Keep Your Lab Ahead of the Pack with ISO/IEC 17025 Accreditation

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.

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.