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What is the main difference between ISO 9001 and 13485?

Quality management systems play a crucial role in ensuring the efficiency, effectiveness, and safety of various industries. Two widely recognized international standards for quality management are ISO 9001 and ISO 13485. While both aim to improve organizational processes, there are significant differences between these standards.

ISO 9001: Ensuring Quality in General Business Settings

ISO 9001 is a generic quality management standard applicable to any organization, regardless of its size or sector. It focuses on enhancing customer satisfaction by meeting their requirements and continually improving quality management systems. This standard emphasizes the importance of process monitoring, measurement, and analysis. An ISO 9001 certification assures customers that a company has a strong commitment to quality management and a focus on customer satisfaction.

ISO 13485: Quality Management for Medical Devices

ISO 13485, on the other hand, is specific to the medical device industry. It provides a framework for organizations involved in the design, development, production, installation, and servicing of medical devices. Compliance with ISO 13485 demonstrates a company's ability to meet regulatory requirements related to medical devices and ensures the consistency, reliability, and safety of such products. ISO 13485 places an emphasis on risk management, traceability, and documentation control within the context of medical device manufacturing processes.

The Key Differences

One of the significant differences between ISO 9001 and ISO 13485 is the scope of application. ISO 9001 can be implemented in any organization, irrespective of the industry, whereas ISO 13485 is specific to the medical device field. Additionally, ISO 13485 puts more emphasis on regulatory compliance and risk management compared to ISO 9001.

Another key difference lies in the documentation requirements. ISO 9001 requires organizations to establish and maintain documented procedures, while ISO 13485 mandates detailed documentation for various stages of a product's lifecycle, including design, development, production, and servicing.


In conclusion, ISO 9001 and ISO 13485 share the same fundamental principles of quality management but differ significantly in their scope and specific requirements. While ISO 9001 focuses on improving overall organizational processes, ISO 13485 is tailored specifically for medical device manufacturers to ensure compliance with regulatory standards and maintain the safety and effectiveness of their products.


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