Laboratories face many of the same challenges as any business. Laboratory managers juggle multiple priorities including competition, internal processes, staff development, financial management, and the list goes on. Perhaps unique to the testing laboratory is the knowledge that their work can impact critical decisions made by their customers and other users of laboratory data. These can be business decisions such as a mining company deciding if an ore body is worth developing; decisions affecting the health and safety of the public, such as a food producer deciding a product is safe to be consumed or a toy manufacturer deciding that a particular toy is safe for children to play with; and regulatory decisions such as refusing to allow a product into the country because it contains high levels of lead or some other contaminant, or banning a chemical because it presents a serious risk of harm to the public and\or the environment. All these decisions and many more rely on the results of laboratory tests. How can decision makers have confidence that the data they are relying on can be trusted? How do they know the laboratory is competent to perform the testing?
In a word, accreditation. To be more specific, accreditation to ISO/IEC 17025 by an Accreditation Body (AB) that is a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC MRA).
ISO/IEC 17025 accredited labs
Laboratory accreditation is the best assurance that the data you are relying on was generated in a competent laboratory. Laboratories that have been accredited to the ISO/IEC 17025 standard have been assessed by an independent, impartial third party accreditation body and have been found to meet the requirements of the standard and are technically competent to conduct the testing for which they are accredited. This independent assessment includes all elements that contribute to the production of accurate, reliable test data including the competence of staff; the validity and appropriateness of test methods; the traceability of measurements and calibrations to national standards; the suitability, calibration, and maintenance of test equipment; the testing environment, and so on.
Laboratories realize many benefits from being accredited. Some of these are:
- Continuous improvement. An AB regularly reassesses an accredited laboratory, which can help make continual improvements to the laboratory’s operations.
- Access to testing work. Many government bodies require that test results submitted to them be generated in an accredited laboratory. A lab that is not accredited cannot bid on this work.
- Meeting the requirements of accreditation does take time but it can be a time saver for commercial labs when it cuts down on the independent assessment of the laboratory by clients or potential clients who insist that their own staff audit the laboratory. If clients and potential clients reply on the AB’s assessment instead of conducting their own audits, the burden on the laboratory can be reduced.
- International recognition of the laboratory’s competence. This is where the importance of accreditation by ABs that are signatories to the ILAC MRA becomes apparent. The aim of the ILAC MRA is “tested once, accepted everywhere.” This can help importers and exporters by reducing the need for repeat testing.
Government regulators and businesses that use laboratory test results can be confident that the results they receive from an ISO/IEC 17025 accredited laboratory are reliable and that the laboratory is technically competent to conduct the testing. Regulatory decisions can have important repercussions for manufacturers and importers. Is that lot of product safe to be sold to consumers? Should the importer be allowed to bring it into the country? The answers to these questions often depend on the results from the laboratory that analyzed the product. As a regulator, you want to make the right decision. Likewise, as a manufacturer, you don’t want to put consumers at risk. Using an accredited laboratory is the obvious choice as you know the laboratory is competent to perform the tests it is accredited for. This can reduce the time and cost of retesting and the risk of producing or supplying a defective product, which can impact a company’s reputation.
Clearly the general public benefits as well. Consumers want assurances that the products and services they purchase meet their expectations and conform to specific requirements. Reliable test data means consumer goods of consistent quality that conform to applicable standards.
Beyond a quality management system, accreditation is a global standard that recognizes the technical competence of a laboratory to perform specified tests. It involves on-site assessments as well as ongoing proficiency testing. Increasingly, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited.
Accreditation can provide multiple market advantages. Highly regarded, this benchmark of performance reflects internationally accepted testing and measurement practices. Companies looking to expand globally are helped by the ISO/IEC 17025 standard having recognition globally. As an exporter, this means reducing or eliminating the need for products or materials to be re-tested in another country.
The Canadian Association for Laboratory Accreditation (CALA), is an Accreditation Body that also offers Proficiency Testing (PT) and training services. CALA has analyzed laboratory performance using multiple years of PT results to compare the performance of accredited and non-accredited laboratories. The difference is striking—accredited laboratories consistently outperform non-accredited laboratories. Readers should refer to Ken Middlebrook’s article Do accredited laboratories perform better in proficiency testing than non-accredited laboratories?:
To the uninitiated, the terminology around accreditation, certification, and licensing can be confusing. It doesn’t help that the terms are often misused, including by those who should know better. The ISO 9001 standard is widely used in manufacturing and service organizations for managing the quality of their product or service. Certification of an organization’s quality management system against ISO 9001 aims at confirming the compliance of the management system to this standard. While laboratories may be certified to ISO 9001 or may be part of a larger organization that is certified to ISO 9001, this certification does not say anything about the technical competence of a laboratory. The ISO 9001 standard simply does not address technical competence.
Similarly, laboratories may be licensed by government organizations to conduct certain types of testing. This licensing is not the same as ISO/IEC 17025 accreditation and demonstrated technical competence is not always a condition of licensing.
Some laboratories may view ISO/IEC 17025 accreditation as nothing more than the cost of doing business and those outside the laboratory community may have little knowledge or awareness of accreditation. This is unfortunate as accreditation brings many benefits to the laboratory and the users of laboratory data. The laboratory can be confident it is producing accurate, reliable data and the end users of that data can be confident in the decisions they are making based on the data. When laboratories are accredited, we all benefit.
Andrew Adams is president and CEO of CALA Inc., the Canadian Association for Laboratory Accreditation. Adams joined CALA in 2017 after more than 30 years with the federal government, in particular, Health Canada and the Canadian Food Inspection Agency. Adams began working for Health Canada as a bench chemist then held progressively senior positions managing laboratories and laboratory networks. He is the recipient of several awards, including the 2014 Public Service Award of Excellence for Employee Innovation presented by the Governor General of Canada, and the Health Canada Deputy Minister’s Award for Excellence in Innovation and Creativity. Adams holds a Bachelor’s Degree of Science in Chemistry and Certificates in Quality Assurance Management and Public Sector Management.