Textual Amendments
F1Schs. 1A-1K 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. 27 para. 49 (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
1. Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 4 and 7, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned satisfy the requirements of these Regulations that apply to them.E+W+S
2. The manufacturer shall establish the technical documentation set out in regulations 44 and 45. The documentation shall make it possible to assess the instrument's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument.
3. The manufacturer shall keep the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market.E+W+S
4. The manufacturer shall operate an approved quality system for production, final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 5 and shall be subject to surveillance as specified in paragraph 6.
5.1. The manufacturer shall lodge an application for assessment of his quality system with an approved body of his choice, for the measuring instruments concerned.E+W+S
The application shall include:
(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
(b)a written declaration that the same application has not been lodged with any other approved body;
(c)all relevant information for the instrument category envisaged;
(d)the documentation concerning the quality system;
(e)the technical documentation referred to in paragraph 2.
5.2. The quality system shall ensure compliance of the regulated measuring instruments with the requirements of these Regulations that apply to them.E+W+S
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. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, 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, qualification reports on the personnel concerned;
(e)the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
5.3. The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 5.2.E+W+S
It shall 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.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of these Regulations. The audit shall include an assessment visit to the manufacturer's premises.
The auditing team shall review the technical documentation referred to in paragraph 2 in order 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 instrument with those requirements.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.
5.4. 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.E+W+S
5.5. The manufacturer shall keep the approved body that has approved the quality system informed of any intended change of the quality system.E+W+S
The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 5.2 or whether a re-assessment is necessary.
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
6.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.E+W+S
6.2. The manufacturer shall, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:E+W+S
(a)the quality system documentation;
(b)the technical documentation referred to in paragraph 2;
(c)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned.
6.3. The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.E+W+S
6.4. In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.E+W+S
7.1. The manufacturer shall affix the UK marking, the M marking set out in these Regulations, and, under the responsibility of the approved body referred to in paragraph 5.1, the latter's identification number to each individual regulated measuring instrument that satisfies the applicable requirements of these Regulations.E+W+S
7.2. The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument model for which it has been drawn up.E+W+S
A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request.
A copy of the declaration of conformity shall be supplied with each regulated measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.
8. The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the market surveillance authorities:E+W+S
(a)the documentation referred to in paragraph 5.1;
(b)the information relating to the change referred to in paragraph 5.5, as approved;
(c)the decisions and reports of the approved body referred to in paragraphs 5.5, 6.3 and 6.4.
9. Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted.E+W+S
10. The manufacturer's obligations set out in paragraphs 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.]