One of the most important communication elements for a Quality Management System (QMS) is the Quality Policy and Quality Objectives. Together, they set the company's direction and help demonstrate the most essential quality aspects from management. In addition, implementation is a QMS requirement from FDA's QSR, ISO 13485:2003, and ISO 13485:2016.
Poor implementation can both diminish communication and create problems with regulators. A well-structured Quality Policy, with the required elements, provides the framework for the Quality Objectives. In QSR, the policy and objectives become part of the Quality System Record.
Management reviews the policy and objectives on a regular basis. The standard approach includes this as an element in the Management Review.
Objectives of the Presentation
Why Should you Attend
- Explain the QSR requirements for the Quality Policy and Quality Objectives
- Describe the methods an FDA Investigator uses to verify compliance
- Identify the additional requirements from ISO 13485:2003 and from ISO 13485:2016
- Provide example for Quality Policies illustrating the requirements
- Describe the methods to develop Quality Objectives from the Quality Policy
- Provide a description of the three types of metrics
- Show how to use Excel to develop a graphical approach to the metrics
Medical device manufacturers have received Warning Letters for not implementing or communicating the Quality Policy and Quality Objectives. In addition, management can set the quality expectations and continuous improvement intentions through these management tools. Attending this presentation provides the tools and knowledge to develop an effective program.
Who will Benefit
The presentation focuses on the Quality Policy, the Quality Objectives, and the associated metrics. This is of particular interest to:
- Quality Managers
- Management Representatives
- Management Review attendees
- Managers of QMS processes
- Continuous Improvement Specialists
- Quality Engineers
- Production Managers
A checklist to help ensure your system is prepared for your next FDA Inspection or Notified Body audit.