Case Study

Importance of CMC and accredited calibration for global acceptance

Summary

A medical device manufacturer specialised in flow-based medical equipment used the National Metrology Institute (NMI) of its own economy for flow calibration to export medical devices. The calibration certificate was rejected by the importing economy because the NMI did not have an internationally recognised Calibration and Measurement Capability (CMC) for flow and International Laboratory Accreditation Cooperation (ILAC) traceability requirements were not met. The manufacturer accredited its own calibration laboratory to ISO/IEC 17025 and gained recognition in the CMC Bureau International Des Poids et Mesures (BIPM) Key Comparison Database (KCDB) for flow measurements and the calibration certificates were accepted thereafter.

Background

To maintain measurement traceability, a medical device manufacturer specialising in flow-based medical equipment, such as infusion pump analysers, ventilator flow sensors, gas flow analysers, etc., used the NMI of its own economy for flow calibration. The manufacturer selected the NMI due to its highly accurate instruments.

Normally, NMIs are the apex bodies for national traceability. However, this NMI did not have a published CMC in the BIPM Key Comparison Database for flow measurements.

Strategy

The manufacturer exported its devices to another economy, and during the regulatory review, the importing economy’s authority examined the calibration certificates. Although the calibration was performed by a National Metrology Institute, the certificates were rejected because:

• The NMI did not have an internationally recognised CMC for flow, and
• Additional documentary evidence required per ILAC P10:07/2020 – ILAC Policy on Metrological Traceability of Measurement Results, Appendix A, Clause 3(a), was not provided by the NMI.

As a result, the traceability was not accepted as the device failed to meet regulatory traceability requirements of the importing economy. Therefore, the export consignment was delayed, resulting in financial losses.

After this incident, the manufacturer decided to establish its own calibration laboratory and proceeded to pursue accreditation to ISO/IEC 17025 for flow calibration. During the accreditation process, the accreditation body reviewed:

• Traceability requirements
• CMC recognition
• International acceptance criteria

At this stage, the manufacturer realised that Calibration from an NMI is not automatically accepted internationally unless the NMI has CMC entries in the BIPM KCDB for the specific parameter and that NMI results without CMC can be accepted only if ILAC P10, Appendix A, Clause 3(a) requirements are fulfilled with appropriate additional documents to the customer.

Results and impact

The accreditation process was key to helping the manufacturer’s understanding of the issue as assessors also explained that:

• For global trade, calibration must have internationally recognised traceability.
• Traceability through an NMI without CMC is usually limited to domestic use.
• Only CMC-listed capabilities are accepted under ILAC–CIPM mutual recognition arrangements, unless extra documentation ILAC P10 Appendix A / Clause 3(a) is provided.

Not fully understanding the intent of ILAC P10 and the function of the BIPM Key Comparison Database which facilitates mutual recognition of calibration results across economies was the cause of the earlier export rejection.

Corrective Action

To avoid future rejections:

• The manufacturer completed the ISO/IEC 17025 accreditation process for its new calibration laboratory.
• Traceability was then established through an NMI in another economy with valid CMC entries for flow in the BIPM KCDB.

The manufacturer’s Calibration reports thereafter include an accreditation symbol that has recognised international acceptance under the ILAC MRA.

Outcome

After adopting accredited calibration with proper CMC traceability:

• Export certificates were immediately accepted.
• No regulatory objections were raised.
• Export shipments resumed smoothly.
• Customer confidence increased.
• Financial losses due to rejection were avoided.
• Internal understanding of the international metrology infrastructure improved significantly.

Contact

Giulia Surani, Calibration Program Manager, IAS