R&D Lab ISO 9001 certification

#1
Hi !
We want to certify our R&D laboratory against ISO9001 next year. Then, the year after, we want to get it certified ISO17025.
I would like to have some ideas in terms of planning and project management if anyone has some experience or recommendation on these projects.
Thanks
Herve
 
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#2
Hello !
I need a little bit of guidance. We are starting the process to get our R&D lab ISO9001 certified in a couple month. It's a lab that has some procedures as they started the certification process in the past (maybe 5 years ago) but never finished it.
Today part of the staff is new, the building is new. I am in favor of a greenfield approach.
How would you approach the team and convince them to drop all they have in terms of procedures, SOP and start from scratch?

Thank you!
 

John C. Abnet

Teacher, sensei, kennari
Staff member
#4
Good day @hmorvan ;
@yodon asks some valid questions.

I have a few also....

1- What is the motivation/purpose for the R&D lab to be ISO 9001 certified? (only if "we" understand the intent/goal can "we" determine if those goals are met are not.)

2- ISO 9001 does not get into "how" things are done. In fact, ISO 9001 is fairly non-prescriptive and simply provides a framework of requirements that help to ensure an organization is addressing/considering good practices as defined by the standard (and, of course, by your internal organization). What is it then about becoming certified to ISO 9001 that would cause a "clean slate"....discounting all current methods?


Hope this helps (by prompting some thought).

Be well.
 

Sidney Vianna

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Staff member
Admin
#5
1- What is the motivation/purpose for the R&D lab to be ISO 9001 certified?
That is, indeed, the crucial aspect. What is the "product" of an R&D lab and who is the customer? These are the two most basic questions anyone must answer, prior to engaging in implementing ISO 9001 in any organization. Until one clearly understands what is the product and who is the customer of that product, the lab must not engage in any procedural development.

In my experience, most ISO 9001 certification efforts related to pure R&D labs were not sustainable due to the perceived stifling of work , which is the antithesis of research, and the fact that each R&D "project" was unique, not very pliable to fit cast-in-stone procedures. Until the organization clearly understands WHY they are doing it, they tend to go nowhere; fast. As in this case.
 
Last edited:
#6
Hi,
Thanks for your questions; See my responses
1-Are the procedures not working? Are the employees familiar with the existing procedures? The procedures are not updated and not used. Employees are mostly new now and did not familiarize with the old documents since they were not up to date.
2- What is the motivation/purpose for the R&D lab to be ISO 9001 certified? To provide a clear quality framework to the R&D operations and to harmonize with the rest of the operations/business.
3-What is the "product" of an R&D lab and who is the customer? The R&D lab produces new products according to market or customer specific demand. They also provide precise measurement. And this is why we want to go for the ISO 17025 later

Thanks
Herve
 

yodon

Staff member
Super Moderator
#7
If the existing procedures aren't used and aren't aligned with the business processes, sure doesn't seem like there should be a reason to use them even as a jumping-off point.

In terms of getting started, I would get both standards to ensure whatever you start on will align with both. To me, document and record control is pretty much foundational stuff so I like to get that on the right path early.
 

Sidney Vianna

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Staff member
Admin
#8
To provide a clear quality framework to the R&D operations and to harmonize with the rest of the operations/business.
That being the case, the lab should be part of the whole organization system, not a separate entity implementing ISO 9001 as a stand alone entity. Further, ISO 9001 does not address research; it does address product Development (the D in R&D)
The R&D lab produces new products according to market or customer specific demand.
Do you mean to say that the lab DEVELOPS new product models? Or they MANUFACTURE new products? The word produces in this context is ambiguous.
 
#9
That being the case, the lab should be part of the whole organization system, not a separate entity implementing ISO 9001 as a stand alone entity. Further, ISO 9001 does not address research; it does address product Development (the D in R&D)
Do you mean to say that the lab DEVELOPS new product models? Or they MANUFACTURE new products? The word produces in this context is ambiguous.
Hi Sidney,
The lab is part of the organization. The idea is to have them ISO9001 compliant and be audited as such. The organization took the 8.3 exclusion and now we want to integrate it.

They DEVELOP new products.

Thanks
 

Sidney Vianna

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Staff member
Admin
#10
The lab is part of the organization. The idea is to have them ISO9001 compliant and be audited as such. The organization took the 8.3 exclusion and now we want to integrate it.
If they are part of the organization, they should have not been able to claim non applicability of 8.3 before, but setting that aside for the time being, my advice is that the lab shall not seek ISO 9001 implementation and certification as a separate entity. I have seen that attempts a few times, and in my experience it always ended up in failures. The lab main core process is PRODUCT development, which is part of ISO 9001 8.3.

The route I would seek is for the whole organization to do what they should have done from the get go and expand their scope of the QMS and certification to include 8.3, what will force the lab to develop the processes and subprocesses necessary to deliver conformance with the applicable requirements of the standard.

Good luck.
 
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