ISO 9001:2008 Awareness Presentation

80,905 views

Published on

ISO 9001:2008 Awareness Presentation

Published in: Business, Technology
200 Comments
342 Likes
Statistics
Notes
No Downloads
Views
Total views
80,905
On SlideShare
0
From Embeds
0
Number of Embeds
3,841
Actions
Shares
0
Downloads
1,063
Comments
200
Likes
342
Embeds 0
No embeds

No notes for slide

ISO 9001:2008 Awareness Presentation

  1. 1. ISO 9001:2008Awareness Presentationwww.iso9001consultant.org
  2. 2. Suitable for allkinds ofinterestedaudiences
  3. 3. Empty your cup andenjoy the presentationFacts about ISO 90011. ISO 9001 is beingimplemented in 175countries around theworld2. Over 1.2 millioncertificates issuedworldwide3. ISO has 163 membercountries
  4. 4. • Bachelor’s degree in Business• Diploma in internationaltrade• Certificate in civil engineering• Member of Institute Qualityof Malaysia• Trained in ISO 9001, ISO14001, OHSAS 18001Presenter: Leo
  5. 5. What is ISO 9001?• It’s a quality managementsystem that can beadopted by any kind oforganization• The system is focusedtowards the meeting ofcustomer requirementsand enhancing ofcustomer satisfactionKeywords:1. Quality2. Management system3. Customer requirements4. Customer satisfaction
  6. 6. What is ISO 9001?• This system has 4 components or elements andthey are applied within your businessmanagement:a) Management responsibilityb) Resource managementc) Product realizationd) Measurement, analysis and improvement• Before we explore these elements, why is ISO9001 necessary for your organization?
  7. 7. Why do we need ISO 9001?• To be effective in whatever we do, we need asystem of doing things to be consistent. Just likecraftsmen, managers need a good managementtool to get the job done.• There are too many activities in any organization.Easy to lose track of things and focus. Easy to getdistracted. Managers need a good system to keepthings in order.• Systemizing of activities is a naturalphenomenon. We do it all the time – privately,publicly or commercially
  8. 8. Why do we need ISO 9001?• A business faces great risks – biginvestments, customer expectations, jobs,credibility, etc. The business owner mustdo all he can to ensure success, or he/shewill fail.• Every major economy in the world adoptsit! Governments give recognition to it.Because it works.
  9. 9. Global Issuance ofISO 9001 Certificates0200,000400,000600,000800,0001,000,0001,200,000No of ISO 9001 certificates2000200120022003200420052006200720082009
  10. 10. ISO Survey 2010ISO 9001 Certificates issued by region
  11. 11. You already have a system of doingthings too!• But is it effective? If you keep doing what youalways do, you will always get the same result.• ISO 9001 is an option, a good one. It requiresyour organization to document your businessprocesses (QMS), monitor, measure, analyzeand improve it.• Business owners and top management needto make a strategic decision on whether toimplement the ISO 9001 QMS.
  12. 12. Biggest benefit• The ISO 9001:2008 Standardprovides managers with atool that is designed tocontinually improve theirbusiness performance.• ISO 9001 requires you to:– Plan what you want to do,– Follow that plan,– Monitor, measure andanalyze your execution ofthe plan, and– Improve the plan.Planningis the keyP D C A
  13. 13. • A well-designed and well-implemented qualitymanagement system can and should eliminate
  14. 14. What is ISO 9001?• ISO = InternationalOrganization forStandardization• isos = Greek = equal• 9001 = unique IDnumber• 2008 = Year it waspublishedFormation 23 February 1947Type NGOPurpose Int’l standardizationHQ GenevaMembership 63 countriesWebsite www.iso.orgNo. of stds over 18,000
  15. 15. ISO 9000 Familya) ISO 9001:2008 Quality Management Systems –Requirementsb) ISO 9000:2005 Fundamentals and vocabularyc) ISO 19011:2011 Guidelines for auditing managementsystemsd) ISO 9004:2009 Managing for the sustained success ofan organization — A quality management approach• The term “ISO 9000” is frequently used to refer to theISO 9001 standard• Only ISO 9001 is auditable. The rest serves asreferences only.
