Perhaps motivated by recognition that each laboratory has some level of uniqueness, the developers of the 2017 version instituted a pure management approach rather than the 2005 standard’s more prescriptive approach. The 2005 standard also included requirements for a laboratory’s quality manual and its organization. The 2005 standard managed risk for the laboratory by defining policies (nine of them), procedures (more than thirty), specifics on staffing, and management positions (including technical manager and quality assurance manager and their qualifications). No doubt there are considerable differences between the 20 versions. Now, people are finding fault with the 2017 version’s supposed lack of structure.
ISO 17025 2017 RISK MANAGEMENT TEMPLATE UPDATE
But at the time, the 2005 update was criticized for being overly prescriptive. A decade earlier, the laboratory community had expressed mild outrage about the 2005 update of ISO/IEC 17025, which introduced few, if any, changes it merely formalized guidance from an earlier standard (ISO Guide 25, now withdrawn) that the laboratory community had been using for years.
It is ironic that the introduction of ISO/IEC 17025:2017 created this concern. Why was this a problem? Because laboratories were accustomed to having policies and procedures defined by the accrediting body (AIHA-LAP, in the case of industrial hygiene laboratories) rather than assuming that responsibility themselves.
The primary cause of this unsettling was the introduction of “risk-based thinking,” a management model that essentially places responsibility for defining and organizing a laboratory’s policies and procedures directly on laboratory management.
The AIHA Laboratory Accreditation Programs’ implementation of the 2017 update of ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories, created some confusion and angst within the laboratory community.
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