ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.
ISO/IEC 17025:2005 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025:2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.
ISO/IEC 17025:2005 is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. ISO/IEC 17025:2005 is not intended to be used as the basis for certification of laboratories.
Compliance with regulatory and safety requirements on the operation of laboratories is not covered by ISO/IEC 17025:2005.
There are five basic elements that make up the review process for ISO 17025 certification
- Scope: The area of the lab being evaluated that will represent the lab as a whole (i.e. mechanical equipment, environmental conditions)
- Normative References: Documents that give the most recent information about every area of the process and equipment standards.
- Terms and Definitions: The labeling of all equipment, instruments, work stations, employees, and defining instructions, protocol, procedure, and safety measures.
- Management Requirements: EX: document control, service to clients, contract reviews, preventative actions, internal audits, management reviews, etc.
- Technical Requirements: EX: Safe working conditions, functional equipment, proper calibration of devices, handling of tests and substances, result reporting etc.
Benefits of ISO 17025 Certification
- Increase of confidence in Testing/ Calibration data and of personnel performing work.
- Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
- Potential increase in business due to enhanced customer confidence and satisfaction.
- Customers can search and identify the laboratories accredited by The Accreditation Member Body for their specific requirements from their website or Directory of Accredited Laboratories.
- Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories.
- Savings in terms of time and money due to reduction or elimination of the need for re-testing of products.
- Improved national and global reputation and image of the laboratory.
- Continually improving data quality and laboratory effectiveness.