On consecutive days in November 2017, the International Organization for Standardization published revised versions of ISO/IEC 17025 and ISO/IEC 17011. These are the international standards followed by accredited testing/calibration laboratories and by accreditation bodies, respectively. AIHA Laboratory Accreditation Programs, LLC is evaluated against ISO 17011 to maintain international recognition by the International Laboratory Accreditation Cooperation, or ILAC, while the laboratories accredited by AIHA-LAP are assessed to ISO 17025. This article highlights some of the major changes of both revised standards and—for the benefit of its accredited laboratories and customers—describes what AIHA-LAP is and will be doing to implement the new standards. 

ISO/IEC 17025:2017  Many of the elements from the 2005 version of ISO 17025, General requirements for the competence of testing and calibration laboratories, are still present in the latest revision, and laboratories will likely find that they are compliant with much of the revised standard. The major changes to ISO 17025 include the following: Restructuring and alignment. ISO 17025 has been restructured to be more in line with new ISO formatting guidelines. Because of these changes, the standard is similar to new ISO 17000 standards such as ISO/IEC 17020 (for inspection bodies) and ISO/IEC 17065 (for product certification bodies). The good news for accredited testing laboratories is that most of the technical requirements were not changed—they were just moved to other places in the standard.
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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.  Focus on outcomes. 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.  Management system options. 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.  Emphasis on impartiality. 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. Risk-based thinking. 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. 
Table 1. Requirements in ISO/IEC 17025:2017 That Include “Risk”
It is believed that when laboratories address risks and opportunities, they establish a basis for increasing the effectiveness of their management systems, achieving improved results, and preventing negative effects. Again, the laboratories are responsible for deciding which risks and opportunities need to be addressed and which processes they will use to identify and mitigate risks.  AIHA-LAP will provide more guidance to its volunteers, site assessors, and laboratories to help them better understand risk and tools that can be used to meet the risk-related requirements of ISO 17025 (such as matrices to help prioritize risks).  Confidentiality. The revised standard includes stronger language on confidentiality. Laboratories are now required to execute legally enforceable agreements for the management of all information obtained or created during the performance of laboratory activities. Laboratories are also required to notify customers if information is going to be made public.  As an ILAC-recognized accreditation body, AIHA-LAP must adhere to ILAC’s three-year implementation period and accredit all laboratories to the revised ISO 17025 by November 2020. All AIHA-LAP site assessors, volunteers, and staff have been trained on the revised standard, and AIHA-LAP has revised its accreditation policies, which are now posted on the AIHA-LAP website along with a new accreditation application. An updated AIHA-LAP Site Assessor Checklist is also available to labs seeking initial accreditation or reaccreditation with proof of purchase of the new standard.  After much deliberation, the Analytical Accreditation Board—the volunteer body that advises AIHA-LAP on policy changes—likewise eliminated many terms and some of the more prescriptive AIHA-LAP requirements to make AIHA-LAP policies more in line with the revised ISO 17025. The result of these changes is a more flexible and performance-based approach for labs to demonstrate competency. All labs accredited by AIHA-LAP, as well as those applying for accreditation for the first time, are now required to use AIHA-LAP’s 2018 accreditation application and will be assessed to the 2018 policies. All AIHA-LAP-accredited laboratories successfully assessed to the 2018 AIHA-LAP policies will receive a certificate reflecting accreditation to the revised standard and can sign an agreement with AIHA-LAP to receive an updated laboratory-specific accreditation symbol that includes ISO/IEC 17025:2017. Please note that laboratories holding the ISO/IEC 17025:2005 certificates will no longer be recognized by AIHA-LAP after Nov. 30, 2020.  All AIHA-LAP-accredited laboratories are encouraged to prepare for the transition to ISO/IEC 17025:2017 (even if they are not due to be assessed in 2018) by purchasing the 2017 standard, training employees, and evaluating the management system documentation to conduct a gap analysis.  The revised ISO 17025 includes information encouraging users to share their views on the standard and suggest changes for future revisions. To facilitate this process, ISO’s Committee on Conformity Assessment has developed an online survey to collect this information from users of the standard and will prepare an analysis of the feedback by November 2018. AIHA-LAP will disseminate the survey to its accredited laboratories by Aug. 17, 2018. All laboratories that have started implementing the 2017 version of the standard are encouraged to complete the survey.  ISO/IEC 17011: 2017  As with the revised ISO 17025, changes to ISO 17011, Conformity Assessment–Requirements for accreditation bodies accrediting conformity assessment bodies, align the standard with other ISO 17000 standards but also strengthen language on impartiality, confidentiality, complaints and appeals (made to accreditation bodies), and management systems. The revised ISO 17011 also includes language on risk-based thinking.  Other changes to the standard include:
  • recognition of proficiency testing as an accreditation activity
  • addition of new definitions, including one for “accreditation scheme” (a specific description of how accreditation is to be achieved)
  • incorporation of competence criteria in the document, including an informative annex on knowledge and skills needed by employees of accreditation bodies 
AIHA-LAP must demonstrate compliance to the revised ISO 17011 by November 2020 and must share its implementation plan and undergo a document review with its ILAC regional bodies (the Asia Pacific Laboratory Accreditation Cooperation and the Inter-American Accreditation Cooperation) by mid-2019. All AIHA-LAP staff have been trained on the new ISO 17011, and a gap analysis has been performed on existing policies and procedures. Like the testing laboratories it accredits, AIHA-LAP will work to incorporate risk-based thinking into its operations and, more importantly, address any risks that are identified. Over the next year, AIHA-LAP-accredited laboratories will see a few more changes in AIHA-LAP policies and even the accreditation application as AIHA-LAP works to comply with the revised ISO 17011. For example, all laboratories will be asked to enter into legally enforceable agreements with AIHA-LAP upon applying for accreditation or reaccreditation and, among other commitments, agree to work with the accreditation body as complaints against the laboratories are investigated. AIHA-LAP will also include suspended scopes, programs, and laboratories on its publicly available website—something not typically done in the past. THE ULTIMATE BENEFICIARIES While the immediate effects of the revisions to ISO 17025 and ISO 17011 will be felt by AIHA-LAP and its accredited laboratories, the ultimate beneficiaries are the laboratories’ customers. Industrial hygienists and occupational health and safety professionals who use labs accredited to these standards can be confident that laboratory personnel are competent, that laboratory equipment has been properly calibrated and maintained, and that laboratory processes will generate sound, defensible data.  Should you have any questions or require more information about the revised ISO 17025 or ISO 17011 or AIHA-LAP’s timeline for implementation, email Cheryl Morton or Geneva Bowman. CHERYL MORTON is managing director of AIHA Laboratory Accreditation Programs, LLC. She can be reached via email. GENEVA BOWMAN is quality systems and technical manager of AIHA Laboratory Accreditation Programs, LLC. She can be reached via email. Send feedback to The Synergist.

