Focus on ISO 13485

Normec VQZ has taken the next significant step in its strategic development: With its application for accreditation extension to include certification according to ISO 13485, the company is preparing to audit and certify quality management systems for manufacturers of medical devices in additional areas in the future.

What does ISO 13485 actually mean?

The ISO 13485 standard is the international standard for quality management systems in the field of medical devices. It specifies requirements that are specifically tailored to the regulatory needs and safety requirements of the medical technology industry – from manufacturing and storage to sterilization and software integration.

Extensive expertise applied for

The application submitted by Normec VQZ covers a wide range of medical devices, including non-active and active products. Services such as maintenance, transport, and regulatory consulting are also included in the scope. The focus is on companies that are involved in one or more stages of the life cycle of a medical device, including healthcare facilities and manufacturers of custom-made products.

Why is this important for the industry?

With the ISO 13485 accreditation extension, Normec VQZ is expanding its service portfolio to include an increasingly relevant market. For customers, this means that in future they will be able to obtain everything from a single source – even in the sensitive field of medical technology, where compliance with standards and quality assurance are not only economically essential but also ethically and legally indispensable.

The next step: assessment and recognition

The process is not yet complete – after review and examination of the documents, assessment by the accreditation body is pending. Only then will official recognition be granted. But one thing is already clear: the course has been set for a forward-looking expansion of Normec VQZ's range of services.

Transparency and responsibility

The application for expansion is part of a broader commitment to quality, reliability, and regulatory clarity. Normec VQZ is thus positioning itself as a reliable partner for organizations that want to achieve sustainable success in a highly regulated industry.