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ISO 9000 in brief
The ISO 9000
standard is one of the best known international
standards; it is implemented by countless
companies and other organizations in over 150
countries. ISO 9000 addresses "quality
management". This means what the
organization does to fulfill:
-
their customers'
quality requirements, plus
-
any applicable
regulatory requirements,
while aiming to
What is the Difference between ISO 9000, ISO
9001, and ISO 9001:2000? And what are ISO 9002
and ISO 9003?
The quick
answer is “none”. These terms are all used to
describe the ISO 9001 standard. Prior to
December 2000, there used to be an ISO 9001, an
ISO 9002 and an ISO 9003 standard; without
focusing on the technical differences between
them, people would just simply refer to each as
ISO 9000. In December 2000, the International
Organization for Standardization (ISO) merged
ISO 9001, ISO 9002, and ISO 9003 into a revised
ISO 9001 standard. In order to distinguish
between the previous ISO 9001 version, the
current standard is often referred to as ISO
9001:2000 or ISO 9000:2000 (":2000" indicates
the year of the revision).
For all practical
purposes, ISO 9000 and ISO 9001 mean the same.
► Tip: More detailed information can be found on
www.iso.ch.
Summary of the ISO 9001 Standard
The ISO 9000
standard contains requirements affecting
virtually all aspects of any company. Because
ISO 9000 is designed for any company of any size
and in any industry, the requirements are rather
broad and hard to read. The ISO 9001:2000
requirements fall into the following sections:
Section 1:
Quality Management System
This section of the ISO 9001:2000 standard
outlines the necessary steps to implement the
ISO 9001 quality management system:
-
Identify the
process (or activities) needed for the
quality management system,
-
Determine the
sequence and interaction of these processes,
-
Determine how
these processes are effectively operated and
controlled,
-
Ensure that all
information is available to support the
operation and monitoring of these processes,
-
Measure, monitor
and analyze these processes, and implement
action necessary to correct the processes
and achieve continual improvement.
The ISO 9000
quality management system requires documentation
that includes a quality manual, certain
procedures, as well as work instructions. All
documentation (including quality records) must
be controlled according to a document control
procedure. Also in this section, ISO 9001
emphasizes the need for continuous improvement.
► Tip: Most companies find the documentation
requirements daunting. The use of templates can
be of tremendous benefits
(see our section on
templates).
Section 2:
Management Responsibility
ISO 9001:2000
places great emphasis on top management’s
commitment to quality. This section requires a
quality policy and quality objectives, and it
reinforces the involvement of top management
with customer requirements.
This ISO 9001
section also requires top management to
establish responsibilities and authorities
within the company, including the establishment
of an ISO 9000 management representative.
► Tip: Use a good standard format for all job
descriptions – this will save much time when
creating new job descriptions,
when advertising
positions, when performing employee evaluations,
etc.
Section 3:
Resource Management
This section
of ISO 9001:2000 clarifies the requirement for a
company to determine and provide, in a timely
manner, resources (for example, equipment,
facilities, etc) needed to implement and improve
the processes of the ISO 9001 quality management
system and to address customer satisfaction.
This section also includes requirements for
employee training, as well as for the physical
facilities and the work environment.
► Tip:
Integrate your company’s HR function well into
your ISO 9001 quality system, and make them take
on a leading role
during the ISO 9001
implementation.
Section 4:
Product Realization
The ISO
9001:2000 standard defines Product Realization
as “that sequence of processes and sub processes
required to achieve the product.” This is how
your product is designed, produced, tested,
handled, shipped, etc. This section also applies
to service providers. Emphasis is placed on how
the company understands, communicates and
actually meets customer requirements. This
section also contains various requirements for
the design of products and for the planning of
processes, projects and services.
► Tip:
Most
companies write work instructions and flowcharts
to define and standardize their work processes.
You will
save yourself much time if you follow
the ISO 9001 requirements for document control
from the outset
when writing
these
documents.
Section 5:
Measurement, Analysis and Improvement
The last
section of the ISO 9001:2000 standard closes the
loop by providing requirements for measurement
and monitoring activities, so that the company
can immediately identify when not on track.
Measurement and monitoring activities also
include internal audits and the monitoring of
customer perception as to whether the company
has fulfilled customer requirements. All of
these activities must be defined, planned and
implemented. Measuring and monitoring allows the
company to manage by fact, not by guess.
