Quality Management Program
Since 2013 all lithium cells and batteries must be manufactured according to a documented quality management program. At the moment it doesn´t have to be a certified system, e.g. like ISO 9001, yet. But it must be a system documented in writing which must be provided to the appropriate authority upon request. As shipper of lithium cells and batteries you must have a written confirmation of the existence of this quality management program by the cell/battery or equipment manufacturer. Without this confirmation the transport is prohibited.
The quality management program must fulfill the following requirements (This is the original text of the requirements in Italic):
Cells and batteries must be manufactured under a quality management program that includes:
(i) a description of the organizational structure and responsibilities of personnel with regard to design and product quality;
(ii) the relevant inspection and test, quality control, quality assurance and process operation instructions that will be used;
(iii) process controls that should include relevant activities to prevent and detect internal short circuit failure during manufacture of cells;
(iv) quality records, such as inspection reports, test data, calibration data and certificates. Test data must be kept and made available to the appropriate national authority upon request;;
(v) management reviews to ensure the effective operation of the quality management program;
(vi) a process for control of documents and their revision;
(vii) a means for control of cells or batteries that are not conforming to the type tested as mentioned in (a) above;
(viii) training programs and qualification procedures for relevant personnel; and
(ix) procedures to ensure that there is no damage to the final product.
Note: In house quality management programs may be accepted. Third party certification is not required, but the procedures listed in 1. to 9. above must be properly recorded and traceable. A copy of the quality management program must be made available to the appropriate national authority upon request.
Sources / References:
UN Model Regulations on the Transport of Dangerous Goods: Section 2.9.4 e)
ICAO TI: Part 2, 2;9.3.1 e)
IATA DGR: 126.96.36.199.1 (e)
IMDG Code: 2.9.4 e)
ADR/RID/ADN: 188.8.131.52.7 e)