5.1.3 適合性評価の関係者 – サプライチェーンにおける適合性評価の位置付け

Conformity assessment is a responsibility of the manufacturer. However, if required by the relevant legislation, a third party must be involved in the conformity assessment procedure.

In total there are three possibilities:

—There is no third-party involvement. This may concern the case where, according to the legislator, a declaration (accompanied by the relevant technical examinations and documentation) of the manufacturer is enough to ensure the conformity of the product(s) in question against the relevant legislative requirements. In this case the manufacturer himself carries out all required controls and checks, establishes the technical documentation and ensures the conformity of the production process.

—Conformity assessment is performed with the involvement of an accredited in-house conformity assessment body that forms a part of the manufacturer’s organisation. However this in-house body must not have any activities other than conformity assessment and must be independent from any commercial, design and production entities (see for details Article R21 of Annex I of Decision No 768/2008/EC). It has to demonstrate the same technical competence and impartiality as external conformity assessment bodies, through accreditation.

—Whenever appropriate for a specific sector, the legislator may acknowledge the fact that manufacturers operate very well equipped testing laboratories or premises. This may be the case for new innovative complex products for which the testing know-how remains inside the manufacturers.

—In some other cases the legislator may consider the intervention of a third party i.e. an external conformity assessment body, necessary. Such a body must be impartial and fully independent from the organisation or the product it assesses (see also Article R17(3) of Annex I of Decision No 768/2008/EC), it cannot engage in any activity that may conflict with its independence (see also Article R21(2)(c) of Annex I of Decision No 768/2008/EC) and thus it cannot have user or other interests in the product to be assessed.

It is the responsibility of the Member States to notify those third party conformity assessment bodies within their jurisdiction that they consider technically competent to assess the compliance of products with the requirements of the Union harmonisation legislation that applies to them. In-house bodies cannot be notified but they have still to demonstrate the same technical competence as external bodies, through accreditation. Member States must also ensure that the (in-house or external) bodies permanently maintain their technical competence.

Taking the above into account, the stakeholders in a conformity assessment procedure are the following:

a)The legislator who:

—sets out the legal requirements that products have to fulfil;

—selects conformity assessment modules/procedures from the menu set out under Decision No 768/2008/EC.

b)The manufacturer who:

—designs, manufactures and tests the product or has it designed, manufactured or tested;

—draws up the technical documentation of the product;

—takes all measures necessary to ensure compliance of the products;

—upon positive assessment of the products, draws up the EU Declaration of Conformity and affixes the CE marking on the products if the legislation so requires;

—upon intervention of a notified body, affixes the notified body’s identification number to the product if the legislation so requires.

It must be clear that it is always the manufacturer who takes responsibility for the conformity of his products with the relevant legislative requirements. In this respect, the economic operator that places the product on the market under its name or trademark becomes automatically the manufacturer for the purposes of Union harmonisation legislation. Therefore he takes the entire responsibility for the conformity assessment (design and production) of the product, even if this has been actually done by somebody else. Furthermore he must be in the possession of all documentation and, where relevant, certificates necessary to demonstrate the conformity of the product, but these do not need to be under his name.

c)The (in-house or external) conformity assessment body that:

—performs checks and assessments, if the legislation so provides;

—upon positive assessment issues the approval certificate or attestation as required by the applicable legislation.

A conformity assessment body wishing to carry out conformity assessment for one or several module(s) under a given piece of Union harmonisation legislation has to be assessed according to all the requirements for the different modules it wishes to offer services for (see under 5.2.3). A body wishing to offer conformity assessment services under a Union harmonisation act has to offer services for at least one module from those indicated in the Union harmonisation act. It must be noted that there is no obligation for a body to offer services for more than one module, but it must take on the responsibility for a whole module.

The exact position of conformity assessment in the supply chain is depicted under Flowchart 2.