CELEX: 51989PC0209
Language: en
Date: 1989-07-24
Title: PROPOSAL FOR A COUNCIL DECISION CONCERNING THE MODULES FOR THE VARIOUS PHASES OF THE CONFORMITY ASSESSMENT PROCEDURES WHICH ARE INTENDED TO BE USED IN THE TECHNICAL HARMONIZATION DIRECTIVES

8. 9. 89                         Official Journal of the European Communities                            No C 231/3
                                                         II
                                                (Preparatory Acts)
                                           COMMISSION
         Proposal for a Council Decision concerning the modules for the various phases of the
         conformity assessment procedures which are intended to be used in the technical harmonization
                                                     directives
                                         COM(89) 209 final — SYN 208
                                 (Submitted by the Commission on 15 June 1989)
                                                  (89/C 231/03)
         THE COUNCIL OF THE EUROPEAN COMMUNITIES,
         Having regard to the Treaty establishing the European Economic Community, and in
         particular Article 100a thereof,
         Having regard to the proposal from the Commission,
         in cooperation with the European Parliament,
         Having regard to the opinion of the Economic and Social Committee,
         Whereas the introduction of harmonized methods for the assessment of conformity and the
         adoption of a common doctrine for their implementation is likely to facilitate the adoption of
         future technical harmonization directives, the placing on the market of industrial products and
         thus be conducive to the completion of the internal market by 31 December 1992,
         HAS ADOPTED THIS DECISION:
                                                    Sole Article
         The modules for the various phases of the procedures for conformity assessment which are to
         be used in the technical harmonization Directives relating to the marketing of industrial
         products will be chosen from among those listed in the Annex to this Decision and in
         accordance with the criteria set out therein.
 ---pagebreak--- N o C 231/4                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s               8. 9. 89
                                                                  ANNEX
           CONFORMITY            ASSESSMENT         PROCEDURES IN T H E                 TECHNICAL           HARMONIZATION
                                                               DIRECTIVES
            I. General guidelines
               The principal guidelines for the use of conformity assessment procedures in the technical harmonization
               Directives are the following:
               (a) the essential objective of a conformity assessment procedure is to give to the users, consumers and
                   public authorities, the assurance that products placed on the market conform to the various
                   requirements expected of them as these are expressed in the provisions of the Directives;
               (b) conformity assessment can be subdivided into modules which relate to the control of the design
                   phase of products or to the control of their production phase; in certain specific cases these two
                   functions are so inseparable they must be combined to constitute a module (e.g. modules A, G and
                   H);
               (c) as a generale rule a product should undergo a control in both phases before being able to be placed
                   on the market if the results are positive;
               (d) there are a variety of modules which cover the two phases in a variety of ways. The Directives shall
                   set the range of possible choices which can be considered by the Council to give the public auth-
                   orities the acceptable level of safety they seek, for a given product or product sector;
               (e) in setting the range of possible choices open to the manufacturer, the Directives will take into
                   consideration, in particular, such issues as the appropriateness of the modules to the type of
                   products, the nature of the risks involved, the economic infrastructures of the given sector (e.g.
                   existence or non-existence of third parties), the types and importance of production etc;
               (f) the Directives will set out the requirements governing the conditions in which the manufacturer
                   makes his choice as to the most appropriate modules for his production;
               (g) the Directives should, in setting the range of possible modules for a given product or product
                   sector, attempt to leave as wide a choice to the manufacturer as is consistent with ensuring an
                   acceptably high level of protection, as laid down by the essential requirements; the Directives
                   should avoid imposing unnecessary modules which would be too onerous relative to the objectives
                   of the Directive concerned;
               (h) notified bodies should be encouraged, whenever possible, to apply the modules without undue
                   burden for the economic operators in order to ensure consistent interpretation and application of
                   the modules. The European Organization for Testing and Certification or, in its absence, the
                   Commission will organize close cooperation between the notified bodies;
               (i) whenever Directives provide the possibility for the manufacturer to use quality assurance
                   techniques, they must also wherever possible provide for the possibility of recourse to product
                   certification;
               (j) for the purposes of operating the various modules, Member States shall notify only competent
                   bodies which comply with the requirements of the Directives; bodies accredited to apply the EN
                   45 000 series or which can produce documentary evidence that they conform to the EN 45 000
                   series shall be considered to conform to the requirements of the Directives. Member States which
                   do not notify accredited bodies shall be invited to produce the documentary evidence that they
                   conform to the requirements of the Directive;
               (k) lists of notified bodies shall be published by the Commission in the OJEC and constantly updated;
               (1) the CE mark (accompanied, wherever appropriate, by the identification symbol of the third party
                   involved in the control of the production phase) shall be affixed to show that the production phase
                   has been carried out satisfactorily only having regard to the requirements of the Directives.
