What is ISO 9001:2000?

A step by step
guide to

Q U A L I T Y

M A N A G E M E N T

S Y S T E M S

ISO 9001:2000

Contents
*ISO 9001:2000 QUALITY SYSTEMS AND PLAN-DO-CHECK-ACT .......1
*EIGHT QUALITY MANAGEMENT PRINCIPLES..........................................4
*SECTION 4.0 QUALITY MANAGEMENT SYSTEM ....................................6
*SECTION 5.0 MANAGEMENT RESPONSIBILITY........................................8
*SECTION 6.0 RESOURCE MANAGEMENT ................................................9
*SECTION 7.0 PRODUCT REALIZATION....................................................10
*SECTION 8.0 MEASUREMENT ANALYSIS AND IMPROVEMENT...........11
*WHERE CAN I FIND OUT MORE ? WHO CAN HELP ME ? ....................13

*This symbol may only be displayed by those organizations

that register with BSI. Users of this guide are reminded that
copyright subsists. No part of this publication may be reproduced
in any form without prior permission in writing from BSI, *2001.
All rights reserved.

ISO 9000:2000 Quality Systems

and Plan-Do-Check-Act
An Introduction to ISO 9000:2000 Quality Systems

This booklet has been produced as an introduction to ISO 9000:2000

Quality Management Systems. ISO 9000 is a series of three standards,
but this guide refers to the sections you will find in ISO 9001, a standard designed to specify requirements for a quality management
system where an organization:
(a) aims to enhance customer satisfaction through the effective
application of the system, including processes for continual business
improvement, and
(b) needs to demonstrate its ability to provide products and services
that constantly meet customer and applicable regulatory requirements.
Over 350,000 companies world wide use ISO 9000 to help them run
their organization. The benefits they find include:
1. Improved consistency of service/product performance and
therefore higher customer satisfaction levels.
2. Improved customer perception of the organizations image,
culture and performance.
3. Improved productivity and efficiency, which lead to cost
reductions.
4. Improved communications, morale and job satisfaction - staff
understand what is expected of them and each other.
5. Competitive advantage and increased marketing and sales
opportunities.

Introducing Chuck
To set the scene, let us introduce you to Chuck, who explains the criteria of
ISO 9001 and discusses the benefits of implementing a quality system with
his business associates over dinner.

ISO 9001 Quality Systems

Q. We hear you are registered to something called ISO 9001?

A. Yes we are, and what a difference its made to our organization.

Q. Really? We dont fully understand what ISO 9001 is.

A. Its an international standard for quality management systems and

is recognized worldwide.
Q. Whats a quality management system?

A. Its a common sense, documented, business management system

that can be applied to all business sectors and all sizes of companies. If you think of a business as a set of processes, it identifies
the key process areas that need to be addressed to ensure quality
is managed effectively.

Q. What is a process?

A. A process is an activity, supported by resources and management,

for enabling the transformation of inputs into outputs. The outputs from one process often form the input to the next.
Q. So what does ISO 9001 have to do with processes?

A. ISO 9001 suggests that the application and management of a system of processes is an effective way to ensure good quality management. To adopt this process approach ISO 9001 includes a
Plan-Do- Check- Act (PDCA) methodology that can be applied to
all processes and can briefly be described as follows:
Plan: establish the objectives and processes necessary to deliver
results in accordance with customer requirements and the
organization policies.
Do:

implement the processes.

Check: monitor and measure processes and products against

policies, objectives and requirements for the product and
report the results.
Act:

take actions to continually improve process performance.

The continual imrovement model in the standard, looks like this:

Eight Quality Management

Principles:
Q. OK, so an ISO 9001:2000 quality management
system is based around the management of
individual processes, which when put together
as a whole, help you to effectively manage your
entire business. The PDCA model helps manage the individual
processes. Then the continual improvement model shows the
different areas where process management can be applied, including
the organizations interaction with customers, and how when these
are working together, continual improvement can be achieved.
So what do we need to know next?

A. You seem to have clear understanding so far. Next you need to

understand some more of the fundamentals of a good quality
management system; that is the 8 quality management principles.
The first is Customer Focus. If you look at the continual improvement model I just showed you it is fairly simple. On the left hand
side of the model as inputs to the quality management system we
have customer requirements and on the right hand side we have
customer satisfaction. Its all about meeting our customer needs
with an aim of enhancing their satisfaction level with our products
and services.
The second is Leadership. We need to demonstrate and practice
sound leadership skills within our organization, that is to say Lead
by example.
The third is Involvement of
People. People are our most valuable resource, and it is therefore of
vital importance that they are party to
any decisions and activities effecting
the Quality Management System.
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The fourth is The Process approach. This was defined on page 4,

as the application and management of a system of processes, and
their interaction.
The fifth is A System approach to Management. Being aware of
what systems are in place and improving our systems is a sure way
of enhancing our products and services and ultimately the satisfaction levels of both internal and external customers.
The Sixth is Continual Improvement. By knowing what we do
and how well , we can identify ways to improve both our systems
and our processes.
The seventh is Factual approach to decision making. By analysis
of data, conducting internal audits and management reviews we
can improve business performance and the quality of our products
and services.
The eighth is Mutually beneficial Supplier Relationship. By
communicating and working with our suppliers we can ensure
that in the process of them satisfying our needs they can also gain
benefits in terms of decreased cost and improved performance.

