Quality Manual Statements - ISO 9001:2008 Design and Development Exclusions

[AdamEve]

Hi there again,

I have two queries which I will greatly appreciate your kind replies and inputs.


1) Scope of Work is defined in the Quality Manual as stated herein;

"Construction of Mechanical & Infrasturcture Projects, Roads and Buildings as per customer requirements, concrete plant and asphalt plant."

• Does this imply that the clause 7.3 of ISO 9001:2008 is applicable? or to be excluded?

2) Part of the Quality Manual states that;
"If the scope of work of a project includes design, the company will outsource such design works to external design consultancy firms. Control is ensured thru design review and verification procedures No. QMP-DE-010."

Also, part of the Quality Manual for Design and Development states that;
"The ESP (organization) shall carry out the design and development activities in the operations where requried by the customer, although there are required in some projects and excluded in the most. The client often..."

My question is this:

• Does these two statements found in the QUality Manual simply and directly says that the clause 7.3 of ISO 9001:2008 is NOT TO BE EXCLUDED?
• If YES, then it is only rightful for the AUDITOR to audit the DESIGN process?

THANK YOU SO MUCH AND WAITING FOR YOUR VALUABLE REPLY.

GOD BLESS YOU ALL.

 

[Big Jim]

Re: ISO 9001:2008 Design and Development Exclusions

You cannot exclude what you outsource so this would be a design company.

You may wish to look more closely at your second part. I have seen companies that said they would outsource design when needed, but in actual practice had never found the need to do so. I remember in in particular that changed their stance to recommending engineering firms to their customer instead of outsourcing.

Also remember that engineering is not necessarily design. Engineering activity that is performed to determine how to do the job falls under element 7.1, planning for production, not 7.3, design and development.

 

[AdamEve]

Re: ISO 9001:2008 Design and Development Exclusions

Dear Sir,


Good day.

Thank you for your valuable input.

God bless

 

[AdamEve]

Re: ISO 9001:2008 Design and Development Exclusions

Dear Sir,

Good day.

Allow me to ask another question:

Let's assume that the exclusion of clause 7.3 is justified, HOW IS IT GOING TO BE STATED IN THE QUALITY MANUAL (including clause 7.3.1 to 7.3.7).?

Thanks again

 

[Jim Wynne]

Re: ISO 9001:2008 Design and Development Exclusions

Dear Sir,

Good day.

Allow me to ask another question:

Let's assume that the exclusion of clause 7.3 is justified, HOW IS IT GOING TO BE STATED IN THE QUALITY MANUAL (including clause 7.3.1 to 7.3.7).?

Thanks again

4.2.2 of ISO 9001:2008 says, in part:
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions...

The manual has to include a description of the scope of the QMS, so the exclusion(s) are normally cited in the same place.

The manual doesn't have to be written according to the clauses of the standard (and in most cases shouldn't be, imo) but if it is, you include the exclusions in your scope declaration, and then just omit the relevant clauses in the manual, or just say "Excluded" as appropriate.

 

[Big Jim]

When writing a manual, I usually have a page dedicated to the scope, where I show the scope statement with the justification for exclusion immediately below it. I usually also have the geographic scope on the same page where I show the address or addresses.

For the exclusion statement, I might say something like:

7.3 Design and development. We are not involved with design. We build to customer specification only.

 

[AdamEve]

Dear Sirs,

Your valuable input is taken as a guide.