Method for recording inspection activities

I am interested in moving towards this method of capturing data as we currently only record dimensional data on a paper that is filed away. Data is not being used in SPC or any track/trend analysis. If something is found out of tolerance, the manufacturer is notified of the issue.

Reading ISO 13485-2016, it seems that sections 7.4.3 & 4.2.5 only state that inspection activities are to be established and maintained. I believe the method described above would be acceptable and would like to have an outside opinion. Thanks!

Answer:

The method that you described above is acceptable if you are ok with that. Here is just important to point out that the company determines the specification of the purchased product, and that the company is solely responsible for how thorough the verification of the purchased product will be. If using this method you are sure that you will see and register products that stand out from the required measures, then this is acceptable.

For more details on how to implement requirement 7.4, please read article: How can ISO 13485 clause 7.4, Purchasing, enhance procurement?
https://advisera.com/13485academy/blog/2018/04/18/how-can-iso-13485-clause-7-4-purchasing-enhance-procurement/