PART III: EC CONFORMITY-ASSESSMENT PROCEDURE
EC conformity-assessment procedure
11.—(1) Subject to paragraph (2) below, the EC conformity-assessment procedure in accordance with which equipment shall be manufactured is–
(a)the EC type-examination procedure and, subject to the limitations specified in Merchant Shipping Notice MSN 1734, one of the following:
(i)the EC declaration of conformity to type procedure;
(ii)the EC production quality assurance procedure;
(iii)the EC product quality assurance procedure; or
(iv)the EC product verification procedure; or
(b)the EC full quality assurance procedure.
(2) Equipment produced individually or in small quantities and not in series or in mass may be manufactured in accordance with the EC unit verification conformity-assessment procedure.
EC type-examination
12.—(1) An application for EC type-examination made to a notified body in respect of equipment may be made in writing by the manufacturer or his authorised representative within the Community (in this regulation referred to as “the applicant”).
(2) An application under paragraph (1) above shall include–
(a)the name and address of the manufacturer and, if the application is lodged by the manufacturer’s authorised representative, the name and address of that person;
(b)a written declaration that the same application has not been lodged simultaneously with any other notified body; and
(c)the technical documentation specified in Schedule 2.
(3) The applicant shall place at the disposal of the notified body a specimen representative of the product envisaged and shall provide further specimens if so requested by the notified body.
(4) On an application made to it under paragraph (1) above a notified body shall–
(a)examine the technical documentation submitted by the applicant and verify that the specimen has been manufactured in accordance with the technical documentation;
(b)agree with the applicant where the examinations and tests shall be carried out; and
(c)carry out, or have carried out, the appropriate examinations and tests to check whether the applicable international standards are satisfied.
(5) Where the notified body is satisfied, after performing its functions under paragraph (4) above, that the specimen satisfies the applicable international standards, it shall issue an EC type-examination certificate to the applicant.
(6) An EC type-examination certificate issued pursuant to paragraph (5) above shall include–
(a)the name and address of the manufacturer;
(b)details of the equipment to which it relates;
(c)the results of the examinations and tests carried out;
(d)the conditions (if any) of its validity; and
(e)the information necessary to identify the approved specimen,
and a list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified body.
(7) Where a notified body refuses to issue an EC type-examination certificate, it shall give in writing detailed reasons for its decision to the applicant, and if that notified body is a body other than the Maritime and Coastguard Agency it shall provide a copy of such reasons to the Maritime and Coastguard Agency.
(8) If an applicant applies for an EC type-examination for equipment in respect of which an EC type-examination certificate has been refused, he shall, in his application to the notified body, include all relevant documentation, including–
(a)the original examination and test results;
(b)the detailed reasons provided by the notified body for the previous refusal; and
(c)details of all modifications made to the equipment since the previous application.
(9) If any modifications are made to equipment in respect of which an EC type-examination certificate has been issued, the applicant shall inform the notified body which issued the certificate.
(10) If any modifications notified under paragraph (9) above are such that they may affect the equipment’s compliance with applicable international standards, the notified body shall satisfy itself, by further examinations and tests if necessary, that the equipment as modified complies with the applicable international standards and, if so satisfied, shall–
(a)approve the modifications to the equipment; and
(b)issue an addition to the original EC type-examination certificate in respect thereof.
(11) A notified body shall–
(a)on request, provide flag member States and other notified bodies with all relevant information concerning the EC type-examination certificates and additions thereto it has issued, including any it has withdrawn;
(b)on request, provide other notified bodies with copies of the EC type-examination certificates and additions thereto it has issued; and
(c)keep at the disposal of other notified bodies the annexes to the EC type-examination certificates it has issued.
(12) A manufacturer, or his authorised representative established within the Community, shall, in respect of an EC type-examination certificate issued to him, keep a copy of the technical documentation submitted with the application and the EC type-examination certificate, and any additions thereto, for at least 10 years after the last item of equipment to which the certificate relates has been manufactured.
