R&D and Design Process. Where the borders are?

[trainerbob]

I think there is enough leeway in ISO to allow the organization to determine where 7.3 starts. I usually think of terms of interaction with a customer.

As far as calibration of your hi-tech devices I would refer you to 7.6a that says "where no such standards exist, the basis used for calibration or verification shall be recorded (see 4.2.4)"

 

[Daniele Italy]

WOW,I'm happy to have rised such discussion,I agree again with Sidney . Of course we have a process before the Design process ,described on suitable procedure, which is called R&D :its output is the input for the design and indrustrialization process.
Let me "comment" step by step the standard 7.3:
7.3.1 ...duringthe design anddevelpment the orhanization shall detrmine:
- the design and dev phase when an idea is developed one can know the start of the process but not when it will be completed and many times the results are not the expected one but even better for another different application ( remeber that the penicillin was descovered by chance, and many times some of our products , developed from one idea,were sucessfulyy used in other complete different application) . Some time it also take 2 years or more for the starting of the prototype assembly.
7.3.2 design inputs:
- functional andperforfance requirement: Have you never dealed with the R&D labs of the big group like Philips,Osram, Hitachi Toshiba ect? during their starting study they don't know what they really want, the product is jointly researched and tailor made on the project. Than no requirements till the beta prototype ( the one close to the final configuration) is produced after many alpha trials.
....requirement shall be complete, unambiguous and not in conflict... At the starting of the idea development, there are so many changes in the configuration ( even 3-4 pre-pototype per week ) that it is impossible to have complete and unambigous requirements.

Thanks and up with the democracy of course.. but a standard should be a little bit more clear in defining some important aspects like the ones we are discussing about, otherwise during the audit there will be lways some confusions or misunderstanding.

 

[Helmut Jilling]

...during their starting study they don't know what they really want, the product is jointly researched and tailor made on the project. Than no requirements till the beta prototype ( the one close to the final configuration) is produced after many alpha trials.
....requirement shall be complete, unambiguous and not in conflict... At the starting of the idea development, there are so many changes in the configuration ( even 3-4 pre-pototype per week ) that it is impossible to have complete and unambigous requirements.

... but a standard should be a little bit more clear in defining some important aspects like the ones we are discussing about, otherwise during the audit there will be lways some confusions or misunderstanding.

That is why I suggested that each organization will need to define it to the degree they feel is appropriate. That is partly Sidney's point, and I would agree to a certian degree. But, I take issue with the blanket statement that R&D is clearly not included in ISO 9001. It will be different with different organizations.

In some, R&D is simply a tweaking of existing designs and ideas. In others, as you cite, it is a very undefined activity. The standard cannot try to be more clear in defining something so different from situation to situation, so it leaves it up to each organization to define.

I recently took over a client who is certified to ISO 9001. Their only product (service) is "blue sky R&D." Am I to suggest they are outside the scope of ISO 9001? Of course not! But, what i did is suggest they tried too hard to document every detail of how they will conceptualize R&D in their procedures. They were very happy to hear they could lose most of the rigid detail they put in place (because the previous auditor told them they had to). But, they obviously will still do things like record control, and calibration and such.

So, some procedures are useful and appropriate, but each organization needs to decide what needs to be documented. Refer to cl 4.2.1.d for further guidance, plus ISO 9004 and 9000 may also help here.

 

[Sidney Vianna]

Their only product (service) is "blue sky R&D." Am I to suggest they are outside the scope of ISO 9001? Of course not!

That is exactly why I said:

Unless an organization's product is pure research, the typical research function falls outside of the scope of ISO 9001.

When research IS your product, then your product realization process is the performance of (guess what) RESEARCH.

There you have folks:

In this thread, we have had opinions such as:

• The typical research does not fall within ISO 9001 application, even though sound quality management principles should be applied to research.
• Research is part of ISO 9001, but the organization has a lot of latitude to decide how much of ISO 9001 they need to apply to research.
• It is up to the organization to decide if ISO 9001 applies or not to their research.

 

[Helmut Jilling]

That is exactly why I said:When research IS your product, then your product realization process is the performance of (guess what) RESEARCH.

There you have folks:

In this thread, we have had opinions such as:

• The typical research does not fall within ISO 9001 application, even though sound quality management principles should be applied to research.
• Research is part of ISO 9001, but the organization has a lot of latitude to decide how much of ISO 9001 they need to apply to research.
• It is up to the organization to decide if ISO 9001 applies or not to their research.

And, it has to be considered on a case by case basis for each organization, whether their R&Dactivities should be considered "part of the quality management system. I don't see anywhere in ISO where it is more defined more clearly. In some organizations, it certainly is part of their QMS, and they should not try to avoid it. In other cases, it isfar removed, and there is little reason to fully incorporate it.

Paul and I had the same go-around on whether IT support should be considered a Supporting Process, in the same way Maintenance is. The standard simply does not answer all questions clearly, so reasonable people need to make reasonable, beneficial decisions.

 

[Big Jim]

And, it has to be considered on a case by case basis for each organization, whether their R&Dactivities should be considered "part of the quality management system. I don't see anywhere in ISO where it is more defined more clearly. In some organizations, it certainly is part of their QMS, and they should not try to avoid it. In other cases, it isfar removed, and there is little reason to fully incorporate it.

Paul and I had the same go-around on whether IT support should be considered a Supporting Process, in the same way Maintenance is. The standard simply does not answer all questions clearly, so reasonable people need to make reasonable, beneficial decisions.

May I add a comment about R & D activities?

Although it may not be quite in the realm of design in some situations, it is certainly always on the cusp of design planning (7.3.1) and should be carefully considered as to its fit and involvement.