Top Management Representative (QMB)

Working responsibly is the be-all and end-all in modern production processes. The "top management representative" (or quality management representative, QMB) plays a key role in achieving any quality goals in a manufacturing environment. Especially in the field of medical device manufacturing this position is of great importance thus associated with having to have the knowledge and expertise about many regulations and standards surrounding medical devices and/or IVDs.

For a certified quality management system according to the industry standard DIN EN ISO 13485 the company management must appoint a qualified person who acts independently of other responsibilities as a quality management representative and takes care of all related tasks, including the maintenance of the quality manual.

There are various rights and responsibilities associated with this position:

• Documentation: The QMB ensures all processes required for a quality management system are documented.
• Control: Key performance indicators (KPI) should be collected regularly. Statistics should be prepared for management to demonstrate the effectiveness and improvements made in manufacturing and the quality management system (QMS) with respect to the set quality objectives.
• Information: The QMB promotes awareness of all quality requirements or needed regulations throughout the organisation.

NEMIUS offers you the solution of an external top management representative (or QMB) to ensure you reliably achieve your quality objectives. We comprehensively take over the regulatory tasks according to DIN EN ISO 13485, so you can concentrate on your daily business.

• Describing your business processes objectively and efficiently using our expert’s external view
• Covering these extensive QM tasks by an external QMB thus saving costs by interpreting your requirements and quality objectives appropriately
• Gaining new solution proposals and impulses for your company by accessing our proven experiences as an external QMB
• Prompt integration of innovations and changes from regulations and standards and norms into your QM or manufacturing processes
• Achieving your quality objectives thus securing the possibility to pass upcoming audits and monitoring visits for certification, and/or supplier audits

Instead of laboriously familiarising yourself with the subject matter and possibly having to put up with delays due to a quality management manual and the definition of quality objectives, you can devote yourself to the day-to-day business with peace of mind with our external support.

We offer more than just ticking off a list of checkboxes. Instead of tunnel vision, we think outside the box and take a long-term, detailed view of quality objectives and their implementation. We bring our experience from a wide range of companies to your organisation to support your processes, or CAPA measures.

With our service, you not only get the assurance that tasks and quality objectives are reliably completed in all aspects. We also offer you valuable information and a wealth of experience for your business processes. Get in touch with us today!