Transition to ISO 13485:2016 together with ISO 9001:2015

[htcoztrk]

Hello all,

We're a medical device manufacturer holding QMS based on ISO 9001:2015 and ISO 13485:2012. Our QMS was based on ISO 13485:2012 integrated with ISO 9001. But now the introduction of ISO 13485:2016 states on clause 0.4 Relationship with ISO 9001 that "this is a stand-alone standard". Even though our company activity is in medical field, there are many tenders also requiring ISO 9001 certificate as well so we have to keep QMS according to both ISO 9001 and ISO 13485.

Now my question is that because ISO 13485:2016 is a stand-alone standard, we cannot build it over ISO 9001:2015. But can we build ISO 9001:2015 over ISO 13485:2016? I reivewed the ISO 9001:2015 standard but couldn't see any clause stating that it is a stand-alone standard.

-Hatice

 

[JoshuaFroud]

Hello Hatice

I have recently finished the transition from 9001:2008 and 13485:2003/2012 to 9001:2015 and 13485:2016. We run these two standards together as a single system. It is slightly more difficult now as they do not follow the same pattern but it is not an overly difficult task to do.

What it means by a stand-alone standard is that it can be used without any other input. It does not mean that they cannot be used in conjunction with another standard.

To handle my transitions, we essentially did a gap analysis against the current QMS for both 9001:2015 and 13485:2016 and then updated in line with the new and updated requirements. As the clause numbers no longer follow each other, and there are a few minor complications (i.e. 9001:2015 requiring continual improvements and 13485:2016 not) it is easier to do one then the other rather than trying to do them at the same time.

If you have any questions please let me know.

 

[htcoztrk]

What it means by a stand-alone standard is that it can be used without any other input. It does not mean that they cannot be used in conjunction with another standard.

Hi Joshua,

Thank you for your reply. First of all, I wish you a happy and prosperous new year.

I have an upcoming survaillance audit and I actually sent our new QM to the auditor for review prior to audit. However the lead auditor and NB told me that because ISO 13485:2016 is a stand-along standard we cannot build it over ISO 9001:2015. Our whole QM and document idetifications are based on ISO 9001:2015 (e.g. document shorcode/9001 clause no/procedure order no). We also made a gap analysis agaisnt QMS requirements for both 9001:2015 and 13485:2016 then put a correlation table showing section name, description, ISO 9001:2015 clause and ISO 13485:2016 clause. They told me that they will perform the audit for this time but in case if we do not change the QM and QMS until next audit they will not be able to perform the surveillance audit because they perform the audit according to ISO 13485:2016.

To be frank, this doesn't seem logical to me. Because I believe the important thing is that you cover the all requirements of the both standard and show which section corresponds to which clause of both standard. Our QMS certificates are from a different certification body from UK. But we did not have any problem with auditors from certification body.

So I'm really confused what should I do about it. I thought about 3 possible solution but not sure if they are convenient:
a) Make two different QM but keep the QMS documentation based on ISO 9001:2015's clauses
b) Re-set the whole QM and QMS based on ISO 13485:2016 then add the updated requirements of ISO 9001:2015 over this QMS. But this means a lot work to be re-done, lots of time and effort
c) re-set a QM and QMS based on ordinal numbers which does not correspond to any clause of either ISO 9001:2015 or ISO 13485:2016 so we won't be bulding any standard over another.

Kind Regards

 

[AndyN]

It sounds as if your auditor is confused. Having 2 standards and holding certification for both may be that they are "stand alone", however, your Quality Management System is YOURS and can be as integrated as you wish it to be. It's NOT for the NB auditor to dictate such things. I'd take the issue up with the NB's management as you are on schedule for the audit and don't want a train wreck with an auditor who doesn't understand basics...

 

[Sidney Vianna]

So I'm really confused what should I do about it. I thought about 3 possible solution but not sure if they are convenient:
a) Make two different QM but keep the QMS documentation based on ISO 9001:2015's clauses
b) Re-set the whole QM and QMS based on ISO 13485:2016 then add the updated requirements of ISO 9001:2015 over this QMS. But this means a lot work to be re-done, lots of time and effort
c) re-set a QM and QMS based on ordinal numbers which does not correspond to any clause of either ISO 9001:2015 or ISO 13485:2016 so we won't be bulding any standard over another.

