Lead Auditor / Auditor Course For Quality Management Systems ISO 9001:2008
INSTITUTE OF QUALITYLead Auditor / Auditor CourseFor Quality Management SystemsISO 9001:2008Apr 2010INTRODUCTIONApr 201021
INTRODUCTION OF PARTICIPANTS¾ Participants are requested to find a partner each.¾ You are expected to find out professional information aboutyour partner in 2 minutes. Also enquire his / her keyexpected learning from the programme.¾ Please record your findings. Write down your name and thedetails collected from your partner¾ Each participant would in turn introduce his partner to thegroup and his key expected learning.¾ Hand over your recorded findings to the tutors.Duration : 30 Minutes3Apr 2010COURSE FORMAT¾ FOR A DURATION OF FIVE DAYS¾ COVERS THE REQUIREMENTS OF IRCA / NABET¾ ENABLES SUCCESSFUL CANDIDATES TO REGISTER¾ INCLUDES CLASSROOM SESSIONS, SYNDICATEWORKSHOPS, ROLE PLAY EXERCISES¾ EXTENSIVE EXAMPLES AND CASE STUDIES BASED ONINDUSTRY SITUATIONSApr 201042
COURSE LEARNING OBJECTIVES PURPOSE OF QUALITY MANAGEMENT SYSTEM & 8 QUALITY MANAGEMENTPRINCIPLES STANDARDS – ISO 9000, ISO 9001, ISO 9004, ISO 19011 & THEIRINTERRELATIONSHIPS. INTERPRETATION OF ISO 9001 IN CONTEXT TO THE AUDIT ROLES AND RESPONSIBILITIES OF AUDITORS AND LEAD AUDITORS. PLAN AND CONDUCT AN AUDIT, GATHER OBJECTIVE EVIDENCE VIA VARIOUSMETHODS AND DETERMINE CONFORMITY TO THE REQUIREMENTS AUDIT REPORT WRITING AUDIT FOLLOW UP – EVALUATING THE EFFECTIVENESS OF CORRECTIVEACTION IMPLEMENTATION CERTIFICATION AND ACCREDITATION PROCESSES AUDITOR CERTIFICATION AND ROLE OF IRCA / NABET5Apr 2010COURSE PROGRAMME¾ BLEND OF LECTURES, INTERACTIVE WORKSHOPS ANDPRESENTATIONS¾ ROLE PLAY ON OPENING AND CLOSING MEETINGS¾ INCLUDES PRE-COURSE MATERIAL ANDCOURSE MATERIAL¾ CONTINUOUS ASSESSMENT OF PARTICIPANTS¾ COURSE EXAMINATIONApr 201063
DELEGATE RESPONSIBILITIES¾ COURSE IS INTENSIVE, HENCE FULL ATTENTION ANDDILIGENCE IS REQUIRED¾ TIME SCHEDULES ARE IMPORTANT¾ BE ALERT, INTERACTIVE AND CO-OPERATIVE¾ TAKING NOTES¾ USE OF MOBILE PHONES PROHIBITED¾ DELEGATES APPEAL AND COMPLAINT7Apr 2010EVALUATION PROCESS & CRITERIA CONTINUOUS ASSESSMENT SKILL BASED PRACTICAL WORK¾ TUTOR MARKED¾ PRESENTATION / ROLE PLAY¾ QUIZZES DAILY ASSESSMENT– CONTRIBUTION, QUESTIONING, COMMUNICATION,REPORTING, PARTICIPATION IN TEAM– PERSONAL ATTRIBUTES: ATTITUDE,MANNER,SUITABILITY AS AUDITOR– ATTENDANCE, PUNCTUALITY AND PARTICIPATION¾ RESITTING THE EXAMINATION OR THE COURSE WRITTEN EXAMINATIONApr 201084
ISSUE OF CERTIFICATES¾ SUCCESSSFUL COMPLETION CERTIFICATE WHEN THE DELEGATE HAS PASSSED BOTH THEWRITTEN EXAMINATION AND CONTINUOUSASSESSMENT¾ ATTENDANCE CERTIFICATE WHEN THE DELEGATE HAS NOT PASSSED THE WRITTENEXAMINATION BUT SATISFIES THE CONTINUOUSASSESSMENT AND ATTENDANCE REQUIREMENT¾ LETTER OF ATTENDANCE WHEN THE DELEGATE IS NOT MEETING ANY OF THEABOVE BUT SATISFIES ATTENDANCE REQUIREMENTONLY9Apr 2010SECTION – 1Introduction to QMSApr 2010105
Learning ObjectivesBy the end of the session successful students willbe able to : Explain the purpose and business benefits of a qualitymanagement system. Explain the 8 principles of quality management. Explain the process approach to management systems.11Apr 2010CertificationandrecognitionStreamliningthe systemsPurpose ofQMSImprovementinperformanceApr 2010Benefitsto stakeholdersEnhancedmarketstanding126
BENEFITS OF QUALITY MANAGEMENT¾ CUSTOMER CONFIDENCE¾ CONSISTENCY IN QUALITY¾ REDUCTION IN WASTE AND REWORK¾ EMPLOYEE PARTICIPATION¾ REDUCTION IN LIABILITIES¾ IMPROVEMENT IN PROFIT¾ CONTINUAL IMPROVEMENT13Apr 2010Activity on understanding QMPsGroup exercise :Relate the following QMPS withorganizations with the attribute most identifiable to themProcess ApproachFactual decisionmakingCustomer FocusContinual improvementSystems ApproachSupplier relationshipInvolvement of peopleLeadershipDuration 15 min.Apr 2010147
