ISO 17025 What Does It Mean To You?
A new documentary quality standard for calibration laboratories was issued in 1999. ISO 17025 is an important step forward in the development of an effective global compliance system for calibration and testing laboratories. The clients of a laboratory that are ISO 17025 compliant can now expect their vendor adheres to a strict set of requirements designed to guarantee the reliability of the measurements provided. For the laboratory customer this means a higher level of confidence in the results, for the laboratory itself it means strict adherence to procedural guidelines in an unbiased environment.
What is this new ISO standard? In a nutshell ISO 17025 supercedes ISO/IEC Lab Guide 25 as well as Z-540 and contains all of the requirements that calibration laboratories have to meet to demonstrate they operate a quality system, are technically competent, and are able to generate technically valid results. ISO 17025 simplifies things, too. All of the quality elements of ISO 9002 are fully integrated into ISO 17025. This means that any laboratory operating under an ISO 17025 Quality system will be compliant to ISO 9002.
Accreditation attests to the technical capability of a laboratory to carry out certain types of measurement. The process of accreditation (establishing it and maintaining it) is a significant and costly undertaking. Most laboratories today are not accredited and many will not be in a position to justify the investment. Certain industries will likely insist on ISO 17025 compliance; biomedical, aerospace and telecommunication are three. In these industries some rationalization of laboratories is likely.
An important technical requirement of ISO 17025 is the need to evaluate measurement uncertainty for measurements within the scope of accreditation. This again “raises the bar” in terms of technical capability. Some labs may not be able to meet this requirement.
Another important requirement is that laboratories must now report “as found, as left” data.
Some other requirements that ISO 17025 will impose are:
- Training requirements for laboratory personnel have been strengthened. Training goals must be established.
- The quality system must address how the laboratory and its staff remain impartial and free from influences that might affect the quality of their work.
- Competency of subcontractors must be evaluated. A subcontractor must meet the meet the requirements of ISO 17025.
- The process for in-service checks between calibrations and verifications must be identified and proceduralized.
- Uncertainty of measurements and/or a statement of compliance are required on all calibration certificates when it is necessary for the interpretation of calibration results.
- More technical records must be maintained including observations, calculations, factors affecting uncertainty, notes and staff reports.
The list above is not exhaustive. More information on ISO 17025 is available at: www.ilac.org
ISO 17025 is another step up in improving measurement laboratory quality. Meeting this standard will not be feasible for all laboratories. Those that do meet the standard will certainly warrant the high degree of credibility that ISO 17025 implies.