The ISO 13485 Medical Devices Quality Management System standard is a standard prepared and published by the Technical Committee of the International Standards Organization, which was last revised in 2012. ISO 13485 standardis a quality standard for designing, developing, manufacturing, assembling and installing medical devices and providing after-sales technical support services. Already on the basis of 9001 Quality Management System. In order to prove to customers the ability to meet their expectations regarding medical devices, medical device manufacturers establish and manage ISO 13845 standards in their enterprises and obtain ISO 13845 Certificate. Based on the ISO 9001 standard, it is not a product standard, but a process standard. Therefore, it is not enough to have ISO 9001 Quality Management System Certificate alone. Technical values ​​and regulations regarding the production and service of medical devices should be harmonized with this Quality Management System. Therefore, to establish the ISO 13845 standard, which is designed taking into account the characteristics and conditions of medical devices and ISO 13845 Certificate need to take.

ISO 13485. Medical Devices Quality Management System standard is defined as follows:

0. Login

0.1 General

0.2 Process approach

0.3 Relations with other standards (relations with ISO 9001, relations with ISO / TR 14969)

0.4 Compatibility with other management systems

1. General definitions and applications

2. Other standards and documents cited

3. Terms and definitions (implantable active medical device, active medical device, customer complaint, labeling, medical device, sterile medical device)

4. Medical Device Quality Management System

4.1 General conditions

4.2 Documentation requirements (general, quality manual, checking documents, checking records)

5. Management responsibility

5.1 Management's commitment

5.2 Customer-oriented

5.3 Quality policy

5.4 Planning

5.5 Responsibility, authority and communication

5.6 Management review

6. Resource management

6.1 Providing resources

6.2 Human resources

6.3 Infrastructure

6.4 Operating environment

7. Product realization

7.1 Product realization planning

7.2 Customer-related processes

7.3 Design and development

7.4 Purchase

7.5 Production and service delivery

7.6 Monitoring and measuring devices control

8 Measurement, analysis and improvement

8.1 General

8.2 Monitoring and measuring

8.3 Control of unsuitable product

8.4 Data analysis

8.5 Corrective and preventive action

As you can see, the scope of this stadium is basically very similar to the 9001 Quality Management System.

 

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