PRINCIPLES OF QUALITYMANAGEMENT¾ TO LEAD AND OPERATE AN ORGANIZATIONSUCCESSFULLY, IT IS NECESSARY TO DIRECT ANDCONTROL IT IN A SYSTEMATIC ANDTRANSPARENT MANNER¾ MANAGING AN ORGANIZATION ENCOMPASSESQUALITY MANAGEMENT AMONGST OTHERMANAGEMENT DISCIPLINES¾ EIGHT QUALITY MANAGEMENT PRINCIPLES HAVE BEENIDENTIFIED AND THEY FORM THE BASIS OF ISO 9001 :2008 STANDARD15Apr 2010PRINCIPLES OF QUALITYMANAGEMENT QUALITY MANAGEMENTPRINCIPLE 1QUALITY MANAGEMENTPRINCIPLE 2 “CUSTOMER FOCUSEDORGANIZATION”“LEADERSHIP” ORGANIZATIONS DEPEND ON THEIRCUSTOMERS AND THEREFORESHOULD UNDERSTAND CURRENTAND FUTURE CUSTOMER NEEDS,MEET CUSTOMER REQUIREMENTSAND STRIVE TO EXCEED CUSTOMEREXPECTATIONS.Apr 2010LEADERS ESTABLISH UNITY OF PURPOSEAND DIRECTION OF THE ORGANIZATION.THEY CREATE THE INTERNAL ENVIRONMENTIN WHICH PEOPLE CAN BECOME FULLYINVOLVED IN ACHIEVING THEORGANIZATION’S OBJECTIVE168
PRINCIPLES OF QUALITYMANAGEMENT QUALITY MANAGEMENTPRINCIPLE 3QUALITY MANAGEMENTPRINCIPLE 4 “INVOLVEMENT OF PEOPLE”“PROCESS APPROACH” A DESIRED RESULT IS ACHIEVED MOREEFFICIENTLY WHEN RELATEDRESOURCES AND ACTIVITIES AREMANAGED AS A PROCESSPEOPLE OF ALL LEVELS ARE THEESSENCE OF AN ORGANIZATIONAND THEIR FULL INVOLVEMENTENABLES THEIR ABILITIES TO BEUSED FOR THE ORGANISATION’SBENEFIT17Apr 2010PRINCIPLES OF QUALITYMANAGEMENT QUALITY MANAGEMENTPRINCIPLE 5QUALITY MANAGEMENTPRINCIPLE 6 “SYSTEM APPROACH TOMANAGEMENT”“CONTINUAL IMPROVEMENT” IDENTIFYING, UNDERSTANDINGAND MANAGING A SYSTEM OFINTERRELATED PROCESSES FORA GIVEN OBJECTIVE IMPROVESTHE EFFECTIVENESS ANDEFFICIENCY OF THEORGANIZATIONCONTINUAL IMPROVEMENT SHOULD BEA PERMANENT OBJECTIVE OF THEORGANIZATIONApr 2010189
PRINCIPLES OF QUALITYMANAGEMENT QUALITY MANAGEMENTPRINCIPLE 7QUALITY MANAGEMENTPRINCIPLE 8 “FACTUAL APPROACH TO“MUTUALLY BENEFICIALSUPPLIER RELATIONSHIP”DECISION MAKING” EFFECTIVE DECISIONS AREBASED ON THE ANALYSIS OFDATA AND INFORMATIONAN ORGANISATION AND ITSSUPPLIERS ARE INTERDEPENDENTAND A MUTUALLY BENEFICIALRELATIONSHIP ENHANCES THEABILITY OF BOTH TO CREATE VALUE19Apr 2010PDCA APPROACH¾ CONCEPT INTRODUCED BY DR.SHEWHART INEARLY 40’S¾ POPULARIZED BY DR. DEMING IN THE 1950’S¾ BECAME KNOWN AS DEMING CYCLE¾ PDCA STANDS FOR PLAN, DO, CHECK AND ACT¾ PDCA CYCLE CAN BE APPLIED AT ALL LEVELS WITHINTHE ORGANIZATIONApr 20102010
PDCA CyclePDCA cycle can be applied at all levels within the organization21Apr 2010Activity on PDCAGroup exercise Apply Plan, Do, Check and Act oncommon activities like Making Tea Organizing a Picnic Home budgeting Reaching Place of workDuration 30 min.Apr 20102211
PROCESSSET OF INTERRELATED OR INTERACTING ACTIVITIES WHICHTRANSFORM INPUTS INTO OUTPUTS (ISO 9000-2008)¾ OUTPUTS FROM ONE PROCESS ARE TYPICALLY INPUTSINTO OTHER PROCESSES,¾ PROCESSES MAY BE INTERRELATED ORINDEPENDENT,¾ OVERALL AIM IS TO ADD VALUE BY PLANNING ANDCONTROLLING PROCESSES23Apr 2010BASIC PROCESS MODELCON TROL / P R OC ED UR ESMA N AG EM ENTDESIREDCU STOM ERINP U TCU STOM ERSATISFA C TIO NPROCESS ACTIVITIESOUTPU TSEN ABLER S(RESU LTS)MO N ITO R ING M EASU REM EN TSApr 20102412
PRODUCT¾ THE RESULT OF A PROCESS (ISO 9000-2008)¾ 4 GENERIC PRODUCT CATEGORIESTANGIBLE PRODUCTS HARDWARE PROCESSED MATERIAL SOFTWARE SERVICE¾ MOST PRODUCTS ARE COMBINATION OF THESE25Apr 2010PROCESSAN ACTIVITY USING RESOURCES, AND MANAGED IN ORDER TOENABLE THE TRANSFORMATION OF INPUTS INTO OUTPUTS,CAN BE CONSIDERED AS A PROCESS. OFTEN, THE OUTPUTFROM ONE PROCESS DIRECTLY FORMS THE INPUT TO THENEXT PROCESSPROCESS APPROACHTHE APPLICATION OF A SYSTEM OF PROCESSES WITHINAN ORGANIZATION, TOGETHER WITH THE IDENTIFICATIONAND INTERACTIONS OF THESE PROCESSES AND THEIRMANAGEMENT, CAN BE REFERRED AS THE PROCESSAPPROACHApr 20102613
DOCUMENTING A PROCESS DOCUMENTING A PROCESS INVOLVES : IDENTIFY THE PROCESS OWNER IDENTIFY INPUTS AND EXPECTED OUTPUTS / RESULTS DEFINE THE CHARACTERISTICS OF INPUTS AND OUTPUTS DEFINE THE BOUNDARIES OF THE PROCESS DETERMINE THE ACTIVITIES AND THE SEQUENCE IDENTIFY RESOURCES AND RESPONSIBILITIES DETERMINE THE CRITERIA AND METHODS TO ENSURE THEOPERATION AND CONTROL ARE EFFECTIVE (SOPs ANDCHECKING POINTS) DETERMINE PROCESS PERFORMANCE MEASURES27Apr 2010QMS PROCESSESQMS TYPICALLY INCLUDES PROCESSES FOR¾MANAGEMENT ACTIVITIES¾PROVISION OF RESOURCES¾PRODUCT REALIZATION¾MEASUREMENTProcesses are not restricted to productionor service delivery activities onlyApr 20102814
