Knowledge Center

Agile quality management is an approach within the business and organizational world that aims to place flexibility, adaptability and continuous improvement at the heart of quality management. It is a response to the increasingly volatile, uncertain, complex and ambiguous (VUCA) conditions as well as the brittle, uncertain, non-linear and incomprehensible (BANI) conditions under which modern organizations operate. "Agile Quality Management at a Glance" explains the core concepts, meanings and applications of agile quality management in an agile world.

The continuous improvement process (CIP), also known as the ongoing improvement process, is a method from quality management (ISO 9001) to continuously achieve small improvements in process quality, process quality, product quality, delivery capability and service quality.

The overall goal is to increase effectiveness and quality in organizations or companies through continuous improvement of internal procedures and processes.

ISO 9001 is facing its next revision. The focus of the discussions and the approach to the actual content of the ISO 9001 revision in 2026: so-called emerging trends - developments that show how quality management systems must adapt to a changing world.

Climate change, digitalization, new expectations of companies and organizations require a rethink, or at least a broader view than before. Dealing with emerging trends - also known as emerging themes or megatrends - can help to ensure that quality remains effective and relevant in the future - without fundamentally changing the proven structure of the standard.

From a Notified Body’s Perspective: What Manufacturers Really Need to Know About Classification, Clinical Evidence, and Conformity Assessment

The question sounds simple, but it is crucial from a regulatory standpoint: Is my software even a medical device? And if so, how is it classified and certified? Under the EU Medical Device Regulation (MDR), this depends entirely on the intended purpose. Software can be a standalone medical device or control or influence the use of another medical device. This is precisely where the regulatory framework for classification, clinical evidence, and conformity assessment begins.