Paragraph 2 System for ensuring EC quality of production by means of monitoring

The purpose of supervision is to ensure that a manufacturer correctly fulfils the obligations arising from the approved quality-control system.

The manufacturer shall authorize the body to have access, for purposes of inspection, to PPE inspection, testing and storage sites and shall provide the body with all requisite information, in particular:

• documentation on the quality-control system,

• technical documentation,

• quality control manuals.

The body shall periodically carry out audits to ensure that the manufacturer is maintaining and applying the approved quality-control system and shall provide the manufacturer with a copy of the audit report.

In addition, the body may make unnannounced visits to the manufacturer. In the course of such visits the body shall provide the manufacturer with a report of the visit and, if appropriate, with an audit report.

The manufacturer must be able to present, on request, the report of the body of which notification has been given.