PROCUREMENT PROCESS Procure material as perrequired specs and atrequired date Improve quality of incomingmaterial Improve turn over Optimise inventory Cost reduction Timely payment of vendorsActions on vendor relatedquality problem Improvement project with Training needs of dept.vendorPersonnel & vendorsPA Review of pending payments beyondagreed timeReview incoming material go ratew.r.t. goal (item wise)Chronic vendor problemsCost reduction achievement reviewStatus of inventory item wise &reduction of prod. Lead Time. (itemwise)Review of matl. With MaterialRequirement Planning % (MRP)delivery adheranceReview inspection cycle timeincoming (itemwise SRV)DC Vendor selection andevaluationCost reduction projectallotmentProcure products as per drgand tech specs.Periodic process audit andperiodic RatingProcessing of bill/invoiceInventory managementDisposal of receipt rejection29Apr 2010EVALUATING A PROCESS WITHIN THE QMSINCLUDES AUDIT OF : PROCESS INPUTS, OUTPUTS & RESULTS PROCESS MEASURES, LINKAGE WITH QUALITY OBJECTIVES& MEASURES FOR CONTINUAL IMPROVEMENTTHROUGH THE 4 BASIC QUESTIONS IS THE PROCESS IDENTIFIED & APPROPRIATELY DEFINED ? ARE RESPONSIBILITIES ASSIGNED ? ARE THE PROCEDURES IMPLEMENTED & MAINTAINED ? IS THE PROCESS EFFECTIVE IN ACHIEVING THE REQUIREDRESULTS?PROCESSES MAY OR MAY NOT BE DEFINED BYDOCUMENTATIONApr 20103015
Activity on understanding and documentingProcess ApproachTeam exerciseIdentify the inter-linkages of a tutor givenProcess of an organization with the otherrelevant processesPresent on Flip ChartsDuration 30 min.31Apr Apr 20103216
SECTION – 233Apr 2010Learning Objective By the end of the session successful studentswill be able to :¾ Explain the purpose, content & interrelationship of ISO 9000, ISO 9001 & ISO 9004Apr 20103417
Session 2aPurpose, content & inter – relationshipof ISO 9000 family of StandardsApr 201035Activity on identifying the Purpose ofISO 9000 Series of Standards Read section 0.1 of ISO 9000:2005 of Precourse reading material In your syndicate groups discuss and listdown the purpose of ISO 9000 series ofStandards for an organizationDuration 20 min.Apr 20103618
ISO 9000 FamilyISO 9000:2005 – Quality Management Systems - Fundamentals AndVocabularyISO 9001:2008 – Quality Management Systems - RequirementsISO 9004:2009 – Managing for Sustained success of an organization – aquality management approachISO 19011 : 2002 – Guidelines On Quality And / Or Environmental ManagementSystems Auditing37Apr 2010IS O 9 0 0 4ISO 9001 PerspectiveQuality of product and customersatisfaction (effectiveness)I SO 90 0 1ISO 9004 PerspectiveWider focus on quality management than ISO 9001.Addresses the needs and expectations of all relevantInterested parties.Systematic and continual improvement of theorganization's overall performance.Apr 20103819
ISO 9001 & 9004 : Relationship diagramApr 201039OAuditing Standards (Guidelines)Guideline Standards originally published by ISOQuality Management119 01 ISO 10011-1:1990 Guidelines for auditing quality systems -- Part 1: Auditing ISO 10011-2:1991 Guidelines for auditing quality systems -- Part 2: Qualification criteria forquality systems auditors ISO 10011-3:1991 Guidelines for auditing quality systems -- Part 3: Management of auditprogrammesEnvironmental Management deeserOSIydbupsISO 14011:1996Guidelines for environmental auditing -- Audit procedures -- Auditing ofowmanagementenvironmentalsystemsNISO 14012:1996 Guidelines for environmental auditing -- Qualification criteria forISO 14010:1996 Guidelines for environmental auditing -- General principlesenvironmental auditorsApr 20104020