► Tip:
This is
a very important section of the ISO 9001
standard. Depending on how it is implemented, it
can add
tremendous value or create bureaucracy
and waste. We highly recommend placing emphasis
on this crucial
ISO 9001 section.
The ISO 9000 Quality Manual
The standard
requires companies to write an ISO 9000 quality
manual that defines how each requirement of the
rather broad ISO 9001:2000 standard is applied
at the company. In a sense, the ISO 9000 quality
manual is a company specific version of the
standard.
While writing
the quality manual represents a big hurdle for
most companies, the ISO 9001:2000 standard
requires further details in form of ISO 9000
quality procedures, a quality policy and quality
objectives. Most companies make the mistake of
creating various different documents to meet
these requirements; however, this usually is the
beginning of a cumbersome and bureaucratic ISO
9000 quality system.
► Tip:
Combine the
different documentation requirements (i.e.,
quality manual, procedures, corporate policy and
objectives)
as much as possible into one
comprehensive manual. This reduces repetition
and bureaucracy, and it saves time
implementing
the quality system.
Templates for Quality Manuals and Forms
Using
templates for ISO 9001 quality manuals,
procedures and forms can have huge benefits for
an organization. Templates are usually in the
form of existing and proven manuals, procedures
and forms. Follow the link for more information
on the use of
Templates.
► Tip: The ISO 9000 quality manual and the ISO
9000 quality procedures are a vital part of any
ISO 9001 quality system.
You can get a huge head
start by purchasing a good template quality
manual (a sample quality manual that you can
use
as a good example and that you can modify to
make it your own quality manual). There are
numerous
companies that sell ISO 9000 quality
manuals that you can use as templates to create
your own quality manual.
We urge you to
carefully evaluate them before making a purchase
decision as we found the majority to be
convoluted, bureaucratic and cumbersome. See our
Resources
section for suggestions and reviews.
What is ISO
9001 Certification?
ISO 9001 certification is also known as ISO 9001
registration, ISO 9000 certification (if one is
less precise), ISO 9000 registration, ISO
9001:2000 certification (if one specifically
refers to the latest version of the ISO 9001
standard), or ISO 9001:2000 registration. All of
these refer to an independent certification body
attesting that your company’s ISO 9001 quality
management system meets all requirements of the
ISO 9001 2000 standard. Typically, the
certification company sends one or more auditors
to perform an initial audit of the quality
management system. If no significant gaps
to the ISO 9000 requirements are discovered, a
certificate is issued. The certificate is
typically valid for three years provided that
period audits (usually every 6 - 12 months)
continue to show compliance.
► Tip: Evaluate your registrar carefully with
the goal of finding a registrar whose auditors
are flexible (because there are
countless ways
of fulfilling the ISO 9000 requirements and some
may fit better for an individual business) and
whose
auditors don't mind sharing their
experiences (auditors are not allowed to consult
but they are allowed to share what
they have
seen to work for other companies).
The Benefits
of ISO 9000
The benefits of ISO 9000 certification are:
-
Improvement:
ISO 9001 is an excellent tool to develop a
strong foundation of good processes and
systems. Processes and systems are essential
for the performance and expansion of any
company. Quality improvements come along
with this. Remember, ISO 9001 was developed
as a real tool to improve companies.
-
Marketing:
ISO 9001 certification can effectively used
in marketing as it is a well-recognized
standard for quality; it shows your
customers that you take quality seriously,
that you are proactive and that you put your
customers’ satisfaction first.
-
Customer
Requirements: if your company provides
products or services to other companies,
some of those customers may require you to
be ISO
9001 certified in order to do business with
you.
What is this all
about?
According to the
rules of the International Organization for
Standardization (ISO - the publisher of the ISO
standards), the ISO 9000 standard undergoes
review and revision every 6-8 years. In
the past, ISO 9000 was revised in 1994 and in
2000. In the end of the year 2008 there
will be another revision published, which will
be called ISO 9000:2008.
What are the changes in ISO 9000:2008?
At this time, ISO
9000:2008 has not been published so we can only
make an educated guess based on the drafts of
the revisions that have been circulated.
However, based on the drafts, we expect that ISO
9000:2008 will change only very little from the
current ISO 9000:2000. There will be
changes to the wording but little, if any,
substantial changes to the actual requirements;
in other words, we don't expect many additional
requirements or removed requirements of ISO
9000.
