{
  "url": "https://openlegislation.uk/eu-regulation-2016-425/annex-VIII/division-CONFORMITY/division-3/division-3.3",
  "json_url": "https://openlegislation.uk/eu-regulation-2016-425/annex-VIII/division-CONFORMITY/division-3/division-3.3.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/3.3",
  "kind": "division",
  "number": "3.3",
  "heading": null,
  "text": "The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.\nIt 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.\nIn addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the field of PPE and technology concerned, and knowledge of the applicable essential health and safety requirements. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation of the PPE referred to in point 3.1 to verify the manufacturer's ability to identify the applicable essential health and safety requirements and to carry out the necessary examinations with a view to ensuring conformity of the PPE with those requirements.\nThe result of that assessment shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in Annex 8 para. 3.3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(c); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Word in Annex 8 para. 3.3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(e); 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/3.3",
    "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."
}