ISO 9001 Process Approach

ISO 9001 and the process approach are the focus of this course. The process approach is mentioned in the introduction of ISO 9001 and throughout the standard. We're going to focus on that specific aspect of the standard. I'm going to be discussing processes in detail. A process comprises inputs, activities, and outputs.

There’s nothing more important in today’s market than the ability to effectively deliver value to your customers. It is only possible through efficient resources management, leadership, and identifying customer needs and requirements. Being able to do this at a process level is essential.

Any organization-type of any size and in any industry can implement ISO 9001. An organization can use it as a generic management system and tailor it to their needs. All organizations can break down their activities into processes with inputs, activities, and outputs. Analyzing these processes and taking actions to plan, maintain, and improve them leads to increased customer satisfaction.

ISO 9001 requires organizations to determine the needs and expectations of their interested parties. They then develop a system that enables them to fulfill the requirements. The systems are made up of processes and must be regularly evaluated and updated based on changing circumstances and trends.

ISO 9001 is a risk-based system. A core purpose of the entire management system is to prevent adverse events from occurring. Therefore, it’s vital to understand the risks associated with each process. Furthermore, such assessments lead to the discovery of new opportunities. While analyzing different processes and communicating with interested parties, you will become aware of new opportunities. These can be opportunities for innovation, improved terms, and conditions, investments in new infrastructure, or new training opportunities.

A foundational concept of quality management is continual improvement. It means that leadership or top management must reassess the management system processes at regular intervals. There have to be procedures in place for management to evaluate and assess the impacts of their actions. These reports can help them make better decisions in the future and restart the cycle of plan-do-check-act. In this course, you'll learn how to apply plan-do-check-act to processes.