Keep current ISO 13485 registrar AND add new for CMDCAS

S

soward

#11
Re: Keep current ISO 13485 registar AND add new for CMDCAS

If I understood, a separate audit for CMDCAS is required regardless of registrar. Why then is it financially better to change registrars rather than simply scheduling another audit with a CMDCAS registrar?
 
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R

Roland Cooke

#12
Re: Keep current ISO 13485 registar AND add new for CMDCAS

If I understood, a separate audit for CMDCAS is required regardless of registrar. Why then is it financially better to change registrars rather than simply scheduling another audit with a CMDCAS registrar?

I don't understand your question. :confused:



To explain:

After the initial audit, SGS operates a three-year audit cycle, with a more detailed recertification every "fourth" year. Shorter surveillance audits take place in the intervening years.

HC requires us to perform a recertification audit in order to add registration under CMDCAS, regardless of when the audit takes place. Thus, market concerns notwithstanding, it makes most economic sense for our clients to add CMDCAS at the initial audit, or at a recertification audit.



When we transfer a client that already holds appropriate registration, we would generally perform a recertification-length audit. So in the case of the OP, he would need a recertification length audit anyway, with CMDCAS included as part of that transfer audit.
(We wouldn't perform the transfer audit and then come back a week later to do the same all over again with CMDCAS!)
 
S

soward

#13
It is my goal to keep everyone else as confused as I am.

No, really, sorry for the confusion, it is on my part. I misunderstood the "add-on" discussion. Now if the CMDCAS requirements are "added-on" as part of the regular audit schedule (with a complete initial audit to begin the CMDCAS cycle) then of course one registrar is the answer. If a completely separate audit is required then it wouldn't matter so much. A completely separate audit (I'll be back next week) makes no sense but it wouldn't be the first time a bureaucratic requirement made no sense.
 
R

Roland Cooke

#14
Just to clarify by what I mean by an "add-on" audit, that would typically be for things like new products, new manufacturing processes, new building and/or change of location, etc.
If the timing doesn't allow us to fold our required oversight activity into a recertification audit, we could bolt on the required additional time onto a routine surveillance audit, or perhaps do a special out-of-sequence audit.

(At SGS we call those bolt-on jobs 'Extension To Scope' audits, even though sometimes the text of certificate doesn't actually change. For example, in the case of a change in sterilization supplier and/or method, that's a significant change requiring our oversight, but the certificate would still say "sterile" at the end of the process).
 
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