  16. 16. ISO 9001 HistoryIt all started when the US Military were getting sub-par products from their suppliers.Then it caught on.YEAR STANDARDS TITLE1959 MIL-Q-9858 QUALITY PROGRAM REQUIREMENTS1969 AQAP NATO ALLIED QUALITY ASSURANCE PUBLICATIONS1974 BS 5179 GUIDELINES FOR QUALITY ASSURANCE1979 BS 5750 SPECIFICATION FOR DESIGN DEVELOPMENT, PRODUCTION,INSTALLATION AND SERVICING1987 ISO 9001:1987 Model for quality assurance in design, development,production, installation, and servicingISO 9002:1987 Model for quality assurance in production, installation, andservicingISO 9003:1987 Model for quality assurance in final inspection and test1994 ISO 9001:1994 QUALITY SYSTEMS – MODEL FOR QUALITY ASSURANCE2000 ISO 9001:2000 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS2008 ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS- REQUIREMENTS
  17. 17. What is ISO 9001:2008 QualityManagement Systems - Requirements?• Quality = degree to which customer requirements havebeen met• Management = coordinated activities to direct andcontrol an organization• System = set of interrelated or interacting elements• Quality management system = a system to direct andcontrol an organization with regard to quality• Requirements = a set of management parameters yourQMS
  18. 18. More about quality• How do you know requirements have been met?– Review = confirm that requirements are accurate– Verify = measure accuracy of output against requirements– Validate = Get feedback from customer/end-user• Nonconformance = failure to fulfill requirements• Nonconformance = error• All forms of nonconformances require corrections andcorrective action to prevent recurrences• Correction = Elimination of error• Corrective action = Elimination of the root causes ofthe error (Ask WHY 5 times)
  19. 19. Root cause analysisRoot cause Effect 1 Effect 2 Effect 3 Direct cause Nonconformity1. Why did the nonconformity occur?2. Why did the direct cause occur?3. Why did effect 3 occur?4. Why did effect 2 occur?5. Why did effect 1 occur?
  20. 20. 8 Quality Management PrinciplesThe ISO 9001Standard is basedon these principles1. Customer focus2. Leadership3. Involvement of people4. Process approach5. System approach tomanagement6. Continual improvement7. Factual approach to decisionmaking8. Mutually beneficial supplierrelationships
  21. 21. System approach• Quality must be managed by a system to beeffective• This system is done for you, as represented bythe ISO 9001:2008 standard• Recall: A system is a set of interrelated orinteracting elements• System approach is described in Clause 4.1• The description of Clause 4.1 matches the PDCAapproach to process management -Plan, Do, Check, Act
  22. 22. System and process approach• Quality must be managed by a system• The system must be managed using theprocess approach because the system is madeup of processes• These processes are linked to each other• A process has inputs, resources, activities, outputs and customers.Manage them all.
  23. 23. ISO Lingo• Product = Any output- physical product orservices• Output = product• Product = result of a process• Process = a set of inter-relating activities focusedtowards producing the output• Input = requirementsinput process output
  24. 24. Process approachinput Your process outputCan be applied to anyother process that youmanage
  25. 25. Process approach• Every process require specificinputs, resources, activities, outputs and customers• What you can do now is:– Define and document the inputs– Define and document the kinds of resources that yourprocess use– Define and document the activities and their interactions– Define and document the responsibilities– Define and document the outputs• You can name this document as Department ControlPlan• Then execute this plan, and monitor, measure, analyzeand improve its performance (KPI)• Thus, Plan – Do - Check – Act (Edward Demmings)
  26. 26. Anatomy of aprocessProcessInputsActivitiesOutputsResourcesEvery processhas an owner
  27. 27. Process management
  28. 28. ISO 9001:2008 ELEMENTSinput Your QMS output
  29. 29. ISO 9001:2008 Structure• Clause 1 Scope• Clause 2 Normative references• Clause 3 Terms and definitions• Clause 4 Quality management system• Clause 5 Management responsibility• Clause 6 Resource management• Clause 7 Product realization• Clause 8 Measurement, analysis and improvement
  30. 30. Your QMSQuality managementsystemGeneral requirementsDocumentationrequirementsResource managementProduct realizationMeasurement, analysisand improvement
  31. 31. Clause 1 Scope• Your organization should consider to adoptthe ISO 9001 standard if it– needs to demonstrate its ability to consistentlyprovide product that meets customer andapplicable statutory and regulatoryrequirements, and– aims to enhance customer satisfaction throughthe effective application of the system, includingprocesses for continual improvement of thesystem and the assurance of conformity tocustomer and applicable statutory and regulatoryrequirements.
