The Boiler (Efficiency) Regulations 1993

Part II

Production quality assurance

4.—(1) This Part of the Schedule describes the procedure whereby the manufacturer who satisfies the obligations of paragraph 5 of this Schedule 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 these Regulations.

(2) The manufacturer or his authorised representative established within the Community shall affix the EC mark to each product and draw up a written declaration of conformity.

(3) The EC mark shall be accompanied by the identification number of the notified body responsible for the checks referred to in paragraph 7.

(4) Before 1st January 1995—

(a) sub-paragraph (2) shall have effect with the omission of the words “or his authorised representative established within the Community”were omitted; and

(b) sub-paragraph (3) shall have effect with the substitution for the word “number” of the word “symbol”.

5.  The manufacturer shall operate an approved quality system for production, final product inspection and testing as specified in paragraph 6. He shall be subject to the checks referred to in paragraph 7.

Quality system

6.—(1) The manufacturer shall lodge an application for assessment of his quality system with a notified body of his choice, for the products concerned.

(2) The application shall include—

(a) all relevant information for the product category envisaged,

(b) the documents concerning the quality system,

(c) the technical documents pertaining to the approved type and a copy of the EC type-examination certificate.

(3) The quality system shall ensure conformity of appliances with the type as described in the EC type-examination certificate and with the requirements of these Regulations that apply to them.

(4) 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.The quality system documents shall permit a consistent interpretation of the quality programmes, plans, manuals and quality records.

(5) The quality system shall contain in particular an adequate description of —

(a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to appliance quality,

(b) the manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

(c) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

(d) the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc., and

(e) the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

(6) The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in sub-paragraphs (3) to (5) of this paragraph. It shall presume conformity with those requirements in respect of quality systems that implement the relevant harmonised standard. The auditing team shall have at least one member with experience of assessing the relevant product technology. The assessment procedure shall include an inspection visit to the manufacturer’s premises.

(7) The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the duly substantiated assessment decision.

(8) The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and maintain it at an adequate and efficient level.

(9) The manufacturer or his authorised representative shall keep the notified body that has approved the quality system informed of any proposed change in the quality system.

(10) The notified body shall assess the changes proposed and decide whether the altered quality system will still satisfy the requirements referred to in sub-paragraph (3) to (5) of this paragraph or whether reassessment is required. (11) The notified body shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the substantiated assessment decision.

Monitoring under the responsibility of the notified body

7.—(1) The purpose of monitoring is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

(2) The manufacturer shall allow the notified body access for inspection purposes to the manufacturing, inspection, testing and storage premises and provide it with all necessary information, in particular —

(a) the quality system documents,

(b) the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

(3) The notified body shall periodically carry out audits to ensure that the manufacturer maintains and applies the quality system and provides an audit report to the manufacturer.

(4) Additionally the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out tests or have them carried out to verify that the quality system is functioning correctly; if necessary, the notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

8.  Each notified body shall give the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.