Quality Management System for R&D (Research & Development) work

Dear Covers,

Of late, I came across a discussion on QMS for Research & Development (R&D). To the best of my knowledge, ISO 9001 does not define requirements for the R&D function of an Organization, is n't it? Somebody can shed light on this?
Thanks in advance.

Chennaiite said:

Dear Covers,

Of late, I came across a discussion on QMS for Research & Development (R&D). To the best of my knowledge, ISO 9001 does not define requirements for the R&D function of an Organization, is n't it? Somebody can shed light on this?
Thanks in advance.

Click to expand...

Here you can find a very good research paper on 'Planning an R&D Management System based on ISO 9001', published by a Chinese University.

You can also refer to this thread: Suppliers for R&D department - Approved? for information related to suppliers for R&D department.

Hope this helps.

Chennaiite said:

.................. To the best of my knowledge, ISO 9001 does not define requirements for the R&D function of an Organization, is n't it?.........................

Click to expand...

True, but you are supposed to understand your business, its processes and its needs and then fit the requirements of the standard around it with the hope of achieving maximum benefits.

Where it should come in and how would depend on what you do and how you want it. Reading this previous discussion should help : Research and Development Process - Where does research end and development begin

Chennaiite said:

Dear Covers,

Of late, I came across a discussion on QMS for Research & Development (R&D). To the best of my knowledge, ISO 9001 does not define requirements for the R&D function of an Organization, is n't it? Somebody can shed light on this?
Thanks in advance.

Click to expand...

Hi,

I have implemented ISO 9001 into an R&D company with great sucess as the President took ISO as a business management system and used it to improve the company which has went own to start its own manufacturing company and is having great sucess. So ISO does not deal directly with the research side but as stated below it does tie into Design & Development (Thanks Umang).

Best regards,

Al40

Chennaiite said:

Dear Covers,

Of late, I came across a discussion on QMS for Research & Development (R&D). To the best of my knowledge, ISO 9001 does not define requirements for the R&D function of an Organization, is n't it? Somebody can shed light on this?
Thanks in advance.

Click to expand...

Please allow me to disagree with you. ISO does define this requirement in 7.3

7.3 Design and development 7.3.1 Desisign and development planning

The organisation shall plan and control the design and development of the product.

During the design and development planning the organisation shall determine

a) the design and development stages

b) the review, verification and validation that are appropiate to each design and development stage, and

c) the responsibilities and authorities for design and development..........

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What else do you think is missing, except the use of nomenclature 'R&D'.

Umang

Umang Vidyarthi said:

Please allow me to disagree with you. ISO does define this requirement in 7.3



What else do you think is missing, except the use of nomenclature 'R&D'.

Umang

Click to expand...

I stand corrected I was leaning more towards the Research side.

Thanks,

Al40

ISO 9001 applies to any organization. The Plan, Do, Check, Act cycle and the Process Approach can be applied to any area of any organization.

To say that ISO 9001 does not apply to subject "X" brings into question one's understanding of these core concepts. See section 4.1 of ISO 9001 for examples of general requirements that can apply to any organization or any piece of a quality system. There are other general requirements that apply (4.2.4, 4.2.3, 5.4.1, 5.4.2, 6.2, 6.3, 8.2.3, 8.5.2, 8.5.3, etc.)

And has been already stated, "R&D" and ISO 9001's "Design and development" are similar and may even be equivalent for organizations.

Dear all,

I am a new user to this forum. My company is a R&D organization and the product is the new technology.

1) How to comply the ISO 9001 requirements clause 7.3? Our company deliver the technical know-how to customer through applied research and we do not involve any tailor-made design on customer product.

2) I think I can not exclude clause 7.5.1 requirements just saying that I fulfill clause 7.3 requirements, am I right?

3) How to fulfill the 7.5.2 requirements for R&D organization?

Thank you for your help and advice in advance!