Question regarding where "validations" fit according to ISO 13485:2016

[duff999]

Hello All

I have a few questions as to what clause fits certain type of validation we are/want to perform, while I develop the SOP's.

1. For Process (IQ, OQ, PQ) and software, I believe clauses 4.16, and 7.5.6 are appropriate and have developed this SOP accordingly.

2. I'm struggling a bit on the next items:

- Product Conformance, would this be part of my design and development SOP?
- For laboratory and equipment cleaning, I am not sure where this should fit? Possibly process?

Any help would be appreciated.

Thanks

 

[DannyK]

Hello All

I have a few questions as to what clause fits certain type of validation we are/want to perform, while I develop the SOP's.

1. For Process (IQ, OQ, PQ) and software, I believe clauses 4.16, and 7.5.6 are appropriate and have developed this SOP accordingly.

2. I'm struggling a bit on the next items:

- Product Conformance, would this be part of my design and development SOP?
- For laboratory and equipment cleaning, I am not sure where this should fit? Possibly process?

Any help would be appreciated.

Thanks

Product Conformance could be clause 8.2.6 Monitoring and Measurement of product
Equipment Cleaning could be clause 6.3 Infrastructure.