ISO 13485:2003 Compliance Audit Checklist - Example Attached

C

Carlo

#1
ISO 13485:2003 audit checklist

Hi everyone,

This is my first post so please bear with me. I am seeking a checklist to compare our QMS system with the 13485:2003. We are scheduled to be audited soon so we would like to line up our ducks so to speak. Can anyone point me in the right direction.

Thanks for all your help

Carlo
 
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A

Aaron Lupo

#2
Carlo said:
Hi everyone,

This is my first post so please bear with me. I am seeking a checklist to compare our QMS system with the 13485:2003. We are scheduled to be audited soon so we would like to line up our ducks so to speak. Can anyone point me in the right direction.

Thanks for all your help

Carlo
Hope this helps!
 
#3
This would be of a great help!!

Just found this site and it looks great! I'm new to the site and the subject checklist seems as it would be a great tool -- however I'm unable to download. I promise to be a contributor in the future -- how can I access this?? Please advise. Thanks! :thanx:
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#4
Compliance Audit Guy said:
Just found this site and it looks great! I'm new to the site and the subject checklist seems as it would be a great tool -- however I'm unable to download. I promise to be a contributor in the future -- how can I access this?? Please advise. Thanks! :thanx:
If you contribute, you can download within a day. Otherwise e-mail Marc.
 
S

sharda

#7
13485 or 9001 for a mixed bag?

Does anyone have any views on which certification should be applied for in the following situation (our Company):

We are manufacturers of medical and non-medical devices, with the medical part of the business being the focus. As medical device manufacturers, we are more interested in the 13485 certification. However, there is some confusion/concern that not certifying the non-medical part of the Business could create some problems. Thus we are considering doing 9001 + 13485 however the extra work and registration fees are prohibitive prospects.

Any thoughts?

Thank you much for your help.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#8
sharda said:
Does anyone have any views on which certification should be applied for in the following situation (our Company):

We are manufacturers of medical and non-medical devices, with the medical part of the business being the focus. As medical device manufacturers, we are more interested in the 13485 certification. However, there is some confusion/concern that not certifying the non-medical part of the Business could create some problems. Thus we are considering doing 9001 + 13485 however the extra work and registration fees are prohibitive prospects.

Any thoughts?

Thank you much for your help.
Hi Sharda and welcome to The Cove.

We manufacture only medical devices, yet we have certificates for both ISO 9001 and ISO 13485. You should get certified to ISO 13485 for your medical devices. The additional ISO 9001 cert is minimal, primarily concerning customer satisfaction and continual improvement of your QMS.

There was no additional cost for us to get both certifications. My advice is to speak to your prospective registrar about this. If they want to impose additional cost, find one that doesn't.
 

DannyK

Trusted Information Resource
#9
Hi Sharda,

I have several clients who have just their medical device processes registered to ISO 13485:2003.

If you are already using the tools such as corrective/preventive action, internal audit, nonconformances, and have measurable objectives, I think it would be worthwhile to add ISO9001:2000 to the non-medical side of your company.

You should get quotes from several registrars and ask them to quote different options.

Danny
 
H

Hello - 2006

#10
My company was certified for ISO 9001 last year and has been certified for ISO 13485:2003 recently. Our NB advised us to carry out the audit together and they will charge us according to the manday needed to carry out the audit. You might ask your NB whether it is possible to include different audit scope for those 2 certification.

Best of luck.
 
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