ISO 9001 Mandatory Records

There are 21 mandatory records required by ISO 9001:2008. Of course you can decide to keep more
than those listed below but we do recommend to keep your system as simple as possible. The fewer
documents and records you have, the fewer aspects an auditor will have to audit.
Mandatory Records

Examples

5.6.1 Management Review

Management review minutes

6.2.2e Education, training, skills and experience

Training records/matrix, resumes

7.1d Evidence of realization process

Project quality plan

7.2.2 Results of the review of requirements related to the product and Change review
actions arising from the review
7.3.2 Design and development inputs relating to product requirements Customer specifications
7.3.4 Results of design and development reviews and any necessary

Design development minutes

actions
7.3.5 Results of design and development verification and any

Design plans, test plans

necessary actions
7.3.6 Results of design and development validation and any necessary User acceptance test plans,
actions

acceptance records

7.3.7 Results of the review of design and development changes and

Design review minutes, change

any necessary actions

requests

7.4.1 Results of supplier evaluations and any necessary actions arising Supplier evaluation, approved
from the evaluations

suppliers list

7.5.2d Demonstrate the validation of processes where the resulting

Schedule of achieved results

output cannot be verified by subsequent monitoring or measurement

7.5.3 The unique identification of the product, where traceability is a

Equipment register

requirement
7.5.4 Customer property that is lost, damaged or otherwise found to

Delivery notes, site visits,

be unsuitable for use

defective materials report

7.6 Results of calibration and verification of measuring equipment

Calibration certificates

7.6 Validity of the previous measuring results when the measuring

Test plan results

equipment is found not to conform to requirements

7.6a Basis used for calibration or verification of measuring equipment Customer specification, corporate
where no international or national measurement standards exist

standards

8.2.2 Internal audit results and follow-up action

Internal audit report

8.2.4 Indication of the person(s) authorising release of product

Product acceptance/release report

8.3 Nature of the product nonconformities and any subsequent actions Non conformance report,
taken, including concessions obtained

consession report

8.5.2 Results of corrective action

Corrective action report

8.5.3 Results of preventative action

Preventative action report

Please note that although these quality records are mandatory, if the scope of your QMS does not include
a particular section, these records can be excluded.
For example, if your organization only distributes products, and you don't do design and development,
section 7.3 can be excluded from the scope. Noted in the appropriate section of the quality manual of
course!