Exclusion of 'Design and Development' from scope of certification

v9991

Trusted Information Resource
#1
1. when the customer provides the specification ( or reference dimensions), and rest of the activities ( from fabrication/design of moulds/change parts are taken up by manufacturer), can the manufacturer claim the exclusion of 'design and development' for the 13485 requirements.
2. when the manufacturer has an sister concern which deals with fabrication & design, can the manufacturer still claim the exclusion of 'design and development' for the 13485 requirement.

my contention is that, manufacturer needs to comply to the requirement; either by calling out the either the scope of activities or establishing the dependence/traceability to the syster concern.

lets say, I am talking about syringe, which, individually constitutes as primary packaging material,; but when assembled with stopper-plunger and supplied as "ready to use or ready to fill", would constitute an 'device'; Now the question is, whether the manufacturer can claim exclusion of 'design and development'.
 
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John Broomfield

Staff member
Super Moderator
#2
v9991,

Design is pure service. Is that “sister concern” included in the scope of your management system? And is top management split or whole when it comes to jurisdiction over the whole system?

But take another look at the other services valued by your customers and you’ll see that your company provides a service which includes products instead of just products.

The days of omitting the design, delivery and continual improvement of our services from our management system are over.

Indeed, your website may already advertise your fabrication services.

Best wishes,

John
 

Marcelo

Inactive Registered Visitor
#3
You can only claim exclusion if applicable regulatory requirements allow it. This was originally created because the us FDA allow some devices (in particular class I devices) to not comply with design and development requirements.

This is not a decision of the manufacturer. It's a decision of the regulator, and only if the emulator allows this, then the manufacturer can claim the exclusion.
 

somashekar

Staff member
Super Moderator
#4
1. when the customer provides the specification ( or reference dimensions), and rest of the activities ( from fabrication/design of moulds/change parts are taken up by manufacturer), can the manufacturer claim the exclusion of 'design and development' for the 13485 requirements.
2. when the manufacturer has an sister concern which deals with fabrication & design, can the manufacturer still claim the exclusion of 'design and development' for the 13485 requirement.

my contention is that, manufacturer needs to comply to the requirement; either by calling out the either the scope of activities or establishing the dependence/traceability to the syster concern.

lets say, I am talking about syringe, which, individually constitutes as primary packaging material,; but when assembled with stopper-plunger and supplied as "ready to use or ready to fill", would constitute an 'device'; Now the question is, whether the manufacturer can claim exclusion of 'design and development'.
1. It is the customer device and not your device as far as the business / regulatory is concerned. All the activities that you say you are doing has the final transfer from customer (see 7.3.8). At least on records it must be clear the specifications / specification changes have customer approval.
Reference dimensions has no place in design and development output or in the manufacturing.
Now you can exclude 7.3 (blame it all on the customer) ... OR Include 7.3 (if you have all the activities in your QMS control from 7.3.1 till 7.3.10, and you are able to showcase the customer approval at all needed places). Now its the call of your CB to decide to acknowledge that you have design and development capability, and that can also be strengthened with a good design and development agreement with your customer which will state what will be your responsibilities and what will be customer responsibilities and authorities. We have successfully done that.
 

Marcelo

Inactive Registered Visitor
#5
Now its the call of your CB to decide to acknowledge that you have design and development capability,.
This has nothing to do with a CB decision, it's a regulator/regulatory requirements decision. If the regulatory requirement (thus, the regulator) decides that you do not need to comply with the design and development requirement, you can exclude it. you can even exclude it if you DO have design and development (the only things is that the regulator says that it won't verify it). So again, this is a regulator decision, not a manufacturer/CB decision.
 

v9991

Trusted Information Resource
#6
This has nothing to do with a CB decision, it's a regulator/regulatory requirements decision. If the regulatory requirement (thus, the regulator) decides that you do not need to comply with the design and development requirement, you can exclude it. you can even exclude it if you DO have design and development (the only things is that the regulator says that it won't verify it). So again, this is a regulator decision, not a manufacturer/CB decision.
for the category of device component, ISO compliance is adequate., hence the question would roll back to CB or QMS ( either of supplier or customer!)

