Heinz Herenz Medizinalbedarf GmbH has been your reliable partner in the field of medical & laboratory supplies for over 75 years. This success is also due to our pronounced quality awareness from which we have derived our quality policy.
In order to meet the requirements of our quality policy, Heinz Herenz Medizinal GmbH has established and lives by a comprehensive and carefully thought-out Quality Management System (QMS). This QMS forms the basis for our being certified – for more than 20 years – by our Notified Body. The current certification is in accordance with DIN EN ISO 13485:2016.
You can find our current certificates here.
We also regularly check the effectiveness of our QMS internally with a team of seven internal auditors using an internal audit program. The aim of this audit program is, among other things, to optimize our processes and to uncover and exploit potential for improvement in all areas. All of this follows a risk-based approach to ensure patient safety.
We see the challenges of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) as an opportunity to critically review our QMS. In this context, we are constantly optimizing our QMS and adapting it to the stricter requirements of the MDR and IVDR regulations.
The quality and safety of our products is and remains an essential criterion for our purchasing decisions with suppliers. Thus, our customers can always be sure to purchase compliant products of the highest quality.
It is common knowledge that a QMS can only be as good as the people who implement it. For this reason, we have launched an internal training program. The goal of this program is to sensitize and train all employees to the new requirements.
Furthermore, we are a member of Life Science North. There we use the opportunity to keep our knowledge up to date and to exchange experiences with other medical device manufacturers, Notified Bodies and authorities.
Hamburg in December 2022
Quality Management Representative