What are the QMS Roles and Responsibilities that ISO 9001: 2015 Identifies as Necessary?
The Quality Management System (QMS) is a set of policies, procedures, and processes that an organization uses to manage its quality-related activities. The QMS roles that ISO 9001:2015 identifies as necessary include:
- Quality management representative.
- Quality policy development and review.
- Quality objectives development and review.
- Quality planning.
- Quality control.
- Quality assurance.
- Quality improvement.
The QMS roles are essential to the success of any organization that wants to improve its quality management practices. By clearly defining these roles and responsibilities, organizations can ensure that all quality-related activities are properly coordinated and aligned with their overall business goals.
How Can You Document The QMS Roles and Responsibilities?
Documenting the roles and responsibilities of those who design, implement, operate, and maintain your quality management system (QMS) is critical to the success of your quality management system. It is also a requirement of ISO 9001.
One way to document roles and responsibilities is to create a responsibility matrix. This is a table that lists all the roles and responsibilities within your organization, along with the name of the individual or department responsible for each task.
Another way to document roles and responsibilities is to create a set of quality procedures that spell out who is responsible for each task. This approach is often used in conjunction with a responsibility matrix.
Whatever approach you choose, it is important to ensure that everyone in your organization understands their roles and responsibilities and that they are properly documented.
What Are the Differences Between Quality Procedures and Work Instructions?
Quality procedures and work instructions are both documents that can be used to document roles and responsibilities. The main difference between the two is that quality procedures describe how a task should be performed, while work instructions describe how a task is performed.
For example, a quality procedure for conducting customer satisfaction surveys might require that surveys be conducted once per quarter. Work instructions for conducting customer satisfaction surveys might provide specific instructions on how to conduct the survey, including what questions to ask and how to tabulate the results.
Under clause 5.3 of the ISO 9001 standard, top management is required to assign the responsibility and authority for the following:
• Planning and implementing the quality management system.
• Ensure that quality objectives are established.
• Ensure the availability of resources.
• Communicate the importance of meeting customer requirements.
• Ensure that customer complaint is handled promptly and effectively.
• Monitoring performance.
• Promoting continuous improvement.
• Taking corrective and preventive actions.
• Conducting management reviews.