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ISO 17025

ISO 17025

Quality Management in Testing & Calibration Laboratories & ISO 17025:2005

 

The first edition (1999) of this International Standard was produced as the result of extensive experience in the implementation of ISO/IEC Guide 25 and EN 45001, both of which it replaced. It contained all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a management system, are technically competent, and are able to generate technically valid results.
The first edition referred to ISO 9001:1994 and ISO 9002:1994. These standards have been superseded by ISO 9001, which made an alignment of ISO/IEC 17025 necessary. In this second edition, clauses have been amended or added only when considered necessary in the light of ISO 9001.
The contents of ISO/IEC 17025 - The ISO/IEC 17025 standard itself comprises five elements that are Scope, Normative References, Terms and Definitions, Management Requirements and Technical Requirements. The two main sections in ISO/IEC 17025 are Management Requirements and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements includes factors which determines the correctness and reliability of the tests and calibrations performed in laboratory.
Clause 4 specifies the requirements for sound management. Clause 5 specifies the requirements for technical competence for the type of tests and/or calibrations the laboratory undertakes.
Growth in the use of management systems generally has increased the need to ensure that laboratories which form part of larger organizations or offer other services can operate to a quality management system that is seen as compliant with ISO 9001 as well as with this International Standard. Care has been taken, therefore, to incorporate all those requirements of ISO 9001 that are relevant to the scope of testing and calibration services that are covered by the laboratory's management system.
Testing and calibration laboratories that comply with this International Standard will therefore also operate in accordance with ISO 9001.
Conformity of the quality management system within which the laboratory operates to the requirements of ISO 9001 does not of itself demonstrate the competence of the laboratory to produce technically valid data and results. Nor does demonstrated conformity to this International Standard imply conformity of the quality management system within which the laboratory operates to all the requirements of ISO 9001.
The acceptance of testing and calibration results between countries should be facilitated if laboratories comply with this International Standard. 
The use of this International Standard will facilitate cooperation between laboratories and other bodies, and assist in the exchange of information and experience, and in the harmonization of standards and procedures.

Oxford Cert  Services
•    Internal Approval - Oxford Cert offer assessment and Internal Approval against ISO 17025.
•    Internal AuditAssessments - Oxford Cert offer gap analysis, preliminary assessments to prepare you for certification.
•    Training -Oxford Cert offer training which will prepare you and your staff before and after the certification process.