ISO 13485:2016 Clause 8.2.1

[agrpyl]

As per ISO 13485:2016 Clause 8.2.1 Feedback, "The organization shall document procedures for the feedback process. This feedback process shall include provisions to gather data from production as well as post-production activities".
What are the source of feedback for "production" activities ?

 

[Tidge]

As per ISO 13485:2016 Clause 8.2.1 Feedback, "The organization shall document procedures for the feedback process. This feedback process shall include provisions to gather data from production as well as post-production activities".
What are the source of feedback for "production" activities ?

Non-conformances (materials, environmental excursions, etc.) , scrap, activities triggered by process monitoring, etc.

 

[chris1price]

CAPAs, non-conformances, deviations - anything that has potential to effect customer requirements.

 

[yodon]

at the risk of piling on, to further add to the list: rework and in-process and final acceptance test failures