General requirements for the competence of testing and calibration laboratories have been developed in response to build confidence in the laboratory activities. Laboratory accreditation is a procedure by which an authoritative body gives formal recognition of technical competence for specific tests / measurements, based on third party assessment based on ISO/IEC 17025:2005 standard. The ISO/IEC 17025 standard is developed based on the ISO Guide 25. ISO/IEC 17025 accreditation is managed by International Laboratory Accreditation Co–operation Committee (ILAC) as well as Asia Pacific Laboratory Accreditation Co–operation Committee (APLAC) Mutual Recognition Arrangements (MRA). ILAC and APLAC are engaged upon development and updating of guidelines connected with accreditation activities. Such international arrangements facilitate acceptance of test/calibration results between countries to which MRA partners represent. On accreditation of laboratory by such recognized body the test / calibration report of laboratory gets global acceptance due to such mutual recognition. General requirements for the competence of testing and calibration laboratory were initially published in year 1999 and then it was revised in 2005. At present the ISO/IEC 17025:2005 version is in the implementation. The iso 17025 standard for laboratory accreditation is mainly focus on independent testing and calibration laboratories as well as laboratories of company / laboratory.
Benefits of ISO 17025 Accreditation System
- Improved efficiency, productivity and effectiveness in the overall laboratory operation by ISO 17025 accreditation,
- Improved level of motivation, co–operation, workmanship and iso 17025 quality awareness including competence,
- Increase of confidence in Testing / Calibration data and of personnel performing work. Greater control of processes and activities throughout laboratory. Savings in terms of time and money due to reduction or elimination of the need for re–testing,
- Provide tips on analysis of data as well as measure uncertainty and perfect record keeping as per ISO/IEC 17025 standard.
- Provide guidelines and better control for maintenance of instruments, preservation of test / calibration records etc
- Establish confidence of management and customers on results as well as reports and increase customer trust as well as market share.
- Better image of laboratory as a Quality test/calibration laboratory in Global market.
- Worldwide recognition and credibility
- An ISO 17025 accredited laboratories have a definite edge over competitors.
ISO/IEC 17025 Accreditation Certificate
ISO/IEC 17025:2005 certification is an accreditation, which is granted to the laboratory by an ILAC/APLAC approved Accreditation body. ISO/IEC 17025 Accreditation Certificate is issued by Accreditation body, which is authorized by ILAC or APLC to provide accreditation under the ISO/IEC 17025:2005. The iso 17025 accreditation certificate is issued for the period of 2 years after successful completion of pre–assessment and registration (Final) assessment. The certificate of ISO/IEC 17025 system is valid till 2 years from the date of issue. Surveillance audits are conducted by the Accreditation body after one year. Upon completion of 2 years cycle, at every 2 years renewal audit will be conducted without any periodic surveillance assessment. This ISO/IEC 17025 certificate is given in India by MRA like NABL and many customers talk it ias NABL accreditation also. Globally this certificate is given by UKAS, IAS, DAC etc.
Steps involved in ISO/IEC 17025 Consultancy Services
Roots Management Services, an ISO/IEC 17025 consultancy company is having vast laboratory experience in the implementation of ISO/IEC 17025:2005 for all types of laboratories, such as testing laboratory in the field of civil engineering material testing, metallurgical testing, environmental parameters testing, chemical testing, optical testing, thermal testing, fluid flow testing etc. as well as calibration laboratories in the field of Mechanical, pressure, thermal, optical, electro–technical etc. Roots, ISO 17025 consultancy in India develops the system for its customers in the following manners;
- Micro–level survey for each and every test/calibration parameter of the laboratory and preparation of detail Gap analysis report,
- Preparation of applicable documents required by ISO/IEC 17025:2005 based on detail study of all activities of the Laboratory,
- ISO/IEC 17025 training to all levels of employees within the Laboratory,
- Calculation of measurement of uncertainty and providing software for the same.
- Helps in effective implementation of laboratory system by periodic visit till iso/iec 17025 accreditation,
- Conduct internal audit to check readiness for the iso 17025 accreditation.
- Conduct management review meeting in presence of Top Management to guide the Laboratory for effective implementation on all the issues related to testing / calibration.
- Witnessing / demonstration of test parameter/calibration to build confidence among the employees etc.
- Preaduti and final audit by accreditation body auditors and help laboratories in closing the NCR given by them
Technical Requirements of ISO/IEC 17025 Certification
Following are the technical requirements of ISO/IEC 17025 accreditation for Laboratory has to identify during implementation of system –
- Nominate one person as Quality Manager for establishing, implementation and monitoring of effective implementation of the management systems requirements,
- Nominate one person as Technical Manager for establishing, implementation and monitoring of effective implementation of the technical requirements,
- Test / calibration parameter, its range of testing, limit of detection and Uncertainty of Measurement,
- Calculation of Uncertainty of Measurement of each test / calibration parameters,
- Analysis of re–test or re–calibration results statistically,
- Inter Laboratory Comparison and identification of “Z” Score or En Value based on statistical analysis.