Laboratory Accreditation 101
In this Q&A, Elizabeth Carbonella of A2LA outlines the process of laboratory accreditation and the associated benefits
Michelle Dotzert is the creative services manager for Lab Manager. She holds a PhD in Kinesiology (specializing in exercise biochemistry) from the University of Western Ontario. Her research examined the...
ViewFull Profile.Learn about ourEditorial Policies.
Elizabeth Carbonella, accreditation manager for the inspection body and materials testing team at the American Association for Laboratory Accreditation (A2LA) discusses the process of laboratory accreditation and the associated benefits.
Q: What is laboratory accreditation and which international standards apply to different types of laboratories?
A: In the most generalized sense, “accreditation” is a process where an authoritative body—such as A2LA—formally recognizes an organization’s competence to perform a specific set of tasks. The organization seeking recognition from the authoritative body is called a “conformity assessment body,” which we abbreviate as CAB. There are many different international standards that cover different activities, such as proficiency testing or product certification, and many organizations that perform these functions seek accreditation, but laboratories make up the majority of our CABs.
For laboratories, the standard used as the basis for accreditation is ISO/IEC 17025, entitled, General requirements for the competence of testing and calibration laboratories. This is a standard developed by an independent, international group of experts and it exists to support uniformity and impartiality across organizations, industries, and countries. ISO/IEC 17025 includes requirements for staff competence, the validity and appropriateness of methods, measurement traceability, equipment maintenance, and so much beyond that. It is a very comprehensive standard.
Q: What are some of the key benefits of becoming an accredited laboratory?
A: There are many cases where a potential customer or a professional organization will require that a laboratory be accredited, so it could be driven by external parties, or a laboratory could use accreditation to significantly expand their customer base and business opportunities. Even in cases where accreditation isn’t a requirement, it’s a major marketing advantage. It provides impartial assurance that a laboratory’s methods and results can be relied on and demonstrates a commitment to quality. The process of assessment required for accreditation can reveal organizational inefficiencies or places where corrective action is needed and addressing these can help the lab run more smoothly in the long term. For laboratories working internationally, accreditation to an international standard also significantly reduces import/export barriers.
Q: Does becoming an accredited laboratory have benefits for individuals or groups outside the laboratory organization?
A: Very much so. In fact, the party who benefits most from accreditation is the end user, who usually never has to think about accreditation at all. Food testing is a good example of this: food testing laboratories verify that food products are accurately labeled and free of contaminants, which is crucial to public health. Accreditation ensures that food testing laboratories are competent and able to produce reliable results. Thanks to accreditation, consumers can rest assured that the products they use were tested in accordance with comprehensive international standards.
Q: What is involved in the accreditation process? What are some common challenges laboratories encounter along the way?
A: To prepare to apply, laboratories should document their management system in compliance with the requirements of the standard, implement their newly documented procedures, check results and activities through an internal audit, and finally, make any adjustments as needed. PDCA is a helpful acronym for quality managers in the lab to follow: Plan, Do, Check, Act.
The initial accreditation process with A2LA consists of four phases: application, assessment, corrective action, and final accreditation decision. The application process with A2LA is done entirely online. The initial assessment is an on-site assessment performed by an assessor or team of assessors who are technical experts in the testing and/or calibration activities that they assess, and they have extensive training on the ISO/IEC 17025 standard. The assessment team will lay out a schedule and request interviews and records to assess the laboratory’s conformance to the standard. Observation of testing and/or calibration activities are required to ensure competence of staff to appropriately perform these activities. At the conclusion of the on-site assessment, a report will be given to the laboratory, identifying any deficiencies where the laboratory may not fully meet the standard’s requirements.
The corrective action phase of the accreditation process is when the laboratories provide documentation, records, and a cause analysis to resolve any deficiencies cited against the ISO/IEC 17025 standard, technical methods, or A2LA program-specific requirements. This process is a back and forth process between the laboratory and A2LA staff to ensure that appropriate actions are implemented to address deficiencies.
The last step in initial accreditation is the final accreditation decision. After A2LA staff feels that all cited deficiencies have been resolved, the entire assessment report and corrective action records are sent to our accreditation council, a panel made up of volunteer experts in various fields of testing and calibration. This group reviews the information and makes the decision to grant accreditation. In terms of challenges during this process, maintaining records and applying proper document control are common stumbling blocks we observe during assessments. ISO/IEC 17025 heavily emphasizes the need for an audit trail, so it’s very important for labs to keep a clear and comprehensive chain of records, and for procedures to clearly state how activities are performed.
Q: What strategies can laboratories take to prepare for accreditation?
A: It’s important to familiarize yourself with the standard you are seeking accreditation to, but standards are fairly dense and complex documents. There are a number of training courses available that can help you understand the relevant standard. We also highly recommend that laboratories perform an internal audit. An internal audit is like a practice run for your initial accreditation assessment, allowing you to prepare and find gaps in your quality management system, instead of having them come up during the assessment. Other areas laboratories should focus on when preparing for accreditation include obtaining accredited calibrations, applying appropriate document control, and compiling records to show implementation of the requirements.
Elizabeth Carbonella is the accreditation manager for the inspection body and materials testing team with A2LA. She has more than 13 years of experience with A2LA and has worked hands-on in nearly every aspect of the accreditation process at various points in her career. She currently oversees a team of accreditation professionals working in ISO/IEC 17025 mechanical, chemical, non-destructive, construction materials, and geotechnical laboratories, as well as ISO/IEC 17020 inspection bodies. She is an expert is ISO/IEC 17025, ISO/IEC 17020, internal auditing, and root cause analysis. Carbonella is also an authorized peer evaluator for APAC and IAAC. She can be reached at ecarbonella@a2la.org.