ATEX - Responsibility for a Declaration of Conformity

[JoCam]

Hi All,

I work for a sub-contract manufacturer in the electronics industry.

We manufacture product to customer requirements, and are exempt from the design clause of the numerous standards we are certified to, including AS9100, TS16949 and ISO 13485.

One of our customers require us to assemble product that is to be used in explosive atmospheres, and are certified to the Atex Directive. As a result of this we were required to comply with the applicable sections of 80079-34, mainly purchasing, production, internal auditing and control of non-conforming product. The customers accreditation body for Atex then audited us to ensure our compliance with the applicable sections of 80079-34.

We were accepted as compliant, and now make the aforementioned product.

We have been approached by another customer to assemble their product that is to be used in an explosive atmosphere, and one of the things they would like us to do is provide a Declaration of Conformity with the product. This is where I need your help.

We are the sub-contract manufacturer, and do not hold any Atex certification or work to the Atex Directive. I am therefore of the belief that the organisation that designs and distributes the product should supply the D of C, as they are the owner of the Technical File.

Is this correct?

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[John Broomfield]

JoCam,

Your customer wants no break in the chain of conformity.

The designer may verify and validate design specifications for the parts and assemblies but only you can certify conformity of assembly to the spec. Your suppliers of the parts may in turn need to certify conformity of their parts.

You can only issue the DoC to the extent of your scope of work and the designer cannot declare conformity beyond the scope of its work.

John

 

[JoCam]

Thank you John,

While I am quite happy to supply certificates of conformity stating that we have manufactured the product to the applicable sections of standard 80079-34, I was of the belief that a declaration of conformity is more related to the product itself, and encompasses the full requirements of the ATEX Directive, which we as the sub-contract manufacturer do not work to.

 

[John Broomfield]

Thank you John,

While I am quite happy to supply certificates of conformity stating that we have manufactured the product to the applicable sections of standard 80079-34, I was of the belief that a declaration of conformity is more related to the product itself, and encompasses the full requirements of the ATEX Directive, which we as the sub-contract manufacturer do not work to.

JoCam,

Yes, the final DoC for the product as a whole will, to some extent, be based on evidence of conformity from each player in the supply chain.

I'll be quiet now and wait to learn from a Cover who is an ATEX expert.

John

 

[somashekar]

No please Jocam.
You can issue your C of C or any other document as required by the customer.
Not the D of C.
For more details read the attached Atex guidelines

 

[mmagargee]

Hello JoCam,
Sorry I am late to respond.

The organization that holds the EX certificate cannot subcontract the responsibility for ensuring product conformance to the certificate.

We are an ATEX/IECEx product manufacturer and we get our explosionproof enclosures from a subcontractor. We do rely on his dimensional verifications (so long as he provides a declaration of conformity to ISO/IEC 17050-1 with each batch). This is according to ISO/IEC80079-34, clause 7.4.3 c) which states that no further verification of the product or service is required provided that 1. the 17050-1 C of C is provided, 2. the supplier has been evaluated as having the capability to meet all specified requirements (see clause 7.4.1), 3. after considering the competence of the supplier, the nature of the purchased product, and how critical it is to the type of protection.

But clause 7.4.1 a) states that "while manufacture, testing and final inspection may be sub-contracted, the responsibility for ensuring conformance with the Ex certificate shall not be subcontracted."

In other words, you can issue a C of C that you have done all of the required final inspections, all of the routine testing, and have correctly manufactured the product. But this C of C is according to 17050-1. It is the manufacturer's responsibility to ensure conformance with the Ex certificate (the "Declaration of Conformity").

 

[JoCam]

mmagargee,

Thank you very much for this response. This has confirmed what I already believed.

Thanks again.