ISO 13485:2003 documentation vs. ISO 9001:2000 documentation

Izatul · #1 10th February 2007, 02:27 PM

Hi experts..
I'm engineering student and now doing research on ISO 13485:2003 implementation and registration. I've read the standard but still blurr about the documentation requirements. I’ve found that ISO 13485:2003 documentation requires additional documented procedure compared to ISO 9001:2000 documentations, where minimum 19 procedures are required for the medical device manufacturers to be documented.
1. Is it a compulsory and manufacturer must comply all the 19 procedures?
2. Is the levels of documentation for ISO 13485:2003 is exactly same with those in ISO 9001 which have 4 levels of documentations? How about the criteria for each level? Is it similar?
3. Is it any additional contents for the quality manual, as well as another documents or records in order to meet regulatory requirements?

I hope anyone can gives me some directions about it. I did'n found much source and information about the ISO 13485:2003 documentation procedures and have tailoring it with those in ISO 9001:2000. I’m very appreciate for all the kind and attention. Thanx so much!

**Gert Sorensen** · #2 10th February 2007, 02:49 PM

You may want to search the site for the combination of keywords:

9001 13485 documentation. There is a lot of threads relating to this issue, and it may help your understanding of the subject to browse through them.

**SilverHawk** · #3 11th February 2007, 09:08 AM

Izatul, the organization has to address the minimum documentation requirments. See attachment.

Izatul · #4 11th February 2007, 03:27 PM

Dear Mr.'SliverHalk'..
Thanx so much for the very valuable attachment. I'm very appreciate it and it help me a lot.
I'm quite confuse between the 'required procedure' and the 'required to be documented'. What is actually the difference between them? Procedure also need to be documented rite? Or organization only need to documented the 5 minimum documentation requirement?

**SilverHawk** · #5 13th February 2007, 10:33 AM

If you cehck the ISO 13485 standard, you will be able to find the word, "documented procedures" and "documented requirements". These are two different documented items.

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