Quality is our priority. We therefore carefully monitor the product’s quality during development and production, from the initial concept right through to product delivery. Even once the product is on the market we continue to actively safeguard its quality.
In view of the breadth of the quality domain our team is subdivided as follows:
- Company-wide quality aspects, such as our method of working set out in the quality system, audits, CAPAs, Occupational Health & Safety (ARBO) and the environment;
- Quality during the development phase;
- Quality during the production process and service activities.
Substantively involved with a critical outlook
From the very beginning in a project we contribute our ideas about the project approach and how it lines up with the quality system. In addition, we are also responsible for overseeing the documentation and the risk management. To introduce an especially safe product to the market, we investigate what could go wrong and translate this into extra measures. For example, suppose a patient’s visitors drops a cup of coffee on the patient’s breathing apparatus. What happens then? For example, would this cause a short circuit?
From project approach to certification
In a project we are part of the multidisciplinary team throughout the entire process. Because we have a great deal of contact with colleagues in other disciplines and we have a medical or medical engineering background ourselves, we are substantively involved and are able to oversee the processes at a high level.
In addition, we review the system requirements and the impact of ‘quality’ on the project. Are the requirements clearly stated and do they include the relevant legislative requirements and standards? We are also responsible for supporting or conducting test and CE processes. We provide the client with a full service solution by testing their product/product design for electrical safety and EMC compatibility on their behalf. We complete the technical dossier needed to complete the certification process. And, if applicable, we register the product for each country of sale.
Quality during production, purchase and service
After development, the challenge is to safeguard the specified quality standard. We do this by:
- Documenting the required quality objectives, standards and rejection criteria for each product.
- Ensuring that the relevant ISO13485 / ISO9001 process-based requirements at our suppliers are properly set up, for example by signing quality agreements and conducting process audits.
- Checking the quality of incoming goods and conducting final inspections before the products leave the production floor.
- Ensuring that during production all prescribed processes are followed.
- For complaints from the field, tracking down the cause and assessing the impact. Initiating improvement plans for the future where necessary.