ISO 9001:2008 Clause 7.3 Design and Development Exclusions Question

W

wcrobin

#1
Hello,

I'm currently working on implementing an ISO 9001:2008 QMS in my company, as stipulated by our government contract. Currently, we have two sites, one is our headquarters, where the top managment is located, and the other is an office which is dedicated to the completion of the government contract.

Our headquarters office and "design" office are being ISO 9001:2008 certified seperately. Currently, our headquarters office only handles communication with the customer. Our headquarters collects requirements, comments, and feedback surveys from the customer, then relays that information to the Program Manager at the "design" office. The Program manager then uses these inputs towards tailoring and improving the final product.

My question is whether our Headquarters ISO certification is able to gain an exemption on 7.3 - Design and Development, because none of the design and development occurs in the headquarters office?

Furthermore, could anyone point me at any previous threads or websites which offer any insight into my situation (the seperate ISO certifications, one corporate headquarters and one for the design facilities)?

Thankyou,
Will
 
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Stijloor

Staff member
Super Moderator
#2
Re: Question concerning ISO 9001:2008 Clause 7.3 Design and Development Exclusions

Hello,

I'm currently working on implementing an ISO 9001:2008 QMS in my company, as stipulated by our government contract. Currently, we have two sites, one is our headquarters, where the top management is located, and the other is an office which is dedicated to the completion of the government contract.

Our headquarters office and "design" office are being ISO 9001:2008 certified separately. Currently, our headquarters office only handles communication with the customer. Our headquarters collects requirements, comments, and feedback surveys from the customer, then relays that information to the Program Manager at the "design" office. The Program manager then uses these inputs towards tailoring and improving the final product.

My question is whether our Headquarters ISO certification is able to gain an exemption on 7.3 - Design and Development, because none of the design and development occurs in the headquarters office?

Furthermore, could anyone point me at any previous threads or websites which offer any insight into my situation (the separate ISO certifications, one corporate headquarters and one for the design facilities)?

Thank you,
Will
Can any of our Certification Body/Registrar representatives help?

Thank you!

Stijloor.
 
#3
Re: Question concerning ISO 9001:2008 Clause 7.3 Design and Development Exclusions

Hello,

I'm currently working on implementing an ISO 9001:2008 QMS in my company, as stipulated by our government contract. Currently, we have two sites, one is our headquarters, where the top managment is located, and the other is an office which is dedicated to the completion of the government contract.

Our headquarters office and "design" office are being ISO 9001:2008 certified seperately. Currently, our headquarters office only handles communication with the customer. Our headquarters collects requirements, comments, and feedback surveys from the customer, then relays that information to the Program Manager at the "design" office. The Program manager then uses these inputs towards tailoring and improving the final product.

My question is whether our Headquarters ISO certification is able to gain an exemption on 7.3 - Design and Development, because none of the design and development occurs in the headquarters office?

Furthermore, could anyone point me at any previous threads or websites which offer any insight into my situation (the seperate ISO certifications, one corporate headquarters and one for the design facilities)?

Thankyou,
Will
Will: Yes, you can do this, but I have to ask why you'd want to. You'll be essentially duplicating much of the qms in two places and there's a cost benefit to having a shared qms. You might go for separate certification of there's a business case - for example, designs are 'sold' to customers, but if we knew more, we could give better advice.
 
#4
Re: Question concerning ISO 9001:2008 Clause 7.3 Design and Development Exclusions

Will: Yes, you can do this, but I have to ask why you'd want to. You'll be essentially duplicating much of the qms in two places and there's a cost benefit to having a shared qms. You might go for separate certification of there's a business case - for example, designs are 'sold' to customers, but if we knew more, we could give better advice.
I would ask the same question.

I would also mention that it depends on how the second site handles any design involvement. If they handle it as an outsourced process, it cannot be excluded. You cannot exclude what you outsource.

This is a question that you should really be addressing with the certification body you choose to use.
 
Q

qualitymanager

#5
Re: Question concerning ISO 9001:2008 Clause 7.3 Design and Development Exclusions

In my early days I remember being told that the legal entity is certified - any other sites and/or departments are covered by scope change.

Has this approach been changed by registrars? (Assuming my information was correct)
 

John Broomfield

Staff member
Super Moderator
#6
Re: Question concerning ISO 9001:2008 Clause 7.3 Design and Development Exclusions

Hello,

I'm currently working on implementing an ISO 9001:2008 QMS in my company, as stipulated by our government contract. Currently, we have two sites, one is our headquarters, where the top managment is located, and the other is an office which is dedicated to the completion of the government contract.

Our headquarters office and "design" office are being ISO 9001:2008 certified seperately. Currently, our headquarters office only handles communication with the customer. Our headquarters collects requirements, comments, and feedback surveys from the customer, then relays that information to the Program Manager at the "design" office. The Program manager then uses these inputs towards tailoring and improving the final product.

My question is whether our Headquarters ISO certification is able to gain an exemption on 7.3 - Design and Development, because none of the design and development occurs in the headquarters office?

Furthermore, could anyone point me at any previous threads or websites which offer any insight into my situation (the seperate ISO certifications, one corporate headquarters and one for the design facilities)?

Thankyou,
Will
Will,

For your one management system could specify several scope statements:

  1. Scope of the entire management system
  2. Scope that applies to your head office
  3. Scope that applies to your other facility
  4. Scope of certification
1 may be the same as 4 in which case you need only three scope statements. Or 4 may be narrower that 1 because you see no value in certifying that part of your management system.

Developing your management system just for certification for a government contract seems somewhat limiting.

Surely, your organization needs to develop, use and improve its management system beyond this contract to to add value and prevent loss while assuring quality?

John
 
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