Making the climb to ISO/IEC 17025

professionals who work in calibration, inspection and testing laboratories must also prepare before they lead their organisations up the slopes of ISO standards registration. They will not be selecting ropes and ice picks,


but these quality management system “mountaineers” must select the gear that will underwrite the success of their businesses and ensure the precision required by their industry. Successful products, the viability of the labs and even the safety of human lives depend upon careful preparation and the right tools. As the guidelines for ISO standards become

more stringent, calibration management software increasingly offers the most reliable tools to catalogue, organise, guide and evaluate a calibration lab’s progress through specific procedures. Software is invaluable in helping to establish a systematic, predictable approach to lab operations. Auditors understand the necessity of reliable software solutions and value data from such systems, especially when they are integrated into a lab’s daily activities. A virtual Swiss army knife loaded with features, quality software is a vital tool for companies attempting to achieve registration to various ISO standards. Historically, labs have looked to ISO 9001 for

guidelines on ensuring quality processes in calibration, inspection and testing. The increased acceptance of the ISO/IEC 17025 standard has introduced a new level of complexity in the “ascent” to registration. These standards address

ike dedicated mountain climbers who carefully plan their expeditions to the summits of Everest or Kilimanjaro, quality

aspects of lab competency as well as reliability in calibration procedures and results. Labs that set excellence as their goal must move beyond the procedural competence demanded by ISO 9001 and demonstrate competence through the “technically valid data and results” required by ISO/IEC 17025. Accurate measurement estimations, competent lab technicians, and traceability of methods and equipment are vital parts of the standard’s requirements. The right software product can sustain

day-to-day lab operations while allowing maximum flexibility for ISO/IEC 17025 accreditation challenges. Labs that research the standard as well as the required tools for the journey will be assured of success. ISO/IEC 17025’s section 5 regarding technical requirements represents the first leg of the ascent, and it can be conquered almost entirely by a properly constructed software solution. Let us look at some specific situations.

CertIfICAteS of CAlIbrAtIon The process for creating certificates of calibration (or “certs”) must be extremely flexible to allow for modifications required by ISO/IEC 17025 specifications. Make sure your calibration management software can generate unique cert numbers and that it offers plenty of options to display data collected from calibrations or tests on the certificate. Section 5.10 provides a comprehensive list of the minimal characteristics for certs or test reports. These items include (but are not limited to) title, lab address, calibration location, custom information, equipment calibrated, date and time, methods used, test point findings and technician’s signatures. Custom certs for customer and/or equipment

type should also be available to allow for specifications in section 5.10.1, which emphasises that customer requirements must be fulfilled. Also check that additional riders can be included with the cert, and that outsourced certificates can be added to the system so that complete documentation is made available.

ChArtS, trend AnAlySIS And proCeSS workflow Look for software that supports charts and calibration trend reports. These data support statistical analysis of the overall calibration system and allow technicians to visualise the effects of procedural changes. Software that tracks equipment through the lab reduces the chance of mishandling at any


Accreditation – IndySoft’s Calibration software can help calibration labs scale this standards summit

step. This functionality is generally referred to as “workflow” (or “process modelling”) and it ensures, through a system of data checks, that employees follow exact procedures as equipment moves through the lab. Systems that provide visual feedback or enforce rules for the use of equipment reduce training costs and ensure reproducibility of lab policies. When evaluating the process provided by any system, ask yourself if the software will force you to radically alter your existing workflow or allow you to maintain your existing in-house procedures. The difference here can mean reduced training and deployment times.

trACkIng Keeping a record of “tracks” is valuable for both mountaineers and quality professionals. A reliable calibration management package should allow for entry and tracking of any equipment used for testing or calibration. Ensure that equipment records meet at least the minimum requirements of section 5.5.5, which includes such items as unique identifiers, manufacturer and model number, equipment documentation, historical records, and calibration and/or maintenance procedure scheduling. Software should clearly identify reference

standards, traceable to the International System of Units, and allow for tracking and calibration in addition to scheduled or impromptu checks. Off- site calibration of references should be logged and marked “unavailable” until they are returned and validated for use. A powerful system will allow you to scan and attach all relevant documents to complete your paper trail. Document storage in a central location or

database is not required by the standard, but it does offer greater control. Just make certain that a complete record of the equipment’s calibration history can be stored or referenced in some manner.

preventIve mAIntenAnCe In a lab or manufacturing environment, preventive maintenance is important to ensure timely upkeep of internal equipment and compliance with section 5.5.6. If any equipment is allowed outside the lab, the system should log its exit and prompt you to perform required performance checks upon its return. Systems that schedule maintenance procedures reduce the chance of missing an important cycle that might be uncovered during an audit. Validations of methods are also essential to a quality management system. Search out packages

January 2019 Instrumentation Monthly

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