ISO 13485 Practical Internal Audit Checklist - Standard vs. Process Based

Dear all,
Thank you for your replys and inputs, which I used it to develop the attached checklist which is intended to be as supplementry to the ISO 9001 audit checklist. My checklist contains the specific items that is required for the compliance with ISO 13485 and the MDD. I am sure that it fits sterile products of class IIa or IIb, any higher clases I am not sure. Please all feel free to use and please comment so I will try to make it better.

Hi, ISO Man

Would you share your ISO 13485;2003 Checklist to me ?
I should study ISO 13485 but also I think it is good way to understand 'what is the point'.
(my mail add: alexjo(at)korea(dot)com)

Thanks

Hello ISO MAN,

ISO MAN said:

My checklist contains the specific items that is required for the compliance with ISO 13485 and the MDD. I am sure that it fits sterile products of class IIa or IIb, any higher clases I am not sure. Please all feel free to use and please comment so I will try to make it better.

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Did you mention, that you can follow different approaches of the MDD 93/42/EEC?

It depends, if you choose the path of
Annex II (Full quality assurance system), or
Annex III (EC type-examination) plus
- Annex IV (EC verification) or
- Annex V (Production quality assurance) or
- Annex VI (Product quality assurance).

Therefore you will have different scopes and exclusions of the Standard and a different content of the audit-checklist.

regards~ghw

ISO/TR 14969:2004 is the guidance on ISO 13485:2003. It's a very helpful document.

ISO MAN said:

Dear all,
Can you help me to find practical audit checklist which is written not against the clauses of the standard only, but it also written against the specific requirements and its interpetation. My checklist which was following the standard structure was not accepted by our certification body on the ground that it does not cover the specific areas and its interpertation. THANKS

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Process check list

ISO MAN said:

Dear all,
Can you help me to find practical audit checklist which is written not against the clauses of the standard only, but it also written against the specific requirements and its interpetation. My checklist which was following the standard structure was not accepted by our certification body on the ground that it does not cover the specific areas and its interpertation. THANKS

Click to expand...

Here is a sheet I have been using. This allows you to identify the processes on the top, then you simply list the elements of the process by checking off the applicable ones on the side under that process. This shows you are examing the process, and what ISO elements you look at. The other pages show how you examined the process in detail. This is pretty self explanatory, so good luck, your registrar should take it, but please if you use it, reformat it a lot. I do consulting, and I would hate for people to know I am giving stuff away

Scott Hiscock said:

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Why not take your flowcharts, metrics, procedures, the criteria you defined to answer clause 4.1.c, the objectives and targets, and the training skills requirements, and audit how well those various things are understood and followed?

If you do that for each process, then you will have done a process audit for each process and evaluated both compliance and effectiveness. That should give you a pile of improvement ideas.

Is it possible for me to find a chacklist which covers ISO 9001:2000, ISO 13485:2003 and QSR requirements. Has anyone seen some or know the link where I can find one? Please help. I just got about four weeks to have the External audit. Being new to the company and not finding an existing checklist I need an urgent help.
PLEASE HELP.

If, beyond the checklist, you meet the requirements on the standard, then you should have no problem. I think your auditor had the wrong focus here (in the prezumtion that you covered the aspects of the standard in your production). The focus is the processes and the supporting procedures and documentation, not the checklist.

Re: ISO 13485 Practical Audit Checklist

Are you still looking for this?