ISO 19011:2002 Guidelines for Quality and/or Environmental ManagementSystems auditing Published in October 2002 jointly ISO/TC 176, Qualitymanagement and Quality Assurance and ISO/TC 207Environmental Management Replaced ISO 10011-1:1990, ISO 10011-2:1991, ISO 101113:1991, ISO 14010:1996,14011:1996,ISO 14012:1996 andcombined all aspects into generic guidelines The standard is intended to act as a guide to all auditors,including those who audit internally within their ownorganization. Can be applied to Management systems other than QMSand EMS41Apr 2010αNATIONALSTANDARDSISO 9000 SERIES 19879001 9002 9003ISO 9000ISO 9004EN29001 29002 29003EN 29000EN 29004ISO 9000 SERIES 19949001 9002 9003ISO 9000-1, 9000-2ISO 9004-1, 9004-2, 9004-3ISO 9001 : 2000ISO 9004 : 2000ISO 9001 : 2008ISO 9000 : 2005ISO 9004 : 2009(CONTRACTUAL)Apr 2010(NON-CONTRACTUAL)4221
How is ISO Standard Revised¾International organization for standardization (ISO)is a federation of national standards bodies¾ISO works through technical committees.(TC–176 has the responsibility to issue and updateISO 9000 standards )¾TC – 176 is supported by Sub Committees andWorking Groups (WG)¾The standard progresses from Preliminary WorkingDraft (PWD) Î Committee Draft (CD) Î DraftInternational Standard (DIS) Î Finalized DraftInternational Standard (FDIS) Î PublishedInternational Standard¾The standard is published only after positive votesfrom members43Apr 2010Activity on identifying differences between AuditableStandard (AS) & Guidance Documents (GD)StandardAS/ GDWhy?ISO 9000ISO 9001ISO 9004ISO 19011Identify the auditable standards & the guidance documents from the tableDiscuss the rationale for this distinction in your syndicate groupDuration 20 min.Apr 20104422
Auditable Standards /Guidance Documents¾ Auditable standard - ISO 9001:2008 Requirements for a QMS as specified Audits are carried out against therequirements of ISO 9001.¾ Guidance documents ISO 9000 - fundamentals & vocabulary ISO 9004 - Managing for Sustainedsuccess of an organization – a qualitymanagement approach “Notes” under requirement specified inISO 9001 standardISO 9001:2008Requirements45Apr 2010Legal compliance vs conformance to ISO 9001(1)¾ The statutory & regulatory requirementsapplicable to products, as specified bythe controlling authorities are to becomplied under all circumstances.– Euro norms for the automobileExamplesvehicles– Safety for medical equipments– Intrinsically safe equipment in gasdangerous zone– FDA regulations for food products& medicinesApr 20104623
Legal compliance vs conformance to ISO 9001(2)Vendorselection bycorporateCustomer drivenConformanceto QMSstandardMarket image& entry intonew marketsVoluntary decision47Apr 2010Session 2bQMS TerminologyApr 20104824
Activity on vocabulary Match the key phrases of thedefinitions with the vocabularyin the table provided withinyour respective teams List your points of doubt on theflip chartsDuration 30 min.49Apr 2010Definition TerminologyA. Information and its supporting medium3. Customer SatisfactionC. . who directs and controls an organization, at the highest levelD. Document specifying the quality management system of an organization4. Quality Policy5. Quality Objectives6. Top Management7. Quality Management8. Quality Control9. Quality Assurance10. Quality Planning11. Quality Improvement12. Quality ManagementSystems13. Conformity14. Non – Conformity15. Defect16. DocumentApr 2010Definition1. Quality2. GradeB. . increasing the ability to fulfill quality requirementsE. .inherent characteristics fulfills requirementsF. aimed for, related to qualityG. Document specifying . procedure and associated resources a specificproject, product, process or contractH. Extent to which planned activities are realized and planned results achievedI. Management system to direct and control an organization .J. Co-ordinated activities to direct and control an Organization K. The non – fulfillment of a