MDD Audit Plan that covers ISO 13485 sections and the MDD sections

[spiaseck]

Does anyone have a good audit plan that covers ISO 13485 sections and the MDD sections?
Thanks

 

[Marc]

Any takers on a good audit plan that covers ISO 13485 sections and the MDD sections?

 

[Al Rosen]

I think it may be difficult to find since auditing is done on a process basis and not by element. My audit plan is specific to my organization's processes. For example, we have a customer service and technical support process that includes customer feedback and complaints. If your process is not the same, how will my audit plan apply to your process? If all you want is an element or clause checklist, you can find many in the post attachments list.

 

[Marc]

Thanks for the input, Al!

 

[spiaseck]

Here's a copy of my Non conformances from NB Audit.


No evidence that MDD requirements are covered as part of internal audit
The annual audit of MDD requirements not being done.

 

[rells]

I think it may be difficult to find since auditing is done on a process basis and not by element. My audit plan is specific to my organization's processes. For example, we have a customer service and technical support process that includes customer feedback and complaints. If your process is not the same, how will my audit plan apply to your process? If all you want is an element or clause checklist, you can find many in the post attachments list.

A model audit plan by process, regardless of applicability of finer points to the industry, is probably all that's needed to help this individual through the immediate pain.