Is the ISO 13485 auditor being too picky concerning CMDCAS?

[blmuskrat]

Thanks for the info on the revision to the 13485.

My question is how far should an aduitor (3rd party) drive down on the elements of the current 13485 to CMDCAS certification, which we have for entrance into Canada for medcial devices? All the basics and then some are covered and it seems like fly specs are being picked out of pepper even though no product has been made available to Canada. Seems like if all the I's are not dotted and the T's are not crossed, we exhibit a N/C in the audit. Your opinions please, thanks.

 

[AndyN]

Thanks for the info on the revision to the 13485.

My question is how far should an aduitor (3rd party) drive down on the elements of the current 13485 to CMDCAS certification, which we have for entrance into Canada for medcial devices? All the basics and then some are covered and it seems like fly specs are being picked out of pepper even though no product has been made available to Canada. Seems like if all the I's are not dotted and the T's are not crossed, we exhibit a N/C in the audit. Your opinions please, thanks.

If it's not applicable, they shouldn't audit to it! CMDCAS is a specific set of audit criteria, which should be in the agreement you have with the CB. If it's not mentioned, the auditor is out of scope - end of story!

 

[Sidney Vianna]

Your opinions please, thanks.

It is very difficult for anyone to provide feedback, based on generalities. If you are certified under Health Canada for the CMDCAS program, ISO 13485 requirements apply.

If you want to receive specific, actionable feedback, please provide details of what you perceive to be nit picky findings and nonconformities. Only then, meaningful comments can be provided. As a rule of thumb, medical devices are normally associated with significant risks and if we had to choose between an easy auditor and one that is strict, I think the consensus would be better for softgraders and easy auditors to stay away from the sector.

 

[blmuskrat]

Update to previous post, sorry it 's long. In attempt to get certification for Class II and Class III medical devices in Canada the CMDCAS certificate previously issued by the registrar did not state design, development or manufacturing in the scope and Canada rejected the certificate due to the lack of those words. Quoting the GD207 section 2.6.1 QMS Processes, Including Related Services: A Manufacturer of a Class II device complies with MDR section 32(2)(f) by providing to Health Canada “a copy of the quality management system certificate certifying that the quality management system under which the device is manufactured...” A Manufacturer of a Class III or IV device complies with MDR sections 32(3)(j) or 32(4)(p) respectively by providing to Health Canada “a copy of the quality management system certificate certifying that the quality management system under which the device is designed and manufactured...” Thus, depending on the class of the device(s) involved, the scope statement will contain “manufacture” or “design and manufacture”. A certificate which lacks “design” in the scope statement that is submitted in relation to a Class III or IV device will not be accepted by Health Canada. A certificate which lacks “manufacture” in the scope statement, regardless of the device class involved, will not be accepted by Health Canada.

Basically, the QMS sets in place all the requirements for CMDCAS and the MDR SOR 98- 282, but the auditor is driving down the documentation(s) and other aspects as being N/C due to lack of objective/subjective evidence as we are just starting Design History FIles, however, the processes are set in place respectively to the requirements and don't seem lacking.

Hope this helps.

 

[Sidney Vianna]

Basically, the QMS sets in place all the requirements for CMDCAS and the MDR SOR 98- 282, but the auditor is driving down the documentation(s) and other aspects as being N/C due to lack of objective/subjective evidence as we are just starting Design History FIles, however, the processes are set in place respectively to the requirements and don't seem lacking.

It seems to me that, what you are calling a QMS is nothing more than a collection of documents, such as a manual and procedures. But, and in reality, a QMS is NOT the same as documentation. It is the operationalization of the documentation, processes and activities.

As far as I can tell, your CB auditor is doing his/her job which is supposed to assess if your system complies with the applicable requirements by comparing audit evidence against audit criteria.

Some misguided auditors and CB's give "full credit" for the existence of procedures and fail to assess if evidence shows effective implementation. It looks like the timing of your audit was poorly planned and without evidence to show to the auditor, s/he can not issue a recommendation for certification. All of that should have been caught in a stage 1 audit, though. Did you have one?

 

[Ronen E]

If you are "just starting DHFs" then you're not yet ready for an ISO 13485 certification audit that aims at including D&D; regardless of whether you're simply just starting the D&D work, or have already finished and trying to retroactively create the DHFs.

Cheers,
Ronen.