Competence of Testing and Calibration Laboratories
What is ISO 17025?
ISO 17025 is a “Management system” that refers to the organization’s structure for managing its processes—or activities—that transform inputs of resources into a product or service which meet the organization’s objectives. These objectives consist of satisfying the customer’s quality requirements, complying to regulations or meeting environmental objectives.
ISO 9001 is a generic management standard that can be applied to any business enterprise, public administration or government department.
Growth in the use of management systems generally has increased the need to ensure that laboratories can operate to a standard that is seen as compliant with ISO 9001 as well as demonstrating technical competency. Therefore, ISO 17025 was written to incorporate all the ISO 9001 requirements that are relevant to the scope of testing and calibration services as well as specifying the technical requirements for technical competence.
Testing and calibration laboratories that comply with ISO 17025 also operate in accordance with ISO 9001.
ISO 17025 Requirements
The Contents of ISO 17025
The ISO 17025 standard itself is comprised of 5 elements:
- Scope
- Normative references
- Terms and definitions
- Management requirements
- Technical requirements
Elements 4 and 5 contain the actual accreditation requirements.
Accreditation Management Requirements
- Organization
- Quality system
- Document control
- Review of requests, tenders and contracts
- Subcontracting of tests and calibrations
- Purchasing services and supplies
- Service to client
- Complaints
- Control of nonconforming testing and/or calibration work
- Corrective action
- Preventive action
- Control of records
- Internal audits
- Management reviews
Technical Requirements
- General
- Personnel – Accommodation/environmental conditions
- Test and calibration methods and method validation
- Equipment
- Measurement traceability
- Sampling
- Handling of test and calibration items
- Assuring the quality of test and calibration results
- Reporting the results
ISO17025 FAQ
The ISO 17025 Quality Management System Model provides structure using the industry standard ISO 9001 approach. It embraces trusted methods and frameworks to help provide a stable quality environment.
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