List of Mandatory Records for ISO 9001:2008 Requirement 1. Records of Management Review ISO clause 5.6.

1 Example Schedules for the year; Notice of management review meeting (with agenda) Minutes of meeting Training plan; Training records; employee biodata; evaluation of training effectiveness; employee evaluation; List of critical production equipment; list of monitoring and measuring equipment; maintenance records/logs Production records Responsibility/ generator Secretary/DCO

2. Records of education, training, skills and experience

6.2.2e

HR

Maintenance

3. Evidence that the product realization process and resulting product fulfill requirements 4. Results of the review of requirements related to the product and subsequent actions 5. Design and development inputs relating to product requirements 6. Result of design and development reviews and any necessary actions 7. Results of design and development verification and any necessary actions 8. Results of design and development validation and any necessary actions 9. Results of the review of design and development changes and any necessary actions 10. Results of supplier evaluations and any necessary actions arising from the evaluations 11. Record of validation of special processes (where the resulting output cannot be verified by subsequent monitoring or measurement), where required 12. The unique identification of the product (where traceability is required) 13. Customer property that is lost, damaged or otherwise found to be unsuitable for use 14. Basis used for calibration or verification of measuring

7.1d

Production

7.2.2

7.3.2 7.3.4

Signature on the job order slip or purchase orders received from client and the subsequent actions to be taken Customer specifications, proof that the design was approved Minutes of meeting related to design and development Design plan; record of verification activities (adherence to the design plan) Test plans, test reports and acceptance records Minutes of the design review meeting

Approving authority Design and Development Design and Development Design and Development Design and Development Design and Development Purchasing

7.3.5

7.3.6

7.3.7

7.4.1

7.5.2d

Supplier evaluation record; list of accredited suppliers CV, supplier credentials Report of activity conducted

Production

7.5.3

Records of product serial numbers

Production personnel Production/ delivery personnel Production personnel

7.5.4

Incoming inspection reports, NC reports, delivery reports Record of verification activity indicating the assumptions/basis used

7.6a

1 of 2

List of Mandatory Records for ISO 9001:2008 Requirement equipment where no international or national measurement standards exist 15. Validity of the previous measuring results when the equipment is found not to conform to requirements 16. Results of calibration and verification of measuring equipment 17. Evidence of customer satisfaction 18. Internal audit records and IQA results 19. Evidence of conformity with acceptance criteria 20. Identification of the person authorizing the release of product for delivery to the customer 21. Nature of the nonconformities and any subsequent actions taken, including concessions obtained 22. Results of corrective action 23. Results of preventive action Implied Requirements Evidence that the importance of meeting statutory and regulatory requirements are communicated to the organization Evidence that documents and records are controlled Evidence that responsibilities and authorities are defined 5.1 Updated licenses and permits Manager ISO clause Example Responsibility/ generator

7.6

Record of tests conducted

Production personnel

7.6

Calibration certificates, calibration logs

Production personnel

8.2.1 8.2.2 8.2.4

8.2.4

8.3

Customer satisfaction surveys, warranty claims Marketing and sales personnel Audit program Internal Quality Internal audit report Audit Officer Inspection and test records QA personnel; Approving authority Release authority record Production/QA personnel; Approving authority Nonconformance report; report of Authorized concessions made personnel

8.5.2 8.5.3

Corrective action reports; CA log Preventive action reports; PA log

Authorized personnel Authorized personnel

4.2.3 and 4.2.4 5.5.1

List of Controlled Documents; List of Records; List of References Organizational chart; employee duties and responsibilities; job description Designations and appointments of production, marketing, admin and sales personnel ; QMR, IQA officer and Document Control Officer

Secretary/DCO

Manager HR Manager

2 of 2