           II. Modules for conformity assessment
               Explanatory notes
               Specific directives may allow the CE mark to be affixed to the packaging or the accompanying docu-
               mentation, instead of to the product itself.
 ---pagebreak--- 8. 9. 89                           Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                N o C 231/5
         The declaration of conformity or the certificate of conformity (whichever of the two applies in the
         directive concerned) shall cover either individual or several products and shall either accompany the
         product(s) covered or be kept by the manufacturer. The appropriate solution for the directive
         concerned will be specified.
         References to articles refer to the standard paragraphs of Annex II B of the Council resolution of
         7 May 1985 (OJ No C 136 of 4 June 1985 p. 1), and which have become standard articles in the New
         Approach Directives.
         The development of computerized telecommunications as a means of publication of certificates issued
         by notified bodies is envisaged within INSIS.
         Specific directives may use modules A, C and H with additional sections containing supplementary
         requirements (which figure in the boxes in the modules).
         Modules C and D are designed to be used in combination with module B (EC type examination).
         Modules E and F will also normally be used in combination with module B; however, in special cases
         (for example when dealing with certain products of very simple design and construction) they may be
         used on their own.
                                                             MODULE A
                                          EC DECLARATION O F CONFORMITY
         1. The EEC declaration of conformity is the procedure whereby the manufacturer or his authorized
            representative established within the Community ensures and declares that the products concerned
            satisfy the requirements of the directive that apply to them. The manufacturer shall affix the CE
            mark to each product and draw up a written declaration of conformity.
         2. The manufacturer shall establish the technical documentation described in paragraph 3 and he or his
            authorized representative established within the Community shall keep it for a period ending at least
             10 years (') after the last product has been manufactured at the disposal of the relevant national
            authorities for inspection purposes.
            Where neither the manufacturer nor his authorized representative is established within the
            Community, the obligation to keep the technical documentation available shall be the responsibility
            of the person who places the product on the Community market.
         3. The technical documentation shall enable understanding of the design, manufacture and operation
            of the product, and shall enable assessment of conformity with the requirements of the directive.
            The documentation shall contain so far as relevant for assessment:
            — a general description of the product,
            — conceptual design and manufacturing drawings and schemes of components, sub-assemblies,
                 circuits, etc,
            — descriptions and explanations necessary for the understanding of said drawings and schemes and
                 the operation of the product,
            — a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the
                 solutions adopted to meet the essential requirements of the directive where the standards referred
                 to in Article 5 have not been applied,
            — results of design calculations made, examinations carried out, etc.,
            — test reports.
         4. The manufacturer shall take all measures necessary in order that the manufacturing process shall
             ensure compliance of the manufactured products with the technical documentation referred to in
            paragraph 2 and with the requirements of the directive that apply to them.
         (Possible supplementary requirements)
                  For each product manufactured one or more tests on one or more specific aspects of the product
                  shall be carried out by the manufacturer or on his behalf (2). The tests shall be carried out in the
                  presence of a notified body, chosen by the manufacturer, or by that notified body.
