ISO/IEC has just published a new version of the standard: General Requirements for the Competence of Testing and Calibration Laboratories. The standard, first published in 1999, has been acknowledged as the international benchmark for approving the competence of the testing and calibration laboratories that play a vital role in trade, in product development and manufacturing, and in protection of the consumer. The new standard does not suggest changes to the technical requirements. The modifications relate mainly to the management requirements in order to harmonize with the quality management standard ISO 9001:2000. Accreditation bodies will allow laboratories up to two years to implement the new standard.
The attainment of accreditation is mandatory for some regulatory work areas and frequently is the basis of contracts for analytical work. In 2000 the draft has been replaced by the International Standard ISO/IEC DIS 17025: General Requirements for the Competence of Testing and Calibration Laboratories.
The ISO 17025 standard states that if testing and calibration laboratories comply with ISO 17025, you also operate in accordance with ISO 9001. However, calibration against ISO9001 does not itself demonstrate the competence of the laboratory to produce technically valid data and results.
Many laboratories will want to get registration to ISO 9000 along with the 17025 accreditation. To address this request, some accreditation bodies and registrars are working out a partnership to use one auditor to perform both the 17025 audit and the ISO 9000 audit simultaneously. Talk to the accreditation body and the registrar to see if they can provide this service.
This part aligns management aspects of ISO/IEC DIS 17025 with ISO 9001/2. It is expected that laboratories implementing ISO/IEC DIS 17025 would only need a single quality system.
Management requirements include paragraphs on
Organization and management (4.1) Quality system (4.2) Document control (4.3) Review of request (4.4) Subcontracting of tests and calibrations (4.5) Purchasing services and supplies (4.6) Service to the client (4.7) Complaints (4.8) Control of non-conformity testing (4.9) Corrective action (4.10) Preventive action (4.11) Records (4.12) Internal audits (4.13) Management reviews (4.14) Technical Requirements
Technical requirements include paragraphs with much details on
General (5.1) Personnel (5.2) Accommodation and environmental conditions (5.3) Test and calibration methods including sampling (5.4) This includes requirements for method validation (laboratory developed, non-standardized, standardized but used outside of their intended range) and measurement uncertainty Equipment (5.5) Measurement traceability Sampling (5.7) Handling and transportation of of test and calibration items (5.8) Assuring the quality of test and calibration results (5.9) Assuring the quality of test and calibration results (5.10) Recommendation to laboratories:
They may develop an active plan on how to implement ISO/IEC DIS 17025. The plan should include
Steps for implementation A time schedule with checkpoints Resources needed for implementation References
ISO/IEC DIS 17025 (2005), International Organisation for Standardization, Geneva, Switzerland MC Walsh, Revision of ISO Guide 25, Accreditation and Quality Assurance, Vol. 4, Number 8, August 1999, 365/368
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