requirementL. Document stating results achieved or providing evidence M. Part of quality management focused on providing confidence .N. Overall intentions and direction of an organization .O. Category or rank given . having the same functional useP. Relationship between the result achieved and resources used17. Quality PlanQ. Customer’s perception customer’s requirements have been fulfilled18. Quality Manual19. Record20. EffectivenessR. The non – fulfillment of a requirement, related to an intended or specified useS. Part of quality management focused on Fulfilling quality requirementsT. Part of quality management, focused on setting quality objectives and specifyingnecessary operational process and related resources to fulfill the quality objectives21. EfficiencyU. The fulfillment of a requirement5025
QUALITYDEGREE TO WHICH A SET OF INHERENT CHARACTERISTICSFULFILLS REQUIREMENTSGRADECATEGORY OR RANK GIVEN TO DIFFERENT QUALITYREQUIREMENTS FOR PRODUCTS, PROCESSES OR SYSTEMS HAVINGTHE SAME FUNCTIONAL USECUSTOMER SATISFACTIONCUSTOMER’S PERCEPTION OF THE DEGREE TO WHICHTHE CUSTOMER’S REQUIREMENTS HAVE BEEN FULFILLED51Apr 2010QUALITY POLICYOVERALL INTENTIONS AND DIRECTION OF AN ORGANIZATIONRELATED TO QUALITY, AS FORMALLY EXPRESSED BY TOPMANAGEMENTQUALITY OBJECTIVESSOMETHING SOUGHT OR AIMED FOR, RELATED TO QUALITYApr 20105226
TOP MANAGEMENTPERSON OR GROUP OF PEOPLE WHODIRECTS AND CONTROLS AN ORGANIZATION,AT THE HIGHEST LEVEL53Apr 2010QUALITY MANAGEMENTCO-ORDINATED ACTIVITIES TO DIRECT AND CONTROL ANORGANIZATION WITH REGARD TO QUALITYQUALITY CONTROLPART OF QUALITY MANAGEMENT FOCUSED ONFULFILLING QUALITY REQUIREMENTSQUALITY ASSURANCEPART OF QUALITY MANAGEMENT FOCUSED ON PROVIDINGCONFIDENCE THAT QUALITY REQUIREMENTS WILL BE FULFILLEDApr 20105427
QUALITY PLANNINGPART OF QUALITY MANAGEMENT, FOCUSED ON SETTINGQUALITY OBJECTIVES AND SPECIFYING NECESSARYOPERATIONAL PROCESS AND RELATED RESOURCES TOFULFILL THE QUALITY OBJECTIVESQUALITY IMPROVEMENTPART OF QUALITY MANAGEMENT, FOCUSED ON INCREASINGTHE ABILITY TO FULFIL QUALITY REQUIREMENTS55Apr 2010QUALITY MANAGEMENT SYSTEMSMANAGEMENT SYSTEM TO DIRECT AND CONTROL ANORGANIZATION WITH REGARD TO QUALITYApr 20105628
CONFORMITYTHE FULFILLMENT OF A REQUIREMENTNON – CONFORMITYTHE NON – FULFILLMENT OF A REQUIREMENTDEFECTTHE NON – FULFILLMENT OF A REQUIREMENT, RELATED TO ANINTENDED OR SPECIFIED USE57Apr 2010DOCUMENTINFORMATION AND ITS SUPPORTING MEDIUMQUALITY PLANDOCUMENT SPECIFYING WHICH PROCEDURE AND ASSOCIATEDRESOURCES SHALL BE APPLIED BY WHOM AND WHEN TO ASPECIFIC PROJECT, PRODUCT, PROCESS OR CONTRACTQUALITY MANUALDOCUMENT SPECIFYING THE QUALITY MANAGEMENT SYSTEM OF ANORGANIZATIONRECORDDOCUMENT STATING RESULTS ACHIEVED OR PROVIDING EVIDENCEOF ACTIVITIES PERFORMEDApr 20105829
EFFECTIVENESSEXTENT TO WHICH PLANNED ACTIVITIES ARE REALIZED ANDPLANNED RESULTS ACHIEVEDEFFICIENCYRELATIONSHIP BETWEEN THE RESULT ACHIEVED AND RESOURCESUSED59Apr 2010Session 2cISO 9001: 2008 QMS RequirementsApr 20106030
Continual improvement ofthe quality management sis ProductValue adding activitiesInformation flow61Apr 20101. Scope and general2. Normative references3. Terms & definitionsClauses4. Quality management system5. Management responsibility6. Resource management7. Product realization8. Measurement, analysis and improvementApr 20106231
Scope of ISO 9001General¾ This international standard specifies requirements for a qualitymanagement system where an organization Needs to demonstrate its ability to consistently provide productthat meets customer and applicable statutory & regulatoryrequirements, and Aims to enhance customer satisfaction through the applicationof the system, including processes for continual improvementof the system and the assurance of conformity to customer andapplicable statutory & regulatory requirements.Note : 1a in this international standard, the term “product” applies only tothe product intended for, or required by, a customer.63Apr 2010Scope of ISO 9001Application¾ All requirements of this international standard are genericand are intended to be applicable to all organizationsregardless of type, size and the product provided¾ Where any requirements of the standard cannot be applieddue to the nature of an organization and its products, thiscan be considered for exclusion.