Our regulatory department is responsible for ensuring that the company's products comply with the various regulations in force.
Our regulatory department works closely with the R&D, sales, marketing and quality teams to ensure that regulatory protocols are properly in place and followed and that quality and safety requirements are always met when products are launched to the market.
It ensures the filing and follow-up of regulatory files with the competent authorities.
Our quality department is responsible for all the company's processes. In addition, it is in charge of the continuous improvement process for the Quality Management System (QMS).
This department is composed of a team responsible for controls, analyses and batch releases to ensure the conformity of products shipped to the market.
The quality department has an internal laboratory equipped with technical equipments allowing various measurements of filtration, respiratory resistance, material resistance, weight, absorption capacity and material thickness.
The certifications and standards to which we comply
ISO 9001: 2015 certified, Quality management system
Certified ISO 13485: 2016, Quality management systems for medical devices
Compliance with EU Regulation 2017/745 on medical devices
Compliance with EU Regulation 2016/425 on personal protective equipment
Our quality approach
Kolmi Hopen's employees and management have established a quality policy based on the continuous improvement of the products and services the company provides to its customers.
Our objective is to achieve the highest level of customer satisfaction. This is reflected both in our ability to meet the needs of our customers and in our ability to provide them, at all times, with high quality products.
We encourage all our employees to strive for the highest level of excellence in everything they do, thus contributing to the Company's Global Quality objectives.
Examples of products concerned by the various regulations (PPE, etc...)
Personal protective equipment (PPE) :
- Respiratory half-masks
Medical Devices (MD) :
- Medical masks
- Headcovers, Caps
- Care Drapes
- Impregnated washclothes
- Disinfecting wipes
- Disposable gloves