The International Organization for Standardization (ISO) developed ISO 17025 accreditation for use in laboratories that perform testing and calibrations. ISO 17025 covers standard testing, nonstandard testing and lab-developed testing methods. The current release was published in 2005.
According to EHow: "All labs that are ISO 17025-compliant must meet several requirements. Samples must be well documented and uniquely identified, and test results must be monitored for quality and integrity. Testing equipment must be calibrated and maintained. Written procedures should be used for all aspects of lab activities." Indeed, labs must undergo rigorous annual inspection to maintain their accreditation.
Per the ISO website:
"Many countries around the world have one or more organizations responsible for the accreditation of their nation’s laboratories. Most of these accreditation bodies have now adopted ISO/IEC 17025 as the basis for accrediting their country’s testing and calibration laboratories. This has helped countries employ a uniform approach to determining laboratory competence. It has also encouraged laboratories to adopt internationally accepted testing and measurement practices, where possible. In order for accreditation bodies (at various part of the world) to recognize each others' accreditations, the International Laboratory Accreditation Cooperation (ILAC) worked to establish methods of evaluating accreditation bodies against another ISO standard (ISO/IEC Guide 58 - which became ISO/IEC 17011). Around the world, geo-political regions such as the European Community, and Asia-Pacific, the Americas and others, established regional cooperations to manage the work needed for such mutual recognition. These regional bodies (all working within the ILAC umbrella) include European Accreditation Cooperation (EA), the Asia Pacific Laboratory Accreditation Cooperation (APLAC), Southern Africa Accreditation Cooperation (SADCA) and the Inter-American Accreditation Cooperation (IAAC).
Though, the Management Requirements of ISO/IEC 17025 has similarity with ISO 9001, it cannot be interpreted to be the same as certification against the ISO 9000 series Standards. Confidence in accreditation can only be obtained by a transparent system of control over the accredited laboratories and an assurance given by the accreditation body that the accredited laboratory constantly fulfills the accreditation criteria. Thus, demonstration of compliance with Management and Technical Requirements will allow the laboratories to operate a quality management system for their testing and calibration activities that also meets the principles of ISO 9001 and at the same time has the people, with the skills and knowledge, the environment with the facilities and equipment, the quality control and the procedures that are required to produce valid results."
Why does this matter? Because the International Standard is applicable to all organizations. Most importantly, these include all laboratories where testing and calibrations to certify products are performed. That means if you outsource to one lab that sends to another and another, etc. - as long as it is ISO 17025 certified, you are covered.
As one lab which participates, Fauske & Associates implements a quality management system to ensure compliance with requirements set forth by the ISO 17025 standard. Beginning with defining management roles and responsibilities through establishment of individual procedures for unique departments, care is taken to ensure that all employees are provided with the appropriate resources, guidelines and communication processes.
FAI establishes specific goals for three priority areas including safety, customer service and quality data. The end goal is to ensure a safe environment for employees while delivering the highest quality services and data to customers seeking non nuclear testing.
Protocols are in place to ensure that testing will meet customer expectations, that reliable vendors are used, that customer issues are resolved in a timely manner and that documentation is properly maintained. FAI has multiple methods and procedures in place to ensure that customers receive the highest quality of data. Systems are also in place to track non-conformances, corrective actions, preventive actions and ongoing process improvements.
The quality management system is a continually evolving program at FAI and is updated as needed to improve processes and provide outstanding and professional service to customers.
Here are additional benefits per the Standards.org site:
- 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.
