Regulation (EU) 2017/746 of the European Parliament and of the CouncilDangos y teitl llawn

2. QUALITY MANAGEMENT REQUIREMENTS

2.1. The notified body shall establish, document, implement, maintain and operate a quality management system that is appropriate to the nature, area and scale of its conformity assessment activities and is capable of supporting and demonstrating the consistent fulfilment of the requirements of this Regulation.

2.2. The quality management system of the notified body shall address at least the following:

(a)

management system structure and documentation, including policies and objectives for its activities;

(b)

policies for assignment of activities and responsibilities to personnel;

(c)

assessment and decision-making processes in accordance with the tasks, responsibilities and role of the notified body's personnel and top-level management;

(d)

the planning, conduct, evaluation and, if necessary, adaptation of its conformity assessment procedures;

(e)

control of documents;

(f)

control of records;

(g)

management reviews;

(h)

internal audits;

(i)

corrective and preventive actions;

(j)

complaints and appeals;

(k)

continuous training.

Where documents are used in various languages, the notified body shall ensure and control that they have the same content.

2.3. The top-level management of the notified body shall ensure that the quality management system is fully understood, implemented and maintained throughout the notified body organisation including subsidiaries and subcontractors involved in conformity assessment activities pursuant to this Regulation.

2.4. The notified body shall require all personnel to formally commit themselves by a signature or equivalent to comply with the procedures defined by the notified body. That commitment shall cover aspects relating to confidentiality and to independence from commercial and other interests, and any existing or prior association with clients. The personnel shall be required to complete written statements indicating their compliance with confidentiality, independence and impartiality principles.