Process Improvement Essentials: CMMI, Six SIGMA, and ISO 9001

5.4. ISO 9000: Sections 1 Through 3

The ISO 9001:2000 Standard is organized (roughly) into two basic parts. Sections 1 through 3 provide introductory and overview material. Sections 4 through 8 provide the requirements for the makeup, management, use, and maintenance of the quality management system. Sections 4 through 8 of the manual are discussed in some detail in this chapter, but before I look at these sections, I'll touch briefly on Sections 1 through 3, as they set the stage for the intention of the Standard and its particular audiences.

5.4.1. Section 1. Scope

Section 1 of ISO 9001 defines the scope of the Standard. Basically, it defines in two subsections the intended audience for the Standardthat is, the types of organizations it is designed for and how it might be used by them.

5.4.1.1. 1.1. General (documents the specification as an official standard)

This section begins by specifying that the document represents an international standard for quality management systems. This is an ISO organizational requirement, a seal of authenticity. All official ISO Standards carry two common marks. The first is the registered ISO logo. This shows that the document has been officially released by the International Organization for Standardization. The second is the statement that the document is an international standard. The ISO releases many documents over the course of a year: reports, analyses, study results. But not all are to be taken as official standards. The "international standard" statement confirms the nature of the document. These two marks the logo and the statementappear on all 1,400+ standards that the ISO maintains.

This section then looks to the intended purpose of ISO 9001:2000. It states that ISO 9001 is intended to be used as an aid for organizations that have one (or both) of two objectives in mind. First, the standard is designed for organizations that want to demonstrate in an objective and broadly recognized manner that they have the ability to perform in a way that consistently meets customer and/or applicable regulatory requirements. Second, it's intended to help organizations that want to enhance customer satisfaction through the use of a formalized model, one that is based on consistent and repeatable processes and that has at its foundation the philosophy of continual improvement.

So, in essence, use of ISO 9001 can be applied to organizations operating toward three subobjectives (as shown in Figure 5-1):

• A focus on meeting customer requirements

• A focus on management through process

• A focus on continuous process improvement

5.4.1.2. 1.2. Application (defines the Standard as "generic"; applicable to many industries)

The audience descriptions found in Section 1.1 are extended here in 1.2. This section is titled Application. Application has to do with the applicability of the requirements found in the 9001 Standard. The requirements contained here are defined as being "generic"that is, they are not industry specific. They can be applied to all types of organizations, regardless of size, structure, or industry focus.

This is an important trait of ISO 9001. It can be used just as well at a shoestring factory as at the Jet Propulsion Laboratory. The requirements are articulated in such a way that they can be applied to just about any manufacturing, production, or service provisioning activity. How you apply them will depend on the needs and operational characteristics of your organization.

With this in mind, this section also allows an exclusion. It states that where a certain requirement proves to be irrelevant or impractical for a certain organization or for a certain product it produces, the requirement may be omitted. However, you should take a certain amount of care with the generosity of this exclusion. Such omissions are limited only to the requirements stipulated in Section 7 of the Standard (Product and Service Provision; see page 169). These requirements impact how your particular production process is managed, monitored, and controlled.

What may not be excluded are the requirements in the other sections of the Standard. These requirements are in place to ensure that the organization establishes a formal focus on meeting customer and regulatory requirements, on establishing a formalized process-based quality program to meet its quality objectives, and on making a commitment to continually improving the program.

These core activities of ISO 9000 are essential to its nature. Without them, the intention and benefits of the Standard become severely compromised, and so, in the spirit of compliance, they should not be omitted.

5.4.2. Section 2. Normative Reference (the Latest Issue of This Standard Can Be Used As a Legal Reference)

This section provides a dose of legalistic caveat emptor. Because ISO 9001 is an official international standard, parties can enter into legal agreements based on the requirements and definitions of the Standard, and these requirements and definitions can be expected to be held up as "superlatives" should any disagreement or dispute arise between the parties. That is, in fact, one of the strengths that using an ISO Standard provides. It is globally recognized as a common benchmark.

But Standards and their requirements and definitions can, and do, change over time. This section therefore also reminds us of that. The intention here is to encourage parties adopting, referencing, or using the 9001 Standard to make sure the material they have acquired represents the latest version available and that all parties have settled on this most recent version.

5.4.3. Section 3. Terms and Conditions (Some Modification of Terms from Previous Versions)

This section provides some basic update and addendum data on the use of certain terms and definitions that appear throughout ISO 9001. Basically this section endorses the definitions contained in the glossary of the ISO 9000 family of standards (9001, 9002, 9003). Inclusion of this glossary is out of the scope of this review, but the same glossary is brought forward in the 9001 document, with the exception of three definitions.

The term customer has been refined to place more emphasis on the independent nature of the party (whether internal or external). The customer has one or more of the following traits: it's the person or party that pays you to perform the work, it's the person or party to whom you have a contractual relationship, or it's the person or party to whom you are required to deliver the product.

Another change comes with the term supplier. This has been updated to organization. In the 9000 Standard, supplier was used to indicate the entity managing the ISO quality system or seeking ISO registration. But that term was deemed to be somewhat imprecise, not taking into account terms used to identify subcontractors and supplying vendors. Organization was selected as being clearer.

And so the term sub-contractor was elevated to supplier. Supplier now indicates a subcontractor, consultant, or vendor from which the organization obtains goods or services.