EC declaration of conformity to type
13.—(1) If a manufacturer decides, in accordance with the requirements of Merchant Shipping Notice MSN 1734, to apply the EC declaration of conformity to type procedure to equipment in respect of which an EC type-examination certificate has been issued, the manufacturer or his authorised representative established within the Community shall–
(a)ensure and declare that the items of equipment–
(i)conform to the specimen in respect of which the EC type-examination certificate was issued; and
(ii)satisfy the applicable international standards;
(b)affix the mark referred to in regulation 18 below to each item of equipment to which it relates; and
(c)draw up a written declaration of conformity.
(2) A manufacturer applying the EC declaration of conformity to type procedure to equipment shall take all measures necessary to ensure that the equipment’s manufacturing process ensures that the equipment–
(a)conforms to the specimen in respect of which the EC type-examination certificate was issued; and
(b)satisfies the applicable international standards.
(3) The manufacturer or his authorised representative established within the Community shall keep a copy of the declaration of conformity referred to in paragraph (1)(c) above for at least 10 years after the last item of equipment to which it relates has been manufactured.
EC production quality assurance and product quality assurance procedures
14.—(1) A manufacturer who decides, in accordance with Merchant Shipping Notice MSN 1734, to apply either the EC production quality assurance procedure or the EC product quality assurance procedure to equipment in respect of which an EC type-examination certificate has been issued, may apply to a notified body for approval of his quality assurance system; and such an application shall be made in writing and shall include–
(a)all relevant information for the equipment category envisaged;
(b)the documentation concerning the system;
(c)the technical documentation of the specimen of the equipment and a copy of the EC type-examination certificate issued in respect of it; and
(d)an undertaking by the manufacturer–
(i)to fulfil the obligations arising from the approved system; and
(ii)to maintain the system as approved so that it remains adequate and efficient.
(2) On an application made to it under paragraph (1) above, the notified body shall evaluate the manufacturer’s quality assurance system to determine whether–
(a)on an application for approval of a system to be used in a production quality assurance procedure, it satisfies the requirements referred to in paragraph 3.2, of the section entitled “Production-Quality Assurance (Module D)”, in Annex B of the Directive and set out in Merchant Shipping Notice 1734; or
(b)on an application for approval of a system to be used in a product quality assurance procedure, it satisfies the requirements referred to in paragraph 3.2, of the section entitled “Product-Quality Assurance (Module E)”, in Annex B of the Directive and set out in Merchant Shipping Notice 1734,
and, if the system implements the relevant harmonised standard, it shall be taken to satisfy the said requirements.
(3) When determining whether a manufacturer’s quality assurance system satisfies the requirements referred to in paragraph (2) above, the notified body shall–
(a)include on the relevant auditing team at least one person with experience of assessment in the equipment technology concerned; and
(b)include within the assessment procedure at least one visit to the manufacturer’s premises.
(4) Where the notified body is satisfied, on an application made to it under paragraph (1) above and after evaluating the manufacturer’s quality assurance system, that the system satisfies the relevant requirements referred to in paragraph (2) above it shall grant to the manufacturer an approval of the system.
(5) In its approval under paragraph (4) above the notified body shall include the conclusions of any examinations and the evaluation carried out by it.
(6) A manufacturer to whom an approval has been granted in respect of a quality assurance system under paragraph (4) above shall have authority to make EC declarations of conformity in accordance with paragraph (13) below.
(7) Where the notified body is not satisfied as is mentioned in paragraph (4) above, it shall inform the manufacturer in writing–
(a)of its decision to refuse to grant an approval in respect of the system; and
(b)the conclusions of any examinations and the evaluation carried out by it.
(8) Where a notified body has granted an approval under paragraph (4) above, it shall periodically carry out audits of the approved system to ensure that the manufacturer maintains and applies the approved system and fulfils his obligations arising out of the approved system.
(9) The notified body shall provide the manufacturer with an audit report in respect of each periodic audit undertaken in accordance with paragraph (8) above.
