Internal Auditing of MDD and CMDR Requirements

[BigManP]

I recently went through an ISO 13485 audit with our notified body. In addition, we are audited to Part 1 of the Canadian Medical Device Regulations and 93/42/EEC Annex II 3.2. During the Internal Audit section of the audit, we got a minor nonconformance for not including EU and Canadian labeling requirements in the scope of our internal audits. While I agree that is within the scope of the NB audit, I don't see the requirement that it has to be included in our internal audit schedule. Can anyone point me to that link? Furthermore, the auditor only wrote us up for the labeling requirements, do other parts of the MMD or CMDR need to be covered by internal audits?

Thanks a lot for the help.

Paul

 

[sreenu927]

Hi Paul,

Usually the internal audit schedule will/should cover Health Canada and MDD requirements, apart from ISO 13485 in a broader sense. May not be specific to each and every clause or section , as audit is based on sampling; may not be 100% audit. If you indicate in your internal audit schedule that the scope is so and so systems(or functions/processes) as per ISO 13485, EU MDD and HC MDR, then you can argue with your auditor on this minor NC.

Regards,
Sreenu

 

[rob73]

Were labeling requirements covered during the design and development process? if so you may be able to argue that it has been covered during internal auditing of D&D. We use a simple content review of both labeling and instructions.

 

[BigManP]

Thank you Sreenu and Rob for your comments. I do agree that these requirements should be covered under the scope of our NB audit, but I just don't see the direct link to the requirement that they be covered by our internal audit schedule. We also have never been written up for this in the past. Rob, while we do look at labels under D&D, we don't really have a formal method of approving them per the MDD like the table you provided. All of our devices are pretty basic and similar, so the first labels were created by following the MDD and CMDR. This format was verified by the review and approval of our NB and Health Canada. From there, I just swap out part numbers and descriptions for the new products, but the format and content is the same. They are then transposed onto blueprints and controlled that way.

In looking at 13485, is it 8.2.2 a) ...to the requirements of this International Standard and to the quality management system requirements established by the organization ... that require it to be covered? One of our quality objectives is: To demonstrate that the quality system is being achieved, maintained and continually improved in accordance with ISO 13485, FDA QSR, European MDD, Canadian CMDR and [FONT=&quot]Brazilian RDC #59. [/FONT]If so, then all requirements should be audited not just labeling. Right?

In the end, I probably need to just take it up with the auditor, but I appreciate your help so I can go into the conversation with a little more knowledge on my end.

Thanks, Paul

 

[pkost]

Just because it has not been raised as a non conformance before, does not mean that it isn't a non conformance!


Labelling and artwork creation is an important part of the design process, even if it is simple and repetetive. I would expect the process around this to be audited. If you exclude their review and approval from the design process, I would expect to see this somewhere else and the process audited - otherwise you are not auditing your entire QMS!

 

[somashekar]

When you get some time, see the Post attachment list and search for audit checklist. You will find several that maps ISO13485 requirements + MDD / CMDR requirements.
Your internal audit must cover scope of ISO13485 QMS + the regulatory to which your QMS aligns. You will have a cross linked reference of these regulatory requirements mapped to the ISO13485 requirements perhaps in your QMS manual or elsewhere. This must help you make a good audit program. Some aspects (like the label) could also be listed that are not linked to ISO13485 clauses. Your audit program must also consider this too. Good planning for audit is the key.