Executed ISO 13485 Internal Audit template

hnasri

Registered
Is there an executed ISO 13485 internal audit template in this forum or elsewhere where you can find the specific documents/records/SOP's responding to the specific sub-clauses under Clauses 7 and 8 (product realization and monitoring & measurement)?
 

yodon

Leader
Super Moderator
That's rather (company) private information. Somebody may share, but I wouldn't expect it.

The standard is pretty clear on what the expectations are for documented evidence of compliance. Product realization includes (in part) all the design control docs / records (design inputs, outputs, reviews, V&V, etc.). Monitoring and measurement includes complaint & feedback records, internal audit records, and all the way through CAPA (records).

Is there maybe something in particular you're unclear about?
 

Tidge

Trusted Information Resource
As @yodon wrote: Another company's tracing to their internal documents won't help very much. If no formal tracing already exists and there is a hesitancy to start the exercise from scratch... or folks are otherwise flummoxed how to start... a past audit of the Quality System might offer some clues as to what was reviewed for each clause.

From memory: There exists an informative guidance document that shows the two-way traceability with explanations from (FDA 21 CFR 820) <-> (ISO 13485). You may want to trace the internal company procedures to each of those while you start the exercise... or leverage tracing that may already have been done for 21 CFR 820.
 
Top Bottom