Scope Definition - Scope of ISO 9001 Registration

S

SmokeMonster

#1
Hi All,

I work for a Biotechnology company and I've been tasked with implementing ISO9001 to the Manufacturing department.

My wish is to exclude the R and D department from the scope. What are the criteria for deciding whether I can exclude them?

As far as how they interact with the Manufacturing dept: they perform research (sometimes driven by customer requirements via the Marketing dept) and then pass early designs to the Manufacturing dept to turn it into something that can be manufactured.

Thanks,
SM :)
 
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Stijloor

Staff member
Super Moderator
#2
Re: Scope Definition

Hi All,

I work for a Biotechnology company and I've been tasked with implementing ISO9001 to the Manufacturing department.

My wish is to exclude the R and D department from the scope. What are the criteria for deciding whether I can exclude them?

As far as how they interact with the Manufacturing dept: they perform research (sometimes driven by customer requirements via the Marketing dept) and then pass early designs to the Manufacturing dept to turn it into something that can be manufactured.

Thanks,
SM :)
Welcome to The Cove Forums! :bigwave: :bigwave:

You will have a difficult time justifying why R&D (7.3 Design and Development) should be excluded from your scope of registration/certification. In your last paragraph, you precisely stated why D&D can not be excluded.

Stijloor.
 

harry

Trusted Information Resource
#4
My wish is to exclude the R and D department from the scope.
I am not too sure what's your rationale for doing so. The requirements of the standard doesn't really add anything new for R&D. It encourages good practices - organized and structured approach towards an important activity.

In practice, most people would had done or covered most of whats required. All they need to do is to organize it properly. Depending on what you do, there may be a lot of trial and error in the initial stages of R&D, which you can choose to exclude documenting it (but keep your notes and records) because it is nowhere near the design and development stage.
 
#5
I have a feeling that your R & D Department is accustomed to running free and loose and bristle at the idea of marching to anyone's drum but their own.

If you can help the R & D leadership understand what each of the components of element 7.3 are, you may be able to enlist them to help figure out how to show that they meet those requirements. If they are an effective R & D group (and I'm sure they are) they probably already do most everything needed.

I have run into this MANY times.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
My wish is to exclude the R and D department from the scope. What are the criteria for deciding whether I can exclude them?
First of all, pure RESEARCH is typically outside the scope of ISO 9001. The product DEVELOPMENT is covered under 7.3. The processes associated with product development are critical for regulatory compliance and customer satisfaction, thus, and in principle, can not be excluded from the QMS seeking certification. That is the suggested line of thought by ISO TC 176.

If a process (either performed in house or outsourced) has a clear impact on the organization's ability to satisfy the customer and/or (product) regulatory compliance, they can not be excluded from the QMS.
 

somashekar

Staff member
Admin
#7
I am not too sure what's your rationale for doing so. The requirements of the standard doesn't really add anything new for R&D. It encourages good practices - organized and structured approach towards an important activity.

In practice, most people would had done or covered most of whats required. All they need to do is to organize it properly. Depending on what you do, there may be a lot of trial and error in the initial stages of R&D, which you can choose to exclude documenting it (but keep your notes and records) because it is nowhere near the design and development stage.
7.3 is Design & Development, and steps that are logically executed in this to deliver outputs to manufacturing is outlined here. As said in post # 6, do not title it as Research activity. In this process several of the manufacturing inputs are taken in reviews to optimize the design, since this is design and development for a manufacturing activity as detailed by you.
There is no scope in your situation to be called as "contract manufacturer", who executes the manufacturing based on the design outputs completely given and controlled by the customer. Hence instead of wishing 7.3 exclusion, you have strong reasons to include 7.3 and make a full blown QMS certified. Perhaps certain section of the design and development rests with your customer and this can be well mapped in your design plan. I guess you need the 7.3 to be within your QMS ...
 
#8
First of all, pure RESEARCH is typically outside the scope of ISO 9001. The product DEVELOPMENT is covered under 7.3. The processes associated with product development are critical for regulatory compliance and customer satisfaction, thus, and in principle, can not be excluded from the QMS seeking certification. That is the suggested line of thought by ISO TC 176.

If a process (either performed in house or outsourced) has a clear impact on the organization's ability to satisfy the customer and/or (product) regulatory compliance, they can not be excluded from the QMS.
Yes, but that very thin line between "Research" and "Design" is often very blured.
 
S

samsung

#9
from the Britannica Concise Encyclopedia
research and development (R&D)
In industry, two closely related processes by which new products and new forms of old products are created through technological innovation.

The work generally focuses on two types of research, basic and applied. Basic research is directed toward a generalized goal (e.g., genetic research in a pharmaceutical laboratory). Applied research directs the results of basic research toward the needs of a specific industry and results in the development of new or modified products or processes. In addition to carrying out basic and applied research and developing models, R&D staff may evaluate the efficiency and cost of the product.
& also from the Raynet Business & Marketing Glossary
discovering new knowledge about products, processes, and services, and then applying that knowledge to create new and improved products, processes, and services that fill market needs.
These definitions are perfectly in line with what everyone else has quoted in this thread.
 
D

DrM2u

#10
Hi All,

I work for a Biotechnology company and I've been tasked with implementing ISO9001 to the Manufacturing department.

My wish is to exclude the R and D department from the scope. What are the criteria for deciding whether I can exclude them?

As far as how they interact with the Manufacturing dept: they perform research (sometimes driven by customer requirements via the Marketing dept) and then pass early designs to the Manufacturing dept to turn it into something that can be manufactured.

Thanks,
SM :)
:mg: I cannot believe what I am reading from the others posters!:mg: (OK, I am a little harsh on you guys here! My bad!)

- To quote the ISO 9001:2008 standard, clause 1.2: "all requirements of this international standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided".
- To quote Webster's dictionary: an organization is "an administrative and functional structure; the personnel of such a structure".
- Nowhere in the standard is written that the requirements shall apply to the whole company

Put the three together and the conclusion is: IT IS UP TO THE ORGANIZATION TO DEFINE THE SCOPE OF THE REGISTRATION.

This means that a company can define its scope of registration to be limited only to the manufacturing part of the business or any other parts that it wants registered. This is done every day in many industries and by many corporations. Do you think that Ford or GM or Chrysler have only one registration certificate and only one scope?!? Think again! The common practice is to register major departments and plants as stand alone 'organizations' with their own certificates.

So, to get back to the OP's question, you can define the scope of registration as you wish. If you chose to exclude R&D then let it be so! Heck, you can exclude half of your manufacturing if you choose. Keep in mind that R&D could still be regarded as a 'supplier' and/or a 'customer' to the manufacturing organization, depending on how the two interract and fit in the corporate puzzle. I suggest that you consult with your registrar of choice to ensure that the scope is worded adequately and don't let them talk you into something you don't want to do. Ask "where is it written or sanctioned?" before accepting a 'requirement' or an interpretation that do not make sense to your organization!

How's that for :2cents:?!?
 
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