Required Records

A record is defined in ISO 9000:2005, 3.7.6, as a “document stating results achieved or providing evidence of activities performed”.

According to ISO 9001:2008, 4.2.1.c, the quality management system documentation must include the records required by the standard. Specific records are identified in the standard for:

1. Management review – 5.6.1
2. Education, training, skills, and experience – 6.2.2.e
3. Evidence that realization processes and resulting product meet requirements – 7.1.d
4. Results of review of product requirements and actions arising from review – 7.2.2
5. Inputs relating to product requirements – 7.3.2
6. Results of design and development reviews and any necessary actions – 7.3.4
7. Results of design and development verification and any necessary actions – 7.3.5
8. Results of design and development validation and any necessary actions – 7.3.6
9. Identification of design and development changes – 7.3.7
10. Results of review of design and development changes and needed actions – 7.3.7
11. Results of supplier evaluations and any necessary actions – 7.4.1
12. Records for process validation to demonstrate ability to achieve results – 7.5.2.d
13. Unique product identification if traceability is a requirement – 7.5.3
14. Lost, damaged, or unsuitable customer property – 7.5.4
15. Basis for calibration or verification where no measurement standards exist – 7.6.a
16. Assessment of validity of prior results if equipment is found nonconforming – 7.6
17. Results of calibration and verification – 7.6
18. Records of internal audits and their results – 8.2.2
19. Evidence of conformity with the acceptance criteria – 8.2.4
20. Person(s) authorizing release of product for delivery to customer – 8.2.4
21. Nature of nonconformities and any subsequent actions, including concessions – 8.3
22. Results of corrective actions taken – 8.5.2
23. Results of preventive actions taken – 8.5.3

Other Records
ISO 9001:2008, 4.2.1.d, states quality management system documentation must also include records determined by the organization as necessary to ensure the effective planning, operation, and control of its processes. Clause 4.2.4 of the standard refers to records kept as evidence of conformity to requirements.

So, in addition to the records specifically mentioned in the standard, other records will be needed for the effective planning, operation, and control of processes, as well as, proof of conformity to requirements.

Record Control
The required records, and others added by the organization, must be placed under record control. Clause 4.2.4 requires organizations to establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention, and disposition of their records.