Laboratory accreditation to the ISO/IEC 17025:2017 standard indicates technical competency. These labs, including BDC Laboratories, will provide consistently valid results.
ISO/IEC 17025:2017 accredited labs undergo annual conformity assessment to demonstrate to an accreditation body, recognized by the International Laboratory Accreditation Cooperation (ILAC), that their test methods and results are valid. Test methods are typically based on the international standards identified in the laboratory’s scope of accreditation attached as a supplement to the certificate of accreditation.
Ensuring the validity of test results starts with identifying what contributes to measurement uncertainty. Measurement uncertainty analysis provides upper and lower bounds of accuracy to establish the expected variance for each test method. After measurement uncertainty is established, a proficiency test plan is created to monitor the long-term repeatability of test methods and is assessed as part of the annual review by the accreditation body.
Accredited labs must comply with the ISO/IEC 17025:2017 requirements for technical records. The requirements are consistent with the U.S. Food and Drug Administration’s (FDA) expectation that quality records are Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA). In addition to meeting ALCOA expectations, ISO/IEC 17025:2017 requires the review of data and results, as well as established controls related to any changes to preserve the integrity of the original entry.
For the benefit of meeting supplier qualification requirements, the ISO/IEC 17025:2017 accreditation provides evidence that the lab has a Quality Management System (QMS) that can consistently meet internal, statutory, and regulatory requirements. The ISO/IEC 17025:2017 QMS is generally equivalent to ISO 9001. Labs have the option to provide an accreditation body with an ISO 9001 certificate instead of having the QMS elements audited. When applying a supplier qualification process that is commensurate with risk, you seldom need more than a copy of the ISO/IEC 17025:2017 certificate and scope of accreditation.
Confidentiality is a requirement in ISO/IEC 17025:2017. Accredited labs must have an approved procedure to ensure customer confidentiality and demonstrate procedural compliance for the accreditation body. With ISO/IEC 17025:2017-accredited labs you can rest assured that the tests and results remain confidential. Similar requirements are in place to ensure labs remain impartial to avoid biased results.
At BDC Laboratories, we’re committed to providing the highest level of quality for all our services and product offerings, that’s why we’re ISO/IEC 17025:2017 accredited. View our certificate and scope of accreditation to see all our accredited tests.