Q. Chuck, I think we are already doing some of these things.

Is that possible?

A. Yes, many businesses do these things

without realizing, as they are common
sense. Where ISO 9001 can help, is by
providing a framework to build on these
principles. At the end of
the day ISO 9001 is
an excellent tool for
improving your business
performance.

Section 4.0 Quality Management

Systems
Q. Chuck, thats interesting. So where would we start?

A. Well now I have introduced you to the basics, you would start by
looking at Clause 4.0 as this really sets the scene for the rest of the ISO
9001 standard. It emphasizes the need to document, implement and
maintain a quality management system and continually improve its
effectiveness. Notice that section 4.0 has a strong relationship with
the other 4 clauses. Section 4.0 covers Documentation requirements,
including the need to create a quality manual and documented procedures required by the standard. Section 4.0 also requires documented
statements of quality policy and objectives.
Q. Is that all that we need?

A. Not exactly, It also requires us to control documents we create and to

control records that demonstrate we have followed our system.
Q. It sounds like a lot of documentation is involved?

A. I know it does sound that way, and it is a commonly held misconception. Many companies are getting very smart in how they present
their quality system and manual. A quality system could be a creative
one page or very large document. Organizations need to look at
what is best for their business. They should avoid creating over burdensome documentation as this is not the intent of the standard.
Many companies are using process mapping software and business
mapping to clearly identify what documentation is critical in the
application of their quality management system. Many others are
placing their quality system on intranets or referencing material on
the internet.

Document and Data Control

Q. OK. So who needs what
information?

A. Procedures and other

information are only given
to those who really need
them, and we keep a
record of what we have issued
to whom.
Q. What happens if things change?

A. Easy, we update the information

and inform the relevant people as part
of the formal system. We then ensure obsolete
documents are archived or destroyed.

Control of Quality Records

Q. What information do we need to keep?

A. We need to retain information that demonstrates that activities

carried out within the quality system were to our satisfaction.
For example, records of staff training, reviewed contracts and
inspected products, as well as evidence of legal and regulatory
compliance.
Q. OK what comes next?

A. Well naturally any good quality management system starts at the

top and the next section gets senior management involved and
says there are a few things they must do to ensure the quality
management system works efficiently.

Section 5.0 Management

Responsibility
Q. What do you mean by senior management?

A. In the context of ISO 9001, senior management are the

people responsible for setting quality policy for a given location
or activity. They could be the CEO, a site manager or a corporate
quality director.
Q. Are there things they will already be doing?

A. Id think most organizations will be doing some of them. Such as

communicating the need to continually improve, meet customer,
regulatory and statutory requirements, as well as organizational
structure.
Q. What does organizational structure
have to do with quality?

A. Its to ensure all staff are aware

of lines of responsibility and
understand what impact their
decisions have on the
organization.
Q. So what might we not be doing?

A. Most of this element involves

formalizing the quality management system and giving it legitimacy.
Such as the management representatives responsible for
implementing the quality system and reporting back to management on performance, through management review meetings.
There is also a requirement for a statement of commitment to
quality from senior management, through the quality policy.

6.0 Resource Management

Q. OK so we have management commitment and the infrastructure to
help maintain quality. What else is needed?

A. Well the day-to-day management of quality and effectiveness

relies on using the appropriate resources for each task. These
include the people conducting activities, the tools they have and
supporting services.
Q. So is staff training part of the quality system?

A. Most certainly, as is the working environment in which they

operate, meaning the workplace and whether it is well light,
ventilated and ergonomically correct. And the management review
mentioned earlier may result in the need to change the environment or improve staff training. So you can see where section 6 of
the continual improvement model comes in, leading to continual
improvement of not only the quality system, but also the company.
Q. Do we need to demonstrate that our staff our
competent for their roles?

A. Yes. This can be done by showing they have had the appropriate
classroom or on the job training, or that they have sufficient years
of experience to be considered competent. By reviewing before
and after training it is easy to demonstrate whether or not a
person is more effective as a result.
Q. Does that include what they do, or
is it just the tools?

