ISO 13485:2016 - Medical Device Management System
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Medical Devices Management System

ISO 13485:2016 - Medical Device Management System

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).

Benefits of ISO 13485

Safety and quality are non-negotiable in the medical devices industry, that’s where ISO 13485 comes into play.

Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry.

Integration with additional compliance requirements

While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principle difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.

Other specific differences include:
1. the promotion and awareness of regulatory requirements as a management responsibility. Examples of market-specific regulatory requirements include 21 CFR 820, the Quality System Regulation for medical devices sold in the United States, enforced by the U.S. Food and Drug Administration (FDA), or the Medical Devices Directive 93/42/EEC, required for doing business in the European Union
2. controls in the work environment to ensure product safety
3. focus on risk management activities and design control activities during product development
4. specific requirements for inspection and traceability for implantable devices
5. specific requirements for documentation and validation of processes for sterile medical devices
6. specific requirements for verification of the effectiveness of corrective and preventive actions

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