Integrating both ISO 13485 and TS 16949 into the same quality manual

[sbehensky]

I am working for a company that is TS registered and looking to registration to ISO 13485. We do a little for the auto industry and supply some components to the med industry.
What I'm trying to do is integrate both into the same quality manual vs having two seperate manuals.
Has anyone gone through this process before and could I get some guidance?
I know that there are many confilcts (maintain effectiveness vs. continual improvement etc.)

 

[Ajit Basrur]

Re: ISO 13485 and TS 16949

I am working for a company that is TS registered and looking to registration to ISO 13485. We do a little for the auto industry and supply some components to the med industry.
What I'm trying to do is integrate both into the same quality manual vs having two seperate manuals.
Has anyone gone through this process before and could I get some guidance?
I know that there are many confilcts (maintain effectiveness vs. continual improvement etc.)

We have ISO 13485 and TS 16949 - both are good strong systems.

Try not to come up with different manuals but integrate into one.

 

[wrodnigg]

Re: ISO 13485 and TS 16949

We have certified a company that is primarily working for the automotive industry, but also producing some parts for medical device manufacturers.

Not a problem at all, just start with a gap analysis and integrate the additional requirements into your quality management system.

 

[Woraphot]

Re: ISO 13485 and TS 16949

Hi,

May I ask another question. Could we merge the audit for certification between TS 16949 and ISO 13485 ?

Thanks,
Woraphot

 

[Ajit Basrur]

Re: ISO 13485 and TS 16949

Hi,

May I ask another question. Could we merge the audit for certification between TS 16949 and ISO 13485 ?

Thanks,
Woraphot

Woraphat,

What do you mean by merge - does it mean that auditors for both ISO 13485 and TS 16949 perform audit together ?

 

[Woraphot]

Re: ISO 13485 and TS 16949

Hi,

Yes, it does. It may help to reduce manday for TS16949 and ISO13485 audit with common clause in the same time.

Thanks,
Woraphot

 

[wrodnigg]

Re: ISO 13485 and TS 16949

...if you find an auditor with competence in both fields...

But yes, there are certification bodies which (can) offer audit teams for both standards. This could reduce the audit days and maybe the audit fees.

 

[Ajit Basrur]

Re: ISO 13485 and TS 16949

Yes, its possible but talk to to your certification body.

Also remember that your resources would be divided in 2 sets and thus you should be having 2 sets of competent staff to answer different set of auditors