Are there specific rules regarding ISO 13485 and R&D?

[Mandy]

I recently started a job building up the quality system of a very small company (15 workers).
There is no manufacturing and most people are doing R&D.
​Management want to introduce a quality system (kudos to them!) and that's where I come in.
However my background is quality management in a larger company that manufactured and marketed their products. I am unsure how much the ISO 13485 applies to all the R&D work being done.
Obviously things like calibration, traceability, etc. are important but are there specific rules regarding ISO and R&D?
Thanks
Mandy

 

[Marcelo]

Re: Are there specific rules regarding ISO and R&D

ISO 13485 (and other ISO QMS standards) have requirements for design control. But besides design and development planning, the requirements begin in design input (when you have product requirements). Which means that usually the R part of R&D do not have specific requirements for control (but it really depends on your design process).

 

[Ronen E]

Hi Mandy,

What many people in Israel relate to as "R&D" is actually Design and Development. Not many companies conduct real basic research, especially not very small ones. In the ISO 13485 context, probably most of your "R&D" activities fall under s. 7.3. Other than that, the generic parts such as Document Control and Purchasing Controls apply to all.

Marcelo is correct in stating that the fuzzy front end (FFE) of D&D is not well covered by ISO 13485. It's worth your while to think through how you're going to handle that portion - you want to leave enough slack but still capture the knowledge and experience for use in later stages. Then, your FFE principles and methods can be integrated into your Design Control SOPs even though it's something that is outside ISO 13485's scope.

Cheers,
Ronen.

 

[gholland]

ISO 13485 sections 7.1 and .2 address the pre-work for design and development. Establishing quality goals and customer/user needs of the device are essential to the design and development of the device. Philosophy being how can you design a product if you don't know what the user/customer needs out of it? Proving you have considered user needs and have documented their review and approval is an important part of the process.

 

[Ronen E]

ISO 13485 sections 7.1 and .2 address the pre-work for design and development. Establishing quality goals and customer/user needs of the device are essential to the design and development of the device. Philosophy being how can you design a product if you don't know what the user/customer needs out of it? Proving you have considered user needs and have documented their review and approval is an important part of the process.

I was referring to even earlier stages. Of course the establishment of user needs is a part of the design and development process and of ISO 13485 scope.

In theory the design process is a linear one and the establishment of user needs would be the starting point. In reality there is a fuzzy phase that precedes that and it's not of a linear nature or a very predictable one either. It doesn't necessarily mean that the work is not effective or well documented. It just means it doesn't lend itself too well to prescribed procedures. Probably any one who's done new device development knows what I'm referring to.

Cheers,
Ronen.