During the last week of April, CALA hosted our Biennial Training session for our volunteer assessors. The focus of the training sessions was on the revised ISO/IEC 17025 standard and the impacts on assessments.
The changes to the standard are expected to impact what assessments will look like. There was general agreement that assessing what used to be included in Section 4 of the 2005 version of the standard will take more time. Also, assessments will be less compartmentalized. For example, it was common for one assessor, usually the lead, to assess the management requirements, while the rest of the team would look at the technical requirements of the standard. With the changed structure of the standard, laboratories can expect some of the management items to be included in the technical assessments. Assessing risk based thinking is one example of the type of thing you may see being assessed in all areas.
Laboratories may find that the assessors are digging a bit more deeply than on previous assessments. Assessors were always looking beyond the required policies and procedures to see that laboratory’s documents covered the requirements. Now, with the standard dropping many of the prescriptive requirements for policies and procedures, and replacing them with statements such as “ensure that…,” assessors are talking about what they should be looking at and what questions they should be asking to ensure that laboratories are meeting the requirements of the standard.
Are you ready for your assessment to ISO/IEC 17025:2017? You should be completing an Internal Audit against the 2017 standard to check if you are meeting the new requirements. CALA Training can help get your auditors up to speed on the new standard. Check out the courses on the 2017 standard by clicking here.
What do you think will change in the assessments to ISO/IEC 17025:2017? Leave us a comment and let us know.