A. Its just the tools. What

they do is covered in
Product Realization in
7.0. But dont forget it
includes the equipment
and environment in
which they work, as
mentioned above.
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7.0 Product Realization

Q. Does Product Realization mean the products and
services we provide?

A. Yes. Once you understand what the customer

requires, you need processes in place to ensure these
requirements are met, and their effectiveness is measured.
Q. OK, then whats next?

A. First you must decide whether to include design, which not all
companies do, so it is not always included as part of a quality
system. If it is, records should be kept, so the same mistakes arent
made, and successes recorded for use next time.
Q. That makes sense. Then I suppose you have to plan the production
process?

A. Yes planning, scheduling resources, and purchasing are all part of this
process. Then when you get into it you have to ensure service provision, work instructions (people know what they are doing), traceability, preservation, monitoring and measurement devices are all in place.
Q. So how do I know what a customer requires?

A. Well you need to establish customer requirements from the outset.

And you also need to understand their unstated requirements, such
as what the product or service is going to be used for. At the same
time you must also meet statutory and regulatory requirements.
Q. So that is how you ensure the customer gets what they
want and we maintain our quality?

A. Yes, but it doesnt end there, as customer

feedback is part of our quality management system, both negative and positive.
This brings us to Section 8.0, which is
measurement, analysis and improvement. Recording actual performance and
analyzing it helps to identify areas of improvement.
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8.0 Measurement, Analysis and

Improvement
Q. What does this section involve Chuck?

A. Well, Section 8.0 is the key to a successful business. It involves

those measurements being made that can help us to improve our
business and demonstrate conformity of product. Usually it
involves the use of statistical techniques if appropriate.

Q. What does our organization need to

measure and analyze?

A. Levels of customer satisfaction are a good

place to start,
internal audits are
another. There are
many possibilities
here, including
monitoring and
measuring of our
processes and product.

Q. What happens if our processes result in a non-conforming product or

service?

A. If that happens, your organization needs to ensure that any resulting product is prevented from unintended use. A documented
procedure needs to ensure that action is taken to eliminate the
defected, non-conforming product, and that the resulting product
is dealt with in an appropriate manner.

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Q. You mentioned analysis of data, what data should our organization

measure?

A. The requirements are that you measure at a minimum customer

satisfaction, conformity to product requirements, characteristics
and trends of processes and products as well as suppliers.
Q. What about improvement?

A. The standard references the use of the quality policy, objectives,

audit results, analysis of data, corrective and preventive actions
and management review.
Q. Corrective and Preventive actions, what does this involve?

A. The aim of the standard is the prevention of nonconformity.

This can be done in two ways- through corrective or preventative
actions. Corrective actions are put into place once something has
been identified as having gone wrong. Preventative actions are
more proactive and are put in place once something has been
identified as possibly going wrong.
Of course, it is necessary to keep records of any corrective or
preventive actions taken.
Q. What doesnt this quality management system do?

A. Well ISO 9001 indicates that a quality system is in place that

is capable of meeting customer requirements. A common
misconception is that it indicates that every product or service will
be defect free- this is more the realm of product certification.

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Q. It really does sound useful, where can I find out more?

A. Well that gave you a flavor of what is involved in developing a

quality management system to the requirements of ISO 9001:2000,
and Im sure you will agree it makes a lot of sense. Our experience
shows that such a system has helped us:
increase competitiveness
improve staff morale
reduce waste
improve awareness of improvement opportunities
Q. At the beginning I said I heard you were registered to ISO 9001, what
does being registered mean?

A. Well being registered means that a 3rd party such as BSI visits and
assesses the way the systems and processes work within the company. If everything is running in accordance with the requirements
of the standard they issue a certificate registering us to ISO 9001.
This gives independent verification to our customers and other
stakeholders that we are a quality company.

For further information, please contact

BSI Management Systems:
USA
Tel: 1 800 862 4977 703 437 9000
Fax: 703 437 9001
Canada
Tel: 1 800 862 6752 416 620 9991
Fax: 416 620 9911
inquiry@bsiamericas.com
www.bsiamericas.com

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Y O U R

I S O

Q U E S T I O N S

A N S W E R E D

9 0 0 1 : 2 0 0 0

BSI, Inc.
12110 Sunset Hills Road, Suite 140
Reston, VA 20190
USA
Tel

1 800 862 4977

703 437 9000

Fax

703 437 9001

BSI Management Systems Canada Inc.

17 Four Seasons Place, Suite 102
Toronto ON M9B 6E6
Canada

Quality

Tel

1 800 862 6752

416 620 9991

Management

Fax

416 620 9911

Systems

inquiry@bsiamericas.com
www.bsiamericas.com

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