Figure 1. AIHA-LAP introduced new program-specific accreditation symbols in February 2017.
DEPARTMENTS
LABORATORIES
CHERYL O. MORTON
is managing director of AIHA Laboratory Accreditation Programs, LLC. She can be reached at (703) 846-0789 or via email
.A Look Ahead for the Laboratory Community
New Symbols, Revised Standard Could Affect Laboratories and Their Clients
BY CHERYL O. MORTON
Those who rely on laboratories accredited by AIHA Laboratory Accreditation Programs, LLC should be aware of several changes our laboratory community is experiencing this year. These changes include newly adopted accreditation symbols and the potential impact of revisions to the ISO/IEC 17025 standard due later this year.UPDATED SYMBOLS
Once a laboratory achieves accreditation, it has the option of entering into a license agreement with AIHA-LAP that allows the lab to use an AIHA-LAP accreditation symbol. In February 2017, AIHA-LAP made available updated accreditation symbols that many laboratories are already starting to use. The program-specific symbols cover each of AIHA-LAP’s lab accreditation programs, including environmental lead, environmental microbiology, food, industrial hygiene, and unique scopes. Accredited laboratories that opt to use these symbols have until February 2018 to incorporate them into applicable laboratory documents. AIHA-LAP encourages laboratories that have invested the time, effort, and resources to obtain accreditation to properly display these symbols in advertising to help customers select the right laboratories to meet their testing needs.
AIHA-LAP is the owner of its accreditation symbols, which are registered with the U.S. Patent and Trademark Office. Until the current symbol is completely phased out, both the current symbol and the new set of symbols will be registered. Accreditation symbols are program-specific and can only be used for programs and scopes for which a laboratory is accredited. Lastly, an accredited laboratory’s ID number must be used with the accreditation symbol. The ID number is a unique identification number tied to a specific laboratory location and the specific AIHA-LAP program and analyses performed at that laboratory.
MISLEADING ADVERTISING
A laboratory that has opted not to undergo the rigorous accreditation process for a specific AIHA-LAP program should not market itself as accredited in that program. AIHA-LAP considers this to be misleading to customers, and our policies are very clear that accreditation symbols cannot be used in a misleading manner.
An example of misleading advertising would be displaying a lab ID, accreditation statement, or symbol for a specific program in an ad or on a website for services not covered by a laboratory’s accreditation. It’s also considered misleading to use lab IDs, accreditation statements, or symbols on reports that have unaccredited test results without indicating the non-accredited tests. Labs shouldn’t use AIHA-LAP accreditation symbols or statements in an ad or on a website that lists all of a laboratory’s locations but does not indicate which sites offer which types of accredited services.
AIHA-LAP does not accredit products, so lab IDs, accreditation statements, or symbols should never be used on product packaging or package inserts. Continued use of a lab ID, accreditation statements, or symbols for a suspended scope or program is not permitted.
AIHA-LAP staff, volunteers, and site assessors work hard to ensure that our accreditation programs are reputable, credible, and valuable to all who seek accreditation. Advertising and marketing in ways that obscure whether a laboratory is accredited for a particular service or in a particular location devalue the accreditation program in the eyes of customers—and that’s the last thing that we or the laboratory community want.
We look forward to working with our laboratories and customers to strengthen the value of AIHA-LAP accreditation for all of our accredited labs. Please contact me if you have questions about the new accreditation symbols or find any inappropriate use of AIHA-LAP symbols or the AIHA-LAP logos, which only we are allowed to use.
Much discussion in the international community over the past year has focused on whether sampling is an accreditation activity like testing and calibration.
THE NEW ISO/IEC 17025
The ISO standard that AIHA-LAP accredited laboratories follow, ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories, is currently being revised by ISO's Committee on Conformity Assessment (ISO/CASCO), which is responsible for all conformity assessment standards. Since ISO/CASCO is still deliberating the language in the new standard and revising current drafts, no one can say with absolute certainty what changes will appear in the final version of the standard. However, based on discussions AIHA-LAP has had with its counterparts, we have an idea which changes are more likely to be reflected in the final published standard.
AIHA-LAP anticipates that the revised standard will be totally restructured per the format mandated by ISO/CASCO. The other significant change, which will also be mandated by ISO/CASCO, will be the inclusion of language allowing for two options to fulfill the management system requirements: so-called Option A and Option B.
Option A is essentially how laboratories are assessed under the current standard. It will require 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.
Option B will allow 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. A laboratory being assessed using Option A would not have to be assessed for the management system requirements.
New language on impartiality will also be added to the new 17025—a concept already familiar to accreditation bodies, like AIHA-LAP, that are recognized by the International Laboratory Accreditation Cooperation (ILAC). Impartiality is a key component of ISO 17011, the standard that accreditation bodies are evaluated against, and is one of the reasons why in 2009 AIHA formed three separate limited liability companies: AIHA-LAP, AIHA Proficiency Analytical Testing Programs, and AIHA Registry Programs. This new language will force AIHA-LAP accredited laboratories to demonstrate that they have no affiliated businesses or relationships that could impact their work. During site assessments, AIHA-LAP will look to ensure that none of the lab’s business relationships could create the impression that its work could be comprised.
The new standard will also reportedly include stronger language on complaints, confidentiality, and measurement uncertainty. Although the new language may involve more work for labs, it will ultimately mean that laboratory clients will have even greater confidence in the data generated by our accredited labs.
Finally, much discussion in the international community over the past year has focused on whether sampling is an accreditation activity like testing and calibration. While it’s less likely that the revised standard will make dramatic changes to the language on sampling, the latest thinking is that it may include language to clarify that, when activities are done in conjunction with accredited testing activities, organizations that conduct only sampling may indeed be accredited under ISO 17025.
As this issue went to press, the revised standard was expected to be released at the end of 2017. AIHA-LAP expects to have all of its laboratories accredited to the new standard within the three-year implementation period.
