# Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance), Division 3.2

Extent: E+W+S+N.I.

The quality system shall ensure that the PPE is in conformity with the type described in the ... type-examination certificate and complies with the applicable requirements of this Regulation.
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. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
The quality system documentation 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 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.

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Source: https://www.legislation.gov.uk/eur/2016/425/annex/VIII/division/CONFORMITY/division/3/division/3.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2016-425/annex-VIII/division-CONFORMITY/division-3/division-3.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.