 ---pagebreak--- N o C 231/6                           Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                    8. 9. 89
                    A notified body chosen by the manufacturer shall carry out or have carried out product checks
                    at random intervals. An adequate sample of the final products, taken on site by the notified
                    body, shall be examined and appropriate tests as set out in the relevant standard(s) referred to in
                    Article 5, or equivalent tests, shall be carried out to check the conformity of the production
                    output with the relevant requirements of the directive. In those cases where one or more of the
                    products checked do not conform the notified body shall take appropriate measures.
                    The product checking shall use the following elements:
                    (Relevant elements shall be specified here such as for example the statistical method to be applied, the
                    sampling plan with its operational characteristics, etc).
                                                                 MODULE B
                                                       EC TYPE EXAMINATION
            1. The EC type examination is that part of the procedure by which a notified body ascertains and
               attests that a specimen, representative of the production planned, meets the provisions of the
               directive that apply to it.
            2. The application for the type examination shall be lodged by the manufacturer or his authorized
               representative established within the Community with a notified body.
               The application shall include:
               — the name and address of the manufacturer and, if the application is lodged by the authorized
                   representative, his name and address in addition,
               — a written declaration that the application has not been lodged with any other notified body,
               — the technical documentation, as described in paragraph 3.
               The applicant shall place at the disposal of the notified body a specimen, representative of the
               production envisaged and hereinafter called 'type' ('). The notified body may request further
               specimens if needed for carrying out the test programme.
            3. The technical documentation shall enable understanding of the design, manufacture and operation
               of the product, and shall enable assessment of conformity with the requirements of the directive.
               The documentation shall contain so far as relevant for assessment:
               — a general description of the type,
               — conceptual design and manufacturing drawings and schemes of components, sub-assemblies,
                   circuits, etc,
               — descriptions and explanations necessary for the understanding of said drawings and schemes and
                   the operation of the product,
               — a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the
                   solutions adopted to meet the essential requirements where the standards referred to in Article 5
                   have not been applied;
               — results of design calculations made, examinations carried out, etc,
               — test reports.
            4. The notified body shall,
               4.1. examine the technical documentation, verify that the type has been manufactured in conformity
                     with the technical documentation and identify the elements which have been designed in
                     accordance with the relevant provisions of the standards referred to in Article 5, as well as the
                     elements which have been designed without applying the relevant provisions of those standards;
               4.2. perform or have performed the appropriate examinations and necessary tests to check whether,
                     where the standards referred to in Article 5 have not been applied, the solutions adopted by the
                     manufacturer meet the essential requirements of the directive;
               4.3. perform or have performed the appropriate examinations and necessary tests to check whether,
                    where the manufacturer has chosen to apply the relevant standards, these have been applied
                     effectively;
               4.4. agree with the applicant the location where the examinations and necessary tests shall be carried
                     out.
 ---pagebreak--- 8. 9. 89                           Official J o u r n a l of the E u r o p e a n Communities                             N o C 231/7
         5. Where the type meets the provisions of the directive, the notified body shall issue an EC type exam-
            ination certificate to the applicant. The certificate shall contain the name and address of the manu-
            facturer, conclusions of the examination, conditions for its validity and the necessary data for identi-
            fication of the approved type.
            The relevant parts of the technical documentation shall be annexed to the certificate and a copy kept
            by the notified body.
         6. The applicant shall keep the notified body that has issued the EC type examination certificate
            informed of any modification to the approved product.
            Modifications to the approved product must receive additional approval from the notified body that
            issued the EC type examination certificate where such changes may affect the conformity with the
            essential requirements or the prescribed conditions for use of the product. This additional approval is
            given in the form of an addition to the original EC type examination certificate.
         7. Each notified body shall publish periodically the relevant information concerning
            — the applications for EC type examination received,
            — the EC type examination certificates and additions issued,
            — the EC type examination certificates and additions refused,
            — the EX type examination certificates and additions withdrawn.
         8. The other notified bodies may receive copies of the EC type examination certificates and/or their
            additions. The annexes to the certificates shall be kept at the disposal of the other notified bodies.