How does the 2008 Revision affect me?
Since we don't
expect many substantial changes to the
requirements of ISO 9000, we don't expect that
the 2008 revision of ISO 9000 will affect you
much. However, if there are changes to the
requirements...
If your company is
currently registered to ISO 9001:2000:
Your company will be
required to implement the changes within a set
period of time (likely 1-3 years) in order to
maintain certification. After you
implemented the changes, an auditor (sent by
your registrar) will verify compliance with the
new ISO 9001:2008 requirements.
-
Until ISO
9001:2008 is actually published in late
2008, you don't need to do anything.
-
After the ISO
9001:2008 publication, we suggest that you
contact your registrar to discuss what
changes are necessary and within which
period of time.
-
If you based
your ISO 9001:2000 documentation on
templates, we suggest that you contact the
provider of your templates regarding an
upgrade to ISO 9001:2008.
If your company is
currently in the process of implementing ISO
9001:
If you are currently
implementing ISO 9001:2000, we recommend that
you continue with your implementation of ISO
9001:2000. It will be much faster and more
efficient to continue with the ISO 9001:2000
implementation and later make any changes to
convert to ISO 9001:2008 (again, we don't
anticipate that there will be many, if any,
changes required).
-
If you completed
ISO 9001:2000 implementation before ISO
9001:2008 is published in late 2008, we
suggest you do not waste time but
immediately get certified to ISO 9001:2000,
and then later follow our tips above.
-
If ISO 9001:2008
is published prior to you getting certified
and if you based your ISO 9001:2000
documentation on templates, we suggest that
you contact the provider of your templates
regarding an upgrade to ISO 9001:2008.
If you are planning
on implementing ISO 9001:
If you haven't
started ISO 9001 implementation, there is no
reason to delay the implementation due to the
upcoming publication of ISO 9001:2008.
Remember, the sooner you complete your ISO 9001
implementation, the sooner you can benefit from
it (see Benefits below). We expect that
any necessary changes based on the ISO 9001:2008
revision will be easy to implement.
-
We recommend
that you do NOT change your approach or
delay your ISO 9001 implementation due to
the upcoming ISO 9001:2008 revision.
-
If you are
planning on using templates for your ISO
9001 documentation (see our section on
Templates),
you may want to consider a template supplier
that offers free compliance upgrades.
► Tip: See our
Resources
section for providers of ISO 9000
quality manual templates, forms and other
resources that will
offer free ISO 9000:2008
compliance upgrades.
When is the Best
Time to start the ISO 9001 Implementation?
Ideally you should
begin your ISO 9001 2000 implementation when you
first start up your company. If you are in the
position of starting up a new company, you
should be setting up your business processes
according to ISO 9001 2000 requirements and
start to implement ISO 9001 before hiring your
employees. This is the most efficient approach
as your company not only immediately reaps the
benefits from ISO 9000 but you also don’t have
to overcome resistance to change when adjusting
work processes later to meet the requirements of
the ISO 9000 2000 standard.
However, most
companies have been long established before they
start their ISO 9001:2000 implementation. Since
a complete ISO 9001 quality system brings many
benefits to a company, it’s always better to
start the ISO 9001 implementation sooner rather
than later.
How do I start the
ISO 9000 implementation?
As a first step, you
should make yourself familiar with the ISO
9001:2000 standard and its requirements. You can
find some important information on ISO 9001:2000
and links to organizations selling the standard
in our
Resources
section.
How long does it
take to implement ISO 9001?
It depends on you
and your company. The very fastest is 2-3 months
because most ISO 9001 registrars require at
least 2 months ISO 9001 track record before the
certification audit. More realistically: if you
have a relatively small company (say, less than
20 employees), if your employees are motivated
and if they don’t oppose change, if you have the
backing of all senior executives, if you and
other managers are ready to put some significant
time and efforts into this endeavor, and if you
use a really good ISO 9001 quality manual
template (a sample ISO 9000 quality manual that
you can modify to make it your own ISO 9000
quality manual), then you may be able to get
certified in as short as 3-4 months; templates
for ISO 9000 forms are an additional time-saver.
Some companies are significantly slower, with
6-12 months not being unusual. However,
companies that write their ISO 9001 quality
manual and their ISO 9001 quality procedures
from scratch, rather than base them on a proven
sample ISO 9001 quality manual, often take up to
2 years or longer.
