AMC11 Article 15(1)(e) Conditions for obtaining a certificate

MANAGEMENT SYSTEM — COMPLIANCE MONITORING

The applicant should:

(a)     specify the basic structure of the compliance monitoring function, structured according to the size of the service provider and the complexity of the activities to be monitored, including those which have been subcontracted;

(b)     monitor compliance with the procedures they have designed to ensure that services are provided with the required level of safety and quality, as applicable; in doing so, they should as a minimum, and where appropriate, monitor:

(1)     manuals, logs, and records;

(2)     training standards; and

(3)     management system procedures;

(c)      ensure that a staff member is responsible for compliance monitoring to ensure that the organisation continues to meet the applicable requirements; the accountable manager should ensure that adequate resources are allocated for compliance monitoring;

(d)     ensure that the personnel involved in compliance monitoring have access to all parts of the applicant’s management system documentation and, as necessary, of any subcontracted organisation; in the case the person responsible for compliance monitoring also acts as safety manager, the accountable manager, with regard to their direct accountability for safety, should ensure that sufficient resources are allocated to both functions, taking into account the size of the applicant, and the nature and complexity of its activities; the independence of the compliance monitoring function should be established by ensuring that audits and inspections are carried out by personnel not directly involved in the activity being audited;

(e)     ensure that the relevant documentation includes relevant part(s) of the applicant’s management system documentation; the relevant documentation should also include:

(1)     terminology;

(2)     a description of the service provider;

(3)     allocation of duties and responsibilities;

(4)     procedures for ensuring compliance; and

(5)     the compliance monitoring programme, reflecting:

(i)      the schedule of the monitoring programme;

(ii)     audit procedures;

(iii)     reporting procedures;

(iv)     follow-up and corrective action procedures;

(v)      the record-keeping system; and

(vi)     document control;

(f)      ensure that the personnel responsible for managing the compliance monitoring function receive training in this task; such training should cover compliance monitoring requirements, manuals and procedures related to the task, audit techniques, reporting and recording; the allocation of time and resources should be governed by the volume and complexity of the activities concerned.