The main standard used by testing laboratories world-wide is ISO 17025 (sometimes called ISO/IEC 17025), issued by the International Organization for Standardization. ISO 17025 provides rules for how labs should operate in order to produce consistently valid results. ISO 17025 is also the basis for lab accreditation by bodies such as the American Association for Lab Accreditation.
The complete text of ISO 17025 is available at http://www.usocpressbox.org/usoc/pressbox.nsf/ac7bf642f496016a87256d0d006a340c/1b39aafc829ba275852572fc000de8ee/$FILE/023.PDF. The best general discussion I’ve seen of ISO 17025 is at http://www.labcompliance.com/tutorial/iso17025/default.aspx?sm=d_e.
(The version of ISO 17025 referred to in the ISL is the 1999 version, but at the time of the testing at issue in the FL arbitration, the 2005 version of ISO 17025 was in effect. USADA posted both the 1999 and 2005 versions of ISO 17025 as exhibits in the FL case, so it is not clear which version of ISO 17025 should be applied to the FL case. I have decided to use the 2005 version of ISO 17025 in this analysis. I do not believe that there are material differences between the two versions of ISO 17025 that would affect my analysis here.)
ISO 17025 applies one set of rules to be followed by all kinds of testing laboratories – not just anti-doping laboratories, or medical laboratories, or even laboratories that perform testing on human samples. For this reason, the standards in ISO 17025 are universal and general in nature. However, ISO 17025 recognizes that more specific requirements may be needed in order to ensure that specialty labs are competent to perform their jobs. For this reason, Annex B of ISO 17025 provides guidelines that certain specialty labs must use to supplement the general requirements of ISO 17025. In particular, Annex B.4 of ISO 17025 provides as follows:
[I]t may be necessary to develop a separate document of applications to supplement [ISO 17025] for specific types or groups of tests … Such a document should provide only the necessary supplementary information, while maintaining [ISO 17025] as the governing document through reference.
By its terms, Article 5 of the ISL is a supplementary document under Annex B.4 of ISO 17025, for the field of doping control. As required by ISO 17025, the ISL recognizes that any aspect of testing or management not addressed in the ISL is to be governed by ISO 17025. See ISL Rule 5.1. Moreover, all WADA laboratories are required to be accredited by a national accreditation body and periodically audited according to ISO 17025 (see ISL Rules 4.1.1 and 220.127.116.11), and all WADA lab methods and procedures must eventually be included in the scope of these periodic ISO audits. See ISL Rule 4.2.2.
The principle that ISO 17025 is applicable to anti-doping testing is expressly recognized in the decision of the majority arbitrators in the FL case, who ruled that “violations of the ISO 17025 …can be violations of the ISL for purposes of rebutting the initial presumption favouring the Lab that an AAF has been established.” See http://ia341243.us.archive.org/0/items/Floyd_Landis_USADA_Case_Decision_Documents/UsadaAndLandis-FinalAward20-09-07.pdf paragraph 156-157.
In some of my prior posts, I’ve noted that ISL Rule 7.1 contains language that appears to limit the application of ISO 17025 to anti-doping cases. The applicable language of ISL Rule 7.1 is set forth in full below:
The Laboratory is not required to provide any documentation not specifically included in the Laboratory Documentation Package. Therefore, the Laboratory is not required to support an Adverse Analytical Finding by producing, either to the Testing Authority or in response to discovery requests related to the hearing, standard operating procedures, general quality management documents (e.g., ISO compliance documents) or any other documents not specifically required by Technical Document on Laboratory Documentation Packages. References in the International Standard for Laboratories to ISO requirements are for general quality control purposes only and have no applicability to any adjudication of any specific Adverse Analytical Finding. (emphasis added)
Read broadly, the language in italics above would indicate that a lab’s violation of applicable ISO 17025 standards would not give an athlete a potential defense to an AAF found by the lab. However, this interpretation of ISL Rule 7.1 is contradicted by ISL Rule 5.1, by the express language of the FL decision, and by the fact that specific ISO 17025 requirements are cited more than a dozen times in the ISL, in ways that make it clear that ISO 17025 is an integral part of WADA drug testing. (See, for example, ISL Rules 4.1.1, 4.2.1, 4.2.2, 4.3.1, 18.104.22.168, 22.214.171.124, 126.96.36.199, 5.3.3, 5.3.4, 188.8.131.52, 184.108.40.206.4, 5.3.8, 5.3.10, 5.3.11, 220.127.116.11, 18.104.22.168, 5.4.1, 22.214.171.124, 6.2.1, 6.3.1, and 6.4.7). Consequently, the language in italics in Rule 7.1 should be understood as limited to the matters addressed in that rule. In other words, ISL Rule 7.1 should be understood to state that ISO 17025 requirements are not applicable to determine the documents that a lab is required to include in its Laboratory Document Package (LDP), but that ISO 17025 is applicable to other aspects of the lab’s work.
Let’s summarize. It is clear that in order to understand the ISL, we must also understand ISO 17025. ISO 17025 is the master document, while the ISL provides more specific rules to supplement the general rules in ISO 17025. These two documents are complementary documents that must be read together to understand the rules governing anti-doping testing in cycling. Where the ISL is silent, we must look to ISO 17025 for the governing rules. And as the ISL was written to “follow the format of the ISO 17025 document” (see ISL Rule 5.1), we should read the ISL rules within the context of ISO 17025 and within the structure set forth in ISO 17025.
Up to the Introduction; Back to part 2; On to part 4.