A checklist of the 21 records required by ISO 9001

Keep your system as simple as possible. The fewer records you keep, the fewer things that will be audited.

Checklist Record Number Clause Description Example
1 5.6.1 Management reviews Management review minutes
2 6.2.2e Education, training, skills and experience Training plan, training matrix, training records and CVs
3 7.1d Evidence that the realisation processes and resulting product fulfil requirements Project quality plan
4 7.2.2 Results of the review of requirements related to the product and actions arising from the review Change review
5 7.3.2 Design and development inputs relating to product requirements Customer specifications, design approval logs
6 7.3.4 Results of design and development reviews and any necessary actions Design development minutes
7 7.3.5 Results of design and development verification and any necessary actions Design plan, test plan document outputs
8 7.3.6 Results of design and development validation and any necessary actions Test plans, test reports and acceptance records
9 7.3.7 Results of the review of design and development changes and any necessary actions Design review minutes
10 7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations Supplier evaluations, subcontractor assessments, approved supplier list
11 7.5.2d As required by the organisation to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement Schedules of achieved results
12 7.5.3 The unique identification of the product, where traceability is a requirement Serial number logs
13 7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use Delivery notes, incoming material schedules, defective material reports or NCRs
14 7.6a Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist Customer specifications, corporate standards
15 7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements Test plan document outputs
16 7.6 Results of calibration and verification of measuring equipment Calibration certificates. records and calibration logs
17 8.2.2 Internal audit results and follow-up action Internal audit report
18 8.2.4 Indication of the person(s) authorising release of product. Release acceptance record
19 8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained Non conformance report, concession report
20 8.5.2 Results of corrective action Corrective action reports and logs
21 8.5.3 Results of preventive action Preventive action reports and logs

Some records, such as design and development, may not apply to your organisation if you don’t design anything (maybe you only distribute products). In this case you can specifically exclude yourself from section 7.3 Design and Development and you will not be expected to keep the associated records, but ensure that any exclusions are always stated in the appropriate section of the quality manual.

>> Review the mandatory procedures and documentation requirements