Guidance

Documentation requirements

The ISO Navigator™ database hyperlinks the ISO 9000 principles and the ISO 9001 requirements; and explains them in plain English with practical guidance.

ISO 9001: Control of records 4.2.4

Your organization must implement a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records and that these records must remain legible and identifiable throughout their retention period. Records prove the efficacy of the QMS.

  1. Records prove compliance against requirements
  2. Develop and implement the control of records procedure
  3. Maintain the legibility and accessibility of QMS documents and records

Implementing a document management system could mean keeping certain records that your organization might not be already keeping. Some of these records may seem a little confusing until you become more familiar with the quality standard.

Of course, you are free to keep more records than those listed below, if you feel your organization needs them, but as we always preach; keep your system simple. The fewer documents and records you keep, the fewer things that will be audited, and the more time you will have to actually run your business.

Keep in mind that you are free to combine some of these records where it makes sense, for example, you could combine the corrective and preventive action request log with a simple checkbox to note which one it is.

You could also combine both corrective and preventive action requests onto one form, again with a simple check box to designate its purpose. The following clauses of ISO 9001 contain the instruction 'see 4.2.4' which means that you must retain these 21 records:

  1. 5.6.1 Management review minutes
  2. 6.2.2 Records of education, training, skills and experience
  3. 7.1 Evidence that the realization processes and product fulfil requirements
  4. 7.2.2 Records of sales activities
  5. 7.3.2 Design and development inputs
  6. 7.3.4 Design and development reviews and any related actions
  7. 7.3.5 Design and development verification and any related actions
  8. 7.3.6 Design and development validation and any related actions
  9. 7.3.7 Design and development changes and any related actions
  10. 7.4.1 Results of supplier evaluations and any actions arising
  11. 7.5.2 Records to demonstrate the validation of special processes
  12. 7.5.3 Records of product identification where traceability is required
  13. 7.5.4 Customer property that is lost, damaged or found to be unsuitable
  14. 7.6 Basis used for calibration where no standards exist
  15. 7.6 Validity of the previous results when equipment is out of calibration
  16. 7.6 Results of calibration and verification of measuring equipment
  17. 8.2.2 Internal audit results and follow-up actions
  18. 8.2.4 Indication of the person(s) authorizing release of product
  19. 8.3 Records of the product non-conformities and any subsequent actions
  20. 8.5.2 Results of corrective action
  21. 8.5.3 Results of preventive action

Looking for ISO 9001 mandatory procedure templates? Our quality manual template provides a great foundation for establishing, implementing and documenting the six mandatory procedures that are required by the standard.