Quality assurance: what does your laboratory have to deal with?

The quality requirements imposed on a laboratory are high. The results of lab research can therefore have major consequences, because important decisions are often based on these results. This applies not only to healthcare, but also to industry. Reliable results are therefore crucial. And that starts with setting up a quality management system and keeping it up to date. But aspects such as calibration, validation, accreditation and data privacy also play an important role.

Quality management system

A good quality management system offers transparency, traceability, uniformity and attention to critical points. All aspects are described in a quality manual. Many labs have now automated their quality management systems. This can help you work more efficiently and it also helps to improve traceability.

One of the conditions for a well-functioning quality system is that it is supported from top to bottom within the organization. That is why it is important to properly describe and assign tasks and responsibilities. Everyone is aware of it and thus contributes.

Accreditation

Accreditation literally means: giving confidence. Simply put, accreditation is a type of quality mark that stands for the reliability, expertise and independence of test and research results carried out by accredited laboratories, calibration and inspection institutions. Qualified employees carry out the work according to established and validated procedures.

Calibration

For a good quality result, it is important to know that the equipment in your lab measures reliably. Your equipment therefore needs to be calibrated. Calibration is comparing a measured value from a measuring system with an actual measured value from a standard to determine the deviation. The determined deviation can be tested against a tolerance. In this way, the reliability of a measurement can be assessed.

Validation

Validation is objective evidence through research that an instrument or method is suitable for its intended purpose. In addition to the validation of instruments, increasing attention is being paid to the validation of computer systems and software used in laboratories.