Have reporting requirements changes in ISO/IEC 17025:2017?
Posted by Cathy Wylie on
The reporting requirements in ISO/IEC 17025:2017 have some changes that laboratories will need to take into consideration. In addition to a few new requirements, there are changes in wording in some of the requirements.
Clause 7.8.1.1 is new and requires that results are reviewed and authorized prior to release.
The date of sampling needs to be included in the report if it is critical to the validity and application of the results. In the 2005 version the date of sampling was required if the test reports included the results of sampling.
Reports need to have the date of issue, and need to list any additions to, deviations, or exclusions from the method. (7.8.2.1)
The standard now states that laboratories are responsible for all the information provided in the report, except when the information is provided by the customer. Information from the customer needs to be clearly identified and a disclaimer is required when the information from the customer can affect the validity of results. If samples are provided by the customer (i.e. the laboratory is not responsible for sampling), the report must state that the results apply to the sample as received. (Clause 7.8.2.2)
When laboratories are responsible for sampling, there are specific reporting requirements. A new requirement is that sampling reports include the information required to evaluate measurement uncertainty for subsequent testing or calibration (Clause .8.5 (f))
The standard now has requirements for reports that include statements of conformity. Decision rules need to be documented and need to take risk into account. The results with a statement of conformity need to be clearly identified as such, including which specifications are met or not met, and what decision rule has been applied. (Clause 7.8.6.1 and 7.8.6.2)
When issued reports are changed, amended, or reissued, and change of information needs to be clearly identified. Where applicable, the reason for the change needs to be included in the report. (Clause 7.8.8.1)
Remember, in addition to the changes covered here, there are wording changes. Laboratories need to familiarize themselves with the new requirements. The majority of the requirements related to reporting are similar to the previous requirements, however, changes to the wording may drive a change in your management system. Get to know the new requirements and conduct a gap analysis so you can update your management system to meet the 2017 requirements.