The Supply of Machinery (Safety) Regulations 2008

Changes over time for: PART 10

Alternative versions:

Changes to legislation:

There are currently no known outstanding effects for the The Supply of Machinery (Safety) Regulations 2008, PART 10.

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.

Regulations 11(2)(c), 12(2)(b), 18(1)

PART 10U.K.Annex X: Full quality assurance

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] [F1an 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 [F1a notified] [F1an 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] [F2approved] body.

2.2.	The quality system must ensure conformity of the machinery with the provisions of [F3the Directive] [F3these 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] [F4designated] 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 [F3the Directive] [F3these 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] [F5approved] 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 [F4harmonised] [F4designated] 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] [F6approved] body which approved the quality system of any planned change to it.

	The [F6notified] [F6approved] 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] [F7approved] 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] [F8approved] 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] [F9approved] 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] [F10approved] 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 [F10notified] [F10approved] 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 [F10notified] [F10approved] 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] [F11approved] 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.