requirements for:

a) Reviewing nonconformities (including

customer complaints)b) Determining the causes of nonconformities

c) Evaluating the need for action to ensure thatnonconformities do not recur





d) Determining and implementing action needed

e) Records of the action taken results

f) Reviewing corrective action taken




8.5.3 Preventive Action

Preventive actions shall be taken to eliminatecauses

of potential nonconformities to prevent their

occurrence. Documented procedure shall beestablished to define requirements for:

a) Determining potential nonconformities and

their causes

b) Evaluating the need for action to prevent

occurrence of nonconformities

c) Determining and implementing action needed





d) Records of results action taken

e) Reviewing preventive action taken





DocumentsDocuments

Procedure for measurement and monitoring of processes for effective control.

Methods for use of statistical techniques for

process control and data analysis for

improvement.

Procedure for inspection and release of final

product.

Procedure for dealing with non conforming

product and use of material under

concession.

Procedure for monitoring customer satisfaction

and dealing with customer complaints.

C lause 8 C lause 8




DocumentsDocuments

Procedure of internal audit of QMS, along withcheck list.

Procedure for corrective and preventive action.

Procedure for collection and analysis of data for

effectiveness and improvement of QMS.

RecordsRecords

Process monitoring data and corrective action

taken for process control

Record of product non conformities and

products accepted on concession.





RecordsRecords

Data analysis and activities for continualimprovement.

Result of internal audits and follow up action.

Data on customer feedback and action taken on

customer complaints.


N b dN b d



No bodyNo body

Can AchieveCan Achieve

QQUU ALITY ALITY

WithoutWithout

UU



Thank you !!!Thank you !!!