ISO Standards
ISO 17025
What is ISO/IEC 17025?
ISO/IEC 17025 is a globally recognized standard for organizations performing testing, sampling, or calibration
- It applies to all types and sizes of laboratories and industries
- Latest version: ISO 17025:2017
Who Developed ISO 17025?
The ISO/IEC 17025 standard was created by laboratory experts worldwide, with contributions from:
- 18 liaison organizations, including the International Laboratory Accreditation Cooperation (ILAC)
- Numerous associations representing laboratories
Benefits of ISO/IEC 17025 Certification
1. Consistently Generate Valid Results
- Enhances accuracy and reliability in testing and calibration
2. Increased Confidence from Customers and Stakeholders
- Strengthens trust in your laboratory’s results.
3. Acceptance of Results Without Further Testing
- Promotes efficiency by reducing redundancy
4. Improved Business and International Trade
- Facilitates broader market opportunities
Key Requirements of ISO 17025:2017
ISO 17025:2017 aligns with the ISO 9001:2015 structure and consists of 8 main components:
1. Scope
- Describes the standard’s purpose, objectives, and applicable organizations
2. Normative References
- Provides brief references to guides and standards used in ISO 17025
3. Terms and Definitions
- Defines technical terminology within the standard
4. General Requirements
- Impartiality: Laboratories must ensure results are free from commercial, financial, or external pressures
- Confidentiality: Laboratories must safeguard key information and results
5. Structural Requirements
- Outlines the laboratory’s organizational structure, processes, and management system adherence
6. Resource Requirements
Details six essential components for compliance:
- General resources
- Personnel
- Facilities and environmental conditions
- Equipment
- Metrological traceability
- Externally provided products and services
7. Process Requirements
Includes 11 processes to enhance efficiency:
- Review of requests, tenders, and contracts
- Selection, verification, and validation of methods
- Sampling
- Handling of test/calibration items
- Technical records
- Evaluation of measurement uncertainty
- Ensuring the validity of results
- Reporting of results
- Complaints handling
- Addressing nonconforming work
- Control of data and information management
8. Management System Requirements
Two compliance options:
- Option A: For laboratories with standalone QMS systems
- Option B: For laboratories integrated into organizations using ISO 9001:2015-compliant management systems
Includes:
- Management system documentation
- Document control
- Records control
- Risk and opportunity actions
- Internal audits
- Corrective actions
- Management reviews
Modern Focus on Information Technology
The latest version emphasizes digital transformation, supporting the use of:
- Computer systems.
- Electronic records.
- Electronic results and reports.
Partner with Qualitas Elit
Qualitas Elit can guide your organization through ISO/IEC 17025 compliance. Contact us to ensure smooth implementation and effective certification
