Quality Assurance and Regulatory Affairs (QARA)
Delivering quality
Regulatory and quality compliance requirements have a critical impact on shaping the global landscape and the various workflows in your laboratory. Clinisys is dedicated to helping you meet and address Quality Assurance and Regulatory Affairs (QARA).
Quality is the deciding factor when differentiating Clinisys from other providers of clinical laboratory management information systems. Since inception, our philosophy has been to achieve, adhere and to maintain the highest possible quality management and control certifications.Our quality management system is embedded across our business systems, policies and processes and we invest in tools to support these processes to ensure that all employees are familiar with the processes and that they receive regular updates on any change.
Quality statement
We continually invest in the improvement of our processes and benchmark ourselves against the most demanding international standards. Our adherence to these prime service and quality management standards ensure we deliver a wide range of benefits to you.
A framework for success
The IMS provides a single framework for the following management systems Clinisys maintains certification to:
- ISO 9001 – Quality Management (QMS)
- ISO 13485 – Medical devices (QMS)
- IS0 27001 – Information security (ISMS)
- ISO 20000 – Service Management (SMS)
Best of breed, built from experience
Discover how Clinisys delivers specialized solutions across a broad range of industries which help advance testing, research, and diagnostic challenges in and beyond the modern laboratory.
A clear policy for excellence
To align with Clinisys’ purpose, mission, and strategic direction we have adopted the following IMS Policy.
Clinisys and all its employees are dedicated to maintaining the effectiveness and continual improvement of the Integrated Management System (IMS) and to providing secure, high-quality products and services through the definition of objectives to support the business and customer’s needs as well as applicable statutory and regulatory requirements.
Get in touch
To find out more about transforming your laboratory and meeting your organizational challenges, please get in touch.
