Sch 1A para 96 Quality system
(1) The manufacturer shall lodge an application for assessment of their quality system with the approved body of their choice for the pressure equipment, or assembly, concerned. (2) The application shall include— (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, their name and address as well; (b) the technical documentation for one model of each type of pressure equipment, or assembly, intended to be manufactured which shall, wherever applicable, contain— (i) a general description of the pressure equipment or assembly; (ii) conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits and any other relevant parts, to component level; (iii) descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment or assembly; (iv) a list of the designated standards, applied in part or in full, and descriptions of the solutions adopted to meet the essential safety requirements of these Regulations where those designated standards have not been applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied; (v) results of design calculations made, examinations carried out and the results of any other relevant calculation or examination; (vi) test reports; (c) a written declaration that the same application has not been lodged with any other approved body; and (d) the documentation concerning the quality system. (3) The quality system shall ensure compliance of the pressure equipment, or assembly, with the requirements of these Regulations that apply to it. (4) All 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. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records, including— (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 will not be applied in full, the means that will be used to ensure that the essential requirements of these Regulations that apply to the pressure equipment or assembly will be met; (c) the design control and design verification techniques, processes and systematic actions that will be used when designing the pressure equipment, or assembly, pertaining to the product type covered, particularly with regard to materials in accordance with Part 4 of Schedule 2 to these Regulations; (d) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures used for the permanent joining of parts as approved with paragraph 21 of Schedule 2 to these Regulations; (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, reports concerning the qualifications and approvals of the personnel concerned, particularly of those of the personnel undertaking the permanent joining of parts and the non-destructive test in accordance with paragraphs 21 and 22 of Schedule 2 to these Regulations; and (g) the means of monitoring the achievement of the required design and pressure equipment quality and the effective operation of the quality system. (5) The approved body shall— (a) assess the quality system to determine whether it satisfies the requirements referred to in sub-paragraphs (3) and (4); (b) 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; (c) provide a team with experience in quality management systems; (d) ensure that the audit— (i) is carried out by a team containing at least one member with knowledge of the relevant pressure equipment, or assembly, field and pressure equipment and assembly technology concerned, and knowledge of the applicable requirements of these Regulations; (ii) includes an inspection visit to the manufacturer's premises; (iii) reviews the technical documentation referred to in sub-paragraph (2)(b), to verify the manufacturer's ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements. (6) The decision shall— (a) be notified to the manufacturer, or his authorised representative; (b) contain the conclusions of the audit; and (c) contain a reasoned assessment decision. (7) The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. (8) Where the manufacturer intends to change the quality system— (a) the manufacturer shall inform the approved body that has approved the quality system of the intended change to the quality system; (b) the approved body shall evaluate the proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in subparagraph (5) or whether a reassessment is necessary; (c) the approved body shall notify the manufacturer of its decision; and (d) the notification shall contain the conclusions of the examination and the reasoned assessment decision.