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Is ISO9001 Certificate aaceptable under PED regulations?

Is ISO9001 Certificate aaceptable under PED regulations?

Is ISO9001 Certificate aaceptable under PED regulations?

Hi Guys,
Need some help here with regards to an ISO9001 Certificate which was issued by a Hong Kong office of a Notified Body registered in Europe.

This company is Chinese based and has an import and export business. They are not a manufacturer but a seller of castings to the european market which will become part of equipment which has to comply with the PED Regulations.

The Notified Body for the company in Europe which wants to purchase these castings will not accept the Chinese ISO certificate because the address of the NoBo is stated as Hong Kong and not a European Address (even though headquarters is based in Europe).

Can this certificate be accepted for the supply of castings to form pressure equipment within the European Commumity if it doesn't have a European address for the issuing authority?

Bear in mind that this company is not a manufacturer or material manufacturer so I believe Annex 1 4.3 should not apply

RE: Is ISO9001 Certificate aaceptable under PED regulations?

You have encountered a growing situation that has developed after the PED was issued.  Someone asked what a competent body was for the certification of material.  The reply from the working group is refered to as "guideline 7/2".  This guideline specifically states in Note 3, "The certificate of quality control shall make reference to the legal entity established in the community and its address."  Although it is a guideline and I don't agree with it, Notified Bodies are now invoking it.  Your choices are:

1. Have the fondry get a new certificate which has the European address of the inspecting body on it.

2. Argue with and ultimately fire the current Notified Body and switch to another which views the Guidelines as what they are.  Guidelines, not requirements.

Wether or not a European address is listed on an ISO-9000 certificate has no relevance to the auditors ability to determine material quality.  In fact, forcing everyone to use European agencies for ISO-9000 audits is illegal business practice.  However, it is like fighting City Hall or the DEpartment of Motor Vehicles.  You may ultimately win, but it is going to be a lot of work and a royal pain.

RE: Is ISO9001 Certificate aaceptable under PED regulations?

Thanks for your response BCD.

The point that is being missed here is that this company is not a manufacturer but has an import / export business and does not actually manufacture the castings, these are manufacturered by two other chinese companies "which is another days work".

Is the notified body for the assembly company in Europe classing the chinese import / export company as the "Manufacturer" as he is the guy supplying the castings to the European Market.  

RE: Is ISO9001 Certificate aaceptable under PED regulations?

The whole issue is based on when you can accept the Manufacturers certified material certificates as proof the material is acceptable.

The group certifying the product meets the PED has two options.  Evaluate and certify the material themselves stating compliance to the relevant material standard.  Or if the material supplier has an ISO-9000 certificate that lists the European address on the auditing agency, the group certifying the product can present the certified material test report from the supplier.

It does not matter who does the testing, the original foundry or the exporter.  Whomever does the material testing and isses the material test report must have an ISO-9000 certificate listing the European address of the inspection agency.  Only then can you accept the material test report as proof of compliance to the relevant material standard.

RE: Is ISO9001 Certificate aaceptable under PED regulations?

I do not agree with your statement.
According PED annex I Chapt. 4.3 the material certificate must be issued by the material manufacturer and no one else.  Only the material manufacturer can affirm compliance with the specifiction.  Without knowing the manufacturing process, the inherent scatter of mechanical properties, how should an intermediary or the vessel manufacturer decide if the material is conform to a material standard?  A simple testing on a corner of the product is not sufficient to decide whether the whole product or a complete lot is in conformance with the specification.
See also guideline 7/5 http://ec.europa.eu/enterprise/sectors/pressure-and-gas/files/interpretation_materials_all_en.pdf,
EN 764-5 or EN-10204.  
There are only 4 possibilities.  All 4 possibilies require a certificate according to EN 10204.  Documents according EN 10204 can only be issued by the manufacturer, never by a trader, test lab,..see text of EN 10204.
For a 2.1, 2.2 or 3.2 certificate, no quality assurance system is required by PED.
To issue a 3.1 certificate, the manufacturer must not only have a quality assurance system certified by a competent body established in the Community, he must also undergo a specific assessment for the materials he wants to deliver with 3.1 certificate.
You may consider the European address of the competent body as illegal business practice (same as we Europeans considered trade act 201 and other US-measurements as illegal), but these bodies must be registered and they have a legal responsibility.  

As explained above, documents (not certificates) issued by a trader cannot be refused because a European address is missing, but because it is simply illegal.  

RE: Is ISO9001 Certificate aaceptable under PED regulations?

The Trader is not issuing any certification for the actual material (EN10204 3.1's etc.), this will be issued to them by the foundries manufacturing the actual castings.

The Trader is ISO 9001/2000 certified by the Hong Kong office of a Certification Body which is well established within the community.

I have attached a copy of the certificate in question (client information removed).

My question is "As a Chinese Trader (See scope on certificate) can this ISO Certificate be accepted in the European community for the supply of castings for inclusion on pressure equipment which is compliant to PED 97/23/EC?"

Based on the answer to the above question, assume that the manufacturers of the castings in China have ISO9001 certification by a European Certification body established in the Community and will provide material certs to EN10204 3.1's  

RE: Is ISO9001 Certificate aaceptable under PED regulations?

The ISO 9001 certificate of the trader is without any importance for PED-regulations as there is no requirement.  
If the foundry has
- a valid ISO 9001 certificate from a body estabished in the Community
- has undergone a specific assessment for the materials delivered
I do not see any objection from PED to not accept the material with a 3.1 certificate.   

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