The revised standard is also aligned with the principles on resources and process found in ISO 9001:2015, the standard for quality management. ISO 17025 now requires fewer documented procedures and policies. For example, the standard no longer requires the laboratory to maintain current job descriptions. It also eliminates the term “quality manager”; to demonstrate competence, labs are required instead to identify key personnel and their duties, responsibilities, and authorities.  The revised ISO 17025 focuses on ensuring the quality of results and less on “checking the boxes.” The standard gives laboratories more flexibility to meet its requirements. In other words, the emphasis is on the result of a process instead of a detailed description of tasks and steps.  Definition of laboratory activities. The revised standard defines a laboratory as a body that performs testing, calibration, or sampling associated with subsequent testing and calibration. Because of this definition, which differs from the previous version of the standard, accreditation bodies can now accredit organizations that conduct only sampling activities. Through ILAC’s Accreditation Issues Committee, accreditation bodies around the world are developing an approach for accrediting standalone sampling organizations. AIHA-LAP is considering adding sampling to its portfolio, either as fields of testing under its established programs or as a separate sampling accreditation program, sometime in the next year.  The revised standard allows for two options to fulfill the management system requirements. These are identified in the standard as Option A and Option B.  Option A requires the laboratory to consider the requirements of management system documentation; control of management system documents; control of records; actions to address risks and opportunities; improvement; corrective action; internal audits; and management reviews. This is essentially how laboratories are assessed under the previous version of the standard. Option B allows a laboratory that maintains a management system in accordance with ISO 9001, which sets out the criteria for a quality management system, to be recognized as having fulfilled the intent of the management system requirements as outlined in Option A.  Language has been added to the revised ISO 17025 to strengthen impartiality requirements. This new language will require accredited laboratories to explain their professional relationships with subcontractors, family members, and others who could affect their work. It also requires laboratories to have a process to identify, analyze, evaluate, treat, monitor, and document on an ongoing basis the risks to impartiality arising from its activities. Identified risks need to be mitigated.  Control of data/information management. ISO 17025 now recognizes and incorporates the use of computer systems, electronic records, and the production of electronic results and reports. The revised standard also updates language on laboratory information management so that it now covers “laboratory software configuration/modifications to commercial off-the-shelf software.” Further, the standard requires laboratory information management systems that are managed and maintained off site or through an external provider to comply with all applicable requirements of the standard. One of the more significant changes in the revised standard is the requirement for laboratories to plan and implement actions to address risks and opportunities. This change is likely to present some challenges to accredited testing laboratories. Risk is not always an easy and straightforward concept, even among risk experts.  Risk has been incorporated in the revised ISO 17025 in several sections (see Table 1). Laboratories themselves are responsible for deciding which risks and opportunities (across the entire operation) need to be addressed. It is important to note that laboratories are not required to conduct full risk management activities like those required in ISO 31000 or ISO 9001, although any risk work conducted to meet these standards can probably be used to satisfy some of the ISO 17025 requirements. As indicated in Table 1, risks need to be considered during actions the laboratory takes to address impartiality (as explained earlier), decision rules, corrective actions, nonconforming work, and management reviews.