ISO 13485

Medical Device Quality Management Systems

What is ISO 13485?

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts requirements of ISO 9001 process-based model for a regulated medical device manufacturing environment. Thus it is more prescriptive in nature and requires a more thoroughly documented quality management system.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, delivery through to disposal of medical devices that are safe for their intended purpose.

A medical device manufacturer’s quality management system is the foundation for maintaining regulatory compliance, driving improvement, effectiveness and achieving stakeholder confidence in the manufacturer and their products. The requirements of ISO 13485 provide the model quality management system building blocks of success.

ISO 13485 is an international standard that specifies requirements for regulatory purposes for medical device manufacturers. It provides a framework for companies to meet their customer and regulatory requirements. It is accepted widely as the international standard to address medical device requirements around the world.

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European Union regulatory requirements – MDR 2017/745, MDD 93/42/EEC, and Good Manufacturing Practice (GMP).

It focuses on ensuring consistent quality, product safety and the sustainable success of your products or services, using competent and efficient quality management systems to support them. Persistent pressures from global competition demand that organisations continually improve your products, services, and business processes to remain competitive.

Key elements of the ISO 13485 standard include:

  • Risk management and process-based decision-making.
  • Increased attention on supply chain processes.
  • Explicit requirements for software validation.
  • Effective alignment of local and global regulatory requirements.

Risk Management (ISO 14971)

Risk management is a key component and requirement for ISO 13485 certification. ISO 14971 is a risk management system standard, and was designed to be compatible with ISO 13485. It helps manufacturers meet the increasing global requirements and expectations to implement not only quality, but full risk management systems throughout the entire life cycle of the medical devices they manufacture.

ISO 14971 satisfies the risk management requirement for IEC 60601-1 for medical electrical equipment and systems. It is a helpful tool for manufacturers in identifying and controlling not only the risks associated with their medical devices, but also evaluating interactions with other devices.

ISO 13485 and CE marking

ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry.

ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives.

Although ISO 13485 certification is not a direct requirement for CE marking medical devices under the European Medical Device Directives, it is recognized as a harmonized standard by the European Commission. Therefore compliance with ISO 13485 provides a presumption of conformity with the basic European Union (EU) quality assurance requirements for CE marking (additional EU requirements apply).