Is it possible to have two QMSs? One for each or our two products

[mobylad]

Is it possible to have two QMSs? one for each or our two products. We will have a period of time when the two product will be manufactured in parallel. We didn't originally have such a scenario as we thought that one (our new) product would take over from the other. Because the QMS structure is very different for both products, it made better sense to design a new QMS, including Quality Manual, Processes, Procedures, etc for the new prouduct. Now that we will have two products running in parallel for a period we are wondering if you can have two QMSs. Will a notified body and FDA accept this.

 

[treesei]

Re: Two QMSs within one company

Yes it is possible. The company I worked for is exactly this situation. 90% of the products are consumer electronics under ISO 9001 QMS. 10% are medical devices under ISO 13485. The scope of the medical device products are specified on the ISO cert. There are designated areas for medical device products in the facility. It has been years and such system has not been challenged by anyone.

 

[somashekar]

Re: Two QMSs within one company

Is it possible to have two QMSs? one for each or our two products. We will have a period of time when the two product will be manufactured in parallel. We didn't originally have such a scenario as we thought that one (our new) product would take over from the other. Because the QMS structure is very different for both products, it made better sense to design a new QMS, including Quality Manual, Processes, Procedures, etc for the new prouduct. Now that we will have two products running in parallel for a period we are wondering if you can have two QMSs. Will a notified body and FDA accept this.

A QMS is a system to manage processes well and improve upon it. We are used to calling it as Quality management system (QMS)
I can have one QMS and manage multiple products each very differently and as required by that product.
QMS is global for you, the product is just one around which you apply QMS requirements.
Keeping the products aside, there are many things in your company that are common.
It is possible, but to what effect ?
For me it sound cumbersome, complicated and not worth the doing.

 

[Roberticus]

Re: Two QMSs within one company

... It is possible, but to what effect ?
For me it sound cumbersome, complicated and not worth the doing.

Agreed, and especially within the comparative scope of the 9001 & 13485 standards. They are similar enough to where you'd probably just be better off disclosing any heightened 13485-based documentation or validation requirements for your medical product within 1 set of procedures, which is 1 QMS.

Beyond that, make sure you consider the largely parallel requirements of Customer satisfaction/feedback (9001/13485) and discuss both improvement/maintenance (9001/13485) of your QMS, and you should be good to go...

 

[Shoes]

Re: Two QMSs within one company

I had to run 2 systems once. The Capability Maturity Model for software development and ISO for hardware development. It isn't easy but can be done when necessary.

 

[mobylad]

PS thanks for all the responses. I need to clarify that they are two medical device products. Our current product is manufactured in house, but the new medical device will be almost fully outsourced, however the QMS will remain within house. There would be significantly more work involved in adapting our current QMS to include the new product rather than having an additional QMS for the new product. Bear in mind that the current product will be only running in parallel with the new product for a short period before the new product will run on its own. So back to my original question (although adding some clarification), can a medical device manufacturer, manufacture two different medical devices with a separate QMS for each?

 

[Ronen E]

PS thanks for all the responses. I need to clarify that they are two medical device products. Our current product is manufactured in house, but the new medical device will be almost fully outsourced, however the QMS will remain within house. There would be significantly more work involved in adapting our current QMS to include the new product rather than having an additional QMS for the new product. Bear in mind that the current product will be only running in parallel with the new product for a short period before the new product will run on its own. So back to my original question (although adding some clarification), can a medical device manufacturer, manufacture two different medical devices with a separate QMS for each?

Sounds strange to me but if the period in which they run in parallel is short enough, you might be able to convince your NB. If you had the 2 QMS running in 2 different (geographical) locations it might have been a bit easier.

Cheers,
Ronen.

 

[MIREGMGR]

can a medical device manufacturer, manufacture two different medical devices with a separate QMS for each?

My view is, yes because no rule says you can't.

You however may have to explain yourself to various people with raised eyebrows who think you're out of your mind and/or there must be a rule against it.

 

[Elynn]

Agree with MIREGMGR - There is no rule that says "No".

If your organisation can afford the resources (manpower & $$) to maintain the separate QMSs, will not cause confusion to the users (the employees / workers) and make it easier for the new product, there should be no reasons to say "no"...

However, in the long run, you may wish to merge both into one by comparing the commons and differences... and just work on the clauses with differences.

 

[isoalchemist]

Also in agreement with MIREGMGR and ELYNN, but I'm a bit confused by your statement

There would be significantly more work involved in adapting our current QMS to include the new product rather than having an additional QMS for the new product.

If both products are medical devices and controlled under 21CFR820 and/or ISO13485 what you infer is that all of your business processes ( Man Rev., Purchasing, Audit, Doc Control etc.) are being forced to change because of the product. That seems strange....IMHO I'd take a step back and examine what is really different and needs to change before attempting to maintain 2 QMS systems.