                                                             MODULE C
                                    EC DECLARATION OF CONFORMITY T O TYPE
         1. This declaration of conformity is that part of the procedure whereby the manufacturer ensures and
            declares that the products concerned are in conformity with the type as described in the EC type
            examination certificate and satisfy the requirements of the directive that apply to them. The manu-
            facturer shall affix the CE mark to each product and draw up a written declaration of conformity.
         2. The manufacturer shall take all measures necessary in order that the manufacturing process shall
            ensure compliance of the manufactured products with the type as described in the EC type exam-
            ination certificate and with the requirements of the directive that apply to them.
         (Possible supplementary requirements)
                 A notified body chosen by the manufacturer shall carry out or have carried out product checks
                 at random intervals. An adequate sample of the final products, taken on site by the notified
                 body, shall be examined and appropriate tests as set out in the relevant standard(s) referred to in
                 Article 5, or equivalent tests, shall be carried out to check the conformity of the production
                 output with the relevant requirements of the directive. In those cases where one or more of the
                 products checked do not conform the notified body shall take appropriate measures.
                 The product checking shall use the following elements:
                 (Relevant elements shall be specified here such as for example the statistical method to be applied, the
                 sampling plan with its operational characteristics, etc).
                                                             MODULE D
                   EC DECLARATION O F CONFORMITY T O TYPE (Production Quality Assurance)
         1. This declaration of conformity is that part of the procedure whereby the manufacturer who satisfies
            the obligations of paragraph 2 ensures and declares that the products concerned are in conformity
            with the type as described in the EC type examination certificate and satisfy the requirements of the
            directive that apply to them. The manufacturer shall affix the CE mark to each product and draw up
            a written declaration of conformity. The CE mark shall be accompanied by the identification symbol
            of the notified body responsible for EC surveillance.
 ---pagebreak--- N o C 231/8                           Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s               8. 9. 89
            2. The manufacturer shall operate an approved quality system for production, final product inspection
               and testing as specified in paragraph 3 and shall be subject to EC surveillance as specified in
               paragraph 4.
            3. Quality system
               3.1. The manufacturer shall lodge an application for assessment of his quality system with a notified
                    body.
                    The application shall include:
                    — all relevant information for the product category envisaged,
                    — the quality system's documentation,
                    — an undertaking to carry out the obligations arising from the quality system as approved,
                    — an undertaking to maintain the quality system as approved to ensure its continuing suita-
                        bility and effectiveness,
                    — if applicable, the technical documentation of the approved type and a copy of the EC type
                        examination certificate.
               3.2. The quality system shall ensure compliance of the products with the type as described in the EC
                    type examination certificate and with the requirements of the directive that apply to them.
                    All the elements, requirements and provisions adopted by the manufacturer shall be documented
                    in a systematic and orderly manner in the form of written policies, procedures and instructions.
                    This quality system documentation shall ensure a common understanding of the quality
                    programmes, plans, manuals and records.
                    It shall contain in particular an adequate description of
                    — the quality objectives and the organizational structure, responsibilities and powers of the
                        management with regard to product quality,
                    — the manufacturing, quality control and quality assurance techniques, processes                and
                        systematic actions that will be used,
                    — the examinations and tests that will be carried out before, during and after manufacture, and
                        the frequency with which they will be carried out,
                    — the means to monitor the achievement of the required product quality and the effective
                        operation of the quality system.
               3.3. The notified body shall assess the quality system to determine whether it satisfies the
                    requirements referred to in paragraph 3.2. It shall presume conformity with these requirements
                    in respect of quality systems that implement the relevant harmonized standard (4).
                    The assessment team shall have at least one member experienced as an assessor in the product
                    technology concerned. The evaluation procedure shall include an assessment visit to the manu-
                    facturer's premises.
                    The decision shall be notified to the manufacturer. The notification shall contain the
                    conclusions of the examination and the reasoned assessment decision.
               3.4. The manufacturer or his authorized representative shall keep the notified body that has
                    approved the quality system informed of any intended updating of the quality system.
