IQ, OQ, and PQ part of validation - not listed in ISO13485?

Yes, you are right, IQ, OQ, and PQ are not listed directly in the ISO 13485:2016. However, this is covered by the requirement 7.5.6 Validation of process for production and service provision. There is stated that documented procedure for validation of process must include: equipment qualification and qualification of personnel; and use of specific methods, procedures, and acceptance criteria. So, elements for IQ, OQ, and PQ are covered under this section.

More details you can find in the following article:

• Using ISO 13485 to manage process validation in the medical device manufacturing industry https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/

How Validation report in our ISO 13485:2016 Documentation toolkit looks like, you can see on the following link:

• Validation Report https://advisera.com/13485academy/documentation/validation-report-iso-13485-2016/