Control your measuring and monitoring equipment

Compliance with ISO 13485 and EU MDR/IVDR require clear evidence of effective control over measuring and monitoring processes, equipment, and calibration—a requirement that is easy to underestimate or overlook.

EN ISO 13485:2016/A11:2021 contains a section (7.6) dedicated to the control of monitoring and measuring equipment, which includes both a determination of the monitoring and measurements to be taken and the equipment needed to provide evidence of conformity of products to applicable requirements. As part of the harmonization of the ISO 13485 standard, this section is identified as covering the legal requirements specified in both the EU 2017/745 MDR & 2017/746 IVDR (specifically as part of conformity assessments in Annex IX & XI).

The accuracy, precision, and stability of devices with diagnostic or measuring function are also identified in the GSPR of both the MDR (#15) and IVDR (#14), with reference to appropriate scientific and technical methods and identification of the limits of accuracy.

Additional guidance can be found in the international standard ISO 10012 which is applicable to any organization where measurement processes influence product quality and addresses both the technical and management aspects of measurement systems by:

• ensuring that measurement processes and equipment support product conformity requirements, and
• providing confidence in the accuracy and reliability of measurement results.

To be compliant, manufacturers typically need to consider a wide range of activities including:

• unique identification of each piece of measuring equipment and its calibration status, including relevant labelling.
• scheduling of calibration appropriate to the equipment type, usage frequency and risk of incorrect measurements
• performing calibrations using standards traceable to national or international norms (or provide detailed rationales for the choice of other methods)
• regular verification of equipment accuracy using control samples or secondary standards
• safeguarding against adjustments invalidating measurement results and protection from damage and deterioration during handling, maintenance, and storage (including control of the relevant environment).
• validation of software used for monitoring and measurement, with risk–based approach for revalidation, particularly after changes.
• training personnel in equipment use, calibration and maintenance.
• handling nonconformities related to out of specification equipment, including recalibration or replacement and impact assessment on previously productions based on potentially incorrect measurements.
• maintenance of records in a format accessible to audits & inspections.

The content in the organization’s standard operating procedures therefore needs to clearly establish a standardized workflow for the control, calibration, and maintenance of measuring and monitoring equipment used in production, testing and inspection.