What is a Quality Management System?
In the previous article, we learned about the importance of business processes, and how every business process - from order to delivery - must be well defined, and flawlessly executed to deliver a great customer experience.
The ISO standards - ISO9001, AS9100, ISO13485, IATF16949 - recognize and reinforce the importance of robust business processes, and therefore, these standards require companies to: (1) document their business processes, (2) ensure their employees are trained to operate the business processes, and (3) maintain records demonstrating that the business processes are operating as designed.
Typical business processes include:
- Purchasing Raw Materials or Components
- Managing Non-Conformances
- Managing Gage Calibrations
- Managing Changes to Engineering Drawings and Specifications
Most manufacturers have hundreds of business processes to operate, and therefore require a Quality Management System (QMS) to ensure processes are documented, employees are trained, and processes are operating as designed.
So what is a Quality Management System (QMS)? Contrary to popular belief, a QMS is usually NOT a single system. Instead, a QMS is a combination of software systems with which a company ensures processes are documented, employees are trained, and processes are operating as designed.
The image above shows a typical combination of software systems that make up a Quality Management System. Modern software blurs the lines between many of these systems. For example, some PLM systems may have built-in Document Control capability. As a result, every company's Quality Management System will be at least slightly different.
For example, the business process for purchasing raw materials may be documented in the Document Control system, the employee training logs maintained in the Document Control system, but the process itself may be operated entirely in the ERP system. A typical purchasing process involves a Purchase Requisition created and approved within the ERP system, then delivered to a Buyer, who then converts the Purchase Requisition into a Purchase Order (PO). The buyer negotiates pricing and delivery terms and then issues the PO to a supplier. The supplier then ships the required material, which is received into inventory via the ERP system.
Regulators, certification bodies, and your customers will periodically audit your Quality Management System. They are all looking for assurance that your business processes are documented, your employees are trained, and your business processes are operating as designed.