¾ Exclusions are limited to requirements stated in clause 7.¾ Permissible exclusions are those that do not affect theorganization’s ability or responsibility to provide productthat meets customer and applicable statutory & regulatoryrequirementsApr 20106432
Justification of Exclusions¾ When an organization limits theapplication of the requirements ofthe ISO 9001: 2008, this must bedetailed and justified in theorganization’s quality manual.¾ This must also be clear in any otherpublicly available document, suchas certification/registrationdocument or marketing material65Apr 2010Most Likely Exclusions¾ Within clause 7 (product realization), the following are themost likely requirements, though not the only ones.7.3 Design &development7.5.3Identification &traceability(traceability maynot be applicable)Apr 2010Most LikelyExclusions7.5.4Customerproperty7.6 Controlof monitoring&measuringdevices.6633
Scope of Audit Extent and Boundaries¾Product¾Physical location¾Organizational units¾Activities/ Processes67Apr 2010Activity on Understanding ISO 9001Requirements Refer to E01 of Work Book & CaseStudyTotal Duration 90 min.Individual Work 30 min; Group Work 30 min; Feedback from Exercise 30 minApr 20106834
4.0 QualityManagement System4.1General Requirements4.2Documentation Requirement4.2.1 General4.2.2 Quality Manual4.2.3 Control of Documents4.2.4 Control of Records69Apr 20104.1 General RequirementsOrganization shall establish, document, implement, maintain and continually improve theeffectiveness of a quality management system.The organization shall:a. Determine the processes needed for quality management systems, and its application.b. Determine the sequence and interaction of these processes.c. Determine criteria and methods needed to ensure that both the operation and control ofthese processes are effective.d. Ensure the availability of resources and information necessary to support theseprocesses.e. Monitor, measure where applicable and analyze these processes.f.Implement actions necessary to achieve planned results and continual improvements ofthese processes.These processes shall be managed by the organization in accordance with the requirementsof this international standard.Where an organization chooses to outsource any process, then control the outsourcedprocesses.Note :Apr 2010processes needed for the quality management systems referred to above, should includeprocesses for management activities, provision of resources, product realization andmeasurement analysis & improvement7035
5.0 Management Responsibility5.1Management Commitment5.2Customer Focus5.3Quality Policy5.4Planning5.5Responsibility, Authority And Communication5.6Management Review71Apr 20106.0 Resource ManagementTraining6.1 Provision of Resources6.2 Human Resources6.3 Infrastructure6.4 Work EnvironmentWork EnvironmentApr 20107236
7.0 Product Realization7.1 Planning of Product Realization7.2 Customer – Related Processes7.3 Design And Development7.4 Purchasing7.5 Production & Service Provision7.6 Control of Monitoring & Measuring Devices73Apr 20107.5 Production &Service Provision7.5.1 Control of Production &Service Provision7.5.2 Validation of Processes ForProduction & ServiceProvision7.5.3 Identification & Traceability7.5.4 Customer Property7.5.5 Preservation of ProductApr 20107437
8.0 Measurement, Analysis& Improvement8.1General8.2Monitoring & Measurement8.3Control of Nonconforming Product8.4Analysis of Data8.5ImprovementApr 2010758.2 Monitoring & Measurement8.2.1 Customer Satisfaction8.2.2 Internal Audit8.2.3 Monitoring & Measurement of Processes8.2.4 Monitoring & Measurement of ProductApr 20107638
