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Paragraph

This Annex describes the conformity assessment of machinery referred to in Annex IV (Part 4 of this Schedule), manufactured using a full quality assurance system, and the procedure whereby F1a notified an approved body assesses and approves the quality system and monitors its application.

1.The manufacturer must operate an approved quality system for design, manufacture, final inspection and testing, as specified in point 2 of this Annex, and shall be subject to the surveillance referred to in point 3 of this Annex.
2.Quality system
2.1.An application for assessment of a quality system shall be lodged by the responsible person with a notified an approved body chosen by the responsible person.
The application shall contain:
the name and address of the manufacturer and, where appropriate, the manufacturer's authorised representative,
the places of design, manufacture, inspection, testing and storage of the machinery,
the technical file described in Annex VII (Part 7 of this Schedule), part A, for one model of each category of machinery referred to in Annex IV (Part 4 of this Schedule) which the manufacturer intends to manufacture,
the documentation on the quality system,
a written declaration that the application has not been submitted to another F2notified approved body.
2.2.The quality system must ensure conformity of the machinery with the provisions of F3the Directive these Regulations. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner, in the form of measures, procedures and written instructions. The documentation on the quality system must permit a uniform interpretation of the procedural and quality measures, such as quality programmes, plans, manuals and records.
It must contain, in particular, an adequate description of:
the quality objectives, the organisational structure, and the responsibilities and powers of the management with regard to the design and quality of the machinery,
the technical design specifications, including standards that will be applied and, where published F4harmonised designated standards are not applied in full, the means that will be used to ensure that the essential health and safety requirements are fulfilled,
the design inspection and design verification techniques, processes and systematic actions that will be used when designing machinery covered by the Directive these Regulations,
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,
the inspections and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
the quality records, such as inspection reports and test data, calibration data, and reports on the qualifications of the personnel concerned,
the means of monitoring the achievement of the required design and quality of the machinery, as well as the effective operation of the quality system.
2.3.The F5notified approved body shall assess the quality system to determine whether it satisfies the requirements of point 2.2 of this Annex.
The elements of the quality system which conform to the relevant harmonised designated standard shall be presumed to conform to the corresponding requirements referred to in point 2.2.
The team of auditors must have at least one member who is experienced in the assessment of the technology of the machinery. The assessment procedure shall include an inspection to be carried out at the manufacturer's premises. During the assessment, the team of auditors shall carry out a review of the technical files referred to in the third indent of the second paragraph of point 2.1 of this Annex, to ensure their compliance with the applicable health and safety requirements.
The responsible person shall be notified of the decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. An appeal procedure must be available.
2.4.The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure that it remains appropriate and effective.
The responsible person shall inform the F6notified approved body which approved the quality system of any planned change to it.
The notified approved body shall evaluate the proposed changes and decide whether the modified quality assurance system will continue to satisfy the requirements referred to in point 2.2, 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.
3.Surveillance under the responsibility of the F7notified approved body
3.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
3.2.The manufacturer shall, for inspection purposes, allow the F8notified approved body access to the places of design, manufacture, inspection, testing and storage, and shall provide it with all necessary information, such as:
the documentation concerning the quality system,
the quality records provided for in that part of the quality system concerned with design, such as the results of analyses, calculations, tests, etc.,
the quality records provided for in that part of the quality system concerned with manufacture, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.
3.3.The F9notified approved body shall conduct periodic audits to make sure that the manufacturer is maintaining and applying the quality system; it shall provide the manufacturer with an audit report. The frequency of the periodic audits shall be such that a full reassessment is carried out every three years.
3.4.Moreover, the F10notified approved body may pay the manufacturer unannounced visits. The need for these additional visits and their frequency will be determined on the basis of a visit monitoring system managed by the notified approved body. In particular, the following factors will be taken into account in the visits monitoring system:
the results of previous surveillance visits,
the need to monitor remedial measures,
where appropriate, special conditions attaching to approval of the system,
significant modifications in the organisation of the manufacturing process, measures or techniques.
On the occasion of such visits, the notified approved body may, if necessary, carry out tests or have them carried out in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if a test was carried out, with a test report.
4.The responsible person shall keep available for the national authorities, for a period of ten years from the last date of manufacture:
the documentation referred to in point 2.1 of this Annex,
the decisions and reports of the F11notified approved body referred to in the third and fourth subparagraphs of point 2.4 of this Annex, and in points 3.3 and 3.4 of this Annex.

Annotations

Textual amendments

F1

Words in Sch. 2 Pt. 10 substituted (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. 12 para. 30(a) (with Sch. 12 para. 22) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F2

Word in Sch. 2 Pt. 10 substituted (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. 12 para. 30(b)(i) (with Sch. 12 para. 22) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F3

Words in Sch. 2 Pt. 10 substituted (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. 12 para. 30(c) (with Sch. 12 para. 22) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F4

Word in Sch. 2 Pt. 10 substituted (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. 12 para. 30(d) (with Sch. 12 para. 22) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F5

Word in Sch. 2 Pt. 10 substituted (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. 12 para. 30(b)(ii) (with Sch. 12 para. 22) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F6

Word in Sch. 2 Pt. 10 substituted (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. 12 para. 30(b)(iii) (with Sch. 12 para. 22) (as amended immediately before exit day by S.I. 2019/1246, regs. 1(3), 11(d) and S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F7

Word in Sch. 2 Pt. 10 substituted (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. 12 para. 30(b)(iv) (with Sch. 12 para. 22) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F8

Word in Sch. 2 Pt. 10 substituted (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. 12 para. 30(b)(v) (with Sch. 12 para. 22) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F9

Word in Sch. 2 Pt. 10 substituted (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. 12 para. 30(b)(vi) (with Sch. 12 para. 22) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F10

Word in Sch. 2 Pt. 10 substituted (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. 12 para. 30(b)(vii) (with Sch. 12 para. 22) (as amended immediately before exit day by S.I. 2019/1246, regs. 1(3), 11(d) and S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F11

Word in Sch. 2 Pt. 10 substituted (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. 12 para. 30(b)(viii) (with Sch. 12 para. 22) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)