The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > ISO 13485:2016 - Medical Device Quality Management Systems
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

In which country do I certify my company? (ISO 13485) - Page 2


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links that Cove visitors will find useful in your quest for knowledge:

International Standards Bodies - World Wide Standards Bodies

ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC


NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags (Not all threads are Tagged)
certifications (to a standard), iso 13485 - medical device qms, registration to a standard
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #9  
Old 11th January 2017, 09:40 AM
shimonv

 
 
Total Posts: 171
Re: In which country do I certify my company? (ISO13485)

Quote:
In Reply to Parent Post by lbc3003 View Post

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

Sponsored Links
  Post Number #10  
Old 11th January 2017, 10:04 AM
lbc3003

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

Sure I do!
The issue is that my company is legally created in site A but the employees work remotly from another country. 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!

Last edited by lbc3003; 11th January 2017 at 10:17 AM.
Sponsored Links

  Post Number #11  
Old 11th January 2017, 10:32 AM
shimonv

 
 
Total Posts: 171
Re: In which country do I certify my company? (ISO 13485)

There is no way around this, to my knowledge.
Your best approach is going for multisite certification where site B is the primary address and site A the secondary. Auditing site A is inevitable but you could ask to reduce the frequency of visits to site A, say only during recertification and not on every surveillance. I have no better advise to give you.

Shimon
  Post Number #12  
Old 11th January 2017, 12:02 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,507
Re: In which country do I certify my company? (ISO 13485)

The definition of site according to the IAF Mandatory Document 1 is
Quote:
A site is a permanent location where an organization carries out work or a service.
If, as already admitted, NOTHING happens in Site A, that address can't be part of the certificate. So, a multisite certificate would be for sites B, C and D. There would be no sampling as per IAF MD9. The scope of certification would read something like The Design, Sales and Outsourced Manufacturing of....

To promote the idea of a certification of a facade site is not correct, in my opinion.
  Post Number #13  
Old 11th January 2017, 12:53 PM
shimonv

 
 
Total Posts: 171
Re: In which country do I certify my company? (ISO 13485)

Quote:
In Reply to Parent Post by Sidney Vianna View Post

The definition of site according to the IAF Mandatory Document 1 is


If, as already admitted, NOTHING happens in Site A, that address can't be part of the certificate. So, a multisite certificate would be for sites B, C and D. There would be no sampling as per IAF MD9. The scope of certification would read something like The Design, Sales and Outsourced Manufacturing of....

To promote the idea of a certification of a facade site is not correct, in my opinion.
Hi Sidney,
I do believe it's possible if you have a company representative on call and a quality manual which basically outsource all activities to subcontractors and a bunch of quality agreements to support it. Dodgy? yes, but some companies do it this way because of tax saving issues. I assume that eventually they will put and end to it altogether.

Shimon
  Post Number #14  
Old 11th January 2017, 02:29 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,507
Re: In which country do I certify my company? (ISO 13485)

The willingness to participate in a sham and create an audit and certification program which includes a fašade site just gives more material for those who love to question the credibility of management system certification.

If nothing happens at the "site", then it is not part of the QMS, by definition. Thus, it cannot be listed on a certificate.

The CB and the company can collude on this fašade but, as I said, it will just add to the body of evidence of malpractice.
  Post Number #15  
Old 11th January 2017, 02:43 PM
DEVigil

 
 
Total Posts: 12
Re: In which country do I certify my company? (ISO 13485)

When you say 'nothing' goes on at site A, do you mean there are not even Executive Management activities there?
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > ISO 13485:2016 - Medical Device Quality Management Systems

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Must a Design Outsourcing Company have ISO13485? bennylee ISO 13485:2016 - Medical Device Quality Management Systems 3 23rd March 2015 12:31 AM
Recommend Registrar for a Small Company - ISO13485 mr.mike Registrars (Certification Bodies) and Registration 15 4th May 2011 12:32 AM
How to Calibrate Laser Micrometer when no Calibration Company in the Country? paperclip General Measurement Device and Calibration Topics 3 28th June 2010 07:36 PM
Creating a Sub Company to Certify One Product Line hrrvett ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17 18th October 2007 06:40 AM
Added Value Benefits for a Warehousing Company to be ISO13485 Registered Rob Udo ISO 13485:2016 - Medical Device Quality Management Systems 4 29th August 2006 08:25 AM



The time now is 02:14 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 
 


NOTE: This forum uses "Cookies" - A Peachfarm Internet Property