Design authority for a plastic product for the HGV industry - Possible Exclusions

[epa611]

Some thoughts please from all you experts out there

We are a small comapny (6 people) who wish to implement ISO9001:2008. We are the design authority for a plastic product for the HGV industry and we have a Chinese company make these parts.

By qualifiying my supplier fully and monitoring their progress what would be the perceived opinion on being able to exclude ourselves from the whole of section 7.5?

I would think that I could do this as our site is only an office and we have design authority and thats it!

Yours hopefully,

Paul

 

[Colin]

Re: Possible Exclusions

Hi Paul

Excluding the whole of section 7.5 would be unusual but theoretically possible.

I guess that your 'production and service provision' is design - which you cover under 7.3 - so that probably takes care of 7.5.1 & 7.5.2. As long as you address things like identification and any customer property (including intellectual property) it may be OK.

Who stores and distributes the parts - you or someone else? could 7.5.5 be excluded?

Sorry to be a bit vague but it is not easy to be certain at 'long range' and without knowing the situation well.

 

[Jeff Frost]

Re: Possible Exclusions

The answer would be no because some of these clauses contain where applicable or where appropriate statements that should be addressed by your company. Most companies forget that Clause 7.5 also apply to service organization.

Remove the word “production” and reread the section only using the word “service” and think about what your customers needs are as a service provider. Note by taking the viewpoint of the customer and looking at the following requirements you can see now they apply to your organization.

7.5.1 Control of service provision

The organization shall plan and carry out service they provide under controlled conditions. Controlled conditions shall include, as applicable…

7.5.2 Validation of processes for service provision

The organization shall validate any service process … where the resulting output cannot be verified by subsequent monitoring or measurement…

7.5.3 Identification and traceability

Where appropriate, the organization shall identify the product (produced by your Chinese company) status … Where the customer requires traceability … the organization shall control the product through a unique identification of the product and maintain records

7.5.4 Customer property

The organization shall exercise care with customer property… I.e. Drawings, specifications, credit card numbers etc.


7.5.5 Preservation of product

The organization shall preserve the product during delivery … to the customer.

My recommendation would be to go to either the ISO or ISO/TC 176/SC 2 web sites and review their guidance documents. N524, Guidance on ISO 9001:2008, Clause 1.2 “Application” addresses the concept of exclusion and their justifications for exclusions.

 

[Sam4Quality]

Originally posted by epa611

Some thoughts please from all you experts out there

We are a small comapny (6 people) who wish to implement ISO9001:2008. We are the design authority for a plastic product for the HGV industry and we have a Chinese company make these parts.

By qualifiying my supplier fully and monitoring their progress what would be the perceived opinion on being able to exclude ourselves from the whole of section 7.5?

I would think that I could do this as our site is only an office and we have design authority and thats it!

Yours hopefully,

Paul

IMO, you cannot exclude clause 7.5 at all. Despite being a design firm, you need to conform to all sub-clauses within 7.5, because you are providing a service which is also a product that you deliver to your customer.

Like Jeff mentioned, remove 'production' from the clauses and you have something which you need to work on in terms of conforming to the standards.

Just to make it clearer, Clause # 3 - Terms and Definitions says 'Throughout the text of this International Standard, wherever the term "product" occurs, it can also mean "service”. Your final resulting service, which is the final design drawing, in electronic or in hard copy, is a product to your customer. Hence, you cannot exclude yourself from clause 7.5.

When you are implementing ISO 9001, you are applying standards clause 7.5 to your firm, its products and services, which in this case is the final design, NOT the suppliers product and services! I guess that's what you are looking for.

Hope this helps.

Ciao.