Guidance in Performing a 13485 Gap Analysis

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chasf

Does anyone have a checklist or some other type of aid document to help with performing a gap analysis? We are wanting to enhance our ISO 9001:2000 Quality System by adding ISO 13485:2003 and obtain a dual registration.
 

Doug Tropf

Quite Involved in Discussions
Re: Guidance in Performing a 13485 Gap Aanalysis

Annex B of 13485 documents the similarities and differences between the two standards.
 

AndyN

Moved On
Re: Guidance in Performing a 13485 Gap Aanalysis

Chasf:
There are essentially three types of 'gap' - not necessarily what you'd find on a checklist.........

1. The (obvious) gaps between the two standards - I don't have a copy of 13485 in front of me, but I'm sure they're in there.
2. The gaps between what your organization does vs what 13485 requires
3. The gaps where what you're implementing (even if you have a system in place to either standard) isn't working very effectively. Often this is management review, or corrective actions, etc.

Item 1 is easily fixed, it's #3 that needs addressing properly............
 
C

chasf

Re: Guidance in Performing a 13485 Gap Aanalysis

I have an soft copy of 13485 in MS Word there is no Annex B with it perhaps this part was omitted by the person that gave it to me. We manufacture Medical Device Components for our customers with that in mind we would like to add 13485 to our existing ISO 9001:2000 QMS so the gaps between the two standards (might) be a good place to start. Along with a hard copy of 13485 what other guidance material would you suggest?
 

AndyN

Moved On
Re: Guidance in Performing a 13485 Gap Aanalysis

Have a qualified ISO 13485 consultant perform the gap evaluation and report to your management directly, so they know how big this task is - especially in the area of what needs fixing. They might be a little complacent about what your ISO 9001 system is doing for them......
 

Doug Tropf

Quite Involved in Discussions
Re: Guidance in Performing a 13485 Gap Aanalysis

I have an soft copy of 13485 in MS Word there is no Annex B with it perhaps this part was omitted by the person that gave it to me. We manufacture Medical Device Components for our customers with that in mind we would like to add 13485 to our existing ISO 9001:2000 QMS so the gaps between the two standards (might) be a good place to start. Along with a hard copy of 13485 what other guidance material would you suggest?

Here are some recommended guidance materials:

ISO 14969 - Guidance on the application of 13485.
ISO 14971 - Application of risk management to medical devices.
FDA 29 CFR 820.
 
C

chasf

Re: Guidance in Performing a 13485 Gap Aanalysis

Thank you gentlemen.
 

harry

Trusted Information Resource
Re: Guidance in Performing a 13485 Gap Aanalysis

Perhaps this copy of 'Correspondence between ISO 9001:2000 and ISO 13485:2003 and the US Quality System Regulation' from our post attachments list should enable you to get things started.
 

Attachments

  • Standards_Regulation Comparison using ISO 13485.doc
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chasf

That is just the type of thing I was looking for thanks a million Harry.
 
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