The Recreational Craft Regulations 2017

[F1 Quality system E+W+S

3.— (1) The manufacturer must lodge an application for assessment of the manufacturer's quality system with the approved body of the manufacturer's choice for the products concerned.

(2) The application must include—

(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, the name and address of the authorised representative;

(b) a declaration that the same application has not been lodged with any other approved body;

(c) all relevant information for the product category envisaged;

(d) the documentation concerning the quality system;

(e) the technical documentation of the approved type and a copy of the type examination certificate.

(3) The quality system must ensure that the products—

(a) are in conformity with the type described in the type examination certificate; and

(b) meet the essential requirements that apply to them.

(4) All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions.

(5) The quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records and must, in particular, contain an adequate description of—

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

(b) the corresponding 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 and qualification reports on the personnel concerned; and

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

(6) The approved body must assess the quality system to determine whether it satisfies the requirements referred to in sub-paragraph (3). The approved body must presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard or technical specification.

(7) For the purpose of the assessment referred to in sub-paragraph (6), the approved body must ensure that—

(a) in addition to experience in quality management systems, the auditing team has at least one member with experience of evaluation in the relevant product field and product technology concerned and knowledge of the essential requirements that apply to the products;

(b) the audit includes an assessment visit to the manufacturer's premises; and

(c) the auditing team reviews the technical documentation referred to in sub-paragraph (2)(e) to verify the manufacturer's ability to identify the essential requirements that apply to the products and to carry out the necessary examinations with a view to ensuring compliance of the products with those requirements.

(8) The approved body must notify its decision on whether the quality system satisfies the requirements referred to in sub-paragraph (3) to the manufacturer. The notification must contain the conclusions of the audit and the approved body's reasoned assessment.

(9) The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

(10) The manufacturer must keep the approved body that approved the quality system informed of any intended change to the quality system, and if so informed, the approved body must evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in sub-paragraph (3) or whether a reassessment is necessary.

(11) The approved body must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the approved body's reasoned assessment.]

Textual Amendments

F1 Sch. 15 inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 28 para. 54 (with Sch. 28 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)