Quality Policy

The quality policy defines our quality principles, which guide our daily actions.

For us, acting in a quality-conscious manner means orienting our products to current requirements of our customers and the market, developing and producing high-quality products and services, dealing with resources efficiently and sparingly and always keeping patient safety in focus as our highest quality principle. We also take great care in the selection of our suppliers and maintain a cooperative relationship with them.

In order to fulfil these tasks, the performance of all individual employees is imperative. The quality, safety and performance of our products are continuously improved by their positive contribution and design. In order to keep up with the rapid technical progress in our field of business, our employees constantly make progress via training, information and personal support.

Furthermore, we ensure that all activities relevant to quality and product safety are continuously planned, controlled and monitored. A large number of established monitoring processes across all areas and hierarchies pave the way for the continuous improvement of our established processes. This way, we fulfil the requirements using customer specifications, regulatory rules and other regulations. For this Chromsystems maintains a quality management system that meets the requirements of EN ISO 9001, EN ISO 13485 and IVD Regulation (EU) 2017/746 and in parallel also IVD Directive 98/79/EC as well as participating MDSAP countries (Brazil, USA, Canada and Australia) and all other international markets in which Chromsystems is active.

The management thereby is responsible for the overall performance of the products and for the quality system. The exemplification of the hereby mentioned principles by the executive board and the management enables a successful implementation of our quality policy within the entire company.

Continuous evaluation and assessment based on topicality and success makes it possible to constantly improve the quality policy in the future by innovative thinking and action.


Gräfelfing, 01.09.2021
Michael Meier, Managing Director