The question is Currently we have (3) entities under the parent company that we are planning to develop a single QMS system in place for all 3 companies which include; medical, aerospace and automotive/ other. Past experiences involved his type of project and subsequently audited and never adversely questioned or impacted.
The plan is to make one Quality Manual and combine work instructions like Document Control which is a level 2 a “multi-site” documented procedure unless one of the locations had some system that was totally different then they would have a standalone procedure.
Recent conference calls with several SME’s indicated that it makes sense to go ahead and gradually transition the system under the parent company; having one document for the QAM, one level 2 set of procedures for the 3 companies; example- 1 DC procedure, 1 control of suppliers, 1 calibration, that would address the 3 companies requirements, and same with level 3-4 documentation. Break out company specific documents that relate to only 1 of the 3 companies; or 2 of the 3 companies into separate documents.
While this is in progress, initiate a continuous improvement CAPA, include in the rational - so that we can utilize resources from each entity and everyone is trained in the same manner, etc. Also the subject matter experts mentioned that whether registration audit to one or three procedures, doesn’t matter…. They will audit the system in place at the time of the audit.
So does anyone have other suggestions, like experience, recommendation ? Best Regards, Brian
Hope you are doing well. When I was with another company my team and I had to do this for five business units albeit two of them were small. One of them was registered to ISO 9001, one had a ISO 9001-compliant system and the other three were all ISO 13485 with, at the time, MDD, CMDR & JPAL as well as FDA. The largest business unit was one of the ISO 13485 ones and had the most robust quality system. We waited until all five business units were done being moved into the same building and took the more robust one as the benchmark. We then did a gap analysis against the other systems. After that was completed we took the benchmark business unit's Quality Manual & procedures, smoothed out the differences with the other two ISO 13485 registered business units and revised the Quality Manual and then titled a copy of that for each business with changes appropriate to their business specific needs.
This quality manual & procedures were at the same time being introduced and modified for the ISO 9001 and ISO 9001-compliant business units. The only real issue that was difficult to bridge with this, at the time, was implementing formal risk assessment & mitigation. In the end it worked out and the ISO 9001-compliant business unit was successfully registered to ISO 9001. It was a great team effort and something that we all look back on and are proud of. Of course, I didn't deal with Automotive & Aerospace so I don't know if this helps but that is my experience with this sort of thing.
My experience is integrating ISO 9001, ISO 14001 and OHSAS 18001 (back then). Here is my presentation for the local ASQ Section. This was also published in Quality Progress in the May 2017.issue. Integrating various industry standards pose different challenges. However I hope these experiences shared may be helpful to you.
The objective is proper quality system and exceed FDA quality expectations.
If you merge one system, the positive is less documents, but every time you generate ECO not related documents must be covered. Also on annual trainings not related issues will be addressed that is not needed and Costly!