ISO 13485 Medical Devices QMS - Requirements for Regulatory Purposes Checklist

R

rick melton - 2007

#1
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
 
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howste

Thaumaturge
Super Moderator
#4
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

Starting to get Involved
#5
Hi Cathy

Your attached checklist is very useful for me to introduce the changes of new version of ISO 13485 to my students.
 
#6
ISO 13485: 2003 checklist attachment

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

Many thanks
Pete
 
D

dacindustries

#8
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.
 
S

SilverHawk

#9
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 ...... :biglaugh:
 

howste

Thaumaturge
Super Moderator
#10
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.
 

Attachments

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K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 11
K ISO 13485:2016, Clause 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 13485 and QMS related concepts Training - Small medical device startup company ISO 13485:2016 - Medical Device Quality Management Systems 9
R ISO 9001 versus ISO 13485 for Suppliers to Medical Device Companies ISO 13485:2016 - Medical Device Quality Management Systems 2
C Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed? Other Medical Device Related Standards 5
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J Medical Devices in Japan - Conformity of QMS to ISO 13485 Japan Medical Device Regulations 1
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B ISO 13485 certification advantages when I certify a Class 2a medical device CE Marking (Conformité Européene) / CB Scheme 12
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X Help with ISO 13485 Clause 6.4 as it applies to Medical Device Servicing ISO 13485:2016 - Medical Device Quality Management Systems 25
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P Removing Detection from DFMEA - Medical Device company using ISO 13485 FMEA and Control Plans 3
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D Are we required to obtain ISO-13485 to act as a Sales Channel for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 3
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S Distributor for Products used in Medical Laboratories - Is ISO 13485 Required? ISO 13485:2016 - Medical Device Quality Management Systems 11
T MDD (Medical Device Directive) and ISO 13485 and a lot of Questions EU Medical Device Regulations 3
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F Quality Manual Template for ISO 13485 - Small Contract Medical Device Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
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F Vendor (supplier) for ISO 13485 Medical Devices Co. minimum QA System ISO 13485:2016 - Medical Device Quality Management Systems 3
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