Clarification on ISO 9001 - Exclusion of Design and Development, Clause 7.3

[YKT]

I came from TS background, and understand that 7.3 cannot be really excluded even the company is not responsible of designing the product, as it also applies for design and development of process.

As for ISO9001, my knowledge was from previously ISO9001:1994 era,..and what i learned from my previous consultant was that a company can exclude the clause, as long as you are not designing the product.

Upon some google research recently, it added to my confusion that some practitioners said that even a company is not responsible for product design, they cannot exclude the clause / requirement 7.3, as they need to design their process to run the product also.

I am not sure if they are correct, or they are coming from TS experience, thus saying that.

Would appreciate if any members has any input to this, as it may be confusing as they might have some auditors with TS background an may insist on having 7.3 included, whereelse the company is not responsible for designing of product ???

Thanks

 

[harry]

Re: Clarification on ISO9001 clause 7.3

Clearly addressed by ISO in this document: Guidance on ISO 9001:2008 - Sub-clause 1.2 Application'

 

[somashekar]

Re: Clarification on ISO9001 clause 7.3

I came from TS background, and understand that 7.3 cannot be really excluded even the company is not responsible of designing the product, as it also applies for design and development of process.

As for ISO9001, my knowledge was from previously ISO9001:1994 era,..and what i learned from my previous consultant was that a company can exclude the clause, as long as you are not designing the product.

Upon some google research recently, it added to my confusion that some practitioners said that even a company is not responsible for product design, they cannot exclude the clause / requirement 7.3, as they need to design their process to run the product also.

I am not sure if they are correct, or they are coming from TS experience, thus saying that.

Would appreciate if any members has any input to this, as it may be confusing as they might have some auditors with TS background an may insist on having 7.3 included, whereelse the company is not responsible for designing of product ???

Thanks

Design and development of the process (more say control of production and service provision) is activity that is performed by you to be mapped under 7.5.1 and 7.5.2.
Any input that is specifically required for 7.5.1 / 7.5.2. can also come from 7.3.
If you cannot identify the below 3 activities related to the product managed within your QMS., then you are not into D&D.
a) the design and development stages,
b) the review, verification and validation that are appropriate to each design and development stage, and
c) the responsibilities and authorities for design and development.

Please note that there is no need to re-invent the wheel, however there is every need to design and develop the wheel again and over again based on requirement. This requirement can be your direct requirement (D&D applies), Customer requirement but you do it and customer approves (D&D applies), Customer requirement and he flows down the design & development outputs to you for production and service provisions (D&D exempted)

 

[toto2010]

I came from TS background, and understand that 7.3 cannot be really excluded even the company is not responsible of designing the product, as it also applies for design and development of process.

As for ISO9001, my knowledge was from previously ISO9001:1994 era,..and what i learned from my previous consultant was that a company can exclude the clause, as long as you are not designing the product.

Upon some google research recently, it added to my confusion that some practitioners said that even a company is not responsible for product design, they cannot exclude the clause / requirement 7.3, as they need to design their process to run the product also.

I am not sure if they are correct, or they are coming from TS experience, thus saying that.

Would appreciate if any members has any input to this, as it may be confusing as they might have some auditors with TS background an may insist on having 7.3 included, whereelse the company is not responsible for designing of product ???

Thanks

Hi,
You must know the meaning of "designing" and "product".
Product can be a real product or service.
Design means design a product or service.
For example let say your company provides customer service and it requires a customer relation management (CRM) system. So under 7.3.1, design planning, who design the system? who review the system?
7.3.2 is your customer requirements. you must keep the records of the customer requirements. 7.3.3.. etc.

 

[Big Jim]

I came from TS background, and understand that 7.3 cannot be really excluded even the company is not responsible of designing the product, as it also applies for design and development of process.

As for ISO9001, my knowledge was from previously ISO9001:1994 era,..and what i learned from my previous consultant was that a company can exclude the clause, as long as you are not designing the product.

Upon some google research recently, it added to my confusion that some practitioners said that even a company is not responsible for product design, they cannot exclude the clause / requirement 7.3, as they need to design their process to run the product also.

I am not sure if they are correct, or they are coming from TS experience, thus saying that.

Would appreciate if any members has any input to this, as it may be confusing as they might have some auditors with TS background an may insist on having 7.3 included, whereelse the company is not responsible for designing of product ???

Thanks

If it is not already clear, ISO 9001 DOES NOT classify design of process as part of 7.3. It falls under 7.1, planning for production.

If you have no involvement with design, you can claim all of 7.3 as an exclusion. No involvement includes that you don't outsource it.