Accurate measurements matter, and the role of quality laboratory accreditation
For medical devices, ISO/IEC 17025 compliance matters a great deal to the device manufacturers, the hospitals and the patients. For manufacturers metrology involves:
- Research and development—validation of design concept, validation testing
- New product introduction—setting product specifications
- Operations—calibration and verification during the manufacturing process
- Quality—supporting lean manufacturing, final inspection, and conformance
- Service—calibration and verification
- Sales and marketing—making/delivering claims to specifications
At the hospital level, where the use of the devices is critical to patient care, metrology involves:
- Meeting strict regulatory requirements for patient safety
- Choosing adequate medical instrumentation • Verification and adjustment of medical devices
- Service and repair
If these processes are not handled in-house at the hospital, then choosing capable and competent vendors to support and maintain deployed instrumentation is crucial. For patients, even though they may not be aware, metrology and a trusted laboratory partner really matter when instruments could save a life.
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