As a manufacturer of medical devices, we believe it is very important that our products comply with the most stringent quality requirements in order to guarantee the quality and safety of our products to our users, and end up with satisfied customers as a result. To guarantee the highest possible quality, we comply with ISO standards 9001 and 13485 and we are certified for both. Here is some further information about these certifications.
ISO 9001
Possibly one of the most well-known ISO standards. Here is a description of ISO 9001 in a nutshell. In short, this certificate means that Nea has a quality management system aimed at the management and improvement of its processes. It governs a number of aspects, including how we conduct our quality control. Everything that comes in (raw materials and semi-finished products) and everything that goes out (finished products) is subjected to sample tests. By working in accordance with ISO 9001, Nea guarantees its high quality requirements. The ISO 9001 certificate also means that we are a company focused on improvement. Every year, we draw up a plan with areas for improvement, based on the changing needs and wishes of our clients.
ISO 13485
As a manufacturer of medical devices, we believe it is essential that our products are safe for--and fully comply with--the needs and wishes of our clients. In order to guarantee this, we work in accordance with ISO 13485 standards. This standard is specifically for manufacturers of medical devices and provides for a more stringent control, as compared with ISO 9001, of product risks and business processes.
ISO 14001
Our products are medical devices for the medical sector. We therefore also naturally feel it is important to look after health. Care for the environment is also part of this. Nea works in accordance with ISO 14001, which states the requirements of a good environment management system. In a nutshell, this means that, in the management of our business, structured attention is paid to the environment, and also that harmful impact to the environment is limited as much as possible in our production process. The principles are: complying with laws and regulations for controlling environmental risks and striving for continual improvement of the company’s performance in terms of the environment. In order to comply with this, Nea works in accordance with ISO 14001 and is ISO 14001-certified.
OHSAS 18001
The OHSAS 18001 standard is about working conditions and forms part of the quality management system. This standard sets out the minimum requirements for occupational health and safety management best practice. Nea manages any potential risks in the areas of safety, health and well-being of our staff by fully complying with these standards. The high quality and safety of our products for users begins with the well-being of our workers.\
Nea wishes to offer only the best quality and the highest safety guarantees to our users. We ensure this by way of a comprehensive quality management system based on the standards described