Our management system is based on STORZ MEDICAL AG's principles governing quality, safety and environmental protection. It meets the requirements of internationally accepted standards and regulations and includes, inter alia, a certified quality management system in compliance with the EN ISO 13485:2016 and ISO 9001:2015 standards, as well as a certified environmental management system in accordance with the ISO 14001:2015 standard. The system complies with the requirements of Directive 93/42/EEC concerning medical devices (MDD), Annex II (excluding point 4 of Annex II), and of Taiwan's »Technical Cooperation Programme« (TCP) with certification to EN ISO 13485. Furthermore, additional standards and codes applicable within the scope of the Medical Device Single Audit Program (MDSAP) – e.g. the US FDA's »Quality System Regulation« (QSR) 21 CFR Part 820 – are also complied with.
Our products and services are designed to satisfy all the demands placed on them in relation to quality, safety and environmental protection. This is why product quality control is an essential part of our quality assurance activities, and why the focus of our environmental management measures is on environmental aspects along the life cycle of our products and services. Our goal is to manufacture products in line with market requirements using eco-friendly and resource-saving processes, and to conform to legal and social standards. For the benefit of customers, suppliers and ourselves we want, through continuity, to ensure lasting partnerships and, furthermore, to create long-term competitive advantages, by being a dependable partner in every respect – including quality, sustainability and care for the environment.
Here you will find confirmation of our certification by recognized certification bodies:
Quality management system for medical devices EN ISO 13485:2016
Quality management system ISO 9001:2015
Environmental management system ISO 14001:2015
Quality management system ISO 9001:2015 (IQNet Partner Certificate)
Environmental management system ISO 14001:2015 (IQNet Partner Certificate)