ISO 13485:2003 Clause 1.3 - Applicable Standards and Regulations

[Joconnell]

Good afternoon,

I am just running through with a fine tooth comb before our upcoming surveillance audit, and came upon a question that I wasn't sure about...

Our current quality manual states under 1.3 (ISO 13485:2003) the following:
Applicable Standards and Regulations
-ISO 13485:2003, Medical devices-QMS-Requirements for regulatory purposes
-USA, FDA, 21 CFR 820, Quality system regulations

We are not FDA registered, we are just a component manufacturer to the medical device field, no finished product what so ever. Throughout the manual it makes references such as 'in accordance with the requirements of all applicable standards and regulations.' Is that correct, or should it just say something along the lines of ISO 13485, with reference to 21 CFR 820?

TIA!

 

[RCW]

Our current quality manual states under 1.3 (ISO 13485:2003) the following:
Applicable Standards and Regulations
-ISO 13485:2003, Medical devices-QMS-Requirements for regulatory purposes
-USA, FDA, 21 CFR 820, Quality system regulations

What 1.3 are you making reference to? Is it 1.3 in your company's quality manual? I have ISO 13485:2003 open right in front of me and there is no section 1.3 there.

Throughout the manual it makes references such as 'in accordance with the requirements of all applicable standards and regulations.' Is that correct, or should it just say something along the lines of ISO 13485, with reference to 21 CFR 820?

I'm assuming you mean your quality manual. What are you referencing throughout the manual? Can you provide more specific information?

 

[Joconnell]

Sorry, I was too engrossed in comparison of the standard to our quality manual I got confused! It is 1.3 of our quality manual, refering to application 1.2 in the standard.

An example is under 4.1 (in our manual) it states
'company' has established, documented, implemented, and maintains a Quality Management System in accordance with the requirements of all applicable standards and regulations.

To me that would refer back to our section on applicable standards and regulations, which say we comply with FDA QSR 21 CFR...

Maybe I am over analyzing the concept possibly because I was not the originator, and did not go through the tought process...

 

[RCW]

The only thing I would personally change would be to say "all applicable standards and regulations stated here within.". Is it necessary to say this? Probably not, but at least it provides a tighter link to your other section where you actually state those standards and regulations. Overall it looks like it is just a minor semantics issue.

 

[yodon]

So do you know why the references are there? Do you actually say you do something specifically in accordance with those standards? If not, you're probably better removing them. You may be close to a finding if you can't say what you do that's in compliance.

If you keep them in, do you have physical copies of them? We got pinged once for referencing a standard we didn't physically own (no compliance issue other than we didn't own the standard).

 

[Gert Sorensen]

Good afternoon,

I am just running through with a fine tooth comb before our upcoming surveillance audit, and came upon a question that I wasn't sure about...

Our current quality manual states under 1.3 (ISO 13485:2003) the following:
Applicable Standards and Regulations
-ISO 13485:2003, Medical devices-QMS-Requirements for regulatory purposes
-USA, FDA, 21 CFR 820, Quality system regulations

We are not FDA registered, we are just a component manufacturer to the medical device field, no finished product what so ever. Throughout the manual it makes references such as 'in accordance with the requirements of all applicable standards and regulations.' Is that correct, or should it just say something along the lines of ISO 13485, with reference to 21 CFR 820?

TIA!

Good afternoon to you too

A few things come to mind when I read your post:

1. Did somebody purchase this manual at some point? Broad statements like those tend to originate from a "master file", and the person implementing the document/manual etc. forgot to adapt it to the actual situation
2. Are you a subsupplier to an FDA-registered company? That might explain why one would implement regulation that one was not directly subjected to.
3. Did your company originally plan to be FDA registered?
4. Basically, what's the big deal? The QSR is most of all a set of really good "advice", and even if you are not subjected to the rules you could benefit from adhering to them.

 

[Joconnell]

The origin of the manual is not known to me, a consultant was originally hired to implement the system. We do supply FDA registered companies, so I understand it, in that aspect. Ultimatley my question is, is it safe to call that out, or am I setting us up for some kind of audit problem, or better yet is there different verbiage that can be used to say we follow, but are not officially registered...

 

[Aaron Lupo]

The origin of the manual is not known to me, a consultant was originally hired to implement the system. We do supply FDA registered companies, so I understand it, in that aspect. Ultimatley my question is, is it safe to call that out, or am I setting us up for some kind of audit problem, or better yet is there different verbiage that can be used to say we follow, but are not officially registered...

You either follow the CFR requirements or you don't, it dosen't matter if you are registered or not in my opinion. What do you customers expect, if they expect that you comply with the CFR's you better darn well make sure you do.

 

[Ajit Basrur]

Good afternoon,

I am just running through with a fine tooth comb before our upcoming surveillance audit, and came upon a question that I wasn't sure about...

Our current quality manual states under 1.3 (ISO 13485:2003) the following:
Applicable Standards and Regulations
-ISO 13485:2003, Medical devices-QMS-Requirements for regulatory purposes
-USA, FDA, 21 CFR 820, Quality system regulations

We are not FDA registered, we are just a component manufacturer to the medical device field, no finished product what so ever. Throughout the manual it makes references such as 'in accordance with the requirements of all applicable standards and regulations.' Is that correct, or should it just say something along the lines of ISO 13485, with reference to 21 CFR 820?

TIA!

Hi Joconnell,

Since you will not be manufacturing any finished components, the degree of regulatory impact to you would be much less.

The prime thing that you need to bear in mind is that your quality system should be in in line with ISO 13485, 21 CFR Part 820 and any other national regulatory standards that your customer is located.

Besides, I could not find your location from your profile. If its not US, then also consider the local regulations.