Legacy Products and ISO 13485 Certification

S

steve.matthews

#1
We are a small engineering/manufacturing firm that produces devices and software for several markets, including medical. We are about to apply for ISO 13485 certification, and are implementing a Quality Management System. Current and future products will be covered from initial design to end-of-life by the QMS. This, of course, is not true of older products, even though they are still being sold.

Can anyone provide some guidance on how to deal with products designed prior to ISO certification? Can they be "retrofitted" to become compliant with ISO standards? Note that in most cases, these legacy products are missing documents and records that our QMS specifies, and which would be difficult to reproduce.

--
Steve Matthews
Manager, Technical & Quality Communications
 
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Stijloor

Staff member
Super Moderator
#2
Re: Legacy products and ISO certification

We are a small engineering/manufacturing firm that produces devices and software for several markets, including medical. We are about to apply for ISO 13485 certification, and are implementing a Quality Management System. Current and future products will be covered from initial design to end-of-life by the QMS. This, of course, is not true of older products, even though they are still being sold.

Can anyone provide some guidance on how to deal with products designed prior to ISO certification? Can they be "retrofitted" to become compliant with ISO standards? Note that in most cases, these legacy products are missing documents and records that our QMS specifies, and which would be difficult to reproduce.

--
Steve Matthews
Manager, Technical & Quality Communications
Welcome to The Cove Forums! :bigwave: :bigwave:

I moved your post to an ISO 13485 focused forum.

Stijloor.
 

DannyK

Trusted Information Resource
#3
Hi Steve,

Within your quality manual you can specify the scope of the certification to not include legacy products produced before the QMS was established.
 

somashekar

Staff member
Super Moderator
#4
This is my take.
The QMS came later, those products first. You have design and development in your scope of QMS, and within your design procedure, it is a minimum to have the design output records of the legacy products purely from the point of sustaining it and with a scope to address any change in a systamatic way per your 13485 QMS.
How this design output came to being (the application of the design and development steps) is as you say a legacy and you are only now managing the outputs available.
Even if you do not have outputs as necessary to make these products, firm up what you have as the records of design output and manage them. When you have questions comeup about requirement missing the design output, take that opportunity to create them and strengthen the design document using all your previous learnings and history.
Note: If your device is in your plan for CE with a notified body then this will come equally handy when you have to complete your technical construction file.
 
Last edited:

Ronen E

Problem Solver
Staff member
Moderator
#5
This is my take.
The QMS came later, those products first. You have design and development in your scope of QMS, and within your design procedure, it is a minimum to have the design output records of the legacy products purely from the point of sustaining it and with a scope to address any change in a systamatic way per your 13485 QMS.
How this design output came to being (the application of the design and development steps) is as you say a legacy and you are only now managing the outputs available.
Even if you do not have outputs as necessary to make these products, firm up what you have as the records of design output and manage them. When you have questions comeup about requirement missing the design output, take that opportunity to create them and strengthen the design document using all your previous learnings and history.
Note: If your device is in your plan for CE with a notified body then this will come equally handy when you have to complete your technical construction file.
I generally agree.
I want to add that:
(a) the level of compliance required will typically be in line with the class / risk level of the medical device (low risk -> more leeway).
(b) you may be granted a grace period (maybe even a few years if the risk level is low), but if you continue to make these legacy devices then in the long run you will probably be expected to align with all applicable requirements.

Cheers,
Ronen.
 
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