ISO/IEC 17025 is an international standard that defines the competence requirements for testing and calibration laboratories. It is sometimes described as a “certification,” though it formally establishes laboratory accreditation based on demonstrated technical competence. Laboratories accredited to ISO/IEC 17025 operate under a quality management system designed to support impartiality, traceability, and ongoing compliance.
The standard addresses both organizational and technical requirements, including:
- Laboratory structure and legal identity
- Defined roles and responsibilities
- Personnel competence
- Equipment suitability and facility controls
- Technical processes, such as method validation, result reporting, and sample handling
Together with management system requirements—such as risk-based thinking, document control, and corrective action—these elements form the basis of ISO/IEC 17025 accreditation.
ISO/IEC 17025 Compliance Checklist
Preparation for ISO/IEC 17025 accreditation requires a structured approach, with attention to documentation, internal oversight, and technical rigor. While implementation details vary by laboratory, the standard generally addresses the following requirement domains:
- General and structural requirements: Impartiality, confidentiality, legal status, and clearly defined management responsibilities, supported by documented evidence of personnel competence.
- Resource requirements: Suitable facilities and environmental conditions, appropriately maintained and calibrated equipment, and personnel with demonstrated technical qualifications.
- Process requirements: Validated test methods, quality control procedures, proficiency testing participation, and appropriate handling of test items and results.
- Management system requirements: Internal audits, management reviews, corrective and preventive actions, and controlled documentation supporting the quality system.
Benefits of ISO/IEC 17025 Accreditation
ISO/IEC 17025 accreditation provides a recognized framework for demonstrating laboratory competence and result reliability. For laboratories operating in regulated or quality-sensitive environments, accreditation supports:
- Demonstrated technical competence: Accreditation confirms that testing activities are performed using validated methods by qualified personnel under controlled conditions.
- Reliable and traceable results: Requirements for calibration, measurement traceability, and quality control support consistency and confidence in reported data.
- International acceptance: Because ISO/IEC 17025 is globally recognized, results generated by accredited laboratories are more readily accepted by regulators, partners, and customers across jurisdictions.
- Consistent quality practices: The standard promotes standardized processes, documented procedures, and continuous oversight of both technical and management activities.
Steps to ISO/IEC 17025 Accreditation
Achieving ISO/IEC 17025 accreditation involves implementing and maintaining a laboratory management system aligned with the standard, followed by assessment by an authorized accreditation body. While timelines vary based on laboratory scope and maturity, the process typically includes:
- Planning and gap analysis: Reviewing ISO/IEC 17025 requirements and evaluating existing systems against the standard.
- Documentation development: Establishing or updating quality manuals, procedures, and records to support compliance.
- Implementation and training: Applying documented processes in daily operations and ensuring personnel understand their roles and responsibilities.
- Internal auditing: Assessing the effectiveness of the management system and identifying nonconformities.
- Management review: Reviewing audit findings, quality objectives, and system performance at the management level.
- Accreditation body assessment: Undergoing document review and on-site assessment by the selected accreditation body.
- Corrective actions and accreditation decision: Addressing any identified nonconformities prior to a formal accreditation decision.
Maintaining ISO/IEC 17025 Compliance
Once accredited, laboratories must demonstrate continued compliance through ongoing system maintenance and periodic surveillance assessments. Key activities supporting sustained accreditation include:
- Regular management reviews evaluating system performance and quality objectives
- Routine internal audits to identify and address gaps proactively
- Controlled documentation of methods, training, equipment calibration, and validation activities
- Timely investigation and resolution of nonconformities
- Ongoing monitoring of performance metrics and resource suitability
Maintaining accreditation requires continuous attention to both technical execution and quality system oversight.
BA Sciences and ISO/IEC 17025 Accreditation
BA Sciences is an ISO/IEC 17025–accredited laboratory and has received a Certificate of Accreditation for specific testing activities. The laboratory operates in accordance with ISO/IEC 17025:2017 requirements and supports regulated testing programs through established quality systems, validated methods, and documented technical competence.
For organizations requiring testing performed within an ISO/IEC 17025–accredited framework, BA Sciences provides analytical testing services aligned with applicable regulatory and quality expectations. To learn more about BA Sciences’ ISO/IEC 17025 accreditation or testing capabilities, contact us directly.