Quality management and regulatory affairs

Since 1996, DiaSys Diagnostic Systems GmbH has been certified according international quality management standard. The certification and annual monitoring audits are performed by the TÜV-Rheinland. Certificates are available in German and English.

DiaSys' quality policy

We strive to more than fulfill the expectations of our customers in terms of product quality and professionalism of our services

Our daily activities are determined by the requests and needs of our partners, distributors, users and patients for high quality and reliably applicable in vitro diagnostics and service. Customer satisfaction analysis regarding the quality of our products, processes and services helps us to improve those.

Employees are a mainstay of our group

We challenge our personnel with all their skills and abilities and encourage a culture of good cooperation. They are trained and supported accordingly, to meet our high quality standards. We encourage our employees, to solve tasks independently and to improve processes; therefore, they are authorized with necessary responsibility and competence. In order to ensure employee satisfaction, human resources department has fixed measures for health management measures as an integral part along with other aspects.

Improvement, development and innovation influence our future

We develop, produce and distribute state-of-the-art and safe high quality in-vitro diagnostics, reagents and systems and provide services expected by the customer from us at competitive prices. With the help of market analysis, we want to serve the market with innovative and desired products.

We maintain an effective quality management system

Both the management and all employees are responsible for maintaining and continuously improving our Quality Management System (QMS) at DiaSys and its affiliated subsidiaries. We use quality management not only to improve process quality, our service and products, but as well to lead the company economically and safely into the future. Targeted risk management enables us to understand risks and to manage them in systematically. Should any deviations occur, we take effective measures to understand and eliminate the cause.

We care for making responsible use of natural resources to protect the environment

We are particularly committed to the careful use of natural resources and a sustainable approach within all our business activities. Our environmental objectives comprise continuous improvement of ecologically friendly production processes as well as reduction of disposal waste.

The corporate culture and awareness of social responsibility have induced DiaSys to outline those regulations, which apply to the company, in a Compliance Management System according to ISO 37301, and to integrate it alongside the existing quality management system.

Management measures

The commitment to compliance is clearly communicated by the management. To this end, a declaration of intent to establish a compliance management system and a code of conduct1  have been published. An independent compliance function and a compliance committee have been set up to advise and support the management and to establish, improve and further develop the compliance management system.

Compliance-specific framework

The implementation of specific operating procedures, guidelines and the provision of legal requirements in the company-specific legal register, clearly and transparently define compliance rules at DiaSys. DiaSys complies with both legal requirements and self-defined binding obligations. These are regularly reviewed and updated.

Systematic training

To maintain the effectiveness of the compliance management system, all employees must be familiar with the relevant legal requirements as well as with internal compliance documents. The aim is for all employees to know and adhere to the DiaSys compliance rules. The basis for this is compliance training, which is offered as on-site or online training. Training on topics of fundamental relevance is considered as mandatory for every employee. Further training on specific topics is assigned according to job and responsibility profiles. The training demand is regularly reviewed.

Reporting of irregular behavior

DiaSys encourages employees to report possible irregularities and infringements against law, internal regulations or guidelines. A whistleblower system2  has been set up for this, which allows confidential reporting via various channels. The Compliance Officer follows up on indications of violations in any event. No retaliation or negative consequences need be feared for reporting, even if the report proves to be unfounded or incorrect but was made in good faith or on basis of reasonable suspicion.

Consequence of non-compliant behavior

Compliance violations may result in serious consequences such as warnings, termination, claims for damages, lawsuits, penalties or image loss for employees or the company. The DiaSys principle is zero tolerance regarding compliance violations. Where they do occur, the company acts consistently.

Scope of Compliance Management

Following the establishment of the Compliance Management for DiaSys Diagnostic Systems GmbH, the system will be expanded within the Group.3

1 Will be created when CMS is ready
2 Will be established at the beginning of 2023
Further expansion takes place according to an internal project plan

Compliance politics Download