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

[ISO MAN]

ISO 13485 Practical Audit Checklist

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

 

[Aaron Lupo]

Let me understand you, your Notified Body did not like your checklist so they said you can't use it? As long as your company is meeting the requirments what does it matter to them?

 

[Al Rosen]

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

Hi ISO Man:

Was your audit checklist process based? If not that may be what they had a problem with. I created a checklist for each process. The checklist related the clauses and the procedures that applied to the process. You might want to do something like that.

 

[ISO MAN]

Thank you for your reply. My checklist was covering the processes with reference to the internal procedures. Although I was complying with the requirements, the notified body wants to see the specific clauses of ISO13485 and its interpertation in the checklist as an eidence that they will be covered in the internal audit activities.

 

[Al Rosen]

I don't know what he could have a problem with. Why don't you attach a sample of one of your checklists. It would allow some of us on here to critique it and make suggestions if required. I think your auditor is asking for more than you need.

 

[Cathy]

Al is right ISO Man.

Your auditor is asking too much with regard to the clauses of the standard. You do not need to provide a checklist document that says what you will be auditing in an area.
As along as you can produce 'objective verifiable evidence' that the audit has been completed to a satisfactory standard then you are meeting the clauses of the standard.

The checklist can be created while preparing for the audit. This is acceptable for ISO13485 providing you have trained internal audits.

Have a look at your own procedures do you say you must have a pre-prepared checklist? if it does - remove it, its too tying.

You auditor is talking through his hat! tell him to get off his high horse and stop telling you how to implement your quality system! (well something like that).

One thing I find is that auditors are not challenged enough. If you know your standards and suspect that he is only aserting an opinion, tell him! I do and my auditor and I have a great working relationship and I know they are always on their toes because I will challenge them.

 

[ISO MAN]

Al, Cathy
I think you both right. I chalanged the auditor however she raised NCR against my auditing activities. I enclosed an example of the audit checklist my team use, it is related to the internal documentation which is complying to the ISO 9001:2000, ISO 13485:2003 and MDD 93/42/EEC. Please comment and recomend me a course of action.

 

[Al Rosen]

Al, Cathy
I think you both right. I chalanged the auditor however she raised NCR against my auditing activities. I enclosed an example of the audit checklist my team use, it is related to the internal documentation which is complying to the ISO 9001:2000, ISO 13485:2003 and MDD 93/42/EEC. Please comment and recomend me a course of action.

IMO, If your procedures comply and you audit your process to your procedures, then you meet the requirements.

If the auditor has a problem, take it to the registrar,

 

[howste]

It seems to me that your checklist is very process-oriented. Maybe too much - that may have been the auditor's concern. In the checklist you posted, all I see are process items and very little in the way of ISO 9001/13485 requirements.

One more observation - all of the questions are yes/no pass/fail, where you enter a number for each item. Do the records (filled out checklists) have objective evidence recorded showing what was actually observed during the audit? The small space at the bottom of each page doesn't seem large enough to contain enough detail to show that a thorough audit was done.

My $.02

 

[wrodnigg]

I cannot access the checklist you posted at the moment, but there are a lot of requirements from 13485:2003 which one can address in such a checklist. (i could take a look at it, if you mail it to me)
What is the scope of this checklist?

I also can not understand why an external auditor starts to rail on one of your internal audit-checklists.

He has to assess the conformity of your quality system against the applicable standards.

How you implement your quality documents is your business.