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Guideline G-16

Question

Answer

In practice, this requirement is satisfied when the material manufacturer has a quality assurance system of at least EN ISO 9001 type, certified by a competent body (according to the definition given in PED Guideline G-02) established as a legal entity within the European Community, and when the field of validity of the certification specifies production of material indicating the relevant material types.

The specific assessment of the quality system shall properly cover all the relevant processes and material properties referred to in the material specifications, and attested in the material certificates.

A single reference to section 4.3 of Annex I of PED is not sufficient to validate the quality assurance system of the material manufacturer. The

reference document for quality assurance system which has been used shall be identified. Reference to the PED in the quality assurance system certification is not a mandatory requirement.

See also PED Guidelines G-05, G-07 and I-05.