ISO 17025 -standard
The ISO 17025 standard describes the general and technical requirements for the activities of testing and calibration laboratories.
ISO/IEC 17025
The ISO/IEC 17025 standard describes the general and technical requirements for the operation of testing and calibration laboratories, by following which the organization demonstrates that it is capable of competent, impartial and repeatable work. In accordance with the requirements of the standard, the laboratory must plan and implement measures for handling risks and opportunities, thereby increasing the effectiveness of the management system, achieving better results and preventing harmful effects.
ISO 17025 presents requirements for the laboratory’s resources, processes and management system. The ISO 17025 standard is suitable for all organizations performing laboratory activities, regardless of the number of their personnel.
Implementation of ISO 17025
The laboratory’s management is responsible for the laboratory’s operations, which must meet the operational requirements of the laboratory’s customers, the authorities and the organization granting approval, in addition to the requirements described in the ISO 17025 standard. The qualifications of the organization’s personnel, premises and environmental conditions must be described and they must be suitable for the operation. The equipment needed for the operation (e.g. measuring devices, software, reagents and consumables) must enable the correct execution of the operation and the correctness of the results. The selection, verification and validation of the methods used in the laboratory are a key part of ensuring the correct execution of the operation and the correctness of the results. The organization must also describe the management system either on the basis of ISO 9001-compliant operations or by documenting the management system and the processes included in it (e.g. management of documentation and records, risks and opportunities, improvement, management).
Auditing, certification and accreditation according to ISO 17025
The management system according to the ISO 17025 standard can be certified by an external party. The certificate shows that the management system meets the requirements set by the standard, and its documentation and records show the conformity of the operation.
A central part of the accreditation process is that an independent evaluator checks the competence of the operator of the activity to perform a certain test (qualification area). In this case, the credibility of the certificates issued by the laboratory has been reliably verified by the accreditation body. In Finland, laboratory activities are accredited by FINAS.
Kasve’s ISO 17025 services for our customers’ needs
Kasve’s experts are able to offer a wide range of help related to the ISO 17025 quality management system. We have been involved in building and auditing quality management systems according to the ISO 17025 standard. Kasve’s experts have qualified in the training organized by FINAS to perform a technical assessment according to the ISO 17025 standard.
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