that allow for scheduled or on-demand studies of the measurement system. Often referred to as gauge studies, these options provide statistical data on the overall accuracy of your measurement methods and the technicians who perform them. In a study, data are collected through a series of performed measurements, then compiled into results based on one of various standardised industry calculations. Historical charting or trending of these results for statistical analysis and refinement adds linearity to your analysis.

Security and validation

For a lab or manufacturing environment, security is essential to survival and is addressed in section This specifies not only that your data should be secured, but also that there are checks for validity in data entry and collection. Further, the specification refers to software validation, the process of ensuring that software meets or exceeds its intended use. Look for systems that lock down the database and allow customisation of the security system to reflect users’ needs. This decreases the chance of individuals

modifying data or performing tasks that are beyond their experience, job scope or capabilities.

certainty in uncertainty

Allowing for estimated uncertainty is one of the most important - and most stringent - components of ISO/IEC 17025. By definition, estimated uncertainty implies the degree of confidence in a measurement result’s validity. Because of the complexity surrounding estimated uncertainty calculations, it is also a

Instrumentation Monthly January 2019

definitive dividing point when evaluating calibration management systems that can help achieve compliance to the standard. A variety of factors (referred to as

“parameters” or “contributors”) come together to form an estimated uncertainty value. The lower the number, the higher the confidence in the measurement results. The best systems will meet the requirements of the guide to the expression of uncertainty in measurement (GUM) and incorporate all elements of the calibration process to deliver a high level of confidence in the estimated uncertainty value. Fully automating the correlation of contributors, environmental factors and other lab-provided variables provides a nearly effortless means of calculating values for busy technicians. Modern systems that allow lab managers or uncertainty specialists to administer uncertainty budgets for the entire lab keep the process in control while not impeding technicians’ progress.

Performing a calibration

ISO/IEC 17025 requires proper documentation of the calibration process. Any oversight can create a nonconformance during lab assessments. It is important to have a complete record of the events before, during and after the calibration procedure. Procedures used during the calibration should be connected to the calibration data record - not cross-linked from a global pool where they could be accidentally deleted. A complete calibration record with full traceability will find favour with auditors.

analySing the ProceSS After calculated, well-planned climbs,

mountaineers document their expeditions and pass the information on to their peers. Similarly, quality managers must ensure that the calibration process is documented and show their teams the best route to compliance. In conjunction with the ideal calibration management software package, an internal quality manual dictating procedures for complying to ISO/IEC 17025 can allow managers to retrace steps and calculate the methods used for achieving their labs’ goals.

Planning for the future

Even after a lab has achieved ISO/IEC 17025 accreditation, continual improvements are necessary as standards change or customers’ demands increase. The best tool for any quality software system is one that expands with a lab’s changing needs. Flexible certificates, charts and trend analysis, workflow control, equipment tracking, preventive maintenance, security and estimated uncertainty are all addressed in ISO/IEC 17025 and supply critical guidelines for selecting the ideal system. In the future, calibration management software

systems will continue to improve. Innovations such as automated evaluation of technicians’ training, vendor qualification and other processes will expand to meet the full requirements of ISO/IEC 17025. Because the standard’s specifications are broad, you will not find a software package that covers everything in minute detail. The challenge is to find a balance - a product that helps your lab meet the guidelines while maximising efficiency in quality assurance.

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