External Processes - Subcontracting - Control Requirements

E Wall

Just Me!
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Virgil I would say given the information provided that if I were in your shoes I would persue - module D for the exclusion of 7.3.

I'm not sure if the module E you listed meant including or excluding those clauses listed. I believe you meant for them to be exlcuded - and from a very quick review of each I feel this option is in place for 'Service Only' type businesses rather than manufacturing.

Does anyone else feel like chiming in here? Also, is anyone aware of the US having any 'modules' identified?

Best of Wishes on your endeavor Virgil
Eileen
 
B

B Hartley

Virgil,

Hello once again. You have now made clearer what information and advice you are seeking and I appreciate that being of Romanian language, having a copy of the ISO Standards in French and communicating in English is not that easy.

To me it appears that your are confusing two totally different aspects:-

1) Your Management System Application and Certification to ISO 9001 : 2000

2) Your PRODUCT’S ‘European CE Marking of Conformity Application and Certification’

The section you refer to in ISO 9001 : 2000 re the ‘Modules’ D, E & H (is of course also in the English version of the Standard) DOES NOT APPLY to Certification of your QMS to ISO 9001 : 2000.

It DOES, however, apply to the application for ‘CE’ Certification of Products produced under your QMS (be it either self-certification of ‘CE’ Conformity or via independent Testing and Certification that product is manufactured/has required characteristics to relevant requirements for type of Product to bear ‘CE’ Mark.

If you refer again to your copy of the ISO 9001 : 2000 you will see that the section referring to the modules ‘D, E & H’ is related to guidance re CENELEC for those seeking ‘New Approach European Directives in order to affix CE Mark to Products’.

The criteria re the ISO 9001 : 2000 Standard for permissible Exclusion of Clauses relating to either claims of Compliance to ISO 9001 :2000 or indeed for application for Certification of a QMS to ISO 9001 :2000 is given in Clause 1.2 of the Standard.

I hope this clarifies and is why your initial query reference “(which is important when I decide what module of ISO I apply for)” caused confusion.

Now to cover your most recent clarification of your query:-

If as you say, you Manufacture only to your Client’s design and have NO responsibility or control over the Product Design and Development Process for ANY of the products you manufacture under your QMS you would be correct to exclude Clause 7.3.

In respect of Exclusion of other sub-Clauses in Clause 7 in terms of ISO 9001 : 2000 Certification you will most probably find that your company will do at least something related to all the other Clauses but you have to ask yourself the questions:-

For example 7.4 Purchasing:-

Lets say just for example that your client buys and provides all the parts, raw materials and machines needed for you to make the products ---- You may think that you could exclude 7.4 but most companies would find that they could not as they purchase other tangible and non tangible items or services that if missing or not to requirements will affect product quality. (Staff, Buildings, maintenance to, transport and storage are such purchases).
I would guess 7.3 is the only full exclusion you will find by self questioning that you can make. If you only cover a tiny aspect of one sub–clause you have an opportunity within both your Quality Manual and in the Scope of ISO 9001 : 2000 Registration to qualify e.g. Purchasing excludes purchasing of all ‘xyz’.


Re :- “We are a maufacturing firm, a small one, and in order to sell our products we need the ISO 9000-2000 certification.”

If you mean you only ‘sell’ your product to the Client who asks you to manufacture it to his design and are not selling direct to a third party, then in theory you are not ‘selling’ product but are selling your manufacturing service to your Client as your Customer.
Returning to the ‘CE’ Conformity of Product and the relevance of Modules D, E & H, you have not stated whether your Client requires you to arrange or Declare Products are ‘CE’ Compliant.

CE Marking is not one of my specialist areas but I would surmise that in order to meet the QMS requirements (not considering here all the other non-QMS requirements) for ‘CE’ Marking your Client needs to make the application --- perhaps even based on both his and your QMS Registrations re the ‘CE’ QMS requirements. Certainly I would advise if you have not already done so to discuss all the implications with your Client(s).


Hope this (rather long) explanation helps

Best Regards Brian
 
V

Virgil 1

Hello,

Now, everything is very clear for me, grace to your very sharp and documented responses.
Indeed, I didn't noticed the matter with the "CE" mark, when the modules D,E,H is applied.
I apologize for that.
I want to thank once again to Marc, Eileen, Brian, Lou, Anton (not necessarily in this order) for their time spent and for the proffesionalism.

Have a good day all!

Virgil
 
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