It’s interesting to note that when ISO 13485 refers to management they do not refer to executive management, or senior management, they refer to “top management”.
Why the Term “Top Management”?
They chose the term “top management” to ensure that management responsibility and commitment comes from the top level of the organization. Some organizations may call it “senior” some may call it “executive”, some may refer to “C-level management”, but it doesn’t matter to ISO, as long as it’s the top level.
Evidence of Commitment
The top level management must be able to provide evidence of its commitment to the development and implementation of the quality management system and be able to show that it is effectively maintained.
There are very specific ways the top level management needs to do this, and that is through communicating the importance of meeting the customer and regulatory requirements, establishing the quality policy, establishing quality objectives, conducting management reviews, and ensuring there are adequate resources to ensure the quality system is implemented and effective.
The evidence for these things is fairly simple. If the Quality Manual includes the quality policy and top level management are the signatory approvers, they have evidence it was established.
Management Review
The quality objectives and adequate resources are items that are covered in the management review. So evidence and records of the management review (See Chapter 5.6) provide the evidence of their involvement and that they are meeting the responsibilities required by the standard.