ISO 9001-2008 QMS-Checklist

Sl. No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. Clause SEC 1 SEC 2 SEC 3 SEC 4 DOC 4.2.2 PROC 4.2.3 PROC 4.2.4 SEC 5 DOC 5.3 DOC 5.4.1 REC 5.6.1 SEC 6 REC 6.2.2.e SEC 7 REC 7.1.d 8 Sections Scope Normative Reference Terms and Definitions Quality Management System 3 Essential Documents 6 Mandatory Procedures 21 Compulsory Records Remarks Done

Quality Manual Control of Documents Control of Records Management Responsibility Quality Policy Quality Objectives Management Reviews Resource Management Education, Training, Skills and Experience Product Realization Evidence that realization processes and resulting product fulfill requirement Results of review of product requirements and actions taken as per review Design and development inputs relating to product requirements 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 review of design and development changes and necessary actions

16.

REC 7.2.2

17. 18. 19.

REC 7.3.2 REC 7.3.4 REC 7.3.5

20.

REC 7.3.6

21.

REC 7.3.7

Sl. No. 22. 23. 24. 25. 26. 27.

Clause REC 7.4.1 REC 7.5.2.d REC 7.5.3 REC 7.5.4 REC 7.6.a REC 7.6

8 Sections

3 Essential Documents

6 Mandatory Procedures

28.

REC 7.6

21 Compulsory Records Results of supplier evaluation and necessary action as per evaluation Validation of special processes Unique Identification of product where traceability is required Lost, damaged, unsuitable for use Customer Property Basis of calibration or verification of measuring equipment Validity of previous measuring results for nonconforming measuring equipment Results of calibration and verification of measuring equipment

Remarks

Done

Exclusion taken

29. 30. 31. 32. 33. 34.

SEC 8 PROC 8.2.2 REC 8.2.2 REC 8.2.4 PROC 8.3 REC 8.3

Measurement, Analysis and Improvement Internal Audit Internal Audit results and necessary actions Person authorizing release of product Control of Nonconforming Product Nature of product nonconformities and actions taken and/or concessions obtained Corrective Action Results of corrective action Preventive Action Results of preventive actions Other Procedures Business Development MIS GIS HR IT Other Records

35. 36. 37. 38.

PROC 8.5.2 REC 8.5.2.e PROC 8.5.3 REC 8.5.3.d

39. 40. 41. 42. 43.

Sl. No. 44. 45. 46.

Clause

8 Sections

3 Essential Documents

6 Mandatory Procedures Outsourcing

21 Compulsory Records

Remarks

Done