ISO 13485 Certification - Single ISO certificate for two different business entities?

Q

Quality96 - 2011

I am the QA Manager for a large medical device manufacture based in Germany with 30+ subsidiaries around the world; 18 of which are ISO 13485 certified, 12 do not have a certified QMS in place. My current project is to install an ISO 13485 QMS in these 12 locations.

My question is: Can we have a single ISO certificate for two different business entities (Subsidiaries) that happen to be located in the same building. Entity one fabricates custom devices; entity two services & repairs a completely different product line manufactured in Germany, and sold in the USA. These two entities have nothing to do with each other, except that they are in the same building.

Any advice will be greatly appreciated,

Bill
 

howste

Thaumaturge
Trusted Information Resource
Re: Going For ISO 13485 Certification

A certificate is for a quality management system. In order for them to be under one certificate, they would need to share a common system. They wouldn't need to do everything the same, but top management would need to be shared, management review activities would need to cover both, a quality manual would need to address both (possibly with entity-specific addendums), etc.
 
Q

Quality96 - 2011

Re: Going For ISO 13485 Certification

Thanks Howste,

I suspected that was going to be the case, but it's good to get a second opinion. I am meeting with an auditor from SAI gloabal to get some of the details & scheduling worked out.

Best Regards,
Bill
 

bio_subbu

Super Moderator
Re: ISO 13485 Certification - Single ISO certificate for two different business entit

I am the QA Manager for a large medical device manufacture based in Germany with 30+ subsidiaries around the world; 18 of which are ISO 13485 certified, 12 do not have a certified QMS in place. My current project is to install an ISO 13485 QMS in these 12 locations.

My question is: Can we have a single ISO certificate for two different business entities (Subsidiaries) that happen to be located in the same building. Entity one fabricates custom devices; entity two services & repairs a completely different product line manufactured in Germany, and sold in the USA. These two entities have nothing to do with each other, except that they are in the same building.

Any advice will be greatly appreciated,

Bill

Dear Bill

Just for a heads up, the Global Harmonization Task Force has issued draft guidance to assist regulators and auditing organizations in carrying out quality management system audits of medical device manufacturers with multiple sites.

The guidance contains recommendations on how to plan, organize, conduct, document and review audit programmes for a single device manufacturer with multiple sites operating under the same QMS. The recommendations is do not apply to device manufacturers with multiple businesses employing separate and distinct quality management systems. However, the manufacturers that have multiple businesses with multiple sites all operating within one single Quality Management System. The copy of draft guidance document can be downloaded here.

Hope you will find useful and relevant.

Regards
S. Subramaniam
 

sreenu927

Quite Involved in Discussions
Re: ISO 13485 Certification - Single ISO certificate for two different business entit

Hi Bill..

Its true, as stated above by our fellow covers.
The Certification body will issue a Single ISO 13485 certificate with Manufacturing Site address on the first page, rest all other sites in the appendix page.

As mentioned above, should have one quality manual, i.e.,common quality system and procedures r to be shared by all sites.

The audit will be at respective sites for those corresponding site activities.

In quality manual, you can have a separate organisation chart for different entities, as it they differ in their functionality.

Regards
Sreenu
 
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