Sorry for being blunt, but this is an archaic approach to a quality system. You don't build a quality system around standards, because, if you do that, you are not future-proofing nor revision-proofing the system. You build your quality system seamlessly embedded in your business processes. Organizations that understand that have to do very little, or nothing, when standards they comply with, get revised.
And never, ever align any documentation such as a quality manual to the numbering structure of a standard, for the reasons you just discovered. Similarly, you must never do anything simply to make the lives of external auditors easier.

Can you please also identify the asinine customers you deal with that would expect your organization, a medical device manufacturer, to comply with ISO 9001, if you are already compliant with ISO 13485? That doesn't make any sense whatsoever. Sometimes, suppliers have to educate customers. Have you tried explaining to such customers that ISO 13485 is the proper standard for your context and ISO 9001 is just adding unjustifiable costs to your operation?

 

[JoshuaFroud]

I can understand their point regarding your Quality Manual being that rigid and directly correlated to one or other of the standards. 13485 and 9001 are different now and as Sidney said this approach is somewhat dated. Your Quality Manual should be a document written in your own words defining the business, yes there are a series of required sections and points to cover from both standards but it should be your document not a parroted version of the standard.

Also, as with the QM, your procedures should be for your practices. Again there is a specific set of minimum required procedures set out in the standard but there should be so much more to your QMS than that bare minimum. A QMS should be a living breathing business model that grows and improves the company rather than a series of pieces of paper in a folder linked to clauses in a standard.


To your point Sidney;

Can you please also identify the asinine customers you deal with that would expect your organization, a medical device manufacturer, to comply with ISO 9001, if you are already compliant with ISO 13485? That doesn't make any sense whatsoever. Sometimes, suppliers have to educate customers. Have you tried explaining to such customers that ISO 13485 is the proper standard for your context and ISO 9001 is just adding unjustifiable costs to your operation?

I work for a Medical Device manufacturer who also produces life science equipment using practically the same technology. Our life sciences customers ask for 9001 and our medical 13485. This is why we have both. I have worked at several companies where this is the case.

 

[Ed Panek]

Our auditor also complained that our QMS scheme didn't align literally with the 13485 numbering scheme. I reminded him that the intended audience for the QMS is the users of the system and the needs of the business. Just because our section 5 doesn't match the standards section 5 is not a risk to anyone but an impatient auditor.

 

[AndyN]

Our auditor also complained that our QMS scheme didn't align literally with the 13485 numbering scheme. I reminded him that the intended audience for the QMS is the users of the system and the needs of the business. Just because our section 5 doesn't match the standards section 5 is not a risk to anyone but an impatient auditor.

At which point you show them the door, call the CB/NB and lodge a complaint...

 

[htcoztrk]

I appreciate everyone's participation to the discussion and helpful replies.

You don't build a quality system around standards, because, if you do that, you are not future-proofing nor revision-proofing the system. You build your quality system seamlessly embedded in your business processes. Organizations that understand that have to do very little, or nothing, when standards they comply with, get revised.
And never, ever align any documentation such as a quality manual to the numbering structure of a standard, for the reasons you just discovered.

Thank you for being blunt and all pragmatic information for me. I am very used to build quality system around standards because that how all was in the companies I have worked. But I understand your point and it would definitely be much more convenient and much easier to just update your quality system when standards get revised.
So, in case if we build our quality systema ccording to the order of processes in our organization and align documentation and also quality system to an ordinal numbering structure but put a table in quality manual showing correlation between ordinal numbers and standard clause would be conforming right?

I can understand their point regarding your Quality Manual being that rigid and directly correlated to one or other of the standards. 13485 and 9001 are different now and as Sidney said this approach is somewhat dated. Your Quality Manual should be a document written in your own words defining the business, yes there are a series of required sections and points to cover from both standards but it should be your document not a parroted version of the standard.

Our Quality Manual is already written in our words considering the structure and process in our organization in a way covering minimum requirements of both standard as well as any extra application we carry through. But as you mentioned the problem is that our Quality Manual is rigid and directly directly correlated the standard. Thank you for your all help.

 

[dnowski]

Based on this thread, I am hoping you will be able to help with a similar issue. I am doing some consulting work for a small company, less than 60 employees, and they provide two different products. They currently have two different quality manuals since they are certified to ISO 9001-2015 with design and 13485-2016 without design. They see the value in integrating their manuals to combine processes such as CAPA, training, document control. However, their registrar told them they would not certify them if they did that because of the scope. This is not sitting right with me and based on other threads I have read, as long as they define the scope for each ISO cert, it should not matter about their document structure as long as they can show conformity to the requirements?