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ISO 17025

What is ISO 17025

Management system" 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, such as 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 quality management system that is seen as compliant with ISO 9001 as well as demonstrate 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 will also operate in accordance with ISO 9001.

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 Requirements

  1. 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
  2. Technical Requirements :-
    • General
    • Personnel - Accommodation and 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.

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