further, to clarify, should the 'decision' be dependent on the 'if/when regulatory verifies it' !!!
versus,
whether the established process in practice ( design & development) would determine if relevant section of ISO is complied/.applied or not! ( standardized process, improvement etc )
 

v9991

Trusted Information Resource
#7
Now you can exclude 7.3 (blame it all on the customer) ... OR Include 7.3 (if you have all the activities in your QMS control from 7.3.1 till 7.3.10, and you are able to showcase the customer approval at all needed places). Now its the call of your CB to decide to acknowledge that you have design and development capability, and that can also be strengthened with a good design and development agreement with your customer which will state what will be your responsibilities and what will be customer responsibilities and authorities. We have successfully done that.
1. i practically do not see customer being able to play the role of design-house unless its a sister concern; and even then, the aspects of design transfer- verification - validation etc ought to be maintained at manufacturer.)
the point it, i can visualise scenario for part-compliance ( specific clauses), but not overall exclusion of D&D.

2. When u audit and find an 'capability and practice for design & development' how would you rate the observation. ( critical - major ) etc ( given that the manufacturer has to comply with ISO and QMS has been certified for same with an exclusion to D&D )
 

somashekar

Staff member
Super Moderator
#8
1. i practically do not see customer being able to play the role of design-house unless its a sister concern; and even then, the aspects of design transfer- verification - validation etc ought to be maintained at manufacturer.)
the point it, i can visualise scenario for part-compliance ( specific clauses), but not overall exclusion of D&D.

2. When u audit and find an 'capability and practice for design & development' how would you rate the observation. ( critical - major ) etc ( given that the manufacturer has to comply with ISO and QMS has been certified for same with an exclusion to D&D )
Since this is a post in ISO 13485 sub forum and the medical device in question seems to be your contract manufacturing, prima facie I don't see you as design responsible. So design and development stands an exclusion.
Sister concern or otherwise, your requirement is to get design development outputs from your customer suitable to buy and/ or make which you will take forward to manufacture and test and deliver. Whether you aid in the design and development process of the medical device or not, the aspects of design and development of the medical device is not in the purview.
If you are also into ISO 9001, then there is a possibility ....as in your example.,
ISO 13485 : Contract manufacturing and assembly of medical syringe
ISO 9001 : Design development and manufacturing of Injection molded parts and assemblies
During audit I will always keep the clear scope in the background, and then its easy to pick processes to dwell further.
 

v9991

Trusted Information Resource
#9
Sister concern or otherwise, your requirement is to get design development outputs from your customer suitable to buy and/ or make which you will take forward to manufacture and test and deliver. Whether you aid in the design and development process of the medical device or not, the aspects of design and development of the medical device is not in the purview.
I am not into specifically into these areas yet; I take the point of regulatory scope & iso 9001 vs 13485 scope ,
however on other point,
Especially when sister concern is owning the design & development, still we are in the process of developing the mould, manufacturing and verification - validation of same. Hence the contention is that, we should hold the relevant portion of design controls ( design verification, design transfer, process fmea, design validation (process) etc.)
pl. suggest.
 

somashekar

Staff member
Super Moderator
#10
I am not into specifically into these areas yet; I take the point of regulatory scope & iso 9001 vs 13485 scope ,
however on other point,
Especially when sister concern is owning the design & development, still we are in the process of developing the mould, manufacturing and verification - validation of same. Hence the contention is that, we should hold the relevant portion of design controls ( design verification, design transfer, process fmea, design validation (process) etc.)
pl. suggest.
Getting back to post #4 above, we have successfully done that for ISO 13485. We had a clear customer supplier agreement about design and development responsibility. Our certification scope had the design and development. This is the reason I said to discuss with your CB about this scheme of design and development you are into.
 
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