Integrating Health and Safety into QMS

MetalSkool97

Registered
Hello everyone, I am a long-time lurker and first-time poster.

My firm is a supplier (not legal manufacturer) of IVD medical devices and we hold an ISO 13485 certificate and are compliant to FDA QSR.

Recently, top management at my workplace have expressed their wishes to implement official Occupational Health and Safety (OHS) procedures as a part of the QMS. An increase in safety standards and top management emphasising its importance in the workplace to boot is most certainly a positive thing and I am welcoming it with open arms. In my previous roles, OHS and Quality have been distinct from one another and had their own avenues for reporting / review. However, given our available resource and low-risk manufacturing processes / environment, we are looking to integrate OHS with the Quality Management System.

I do, however, have a few concerns from an ISO 13485 point of view. Specifically, management review meetings and the use of the CAPA process for incident reporting. We are looking at adding OHS to our quality objectives which would be evaluated in management review meetings and are also looking at using the CAPA register for OHS related incidents / actions.

My question is that if we proceed with this and integrate OHS into the Quality Management System what would the impact be from an ISO 13485 point of view as well as that of an FDA inspector? Would us including OHS into our QMS open up the scope for an auditor to inspect these processes? I am also concerned if Quality and OHS are blended in the same processes that they would either dilute or derail each other and become unnecessarily muddled.
 

Sidney Vianna

Post Responsibly
Leader
Admin
My question is that if we proceed with this and integrate OHS into the Quality Management System what would the impact be from an ISO 13485 point of view as well as that of an FDA inspector?
This issue has been addressed here many times. If you do a search, you should be able to find a number of threads on this topic. An FDA inspector should still have to perform the audit in line with the scope of the assignment. If a process (any process) has integrated requirements addressing product quality and safety, environmental management, occupational health and safety, etc, and the scope of the audit is to verify conformity with 13485, the auditor has no business whatsoever in delving into OHS nor environmental compliance. The problem is: auditors come in all sizes, shapes, degrees of professionalism, knowledge, etc. To mitigate the possibility of an auditor/inspector straying out of bounds, this should be discussed and brought up for disclosure during the opening meeting.

Good luck.
 
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