Chapter IV, Article 21 · Commission Implementing Regulation (EU) 2020/1207

Contents

Article 21Quality management system#

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.