  32. 32. • In this International Standard, the term“product” only applies toa) product intended for, or required by, a customer,b) any intended output resulting from the productrealization processes.• All requirements of this International Standardare generic and are intended to be applicableto all organizations, regardless of type, sizeand product provided.
  33. 33. Clause 1.2 Application• Where anyrequirement(s) of thisInternational Standardcannot be applied due tothe nature of anorganization and itsproduct, this can beconsidered for exclusion.• Where exclusions aremade, claims of conformity tothis International Standard arenot acceptable unless theseexclusions are limited torequirements within Clause 7.• And such exclusions do notaffect the organizationsability, or responsibility, toprovide product that meetscustomer and applicablestatutory and regulatoryrequirements.
  34. 34. Clause 2 Normative references• This document is indispensable in theapplication of the ISO 9001 standard:– ISO 9000 – Fundamentals and vocabulary
  35. 35. Clause 3 Terms and definitions• Wherever the term “product” occurs, it canalso mean “service”.
  36. 36. 4.1 QMS General Requirements1. Determine the QMS processes2. Determine the sequence and interactions3. Determine the methods of operations andcontrol4. Provide resources to ensure effective operations(Clause 6)5. Monitor, measure and analyze processes (Clause8.2 to 8.4)6. Improve the effectiveness of the processes(Clause 8.5)
  37. 37. QMS processes are in the circle
  38. 38. Clause 4.2 Documentation requirementsa) Quality Policyb) Quality Manual – todescribe the systemc) Quality ObjectivesRegister – to documentyour quality objectivesd) Control of DocumentsProceduree) Control of RecordsProceduref) Internal Audit Procedure Note: Templates areavailable. g) Control of NonconformingProducth) Corrective ActionProcedurei) Preventive ActionProcedurej) Quality Plank) Control plansl) Other documents, asnecessarym) Records (to showevidence of workperformed in all QMSprocesses)
  39. 39. Control of documentsCreatedocumentGetapprovalRegisterdocumentDistributedocumentReviewdocumentAmenddocumentGet re-approvalUpdateregisterIdentifyexternaldocumentsRegisterexternaldocumentsCheck forupdatesUpdateregisterDispose obsoletedocumentStamp obsoletedocument if retained
  40. 40. Clause 4.2.4 Control of records• Records established to provide evidence ofconformity to requirements and of the effectiveoperation of the quality management systemshall be controlled.• Process owners must identify, classify andmaintain all process records in good and secureconditions throughout retention period.• Records shall remain legible, readily identifiableand retrievable.
  41. 41. Good records management• Enables you toa) conduct business in an orderly, efficient andaccountable mannerb) support and document decision makingc) provide continuity in the event of a disasterd) meet legislative and regulatory requirementse) protect the interests of customers, employeesand stakeholders
  42. 42. Types of records to maintain• Go through the ISO 9001 standard or your Quality Manual• Identify the following phrases where they appear: “Records ……shall be maintained (see 4.2.4)”• Most of the records requirements are readily available, such asproduct planning records, product design records, purchasingrecords, production records, monitoring records, analysis records,employee performance appraisal and training records, jobdescriptions, organization chart, infra maintenance records,contract/sales records, marketing records, customer complaintsrecords, etc.• Records pertaining to the mandatory SOP’s and quality objectivesshall be created.
  43. 43. Clause 5 Management Responsibility• Top management musta) Be committed to the QMSb) Be customer focusedc) Establish a quality policyd) Plan for the QMS in terms of establishing qualityobjectives and management of changee) Assign responsibility, authority and providesuitable communication channelsf) Review the QMS performance
  44. 44. What to do• Read the ISO 9001:2008 Standard• Establish a Quality Policy• Appoint a Management Representative (from mgt rank)• Establish a QMS Committee• Establish your Quality Manual• Establish the 6 mandatory procedures (Clause 4.2)• Establish your Quality Plan• Establish your Department/Process Control Plans• Establish and document your quality objectives• Establish your KPI’s and start collecting data• Implement all the procedures
  45. 45. Key Performance Indicators• Ask this question whendetermining KPI’s:• As the CEO/Manager ofthis organization, whatdata will instantly give methe ability to assess overallperformance at any givenpoint of time?• Then list all them downand select your desiredKPI’s.BalancedscorecardFinancialsProcessesCustomersHumancapital
  46. 46. • Can be used to benchmarkperformance based on inputrequirements (customer wants 100units per month, so give them 100units per month)• Can be used to improve KPIperformance levels – decision mustbe based on past performance dataand existing capacity to be realistic• You can use existing performancelevels to establish your qualityobjectives• Use quality objectives to improve onproductivity levels, decreaseerrors, improve speed, reducecosts, reduce complaints, etc.Qualityobjectives
  47. 47. Employee responsibility• Know the Quality Policy• Aware of the relevance and importanceof their activities and how theycontribute to the achievement of thequality objectives• Comply with the requirements of theQMS, as stated in the QualityManual, procedures, Quality Plan, etc.• Provide feedbacks or ideas about theQMS• Report any nonconformities
  48. 48. Clause 6 Resource management• Clause 6.1 Provision of resources• The organization shall determine and providethe resources neededa) to implement and maintain the qualitymanagement system and continually improve itseffectiveness, andb) to enhance customer satisfaction by meetingcustomer requirements.