Should we use an
ISO 9000 consultant?
We found that ISO
9000 consultants can be of great help, and they
can also cause great damage, depending on the
ISO 9000 consultant and depending on how you use
them.
Good ISO 9000
consultants can add value as trainers. It may be
beneficial if an expert in ISO 9000 matters is
used to train the ISO 9000 management
representative, or to “sell” the benefits of ISO
9000 to top management. However, since most
consultants try to sell their consulting
services, pure ISO 9000 trainers are usually a
much better choice. We have heard of countless
cases in which ISO 9000 consultants purposely
made the ISO 9000 requirements appear overly
complicated and restrictive only in order to
justify the high price of their consulting
services.
The most common
problems that we have encountered are
inefficient and bureaucratic ISO 9000 quality
management systems. These are typically the
result of an ISO 9000 consultant writing and
implementing an overly complicated and
convoluted ISO 9000 quality manual and
procedures.
If outside help is
desired, we recommend using a pure ISO 9000
trainer (either in-house or in a public class)
to teach the management representative and
executive management. We further recommend
developing the ISO 9000 quality management
system in-house as the result is usually more
suitable for the individual company. A great
help and time-saver is the use of template
quality manuals and templates for forms.
ISO 9000
Documentation
ISO 9001 requires several different documents: a
quality manual, quality procedures, a quality
policy and quality objectives; in addition, ISO
9001 requires work instructions that provide
detailed guidelines to employees on how to
perform their work. However, the ISO 9001
standard is very clear that work instructions
need only be created where they add value (for
example, a trained painter will not find value
in instructions on how to paint; on the other
hand, brief instructions (possibly in form of
pictures), displayed right on a machine,
explaining how to replace a filter could be a
great time saver). Forms, which must be kept on
file after they are filled in, are also part of
any ISO 9001 quality management system. Some of
the most typical forms are the Corrective Action
Report Form, the Employee Review Form, and the
Customer Survey. It is important to note that
ISO 9001 does not directly require these forms;
however, ISO 9001 calls for recording certain
information and a well-designed form not only
requires the information but it also walks the
user through the process.
► Tip: Always keep the user
of the document in mind. Some prefer
work instructions in form of pictures, others
like
flowcharts. Most dislike long, convoluted
text.
Cost of an
ISO 9001 Quality System
While operating a good ISO 9001 quality system
results in significant cost savings (even after
paying the periodic audit fees of about $1,000 -
$2,000 per auditor day), the initial
implementation of ISO 9001:2000 can be rather
expensive. Large companies often spend in excess
of hundred thousand dollars, while small
companies could get by with a thousand dollars.
We found that small to medium size companies can
achieve significant savings by implementing the
ISO 9001:2000 quality management system
internally in-house using a good template or
sample for a quality manual and procedures.
It is important to
recognize that an ISO 9001:2000 quality system
is alive and constantly evolving. ISO 9001:2000
includes “continuous improvement” as one of its
requirements, and “continuous improvement” not
only refers to a company’s products and services
but to the ISO 9001:2000 quality management
system itself.
Achieving
Continuous Improvement
The ISO 9000
standard incorporates several processes that
help a company continuously improve:
-
Goals and
Metrics: setting goals on various levels and
using metrics to gage performance.
-
Customer
Feedback: measuring what customers think
about the company and its products or
services.
-
Internal Audits:
periodical evaluating if the company still
meets all ISO 9000 requirements.
-
Corrective
Action: systematical identification of
underlying causes of existing problems and
then correcting these causes.
-
Preventive
Action: systematical search for potential
problems and correcting their underlying
causes before the problems can occur.
-
Management
Review: management’s periodical review of
key business indicators and planning of
improvement initiatives.
► Tip:
We recommend
keeping all employees involved in the ISO 9000
quality system. A great idea is to periodically
send
tips to all employees.
Revising the ISO
9000 Quality Manual
Revising the ISO
9000 quality procedures and the ISO 9000 quality
manual should be a normal part of the
ever-improving ISO 9000 quality system. These
revisions can reach from small corrections to a
total makeover of the entire ISO 9000 quality
system. If you find your company’s ISO 9000
system to be bureaucratic and cumbersome, if you
find your employees completely negative about
ISO 9000, and if you end up extensively
preparing for each audit, then your ISO 9000
system has plenty of opportunities for
improvement and you should consider a complete
makeover.
