ISO13485 Certification Scope - Registering a Subset of our Products

J

JeanG

#1
Dear All,
I know there are lots of ISO experts here, I just came up an unsure question, I am working for my company to achieve ISO13485, the company has ISO9001 certification. The quality system is very comprehensive for one of our software systems (the company is a medical software producer, there are more than 3 different types of software systems), but not for all, in order word, one system is ready to be audited, but another 2 systems are in the preparation stage, documents are everywhere.

My question is Can I ask ISO 13485 auditor to come to audit just for one of our system to obtain the certification? then we will develop 2 other systems to be in compliance with ISO13485. Is this feasible? Or i have to make sure all systems are completed following the QMS, then asking the iso auditor to come to audit?

I do want to help the boss to achieve it ASAP.
Thanks for your help. I just really want to know the answer. Thanks
 
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c.mitch

Quite Involved in Discussions
#2
Re: ISO13485 Certification - Emergency Question - Help, please

I Jean,

It is possible to define the scope of your QMS by including only a given type of SW product or even by quoting a specific list of products.
The drawback of this situation: you'll have to pass a second certification audit to extend the scope of your ISO 13485 QMS.

I've seen some SW manufacturers doing this. This can also have consequences on your qms like splitting
KR

Mitch.
 

somashekar

Staff member
Super Moderator
#3
Re: ISO13485 Certification - Emergency Question - Help, please

Dear All,
I know there are lots of ISO experts here, I just came up an unsure question, I am working for my company to achieve ISO13485, the company has ISO9001 certification. The quality system is very comprehensive for one of our software systems (the company is a medical software producer, there are more than 3 different types of software systems), but not for all, in order word, one system is ready to be audited, but another 2 systems are in the preparation stage, documents are everywhere.

My question is Can I ask ISO 13485 auditor to come to audit just for one of our system to obtain the certification? then we will develop 2 other systems to be in compliance with ISO13485. Is this feasible? Or i have to make sure all systems are completed following the QMS, then asking the iso auditor to come to audit?

I do want to help the boss to achieve it ASAP.
Thanks for your help. I just really want to know the answer. Thanks
ISO13485 is a QMS for your processes that work within your organization making a software medical device. This system cannot be product specific, in sense the same people following a recognized pattern of design develop make and review a s/w product are doing something else for other s/w products. What about the common processes like the document control, records control, CAPA, Audit, resources, infrastructure, and above all top management processes. How can these be existing for one s/w product and missing for others ?
The stage of your s/w product completion is immaterial, as long the the activities up to the stage completed is per your plan and can be supported by necessary records as evidences.
I request you to explain your position with some more clarity.
 
Last edited:

sagai

Quite Involved in Discussions
#4
Re: ISO13485 Certification - Emergency Question - Help, please

Unless those 2 other systems developed by other employees it is difficult for me to understand how they would switch between working practises.
 
J

JeanG

#5
Hi, All
I just had a discussion with my boss, the other 2 systems will take at least 1-2 years to validate, he is very eager to achieve something, he would like to go for ISO13485 ONLY FOR one system, i just want to make sure is this okay? We have common procedures for all systems, such documentation, internal audit, CAPA, Purchasing, Servicing, Maintain Training records etc, the different procedures will be design and development, risk analysis etc.

Thanks for all your help.
 

sagai

Quite Involved in Discussions
#6
ISO13485 is more like a Quality System audit rather than a particular product audit.
Have a question to be honest ...
Why are you keen on for this ISO13485 stuff?
Cheers!
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#7
<snip> I just had a discussion with my boss, the other 2 systems will take at least 1-2 years to validate, he is very eager to achieve something <snip>
I think what you are really going to have to do is discuss it with your registrar. What you are wanting to do is to limit the Scope of registration. Each registrar will potentially have their own limitations in this type of situation.

I think what a few have tried to point out is even if you exclude some products you will have to have the required systems in place and functioning no matter what.

I think I understand where you're coming from. I have seen ISO 9001 and TS 16949 companies limit their scope of registration to certain product lines. Whether it was wise to do that or not was a company decision based upon their unique scenarios. This is more commonly done with TS 16949 than with ISO 9001.
 

somashekar

Staff member
Super Moderator
#8
Hi, All
I just had a discussion with my boss, the other 2 systems will take at least 1-2 years to validate, he is very eager to achieve something, he would like to go for ISO13485 ONLY FOR one system, i just want to make sure is this okay? We have common procedures for all systems, such documentation, internal audit, CAPA, Purchasing, Servicing, Maintain Training records etc, the different procedures will be design and development, risk analysis etc.

Thanks for all your help.
System = Product ... Am I correct ?
Where you have a scope for ISO13485 for designing and providing medical software products, go ahead and get it with your CB.
With your ISO13485 certified and in place, you can continue and complete your 2 ongoing systems or many more as you start new systems ~~~
 
J

JeanG

#9
i understand what you mean, but the situation is we can't get other 2 system validated in such a short period, the QMS is comprehensive, detailed, some procedures are applicable for all systems, some procedures are there for just for the validated system.

System = Product, that's correct.
So do you mean if we call the NB to come to audit our QMS, just assume we only have one product in this company, let say we get the certificate, is this certificate for all systems, for next year, we just need same auditor to come to audit other 2 systems, as a new systems to them. am i right? Can you explain to me a little bit more? The only disadvantage is paying more to NB for 3 different times auditing, right? Thanks
 

Rocke

Involved In Discussions
#10
We did a stepwise implementation and certification, where we started out with excluding development and several product lines from the certification, simply because we had not validated all applicable processes and generated all technical dossiers yet. This was reflected in the products regulatory status of course and discussed up-front with the registrar. We then extended the scope over the next years at each surveillance audit.
It can be done, under the right conditions, but obviously care should be taken not to misrepresent the two systems/products that are not in the scope.
 
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