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 address the competence of staff; testing methodology; equipment and quality; and reporting of test and calibration results.
A prerequisite for a laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard. This standard contains all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a quality system, are technically competent, and are able to generate technically valid results. Key topics covered include the requirements for sound management and for the type of tests and/or calibrations the laboratories undertake.
ISO/IEC 17025 is the global quality standard for testing and calibration laboratories. It is the basis for accreditation from an accreditation body. The current release was published in 2005.
Implementing ISO/IEC 17025 has benefits for laboratories, but the work and costs involved should be considered before proceeding.
Laboratory accreditation provides formal recognition of competence to laboratories, thus raising the efficiency and effectiveness of laboratory operation. It allows customers to select appropriate testing services and minimizes the risk of unreliable results. Laboratories are regularly assessed by the accreditation body to ensure continual compliance with requirements.
Main Benefits of ISO/IEC 17025:
Implementing ISO/IEC 17025 as part of laboratory quality initiatives provides both laboratory and business benefits such as:
Having access to more contracts for testing and/or calibration. Some public and private organizations only give contracts to accredited laboratories. Accreditation will also help to get more contracts from organizations that don’t mandate accreditation, but do give preference to accredited laboratories in competitive situations.
Improved national and global reputation and image of the laboratory.
Continually improving data quality and laboratory effectiveness.
Having a basis for most other quality systems related to laboratories, such as Good Manufacturing Practices and Good Laboratory Practices.
Additional information about the quality of each measurement made during the calibration process,
A means of assessing the relative quality and capability of different calibration laboratories and suppliers from around the world, and
Eliminates the need for supplier auditing – calibration suppliers are independently verified through the accreditation process.
Analytical testing laboratories seeking ISO/IEC 17025 will be impacted in multiple areas. The main difference between good analytical practices and formal accreditation is the amount of documentation to be developed. There is no doubt that any good analytical laboratory uses qualified analysts, checks the performance of equipment used for testing, and validates analytical methods. However, many times the outcome of the tests is not fully documented. ISO/IEC 17025 accreditation requires formal documented environment – ‘what is not documented is a rumor,’ and is viewed by assessors as ‘not being done.’
Who should implement ISO/IEC Standard 17025?
Analytical testing laboratories of companies or organizations that are registered to an ISO 9000 based standard, if laboratory activities are subject to an audit.
Testing laboratories which want to prove to their clients that the analyses are done within a well recognized quality system.
Direct suppliers to organizations that require ISO IEC 17025 accreditation for organizations who has TS 16949 certification.
Laboratories getting official accreditation status by an accreditation body (NABL).
All regulated laboratories can use ISO 17025 as a basis for their operations.
Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. Do you know our facility is a NABL accredited Laboratory for ISO/IEC/17025 certification.