Creating Effective Quality Management Systems.
Effective Quality Management Systems (QMS) are the products of proper implementation. For ISO 9001:2015, that implementation is dependent on a detailed assessment of what processes are required for by the context of the organization. That assessment can also provide guidance for requirements of the management team that needs to be assembled.
Is There a Requirement for a Quality Manager Representative?
ISO 9001:2015 does not have a requirement for a Quality Manager Representative but consideration should be given to creating this position in you organization. When examining the requirements for leadership as described in ISO 9001:2015 it may well serve an organization to centralize the responsibilities of program coordination. This may be particularly important when a large number of specialized processes are required, each with its own owner. The important question to be answered is are all of the requirements of section 5.3 being adequately performed and coordinated?
Section 5.3
- Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.
- Top management shall assign the responsibility and authority for:
a) ensuring that the quality management system conforms to the requirements of this International Standard;
b) ensuring that the processes are delivering their intended outputs;
c) reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in particular to top management;
d) ensuring the promotion of customer focus throughout the organization;
e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
Context of the Organization
If an organization has sufficient complexity, a great deal can be accomplished by having a dedicated Quality Manager Representative that can oversee a these tasks. Because of the broad nature of these task the ideal representative may not be a member of the quality department. In fact having an independent advocate for customer input can be very important. Additionally input from product development teams is equally important.
Getting Perspective in Creating a Quality Management System
It can often be difficult for managers to assess the structure of a QMS. This is because they can be caught up in the immediate requirements of the workplace. It is therefore important to engage a third party with expertise to help with this essential analysis. CVG Strategy experts in ISO 9001 can help you on the path to defining required processes and recommending management structures that are appropriate for your business. Our team has been helping businesses develop Effective Quality Management Systems in a wide array of industries. Contact Us today to see how we can help.