If you have problems trying to make sense of the ISO 9001 standard, try to understand just one clause - 4.1 General requirements. This is the master clause. It dictates what every quality process must do. It is also applicable to any management or supporting processes, where feasible.
Clause 4.1 states that an organization shall establish, document, implement and maintain a quality management system [QMS] and continually improve its effectiveness in accordance with the requirements of the ISO 9001 standard. Your organization shall:
- Determine the processes needed for your QMS and also identify where they are applied throughout your organization
- Determine the sequence and interaction of your QMS processes
- Determine the criteria and methods needed to ensure both the effective operation and control of these processes
- Ensure resources and information are available to support the operation and monitoring of all QMS processes
- Monitor, measure, and analyze your QMS processes
- Implement actions to achieve planned results and continually improve your processes
You shall also control any outsourced processes that affect product conformity to requirements & identify such processes within your QMS. And, your QMS processes should include processes for management activities, provision of resources, product realization, including measurement, analysis and improvement.
To be able to determine your QMS processes, you will need to know your customers' requirements. What is your mission? To serve your customers' needs, wants and expectations? Why? To realize your corporate vision? So that's what it's about. Defining your business processes, including management and support processes.
Plan how these processes are sequenced and how they interact with each other. Since you already know what your customers' requirements, you can proceed to design your processes. Flowchart your QMS processes.
Decide on the best method of control that you can implement in order to ensure that these processes can operate effectively, in terms of producing the desired outputs. You will need procedures, flowcharts, etc. You will need to control any defective products that come into your organization or before they are released to the next process in line or to the customers. You will correct all errors within these processes. These processes will require specific resources. Determine and provide them to these processes.
As you operate your QMS processes, you will want to monitor and measure their performances. This is only natural. You will want to know how much the sales crew is bringing in this month. Or you will want to know how many late deliveries of raw materials occurred for the week. Or how much dollars are being spent in terms of scrapped products. Or you will want to know if production or operations have been able to meet customer demands in terms of quantity and quality.
And when you get those data, you will want some answers as to why they are the way they are. So process analysis comes into play. When you uncover any potential threats or weaknesses, you will want to take actions that will mitigate those scenarios.
And elsewhere, you might be thinking if we can make so much widgets, why not make more for as long as there is demand for them. So you take your performance a notch up the market share's ladder. And you go on this improvement cycle for as long as there's value in it.
If you would just follow these guidelines, you will have an effective quality management system ready to be audited any time. Just remember this diagram: