ISO/IEC 17025
ISO/IEC 17025 is the main international standard for assessing whether testing laboratories are technically competent and reliable. When a lab is accredited to ISO/IEC 17025, an independent body has audited its methods, staff, and equipment to check that the lab can produce valid results.
Also called: ISO 17025, ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories, UNE-EN ISO/IEC 17025, NF EN ISO/IEC 17025, International Organization for Standardization/International Electrotechnical Commission 17025, international organization for standardization/iec 17025
ISO/IEC 17025 is the globally recognized international standard for the competence of testing and calibration laboratories. Developed jointly by ISO and IEC, this standard assesses whether a laboratory operates with technical competence and impartiality. An ISO/IEC 17025 accreditation confirms that an independent accreditation body, such as UKAS or ANAB, has conducted a rigorous audit of the laboratory's management and technical processes.
How ISO/IEC 17025 accreditation ensures laboratory quality in practice
ISO/IEC 17025 accreditation covers the specific laboratory processes behind testing and calibration work to ensure reliable results. It requires highly qualified staff, equipment calibrated using traceable reference materials, and the use of validated methods with evaluated measurement uncertainty. For a peptide or research-chemical Certificate of Analysis (COA), the accreditation of the testing laboratory serves as a strong indicator of quality and reliability, though the document still requires careful review.
Common misunderstandings when evaluating a peptide or research-chemical COA
- Accreditation vs. certification: Laboratories receive official accreditation for their technical competence rather than a general ISO certification, meaning they do not receive a certificate directly from ISO itself.
- Test-specific scope: A laboratory is often accredited only for specific tests, such as HPLC purity, rather than all possible analyses. You must verify that the specific test listed on your COA falls within the laboratory's officially accredited scope.
- Process-based competence: Accreditation validates the laboratory's overall testing process rather than providing a per-document guarantee for every individual result. While it demonstrates high competence, it is not an absolute guarantee that every single test result is flawless.
Sources
- Impact of ISO/IEC 17025 laboratory accreditation in sub-Saharan Africa: a case study
- The limits of accreditation: Monopoly, insularity, and the need for openness in forensic science - PMC
- Meta‐audit of laboratory ISO accreditation inspections: measuring the old emperor's clothes - PMC
- ISO/IEC 17025 — Testing and calibration laboratories - ISO
- ISO/IEC 17025:2017 - General requirements for the competence of ...
- ISO/IEC 17025 - Wikipedia
- What is an ISO 17025 Accreditation (and Why Does it Matter)? - Purafil
- GMP or ISO – What’s the Difference?
- Peptide Testing Lab | HPLC Purity & Identity COA | Prodigy Labs San Diego
- GMP, GLP or ISO 17025: How Do These Apply to ...
- Peptide Certificates of Analysis: How to Read and Verify ...
- Spotlight on accreditation standards: ISO/IEC 17025 for laboratory testing/calibration
- ISO/IEC 17025 – ANAB
- Peptide Testing Lab | ISO 17025 Accredited
- All you need to know about ISO 17025:2017 accredited laboratories - Eurofins USA
- ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories
- Peptides Lab UK Research Quality Standards: Our Full SOP for HPLC Verification, Mass Spectrometry Identity, Endotoxin Testing and Batch Traceability (2026) - Peptides Lab UK
- Peptide Testing Services | ILS Laboratories