anx_VIII__table__24

| 4. | Surveillance under the responsibility of the notified body 4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design, development, production, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: (a) the quality system documentation; (b) the quality records as provided for by the design part of the quality system, such as results of analyses, calculations and tests; (c) the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned. 4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

← anx_VIII__table__23 · All articles · anx_VIII__table__25 →

Source: EUR-Lex CELLAR · retrieved 2026-09-04 · Text as adopted (Official Journal); later amendments are not incorporated in this text.