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What is ISO 13485?
ISO 13485 is an international standard developed by the International Organization for Standardization (ISO), specifically designed for quality management systems in the manufacturing of medical devices. The ISO version was first published in 1996 and has since been revised, updated, with the current version being ISO 13485:2016.
Why is ISO 13485:2016 Certification Needed?
– Compliance with Decree 98/2021/NĐ-CP Issued on November 8, 2021, Regarding Medical Device Management: Decree 98/2021/NĐ-CP on the management of medical devices stipulates that medical device manufacturing facilities must implement a quality management system according to ISO 13485.
– Simplified and Convenient Declaration Procedures: Meeting the requirements of ISO 13485 makes the procedures for the production, classification, and standard declaration of medical devices easier and more convenient.
– Benefits for Businesses Achieving ISO 13485:2016 Certification:
- Positive Impression on Customers: ISO 13485:2016 certification helps create a positive impression with customers and provides a competitive advantage for products in the same category.
- Improved Production Efficiency and Product Quality: This standard assists businesses in enhancing production efficiency, controlling product quality, and minimizing risks.
- International Market Penetration Capability: ISO 13485 is considered a crucial step for compliance with European requirements, enabling businesses to penetrate international markets.
- Effective Control of Internal Processes and Minimization of Error Risks: ISO 13485 certification aids businesses in effectively controlling internal processes and reducing the risk of errors
Versions of ISO 13485
ISO 13485 has undergone several versions and revisions since its initial publication. Below are the versions of ISO 13485:
– ISO 13485:1996: This is the first version of ISO 13485, published in 1996.
– ISO 13485:2003: This version is a revision of ISO 13485:1996, published in 2003.
– ISO 13485:2016: This is the current version of the standard, published in 2016
Entities Subject to ISO 13485:2016 Certification According to Legal Regulations
– Organizations and Businesses in Research and Development of Medical Devices (MD): Organizations and businesses operating in the research and development of medical devices must adhere to ISO 13485 to ensure the quality and safety of their products.
– Installation and Maintenance Facilities for Medical Devices (MD): Facilities specializing in the installation and maintenance of medical devices are also subject to certification under ISO 13485, ensuring that their processes meet quality and safety requirements.
– Businesses Manufacturing Medical Devices: Companies manufacturing medical devices are a primary target of this standard, setting stringent requirements to ensure their products meet quality and safety standards.
– Organizations and Businesses Providing Related Healthcare Services: Organizations and businesses providing healthcare services, such as testing units or services related to medical devices, should also comply with ISO 13485 to ensure the quality of their services
– Storage, Preservation, and Distribution Facilities for Medical Devices (MD): Facilities involved in the storage, preservation, and distribution of medical devices are also required to comply with ISO 13485 to ensure safety and consistency in their processes.
– Hospitals, Laboratories, and Units Regularly Using Medical Devices (MD): Hospitals, laboratories, and units that regularly use medical devices are also subject to certification under ISO 13485 to ensure that the products they use meet quality and safety standards.
ISO 13485:2016 is a voluntary standard that focuses on managing the quality system to ensure the safety of products in the field of medical devices. By establishing and maintaining compliance with this standard, organizations and units can create a working environment that minimizes risks related to the safety of medical products while meeting customer needs and legal requirements