ISO 13485 certification requirements

1. ISO 13485 certification requirements Scope: Define the scope of the QMS, including the products and processes covered by the certification. Documentation: Establish and maintain documented procedures and records required by the standard. Management Responsibility: Top management must demonstrate their commitment to the QMS and take overall responsibility for its effectiveness. Resource Management: Provide adequate resources (personnel, infrastructure, and finances) for the effective implementation and maintenance of the quality management system. Product Realization: This section covers the planning, design, development, and manufacturing processes for medical devices. Measurement, Analysis, and Improvement: Implement processes for monitoring, measuring, and analyzing the QMS performance. This includes conducting internal audits and using the information to improve the system continually. Design and Development: If the organization is involved in the design and development of medical devices, this section outlines specific requirements for these processes. Supplier Management: Establish and maintain a system to ensure that suppliers and contractors provide materials and services that meet quality requirements. Risk Management: Implement a risk management process to identify, analyze, and mitigate risks associated with the use of medical devices. Product Monitoring and Control: Establish controls for product identification, traceability, and preservation to ensure product quality and safety. Validation and Verification: Verify and validate processes to ensure that they meet the required quality standards. Sterilization and Validation: If applicable, implement procedures for the sterilization of medical devices and validate those processes. Unit No – 514, 5th Floor, Sector – 48 Vipul Business Park, Sohna Road Gurgaon, Haryana, 122018 Phone: +91-7011768166, 8860610495 Email: support@siscertifications.com