We require our producers to have a customer and process oriented management system that is certified to EN ISO 9001:2008. The services and deliveries provided by our suppliers must conform to our purchasing requirements and are continuously monitored by us. Every product is subject to our reception inspection in accordance with the specifications. Quality assurance as a management obligation and an ongoing task for every employee is set out in writing in all job descriptions and functional specification documents.
All of our measuring instruments are registered and are periodically calibrated as specified. Customer requirements that go beyond our strict internal quality requirements are defined and implemented in documents referred to as quality assurance agreements.
What is ISO 13485?
The ISO 13485 norm represents the requirements for a comprehensive management system for the design and manufacture of medical products.
Unlike ISO 9001, which aims at continual improvement, the core requirement of ISO 13485:2012 is aimed at product safety.
ISO 13485 contains detailed requirements for topics that concern the manufacture and placing on the market of medical products.
Depending on the classification of the medical product concerned, its application is obligatory for manufacturers of medical products within the scope of conformity assessment procedures. In contrast, the application of ISO 9001 is entirely voluntary, without the basis of a legal requirement.
The ISO 13485:2012 certificate enables us to improve customer satisfaction through:
The ISO norm 13485 (medical products) and the ISO 9000 series of norms (all other products) are the only certification principles to be accepted by all national standardisation and certification associations in the EU and also in many parts of the world.
All areas within the ANTRIMON Group AG depict all relevant main processes and sub-processes electronically. The defined processes are easily accessible to every employee by a mouse click on the process icon. Our aspirations go beyond a clear depiction of the processes. Our employees make daily use of our quality system as an information desk. Templates and tools relating to their work are added here directly.