April 4, 2023

Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 2

Carrying on from the first part of this topic from a couple days ago:  Indeed, it is wise to stick with longstanding principles and corresponding normative requirements for medical device QMS documentation.  And it’s essential to give very careful consideration to notified bodies’ enforcement practices, like those aforementioned.   EN ISO 13485’s (as amended) call for an outline of the structure of the QMS documentation is generally answered by the medical device QMS documentation pyramid (e.g., Tier 1 = policies; Tier 2 = procedures; Tier 3 = work instructions; Tier 4 = records). Moreover, there are specific and unique medical device QMS documentation control requirements that apply to procedures (e.g., PMS procedure and blank form for PMS Plan) as distinguished from records (e.g., the filled-out PMS Plan form for a particular product laying out that product’s specific PMS data types, gathering methods, analytical techniques, particular trigger criteria for improvement action, timelines, responsibilities, etc.).  Mixing and matching these is a recipe for nonconformity.

All this said, as a technical documentation auditor, I might not outright issue a nonconformity just because an organization reimagined a way to cobble together its Tier 2 PMS procedures and its Tier 4 PMS Plan records.  But there would likely be associated low-hanging bad fruit in the form of QMS documentation control nonconformities due to the fundamentally different controls required for procedures as distinguished from records.