                    The notified body shall evaluate the modifications proposed and decide whether the amended
                    quality system will still satisfy the requirements referred to in paragraph 3.2. or whether a
                    re-assessment is required.
                    Is shall notify its decision to the manufacturer. The notification shall contain the conclusions of
                    the examination and the reasoned assessment decision.
            4. EC surveillance
               4.1. The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obli-
                    gations arising out of the approved quality system.
 ---pagebreak--- 8. 9. 89                           Official J o u r n a l of the E u r o p e a n Communities                        N o C 231/9
            4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations
                 of manufacture, inspection and testing, and storage and shall provide it with all necessary infor-
                 mation, in particular
                 — the quality system documentation,
                 — the quality records, such as inspection reports and test data, calibration data, qualification
                      reports of the personnel concerned, etc.
            4.3. The notified body shall periodically (s) carry out audits to make sure that the manufacturer
                 maintains and applies the quality system and shall provide an audit report to the manufacturer.
            4.4. Additionally the notified body may pay unexpected visits to the manufacturer. During such
                 visits full or reduced audits may be carried out by the notified body. The notified body shall
                 provide a visit report and, if applicable, an audit report to the manufacturer.
         5. Each notified body shall publish periodically the relevant information concerning the quality system
            approvals issued and withdrawn.
                                                             MODULE E
                 EC DECLARATION OF CONFORMITY (PRODUCT QUALITY ASSURANCE) (')
         1. This declaration of conformity is that part of the procedure whereby the manufacturer who satisfies
            the obligations of paragraph 2 ensures and declares that the products concerned [are in conformity
            with the type as described in the EC type examination certificate and] satisfy the requirements of the
            directive that apply to them. The manufacturer shall affix the CE mark to each product and draw up
            a written declaration of conformity. The CE mark shall be accompanied by the identification symbol
            of the notified body responsible for EC surveillance.
         2. The manufacturer shall operate an approved quality system for final product inspection and testing
            as specified in paragraph 3 and shall be subject to EC surveillance as specified in paragraph 4.
         3. Quality system
            3.1. The manufacturer shall lodge an application for assessment of his quality system with a notified
                 body.
                 The application shall include:
                 — all relevant information for the product category envisaged,
                 — the quality system's documentation,
                 — an undertaking to carry out the obligations arising from the quality system as approved,
                 — an undertaking to maintain the quality system as approved to ensure its continuing suita-
                     bility and effectiveness,
                 — if applicable, the technical documentation of the approved type and a copy of the EC type
                      examination certificate.
            3.2. Under the quality system each product shall be examined and appropriate tests as set out in the
                 relevant standard(s) referred to in Article 5 or equivalent tests shall be carried out in order to
                 ensure its conformity with the relevant requirements of the directive.
                 All the elements, requirements and provisions adopted by the manufacturer shall be documented
                 in a systematic and orderly manner in the form of written policies, procedures and instructions.
                 This quality system documentation shall ensure a common understanding of the quality
                 programmes, plans, manuals, and records.
                 It shall contain in particular an adequate description of:
                 — the quality objectives and the organizational structure, responsibilities and powers of the
                     management with regard to product quality,
                 — the examinations and tests that will be carried out after manufacture,
                 — the means to monitor the effective operation of the quality system.
 ---pagebreak--- No C 231/10                            Official Journal of the European Communities                                         8. 9. 89
               3.3. The notified body shall assess the quality system to determine whether it satisfies the
                     requirements referred to in paragraph 3.2. It shall presume conformity with these requirements
                     in respect of quality systems that implement the relevant harmonized standard (7).
                    The assessment team shall have at least one member experienced as an assessor in the product
                     technology concerned. The evaluation procedure shall include an assessment visit to the manu-
                     facturer's premises.
                     The decision shall be notified to the manufacturer. The notification shall contain the
                     conclusions of the examination and the reasoned assessment decision.
               3.4. The manufacturer or his authorized representative shall keep the notified body that has
                     approved the quality system informed of any intended updating of the quality system.
