標準簡介
ISO/IEC 17025:2017 是規定檢測和校準實驗室能力、公正性和一致運作一般要求的國際標準。該標準於 2017 年 11 月發布，為第三版，是證明實驗室產生有效、可靠技術結果的全球公認基準。與 ISO 9001 認證不同，實驗室是由認可機構按 ISO 17025 進行「認可」（而非認證），認可機構證明其技術能力。
此標準涵蓋結構要求、資源管理（人員、設施、設備）、流程要求（方法驗證、取樣、量測不確定度、計量追溯性）和管理系統要求。ISO/IEC 17025 認可通常是監管機構對官方檢測的強制要求，包括環境監測、鑑識分析、食品安全、臨床診斷和產品符合性評鑑。全球超過 80,000 間實驗室持有 ISO 17025 認可，此標準是檢測和校準結果全球相互承認架構的基石。
Laboratory Competence
Demonstrates that laboratories are technically competent and produce valid, reliable results. The globally accepted benchmark for testing and calibration laboratory quality.
Measurement Traceability
Requires that measurement results are traceable to the International System of Units (SI) through an unbroken chain of calibrations with stated measurement uncertainties.
Impartiality & Independence
Mandates that laboratories operate impartially, managing risks to impartiality and ensuring that commercial, financial, or other pressures do not compromise technical judgment.
list_alt Key Requirements
- Impartiality and confidentiality obligations
- Structural and resource requirements
- Personnel competence, training, and authorization
- Equipment calibration and metrological traceability
- Method selection, validation, and verification
- Sampling, handling, and transportation of test items
- Quality assurance of results and proficiency testing
- Management system requirements (Options A and B)
Who Needs to Comply?
Testing and calibration laboratories of any size in any sector — including environmental, forensic, clinical, food safety, materials testing, and calibration facilities. Required by many regulatory authorities and often mandated by industry standards and customer specifications.
Key Requirements
Impartiality
Laboratory activities must be undertaken impartially. The laboratory must identify risks to impartiality on an ongoing basis, including relationships with parent organizations, and demonstrate how such risks are eliminated or minimized.
Method Validation
Use appropriate methods and procedures for all tests and calibrations. Non-standard methods, laboratory-developed methods, and modified standard methods must be validated to confirm fitness for intended use.
Metrological Traceability
Ensure measurement results are traceable to SI units through documented unbroken chains of calibration. Maintain calibration records and evaluate measurement uncertainty for all quantitative results.
Quality Assurance of Results
Implement procedures to monitor the validity of results through proficiency testing, interlaboratory comparisons, use of certified reference materials, and replicate testing using the same or different methods.
Management System
Implement a management system covering document control, internal audits, management reviews, corrective actions, and handling of complaints. Two options: develop a bespoke system (Option A) or use an existing ISO 9001 system (Option B).
Penalties & Enforcement
No direct legal penalties — ISO 17025 is a voluntary accreditation standard. However, laboratories that lose accreditation may be unable to perform regulatory testing, lose contracts, and see their test results unrecognized by regulators and trading partners.