How to streamline different documents in a multi plant ISO13485 QMS

[paulag]

Hello everyone,

We are a SME medical device company, 13485 certified, with plants in different european countries. Every of this plant has its own Quality Management / Documentation system. We need a common QM Manual - but the bigger task is to combine all these local SOPs and WIs. Which is the most efficient way to go? Write common SOPs and link with local WIs?

Anyone out there with the same issue? Every help or idea welcome! Thanks a lot!

 

[Kevin Mader]

Re: How to integrate documents in a multi plant ISO13485 QMS

Hi paulag - what is your overall aim? Just to have continuity of practice or is it to be under a single registration?

Regards,

Kevin

 

[mdurivage]

Re: How to integrate documents in a multi plant ISO13485 QMS

One potential problem is with the FDA. If all of your facilities are under the same QWS, if an issue arised all plants can be subject to restrictions.

 

[Kevin Mader]

Re: How to integrate documents in a multi plant ISO13485 QMS

Precisely my thought. I see lots of folks looking to consolidate their many registrations under a single registration. IMO, this is a risky business tactic and for the cost of separate registrations, not worth considering. However, there is benefit to adopt similar policies and practices where appropriate. No two organizations are the same but similarity in policy/practice may be worth considering.

 

[paulag]

Re: How to integrate documents in a multi plant ISO13485 QMS

Thanks for your quick reply and your thoughts...

Yes, the strategic plan is to have all under one registration and common level I and II QMS documentation. That means one manual and general SOPs apply to everone (we are just working on that and already see the issues arising here). But at level III, we will need to keep the WIs specific for every plant, nevertheless somehow connect them to the SOPs.

With all the differences, we need to have similar wordings and a common understanding of the SOPs at every location, else communication and cooperation won't be fun for any of us.

 

[harry]

Re: How to integrate documents in a multi plant ISO13485 QMS

........................ With all the differences, we need to have similar wordings and a common understanding of the SOPs at every location, else communication and cooperation won't be fun for any of us.

I would follow this same approach and I've seen many MNCs doing the same. With regards to certification, you can opt for one cert to cover all (bear in mind the drawbacks the others had pointed out) or one CB with different certs for each site or other combinations (there should be some cost savings). Discuss with your existing or potential CB.

 

[Kevin Mader]

Some benefits of shared content:

- Common understanding/organizational vernacular
- Portability of information

Drawbacks:

- Risks all organizations under the registration (a common procedural problem exists at all sites; significant issues become the "torpedo that sinks the FLEET" not just the site)
- Organizational structures are different (one org has plenty of resources, the other org does not)
- Organizing change/release more difficult
- Lapses in training records (one org familiar with the change, the other org was never told)

My advice: share content before sharing documents and keep registrations independent. You can get some of the benefit of creating procedures in a common organizational language but leave the regulatory baggage behind. Combining registrations under one might be practical in ISO9000-like businesses but the medical device folks that try this experiment usually learn tough lessons. As you note, it's tough getting folks to agree on things. Even tougher when a compliant organization is being made to adopt a noncompliant practice. This adds personal risk to individuals in an organization where the boogiemen and women carry badges. I see the experiment as too problematic to be practical. Think about it - it may be a better thing to stop now and move onto other value add projects. Good luck!

Kevin

 

[paulag]

Thanks again, Kevin!

Will bear your input in mind at further discussions with decision makers and Notified Body.

Regards

Paula

 

[Kevin Mader]

Anytime Paula! PM me if you need specific examples. Unfortunately, I have a few.

Kevin