                     The notified body shall evaluate the modifications proposed and decide whether the amended
                     quality system will still satisfy the requirements referred to in paragraph 3.2. or whether a
                     re-assessment is required.
                     It shall notify its decision to the manufacturer. The notification shall contain the conclusions of
                     the examination and the reasoned assessment decision.
            4. EC surveillance
               4.1. The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obli-
                     gations arising out of the approved quality system.
               4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations
                     of inspection, testing and storage, and shall provide it with all necessary information, in
                     particular
                    — the quality system documentation,
                    — the technical documentation,
                    — the quality records, such as inspection reports and test data, calibration data, qualification
                         reports of the personnel concerned, etc.
               4.3. The notified body shall periodically (") carry out audits to make sure that the manufacturer
                     maintains and applies the quality system and shall provide an audit report to the manufacturer.
               4.4. Additionally the notified body may pay unexpected visits to the manufacturer. During such
                    visits full or reduced audits may be carried out by the notified body. The notified body shall
                     provide a visit report and, if applicable, an audit report to the manufacturer.
            5. Each notified body shall publish periodically the relevant information concerning the quality system
               approvals issued and withdrawn.
                                                             MODULE F
                                                        EC VERIFICATION (6)
            1. The EC verification is that part of the procedure whereby a notified body checks and attests that the
               products concerned are in conformity with the type as described in the EC type examination
               certificate and satisfy the requirements of the directive that apply to them.
            2. The manufacturer shall take all measures necessary in order that the manufacturing process ensures
               conformity of the products (with the type as described in the EC type examination certificate and)
               with the requirements of the directive that apply to them.
            3. The EC verification may be carried out, at the choice of the manufacturer, by examination and
               testing of every individual product as specified in paragraph 4, or by examination and testing of the
               products on a statistical basis as specified in paragraph 5 (').
            4. Verification by examination and testing of every individual product
               4.1. All products shall be individually examined and appropriate tests as set out in the relevant
                     standard(s) referred to in Article 5 or equivalent tests shall be carried out in order to verify their
                     conformity with [the type as described in the EC type examination certificate and] the
                     requirements of the directive that apply to them.
               4.2. The notified body shall affix the CE mark to each approved product and draw up a written
                     certificate of conformity. The CE mark shall be accompanied by the identification symbol of the
                     notified body.
 ---pagebreak--- 8. 9. 89                           Official J o u r n a l of the E u r o p e a n Communities                      N o C 231/11
         5. Statistical verification
            5.1. The manufacturer shall present his products in the form of homogeneous lots and shall take all
                  measures necessary in order that the manufacturing process ensures homogeneity of each lot
                 produced.
            5.2. If appropriate the manufacturer may affix the CE mark to each product (10) during the manu-
                 facturing process. The CE mark shall be accompanied by the identification symbol of the
                 notified body responsible for the statistical verification.
            5.3. All products shall be available for verification in the form of homogeneous lots. A random
                 sample shall be drawn from each lot. Products in a sample shall be individually examined and
                 appropriate tests as set out in the relevant standard(s) referred to in Article 5, or equivalent
                 tests, shall be carried out to ensure their conformity with the relevant requirements of the
                 directive and to determine acceptance or rejection of the lot.
            5.4. The statistical procedure shall use the following elements:
                  (Relevant elements shall be specified here such as for example the statistical method to be
                 applied, the sampling plan with its operational characteristics, etc).
            5.5. If a lot is accepted the notified body shall draw up a written certificate of conformity. All
                 products in the lot may be put on the market except those products from the sample that were
                 found not to be in conformity.
                 If a lot is rejected the notified body or the competent authority shall take appropriate measures
                 to prevent the putting on the market of that lot. In the event of frequent rejection of lots the
                 notified body may suspend the statistical verification.
                                                             MODULE G
                                                    EC U N I T VERIFICATION
         1. The EC unit verification is the procedure whereby a notified body checks and attests that the
            product concerned is in conformity with the requirements of the directive that apply to it. The
            notified body shall affix the CE mark to the product and draw up a written certificate of conformity.
