CONFORMITY ASSESSMENT

5.1. MODULES FOR CONFORMITY ASSESSMENT 5.1.1. WHAT IS A CONFORMITY ASSESSMENT?

• Conformity assessment is the process carried out by the manufacturer of demonstrating whether specified requirements relating to a product have been fulfilled.

• A product is subjected to conformity assessment both during the design and production phase.

Two important elements of every legislative act (either Old or New Approach) covering products are:

• the legislative requirements governing the characteristics of the products covered;

• and the conformity assessment procedures the manufacturer carries out in order to demonstrate that a product, before it is placed on the market, conforms to these legislative requirements.

This guide addresses conformity assessment as this is laid down under Decision No 768/2008/EC (particularly for the Union harmonisation legislation under the ‘New Approach’ and now the New Legislative Framework).

A product is subjected to conformity assessment both during the design and production phase. Conformity assessment is the responsibility of the manufacturer. Should a manufacturer subcontract design or production, he still remains responsible for the execution of conformity assessment.

Conformity assessment must not be confused with market surveillance, which consists of controls by the national market surveillance authorities after the product has been placed on the market. However both techniques are complementary and equally necessary to ensure the protection of the public interests at stake and the smooth functioning of the internal market.

The essential objective of a conformity assessment procedure is to demonstrate that products placed on the market conform to the requirements expressed in the provisions of the relevant legislation.

5.1.2. THE MODULAR STRUCTURE OF CONFORMITY ASSESSMENT IN UNION HARMONISATION LEGISLATION

• In Union harmonisation legislation, conformity assessment procedures cover both design and production phases.

They are composed of one or two modules. Some modules cover both phases. In other cases, distinct modules are used for each phase.

• Decision No 768/2008/EC lays down the “horizontal menu” of conformity assessment modules and the ways procedures are built of modules.

• The legislator selects from the menu of conformity assessment modules/procedures (laid down under Decision No 768/2008/ EC) the most appropriate ones for the concerned sector.

Under Union harmonisation legislation, conformity assessment procedures are composed of one or two conformity assessment modules. As products are subjected to conformity assessment both during the design and production phase, a conformity assessment procedure covers both design and production phases; while a module may cover:

• either one of these two phases (in this case a conformity assessment procedure is composed of two modules);

• or both (in this case a conformity assessment procedure is composed of one module).

Decision No 768/2008/EC, lays down a “horizontal menu” of conformity assessment modules and the ways procedures are built of modules.

The legislator selects from the menu of conformity assessment modules/procedures (laid down under Decision No 768/2008/EC) the most appropriate one(s) in order to address the specific needs of the concerned sector¹⁹⁸. The least

198 Under the Ecodesign directive the conformity assessment procedures (to be specified in the implementing measure) is laid down in the directive itself as a rule, but in duly justified cases the modules of Decision No 768/2008 are prescribed.

onerous modules should be selected taking into account the type of products and hazards involved, the impact on the protection of public interests, the economic infrastructure of the given sector, the methods of production etc., where possible a choice of inspection, certification, and/or QA modules should be provided.

Conformity assessment procedures are equivalent from a legal point of view but not technically identical in terms of methods. Their application in the sectoral legislation aims at providing high level of confidence as regards the conformity of products to the relevant essential requirements.

The intention of the modules as laid down in the Decision No 768/2008/EC is to allow for a limited number of possible procedures.

Nevertheless, the choice offered needs to be sufficiently varied in order to be applicable to the widest range of products concerned.

Union harmonisation legislation establishes conformity assessment procedures by either leaving the manufacturer no choice or by establishing a range of procedures from which the manufacturer must choose. As conformity assessment procedures in Union harmonisation legislation originate from Decision No 768/2008/EC, they remain consistent and coherent. Thus the assessment of product conformity becomes more transparent especially in cases where more than one harmonisation legislative act applies to a product.

5.1.3. ACTORS IN CONFORMITY ASSESSMENT – POSITIONING OF CONFORMITY ASSESSMENT IN THE SUPPLY CHAIN

• Conformity assessment is the responsibility of the manufacturer, whether the legislation provides for the involvement of a notified or in-house accredited conformity assessment body, or not.

• The main actors in conformity assessment are the legislator, the manufacturer and (if provided for by the legislation) the notified or in-house accredited conformity assessment body.

• The modules used for both the design and the production phase or for each phase may or may not involve a notified body.

• In-house accredited conformity assessment bodies must demonstrate the same level of technical competence and impartiality as notified bodies.

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 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 and their competence is sometimes higher than the abilities of certain external bodies. This may be the case for new innovative complex products for which the testing know-how remains inside the manufacturers.

• However 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 Decision No 768/2008/EC), it cannot engage in any activity that may conflict with its independence (see also Article R21(2)(c) 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.

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.