ISO/IEC 17025 is the international standard specifying general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. Published by ISO and IEC, the current version is ISO/IEC 17025:2017. Ovalab is accredited under this standard by the Czech Accreditation Institute (ČIA), Certificate 537/2025, valid until 24 October 2030.
Key Facts About ISO/IEC 17025
- Current version: ISO/IEC 17025:2017, published in November 2017, replacing the 2005 edition.
- Scope: Applies to all organizations performing laboratory activities — testing, calibration, and sampling associated with subsequent testing or calibration.
- Risk-based thinking: The 2017 revision introduced requirements for risk-based thinking aligned with GMP and ISO 9001:2015.
- Impartiality: Laboratories must identify risks to impartiality and demonstrate structural safeguards to ensure objectivity of results.
- Metrological traceability: All measurement results must be traceable to the International System of Units (SI) through an unbroken chain of calibrations.
- Recognition: Accreditation bodies worldwide (ILAC MRA signatories) mutually recognize ISO/IEC 17025 certificates, enabling international acceptance of test reports.
Implementation at Ovalab
Ovalab operates under ISO/IEC 17025:2017 accreditation granted by the Czech Accreditation Institute (ČIA), Certificate 537/2025, valid until 24 October 2030. This accreditation covers analytical testing of food, pharmaceutical, and environmental samples. Combined with GMP certification (SÚKL 74726/2023), Ovalab delivers results accepted by regulatory authorities across the EU.
Frequently Asked Questions
What is the difference between ISO/IEC 17025 and ISO 9001?
ISO 9001 certifies a quality management system, while ISO/IEC 17025 specifically evaluates the technical competence of laboratories to produce valid test and calibration results. ISO/IEC 17025 includes all ISO 9001 management requirements plus laboratory-specific technical requirements.
Is ISO/IEC 17025 accreditation mandatory?
It is not universally mandatory, but many EU regulations and directives require testing by accredited laboratories. For official food control (Regulation EU 2017/625) and pharmaceutical testing, accreditation is effectively required.
How often is ISO/IEC 17025 accreditation renewed?
Accreditation cycles vary by national body. The Czech Accreditation Institute (ČIA) grants accreditation for five-year periods with annual surveillance assessments. Ovalab’s current certificate is valid until 24 October 2030.
What does flexible scope accreditation mean?
Flexible scope allows a laboratory to modify test methods, add matrices, or adopt new standards within a defined framework without requiring a formal scope extension — enabling faster response to client needs.
Does Ovalab's accreditation cover pharmaceutical testing?
Yes. Ovalab’s ISO/IEC 17025 accreditation covers pharmaceutical analysis, complemented by GMP certification (SÚKL 74726/2023) for testing of human medicinal products under EudraLex Volume 4 requirements.