The Non-automatic Weighing Instruments (EEC Requirements) Regulations 1995

Quality system approval and EC declaration of type conformity

13.—(1) An application for approval of a quality system as provided in paragraph 2.3 of Annex II of the Directive shall be made in writing to an approved body; and each application shall be accompanied by an undertaking by the manufacturer—

(a) to carry out the obligations arising fro the approved quality system; and

(b) to maintain the approved quality system to ensure its continuing suitability and effectiveness.

(2) The manufacturer shall make available to the approved body all relevant information including in particular—

(a) the documentation of the quality system presented in a systematic and orderly manner in the form of written rules, rocedures and instructions with a view to ensuring a proper understanding of the quality programmes, plans, manuals and records; and

(b) the design documentation of the instruments.

(3) On application made to it under paragraph (1) above, the approved body shall evaluate the quality system to determine whether it satisfies the requirements referred to in paragraph 2.3.2 of Annex II of the Directive and, if it conforms with the relevant national standard, it shall be taken to conform to those requirements.

(4) Where the approved body is satisfied, on application made to it under paragraph (1) above and after examining and evaluating the quality system, that the system satisfies the requirements referred to in paragraph 2.3.2 of Snnex II of the Directive it shall grant to the manufacturer an approval of the quality system; and accordingly the manufacturer shall have authority to make EC declarations of type conformity in accordance with paragraph (7) below.

(5) The approved body shall—

(a) include in the approval the conclusions of the examination and evaluation carried out by it; and

(b) shall inform the Secretary of State of the granting of the approval with a view to his notifying the other member States.

(6) Where the approved body, after carrying out its duties under paragraph (3) above, refuses to grant an approval of the quality system it shall in writing inform the manufacturer and the Secretary of State of its decision and the grounds for its decision.

(7) Where the manufacturer makes an EC declaration of type conformity, that is to say—

(a) he has adequately implemented an approved quality system;

(b) he has carried out the appropriate examinations and tests; and

(c) he is satisfied that the instruments concerned, where appropriate, have been manufactured in conformity with the approved type and satisfy the provisions of the Directive that apply to them,

the manufacturer or his authorised representative shall, in accordance with regulation 18, affix to each such instrument—

(i) the CE marking;

(ii) the inscriptions;

(iii) the sticker by way of confirmation that the instrument may be used for a Schedule 3 application; and

(iv) the identification number of the approved body which approved the manufacturer’s quality system,

and shall draw up a written declaration of conformity.

(8) In the case of an instrument—

(a) to which the CE marking, identification number and sticker have been affixed; and

(b) to which a disqualification sticker has been affixed under regulation 24, 25 or 27 or any corresponding provision in the law of a member State other than the United Kingdom,

the foregoing provisions of this regulation shall have effect as modified under paragraph (9) below.

(9) In a case to which paragraph (8) above applies, in paragraph (7) above for the words “the manufacturer or his authorised representative shall affix” to the end there shall be substituted the words

• “the manufacturer or his authorised representative shall affix to each such instrument—

  (a)

  the re-qualification sticker;

  (b)

  the identification number of the approved body which approved the manufacturer’s quality system if that number is different from the number already affixed to the instrument.”.