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In which country do I certify my company? (ISO 13485)


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Some Related Topic Tags (Not all threads are Tagged)
certifications (to a standard), iso 13485 - medical device qms, registration to a standard
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  Post Number #1  
Old 10th January 2017, 08:25 AM
lbc3003

 
 
Total Posts: 5
Question In which country do I certify my company? (ISO 13485)

Hi everybody,

I need your help on the certification of my company which has different locations in the world
I have to certify a subsidiary of my company under the ISO 13485 which is based in the country A and which is the legal manufacturer of the products. All the employees of the company are physically based in the subsidiary in the country B. Our product are design and manufactured in countries C & D and they go directly from these country to the client (a subsidiary of the company) in country B (where the employees are based). The product never go in the country A. Where can I realize the certification of my company based in country A? in country A? Can I realize it from country B where all the employees are?
Hope I'm clear in the explanation...
Thanks for your help!

Last edited by Sidney Vianna; 10th January 2017 at 03:20 PM. Reason: space needed between ISO and 13485

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  Post Number #2  
Old 10th January 2017, 09:04 AM
shimonv

 
 
Total Posts: 184
Re: in which country do I certify my company (ISO13485)?

Hello IBC3003,
Not sure that I got it all figured out but the address of the legal manufactured should be included in your ISO 13485 certification.

Practically speaking, you can apply for one certificate with multi-sties. In your case site A and B together. Site C and D are your contract manufacturers; they don't have to have ISO 13485 although it would be nice. It's important that the quality manual per site explains which activity is being performed in that site, and to have good quality agreements with sites C and D.


Cheers,
Shimon
Thank You to shimonv for your informative Post and/or Attachment!
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  Post Number #3  
Old 10th January 2017, 02:33 PM
lbc3003

 
 
Total Posts: 5
Re: in which country do I certify my company (ISO13485)?

Thanks Shimon for you quickly answer! The thing is we have to certify the legal manufacturer of our product (the company in country A) as soon as possible so it will be faster to certify only this company. But in country A, physically there is nothing. The 3 employees of this company are physically based in country B (because they work within other subsidiaries of the group). So they realize activities of the company A from country B. Design and manufacturing are outsourced. All other activities are either outsourced or realized by the 3 employees in country B. So I would like to know if we can certify the company A with it's address in country A from another country (e.g B where the employees realize the activities of the company)? Or we have to realize the certification audit in the country where the company is based?
thanks a lot!

Lucie
  Post Number #4  
Old 10th January 2017, 03:29 PM
shimonv

 
 
Total Posts: 184
Re: In which country do I certify my company? (ISO13485)

Hi Lucie,
I think I understand what you are up against, and I've been there unfortunately.
You need to understand the the certification body has to audit the site whose address appears on the certificate.

As I mentioned before, your quality manual for site A has to be very clear about which functions are being carried where, and you should have a good quality agreement between site A and site B to support your statements.

For the onsite audit you should send your team from site B to site A with the QMS files so they can host the auditor and show him records to inspect. Keep in mind that the certification body may require auditing of site B as well before issuing the ISO certificate.

It is recommended to talk to the certification body ahead of time so as to give them "heads up" and present to them what you plan to do so there won't be any misunderstanding.

Goodluck,
Shimon
Thanks to shimonv for your informative Post and/or Attachment!
  Post Number #5  
Old 10th January 2017, 04:20 PM
lbc3003

 
 
Total Posts: 5
Re: In which country do I certify my company? (ISO 13485)

That's exactly what I didn't want to do...
Ok now I know how I have to deal with it.
Thanks a lot Shimon!
  Post Number #6  
Old 11th January 2017, 01:03 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,203
Re: In which country do I certify my company? (ISO 13485)

Also go thru THIS thread and read the attachment in its posts.... Thanks
  Post Number #7  
Old 11th January 2017, 09:04 AM
lbc3003

 
 
Total Posts: 5
Re: In which country do I certify my company? (ISO13485)

Quote:
In Reply to Parent Post by shimonv View Post

Hi Lucie,
I think I understand what you are up against, and I've been there unfortunately.
You need to understand the the certification body has to audit the site whose address appears on the certificate.

As I mentioned before, your quality manual for site A has to be very clear about which functions are being carried where, and you should have a good quality agreement between site A and site B to support your statements.

For the onsite audit you should send your team from site B to site A with the QMS files so they can host the auditor and show him records to inspect. Keep in mind that the certification body may require auditing of site B as well before issuing the ISO certificate.

It is recommended to talk to the certification body ahead of time so as to give them "heads up" and present to them what you plan to do so there won't be any misunderstanding.

Goodluck,
Shimon
Thanks but I have another question. In our site A we do nothing, there is no activities on this site. Everything in done in site B. So the auditor will come anyway in this site? Because there is nothing to check, I donīt see what point of the standard they can audit on an empty site. if they have to go on the site A, can we do a power to the attorney we have there to realize the audit for example? or only an employee of the company can be audited?
thanks!

Lucie
  Post Number #8  
Old 11th January 2017, 09:31 AM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,631
Re: In which country do I certify my company? (ISO 13485)

If there is nothing there to audit, there's nothing there to be certified either. You cannot certify an address.
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