Freshman needs help with ISO 13485 Audit Process

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#11
Welcome to the Cove! :bigwave:

AndyN's concerns are well founded. The Cove has had discussions on subjects like this one, see links to related threads at the bottom of this page.

Setting up an audit program is not a job for someone who is not well familiar with the standard and the quality management system. I would begin by learning about 13485. I would then consult a book such as The biomedical quality auditor handbook. It is also strongly advisable to get Lead Auditor training.

I hope this helps!
 
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S

szszsz

#12
Thanks!

I know it will be difficult. The scariest problem is that we don't have real field experience. We will study books about QMS auditor.



Welcome to the Cove! :bigwave:

AndyN's concerns are well founded. The Cove has had discussions on subjects like this one, see links to related threads at the bottom of this page.

Setting up an audit program is not a job for someone who is not well familiar with the standard and the quality management system. I would begin by learning about 13485. I would then consult a book such as The biomedical quality auditor handbook. It is also strongly advisable to get Lead Auditor training.

I hope this helps!
 
#13
Thanks!

I know it will be difficult. The scariest problem is that we don't have real field experience. We will study books about QMS auditor.
That will not help you, IMHO! You will be better off saving your time and effort and find a course. Books are, in my experience of 20 years, very confused over the different roles of internal vs external audits...Certainly get the 'extra' from the book suggested by Jennifer, but you will need to develop skills as an auditor. That cannot, in most cases, be done through reading a book - which is why so many courses are available!
 
Last edited:

somashekar

Staff member
Super Moderator
#14
While the ISO13485 is built over the ISO9001 platform, please note that the title of ISO13485 reads: "Medical devices — Quality management systems — Requirements for regulatory purposes"
Have you aligned your medical devices to be also meeting any regulatory requirements ? Requirements of regulations must be well mapped into your QMS processes, so also in the audit requirements.
 
T

treesei

#15
Good news: Jimmy's company is very small with 15 people, which makes many things less messy.

Bad news: Given Jimmy's background, the learning curve is steep.

Instead of lead auditor courses, perhaps the first course to take is an ISO 13485 overview course. For beginners, I recommend a course over a book. He sure will have many questions and will need a teacher or guide in the early days. Will be money well spent.

Sounds like Jimmy lives in Canada. Health Canada device regulations are also a must to at least have some idea about.

Good luck.
 

Ronen E

Problem Solver
Staff member
Moderator
#16
Hi all,

:nope: IMHO you are scaring the guy more than is required...

:yes: It is important to be vigilant and educated, and real-life experience is important, but this is no rocket science...

I believe they can teach themselves anything and everything that they need - especially today, when so many good resources are available online for free. Courses and books can be great but they don't actually replace real-life experience. The only way to gain experience is to... experience!... The choice between a course and a book is many times a matter of personal preference. It has to do with the unique way each and everyone of us absorbs information. For me, courses are usually disappointing (and I attended quite many). When I want to consult or discuss something, I call a specialist or a knowledgeable colleague or a wise friend...

In the OP situation I would consider bringing in an experienced consultant to walk them through the initial certification, ISO 13485, regulation and all, and would look for someone who is not only knowledgeable, but who can, and wants to, also educate and grow other people while doing the job.

He who dares - wins.

Cheers,
Ronen.
 
Last edited:
S

szszsz

#17
I found many courses on Internet also. Can you recommend a few, or what factors should I consider when choosing one? Thanks.

That will not help you, IMHO! You will be better off saving your time and effort and find a course. Books are, in my experience of 20 years, very confused over the different roles of internal vs external audits...Certainly get the 'extra' from the book suggested by Jennifer, but you will need to develop skills as an auditor. That cannot, in most cases, be done through reading a book - which is why so many courses are available!
 
S

szszsz

#18
Currently, we are selling similar products in US and our products comply with FDA regulations. We are moving assembly work to US. We are trying to combine ISO13485 & FDA regs into one system.


While the ISO13485 is built over the ISO9001 platform, please note that the title of ISO13485 reads: "Medical devices — Quality management systems — Requirements for regulatory purposes"
Have you aligned your medical devices to be also meeting any regulatory requirements ? Requirements of regulations must be well mapped into your QMS processes, so also in the audit requirements.
 
S

szszsz

#19
We locate in New York state. I found Health Canada has this guidance. Since it's international standard, the audit process should not vary much.


Good news: Jimmy's company is very small with 15 people, which makes many things less messy.

Bad news: Given Jimmy's background, the learning curve is steep.

Instead of lead auditor courses, perhaps the first course to take is an ISO 13485 overview course. For beginners, I recommend a course over a book. He sure will have many questions and will need a teacher or guide in the early days. Will be money well spent.

Sounds like Jimmy lives in Canada. Health Canada device regulations are also a must to at least have some idea about.

Good luck.
 
S

szszsz

#20
Ronen,

Thanks. I called a couple consulting firms and the quotes are around USD 30,000. We are a small company and ISO 13485 is not mandatory in US, where we are selling the products, so we want to try it by ourselves.


Hi all,

:nope: IMHO you are scaring the guy more than is required...

:yes: It is important to be vigilant and educated, and real-life experience is important, but this is no rocket science...

I believe they can teach themselves anything and everything that they need - especially today, when so many good resources are available online for free. Courses and books can be great but they don't actually replace real-life experience. The only way to gain experience is to... experience!... The choice between a course and a book is many times a matter of personal preference. It has to do with the unique way each and everyone of us absorbs information. For me, courses are usually disappointing (and I attended quite many). When I want to consult or discuss something, I call a specialist or a knowledgeable colleague or a wise friend...

In the OP situation I would consider bringing in an experienced consultant to walk them through the initial certification, ISO 13485, regulation and all, and would look for someone who is not only knowledgeable, but who can, and wants to, also educate and grow other people while doing the job.

He who dares - wins.

Cheers,
Ronen.
 
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