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DocumentsandRecords RequiredbyISO9001:2008

Documents required by ISO 9001:2008


No. 1. 2. 3. Qualitypolicy Qualityobjectives Qualitymanual Description Clause 4.2.1a 4.2.1a 4.2.1b

Procedures required by ISO 9001:2008


No. 1. 2. 3. 4. 5. 6. Controlofdocuments Controlofrecords InternalAudit Controlofnonconformingproduct Correctiveaction Preventiveaction Description Clause 4.2.3 4.2.4 8.2.2 8.3 8.5.2 8.5.3

Records required by ISO 9001:2008


No. 1. 2. 3. Description Clause 5.6.1 6.2.2e 7.1d 7.2.2 7.3.2 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.5.2d 7.5.3 7.5.4 7.6a 7.6 7.6 8.2.2 8.2.4 8.3 8.5.2 8.5.3 Managementreviews Education,training,skillsandexperience Evidencethattherealizationprocessesandresultingproductfulfilsrequirements Resultsofthereviewofrequirementsrelatedtotheproductandactionsarisingfrom 4. thereview 5. Designanddevelopmentinputsrelatingtoproductrequirements 6. Resultsofdesignanddevelopmentreviewsandanynecessaryactions 7. Resultsofdesignanddevelopmentverificationandanynecessaryactions 8. Resultsofdesignanddevelopmentvalidationandanynecessaryactions 9. Resultsofthereviewofdesignanddevelopmentchangesandanynecessaryactions 10. Resultsofsupplierevaluationsandanynecessaryactionsarisingfromtheevaluations Asrequiredbytheorganizationtodemonstratethevalidationofprocesseswherethe 11. resultingoutputcannotbeverifiedby 12. Theuniqueidentificationoftheproduct,wheretraceabilityisarequirement 13. Customerpropertythatislost,damagedorotherwisefoundtobeunsuitableforuse Basis used for calibration or verification of measuring equipment where no 14. internationalornationalmeasurementstandardsexist Validityofthepreviousmeasuringresultswhenthemeasuringequipmentisfoundnot 15. toconformtorequirements 16. Resultsofcalibrationandverificationofmeasuringequipment 17. Internalauditresultsandfollowupactions 18. Indicationoftheperson(s)authorizingreleaseofproduct Nature of the product nonconformities and any subsequent actions taken, including 19. concessionsobtained 20. Resultsofcorrectiveaction 21. Resultsofpreventiveaction Note: Where exclusion are made, which is limited within clause 7, the records will be not necessary

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01 Januari 2009

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