As far as we I can say, the success of a quality management system depends on the management. It is no secret. But how one can evaluate whether the management truly devoted to the QMS or just acts like it one time a year when the external audit pays a visit...

In this article we would review the additional requirements for Management responsibility (chapter 5) as specified by the ISO 13485 Standard with reference to the ISO 9001 Standard.

Chapter 5.1 is a general chapter. In this chapter are presented the general requirements for the top management regarding the quality management system. The specific requirements appear throughout the following chapters 5.2-5.6.
This chapter shall be regarded as a base for self evaluation whether the top management role within the quality management system follows the general requirements. 
Here the management is required to demonstrate, with actions, how it assures that the quality management system would be implemented.  The ISO 9001 Standard requires to continually improving the quality management system while the ISO 13485 Standard requires maintaining the effectiveness of the quality management system. Again, it is emphasized that the top management is not only responsible for developing the quality management system but to realize, implement it and maintain its effectiveness. The top management is responsible to present the evidences for performing the responsibilities.
The management is responsible for:

• Defining a quality policy 
• Determining measurable objective that will maintain the quality management effectiveness. In other words, the top management required to determine objectives, that by fulfilling them, the quality management system would achieve improvement on a systematic basis. The ISO 9001 Standard requires "only" improving the quality management system. The ISO 13485 Standard requires it to be systematically implemented in order to ensure improvement. The difference is caused by the reason that regulatory requirements for medical devices requires constantly to maintain the effectiveness of the quality management system.
• The top management is required to decide about the quality objectives and to ensure that these objectives would be achieved. How? Determine objective that are relevant to the quality policy. After determining the objectives, the top management must collect and analyze data regarding these objectives and to evaluate whether the improvement was achieved or not.
• Define a communication channel between the top management and the employees. The purpose here is to ensure that the management has defined means to deliver and implement the importance of meeting customers' requirements and regulatory requirements among the employees.
• Conducting management review to evaluate the effectiveness of the quality management system. We would later deal with the management review in more details.
• The top management shall ensure allocation of all required resources in order to ensure an effective quality management system.

ISO 13485 Standard Management Responsibility requirements - Customer focus

The ISO 13485 (as well as the ISO 9001), sets requirements that would ensure the top management commitment to the customers. In this article we will review the additional requirements for Management responsibility regarding customer focus as specified by the ISO 13485 Standard with reference to the ISO 9001 Standard.

 The ISO 9001 Standard requires that the top management would ensure that any customers' requirements are met in order to enhance customers' satisfaction. The ISO 13485 Standard requires that the top management shall ensure meeting customers' requirements. There is no reference to customers' satisfaction.
The reason for the difference is that customer's satisfaction should not always be the main objective while producing medical device. As a guiding theme, regulatory regulations are to be the main objective of quality management system under the ISO 13485 Standard requirements for medical devices and not the customers' satisfaction. But still, the organization is required to maintain a method to identify customer's requirements (as indicated in chapter 7.2.1) and to maintain a method to review customers' reaction regarding the product (as indicated in chapter 8.2.1).

ISO 13485 Standard Management Responsibility Requirements - Quality Policy

In general, the quality policy shall represent the nature of the organization. Next requirement for the quality policy is provide the ability to derive the quality objective out of it.  This relation between the quality policy and the quality objective would turn this document into a useful document and just a documented statement. The guys at the ISO organization know with whom they are dealing… The policy shall be reviewed every once in a while (within define intervals, of course). The purpose is to examine how well the policy suits the organization. One appropriate framework for examination is the management.   

After defining the quality policy, the top management shall determine a method to inform the employees about the policy. The employees must not learn the policy by heart but do must know the main principles of the policy and their work should indicate that they do try (at least) to carry it out. 
The addition, or more accurate, the difference here regards, once again to the maintenance of the effectiveness of the quality management system. The ISO 9001 Standard requires defining the areas where improvements shall be pursued and achieved. The ISO 13485 Standard requires defining the areas where improvements would be maintained. The reason for this change is that the top management must initiate defined actions to ensure that the quality management system is effective. The requirement is caused by the general regulatory requirements that a quality management system for medical devices manufacturer would be constantly effective.