ISO 9001 2000 versus ISO 9001 1994

New Standard

In the past, ISO had three standards: ISO 9001:1994, ISO 9002:1994, and ISO 9003:1994. Now there's only one standard: ISO 9001:2000! ISO 9002 and ISO 9003 have been dropped.

So, if you are currently ISO 9002:1994 or ISO 9003:1994 certified, you will now need to become ISO 9001:2000 certified. And if you're now ISO 9001 certified, you're going to have to update your quality system in order to meet the new ISO 9001:2000 requirements.

New Structure

When you compare ISO 9001:1994 and ISO 9001:2000 you’ll notice that ISO has abandoned the 20-clause structure of the old standard. Instead of 20 sections, the new standard now has 5 sections.

ISO reorganized the ISO 9001 standard in order to create a more logical structure, and in order to make it more compatible with the ISO 14001 environmental management standard. While this reorganization is largely a cosmetic change, it could have some rather profound implications if you’ve organized your current quality manual around the old 20-part structure.

New Emphasis

In general, the new standard is more customer-oriented than the old standard. While the old standard was also oriented towards meeting customer requirements and achieving customer satisfaction, the new standard addresses this in much greater detail. In addition, it expects you to communicate with customers and to measure and monitor customer satisfaction.

The new standard also emphasizes the need to make improvements. While the old standard did implicitly expect organizations to make improvements, the new standard makes this explicit. Specifically, ISO 9001 now wants you to evaluate the effectiveness and suitability of your quality management system, and to identify and implement systemic improvements.

New Definitions

In the past, organizations that wished to be certified were referred to as suppliers because they supplied products and services to customers. Since many people were confused by this usage, ISO has decided to use the word organization instead. Now the ISO standards focus on the organization, not the supplier.

The term supplier now refers to the organization’s supplier. The new redefined term supplier replaces the old term subcontractor (which has now been dropped). While this may sound a bit confusing, this new usage simply reflects the way these words are normally used.

While you’re probably familiar with the previous concepts, you may not have heard of the next one. ISO now uses the phrase product realization. While this is a rather abstract concept, it is now central to ISO’s approach. In fact, ISO devotes an entire section to this new concept (Section 7). So what does it mean?

In order to grasp what it means you need to recognize that a product starts out as an idea. The idea is realized or actualized by following a set of product realization processes. Product realization refers to the interconnected processes that are used to bring products into being. In brief, when you start out with an idea and end up with a product, you’ve gone through the process of product realization.

New Requirements

The new ISO 9001:2000 standard introduces some new requirements and modifies some old ones. These requirements are summarized below. For more detail, please see the associated ISO 9001:2000 clauses (in brackets).

Communicate with customers (7.2.3).
Identify customer requirements (5.2, 7.2.1).
Meet customer requirements (5.2).
Monitor and measure customer satisfaction (8.2.1).
Meet regulatory requirements (5.1).
Meet statutory requirements (5.1).
Support internal communication (5.5.3).
Provide quality infrastructure (6.3).
Provide a quality work environment (6.4).
Evaluate the effectiveness of training (6.2.2).
Monitor and measure processes (8.2.3).
Evaluate the suitability of quality management system (8.4).
Evaluate the effectiveness of quality management system (8.4).
Identify quality management system improvements (5.1, 8.4).
Improve quality management system (5.1, 8.5).

New Flexibility

Under the new ISO 9001:2000 standard, you may ignore or exclude some requirements. Requirements that may be ignored under special circumstances are known as exclusions. According to ISO, you may ignore or exclude any of the requirements found in Section 7 Product realization as long as you meet certain conditions.

You may exclude a Section 7 requirement if you cannot apply it. More precisely, you may exclude or ignore a requirement if:

You cannot apply it because of
the nature of your organization, or
You cannot apply it because of the
nature of your products or services

However, you may not exclude or ignore Section 7 requirements if doing so will compromise your ability or willingness to meet the requirements set by customers and regulators.

We believe that this permissible exclusion clause is a very important improvement. We think it’s important because it makes implementation more flexible and conformance less rigid. Because of this significant innovation, you’re more likely to end up with a quality management system that not only complies with ISO’s standards but also meets your organization’s unique needs.

This new, more flexible, approach is further demonstrated in another way. When you study the new ISO 9001 standard, you’ll notice that it is less prescriptive than the old standard. In general, the new standard tells you what to do not how to do it.

This is particularly evident when you look at how many times procedures are required. When you compare the old and the new standard, you’ll notice that procedures are much less often required by the new standard. This more flexible approach gives you more freedom to decide how you’re going to meet the requirements. In general, this should make it easier for you to develop a more suitable and effective quality management system.

New Approach

In order to understand ISO 9001:2000 at a deeper level, you need to recognize that ISO uses a process approach to quality management. While the process approach is not new, the increased emphasis ISO now gives to it is new. It is now central to the way ISO thinks about quality management systems.

According to this approach, a quality management system can be thought of as a single large process that uses many inputs to generate many outputs. This large process is, in turn, made up of many smaller processes. Each of these processes uses inputs from other processes to generate outputs which, in turn, are used by still other processes.

A detailed analysis of the Standard reveals that an ISO 9001:2000 Quality Management System is made up of at least 21 processes (22 if you recognize that the Quality Management System as a whole is also a process). These 21 processes are listed below:

Quality Management Process

Resource Management Process

Regulatory Research Process

Market Research Process

Product Design Process

Purchasing Process

Production Process

Service Provision Process

Product Protection Process

Customer Needs Assessment Process

Customer Communications Process

Internal Communications Process

Document Control Process

Record Keeping Process

Planning Process

Training Process

Internal Audit Process

Management Review Process

Monitoring and Measuring Process

Nonconformance Management Process

Continual Improvement Process

In order to develop a quality management system that meets the new ISO 9001:2000 standard, you must create or modify each of the above processes. You must:

Design each process.

Document each process.

Implement each process.

Support each process.

Monitor each process.

Control each process.

Improve each process.

Each process uses inputs to generate outputs, and all of these processes are interconnected using these input-output relationships. The output from one process becomes the input for other processes. Because of this, inputs and outputs are really the same thing.

In order to ensure that you understand what we're talking about, we've provided the following incomplete list of some general types of inputs/outputs:

Products
Services
Information
Documents
Reports
Records
Results
Needs
Data
Expectations
Requirements
Complaints
Comments
Feedback
Resources
Measurements
Authorizations
Decisions
Plans
Ideas
Solutions
Proposals
Instructions

In summary, an ISO 9001:2000 Quality Management System is made up of many processes, and these processes are glued together by means of many input-output relationships. These input-output relationships turn a simple list of processes into an integrated system. Without these input-output relationships, you wouldn't have a Quality Management System.

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