OpenLegislation

Article 21 Quality management system

United Kingdom

Original text. Later amendments are not shown.

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.