Successful ISO 13485 Audit in Germany, Norway, and the UK; Certification also for Sweden.

The quality of our products and processes is the foundation of our daily work – and it is regularly put to the test. We are pleased to report that our quality management system according to ISO 13485 has been successfully audited and certified. The requirements of ISO 13485 now apply across all locations – for Schuchmann in Germany as well as for sales in our subsidiaries in Norway and the UK.

What does ISO 13485 mean?

ISO 13485 is the internationally recognised standard for quality management systems in medical technology. It ensures that all relevant legal and regulatory requirements – including those from the European Medical Device Regulation (MDR) – are considered and implemented in our processes. However, the implementation of the standard goes far beyond legal minimum requirements:

• We commit to defining and monitoring our quality objectives and quality policy. Only where quality is clearly defined can it be attained as a standard.
• All quality-relevant processes – from development through production to sales – are clearly defined and documented.
• Traceability of our products, as well as effective complaint and corrective action management, are integral parts that ensure smooth workflows.
• The qualification of our employees is also central. As an employer, Schuchmann commits to providing employees with the necessary resources to perform their tasks optimally. Additionally, training, further education, and targeted development of our staff secure the high competence of our team.

In short: The ISO 13485 certification confirms that quality at Schuchmann is not a matter of chance but the result of clearly structured and verified processes.

View certificate here: Certificate ISO 13485

International Certification – A Joint Project

In November 2023, we launched the project to expand our quality management system to our subsidiaries in the UK, Sweden, and Norway. In close coordination, structure was defined, processes documented, and country-specific considerations made. It quickly became clear: a shared, integrated management system is the best solution – for us, for our teams in the countries, and for our customers.

The document review during the audit was conducted collectively for all subsidiaries. Due to similar processes, our Swedish subsidiary will also receive certification. An audit in Sweden is planned for 2026 and 2027. During this year’s re-certification audit, in addition to our German headquarters, our subsidiaries in England and Norway were successfully audited. Furthermore, the subsidiaries are now part of our internal audit program.

Our customers can especially rely on one thing: that our products and services meet the highest quality standards – and that our processes are continuously reviewed, questioned, and improved.

For years, this has allowed us not only to provide reliable supply but also to build lasting partnerships – in the interest of the children, families, and professionals we are privileged to support.

Challenges and Special Features

Of course, international certification also brings new challenges – from language differences to regulatory parameters in the UK after Brexit, and specific procurement procedures in Norway. Jule Beßler, Quality Management Officer at Schuchmann, sees the strengths of a shared quality management system within these challenges:
“We learn from each other, continue to develop, and find solutions that consider all markets. Developing cross-border processes gives us the opportunity to think even better about our work and to specifically improve the service quality in our subsidiaries.”