ISO/IEC 17025 Accreditation
Apollo Analytical's quality program is built on the framework of ISO/IEC 17025:2017 — the international standard governing the competence, impartiality, and consistent operation of testing and calibration laboratories. Our methods, data integrity, and QC checkpoints are aligned to the same industry standards trusted by regulators and biopharma partners worldwide.
- ✓ ISO/IEC 17025:2017 — Quality framework for laboratory competence
- ✓ ISO/IEC 8655 — Pipette calibration and volumetric verification
- ✓ ANSI/NCSL Z540.3 — Calibration system requirements
- ✓ USP <1225> / <1226> — Method validation and verification
ISO/IEC 17025 explained
ISO/IEC 17025 is the international standard for both testing and calibration laboratories. Originally issued by the International Organization for Standardization in 1999 (formerly ISO/IEC Guide 25), the current revision — ISO/IEC 17025:2017 — sets the general requirements for the competence, impartiality, and consistent operation of laboratories of any size.
The standard is organized around two pillars: Technical Requirements — covering the competence of staff, validated methodology, and the suitability of test and calibration equipment — and Management Requirements, which govern the effectiveness and operation of the laboratory's quality management system.
A laboratory pursuing accreditation must maintain a documented quality management system that addresses every element of the standard. Apollo's quality manual, SOPs, and data review workflows are structured directly against this outline.
What does ISO/IEC 17025 measure?
The standard evaluates every input that influences whether a laboratory result can be trusted — from the people running the instruments to the environment the work is performed in.
Individual competence of staff to perform analytical work.
Use of proper equipment along with documented maintenance and calibration.
Sufficient quality assurance and quality control processes in place.
Sampling carried out to the appropriate degree of rigor.
Documented procedures for inspection, testing, and calibration.
Validated methods for obtaining accurate, reproducible data.
The ability to report and record accurate, traceable results.
Traceability to national and international measurement standards.
Proper environmental conditions for testing and calibration.
Proving accreditation status
Accredited laboratories hold two key documents: a Certificate of Accreditation attesting that ISO/IEC 17025 accreditation has been granted, and a Scope of Accreditation defining the specific tests, calibrations, measurement ranges, and uncertainties the accreditation covers. Assessment activities focus on the processes that affect that defined scope.
ISO/IEC 17025 vs. ISO 9001
ISO 9001 is a general quality management standard applicable to almost any business. ISO/IEC 17025 is specifically tailored to testing and calibration laboratories. Critically, ISO 9001 does not evaluate technical competence — it cannot guarantee that test or calibration data is accurate or scientifically defensible. ISO/IEC 17025 fills that gap by directly assessing the technical capability behind every reported result.
Data you can stake decisions on.
Whether you're preparing a regulatory filing, releasing a clinical batch, or qualifying an analytical method, Apollo's 17025-aligned quality program ensures your results stand up to the most rigorous scientific scrutiny.