This June, BSI Group validated and certified the Quality Management System (QMS) of our new business unit Medical Imaging. As a legal manufacturer of PerfusiX-Imaging, we need this ISO 13485 certificate to demonstrate that our Quality Management System (QMS) complies with the Medical Device legislation. Since ZiuZ Research B.V. and ZiuZ Assembly B.V. are critical suppliers of ZiuZ Medical Imaging B.V., these entities are also certified.
‘’In the past months, we went through our business processes, and we worked very hard to achieve this prestigious ISO 13485 certification. A milestone to demonstrate that we as ZiuZ Medical Imaging comply with the Medical Device Legislation.’’ Says Marco van den Berg.
ISO 13485 certificate
ISO 13485 is an internationally recognized standard that sets the bar for quality management systems in the medical device industry. By achieving this certificate, our development approach is in compliance with high-quality standards regarding the safety, service, and delivery of our products.
REACCREDITED WITH ISO 9001 and ISO 27001
ZiuZ Visual Intelligence and its legal entities (ZiuZ Research B.V., ZiuZ Pharma Automation B.V., ZiuZ Forensics B.V., ZiuZ Medical Imaging B.V., and ZiuZ Assembly B.V. are also ISO 9001 and ISO 27001 certified. This means that our Quality Management System (QMS) and Information Security Management System (ISMS) also meet the ISO standards requirements.
ISO 9001 certificate
The management of ZiuZ strives to be a reliable and quality-oriented partner for its stakeholders. As ISO 9001 is the world’s most recognized standard for quality management. ZiuZ believes that this certificate will help the organization meet the needs and expectations of its customers and stakeholders more effectively. Striving for the highest possible quality is one of ZiuZ’s cultural values. The BSI re-confirms the high-quality standards ZiuZ has already achieved, reassuring customers as to their supplier assessment requirements.
ISO/IEC 27001 certificate
As this certificate is the most widely recognized international standard for information security. ZiuZ believes it is necessary to communicate that privacy-sensitive and confidential information is kept strictly secure. The ISO certification gives assurance that ZiuZ has established methodologies and a suitable framework for businesses and IT processes that will help to identify, manage, and reduce risks. A standardized approach also safeguards our method of establishing, implementing, operating, monitoring, and improving our information security goals and objectives.
Click here to view the ISO 13485 certificate.
Click here to view the ISO 9001:2015 certificate.
Click here to view the ISO/IEC 27001:2013 certificate.
Feel free to contact Marco van den Berg if you want to receive ZiuZ’s Statement of Applicability or wish to learn more about the ZiuZ QMS or ISMS.