Textual Amendments
F1Sch. 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)
1. Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer—
(a)fulfils the obligations set out in paragraphs 2 and 5; and
(b)ensures and declares on the manufacturer's sole responsibility that the product concerned—
(i)is in conformity with the type described in the type examination certificate; and
(ii)meets the essential requirements that apply to it.
2. The manufacturer—
(a)must operate an approved quality system for production, final product inspection and testing of the products concerned as specified in paragraph 3; and
(b)is subject to surveillance as specified in paragraph 4.
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.
4.—(1) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
(2) The manufacturer must, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites and must provide it with all necessary information, in particular—
(a)the quality system documentation;
(b)the quality records, such as inspection reports and test data, calibration data, and qualification reports on the personnel concerned.
(3) The approved body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and must provide the manufacturer with an audit report.
(4) In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body must provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
5.—(1) The manufacturer must affix the UK marking and, under the responsibility of the approved body referred to in paragraph 3(1), the approved body's identification number to each individual product that is in conformity with the type described in the type examination certificate and meets the essential requirements that apply to it.
(2) The manufacturer must draw up a declaration of conformity for each product model and keep it at the disposal of the enforcing authority for 10 years after the product has been placed on the market. The declaration of conformity must identify the product model for which it has been drawn up.
(3) The manufacturer must make a copy of the declaration of conformity available to the enforcing authority upon request.
6. The manufacturer must, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the enforcing authority—
(a)a copy of the application referred to in paragraph 3(1) including the information and documentation referred to in paragraph 3(2);
(b)documents relating to any change to the quality system referred to in paragraph 3(10), as approved by the approved body;
(c)the decisions and reports of the approved body referred to in paragraphs 3(11) and 4(3) and (4).
7.—(1) Each approved body must inform the Secretary of State of quality system approvals issued or withdrawn and must, periodically or upon request, make available to the Secretary of State a list of quality system approvals refused, suspended or otherwise restricted.
(2) Each approved body must inform the other approved bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.]