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. 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:

Quality Management Process
Resource Management Process
Regulatory Research Process
Market Research Process
Product Design Process
Purchasing Process
Production Process
Service 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
Measuring and Monitoring Process
Nonconformance Management Process
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.

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First published on December 3, 2000. Updated on December 2, 2011.