# The Recreational Craft Regulations 2017, Paragraph 3: Quality system


(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 product 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) the technical documentation for one model of each category of products intended to be manufactured, which must contain, where applicable, at least the following—
(i) a general description of the product;
(ii) conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits;
(iii) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product;
(iv) a list of the designated standards and other relevant technical specifications applied in full or in part (and where designated standards have been applied in part, the technical documentation must specify the parts which have been applied);
(v) where designated standards have not been applied, descriptions of the solutions adopted to meet the essential requirements;
(vi) results of design calculations made and examinations carried out;
(vii) test reports;
(c) the documentation concerning the quality system; and
(d) a declaration that the same application has not been lodged with any other approved body.
(3) The quality system must ensure that the products 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 design and product quality;
(b) the technical design specifications, including standards, that will be applied and, where the relevant designated standards or technical specifications will not be applied in full, the means that will be used to ensure that the essential requirements that apply to the products will be met;
(c) 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;
(d) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
(e) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
(f) the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned;
(g) the means of monitoring the achievement of the required design and 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 experienced as an assessor 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 sub-paragraph (2)(b) 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 product with those requirements.
(8) The approved body must notify the manufacturer or the manufacturer's authorised representative of its decision on whether the quality system satisfies the requirements referred to in sub-paragraph (3). 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.

---
Source: https://www.legislation.gov.uk/uksi/2017/737/schedule/15/part/10/paragraph/3 (the official version)
Page: https://openlegislation.uk/recreational-craft-regulations-2017/schedule-15/part-10/paragraph-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.