As an independent QMS standard, ISO 13485 originates from the ISO 9000 series of quality management standards widely recognized and accepted internationally. ISO 13485 adopts the process based approach of the earlier version of ISO 9001: ISO 9000:2008, and applies to the regulatory requirements of medical device manufacturing. Although ISO 13485 is based on the concept of "plan, execute, check, and act" of ISO 9001's process approach, it was established for the purpose of regulatory compliance. Therefore, it is more regulatory in nature and requires a more detailed documented quality management system.
二、 Standard features
1. ISO 13485 is important for designers, manufacturers and distributors of medical devices. In addition, as more and more manufacturers require suppliers to pass certification as a prerequisite for cooperation, suppliers and service providers can enhance their market capabilities through ISO 13485 certification.
2. As far as medical device manufacturing is concerned, patient safety largely depends on the quality and consistency of medical products, and ensures the effectiveness of QMS control and maintenance, which is critical for customers, stakeholders, patients, users and regulators.
3. The value of ISO 13485 lies not only in implementation, but also in providing a tool for comprehensive audit to test the effectiveness of the system. It gives manufacturers more confidence to consistently meet and continue to meet regulatory requirements. It also helps to minimize accidents and failures, which may adversely affect patient safety and damage the manufacturer's reputation.
三、 Implementation significance
High performance organizations expect ISO 13485 audits to be complete, competent and relevant, and pose challenges to manufacturers' QMS. The benefits of effective auditing to manufacturers are significant, including:
1. Valuable feedback on the effectiveness of the quality management system
2. Bring confidence to manufacturers to meet regulatory requirements
3. Valuable and recognized reports and certifications
4. Nonconformities and risks found
5. Identify the aspects that need attention