Activity on identifying relationship between QualityManagement Principles (QMPs) & ISO 9001 In your syndicate groups identify theallocated QMPs to the relevant clauses& sub clauses and list down in the flipchartTotal Duration 60 min.77Apr 2010RELATIONSHIP BETWEEN THE QMPs AND ISO 9001ISO 2.18.2.38.2.48.38.48.5.18.5.28.5.3P4P5P6 P7P8 The above relationship are indicative - not exhaustiveApr 2010LEGENDP1 Customer FocusP2 LeadershipP3 People InvolvementP4 Process approachP5P6System ApproachContinual ImprovementP7 Fact Based ApproachP8 Supplier Relationship7839
Session 2dDocumentation for QMS79Apr 2010DocumentationRequirementsISO 9001: 2008 requires Documented statements of quality policy andquality objectives. A quality manual. Documented procedures & records requiredby the standard. Documents needed by the organization toensure effective planning, operation andcontrol of its processes.Apr 20108040
Activity on Documentation Read through 4.2.1 of ISO 9001:2008in your syndicate groups What differences would you expectto see in the documentation of¾ A large scale industry¾ A small scale industry What in your opinion are the reasonsfor these differences ? Tutor lead discussionDuration 10 mins81Apr 2010Areas of differences Degree of Formality¾ Content¾ Number¾ Issue procedures Hierarchy of documents Document numbering system Style of presentation Medium Distribution of responsibilitiesfor document approvalApr 20108241
Typical Quality Management SystemDocumentation HierarchySource: lS/lSO/TR 10013:200183Apr 2010A Typical Quality Manual1.2.3.4.5.6.7.8.Title and scopeTable of contentsReview, approval and revisionQuality policy and objectivesOrganization, responsibility and authorityReferencesQuality management system descriptionAppendicesQualitylManuaSource: lS/lSO/TR 10013:2001Apr 20108442
Structure of a typical Documented procedure TextFlow charts,TablesA combination of theabove, Or any other suitablemethodSource: lS/lSO/TR 10013:200185Apr 2010Content of a typical Documented procedure Title Purpose Scope Responsibility and authority Xmmm xmxxm mxxm mxXmm mxmxmmmmXmxmmxmmm mx mxmxm mxmxmmmX,xmmxmxm xmmm mmmm mmxxm m Description of activities Records Appendices Review, approval and revision Identification of changesSource: lS/lSO/TR 10013:2001Apr 20108643
Work Instructions The structure, format and level of detailused in the work instructions should betailored to the needs of the organization’spersonnel and depends on the complexityof the workSource: lS/lSO/TR 10013:200187Apr 2010Value of Documentation¾ Enables communication of intent and consistency of action¾ Definition of roles for members¾ Enhancement of understanding¾ Control and measurement¾ System becomes auditable¾ Evaluation of the effectiveness and continuingsuitability of QMS¾ Information useful for training and competence building¾ Provides confidence in the QMS¾ Helps in continual improvement¾ Provides repeatability and traceabilityApr 20108844
SECTION – 3Auditing QMS89Apr 2010Section – 3 LEARNING OBJECTIVES: By the end of the section, successful students will be able to:¾ Understand the Audit process¾ Explain the role of auditor to plan, conduct, report andfollow up a QMS audit in accordance with ISO 19011¾ Understand audit responsibilities¾ Develop the skills required to plan, prepare, conduct andreport on audits¾ Understand the certification / registration andaccreditation processes¾ IRCA / NABET Schemes for Auditor certification45
Section – 3Sessions¾ Accreditation certificate and auditor certification (3 a)¾ Role of IRCA / NRBPT and Auditor certification (3 b)¾ Introduction to Auditing (3 c)¾ Auditor responsibilities (3 d)¾ Audit Programmes (3 e)¾ Planning of Audits (3 f) Checklists (3 g)¾ Conducting Audits Opening meeting (3 h) Onsite auditing and audit skills (3 i) Closing meeting (3 j)¾ Audit reporting (3 k)¾ Audit follow up (3 l)Learning Objective – Session 3 By the end of the session, successful studentswill be able to :¾ Explain the role of an auditor to plan,conduct, report and follow up a qualitymanagement system audit in accordance withISO 19011.Apr 20109246
