ISO 13485 Medical Devices QMS - Requirements for Regulatory Purposes Checklist

[rick melton - 2007]

Greetings everyone,
I am a newcomer to the forum, so I am learning the process. I have seen some interesting topics and think this will be very helpful.
I am the Corp Quality Systems Assessment Manager, for a medical company.
All of our divisions and corporate are registered to ISO 9000 and are registering to ISO 13485-2003. I am looking for an audit checklist that will cover all of the requirements. Any recommendations. (I saw one posted by the ISO Guy, but could not open it.)

Thanks in advance fro your help.

Rick

 

[Aaron Lupo]

If you let me know your e-mail address I would be more than happy to e-mail it to you.

 

[Cathy]

Hi Rick,

I have made up this check list to allow me compare additionally requirements to ISO9001;2000. This table needs to be used along side ISO9001;2000 as only the changes are noted here. I have also compared to ISO13485:1996. Hope it is of some use.


Cathy

 

[howste]

Cathy - that looks like a useful tool to compare the standards. I'll be doing a 13485 audit in December, so I'll probably use this spreadsheet to look at the changes.

Thanks!

 

[Karichan]

Hi Cathy

Your attached checklist is very useful for me to introduce the changes of new version of ISO 13485 to my students.

 

[pcomley]

ISO 13485: 2003 checklist attachment

Dear ISOGUY
I too would most apprecaite a copy of your checklist. Going crazy converting.

Many thanks
Pete

 

[electronics guy]

Dear ISOGUY,

A very popular bit of information you have put together!

THANKS!

 

[dacindustries]

DACIndustries

I would be interested in a ISO 13485 checklist and aslo a gap analysis. Anyone help?
I am a consultant that deals woth ISO and AS, but new to the medical.

 

[SilverHawk]

Process Approach Checklist???

I am just wondering why do we have to bother with structured audit checklist? Is it that ISO 9001 & ISO 13485 have adopted the process approach and WHY do we need to develop a long list of checklist???

I am just wondering whether the CBs auditors for ISO 13485 would still look for structured checklist and would the internal auditors still be given a long checklist by their QMR?

I am just wondering ......

 

[howste]

Checklists are tools...

Checklists are just tools to help auditors. IMO there is no best checklist format - it all depends on what the auditor needs to help make the audit process go smoothly. In my case, the checklist reminds me what I need to look for and provides a place to record evidence. I rarely follow the sequence of the checklist, but always make sure that each requirement is addressed before I'm done.

When I audit for registrars I look for evidence that all requirements of the standard have been audited for effectiveness and conformity to requirements. There is no requirement for a checklist at all. But just because it's not required doesn't mean it's a bad idea to have one.

I'm attaching a generic ISO 13485:2003 checklist. It also contains the ISO 9001:2000 requirements for organizations that are interested in both. Black text is common to both standards, blue text is 13485 only, and red text is 9001 only. It has a blank sheet at the end to add company-specific requirements or any other additional questions determined in audit prep. It also has sample questions throughout that might be asked by the auditor to get the information needed (some of this isn't finished yet). If anyone would like to use this as-is or modify it to suit your needs, feel free.