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

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Guest user Created:   Sep 03, 2020 Last commented:   Sep 04, 2020

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

(IQ, OQ, and PQ) part of validation - not listed in ISO13485? but it should be covered by the risk document? Thank you.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Sep 04, 2020

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:

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

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