CMDCAS ISO13485 - Bilateral agreement with SAI global to conduct Certification Audits

S

sabrina.qa

Hi all,

I've been scratching my head over this one. Trying to get a manufacturer set up with an audit from a Health Canada recognised registrar. They already have a notified body, and have informed me their NB has a bilateral agreement with SAI global to conduct certification audits, so they don't need to switch NBs.

I've never heard of this kind of arrangement before.

The explanatory link is Italian, and I've haven't yet received an answer to my query to SAI.

(I'm unable to post the link to the Italian site because this is my first post!)

Any insight?

Thank you in advance.
 
M

MIREGMGR

Sounds complicated.

Who will issue the CMDCAS certificate...the party that issues the ISO 13485 certificate, or the party that does the CMDCAS audit?
 
S

sabrina.qa

Excellent question that I will pass on. I was hoping someone here might have some familiarity with this sort of situation already?

From their site:

"SAI-GLOBAL: accordo bilaterale che riconosce IMQ quale organizzazione delegata ad eseguire le visite ispettive di certicazione e di sorveglianza secondo la ISO 13485 con deviazioni CMDR (schema CMDCAS) per il Ministero della Sanit? Canadese."

English Translation:

"SAI GLOBAL : bilateral agreement that recognizes IMQ which organization delegated to carry out inspections of certicazione and monitoring according to ISO 13485 with deviations CMDR (Scheme CMDCAS ) for the Ministry of Health Canada ."
 
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S

Spazz

Re: CMDCAS ISO13485 - Bilateral agreement with SAI global to conduct Certification Au

Seems kind of fishy to me...

I believe CMDCAS certificates must be issued by a body that is accredited by the Standards Council of Canada on behalf of Health Canada. Certified bodies may use (broken link removed) but have to issue the certificate in their own name.
 

Marc

Fully vaccinated are you?
Leader
Re: CMDCAS ISO13485 - Bilateral agreement with SAI global to conduct Certification Au

<snip> From their site:

"SAI-GLOBAL: accordo bilaterale che riconosce IMQ quale organizzazione delegata ad eseguire le visite ispettive di certicazione e di sorveglianza secondo la ISO 13485 con deviazioni CMDR (schema CMDCAS) per il Ministero della Sanit? Canadese." <snip>
Is this what you are looking at?
.
 

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DannyK

Trusted Information Resource
Re: CMDCAS ISO13485 - Bilateral agreement with SAI global to conduct Certification Au

The certificate would have to be issued by SAI Global since they are recognized by Health Canada and must be performed by a CMDCAS approved auditor.
 
S

sabrina.qa

Re: CMDCAS ISO13485 - Bilateral agreement with SAI global to conduct Certification Au

Hi Spazz,

So this NB would have to be contracted as a subcontractor of the SCC-accredited NB, and the resulting ISO cert would be issued by the SCC-accredited NB.

Hi Marc,

Yes, that is the page they sent me.

Hi DannyK,

Thank you for confirming my understanding.
 
S

Spazz

Re: CMDCAS ISO13485 - Bilateral agreement with SAI global to conduct Certification Au

So this NB would have to be contracted as a subcontractor of the SCC-accredited NB, and the resulting ISO cert would be issued by the SCC-accredited NB.

As far as I can tell, yes, and the SCC-accredited NB (or "registrar") would be responsible for the certificate and the audit. I'd parrot DannyK for the rest.
 
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