1. A verifier shall establish, document, implement and maintain one or more procedures for verification activities as described in Chapter II, and the procedures and processes required by Annex II. When establishing and implementing these procedures and processes the verifier shall carry out the activities listed in Annex II of this Regulation in accordance with the harmonised standard referred to in that Annex.

2. A verifier shall design, document, implement and maintain a management system in accordance with the harmonised standard referred to in Annex II to ensure consistent development, implementation, improvement and review of the procedures and processes referred to in paragraph 1. The management system shall include at least the following:

(a) policies and responsibilities;

(b) management review;

(c) internal audits;

(d) corrective action;

(e) actions to address risk and opportunities and to take preventive action;

(f) control of documented information.