ISO 17025 standards govern the "General requirements for the competence of testing and calibration laboratories". A third version was released in 2017 and is now known as ISO 17025:2017.
What does this mean for software vendors and the labs? The answer is simple. All calibration lab management systems should have their processes aligned with clause 7 of ISO 17025:2017. This means that the digital transformation of calibration labs has to be based on the said spec.
Processing Calibration requests from clients
The process starts with calibration requests from clients. ISO 17025:2017 mandates proper handling and processing of such requests. Calibration lab management systems should have a proper way to notify clients about due dates for their equipment. The system should also provide clients with a system to book their slots. The process should be as seamless as possible.
Choosing calibration method
Based on the requirements of the client, and based on the understanding of the equipment, the system should be able to suggest appropriate calibration methods. There is much scope for AI and ML-based algorithms to play a part in this piece of software.
Pre-test sampling plan
Before testing the equipment, we need to have a test plan with a decent sample size. The system should provide enough input and support the plan preparation.
Handling of equipment
Handling the client equipment at the calibration lab involves various movement registries and logging documents. The software should be able to support the process and store the registry data and logs for future retrieval.
Documentation
The entire calibration process needs to be documented in chronological order. The same should be available for future reference. Some of the documents may be required to be shared with the client. The software should support the seamless sharing of such documents with the client.
Error margin evaluation of your calibration
It is important to ensure results are within the standard error margins. Towards this, the lab should have a proper understanding of the error margins. Software should support that and adequate documentation on this needs to be provided.
Publishing results
Software should support report preparation and automated certificate preparation. This will save much time and resources for the labs. The clients should be able to access the report and the certificates without the need for much manual intervention.
Complaint resolution process
The system should allow clients to raise complaints effortlessly and should take the lab and the client through a complaint resolution process.
Data management and security
All the data and information handled by the lab and the system should be secure. Sensitive data needs to be encrypted. The software should be designed and implemented with data security as a priority.
No side-stepping of ISO 17025:2017 spec
It’s important not to sidestep ISO 17025:2017 specification. It’s the responsibility of the labs and the calibration management software vendors to ensure adherence to the spec when implementing digital transformation.