ISO 9000 AND ISO 9001

EXECUTIVE SUMMARY

ISO 9001 is an international quality management standard. It
is rapidly becoming the most popular quality standard in the
world. Thousands of organizations in over 100 countries
have adopted it, and many more are in the process of doing
so. Why? Because it controls quality. It saves money.
Customers expect it. And competitors use it.

ISO 9001 applies to all types of organizations. It doesn't matter
what size they are or what they do. It can help both product and
service oriented organizations achieve standards of quality that
are recognized and respected throughout the world.

ISO is the International Organization for Standardization.
It is located in Switzerland and was established in 1947 to
develop common international standards in many areas.
Its members come from over 150 national standards bodies.
ISO's purpose is to facilitate international trade by providing
a single set of standards that people everywhere would
recognize and respect.

HOW DOES ISO 9001 2008 WORK?

Here's how it works. You decide that you need to develop a
quality management system that complies with the ISO 9001
requirements. That's your mission. You choose to follow
this path because you feel the need to control or improve the
quality of your products and services, to reduce the costs
associated with poor quality, or to become more competitive. 
Or, you choose this path simply because your customers
expect you to do so or because a governmental body has 
made it mandatory. You then develop a quality management
system that meets the requirements specified by ISO 9001.
In the course of doing so, you may also wish to consult the
ISO 9000 definitions and the ISO 9004 guidelines.

But how do you develop such a quality management
system? There are at least two approaches. You can either
do a gap analysis or follow a detailed quality management
system development plan.

If you've already got a functioning quality management
system, we suggest that you carry out a gap analysis.
A gap analysis will tell you exactly what you need to do to
meet the ISO 9001 standard. It will help you to identify the 
gaps that exist between the ISO 9001 standard and your
organization's processes. Once you know where the gaps
are, you can take steps to fill your gaps. By following this
incremental approach, you will not only comply with the
ISO 9001 standard, but you will also improve the overall
effectiveness of your organization's quality management
system. A gap analysis will also help you to figure out how
much time it will take and how much it will cost to bring your
QMS into compliance with the ISO 9001 standard.

However, if you don't have a quality management system
or you're starting from scratch, we suggest that you use an
ISO 9001 process-based QMS development plan to develop
your quality management system.

Once your QMS has been fully developed and implemented,
you may wish to carry out an internal compliance audit to
ensure that it complies with the ISO 9001 2008 requirements.
Once you're sure that your QMS is fully compliant, you're ready
to ask a registrar (certification body) to audit the effectiveness
of your QMS. If your auditors like what they see, they will
certify that your QMS has met ISO's requirements.

While ISO 9001 is specifically designed to be used for
certification purposes, you don't have to become certified.
ISO does not require formal certification (registration). You
can simply establish a compliant QMS and then announce
to the world that it complies with the ISO 9001 standard. Of
course, your compliance claim may have more credibility
in the marketplace if an independent registrar has
audited your QMS and agrees with your claim.

WHY IS ISO 9001 2008 IMPORTANT?

ISO 9001 is important because of its orientation. While
the content itself is useful and important, the content
alone does not account for its widespread appeal.

ISO 9001 is important because of its international orientation.
Currently, ISO 9001 is supported by national standards bodies
from more than 150 countries. This makes it the logical choice
for any organization that does business internationally or that
serves customers who demand an international standard
of excellence.

ISO 9001 is also important because of its systemic orientation.
We think this is crucial. Many people wrongly emphasize
motivational and attitudinal factors. The assumption is that
quality can only be created if workers are motivated and have
the right attitude. This is fine, but it doesn't go far enough.
Unless you institutionalize the right attitude by supporting
it with the right policies, procedures, records, technologies,
resources, and structures, you will never achieve the standards
of quality that other organizations seem to be able to achieve.
Unless you establish a quality attitude by creating a quality
management system, you will never achieve a world-class
standard of quality.

Simply put, if you want to have a quality attitude you must
have a quality system. This is what ISO recognizes, and 
this is why ISO 9001 is important.

WHAT IS ISO 9000?

The term ISO 9000 unfortunately has two different meanings:
it refers to a single standard (ISO 9000) and it refers to a set
of three standards (ISO 9000, ISO 9001, and ISO 9004). All three
are referred to as quality management system standards.

ISO 9000 discusses definitions and terminology and is used
to clarify the concepts used by the ISO 9001 and ISO 9004
standards. ISO 9001 contains requirements and is often used
for certification purposes while ISO 9004 presents a set of
guidelines and is used to achieve sustained success.

Quality Management Principles

ISO 9001 2008 versus ISO 9001 2000

ISO 9001 2000 versus ISO 9001 1994

Plain English Quality Management Definitions

ISO 9001 2008 Translated into Plain English

How to Upgrade to the ISO 9001 2008 Standard

Quality Management Gap Analysis Tool

How to Develop a Process-based QMS

Process-based QMS Development Plan

Quality Management Audit Program

ISO 9001 2000 Introduction

ISO 9001 2000 Overview

Process Approach

FAQs

ISO 9004 2009 QMS Library

ISO 19011 2011 Auditing Library

AS9100C 2009 Aerospace QMS Library

ISO 13485 2003 Medical Device QMS Library