Digitised measuring instruments: accurate, reliable and traceable

As part of the continued effort for digitalisation, the Indonesian Ministry of Trade (MoT) is planning to implement software for measuring instruments. This way, the quality of products will be better ensured. In measurements, it is essential that the results are accurate, reliable and traceable. Digitalisation has contributed significantly to achieving those qualities with better cost and time efficiency. At present, most measuring instruments are equipped with measuring software. To ensure proper functioning, standardised software requirements and appropriate verification techniques must be applied.

Ms Katharina Gierschke from the Federal Ministry of Economic Affairs and Climate Action (Bundesministerium für Wirtschaft und Klimaschutz – BMWK) opened the exchange by highlighting the importance of digitalisation and harmonisation of standards to support international trade. In addition, Ms Sri Astuti from the Directorate of Metrology, MoT, underlined the need for digital transformation based on the OIML recommendations. These are expected to serve as a benchmark.

Software Validation in Germany – an example

Mr Reinhard Meyer from the Physikalisch-Technische Bundesanstalt (PTB) led the session on software validation by introducing the validation process for software-based measuring instruments. In Germany, software for measuring instruments is regulated within the Measuring Instrument Directive/MID (Directive 2014/32/EU), OIML requirements and the federal law MessEG. Working Group 8.51 in PTB is specifically tasked with working according to the regulated standards.

The document OIML D 31, used by manufacturers to comply with regulated standards, is one of the important OIML toolboxes. It covers the general requirements for legally relevant software-related functionality and security, for verifying instrument compliance, and risk assessment for technical solutions. The document is continuously updated in the course of digitalisation. At PTB, the software assessment is mainly based on the Welmec Guide 7.2 / 7.6 issued in 2022. The Guide includes requirements to comply with the European MID or federal law and provides a risk analysis guide.

In addition, Mr Meyer also described the process of software validation based on his experience. In software assessment, the tester must first process test points before assessing conformity of technical measures taken by the manufacturer. Thereafter, the tester can seek clarification with the manufacturer who should then supply the tester with updated documents and clarifications. Subsequently, the software assessment is optimised to reduce processing time while maintaining or improving the test quality.

Measuring in the future

The exchange concluded with a discussion. The participants are eager to dive deeper into the implementation of software validation and learn more from PTB’s experience. The experts from both countries agree to deepen their cooperation in harmonising legal metrology standards to reduce barriers and support international trade.