Auditing Schedule to ISO 9001, ISO 13485, IVD, MDD and 21 CFR Part 820

All,

I have to create an audit schedule which covers all the requirements as listed above.

Any suggestions?

Re: Auditing to ISO 9001, ISO 13485, IVD, MDD and 21 CFR PART 820

If you attach it for folks here to look at you may get some feedback, but without knowing what you have created it would be hard to make any suggestions.

Re: Auditing to ISO 9001, ISO 13485, IVD, MDD and 21 CFR Part 820

Marc, I think the poster is asking for help to create the schedule rather than comments on one which already exists.

Are we talking about internal audits? if so, I would concentrate on auditing your own processes/procedures as a priority and then 'cross check' with the requirements of the standards.

I am afraid I don't know all the standards you list but I am sure that many of the requirements will be the same e.g. doc control, management review, etc.

I would then try to create a matrix to identify all the requirements and ensure that by auditing the processes/procedures, all the elements of the standards had been covered.

Thanks Colin,

Yes indeed it was a big cry for help.

I was wondering although I didn't specify this if any one has a matrix
which shows the inter relation between the standards and requirements.
I'm sure it would not be to hard to create this but time is of the essence!

lennon121 said:

............................ I was wondering although I didn't specify this if any one has a matrix which shows the inter relation between the standards and requirements.
I'm sure it would not be to hard to create this but time is of the essence!

Click to expand...

If you will do a search in the post attachments list. You may have to combine two existing matrices to get all or a majority of what you want.

Re: Auditing to ISO 9001, ISO 13485, IVD, MDD and 21 CFR Part 820

Colpart said:

Marc, I think the poster is asking for help to create the schedule rather than comments on one which already exists. <snip>

Click to expand...

Sorry - I was busy and mis-read the OP's post. I boo booed.

Thanks Marc,

No worries

lennon121 said:

All,

I have to create an audit schedule which covers all the requirements as listed above.

Any suggestions?

Click to expand...

Do you have a relation matrix that maps all the sections of all the said regulatory with the ISO 13485 clauses ? Do you also need the CMDR .. ?
ISO 9001 and ISO 13485 are pretty much straight and aligned.
You could do a clausewise audit schedule with the help of this, if this style of schedule is acceptable to you.
I will remind myself to attach one such relation matrix tomorrow, from which you can get the clue.

27:08:2010.
See and review to your satisfaction before you make a schedule of audit

Thank you very much.

This will help me in my quest of creating a simplified audit schedule whilst covering requirements.

L