  49. 49. Types of resources• Determine , provide and manage the following:a) Clause 6.2 Competent human resources(competency assessment, training needs analysis)b) Clause 6.3 Suitable and well-maintainedinfrastructures (maintenance ofbuildings, hardware, software, transportation, utilities)c) Clause 6.4 Suitable and well-maintained workenvironment (5S program)d) Consider including financial management in yourQMS to ensure product conformity
  50. 50. • Clause 6.2.1• Personnel performing work affectingconformity to product requirements shall becompetent on the basis of appropriateeducation, training, skills and experience.Establish JobDescriptionHireemployeeAppraiseperformanceIdentifytrainingneedsConducttrainingAssesseffectivenessof trainingPLAN DO CHECK ACT
  51. 51. • Create a survey form which contains thesecolumns:1. Employee’s name2. Job position3. List of routine activities4. List of non-routine activities5. Key performance indicators6. Skills required7. Competency assessment per skill (use scoreratings)8. Recommendation for training• Employees fill in columns 1 to 4• Manager fills in columns 5 to 8• Benefits: Manager can identify workredundancies, activity gaps, competencygaps, need for training and maybe the need tore-engineer the work processes• Output: ?Sometimes, workactivities are notdefined. So there’sa lot of confusionDefining staffduties andresponsibilitiesand analyzingtraining needs toensurecompetence isessential
  52. 52. 5S Program for work environmentmanagementSEIRI SEITON SEISO SEIKETSU SHITSUKESORT SET IN ORDER SHINE STANDARDIZE SUSTAIN
  53. 53. Product realization processes
  54. 54. Clause 7.1 Planning of product realization• The organization shall plan and develop the processesneeded for product realization, in terms ofa) quality objectives and requirements for the productb) the need to establish processes and documents,c) providing resources specific to the productd) required verification, validation, monitoring,measurement, inspection and test activities specific tothe product and the criteria for product acceptancee) records needed to provide evidence that the realizationprocesses and resulting product meet requirements
  55. 55. Clause 7.1 Create a Quality Plan• With the following contents:a) Assigned responsibilities (who’s doing what)b) Quality objectives (productivity/quality targets)c) Customer requirements/Productcharacteristics, features, etc.d) References to procedures to controlproduction/creation, storage, release, delivery, etc.e) Required resources- HR, materials, equipment, etc.f) Requiredverification, validation, monitoring, measurement, inspection and test activities specific to the product and thecriteria for product acceptanceg) Types of records needed to provide evidence that therealization processes and resulting product meetrequirements
  56. 56. What’s a Plan?PLANDuties andresponsibilitiesKPI &QualityobjectivesFlow ofactivitiesQualitycontrolactivitiesOutputdescriptionRequiredphysicalresourcesDescriptionof activitiesSOP’s andrecords
  57. 57. Clause 7.2Customer relatedprocessDetermination ofcustomerrequirementsReview of customerrequirementsCustomercommunication
  58. 58. Design & developmentPlanningInputOutputReviewVerifyValidateControl of changesClause 7.3Create a Design Plan• This clause can beexcluded from your QMSif you don’t design theyour products
  59. 59. Design & development• Review• activity undertaken todetermine thesuitability, adequacy andeffectiveness of thesubject matter to achieveestablished objectives• Verificationconfirmation, through theprovision of objectiveevidence, that specifiedrequirements have beenfulfilled• Validation• confirmation, through theprovision of objectiveevidence, that therequirements for a specificintended use orapplication have beenfulfilled
  60. 60. Design & development• Review• activity undertaken todetermine thesuitability, adequacy andeffectiveness of thesubject matter to achieveestablished objectives• Verificationconfirmation, through theprovision of objectiveevidence, that specifiedrequirements have beenfulfilled• Validation• confirmation, through theprovision of objectiveevidence, that therequirements for a specificintended use orapplication have beenfulfilled
  61. 61. PURCHASINGPurchasing processPurchasing informationVerification of purchasedproductClause 7.4
  62. 62. • Keep records of your purchase orders, suppliers’quotations & delivery orders and inspectionforms for purchased products. Monitor, measureand analyze their performance (only those whosupply materials/equipment/services used withinthe product creation processDeterminepurchaserequirementsIssue RFQEvaluatequotesIssue PO Inspect DOAssesssupplier’sperformancePLAN DO CHECK ACT
