Quality
Quality and regulatory
All KAPSAM products are manufactured under certified quality management systems and a dedicated quality policy.
Quality policy
Certified quality and environmental management.
KAPSAM operates ISO 13485:2016 and ISO 9001:2015 quality management systems (certified by RoyalCert) and ISO 14001 environmental management. Medical devices are audited by a notified body (CE 0425) for the transition from MDD 93/42/EEC to MDR 2017/745.
- ISO 13485:2016 medical device quality management system
- ISO 9001:2015 quality management system
- ISO 14001:2015 environmental management system
- CE 0425 notified body, MDR 2017/745 transition from MDD 93/42/EEC
Electromechanical devices
Tested and validated by accredited laboratories
KAPSAM electromechanical devices follow ASHP and GMP guidelines and are CE marked under the 2014/35/EU Low Voltage Directive.
Standard
IEC 60601
Medical electrical equipment.
Standard
IEC 61010
Safety of electrical equipment for measurement, control and laboratory use.
Standard
IEC 61326
Electromagnetic compatibility for measurement, control and laboratory equipment.
Quality certificates
Download certificates
For further information contact the quality department at quality@kapsamsaglik.com.tr.
Notified body confirmation for the MDD 93/42/EEC to MDR 2017/745 transition.
Associations & guidelines
Standards and guidance KAPSAM follows
Questions
Frequently asked questions
The answers below cover what hospital pharmacy, IT and technical teams ask most often. If your question is not here, our team will answer it directly.
Which quality certificates does KAPSAM hold?
ISO 13485:2016 for medical device quality management, ISO 9001:2015 for quality management and ISO 14001:2015 for environmental management, all available to download.
Are KAPSAM medical devices CE marked?
KAPSAM medical devices are audited by a notified body under CE 0425, covering the transition from MDD 93/42/EEC to MDR 2017/745.
How are sterile disposables tested?
Final controls are carried out by qualified staff in dedicated laboratory areas, and accredited laboratories run biocompatibility, particulate matter, filling volume, chemical and physical tests.
