What is ISO 13485?
The ISO 13485 standard is an effective solution to meet the numerous requirements of a QMS. The adoption of ISO 13485 provides a practical foundation for manufacturers to meet medical device directives, regulations and responsibilities, as well as demonstrate a commitment to the safety and quality of medical devices.
Like ISO 9001, 13485 seeks to implement a quality management system. The difference between them is that, while the first is a general quality management standard and can be implemented by any company or organization, ISO 13485 is a specific standard for medical appliances and devices and quality management from design to manufacture. . Due to this difference, the ISO 13485 standard must be implemented by companies related to the production of medical devices, as well as any and all companies that provide services, products or components that will be inserted in a medical device.
What are the benefits of ISO 13485 certification?
Whether you’re looking to operate internationally or expand your local footprint, ISO 13485 certification can help you improve your overall performance, eliminating uncertainties, and expanding market opportunities. Companies that have this certification demonstrate their commitment to quality, both to customers and to regulatory bodies.
- Increase access to global markets with certification.
- Describes how to review and improve processes throughout the organization.
- Increase efficiency and monitor supplier performance.
- Demonstrates that you produce safer and more effective medical devices.
- Meets regulatory requirements and customer expectations.
ISO 13485:2016 vs ISO 9001:2015
Annex SL provides the basic framework for most ISO Management Systems standards, such as ISO 9001:2015. However, ISO 13485:2016 is not based on the Annex SL structure. Some of the main differences between ISO 13485:2016 and ISO 9001:2015 include:
- Scope of each standard;
- Structure (8 against 10 sections);
- Organization Context;
- Documentation requirements;
- Planning: consideration of risks and opportunities;
- Process Approach;
- No management representative clause in ISO 9001:2015;
- No manual quality manual clause in ISO 9001:2015;
- Performance evaluation;
- Improvement.