(10) In addition to the periodic audits referred to in paragraph (8) above, the notified body may make unannounced visits to the manufacturer’s premises for the same purposes, and in the course of such visits may carry out tests, or cause tests to be carried out, if such tests are necessary to check whether the approved system is functioning correctly.
(11) The notified body shall provide the manufacturer–
(a)if it performs a visit as is mentioned in paragraph (10) above, with a visit report; and
(b)if it performs such tests as are mentioned in paragraph (10) above, with a test report.
(12) Where a manufacturer has been granted an approval by a notified body in respect of his quality assurance system, he shall–
(a)ensure and declare that the items of equipment concerned conform to the specimen in respect of which the EC type-examination certificate was issued;
(b)allow the notified body access for purposes of inspection to his premises where the equipment is manufactured, inspected, tested and stored;
(c)provide the notified body with all necessary information to enable it to perform its surveillance functions under these Regulations, in particular:
(i)the documentation relating to the system; and
(ii)the relevant quality records, such as inspection reports and test data, calibration data and qualification reports in relation to the personnel involved in the system; and
(d)maintain, at the disposal of the Secretary of State, for at least 10 years after the last item of equipment to which the system relates has been manufactured, the documentation referred to in–
(i)paragraph (1)(b) above;
(ii)paragraph (13)(c) below; and
(iii)paragraphs (4), (7), (9) and (11) above.
(13) Where a manufacturer has been granted an approval under paragraph (4) above by a notified body, the manufacturer or his authorised representative established within the Community shall–
(a)affix the mark referred to in regulation 18 below to each item of equipment; which mark shall be accompanied by the identification symbol and number of the notified body responsible for the auditing referred to in paragraph (8) above;
(b)draw-up a written declaration of conformity; and
(c)inform the notified body in writing of any intended modification of the system.
(14) Where a notified body is informed under paragraph (13)(c) above that a manufacturer intends to modify an approved system, it shall–
(a)assess the modifications proposed and determine whether the modified system would still satisfy the relevant requirements referred to in paragraph (2) above or whether a reassessment is required; and
(b)inform the manufacturer of its decision in writing, including the conclusions of any examinations and the evaluation carried out.
(15) A notified body shall, on request, provide the flag member State and the other notified bodies with the relevant information concerning the approvals granted by it, including those withdrawn, under paragraph (4) above.
EC product verification procedure
15.—(1) A manufacturer who decides, in accordance with Merchant Shipping Notice MSN 1734, to apply the EC product verification procedure to equipment in respect of which an EC type-examination certificate has been issued, may apply to a notified body for the carrying out of the appropriate examinations; and such an application shall be made in writing and shall include–
(a)a copy of the EC type-examination certificate in conformity with which the equipment is to be manufactured; and
(b)a statement as to whether the manufacturer requires the notified body to examine each item of equipment or only such batches of equipment as are selected by the body on a random basis.
(2) On an application under paragraph (1) above, the notified body shall carry out appropriate examinations and tests in accordance with paragraphs 3, 4.1 and 5.2 (as appropriate), of the section entitled “Product Verification (Module F)”, in Annex B of the Directive and set out in Merchant Shipping Notice MSN 1734 to check that the equipment complies with the applicable international standards.
(3) Where, after conducting the appropriate examinations and tests, the notified body is satisfied that an item of equipment has been manufactured in conformity with the EC type-examination certificate it shall affix, or cause to be affixed, to the item its identification control symbol and number and draw-up a written certificate of conformity relating to the examinations and tests carried out.
(4) Where a notified body carries out the appropriate examinations and tests in relation to a batch of equipment, it shall not affix its identification control symbol or number to any item of equipment in the batch which is not manufactured in accordance with the EC type-examination certificate.
