Our ISO 9001 Internal Audit Program, ISO 13485 Internal Audit Program, and our Quality Management System Development Plan uses a process approach. We use a process approach, not only because it makes good sense to do so, but also because ISO has made it mandatory. Clause 4.1 of ISO 9001 and ISO 13485 makes it clear that organizations must identify and manage the processes that make up their quality management systems.

The process approach is a management strategy. When managers use a process approach, it means that they manage the processes that make up their organization, the interaction between these processes, and the inputs and outputs that glue these processes together.

But, what’s a process, and what are inputs and outputs? Briefly put, a process uses inputs to generate outputs. Or, more precisely, a process is an integrated set of activities that uses resources to transform inputs into outputs. A system exists whenever several processes are interconnected using such input-output relationships. Processes are interconnected because the output from one process becomes the input for another process. In effect, processes are “glued” together by means of such input output relationships. And because the output of one process becomes the input of another process, inputs and outputs are really the same thing.

Since all of this is rather abstract, we’ll try to make it a bit more concrete with some examples. Below, you’ll find a list of the processes that make up a quality management system and a list of the inputs and outputs that connect or “glue” processes together to form a system.

A quality management system is a network of processes, and a process is made up of people, work, activities, tasks, records, documents, forms, resources, rules, regulations, reports, materials, supplies, tools, equipment, and so on - all the things that are needed to transform inputs into outputs. In general, a quality system includes all the things that are used to regulate, control, and improve the quality of products and services.

Since the process approach is now central to ISO’s approach, we have tried to identify all the processes that make up a complete ISO 9001 2000 Quality Management System. As the following list shows, we’ve identified 22 processes:

When you think about all the processes that make up a quality management system, and then think about the many input-output relationships that “glue” these processes together, you soon realize how complex such a system is. Because of this, you may find it difficult to create a single map or diagram of your entire quality management system. There are just too many processes and too many input-output relationships. As the first diagram above shows, a single map or diagram may provide a general overview, but it’s usefulness will be limited.

For this reason, we suggest that you diagram one process at a time using a single flowchart on a single page (as shown in the diagram below). This will allow you to specify the most important input-output relationships without getting buried in complexity. The diagram below shows, in general terms, how this could be done.

We suggest that you use flowcharting software to diagram your quality management system. We recommend  SmartDraw, ConceptDraw, or Visio for this purpose. These applications are relatively inexpensive and easy to use.

• Describe how your quality system processes interact.
• Define the scope of your quality management system.
  • Explain any reductions in the scope of your system.
  • Justify all exclusions (reductions in scope).
• Document your procedures or refer to them.

Notice that it doesn’t tell you to “regurgitate” the ISO 9001 standard. We mention this because it’s a common practice. Many people simply copy
the ISO 9001 standard and call it a quality manual. If you plan to follow
this approach, please reconsider. It’s pointless, and may violate ISO’s copyright. But more importantly, the ISO 9001 standard doesn’t want
you to do it. What ISO does want you to do is comply with section 4.2.2.

Notice also that a quality manual is not a quality system. A quality manual is just a document, while a quality system is a network of real processes. Your quality manual is supposed to document your quality system; it's not supposed to be your system. Your manual is not your system. They're two different things. Your quality manual is all about paperwork, while your quality system is a web of real processes.

This is an important point. It's important because many people sell quality manuals and computer programs that claim to provide an instant solution. Usually all you have to do is edit the manual or install the program and, bingo, you've got a complete quality management system. This is false and misleading. A manual is just a document and a computer program is just an information system. Your quality system does not sit on your shelf, nor does it live inside your computer.

If you use our approach, your quality manual should be pretty short. Simply describe how your quality system processes interact using the above mapping methods. Once you’ve done this, all you need to do is define the scope (focus) of your quality management system (including reductions in scope) and the procedures that regulate how it functions.

Regarding procedures, we suggest that you define them in a separate document, and simply refer to them within your quality manual. If you use this approach, updates to either your manual or your procedures should be much easier to manage.

We also suggest that you develop a procedure for every process. Every process ought to have a documented procedure that describes the process, and governs and controls how it is carried out. However, this is just our opinion. It is not an ISO 9001 2000 requirement. When it is a requirement, our Quality Management System Development Plan will mention it. Procedures, by the way, can be lengthy documents full of detailed text, or they can be one page flow diagrams. Just make sure
that it meets your organization’s needs and ISO’s requirements.

Based on the above discussion, you will have three different sets of flowcharts if you decide to use diagrams to document your quality management system. You will have a single systemic flowchart,
some process flowcharts, and several procedural flowcharts:

1. Develop a single systemic flowchart for your quality management system as a whole. While such a document will be rather abstract, it will help show how your processes are interrelated and integrated (see diagram 1 above).
    
2. Develop one flowchart for each process and use it to describe how it interacts with other processes using input-output arrows (see diagram 2 above). This set of process flowcharts will describe how your processes interact.
    
3. Develop one flowchart for each process and use it to describe how the process should be performed (see diagram 3 below). This set of flowcharts will make up the procedures that control how processes should be performed. Such procedural flowcharts usually specify a start and stop point with actions (tasks or steps) and decision points in between.

Of course, your flowcharts may not look like ours. That’s fine. Just make sure they meet your needs and address ISO’s requirements.

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