Awarness ISO 9001
Transcript of 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
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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)
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Introduction to Quality and
Standardization
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What is Quality after all?What is Quality after all?
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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
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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
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StandardizationStandardization
The process of developing and agreeing upon Standards.
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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
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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.
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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.
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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.
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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
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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
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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 .
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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.
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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
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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.
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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
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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
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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)
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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
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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..
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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
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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.
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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.
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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
Quality Management Principle No.4
Process Approach
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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...
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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...
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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..
Quality Management Principle No.5
System approach to management
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System approach to management...System approach to management...
ApplicationApplication of of thisthis principleprinciple involvesinvolves::
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..
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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..
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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..
Quality Management Principle No.6
Continual Improvement
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Continual Improvement...Continual Improvement...
ApplicationApplication of of thisthis principleprinciple involvesinvolves::
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..
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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...
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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
Quality Management Principle No.7
Factual approach to decision making
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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
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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
Quality Management Principle No.8
Mutually beneficial supplier relationships
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ApplicationApplication of of thisthis principleprinciple involvesinvolves::
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
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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
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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
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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)
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PDC A MethodologyPDC A Methodology
Plan
Do
check
Act
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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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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
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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
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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
Quality Management System - 2
Q lit M t S t 3
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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
Quality Management System - 3
Q lit M t S t 4
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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
4.24.2 Documentation RequirementsDocumentation Requirements -- 33
Quality Management System - 4
Q lit M t S t 5
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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
4.24.2 Documentation RequirementsDocumentation Requirements -- 44
Quality Management System - 5
D t ti R i t
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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
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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
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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
Management Responsibility - 2
M t R ibilit 3
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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 - 3
Management Responsibility 4
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Specific
Measurable
AchievableResults orientated
Time bound
SMART ObjectivesSMART Objectives
Management Responsibility - 4
Management Responsibility 5
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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
Management Responsibility - 5
5.45.4 PlanningPlanning -- 22
Management Responsibility 6
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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
Management Responsibility - 6
Management Responsibility 7
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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.
Management Responsibility - 7
5.5 Responsibility, Authority and Communication5.5 Responsibility, Authority and Communication -- 22
Management Responsibility 8
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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
Management Responsibility - 8
Management Responsibility 9
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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
Management Responsibility - 9
5.65.6 Management ReviewManagement Review -- 22
Management Responsibility 10
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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
Management Responsibility - 10
5.65.6 Management ReviewManagement Review -- 33
Documentation Requirements
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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
Documentation Requirements
Resource Management - 1
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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.
Resource Management - 1
6.16.1 Provision of ResourcesProvision of Resources
Resource Management - 2
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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
Resource Management - 2
Resource Management - 3
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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
Resource Management - 3
Resource Management - 4
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The organization shall determine and manage
the work environment needed to achieve
conformity to product requirements
6.46.4 Work EnvironmentWork Environment
Resource Management - 4
Documentation Requirements
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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
Documentation Requirements
Product Realization - 1
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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
Product Realization - 2
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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
Product Realization 2
Product Realization - 3
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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
7.27.2 Customer Related ProcessesCustomer Related Processes -- 22
Product Realization 3
Product Realization - 4
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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
7.27.2 Customer Related ProcessesCustomer Related Processes -- 33
Product Realization 4
Product Realization - 5
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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
Product Realization 5
Product Realization - 6
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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
7.37.3 Design and DevelopmentDesign and Development -- 22
Product Realization 6
Product Realization - 7
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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
7.37.3 Design and DevelopmentDesign and Development -- 33
Product Realization 7
Product Realization - 8
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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
7.37.3 Design and DevelopmentDesign and Development -- 44
oduct ea at o 8
Product Realization - 9
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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.
7.37.3 Design and DevelopmentDesign and Development -- 55
Product Realization - 10
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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.
7.37.3 Design and DevelopmentDesign and Development -- 66
Product Realization - 11
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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.
7.37.3 Design and DevelopmentDesign and Development -- 77
Product Realization - 12
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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
Product Realization - 13
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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
7.47.4 PurchasingPurchasing -- 22
Product Realization - 14
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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.
7.47.4 PurchasingPurchasing -- 33
Product Realization - 15
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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
Product Realization - 16
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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
7.57.5 Production and Service ProvisionProduction and Service Provision -- 22
Product Realization - 17
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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
7.57.5 Production and Service ProvisionProduction and Service Provision -- 33
Product Realization - 18
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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
7.57.5 Production and Service ProvisionProduction and Service Provision -- 44
Product Realization - 19
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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
7.57.5 Production and Service ProvisionProduction and Service Provision -- 55
Product Realization - 20
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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
Documentation Requirements
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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
Documentation Requirements
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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..
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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«
Documentation Requirements
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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
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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
Measurement, Analysis and Improvement - 2
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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
Measurement, Analysis and Improvement - 3
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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
8.28.2 Monitoring & MeasurementMonitoring & Measurement -- 22
Measurement, Analysis and Improvement - 4
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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.
8.28.2 Monitoring & MeasurementMonitoring & Measurement -- 33
Measurement, Analysis and Improvement - 5
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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.
8.28.2 Monitoring & MeasurementMonitoring & Measurement -- 44
Measurement, Analysis and Improvement - 6
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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
Measurement, Analysis and Improvement - 7
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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
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Measurement, Analysis and Improvement - 8
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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
Measurement, Analysis and Improvement - 9
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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
Measurement, Analysis and Improvement - 10
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8.58.5 ImprovementImprovement -- 22
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
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8.58.5 ImprovementImprovement -- 33
d) Determining and implementing action needed
e) Records of the action taken results
f) Reviewing corrective action taken
Measurement, Analysis and Improvement - 12
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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
8.58.5 ImprovementImprovement -- 44
Measurement, Analysis and Improvement - 13
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d) Records of results action taken
e) Reviewing preventive action taken
8.58.5 ImprovementImprovement -- 55
Documentation Requirements
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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
Documentation Requirements
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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.
C lause 8 contnd..C lause 8 contnd..
Documentation Requirements
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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.
C lause 8 contnd..C lause 8 contnd..
N b dN b d
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No bodyNo body
Can AchieveCan Achieve
QQUU ALITY ALITY
WithoutWithout
UU
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Thank you !!!Thank you !!!