SESSION 3aCERTIFICATION ANDACCREDITATION¾ CERTIFICATION¾ ACCREDITATION¾ REGISTRATION SCHEME FOR LEAD AUDITORS / AUDITORS¾ PRINCIPLES OF AUDITING¾ CONFIDENTIALITY¾ CONFLICT OF INTEREST93Apr 2010ACCREDITATIONBOARDAPPLICATION FORACCREDITATIONAUDIT AND SURVEILLANCEBY ACCREDITATION BOARDCERTIFICATION BODY (CB)APPLICATION FORCERTIFICATIONAUDIT ANDSURVEILLANCE BY CBORGANIZATIONApr 20109447
CONFORMITY ASSESSMENT IN INGCOURSESQUALITY MANAGEMENTSYSTEM CERTIFICATIONBODIESREGISTRATIONAUDITORLEAD AUDITORPRINCIPALAUDITORDTI:DEPARTMENT OF TRADE AND INDUSTRYNAMAS:NATIONAL MEASUREMENT ACCREDITATION SCHEMEUKAS:UNITED KINGDOM ACCREDITATION SERVICESIRCA:INTERNATIONAL REGISTER OF CERTIFICATED AUDITORSCQI:CHARTERED QUALITY INSTITUTEPROVISIONALAUDITORINTERNALAUDITOR95Apr 2010CONFORMITY ASSESSMENT IN INDIAQuality Council of ationBoard forCertificationBodiesNationalAccreditationBoard forEducation &TrainingNationalAccreditationBoard forHospitals & HealthservicesNationalAccreditation Boardfor Testing &CalibrationLaboratoriesNBQPNational Board forQuality PromotionApr 2010QIESQuality Information &Enquiry Services9648
ACCREDITATIONACCREDITATION OFFERS ASSURANCE TOTHE CERTIFICATION PROCESSREFERENCE STANDARD FOR ACCREDITATIONEN 45012 / ISO 1702197Apr 2010CERTIFICATION CREDIBILITY OF QUALITY SYSTEMCERTIFICATION DEPENDS ON) IMPARTIALITY) WELL DEFINED SCOPE) MAINTENANCE OF THE CERTIFICATE) COMPETENCE OF THE AUDI
3 apr 2010 5 course learning objectives purpose of quality management system & 8 quality management principles standards - iso 9000, iso 9001, iso 9004, iso 19011 & their interrelationships. interpretation of iso 9001 in context to the audit roles and responsibilities of auditors and lead auditors. plan and conduct an audit, gather objective evidence via various
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service i Norge och Finland drivs inom ramen för ett enskilt företag (NRK. 1 och Yleisradio), fin ns det i Sverige tre: Ett för tv (Sveriges Television , SVT ), ett för radio (Sveriges Radio , SR ) och ett för utbildnings program (Sveriges Utbildningsradio, UR, vilket till följd av sin begränsade storlek inte återfinns bland de 25 största
Hotell För hotell anges de tre klasserna A/B, C och D. Det betyder att den "normala" standarden C är acceptabel men att motiven för en högre standard är starka. Ljudklass C motsvarar de tidigare normkraven för hotell, ljudklass A/B motsvarar kraven för moderna hotell med hög standard och ljudklass D kan användas vid
LÄS NOGGRANT FÖLJANDE VILLKOR FÖR APPLE DEVELOPER PROGRAM LICENCE . Apple Developer Program License Agreement Syfte Du vill använda Apple-mjukvara (enligt definitionen nedan) för att utveckla en eller flera Applikationer (enligt definitionen nedan) för Apple-märkta produkter. . Applikationer som utvecklas för iOS-produkter, Apple .
requirements for IRCA QMS 2008 auditor certification. The British Standards Institution 2014 1 of 5 ISO 9001 Quality Management System Lead Auditor Training (IRCA) Course Description . BSI’s “Quality Management Systems (QMS) Auditor/Lead Auditor Training Course (ISO 9001)” course teaches the principles and
Greene 2 Craig Hege AUDITOR (6 Yr.) 1 Greene 2 Cynthia Tobin AUDITOR (6 Yr.) 1 Greene 2 David Green AUDITOR (6 Yr.) 1 Greene 2 Deez Nuts AUDITOR (6 Yr.) 1 Greene 2 Derek Thomson AUDITOR (6 Yr.) 1 Greene 2 Dr. Andrea Malmont AUDITOR (6 Yr.) 1 Greene 2 Lapinski AUDITOR (6 Yr.) 1 Gree
Role of the Lead Auditor Every audit has a lead auditor – even if it’s the only auditor! This person represents the team in communication with the auditee and management. The lead auditor also defines the requirements of each audit assignment, including qualification of other audit team members.
