ARCHIVE: Imports from third countries

Imports from third countries Article 11(6):
implementation of standards EN 45011 or ISO 65 (Commission document 7607/VI/97 rev.3)

1. Conformity with the requirements of standards EN 45011 or ISO 65 for inspection bodies(1) in third countries

As a principle the inspection body in the third country should satisfy the requirements of either the Standard EN 45011 or the equivalent rule at international level Standard ISO 65. Such conformity can be decided by:

1. The official accreditation body designated in the third country (preferably an official accreditation body should be subject to international mutual recognition agreements based on peer evaluation put into place by the International Accreditation Forum - IAF -) or in any MS of the European Union for accreditation inspection bodies.

The official accreditation body in the third country must comply with the requirements for accreditation bodies provided for in Standard ISO 61;

2. The competent authority in the third country (Government).

3. The competent authority in the MS who is going to grant the authorization.

In case 1: the importer must submit to the competent authority the relevant accreditation certificate or other documentary evidence that the inspection body is in conformity with the requirements of standards EN 45011 or ISO 65. The official accreditation process foresees periodical surveillance and re-assessment of the accredited inspection and certification bodies.

In case 2: the importer must submit the legal basis and the documents ensuring that a competent authority in the third country guarantees the conformity of the inspection body with the requirements of standards EN 45011 or ISO 65, and a periodical surveillance and re-assessment of the accredited inspection bodies, according to the requirements of EN 45011 or ISO 65, is made.

In case 3: the importer must submit to the competent authority in the MS all the information required by the competent authority to take a decision on the compliance with standards EN 45011 or ISO 65. A regular periodical surveillance and re-assessment of the accredited inspection bodies, according to the requirements of EN 45011 or ISO 65, must be made by:

independent and competent experts or official accreditation bodies agreed or designated by the competent authority in the MS (other inspection bodies cannot do this work).

The conditions indicated in the first paragraph, point 1 for official accreditation bodies in third countries, applies also to this case 3.


(1) In order to maintain the same technology used in Regulation No. 2092/91 we use the terms "inspection bodies", nevertheless these terms refer to the "certification bodies" indicated in the Standard EN 45011 or ISO 65.

Page published: 26 November 2003