The Seal of Trust: ISO/IEC 17025
ISO/IEC 17025 sets the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. It is an international standard developed jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).
The Scope of ISO/IEC 17025
Applicability: ISO/IEC 17025 applies to all laboratories that perform testing, sampling, or calibration, regardless of their ownership or operation. This includes not just independent commercial labs but also those operated by the government, industries, and other organizations like universities and research centers.
Technical Competence: It is the main standard for labs to obtain accreditation to be recognized as technically competent in most countries. Accreditation is often a requirement by suppliers and regulatory authorities, and without it, the results provided by a laboratory might not be accepted.
Benefits of ISO/IEC 17025 Certification
Trust and Confidence: The standard is essential for maintaining trust and confidence in laboratory results. Its requirements ensure that labs operate impartially and confidentially, which are crucial for the integrity of their results.
Quality of Results: Accreditation to ISO/IEC 17025 supports the provision of accurate and reliable results, which is fundamental in many sectors that rely on precise testing and measurements. The competence of a laboratory is assessed based on the qualifications, training, and experience of its staff, among other factors.
ISO/IEC 17025 certification is a testament to a laboratory’s commitment to excellence in testing and calibration practices. For digital health startups, particularly those developing medical devices that require rigorous testing, having a laboratory that is ISO/IEC 17025 accredited can be a significant assurance of quality and reliability. It indicates that the laboratory has a system in place that is capable of producing valid results, which is critical for the development and validation of medical devices and technologies. …...more
...more
Show less
