ISO 13485 It is an international standard based on the EN ISO 13485:2016 standard, which contains special requirements for medical devices. It includes ISO 9000 Quality Management system requirements and additionally includes special requirements for medical device manufacturers.
This management system standard; It is a standard that defines the specific conditions included in the Quality Management System for Medical Devices by organizations that trade and manufacture medical devices and operate in these fields, and is applied in the project, production, installation and supply stages of medical devices or their related services. It is also compatible with the EU Medical Devices Directive and is available in our country. CE mark It is applied together with .
ISO 13485 Quality Management System for Medical Devices;
- It meets special requirements for sterile medical devices.
- It carries a common language with the EU and other countries in the production, sales and service of medical devices.
- It is used as an important guide to sterilization and hygiene.
- It supports risk grouping of medical devices.
- EN ISO 13485 Certification and CE certification will be possible by showing the features of the products such as health and safety and meeting the minimum requirements.
WHAT ARE THE BENEFITS OF ISO 13485?
- Compliance with laws and regulations is facilitated.
- It reduces product errors.
- It increases profitability.
- It is possible to find and correct the faulty aspects of the system.
- Since it is of international standard, its customer portfolio also expands.
- It supports organizations in increasing their quality awareness.
- Training provides the opportunity for continuous improvement and development.
- It increases customer satisfaction and reduces complaints.
- It enables to increase the design, production and service quality of medical devices.
ISO 13485 CONSULTANCY
As Top Quality Consultancy
- 13485 QMS Requirements
- 13485 Establishing Quality Policy and Objectives
- Documentation Terms
- Fulfillment of 13485 Conditions
- Process Management
- Quality Handbook
- Preparation of Medical Device File
- Document Control
- Control of Records
- Leadership Commitment and Responsibility
- Planning Product Realization
- Customer Related Processes
- Design and Development File
- Verification and Validation of Design and Development
- Purchasing Process File
- Special Conditions for Sterile Medical Device
- traceability
- Complaint Management
- Monitoring and Measuring the Product
- Internal Audit
- Improper Product Control
- Data Analysis
- Ygg Meeting
ISO 13485 Standard It specifies the quality management system conditions of the life cycle of a medical device produced by. That is, it can be used by an organization that has been involved in one or more of its stages for the design, development or provision of activities (e.g. technical support) related to the design and development, manufacture, storage and distribution, installation, maintenance, final decommissioning and disposal of medical devices. QMS requirements indicates. It is one of the indispensable standards that is important for medical device manufacturers.
In addition, this standard is not only used by manufacturers but also by companies that provide products to organizations. suppliers or may be used by other external parties (e.g. raw materials, components, assembly, medical devices, sterilization devices, calibration devices, distribution services, maintenance services). Supplier or outer side, ISO 13485 He or she may choose to comply with the terms of the Standard voluntarily or may be contractually obligated to comply. In our country, suppliers are generally required to comply with this standard both by the decision of the ministry and the decision of the solution partners.
