What are the Management Responsibilities according to ISO 13485 – Lesson 4
Management has an absolute responsibility to foster the quality policy, confirm its alignment, and communicates the mission to employees. They have a responsibility to plan, delegate authority, and communicate effectively. They are also in charge of a periodic review of operations and improvement within the organization, known as the Management review.
Management Commitment
Some of the management job within an organization is to develop goals, the company’s policy, strategic plans, and make decisions on the course of the business. Practically, to be involved in almost everything. It goes without saying that management has to participate in the implementation and maintenance of the QMS.
But this part of the standard tries to point out how necessary is to provide proof of its commitment to quality. It can be demonstrated through:
- Established objectives
- Management reviews
- Available resources
- Focusing on the customers’ requirements
The focus must be on customers as well
For medical device companies, the customers are patients and users of medical devices and technologies designed, developed, and manufactured by their organization. Organizations should always do what is best for their patients and that should become the guiding force for true quality.
Quality policy as all-embracing vision
It’s a document that states about commitment to customers and meeting their needs. As well as ensuring that applicable regulatory and statutory requirements are met, through effective implementation of QMS.
You also can see it as a strategy or kind of a guideline. In a certain way, it’s the backbone to ensuring the effectiveness of your quality management system.
There are a few more things to keep in mind when it comes to Quality Policy.
Quality Policy is also the responsibility of the top management. They have to make sure it complies with all the requirements of the companies QMS without neglecting the company's interests, and its strategic direction should be covered.
The Quality Policy is meant to be periodically reviewed within the framework of management reviews of the QMS. Remember: Creating a purposeful, meaningful quality management policy statement is more than just writing a slogan.
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