Quality Management for the Medical Equipment Industry. High standard. Tailored Perfection

HN Group's quality management system has been developed to meet even the strictest of requirements, including from our numerous customers in the medical equipment industry.

The system is certified according to ISO 13485 and ISO 9001 and is in constant development through close dialogue with our customers, with a focus on both production itself and sales, order management, stocking and delivery processes.

Effective In-House Control

As an element of our in-house control, our quality assistants collect random samples of all manufactured components once every 4 or 8 hours – 24 hours a day, 7 days a week.

The samples are measured to customer specifications and inspected visually against an approved master piece or other customer-specific references.

Quality Control as per Individual Specifications

A number of our customers in the medical equipment industry have quality procedures that are more demanding than HN Group's standard system. Such procedures may include, e.g. PPAP documentation or DOE, OQ and PQ procedures when a new or modified tool is released for production.

We are therefore always ready to enter into a dialogue with your quality team on formulating individually tailored quality management and internal control. And what is more, our physical framework and facilities make it possible to allocate the necessary square metres to customer-dedicated quality processes, e.g. control measurements, visual inspection, etc.