Recommendation for the ISO 13485 certification company

Aliken

Starting to get Involved
Hello,
Our small medical device company (manufacturing several class I, MDR devices ) is trying to select an ISO 13485 certification body for the the first, forthcoming audit. We've contacted several companies including ISOQAR (Bonita Springs, FL); NSF International Strategic Reg. (Ann Arbor, MI); Perry Johnson Reg.(Troy, MI); Smithers Quality Assessments (Akron, OH); and American Systems Registrar (Wyoming, MI).
If anybody has recent experiences with any of these companies as to ISO 13485 certification or can recommend others, please let me know.

Regards,
Daniel
 

Ronen E

Problem Solver
Moderator
Whomever you end up picking, make sure to take a good look at their accreditation.

It might also be a good idea to pick someone close, so that you don't spend too much on their auditor's travel.
 

Aliken

Starting to get Involved
Thank you, Ronen. Yes, I'm checking the accreditation and you are right about the vicinity.
Some companies even offer virtual audits - would you go for that?
 

Ronen E

Problem Solver
Moderator
Thank you, Ronen. Yes, I'm checking the accreditation and you are right about the vicinity.
Some companies even offer virtual audits - would you go for that?
If you're manufacturing physical devices and they don't ask to audit the manufacturing site in person even once, it's a red flashing light (or at least an orange one).
 

Sidney Vianna

Post Responsibly
Leader
Admin
The management system certification sector keeps digging it's own grave, under the auspices of "thinking out of the box", leveraging technology, blah blah blah ...the trivialization and commoditization of system certification to enable as many organizations to attain and maintain certification means rock bottom prices and incompetent auditors. All of that, under the auspices of ISO/CASCO. As exemplified by one of the latest "developments" - Informational - ISO/NP TS 17012 - Guidelines for use of remote methods in conducting audits of management systems

https://iioc.org/wp-content/uploads/2022/01/IIOC-white-paper-–-FINAL-21-Jan-2022.pdf
 

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Aliken

Starting to get Involved
Thank you, Sidney, I'll take that into consideration for the selection of an auditor company.
 
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