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ISO 13485:2003 Documentation Requirements

First: Required Procedure


# 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. Clause 4.2.3 4.2.4 6.3 6.4 6.4 6.4 7.1 7.3.1 7.4.1 7.5.1.2.1 7.5.1.2.2 7.5.1.2.3 7.5.2.1 7.5.2.2 7.5.3.1 7.5.3.1 7.5.3.2 7.5.5 7.5.5 7.6 8.2.1 8.2.1 8.2.2 8.2.4.1 8.3 8.4 8.5.1 8.5.1 8.5.2 8.5.3 Name Control of documents Control of records Maintenance Activities Health, cleanliness and clothing if come in contact with the product can affect it Work environment conditions, monitoring and control Control of contaminated or potential contaminated products to prevent product contamination Risk Management Design and development Purchasing process Product cleanliness Installation activities Servicing activities Validation of the application of the computer S/W Sterilization process validation Product identification Product return identification from normal production Product traceability Product preservation Control of limited shelf life products Control of monitoring and measuring equipment Feedback system (including customer complaint) Post-production phase experience Internal audit Monitoring and measurement of product Control of nonconforming product Analysis of data Advisory notice Vigilance system Corrective action Preventive action

Second: Required to be Documented


# 1. 2. 3. 4. 5. 6. 7. Clause 4.2.1 5.5.1 7.2.2 7.3.1 7.4.1 7.5.2.1 7.3.1 Name Statement of the quality policy Responsibilities and authorities Products requirements Design planning output Supplier selection criteria Defined criteria for review and approval of processes Design and development

Third: Required Records


# 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. Clause 5.6.1 6.2.2 6.3 7.1 (d) 7.1 7.2.2 7.3.2 77.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.3 7.5.1.1 7.5.1.2.2 7.5.1.2.3 7.5.1.3 7.5.2 (d) 7.5.2.1 7.5.2.2 7.5.3 7.5.3.2 7.5.4 7.5.5 7.6 7.6 8.2.2 8.2.4.1 8.2.4.1 8.3 8.4 8.5.1 8.5.2 8.5.3 Name Management review Education, training, skills and experience Maintenance activities Evidence that the realization processes and resulting product fulfil requirements Risk Management Results of the review of requirements related to the product and actions arising from the review Design and development inputs relating to product requirements Design output Results of design and development reviews and any necessary actions Results of design and development verification and any necessary actions Results of design and development validation and any necessary actions Results of the review of design and development changes and any necessary actions Suppler evaluation and necessary actions arising from the evaluation Verification of purchased product Batch file Installation and installation verification Servicing activities Sterilization process parameters As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement S/W validation Sterilization process validation The unique identification of the product, where traceability is a requirement Traceability records Customer property that is lost, damaged or otherwise found to be unsuitable for use Control of limited shelf life products Calibration and verification results Results of calibration and verification of measuring equipment Internal audit Conformity to acceptance criteria Indication of the person(s) authorizing release of product. Nature of the product nonconformities and any subsequent actions taken, including concessions obtained Analysis of data Customer complaints, investigation and action taken Results of corrective action Results of preventive action

Indicate items required for ISO 9001:2000 and ISO 13485:2003