Commission Delegated Regulation (EU) No 44/2014Show full title

3. Continued verification arrangements

3.1 The authority which has granted type-approval may at any time verify the conformity of production control methods applied in each production facility by means of periodic audits. The manufacturer shall for that purpose allow access to the manufacture, inspection, testing, storage and distribution sites and shall provide all necessary information with regard to the quality management system documentation and records.

3.1.1. The normal approach for such periodic audits shall be to monitor the continued effectiveness of the procedures laid down in sections 1 and 2 (initial assessment and product conformity arrangements).

3.1.1.1. Surveillance activities carried out by the technical services (qualified or recognised as required in point 1.3.3) shall be accepted as satisfying the requirements of point 3.1.1 with regard to the procedures established at initial assessment.

3.1.1.2. The normal frequency of these verifications by the approval authority (other than those referred to in point 3.1.1.1) shall be such as to ensure that the relevant conformity of production controls applied in accordance with sections 1 and 2 are reviewed over a period consistent with the climate of trust established by the approval authority.

3.2. At every review, the records of tests and checks and production records, in particular records of those tests or checks documented as required in point 2.2, shall be available to the inspector;

3.3. The inspector may select random samples to be tested in the manufacturer’s laboratory or in the facilities of the technical service, in which case only physical tests shall be carried out. The minimum number of samples may be determined according to the results of the manufacturer’s own verification.

3.4. Where the level of control appears unsatisfactory, or when it seems necessary to verify the validity of the tests carried out in application of point 3.2, the inspector shall select samples to be sent to the technical service to perform physical tests according to the requirements regarding conformity of production set out in point 4 and in the UNECE regulations referred to in Regulation (EU) No 168/2013 or in its delegated acts.

3.5. Where unsatisfactory results are found during an inspection or a monitoring review, the approval authority shall ensure that all necessary steps are taken to restore conformity of production as rapidly as possible.

3.6. In cases where compliance with UNECE regulations is required by Regulation (EU) No 168/2013 or its delegated acts, the manufacturer may choose to apply the provisions of this Annex as an equivalent alternative to the conformity of production requirements in the respective UNECE regulations. However, if points 3.5 or 3.6 apply, all separate conformity of production requirements in the UNECE regulations have to be complied with to the satisfaction of the approval authority until it decides that conformity of production has been restored.