(5) Where, after conducting the appropriate examinations and tests in relation to a batch of equipment, the notified body is not satisfied as is mentioned in paragraph (3) above it shall inform the manufacturer in writing–
(a)of its decision;
(b)of the conclusions of the examinations and tests carried out;
(c)that the batch of equipment shall not be placed on the market, supplied for use or exposed or offered for supply within the United Kingdom.
(6) Where a manufacturer’s equipment is examined and tested by a notified body under this regulation, the manufacturer or his authorised representative established within the Community shall–
(a)ensure and declare that the items of equipment conform to the specimen in respect of which the EC type-examination certificate was issued;
(b)affix the mark referred to in regulation 18 below to each item of equipment to which it relates;
(c)draw-up a written declaration of conformity;
(d)keep a copy of the declaration of conformity referred to in sub-paragraph (c) above for at least 10 years after the last item of equipment to which it relates has been manufactured; and
(e)when the equipment has been placed on board a ship, ensure that he is able to supply the notified body’s certificate of conformity referred to in paragraph (3) above, on request, to the ship’s flag State.
(7) The manufacturer shall–
(a)take all measures necessary to ensure that the manufacturing process ensures that the equipment conforms to the specimen in respect of which the EC type-examination certificate was issued; and
(b)if the equipment is to be examined in batches–
(i)present the equipment to the notified body in homogeneous batches; and
(ii)take all measures necessary to ensure that the manufacturing process ensures the homogeneity of each batch manufactured.
(8) Where the examinations are carried out on batches of equipment the manufacturer may, with the authority of the notified body conducting the examinations and tests, affix the body’s identification control symbol and number to the items of equipment during the manufacturing process.
EC unit verification
16.—(1) A manufacturer who decides, in accordance with regulation 11(2) above, to apply the EC unit verification procedure to equipment may apply to a notified body for the carrying out of the appropriate examinations; and such an application shall be made in writing and include the technical documentation specified in Schedule 2 relating to the equipment to enable the notified body to perform its functions under paragraph (2) below.
(2) On an application under paragraph (1) above, the notified body shall carry out appropriate examinations and tests in accordance with paragraph 2, of the section entitled “Unit Verification (Module G)”, in Annex B of the Directive and set out in Merchant Shipping Notice MSN 1734 to establish whether the equipment complies with the applicable international standards.
(3) Where, after conducting the appropriate examinations and tests, the notified body is satisfied that an item of equipment has been manufactured in conformity with the applicable international standards it shall affix, or cause to be affixed, to the item its identification control symbol and number and draw-up a written certificate of conformity relating to the examinations and tests carried out.
(4) Where a manufacturer’s equipment is examined and tested by a notified body under this regulation, the manufacturer or his authorised representative established within the Community shall–
(a)ensure and declare that the items of equipment satisfy the applicable international standards;
(b)affix the mark referred to in regulation 18 below to each item of equipment to which it relates;
(c)draw-up a written declaration of conformity;
(d)keep a copy of the declaration of conformity referred to in sub-paragraph (c) above for at least 10 years after the last item of equipment to which it relates has been manufactured; and
(e)when the equipment has been placed on board a ship, ensure that he is able to supply the notified body’s certificate of conformity referred to under paragraph (3) above, on request, to the ship’s flag State.
EC full quality assurance
17.—(1) A manufacturer who decides, in accordance with regulation 11(1) above, to apply the EC full quality assurance procedure to equipment, may apply to any notified body for approval of his quality assurance system (in this regulation referred to as “the system”); and such an application shall be made in writing and shall include–
(a)all relevant information for the equipment category envisaged; and
(b)the documentation concerning the system.
(2) On an application made to it under paragraph (1) above, the notified body shall evaluate the system to determine whether it satisfies the requirements referred to in paragraph 3.2, of the section entitled “Full-Quality Assurance (Module H)”, in Annex B of the Directive and set out in Merchant Shipping Notice MSN 1734 and, if the system implements the relevant harmonised standard, it shall be taken to satisfy the said requirements.
