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Keep Your Lab Ahead of the Pack with ISO/IEC 17025 Accreditation
by Christina Brewe
Given the ever-increasing demands of trade globalization and government regulations, as well as the outsourcing of key quality functions, companies are looking to third-party analytical laboratories to meet testing requirements. This decision must guarantee the highest level of quality analytical results possible.
The options available are endless, including the number of laboratories and the degree of variation in testing methodologies employed. The laboratory chosen must distinguish itself from others and gain the company’s confidence.
The first and most important step in setting your laboratory apart from some of your competition is securing ISO/IEC 17025 accreditation. Obtaining accreditation can take a laboratory anywhere from a few months to a few years, depending upon the complexity of the scope of accreditation sought. The evaluation process for obtaining ISO/IEC 17025 will involve a thorough formal external evaluation by an accreditation body of all elements at the analytical laboratory that contribute to production of a sound, accurate, and reliable analytical test or measurement result.
Laboratory accreditation is described as a process that provides formal and external evaluation demonstrating the technical competence of a laboratory and its staff to perform specific types of testing and/or calibrations. The accreditation process ensures that the laboratory has a quality system in place that is sufficient, standardized, functioning, and monitored on an ongoing and routine basis for compliance and continuous improvements. The quality system of the laboratory will provide a comprehensive set of checks and balances to ensure technical competence on an ongoing basis. To companies seeking third-party analysis, this translates to an external approval that the laboratory is sound in its analytical processes.
ISO/IEC 17025 accreditation was first issued in 1999 by the International Organization for Standardization and the Internal Electrotechnical Commission. ISO/IEC 17025 is the main standard of accreditation sought by analytical laboratories and is recognized by industry, government bodies, and regulatory agencies on a global scale. ISO/IEC 17025 accreditation can only be given to an analytical laboratory by an accreditation body. Many accreditation bodies are available within the United States; however, companies should choose one that has a mutual recognition arrangement with International Laboratory Accreditation Cooperation.
In order for one accreditation body to recognize the accreditation of another accreditation body, the ILAC developed its own internal standard for accreditation bodies, known as ISO/IEC 17011. Accreditation bodies that have an MRA with ILAC agree to adhere to the ISO/IEC 17011 standard and submit themselves to routine audits for compliance of their own quality systems. This MRA with ILAC ensures that the accreditation provided by the chosen accreditation body meets the minimum requirements of the ISO/IEC 17025 standard.
This agreement also means that all accreditation bodies that have an MRA with ILAC recognize each other’s accreditation, because they have all agreed to the same minimum requirements of the ISO/IEC 17025 standard. Thus, the analytical laboratory has received accreditation in the form of international recognition and standardization, which will allow its data to be recognized and more readily accepted by international customers due to the homogeneity of a minimum set of accepted standards.
ISO/IEC 17025 accreditation was first issued in 1999 by the International Organization for Standardization and the Internal Electrotechnical Commission. ISO/IEC 17025 is the main standard of accreditation sought by analytical laboratories.
The benefits of laboratory accreditation are seen by the company and by the third-party analytical laboratory. The company, whether it is a manufacturer, a supplier, an importer/exporter, or a customer, should require accreditation of the analytical laboratory to minimize the risk of faulty laboratory analysis, which directly relates to minimizing the risk of producing or supplying a faulty product. Test results obtained from the accredited analytical laboratory provide the company with increased confidence in the technical capabilities of the analytical laboratory and its laboratory staff. This provides the company with greater confidence in the quality of its products.
Companies are encouraged to request a copy of the analytical laboratory’s scope of accreditation. This document will show the specific tests or measurements the analytical laboratory has been audited against and accredited for. The scope of accreditation also provides ranges or measurement uncertainties that accompany those specific tests or measurements. The analytical laboratory should be willing and able to produce its scope of accreditation upon request.
Companies are also encouraged to request a copy of any proficiency data that the analytical laboratory has available related to its scope of accreditation. This proficiency data will provide the customer with a good overall picture of the technical competence of the laboratory staff. The analytical laboratory must routinely participate in external and recognized proficiency programs in order to maintain compliance with the ISO/IEC 17025 standard.
Participation of the analytical laboratory in proficiency programs should be ongoing and should include all of the tests and technical laboratory staff included within the laboratory’s scope of accreditation. The resulting proficiency data must be supplied back to the accrediting body upon completion by the analytical laboratory to ensure ongoing and continued compliance. Accreditation can provide the company with increased confidence in analysis. This can then be used to establish baselines for key analysis and decisions regarding quality of their products. The data that is supplied from an accredited laboratory allows the company’s goods to be more readily accepted in overseas markets upon exportation.
This has also helped many companies adopt a uniform and internationally accepted testing and measurement approach. And when the materials don’t need to be retested upon entering another country, the costs associated with worldwide trade decrease.
The laboratory should be willing to provide many value-added benefits to its customers. A partnership between a company and a laboratory is not based on analytical results alone. The lab should provide technical insight, consulting, interpretation and more.
As mentioned, the benefits of ISO/IEC 17025 accreditation are also relevant to the analytical laboratory. A lab’s accreditation is a reliable indicator of its technical competence and expertise. The accreditation assures the lab’s customer base that the test and calibration data supplied by the lab are accurate, reliable, and sound. Test and calibration data from an accredited laboratory provide confidence that the testing specifications are consistent, are internally and externally audited, are monitored routinely, and provide for continuous improvement, allowing for smoother and greater output of accurate data due to the consistency of work performed by technically competent laboratory staff.
Accredited laboratories are reevaluated on a routine basis to ensure continued compliance to the standard. This allows the laboratory to improve its processes continually.
The choice of an accredited lab is an important decision for any company. The laboratory will become a partner, providing quality test results and technically competent knowledge. The laboratory should be one that is actively involved in industry associations, providing information on advancements in technology that allow for continuous improvement and an expanded level of competence among laboratory staff.
The laboratory should be willing to provide many value-added benefits to its customers. A partnership between a company and a laboratory is not based on analytical results alone. The laboratory should be able to provide technical insight, consulting, interpretation, and regulatory limits information to the company, allowing both parties to better understand the combined goals of food safety and quality.
Ensuring that safe products reach the market is a process that takes many partners. The company should select a laboratory that is accredited to the specific testing requirements needed. This will guarantee the highest level of confidence and quality in the obtained test or measurement result.
Christina Brewe joined Romer Labs in 2002 and serves as laboratory and quality manager.