  63. 63. Production & serviceprovisionControl of production andservice provisionValidation of processes forproduction and serviceprovisionIdentification andtraceabilityCustomer propertyPreservation of productClause 7.5 - Create aProduction/ServicePlan
  64. 64. Clause 7.6 Control of monitoring andmeasuring equipment• The organization shall determine the monitoring andmeasurement to be undertaken and the monitoringand measuring equipment needed to provide evidenceof conformity of product to determined requirements.• Calibrate the monitoring and measuring equipment atsuitable intervals.• Verify the monitoring and measuring equipment atsuitable intervals.• Segregate those equipment which are not calibratedyet or not used within the process. Tag or cage them.• This clause can be excluded from your QMS if you don’t use suchequipment in your product creation process.
  65. 65. Product realization process controlsa) Quality Plan – to document how you intendto meet your customers’ requirementsb) Customer & Legal Requirementsc) Customer complaints handling procedured) Design Plane) Purchasing Proceduref) Production/Service Plang) Monitoring & Measuring Equipment Plan(can be included in Production/Service Plan)
  66. 66. Clause 8 Measurement, analysis and improvement• The organization shall plan and implement the monitoring,measurement, analysis and improvement processesneededa) to demonstrate conformity to product requirements,b) to ensure conformity of the quality management system, andc) to continually improve the effectiveness of the qualitymanagement system.• This shall include determination of applicable methods,including statistical techniques, and the extent of their use.
  67. 67. Why monitor and measure?• If you cannot measure it, youcannot improve it. Lord Kelvin• Measurements provide youwith a baseline to improveupon.
  68. 68. What do you measure?1. Customer satisfaction (Survey, returnsrate, complaints, lost business, etc)2. Process conformance and effectiveness(internal audit)3. Process performance (Key PerformanceIndicators and quality objectives)4. Product characteristics (QC inspection beforerelease to customer) where nonconformingproducts must be controlled
  69. 69. Clause 8.3 Control of nonconforming productsWhere applicable, the organization shall deal withnonconforming product by one or more of the following ways:a) by taking action to eliminate the detected nonconformity;b) by authorizing its use, release or acceptance underconcession by a relevant authority and, whereapplicable, by the customer;c) by taking action to preclude its original intended use orapplication;d) by taking action appropriate to the effects, or potentialeffects, of the nonconformity when nonconforming productis detected after delivery or use has started.
  70. 70. Internal audit process• Purpose is to verify whether your QMSa) Conforms to your Quality Plan,b) Conforms to ISO 9001 requirements,c) Conforms to your QMS requirements, andd) is effectively implemented and maintained.EstablishannualauditscheduleDistributeAudit PlanPerformauditReportfindingsFollow-upactions
  71. 71. Audit defined• Audit is a systematic and documented process forgathering audit evidence and evaluating it against theaudit criteria to determine whether it has been fulfilled• Audit criteria is a set of policies, procedures orrequirements• Audit evidence is records, statements of fact or otherinformation which are relevant to the audit criteriaand verifiable• Audit conclusion is the outcome of an audit providedby the audit team after consideration of the auditobjectives and all audit findings
  72. 72. • What to ask?• What records to inspect?• What activities to observe?1. Remember your purpose is to verifyconformance and effectiveness against aspecific requirement.2. That requirement may come from the ISO9001 Standard, your QualityManual, SOP, etc.3. So the answer depends on what auditcriteria you want to verify4. Remember, your job as an auditor is tolook for the audit evidence, that’s all 5. So use the ISO 9001 Audit Checklist andstart auditing.Audit methodologya) Interviewing the auditeeb) Inspection of documentsand records, etc.c) Observation of ongoingactivities
  73. 73. What do you analyze?• Analyze what you measured:a) Customer satisfaction levelsb) Internal audit resultsc) Product QC inspection resultsd) KPI resultse) Suppliers’ performance.
