About our
Quality Policy

Our Quality Policy is our commitment to increased performance, continuous improvement, and employee and customer satisfaction, focused on business continuity and growth. This can only be warranted when environmental care, sustainability, good working conditions, high product and service quality, and organizational alignment are an integral part of the total enterprise. 
We established our Quality Management System (QMS) to provide a framework for analysis of performance against our goals, to define processes that allow us to deliver products and services that meet the expectations of our customers, and to identify areas for continuous improvement. 

Meeting both ISO 13485:2016 and ISO 9001:2015 requirements, our QMS manages the quality aspects of our business and ensures we comply with all relevant legislative, business and contractual security obligations. NimaGen is committed to fulfilling regulatory requirements. 

ISO 9001:2015  Certificate:  Download PDF
ISO 13485 Certificate:  Download PDF

We will ensure that risks, threats and vulnerabilities associated with our business are effectively identified, assessed and mitigated. Our regularly maintained and frequently audited QMS is driven by the following guiding principles: 

In our opinion, building a high level of quality and customer satisfaction is based on a collaborative approach. This is pivotal in warranting a continued flow of improved and novel products and associated services to the laboratory science community. Feedback from both our customers and employees on this subject is welcomed and encouraged. 

Each business year, our senior management will determine concrete, measurable key performance indicators (KPls) relative to the expectations of both our customers and employees, as well as our business objectives. Performance and progress are monitored and frequently evaluated against these KPls, to assess the effectiveness of our QMS and take appropriate follow-up actions where necessary. We will identify and embrace any opportunity that would be beneficial to our company and our valued customers. 

Ruud van der Steen
CEO NimaGen B.V.

To track our progress towards our company mission and goals, KPI are formulated on selected key areas within the QMS. 

• Compliance/ Certification: It is important to ensure continued compliancy with our certifications (ISO9001 and ISO13485). Internal audits provide an effective method to ensure and assess this initiative;
• QC: The process of quality control helps ensure consistently performing high quality products;
• Order Process & Transfer: An accurate and efficient order handling process will provide an easy and fulfilling customer experience and reliable shipping times;
• Job Profiles: Goals & Objectives; We want to ensure that all employees will have a job profile and goals/objectives to work towards;
• Communications: Good internal communications is important for a healthy organization;
• Customer Survey: By actively asking for feedback from customers, we want to improve customer satisfactions and highlight areas for improvement;
• Brand Recognition: It is important that our (future) customers know about NimaGen and our (possible) products;
• Case Management: Cases represent valuable insight into the effectiveness of the QMS and ensure customer satisfaction;
• Debit Management: A healthy financial basis helps the organization realize its mission and objectives.