            The CE mark shall be accompanied by the identification symbol of the notified body.
         2. The product shall be examined and appropriate tests as set out in the relevant standard(s) referred to
            in Article 5, or equivalent tests, shall be carried out to ensure its conformity with the relevant
            requirements of the directive.
         3. Technical documentation shall be made available to the notified body and shall contain, so far as
            relevant for the assessment:
            — a general description of the product,
            — conceptual design and manufacturing drawings and schemes of components, sub-assemblies,
                circuits, etc,
            — descriptions and explanations necessary for the understanding of said drawings and schemes and
                the operation of the product,
            — a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the
                solutions adopted to meet the essential requirements of the directive where the standards referred
                to in Article 5 have not been applied,
            — results of design calculations made, examinations carried out, etc,
            — test reports.
                                                             MODULE H
                       EC DECLARATION O F CONFORMITY (FULL QUALITY ASSURANCE)
         1. This declaration of conformity is the procedure whereby the manufacturer who satisfies the obli-
            gations of paragraph 2 ensures and declares that the products concerned satisfy the requirements of
            the directive that apply to them. The manufacturer shall affix the CE mark to each product and
            draw up a written declaration of conformity. The CE mark shall be accompanied by the identifi-
            cation symbol of the notified body responsible for the EC surveillance.
         2. The manufacturer shall operate an approved quality system for design, manufacture and final
            product inspection and testing as specified in paragraph 3 and shall be subject to EC surveillance as
            specified in paragraph 4.
 ---pagebreak--- N o C 231/12                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                8. 9. 89
             3. Quality system
                3.1. The manufacturer shall lodge an application for assessment of his quality system with a notified
                      body.
                      The application shall include:
                      — all relevant information for the product category envisaged,
                      — the quality system's documentation,
                      — an undertaking to carry out the obligations arising from the quality system as approved,
                      — an undertaking to maintain the quality system as approved to ensure its continuing suita-
                            bility and effectiveness.
                 3.2. The quality system shall ensure compliance of the products with the requirements of the
                       directive that apply to them.
                      All the elements, requirements and provisions adopted by the manufacturer shall be documented
                       in a systematic and orderly manner in the form of written policies, procedures and instructions.
                      This quality system documentation shall ensure a common understanding of the quality policies
                       and procedures such as quality programmes, plans, manuals, and records.
                       It shall contain in particular an adequate description of:
                      — the quality objectives and the organizational structure, responsibilities and powers of the
                            management with regard to design and product quality,
                       — the technical design specifications, including standards, that will be applied and, where the
                            standards referred to in Article 5 will not be applied in full, the means that will be used to
                            ensure that the essential requirements of the directive that apply to the products will be met,
                       — the design control and design verification techniques, processes and systematic actions that
                            will be used when designing the products pertaining to the product category covered,
                       — the corresponding manufacturing, quality control and quality assurance                 techniques,
                            processes and systematic actions that will be used,
                       — the examinations and tests that will be carried out before, during, and after manufacture,
                            and the frequency with which they will be carried out,
                       — the means to monitor the achievement of the required design and product quality and the
                            effective operation of the quality system.
                 3.3. The notified body shall assess the quality system to determine whether is satisfies the
                       requirements referred to in paragraph 3.2. it shall presume compliance with these requirements
                       in respect of quality systems that implement the relevant harmonized standard (").
                       The assessment team shall have at least one member experienced as an assessor in the product
                       technology concerned. The evaluation procedure shall include an assessment visit to the manu-
                       facturer's premises.
                       The decision shall be notified to the manufacturer. The notification shall contain the
                       conclusions of the examination and the reasoned assessment decision.
                 3.4. The manufacturer or his authorized representative shall keep the notified body that has
                        approved the quality system informed of any intended updating of the quality system.
                        The notified body shall evaluate the modifications proposed and decide whether the amended
                        quality system will still satisfy the requirements referred to in paragraph 3.2. or whether a
                        re-assessment is required.
