Quality Management

Quality management according to ISO 9001 & ISO 13485

Set up QM systems and pass QM audits with confidence

If you are planning to introduce or further develop a QM system, we can provide you with everything you need to know about quality management for the development of products in accordance with ISO 9001 & ISO 13485. Our QM team specialises in quality management and product support for small and medium-sized enterprises (SMEs), medical device manufacturers and pharmaceutical companies.

The goal is to assist you in creating medical devices and SMEs' goods in accordance with regulations and standards, establishing lean QM systems, and confidently passing QM audits.

Services for the implementation of the QM system according to ISO 9001 & ISO 13485

Our team provides you with sustainable support for your QM system without adding extra work to your plate by offering customized services for QM consultation and QM system implementation in compliance with ISO 9001 and ISO 13485. Our QM team is available to you as spokespeople, trainers, implementers, and consultants.

Targeted Help for your quality management

There are many ways in which we can help you with quality management in accordance with ISO 9001 or 13485. Some of these are listed below.

HIGH QUALITY GUARANTEE IN PRODUCT DEVELOPMENT

The organization creates high quality first in the mind. By assisting you in creating goods that adhere to legal requirements and industry standards, passing audits, and effectively launching items onto the market, we help you guarantee high quality in the development of industrial and medical devices.

The main objectives are to raise customer satisfaction, enhance service quality, and improve product quality and safety.

SET UP A LEAN QM SYSTEM THAT IS LIVED

We help you to set up a lean QM system without superfluous content. Only such QM systems are popular because they do not complicate the work of your employees but relieve them.

After all, what use is a well-designed, yet confusing and complicated QM system that is not put into practice?

Increasing the efficiency of company processes as an opportunity

We ensure that increasing the efficiency of company processes can be utilised as an opportunity.

The structure of all quality management systems always follows the process-orientated approach. This means that the core processes and support processes are documented clearly, and interfaces are analysed. The ideas developed jointly by you and our QM team and the minimum standards required by the respective quality management system result in well-documented process optimisations:

Avoid duplication of work by constantly identifying and implementing optimisation potential in company processes
Promote co-operation between departments by improving the interface management of company processes

Trained and experienced QM consultants for your QM project

You will be supported by trained and experienced QM consultants for your QM project. Our QM consultants understand that they are there for you to provide you with sincere help and find sustainable solutions to challenges. Our consultants do not promise you anything they cannot deliver.

Our QM team operates with precision, speed, and structure to ensure your project stays within a reasonable economic framework. Flat structures and a sense of unity among team members allow for the required level of freedom. We always integrate our theoretical knowledge with hands-on experience. This allows us to provide you with solutions focused on practical experience.

Support for the daily work of your employees

Over the years, we have designed numerous QM documents, such as processes, work instructions, forms and checklists for manufacturers of various products.

We have created templates from these QM documents that you can use for your project. Of course, we must customise the templates to suit your company. However, they offer useful assistance and reduce the workload and costs.

Are you interested? Enquire now!