  74. 74. How do you analyze?• Line Chart/Trend Chart/Control Chart - used to detect trends andunusual activities within the data set,• Pareto Chart Analysis - used to analyze the different componentsthat make up the data value in a descending order, complete withthe cumulative percentage line superimposed on it,• SWOT Analysis - used to analyze process strengths, weaknesses,opportunities and threats based on the characteristics of the dataset - whether internal or external,• Arithmetic average or mean - used to identify the averageperformance value of the process,• Median - used to identify the actual middle value of the data set,• Mode - used to identify the most frequent value occurring withinthe data set,• Range - used to identify the difference between the lowest andhighest values ,• Standard deviation – used to identify the SD from the mean• Cause and Effect Analysis - used to analyze the causes and effectsof a given data set,• Risk Analysis - used to identify potential risks given the data set
  75. 75. 024681012Errors What causedthis spike?Trend chartUse it to identify potential problems
  76. 76. Pareto Principle20% of the causes contributes to 80% of the effects• Identify and classifyall problems• Calculate cumulativeoccurrences up to80%• Focus on solvingthose problems• Continually improvethe management ofthose causes• Analyze your salesfigures and identifythe contributors• Focus your efforts oncustomers whocontribute 80% ofthose sales• Focus your efforts onthe sales personnelwho are managingthose customersJoseph M. Juran suggested the principle and named it after Italian economist VilfredoPareto, who observed in 1906 that 80% of the land in Italy was owned by 20% of thepopulation; he developed the principle by observing that 20% of the pea pods in hisgarden contained 80% of the peas.
  77. 77. What to improve?• The organization shall continually improve theeffectiveness of the quality management systemthrough the use of the quality policy, qualityobjectives, audit results, analysis ofdata, corrective and preventive actions andmanagement review.• All nonconformities require corrective actions• All potential nonconformities require preventiveactions.
  78. 78. Corrective action processDetectnonconformityReportnonconformityReviewnonconformityagainst criteriaIssue CARPerform rootcause analysisEvaluate needfor correctiveactionImplementcorrectiveactionRecord theresults ofactions takenVerifyeffectiveness ofactions taken
  79. 79. Preventive action processDetectpotentialnonconformityReportpotentialnonconformityReview againstcriteriaIssue PARPerform rootcause analysisEvaluate needfor preventiveactionImplementpreventiveactionRecord theresults ofactions takenVerifyeffectiveness ofactions taken
  80. 80. Risk analysisPerforming a risk analysis on yourbusiness processes can help youdetect potential nonconformities• Describe the risk• Describe the potential effects• Quantify likelihood of occurrence(consider frequency)• Quantify severity of consequence(consider harm or damage)• Assign risk rating (likelihood xseverity)• Risk rating > 4 shall be controlled(ALARP = as low as reasonablypracticable)Score ratings1 = very low2 = low3 – moderate4 = high5 = very high
  81. 81. Root cause analysisRoot cause Effect Effect Direct cause Nonconformitycauses effectSources of direct causes:1. Human error,2. Material defect,3. Equipment malfunction,4. Ineffective methods of operation or control, or5. Flawed management policies.
  82. 82. Nonconformities• Don’t fear them because–We detect and report them because wedon’t want them to recur–We report and record them because wewant to document the improvements madeto the QMS
  83. 83. ISO 9001 Certification• Performed by independent CertificationBody, such as SIRIM QAS, BVQI, LRQA, SGS• Client gets a renewable 3-year certificate• Phase 1 audit = Adequacy audit =Documentation audit• Phase 2 audit = Conformance audit = Physicalaudit of personnel, records and processes
  84. 84. ISO 9001 Certification• First year = Certification audit• 2nd year = Surveillance audit• 3rd year = Surveillance audit and/or re-certification audit• If after 3 months, nonconformities were notcorrected (via the corrective action procedure)by the client, the ISO 9001 certificate will berevoked by the CB.
  85. 85. • Decide if ISO 9001 is for you• Purchase the standard online• Purchase a Quality Manualtemplate• Appoint a ManagementRepresentative• Appoint a QMS Committee• Read the ISO 9001 Standardand the Quality Manual• Plan your QMS by customizingthe Quality Manual• Plan and implement everyclause within the QualityManualPlan of action
  86. 86. Hope youbenefited fromthat presentation

×