Combined ISO 13485 Certification with ISO 9001:2015

Does anyone have a system set up with both of the new standards how did you do it?

I have a facility looking to go 13485 but wondering how do you pull the 13485 in with the new ISO 9001? Does my scope call out the product line for 13485 and all other lines under ISO

Any insight is welcome or if my thought process is off track let me know that too.


Thanks,
Al40

Hi Al,

This has been discussed in some other Elsmar threads, and if I recall correctly, the general sentiment was that maintaining that dual certification would be onerous and perhaps pointless, beyond the transition to 9001:2015 & 13485:2016.

If you scroll down to the bottom of this page you will find a box that recommends related threads. The top 2 that I see there are somewhat relevant and not too outdated. I remember that there have been more, they can be found through an ordinary search.

Cheers,
Ronen.

Also you can see THIS THREAD

It can be done with some tailoring of the QMS to explain how you meet requirements. Easiest way to do this is to set the system up to meet the more stringent of requirements from the two International Standards. Annex B of 13485 contains a cross reference between ISO 9001:2015 and ISO 13485:2016.

Key point to remember when developing and integrated QMS are:

* Per Clause 0.1 of 13485 and 9001 there is no intent of these International Standards to imply the need for uniformity in the structure, uniformity of documentation or alignment of documentation to the clause structure of this International Standard.

* Quality manual should be used without referencing the numbering system of the standards

* Quality manual should have a 13485 and 9001 appendix to cross reference the requirements of the standards to the manual and procedures of the organization

* More explanation will be required to show how you meet the contradicting requirements between the two standards

I have done this for organizations that needed to meet ISO 13485, ISO 9001 and AS9100 plus a few military standards through in for good measure.

A little late to reply but I recently revised an existing ISO 9001 and ISO 13485 dual QMS to meet the requirements of the new ISO 9001:2015. I was a little worried but actually on the face of it, it wasn't that onerous to do. I'm about to run out the door but if you have any specific questions feel free to ask.

al40 said:

Does anyone have a system set up with both of the new standards how did you do it?

I have a facility looking to go 13485 but wondering how do you pull the 13485 in with the new ISO 9001? Does my scope call out the product line for 13485 and all other lines under ISO

Any insight is welcome or if my thought process is off track let me know that too.


Thanks,
Al40

Click to expand...

Just out of interest, why would you want to keep ISO 9001?

fialor said:

Just out of interest, why would you want to keep ISO 9001?

Click to expand...

I still see several big tenders and government tenders that simply ask the ISO 9001 certification as a requirement..... Business requirement I suppose.

The company I was working with said the same. ISO 9001 is more recognised and is used as a marketing tool including for tenders etc.

Thanks,
Because we have other products that are not medical but are commercial.

RA Princess said:

The company I was working with said the same. ISO 9001 is more recognised and is used as a marketing tool including for tenders etc.

Click to expand...

When I have received such requests/seen them in tenders, I have responded with the ISO 13485 certificate and a little explanation note. This has been sufficient in the past.