New CNAS Accreditation for Group Enterprise Internal Laboratories Explained

On January 12, 2022, the CNAS (China National Accreditation Service for Conformity Assessment) issued the CNAS-EL-21: 2022 to provide guidance for applying for the accreditation for group enterprise internal laboratories. The regulatory instructions will come into effect on March 1, 2022.

Scope

• The core business function of group enterprise internal laboratories should be testing products and related raw materials that are manufactured internally.

• Headquarters of the group enterprise should have its own laboratory operating independently.

Conditions of Accreditation

• The group enterprise internal laboratories should be operated for a minimum duration of 5 years under a constantly improving management system.

• Before applying for the accreditation as group enterprise internal laboratories, the enterprise should have a minimum of 10 laboratories in total, including laboratories of the headquarters and subsidiary companies, that must be CNAS accredited already.

• The group enterprise internal laboratories should have a clear organization structure, and have responsibilities, authorities and interrelationships clearly defined for each management level. The headquarters of the group enterprise or its main laboratory should establish a quality evaluation system for the subsidiary laboratories involved.

Once the accreditation for group enterprise internal laboratories is obtained, manufacturers can facilitate synergy for business operations and meeting regulatory requirements, including self-tests, in China. (More information about self-testing requirements available in our previous blog post).

By Julie Zhang and Jacky Li. Contact Cisema if you would like to learn more.