Clause 5.1.1 of the ISO 13485 standard, like ISO 9001, focuses on "Management commitment" within the context of a Quality Management System (QMS), but it is specifically tailored to the requirements of the medical device industry. ISO 13485:2016 is designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services. It emphasizes the need for a QMS that consistently meets customer requirements and regulatory requirements applicable to medical devices and related services.

5.1.1 Management commitment

Under Clause 5.1.1, ISO 13485:2016 requires top management to demonstrate their commitment to the development and implementation of the quality management system and to continually improving its effectiveness. This includes several specific obligations:

• Providing evidence of their commitment to the development and implementation of the quality management system and to continually improving its effectiveness: This involves actively participating in QMS activities, providing clear evidence of their commitment, and ensuring the QMS is properly implemented and maintained.
• Communicating the importance of meeting customer as well as statutory and regulatory requirements: Top management must ensure that the organization's employees understand the importance of meeting these requirements, emphasizing the need to meet customer expectations and comply with laws and regulations specific to medical devices.
• Establishing the quality policy: The quality policy should be appropriate to the purpose of the organization, include a commitment to comply with requirements and to maintain the effectiveness of the QMS. It should provide a framework for setting and reviewing quality objectives.
• Ensuring quality objectives are established: These objectives should be measurable and consistent with the quality policy, aiming to meet requirements and improve the effectiveness of the QMS.
• Conducting management reviews: Top management should review the QMS at planned intervals to ensure its continuing suitability, adequacy, and effectiveness, addressing the need for changes to policy, objectives, and other elements of the QMS.
• Ensuring the availability of resources: Top management is responsible for providing the necessary resources to implement, maintain, and improve the QMS. This includes human resources, specialized knowledge, technology, and financial resources.

Clause 5.1.1 emphasizes the crucial role of top management in not only being committed to the QMS but also ensuring that this commitment translates into actions that support the system's effectiveness, compliance with regulatory requirements, and the organization's ability to meet customer expectations. This leadership and commitment are essential for fostering a quality culture throughout the organization, ensuring the safety and efficacy of medical devices produced, and maintaining compliance with applicable regulations.