Is it necessary to report within the test report the method used including date of issue or the revision (regardless if test methods based on standards or SOPs)?
Background:
ISO/IEC 17025:2017 requires in article 7.8.2.1: “Each report shall include at least the following information, unless the laboratory has valid reasons for not doing so, thereby minimizing any possibility of misunderstanding or misuse: … f) identification of the method used”.
Therefore it is necessary to clarify if within the test report the identification of the method used shall include the date if issue or its revision. Within this above mentioned article the date of issue is not required in detail (like some other very detailed requirements).
As some surveys have given as results in some countries the used tests methods (standards, SOPs) are always reported including date of issue, in other countries this is not done.
In some interpretation it is found as a requirement (interpretation of above mentioned article 7.8.2.1 f): “The results of test are only useable, meaningful and useful if the methods used are specified. The unique name of a method shall include at least the short title ant the date of issue. This applies regardless of whether it is a standard, an assimilated method or an in-house test procedure.”
Also the ISO/IEC 17025:2017 permits to do not so in case of valid reasons. What are “valid reasons” to do not so?
Further the accreditation certificate includes sometimes the test method including the date of issue (e.g. Germany, Italia, Poland, UK) and sometimes not (e.g. France, Netherlands, Spain, Sweden).
Requirements concerning methods used by laboratories are set in ISO/IEC 17025:2017:
- laboratories shall ensure that they use the latest valid version of methods (cl. 7.2.1.3 )
- test/calibration report shall include the identification of the method used (cl. 7.8.2.1.f)
- the results shall be provided accurately, clearly, unambiguously and objectively (cl. 7.8.1.2)
Requirements for accreditation scopes in the field of testing are defined in ISO/IEC 17011:2017, but no references to issuing date /revision status are mentioned.
Taking into account the above mentioned requirements, even if it is not explicitly required to include the issuing date/revision status of standard methods in test reports, it is believed that it should be a good practice, at least for standard methods, to report it in order to improve comparability of test results among laboratories.
It is clear that this approach doesn’t apply to laboratory developed methods, but in that case the traceability of the revision status is ensured by the lab document control (it is always possible to find what version was used at the issuing of the report),
The “valid reasons not to include the information” recalled in cl. 7.8.2.1 concern to very specific cases where the issue/revision date of the method cannot be specified in the test report for mandatory reasons (i.e. like stakeholder Regulations, WADA); if it is the case, any deviations shall be agreed in the contract.
Note: it should be highlighred that cl. 7.8.1.3 gives the possibility to laboratories to report results in a simplified way.