ISO 13485:2016 is an internationally recognized standard that specifies requirements for a Quality Management System (QMS) specific to the medical devices industry. It ensures organizations consistently design, develop, produce, install, and deliver medical devices that are safe, effective, and compliant with regulatory requirements.

Key Purpose

The primary goal of ISO 13485:2016 is to establish a robust Medical Devices Quality Management System (MDQMS) that:

• Ensures patient safety and product effectiveness.
• Reduces risks associated with medical device use.
• Aligns with global regulatory requirements (FDA, CE Marking, CDSCO, etc.).
• Enhances customer confidence and trust.

Scope of ISO 13485:2016

The standard applies to organizations involved in:

• Design & development of medical devices.
• Production and manufacturing.
• Sterilization, packaging, and labelling.
• Storage, distribution, and installation.
• Servicing of medical devices.
• Supply of related services and components.

Key Requirements of ISO 13485:2016

• Quality Management System (QMS): Documented procedures, policies, and records.
• Risk Management: Identifying, evaluating, and controlling risks.
• Design & Development Control: Ensuring safe and effective device design.
• Supplier & Outsourcing Management: Control of external parties and suppliers.
• Product Realization & Traceability: End-to-end product lifecycle monitoring.
• Regulatory Compliance: Meeting global laws and regulations.
• Post-Market Surveillance: Feedback, complaints handling, and corrective actions.
• Continuous Improvement: Ongoing monitoring and updates to processes.