iso 9001-2000 quality management system design

402 Pages·2003·2.02 MB·English

ISO 9001:2000 Quality
Management System Design
ForalistingofrecenttitlesintheArtechHouse
ProfessionalDevelopmentLibrary,turntothebackofthisbook.
ISO 9001:2000 Quality
Management System Design
Jay Schlickman
Artech House
Boston • London
www.artechhouse.com
LibraryofCongressCataloging-in-PublicationData
Schlickman,JayJ.,1934–
ISO9001:2000qualitymanagementsystemdesign
p.cm.–(ArtechHousetechnologymanagementandprofessionaldevelopmentlibrary)
Includesbibliographicalreferencesandindex.
ISBN1-58053-526-7(alk.paper)
1.ISO9000SeriesStandards. I.Title. II.Series.
TS156.6.S352003
658.5′62–dc21
2002038271
BritishLibraryCataloguinginPublicationData
Schlickman,Jay
ISO9001:2000qualitymanagementsystemdesign—
(ArtechHousetechnologymanagementandprofessionaldevelopmentlibrary)
1.Qualitycontrol 2.ISO9001Standard
I.Title
658.5′62
ISBN1-58053-526-7
CoverdesignbyGaryRagaglia
©2003ARTECHHOUSE,INC.
685CantonStreet
Norwood,MA02062
Allrightsreserved.PrintedandboundintheUnitedStatesofAmerica.Nopartofthisbookmaybereproducedor
utilizedinanyformorbyanymeans,electronicormechanical,includingphotocopying,recording,orbyanyinfor-
mationstorageandretrievalsystem,withoutpermissioninwritingfromthepublisher.
Alltermsmentionedinthisbookthatareknowntobetrademarksorservicemarkshavebeenappropriatelycapi-
talized.ArtechHousecannotattesttotheaccuracyofthisinformation.Useofaterminthisbookshouldnotbe
regardedasaffectingthevalidityofanytrademarkorservicemark.
InternationalStandardBookNumber:1-58053-526-7
LibraryofCongressCatalogCardNumber:2002038271
10987654321
Thisbookisdedicatedtomywife,Judith,
forforty-fiveyearsoftotalqualitymarriageandstillgoingstrong
.
Contents
Preface . . . . . . . . . . . . . xvii
Acknowledgments . . . . . . . . . xxiii
Part I: QMS Design Fundamentals . . . . . 1
1 QMS Foundations . . . . . . . . . . 3
1.1 TheRelevanceofStandards 3
1.2 CoreCompetencies 4
1.2.1 CoreProcesses 5
1.2.2 StrategyToTransformDocumentationintoanOperationalSystem 6
1.3 SelectionofaQMSBaseline 7
Endnotes 8
2 The ISO 9001:2000 QMS . . . . . . . . 11
2.1 TheISO9000QMSDesignContext 11
2.2 EffectiveQMSProcesses 12
2.3 TheISO9000QMSProcessModel 14
2.3.1 QualityManagementSystemDefined 14
2.3.2 OperationalModelforISO9001:2000 14
Endnotes 16
3 QMS Continual Improvement Framework . . 17
3.1 Continuous/ContinualImprovementIsInherent 17
vii
viii Contents
3.1.1 ContinuousVersusContinualImprovementConcept 17
3.1.2 QualityAsaPhilosophy 18
3.1.3 QualityAsaScientificMeasurement 19
3.1.4 ContinualImprovementIsIntrinsicWithintheStandard 19
3.1.5 Customer-DrivenOrientation 19
3.1.6 ShewhartCycle 20
3.2 ContinuousImprovementCycleWithinElements 23
3.2.1 OtherC/I 23
3.2.2 FurtherDemonstration 23
3.2.3 ContinuousImprovementCycle 24
3.2.4 ContinualImprovementImperative 24
3.3 MandatoryDocumentationRequirements 24
3.3.1 AccreditationImpactonGuidelines 25
3.3.2 QMSDesignMethodsToBePresented 28
Endnotes 30
Part II: QMS Documentation Design . . . . 33
4 Recommended QMS Documentation . . . . 35
4.1 OverviewofDocumentationRequirements 35
4.1.1 Introduction 35
4.1.2 RecommendedDocumentationTaxonomy 36
4.2 TheFour-TierPyramidConcept 37
4.2.1 MatrixFormat 38
4.2.2 OperationalTiers 38
4.2.3 Guidelines 38
4.2.4 FourTiers 38
4.2.5 NavigationIsKey 40
4.2.6 ClearlyLinkLowerTiersfromtheManual 40
4.2.7 WaterfallEffect 40
4.2.8 ISO9000HierarchalDrivers 40
4.3 TheISO9001:2000QMSIsToBeDocumented 42
4.3.1 InformationChannelManagement 44
4.3.2 MandatoryTierIILinkageRequirements 45
Endnotes 47
Contents ix
5 Quality Manual Design . . . . . . . . 49
5.1 AQualityManualIsaMandatoryDocument 49
5.1.1 TheManualShouldBeUserFriendly 50
5.1.2 AQualityPolicyStatementIsaMandatoryDocument 51
5.1.3 StatementsofQualityObjectivesAreMandatoryDocuments 51
5.1.4 Example 51
5.1.5 PerformanceRate 54
5.2 TheQualityManualControversy 54
5.2.1 AnIssueofContent 54
5.2.2 Manual’sValue 55
5.2.3 MajorGate 56
5.2.4 CompetitiveAdvantage 57
5.2.5 RationaleforanIneffectiveManual 58
5.2.6 Conclusion 58
5.2.7 ObservedRootCauses 59
5.3 StrategicFrameworkfortheManual 60
5.3.1 UnifiedApproach—IntegrationofEnterpriseStrategy
withQualityManagement 60
5.3.2 UnifiedBusinessandQualityPolicy 60
5.3.3 ProprietaryInformation 63
5.3.4 TheDesignofQualityPolicyStatements 64
5.3.5 Manual’sValueWithintheQMS 65
5.3.6 PrescriptiveVersusParaphrasedMethods 65
5.4 Cross-FunctionalManualActionTeams 66
5.4.1 SectionExperts 66
5.4.2 Ineffectiveness 66
5.5 SHALLAnalysis 67
5.5.1 DefinitionofSHALL 67
5.5.2 AppropriateResponsetotheSHALLS 67
5.5.3 ScopeofEffort 69
5.5.4 EffectiveNumberofSHALLS 69
5.5.5 MethodtoCountSHALLS 71
5.6 ManualSectionLength 73
5.7 Concomitance 73
5.7.1 Requirement 74
5.7.2 TrainingExampleofConcomitance 74
5.7.3 Application 80