ISO 9001 vs. CE Mark European directives

Please help me to clarify the following issue: if a company has the CE mark for thei products and don't has the ISO certificates for the company, the product is OK. I know that the CE mark includes the ISO approvals (is it true or false?).

CE Mark is based on a set of European directives taht deal with product categories. It's much like UL labelling for your product.

I was involved a few years ago with the EMC, electromagnetic compatability directive for the company I was working with. I also got the pleasure of reading the Low Voltage Directive. We would not be allowed to sell in the EU after the directives were enacted without meeting the specs. However, we were able to self-declare.

ISO is also apparently required to sell in the EU now, but registration cannot be self-declared, and it does not call out product specifications as the CE Mark directives do.

Hope this clears some of the confusion up.

AJP

Aida-
I hope I'm addressing your question correctly. I'm not an expert, but I've rubbed shoulders with this issue. At least with medical devices, it depends on the risk-based classification of the equipment.

Per the Medical Device Directive, Class 1 non-sterile/non-measuring devices can be 'self-declared' (see Annex VII)and the CE mark applied without witnessed testing or quality system registration. You do need to have documented testing, technical files, etc. available upon request.

For Class 2a or higher, you need both a Declaration of Conformity and either registration to a recognized quality system (read ISO 900x) or witnessed (and expensive) testing.

This is a narrowly focused response to a very big question and all I can offer based on experience.

This is an area where a good consultant would be worth their weight in platinum!

Best of luck with this one.

Alf

I have to agree with Alf's answer, 'It depends'.

My experience is with the CE Recreational Craft (boats) directive. There are 6 different classes of certificate issued depending on the level of inspection and registration to a Quality system, ranging from no inspection/no registration through to 3rd party independant inspection/ISO9001 registration.