ISO 13485 Section 5: Management Responsibilities

Clause 5 of 13485:2016 focuses on the responsibility of Management, this section has 6 subclauses:

  • 5.1 Management Commitment
  • 5.2 Customer Focus
  • 5.3 Quality Policy
  • 5.4 Planning
  • 5.5 Responsibility, Authority and Communication
  • 5.6 Management Review

5.1 Management Commitment

When it comes to top management, ISO requires management to participate in the implementation and the maintenance of the QMS.  Management plays a critical role, and therefore they need to be involved and ready to lead.

Management has key responsibilities such as meeting on a regular basis, communicating to the organization, establishing QMS policies, making sure that objectives are established, conducting reviews and also determining that resources needed to meet the QMS are available.

5.2 Customer Focus

Management is responsible to make sure that customer requirements and any relevant regulatory requirements are met.

5.3 Quality Policy

Management is also responsible for quality policy, and needs to make sure that the QMS is applicable to their organization, and that the organization is committed and complies with all the requirements of the QMS. Additionally, management needs to provide a framework for establishing and reviewing their QMS. Furthermore, management needs to make sure that the QMS is adequately communicated throughout the organization and understood. Lastly, the QMS must be reviewed for continuing suitability.

5.4 Planning

Top management needs to make sure that the any QMS goals, including regulatory requirements and requirements for products are met, and that they are measurable.

Referring to 4.1, top management must make sure that the QMS is carried out adequately. Also, when changes occur within the organization, they need to make sure that the QMS is being maintained.  

5.5 Responsibility, Authority and Communication

Top management needs to be well organized and define all responsibilities and authorities are defined and communicated. There needs to be documentation of each person, and their responsibilities of managing, performing and verification of work done in regards to the QMS.

Top management is in charge of appointing responsibilities to other staff and management to ensure that the QMS is being met. They also need to be responsibility for communicating internally.

5.6 Management Review

Management review is critical, and therefore making the most of it will be extremely beneficial for your business. These reviews are necessary to maintain your QMS and to see the most improvements. Management review is great and can help bring together all aspects of the QMS in your business and create cohesiveness.

 

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