ISO 13485

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ISO 13485 is an ISO standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as ISO 13485:2003 and ISO 13488. The current version, ISO 13485:2016, emphasizes meeting regulatory as well as customer requirements, risk management, and maintaining effective processes, specifically pertaining to the safe design, manufacture, and distribution of medical devices.

Overview

ISO 13485 is structured to be used by companies involved in the design, production, installation, and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. Compliance with this standard is often seen as the first step in achieving compliance with European regulatory requirements. The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems.

Requirements

The ISO 13485 standard includes specific requirements for manufacture, installation, and servicing and calls for:

• Implementation of a Quality Management System with several enhancements
• Risk management approach to product development and product realization
• Validation of processes
• Compliance with statutory and regulatory requirements
• Effective product traceability and recall systems

Key Differences from ISO 9001

While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system. ISO 13485 does not include the requirement for continual improvement that is inherent in ISO 9001.

Certification

Certification to ISO 13485 takes place when an accredited third party, such as a certification body, audits a company's processes and confirms that the company adheres to the requirements of the standard. Certification is often required by national and international regulations to allow the sale of medical devices in those markets.

Global Acceptance

ISO 13485 is recognized widely in the international medical device industry. It serves as a foundation for manufacturers to address the Medical Device Directive (MDD), the Medical Device Regulation (MDR) in Europe, and other regulatory requirements across the world. Many countries require companies to achieve ISO 13485 certification as a prerequisite to marketing their devices in those countries.

Updates and Future Developments

The ISO 13485 standard was last updated in 2016, and it continues to evolve as new medical technologies and regulatory requirements emerge. Organizations involved in the manufacture of medical devices should monitor changes to this standard to maintain compliance and ensure quality assurance in their products.