# Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices (Text with EEA relevance), Article 21: Quality management system

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

1. Reprocessors shall establish, document, implement, and maintain a QMS for the reprocessing activities.
2. The QMS shall ensure that requirements set out in this Regulation and requirements applicable to reprocessing set out in Regulation (EU) 2017/745 are complied with.
3. The QMS shall cover the organisation of all steps of reprocessing and shall address at least the following aspects:
(a) strategy for regulatory compliance;
(b) procedures for each step of the reprocessing cycle;
(c) description of the responsibilities, of the personnel involved in reprocessing (tasks, qualification, training and continuous training), and description of the premises;
(d) establishment and maintenance of the technical documentation referred to in Article 9;
(e) control of documents and communications concerning the reprocessing activities;
(f) control of records concerning the reprocessing activities;
(g) reporting of incidents and management of corrective and preventive actions and verification of their effectiveness;
(h) risk management;
(i) traceability system, including procedures for disposing or returning to the external reprocessor reprocessed single-use devices that do not belong to the health institution;
(j) internal and external audits;
(k) contract conditions with external entities participating in the reprocessing activities.

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Source: https://www.legislation.gov.uk/eur/2020/1207/article/21 (the official version)
Page: https://openlegislation.uk/eu-regulation-2020-1207/article-21
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.