Mandatory Documents and Records (Ref: ISO 9001:2008)

Mandatory Documents:
Quality Policy Quality Objectives Quality Manual (Scope & Exclusions, Interaction of processes and List of Documented Procedures) Documented Procedures 4.2.3 Control of documents 4.2.4 Control of records 8.2.2 Internal Audit 8.3 Control of nonconforming product 8.5.2 Corrective action 8.5.3 Preventive action

Documents needed by organization to control of its processes

Mandatory Records:
Sl. No. Clause No. Description Actual Records / Document Evidence as appropriate 1. Management Review Meeting Minutes (as per defined Agenda) 2. Internal Communication-MRM 3. Personnel records with detail resume 4. Skill Matrix / Evaluation 02 6.2.2 Records of education, training, skills and experience 5. Training Plan / Schedule 6. Training Attendance Register 7. Effectiveness of Training provided 8. Evidence of product / service realization a. Business plan Vs Actual b. Project plan Vs Actual c. 03 7.1 (d) Evidence of product / process realization Production plan Vs Actual d. Quality plan / Control plan e. Action plan for Quality Objectives & Results f. Resources plan g. Training Plan h. Preventive Maintenance Plan i. Design and Development Plan
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5.6.1

Records for Management Reviews

Mandatory Documents and Records (Ref: ISO 9001:2008)

j. k. l. Calibration Plan Internal Audit Plan Corrective Action Plan Vs Results

m. Preventive Action Plan Vs Results 9. Inquiries Records of the results of Review and actions arising from review Review of requirements related to the product 10. Tender Documents 11. Purchase Orders / Work Orders from customers 12. Results of review and actions arose from the review of product / service requirements of customer 13. Functional and performance requirements 05 7.3.2 Design and developments input, relating to product requirements 14. Applicable statutory regulatory requirements 15. Information derived from previous similar designs Results of review and necessary actions against DD Plan Results of Verification of Output (meeting of Input requirements) Results of validation - intended use. Results of review of design changes and follow-up actions Results of suppliers evaluation and necessary actions 16. Results of review and corrective action report 17. Verification report (Checklist) 18. Corrective action report 19. Validation Results 20. Corrective Action Report 21. Design change note 22. Results after the design change 23. Suppliers Evaluation & Re-evaluations 10 7.4.1 24. List of Approved Suppliers 25. Criteria for selection of Suppliers 26. Process Validation reports Validation of processes for Production and Service provision. Where the resulting output cannot be verified by subsequent monitoring or measurement. Welding (Stud, Fusion, Spot, Seam) Soldering Brazing (Vaccum Furnace, Dip, Torch) Plating Passivation Powder Coating Painting Sealant Application
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7.2.2

06

7.3.4

07

7.3.5

08

7.3.6

09

7.3.7

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7.5.2 (d)

Mandatory Documents and Records (Ref: ISO 9001:2008)

Adhesive Bonding Heat treatment Non-destructive Testing a) Magnetic Particle Inspection b) Penetrant Inspection c) Ultrasonic Inspection d) Radiographic Inspection Anodizing Chemical Film Carburizing Nitriding Spark Machining Blasting (Surface Improvement) Hot Forming Manual Riveting Milk Pasteurization

27. Identification tag 28. Batch no. 29. Model no. 12 7.5.3 Identification records 30. Serial no. 31. Heat no. 32. Coil No. 33. Lot No. 34. Customer property records a. Description of material b. Quantity 13 7.5.4 Customer property records c. Purpose d. Status e. Communication details f. Any issues g. Remarks Basis used for calibration or verification - where no international or national measurement standards exist. Validity of previous measuring results when measuring 35. Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist. 36. Validity of previous results when measuring equipment is found not to
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7.6 (a)

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7.6

Mandatory Documents and Records (Ref: ISO 9001:2008)

equipment is found not to conform with its requirements (calibration) conform to its requirements.

37. Calibration Certificates (Results) 16 7.6 Results of calibration and verification of measuring equipment. 38. Master list of Measuring and test equipment 39. Status sticker on measuring and test equipment 40. Audit Plan 41. Audit Schedule 17 8.2.2 Internal audit results 42. Audit Observations 43. NC Report & Follow-up actions 44. Audit Summary Report & Status 45. Inspection report and / or Test report Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product. a. In-coming b. In-process & c. Final 46. Acceptance Criteria 47. Person(s) authorizing release of product 48. Rejections and Corrective Actions (8.5.2) 19 8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained. 49. Customer complaints and Corrective Actions (8.5.2) 50. Concession reports (by customer) 51. Deviation report (Internal) 52. Verification reports after Re-work 8.5.2 (e) 8.5.3 (d) Effectiveness of Corrective actions taken Effectiveness of Preventive actions taken ***** 53. Problem(s) observed, Analysis, Correction, Corrective action & Effectiveness 54. Expected Problem(s), Analysis, Preventive action & Effectiveness

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8.2.4

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