Let's begin by examining the assumptions that ISO makes.
ISO assumes that:

• Design can influence the quality of a product.
• Training can influence the quality of a product.
• Purchasing can influence the quality of a product.
• Customers can influence the quality of a product.
• Management can influence the quality of a product.
• Technologies can influence the quality of a product.
• Work patterns can influence the quality of a product.
• Resource levels can influence the quality of a product.
• Job descriptions can influence the quality of a product.
• Planning methods can influence the quality of a product.
• Inspection and testing can influence the quality of a product.
• Production processes can influence the quality of a product.
• Reporting relationships can influence the quality of a product.
• Transportation services can influence the quality of a product.
• Policies and procedures can influence the quality of a product.
• Communication patterns can influence the quality of a product.
• Record keeping systems can influence the quality of a product.
• Service delivery practices can influence the quality of a product.
• Inventory control methods can influence the quality of a product.
• Employee knowledge and skill can influence the quality of a product.

Note: When ISO uses the word "product" they also mean "service". From ISO's standpoint, a service is a product. Remember this as you review the previous list of assumptions, and as you study the rest of this section.

In general, ISO assumes that a wide variety of elements influence product quality. These elements are listed in the above assumptions and include items such as design, training, purchasing, and so on.

Because ISO believes that these kinds of elements influence product quality, they want you to control them. More precisely, ISO wants you to control the characteristics that make up each of these elements. For example, ISO wants you to control the characteristics that define the design process, the training process, and the purchasing process. ISO wants you to control the characteristics that define each of the elements in the above list.

So far, we have used the term characteristics. Now, please look at the following equation:

This is what ISO usually means when they use the term quality. For ISO, a quality is nothing more than a characteristic. This is how ISO uses the language. And this is consistent with a larger scientific and philosophical tradition that says that every entity has characteristics or qualities. You, for example, have a particular height, weight, age, nationality, and profession. These are some of your qualities or characteristics.

But notice that ISO does not use the term quality in the usual way. ISO does not want people to use the term quality "to express a degree of excellence" (ISO 8402 2.1). ISO does not think in terms of poor quality or high quality products. As a result, we believe that ISO has sidestepped the central issue. Even though your organization will probably meet every ISO requirement, this odd attitude means that you will, nevertheless, not be able to claim that your ISO program generates high quality products! In spite of this, most quality professionals would probably agree that the ISO 9000 program will assure the quality of any organizations' products, assuming that the program is properly designed, implemented, and managed.

Now let's return to ISO concepts. Based on the above discussion, we can rewrite our previous list in the following way:

• Design qualities influence product qualities.
• Training qualities influence product qualities.
• Purchasing qualities influence product qualities.
• Customer qualities influence product qualities.
• Management qualities influence product qualities.
• Technological qualities influence product qualities.
• Work pattern qualities influence product qualities.
• Resource qualities influence product qualities.
• Job design qualities influence product qualities.
• Planning qualities influence product qualities.
• Inspection and testing qualities influence product qualities.
• Production process qualities influence product qualities.
• Reporting pattern qualities influence product qualities.
• Transportation qualities influence product qualities.
• Policy and procedure qualities influence product qualities.
• Communication qualities influence product qualities.
• Record keeping qualities influence product qualities.
• Service delivery qualities influence product qualities.
• Inventory control qualities influence product qualities.
• Employee qualities influence product qualities.

So, the whole point of a quality system is to control all of the above qualities! The whole point is to control qualities (characteristics). But, notice that ISO is not interested in all of the qualities that make up an organization. ISO is only interested in the qualities or characteristics that influence product quality.

But let's pause for a moment. Let's make sure everybody understands what we mean. Let's look at some examples. When a procedure is written down, the "written down" aspect is a quality; when a reporting pattern is clearly defined, the "clearly defined" aspect is a quality; when a design is approved, the "approved" aspect is a quality or characteristic, and so on for each element.

If you want to conform to the ISO 9000 Standard, your quality system must have the qualities specified by ISO. However, these qualities are all general in nature. At the specific level, you have a lot of freedom to choose exactly what kinds of qualities will define your quality system. Accordingly, we have found it useful to distinguish between general qualities and specific qualities.

Let's look at a simple example. ISO says that your products should have the following kinds of general qualities: they should be properly designed, stored, delivered, installed, and serviced. But, the specific qualities that your products should have depends more on what you and your customers want, not on what ISO wants. In summary: general qualities are determined by ISO and specific qualities are determined by you and your customers.