Laboratories and Accreditation Bodies Tackle Revised ISO Standards
BY CHERYL MORTON AND GENEVA BOWMAN

New Requirements for Labs
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- Ed Rutkowski, Synergist editor
Disadvantages of being unacclimatized:
  • Readily show signs of heat stress when exposed to hot environments.
  • Difficulty replacing all of the water lost in sweat.
  • Failure to replace the water lost will slow or prevent acclimatization.
Benefits of acclimatization:
  • Increased sweating efficiency (earlier onset of sweating, greater sweat production, and reduced electrolyte loss in sweat).
  • Stabilization of the circulation.
  • Work is performed with lower core temperature and heart rate.
  • Increased skin blood flow at a given core temperature.
Acclimatization plan:
  • Gradually increase exposure time in hot environmental conditions over a period of 7 to 14 days.
  • For new workers, the schedule should be no more than 20% of the usual duration of work in the hot environment on day 1 and a no more than 20% increase on each additional day.
  • For workers who have had previous experience with the job, the acclimatization regimen should be no more than 50% of the usual duration of work in the hot environment on day 1, 60% on day 2, 80% on day 3, and 100% on day 4.
  • The time required for non–physically fit individuals to develop acclimatization is about 50% greater than for the physically fit.
Level of acclimatization:
  • Relative to the initial level of physical fitness and the total heat stress experienced by the individual.
Maintaining acclimatization:
  • Can be maintained for a few days of non-heat exposure.
  • Absence from work in the heat for a week or more results in a significant loss in the beneficial adaptations leading to an increase likelihood of acute dehydration, illness, or fatigue.
  • Can be regained in 2 to 3 days upon return to a hot job.
  • Appears to be better maintained by those who are physically fit.
  • Seasonal shifts in temperatures may result in difficulties.
  • Working in hot, humid environments provides adaptive benefits that also apply in hot, desert environments, and vice versa.
  • Air conditioning will not affect acclimatization.
Acclimatization in Workers