(3) Paragraphs (3) to (15) of regulation 14 above shall apply in relation to a system which is the subject of an application under this regulation as they apply to the production quality assurance system and product quality assurance system under that regulation, as if for paragraph (12)(a) there were substituted the following:
“(a)ensure and declare that the items of equipment concerned satisfy the applicable international standards;”.
(4) In addition to the application under paragraph (1) above, the manufacturer shall apply to a notified body for an approval of the design of the equipment which is to be subject to the EC full quality assurance procedure.
(5) An application under paragraph (4) above shall include all documentation necessary to enable the notified body to understand the design, manufacture and operation of the equipment and to assess its compliance with the applicable international standards; and in particular–
(a)the technical design specifications, including standards, that have been applied to the design; and
(b)the necessary supporting evidence, including the results of any tests carried out in an appropriate laboratory by the manufacturer, or on his behalf, for the adequacy of the technical design specifications, in particular where the standards specified in regulation 6 above have not been applied in full.
(6) On an application made to it under paragraph (4) above, the notified body shall examine the design to determine whether it satisfies the applicable international standards.
(7) Where a notified body is satisfied, after examining the design pursuant to paragraph (6) above, that the design satisfies the applicable international standards it shall issue to the manufacturer an EC design-examination certificate.
(8) A certificate issued under paragraph (7) above shall include–
(a)the conclusions of the examination;
(b)the conditions of its validity;
(c)the data necessary to identify the approved design; and
(d)if relevant, a description of the equipment’s functioning.
(9) Where the notified body is not satisfied as is mentioned in paragraph (7) above, it shall inform the manufacturer in writing–
(a)of its decision to refuse to grant an approval in respect of the design; and
(b)the conclusions of any examinations and the evaluation carried out by it.
(10) If any modification is made to a design in respect of which an EC design-examination certificate has been issued, the applicant shall inform the notified body which issued the certificate.
(11) If a modification such as is referred to in paragraph (10) above is such that it may affect the equipment’s compliance with the applicable international standards or any prescribed conditions for the use of the equipment, the notified body shall satisfy itself, by further examinations and tests if necessary, that the design as modified complies with the applicable international standards and, if so satisfied, shall–
(a)approve the modifications to the design; and
(b)issue an addition to the original EC design-examination certificate in respect thereof.
(12) A notified body shall on request, provide flag member States and other notified bodies with all relevant information concerning–
(a)EC design-examination certificates, and additions thereto, it has issued, including any it has withdrawn; and
(b)EC design approvals, and additions thereto, it has granted, including any it has withdrawn.
Affixing of mark of conformity
18.—(1) Subject to paragraph (2) below, the mark to be affixed by the manufacturer or his authorised representative within the Community in accordance with the relevant EC conformity-assessment procedure shall be affixed–
(a)to each item of equipment to which it relates; or
(b)to a data plate attached to the equipment, and shall satisfy the requirements of paragraph (3) below.
(2) If it is not possible or warranted due to the nature of the item of equipment to affix the mark as required by paragraph (1) above, the mark shall be affixed to–
(a)the packaging of the item of equipment;
(b)a label on the item of equipment or its packaging; or
(c)a leaflet distributed with the item of equipment.
(3) The requirements referred to in paragraph (1) above are that the mark shall be affixed to the item of equipment or data plate so as to be visible, legible and indelible throughout the anticipated life of the equipment.
(4) The form of the mark to be affixed shall be that set out in Schedule 3.
(5) The mark as affixed shall be followed by–
(a)the identification symbol and number of the notified body which carried out, or had carried out, the EC conformity-assessment procedure if that body is involved in the production control phase; and
(b)the last two digits of the year in which the mark was affixed.
(6) Where the identification symbol and number of the notified body is to be affixed under paragraph (5)(a) above, it shall be affixed under the responsibility of the notified body either by that body itself or by the manufacturer or his authorised representative established in the Community.
(7) No marks or inscriptions which are likely to mislead any person with regard to the meaning or the graphics of the mark shall be affixed.
(8) The mark shall be affixed at the end of the production phase.