Design & Development Clause 7.3, Applicable or not, What is rule?

Cove Friend,

can any one tell me what is the rule to decide that Design & Development is Applicable to certain Organization or Not.

ISO 9001 clause 1.2 said:

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

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If the organization does design and development of product, it must include it in the scope of the system.

For more information on exclusions see
Guidance on ISO 9001 Sub-clause 1.2 'Application'
For other guidance documents see here
https://isotc.iso.org/livelink/live...c=ll&objId=1069636&objAction=browse&sort=name

howste said:

If the organization does design and development of product, it must include it in the scope of the system.

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Don't forget that there is also partial exclusion to design. To claim all of 7.3 as an exemption a company cannot perform design or participate in design. If they participate in their customer's design but do not otherwise perform design, they need to claim partial design.

Big Jim said:

Don't forget that there is also partial exclusion to design. To claim all of 7.3 as an exemption a company cannot perform design or participate in design. If they participate in their customer's design but do not otherwise perform design, they need to claim partial design.

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What do you mean by participate in their customer's design?

If the customer has design authority and the organization only provides input, then the org. can still exclude design. For design to apply, the organization would need to have some authority to implement or change change product designs. Giving advice to customers is not the same as having design authority.

Big Jim said:

Don't forget that there is also partial exclusion to design. To claim all of 7.3 as an exemption a company cannot perform design or participate in design. If they participate in their customer's design but do not otherwise perform design, they need to claim partial design.

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Not true, Jim. You can't get registered to ISO 9001 including design - unless you have design change authority!

Having input to a customer's design process is nice (a 'mutually beneficial supplier relationship) but it won't allow you to claim design in your scope! Sorry!

If you have experience where a CB had approved a scope like that, then a complaint to ANAB is in order........

Claiming exclusions is not limited to the entirety of an element.

Design responsibility is not the defining factor as to if you have design involvement. Design involvement is the defining factor.

Making suggestions to customers that may change design is design involvement. You are participating in their design inputs.

If you are involved with any part of design, you need to own up to it and define it in your scope of registration.

From 1.2 "Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion."

If you are partially involved in design, how can you claim the entirety of it as an exclusion?

Big Jim said:

Claiming exclusions is not limited to the entirety of an element.

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That is correct.

Big Jim said:

Design responsibility is not the defining factor as to if you have design involvement. Design involvement is the defining factor.

Making suggestions to customers that may change design is design involvement. You are participating in their design inputs.

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That is totally incorrect.

Big Jim said:

Claiming exclusions is not limited to the entirety of an element.

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True, you can claim exclusion from part of a clause.

Big Jim said:

Design responsibility is not the defining factor as to if you have design involvement. Design involvement is the defining factor.

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No, design authority is.

Guidance on ISO 9001:2008 Subclause 1.2 'Application' Example 2 said:

XYZ Electronics was justified with its decision to exclude sub-clause 7.3 Design and development from its QMS since it does not have any authority or accountability for design...

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howste said:

True, you can claim exclusion from part of a clause.

No, design authority is.

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That case does not address partial design.