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

L

lbc3003

#1
Hi everybody,

I need your help on the certification of my company which has different locations in the world :bonk:
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!
:thanx:
 
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shimonv

Trusted Information Resource
#2
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
 
L

lbc3003

#3
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
 

shimonv

Trusted Information Resource
#4
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
 
L

lbc3003

#5
That's exactly what I didn't want to do...:nope:
Ok now I know how I have to deal with it.
Thanks a lot Shimon!
 
L

lbc3003

#7
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 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 don´t 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
 

shimonv

Trusted Information Resource
#9
Re: In which country do I certify my company? (ISO13485)

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 don´t 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
Hi Lucie,
I believe you cannot avoid audit in site A, even if it's an empty parking lot...
The site whose address appears on the certificate has to be audited.
If you like, you can try and find some 'dodgy' certification body from China or North Korea that might be willing to go along with your plan :)

About the attorney you mentioned, he needs to be in some way a member of your organisation and appear on your org charts for site A. Even if you power him as acting site manager he needs to know what's what in your QMS. It's a long shot, I think.

I believe you owe me coffee..

Best,
Shimon
 
L

lbc3003

#10
Sure I do!
The issue is that my company is legally created in site A but the employees work remotly from another country.:bonk: So employees have to go on site A for the certification? There is no way to avoid this... even going under multisite process
Thanks a lot!
 
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