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. 

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.

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.

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.

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.

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. In fact, according to ISO 9001:2000,
clause 4.1, it is now mandatory.

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:

1. Quality Management Process
2. Resource Management Process
3. Regulatory Research Process
4. Market Research Process
5. Product Design Process
6. Purchasing Process
7. Production Process
8. Service Process
9. Product Protection Process
10. Customer Needs Assessment Process
11. Customer Communications Process
12. Internal Communications Process
13. Document Control Process
14. Record Keeping Process
15. Planning Process
16. Training Process
17. Internal Audit Process
18. Management Review Process
19. Measuring and Monitoring Process
20. Nonconformance Management Process
21. Continual Improvement Process

Each of these 21 processes 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, in fact, 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.