How to fulfill management responsibilities in ISO 13485:2016

There have always been requirements regarding management responsibilities in ISO 13485. After all, leadership from top management is part of the foundation of the standard, along with six other quality management principles. And, this is a good thing—without management’s ongoing support, your Quality Management System (QMS) is destined for problems.

What are the management responsibility requirements in the ISO 13485:2016?

Section 5 of the new revision of the standard covers the responsibilities of top management, the bulk of which are the same as, or similar to, the existing requirements in the previous version. The first part describes how top management must show leadership through its commitment to the QMS, including:

  • making sure adequate resources are available when needed
  • holding accountability for the effectiveness of the Quality Management System
  • fostering continual improvement
  • ensuring that the quality objectives and quality policy are aligned with the QMS, and with the company’s strategic goals

The remaining three parts of Section 5 discuss the quality policy and its requirements, the need to put customers first, and the roles, responsibilities, and authorities of the company. These requirements only saw minor changes from the previous revision; for example, top management’s responsibility to ensure the suitability, adequacy, and effectiveness of the QMS remains the same, although a few requirements have been removed—such as those for the QMS representative. The role of top management remains as important as ever.

How can you meet the requirements?

As previously mentioned, the requirements in the ISO 13485:2016 standard haven’t changed much from the previous version, so you don’t have to worry about making major changes to the role of top management in your QMS. That said, here are some important things you should include to illustrate top management’s commitment and involvement in your QMS:

  • Management is involved in assessing the effectiveness of the Quality Management System.
  • Top management gives clear direction for creating the quality policy and quality objectives, communicates this throughout the company, and tracks their progress.
  • Management demonstrates that the QMS is not a side project, but rather an important part of business processes.
  • Management assesses and addresses the need for resources.
  • Management supports and encourages continual improvement.
  • Top management makes sure that a process is in place to understand and meet applicable requirements from customers, as well as local and federal regulations.
  • Management focuses on the customers.
  • Roles, responsibilities, and authorities are properly assigned, and understood both by the assignees, and by other employees who interact with the assignees.

In addition, it’s important to remember that management review and its requirements remain in the new revision, which includes feedback to management on QMS effectiveness and maintenance. The management review process continues to be a key indicator of management’s ongoing commitment to the Quality Management System, and in fact, the new revision has expanded on those requirements. New inputs are required regarding the handling of complaints and reporting to relevant regulatory authorities. Also, the outputs now have requirements regarding actions and decisions that lead to changes to the QMS, and compliance with regulations.

Top management’s involvement isn’t optional

It’s no secret that in order for an ISO 13485 QMS to succeed, it requires support from management. Without such support, other priorities will take center stage, and all that time and money spent implementing the QMS are wasted—and the possible benefits lost.

Use this free Diagram of ISO 13485:2016 Implementation Process in order to control ISO 13485 implementation.