TS EN 928

TS EN 928 is a guidance standard for applying quality management and quality assurance standards to the manufacture of in vitro diagnostic medical devices. It addresses the EN 29001 and EN 46001 pair as well as EN 29002 and EN 46002, placing them in the context of the in vitro diagnostics sector; in other words, it is about adapting a general quality-system framework to products used for medical testing rather than defining product performance requirements itself.

How quality systems relate to in vitro diagnostics

In vitro diagnostic devices include reagents, kits, instruments and related accessories used to generate medical information from samples such as blood, urine or tissue. Quality management in this field is concerned with more than final inspection: it links design, production, traceability, batch consistency and controlled process performance. In this technical setting, TS EN 928 serves as guidance for applying quality standards to the specific realities of IVD manufacture.

What the document covers

• It provides guidance on the application of EN 29001 and EN 29002 together with EN 46001 and EN 46002.
• Its focus is the manufacture of in vitro diagnostic medical devices.
• It translates general quality assurance concepts into the context of IVD products and related laboratory use.
• It is guidance on quality-system application, not a product test method standard.

The technical value of this standard lies in its emphasis on how IVD products are made, not only on whether they function. Traceability, documentation, process control, nonconformity handling and continuous improvement are therefore central quality-system themes for this product area. TS EN 928 is a historically important guidance document in the European adaptation of quality standards for medical devices.