                        It shall notify its decision to the manufacturer. The notification shall contain the conclusions of
                        the examination and the reasoned assessment decision.
              4. EC surveillance
                 4.1. The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obli-
                        gations arising out of the approved quality system.
                  4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations
                        of design, manufacture, inspection and testing, and storage, and shall provide it with all
                        necessary information, in particular
                        — the quality system documentation,
 ---pagebreak--- 8. 9. 89                           Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s             N o C 231/13
                 — the quality records as foreseen by the design part of the quality system, such as results af
                      analyses, calculations, tests, etc,
                 — the quality records as foreseen by the manufacturing part of the quality system, such as
                      inspection reports and test data, calibration data, qualification reports of the personnel
                      concerned, etc.
            4.3. The notified body shall periodically (12) carry out audits to make sure that the manufacturer
                  maintains and applies the quality system and shall provide an audit report to the manufacturer.
            4.4. Additionally the notified body may pay unexpected visits to the manufacturer. During such
                 visits full or reduced audits may be carried out by the notified body. The notified body shall
                 provide a visit report and, if applicable, an audit report to the manufacturer.
         5. Each notified body shall publish periodically the relevant information concerning the quality system
            approvals issued and withdrawn.
            (Possible supplementary requirements)
                 Design examination
                 1. The manufacturer shall lodge an application for examination of the design with a single
                    notified body.
                 2. The application shall enable understanding of the design, manufacture and operation of the
                    product, and shall enable assessment of conformity with the requirements of the directive.
                    Is shall include:
                    — the technical design specifications, including standards, that have been applied,
                    — the necessary supporting evidence for their adequacy, in particular where the standards
                         referred to in Article 5 have not been applied in full. This supporting evidence shall
                         include the results of tests carried out by the appropriate laboratory of the manufacturer
                         or on his behalf.
                 3. The notified body shall examine the application and where the design meets the provisions of
                    the directive that apply to is shall issue an EC design examination certificate to the applicant.
                    The certificate shall contain the conclusions of the examination, conditions for its validity,
                    the necessary data for identification of the approved design and, if relevant, a description of
                    the product's functioning.
                 4. The applicant shall keep the notified body that has issued the EC design examination
                    certificate informed of any modification to the approved design.
                    Modifications to the approved design must receive additional approval from the notified body
                    that issued the EC design examination certificate where such changes may affect the
                    conformity with the essential requirements of the directive or the prescribed conditions for
                    use of the product. This additional approval is given in the form of an addition to the original
                    EC design examination certificate.
                 5. The notified bodies shall publish periodically the relevant information concerning
                    — the applications for EC design examination received,
                    — the EC design examination certificates and additions issued,
                    — the EC design examination certificates and additions refused,
                    — the EC design examination certificates and additions withdrawn.
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                                                                     Footnotes
           (') Specific directives may change this period.
           O If this option is used in a specific directive the products concerned shall be specified, together with the tests to be
               carried out.
           (') A type may cover several product variants provided that the differences between the variants do not affect the level of
               safety and other performance requirements of the product.
           (4) This harmonized standard shall be EN 29002, completed if necessary to take into consideration the specificity of the
               products for which it is implemented.
           (') In specific directives the periodicity may be specified.
           (') When this module is used without module B:
               — it shall be completed (between paragraphs 1 and 2) by paragraphs 2 and 3 of module A, to introduce the need for
                   technical documentation,
               — the text in brackets shall be deleted.
           (') This harmonized standard shall be EN 29003, completed if necessary to take into consideration the specificity of the
               products for which it is implemented.
           (*) In specific directives the periodicity may be specified.
           (') In specific directives the choice of the manufacturer may be limited.
          (10) Specific directives may specify that the CE mark shall be affixed by the notified body.
          (") This harmonized standard shall be EN 29001, completed if necessary to take into consideration the specificity of the
               products for which it is implemented.
          (12) In specific directives the periodicity may be specified.