{
  "url": "https://openlegislation.uk/eu-regulation-2016-425/annex-VIII/division-CONFORMITY/division-3/division-3.2",
  "json_url": "https://openlegislation.uk/eu-regulation-2016-425/annex-VIII/division-CONFORMITY/division-3/division-3.2.json",
  "legislation": "eur/2016/425",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2016-425",
  "path": "annex/VIII/division/CONFORMITY/division/3/division/3.2",
  "kind": "division",
  "number": "3.2",
  "heading": null,
  "text": "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.\nAll 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.\nThe quality system documentation shall, in particular, contain an adequate description of:\n(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;\n(b)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;\n(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;\n(d)the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned; and\n(e)the means of monitoring the achievement of the required product quality and the effective operation of the quality system.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in Annex 8 para. 3.2 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(a); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2016/425/annex/VIII/division/CONFORMITY/division/3/division/3.2",
    "retrieved_at": "2026-11-01T14:45:58.157392+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}