Now let's look at the following equation:

This allows us, once again, to rewrite our previous list:

• Meet design requirements. You will assure product quality.
• Meet training requirements. You will assure product quality.
• Meet purchasing requirements. You will assure product quality.
• Meet customer requirements. You will assure product quality.
• Meet management requirements. You will assure product quality.
• Meet technological requirements. You will assure product quality.
• Meet work pattern requirements. You will assure product quality.
• Meet resource requirements. You will assure product quality.
• Meet job design requirements. You will assure product quality.
• Meet planning requirements. You will assure product quality.
• Meet inspection & testing requirements. You will assure product quality.
• Meet production process requirements. You will assure product quality.
• Meet reporting requirements. You will assure product quality.
• Meet transportation requirements. You will assure product quality.
• Meet policy and procedure requirements. You will assure product quality.
• Meet communication requirements. You will assure product quality.
• Meet record keeping requirements. You will assure product quality.
• Meet service delivery requirements. You will assure product quality.
• Meet inventory control requirements. You will assure product quality.
• Meet employee skill requirements. You will assure product quality.

ISO uses the term requirements because they expect your organization to implement the qualities that they have identified. When ISO wants to tell you what to do, they speak in terms of requirements.

Specifically, ISO wants you to implement the qualities or requirements listed in ISO 9001, ISO 9002, or ISO 9003. ISO wants you to develop a quality system that meets one of these sets of requirements. The remainder of this section will explain, in general terms, how you can develop a quality system that meets the requirements listed in ISO 9001. (ISO 9002 and ISO 9003 are essentially subsets of ISO 9001. So, this section also applies to ISO 9002 and ISO 9003.)

Now that you know that characteristics, qualities, and requirements are different ways of talking about the same thing, let's take a closer look at ISO's quality system requirements. To make it easier to grasp ISO's many quality system requirements, we have organized them in the following way:

1. Leadership requirements.
2. Product design requirements.
3. Purchasing requirements.
4. Contract review requirements.
5. Production requirements.
6. Inventory management requirements.
7. Inspection and testing requirements.
8. Nonconformance management requirements.
9. Measurement requirements.
10. Service requirements.
11. Internal audit requirements.
12. Training requirements.

Each of these 12 sets of quality requirements can be further subdivided by specifying 10 additional requirements. This is shown in the following table.

As you can see, we have identified 12 sets of general requirements, and within each of these we have identified 10 additional requirements. We have taken this approach because it helps us to clarify what ISO wants. When we studied ISO's requirements, it slowly became clear to us that ISO was really combining and confusing two different types of requirements. In effect, ISO has mixed apples and oranges. By failing to distinguish between these two types of requirements, ISO has created needless confusion.

The first set of 12 requirements indicates what functional areas need to be controlled. These include areas such as design, purchasing, and inspection.

The second set of 10 requirements specify how this control should be exercised within each of these 12 areas and what form this control should take. This second set of requirements specifies how quality documents, data, and records should be managed, what form quality policies, plans, procedures, and instructions should take, what technologies and resources are required, and how all of this should be organized.

In more abstract terms, we think of the first set as program requirements, and the second set as process requirements. The first set specifies what programs are needed and the second set specifies what kind of process should be followed by each program. In other words, the first set points to 12 quality programs that need to be developed, while the second set points to the methods, tools, and techniques that should be used by each program. This program-process distinction will help you to understand how you can develop your own quality assurance program.

You can develop a complete quality assurance program by studying each of the 12 sets of program requirements and by recognizing that each of these program requirements are made up of 10 process requirements. For example, you can develop a Quality Leadership Program if you:

1. State your leadership policies.
2. Design a managerial planning process.
3. Develop your leadership procedures.
4. Specify your leadership instructions.
5. Clarify who will provide leadership.
6. Define how your leadership process is organized.
7. Specify how leadership activities will be documented.
8. Clarify what kinds of leadership records will be kept.
9. Indicate what kinds of leadership technologies will be used.
10. Clarify the leadership resources that will be allocated.

If you do the same for each of the 12 sets of program requirements, you will end up with 12 quality programs. And the set of 12 quality programs will constitute your quality assurance program. This is summarized below.

Now let's add another item to our earlier equation. Let's add standards.

Now we have four ways of talking about the same thing. ISO's requirements become standards when they govern and control the attitude and behavior of an organization's management and staff. In general, ISO's requirements become your standards when you build them into your quality assurance program and when the program and its standards begin to influence behavior.

The following table emphasizes the point that your quality assurance program will be made up of 12 types of quality program standards, and that each of these is made up of 10 process standards.

Now that we've discussed the concept of a quality assurance program, we can show you what a quality system looks like, at least in general terms. The table below shows that your quality system is made up of two parts: your quality assurance program and your processes.

As you can see, the basic structure is simple: your quality assurance program controls your processes. More specifically, your 12 quality programs and standards control 12 separate processes. This is shown in the following table.