Subclause 7.8.8.1 states that “When an issued report needs to be changed, amended or re-issued, any change of information shall be clearly identified and, where appropriate, the reason for the change included in the report.”. Subclause 7.8.8.3 states that “When it is necessary to issue a complete new report, this shall be uniquely identified and shall contain a reference to the original that it replaces.”
These subclauses have raised the following question:
If a laboratory issues a new report, is it required that this new report shows changes in comparison to the one it replaces?
The maintenance group of ISO/CASCO has answered: “No, if a new report is issued to replace a previous report, the standard does not require that new report to identify changes from the original report, however, it does require the new report to contain a reference to the original report that it replaces.”
See: https://www.iso.org/committee/54998.html?t=6Wa44wCBknc3viqjDkAz7C6QXVqMQVLo2qBfBj2U3b1z38_WAxghd10I28oEThBJ&view=documents#section-isodocuments-top
(clarification request ISO/IEC 17025 clause 7.8.8 – June 2024).
But, why should clause 7.8.8.1 not be applicable for a complete new report?
Isn’t a new report just a re-issued report with a new report-identification? Otherwise relevant information about the change is missing.
ISO/IEC 17025 (7.8.1.2.) requires that “the results shall be provided accurately, clearly, unambiguously and objectively, usually in a report (e.g. a test report or a calibration certificate or report of sampling)”.
Looking at previous LC FAQs related to the amendments of reports we can read that all of them are in line with the requirement stated above: the final goal shall be that the information provided by the laboratories in the reports needs to be clear to ensure that the information included in it is not taken out of context.
ISO/IEC 17025 § 7.8.8 deals with “Amendments to reports”; when there is a need to amend a report there are two possibilities:
- §7.8.8.1: identify in the changed/amended/re-issued report any changes of information and, where appropriate, the reasons for the changes;
- §7.8.8.3: when it is necessary to issue a complete new report it shall be uniquely identified and a clear reference to the original it replaces shall be included.
If we read § 7.8.8 of ISO/IEC 17025 in its entirety we can understand that the application of §7.8.8.3 doesn’t exclude the application of §7.8.8.1; therefore, in order to provide clear information in the changed/amended/re-issued/new report it is deemed that §7.8.8.1 applies also when complete new reports are issued.