ISO 13485:2016

ISO 13485:2016

QUALITY MANAGEMENT SYSTEM
In the process of harmonization with the European Union, all medical device manufacturers are able to meet current legal obligations, meet customer expectations, and They aim to establish a quality system and certify this quality system in order to increase their efficiency and create legal assurance.
Quality system certification according to the ISO 13485 standard is a step for medical device manufacturers to use the CE mark on their products.
ISO 13485 Standard sets out quality system requirements for organizations operating in the medical sector.
This standard; It is based on the process model of the ISO 9001 Standard. However; GMP (Good Manufacturing Practices) rules‐
compliance, risk management (TS EN ISO 14971), validation and, if applicable, validation of the sterilization process, stability studies, clinical and bi-
ISO 13485 requires additional rules, such as practices related to biological evaluations; Also with management systems such as ISO 14001 or OHSAS 18001
It is compatible.
WHY TS EN ISO 13485?
• To establish quality awareness by establishing a quality system in the organization.
• To comply with current legal regulations.
• Meeting customer needs and expectations.
• Increasing customer satisfaction.
• Identifying the faulty aspects of the system and providing the opportunity to correct them.
• Preventing recalls.
• Increasing profits, efficiency and market share.
• Eliminating risks that may arise from the finished product.
• Continuously ensuring the effectiveness of the system.
• To follow an effective way to use CE marking on products.
• Having a management system that is applicable at national and international levels