Problems related
to ISO 9000
It is not uncommon
to find employees with negative opinions on ISO
9001. Most of them complain about excessive
bureaucracy, much paperwork and extra work
before audits. At the same time, they feel that
there are no benefits to ISO 9001.
These problems are
not the fault of ISO 9001 – these problems
result from the way the ISO 9001 quality
management system was implemented!
Typical Problem
#1: Management Attitude and Purpose
Previously on this
page, we talked about the benefits of ISO 9001:
internal improvements, marketing and customer
requirements. If management desires to implement
ISO 9001 solely for marketing reasons or due to
customer requirements, the resulting ISO 9001
quality system often lacks the all-important
internal improvement component. It is possible
to pretend (even to an experienced auditor) to
have an effective ISO 9001 system in place that
is designed to improve the company, but the
costs due to bureaucracy and efficiency could be
huge.
Typical Problem
#2: Implementation by Consultants
Frequently
management decides to hire ISO 9000 consultants
that are tasked with the implementation of ISO
9001. These ISO 9000 consultants promise to
write a quality manual, quality procedures and
other documents; in many cases, they also
provide implementation training. Typical
problems with this approach are:
-
The ISO 9000
consultant is unfamiliar with the business,
the company and its culture. The resulting
ISO 9001 system does not fit the company.
-
The ISO 9000
consultant tries to justify his high fees by
setting up an overly complicated and
convoluted ISO 9001 quality system.
-
The ISO 9000
consultant does not adjust to the particular
company and sets up a standard ISO 9000
system. These “standard” systems are often
geared towards large corporations, and they
are often far too bureaucratic and labor
intensive for small and medium size
companies.
-
The ISO 9000
consultant is not flexible. Instead of
creatively molding the ISO 9001 system to
fit the realities of the company, the ISO
9000 consultant tries to mold the entire
company to fit his one-fits-all ISO 9001
quality procedures.
Typical Problem
#3: ISO 9000 Management Representative Without
Power
Executive management
of some companies erroneously consider ISO
9001:2000 a documentation task rather than the
change to an improved and systematic management
style. A consequence of this misconception is
the appointment of an ISO 9000 Management
Representative without the power to make real
changes. In these situations, it is very common
to find an increasingly disenchanted ISO 9000
management representative who is desperately
trying to improve the company while top
management pays mere lip service to ISO 9001.
Typical Problem
#4: Insufficient Resources
Unless a company’s
management and performance is well above
average, the implementation of ISO 9000 usually
requires significant resources: the ISO 9001
management representative needs to be trained
and guided, top management needs to be convinced
of the concept of ISO 9001 and its benefits, an
ISO 9001 quality manual, ISO 9001 procedures and
other ISO 9001 documentation needs to be
written, work processes throughout the company
need to be analyzed and streamlined, employees
need to be trained, etc. It is crucial to the
success of the ISO 9001 implementation that
management allocates enough time, as well as
financial resources (for example, for ISO 9001
quality manual templates, or for sample ISO 9001
quality manuals, or for employee training, or
for internal audits and auditor training, etc).
Typical Problem
#5: Lack of Improvement
It is a common misconception that an ISO 9001
quality management system needs to be
implemented, certified and that’s it. In
reality, the ISO 9001 system must constantly
evolve as the company changes, as the market
conditions change, as products change, as
technologies improve and as the competition
moves forward.
Typical Problem
#6: Making it Complicated
ISO 9001 does not need to be complicated! In
fact, the easier to follow and the easier to
understand the ISO 9001 quality manual, the
better the ISO 9001 system! There are countless
reasons for overly complicated and overly
bureaucratic systems, including the problems
mentioned above, including inflexible auditors,
including bad examples, samples or templates,
and including bad training.
► Tip:
It is
interesting to note that the described problems
are a direct consequence of management action
and
management attitude, rather than the often
blamed employee resistance to ISO 9000. Ensuring
that top
management buys into the benefits of
ISO 9000 and that top management remains
actively involved in ISO 9000 will
dramatically
improve any ISO 9001:2000 system. An executive
overview by a competent trainer prior to the
start of
ISO 9001:2000 implementation is highly
recommended.
► Tip:
Implementing
ISO 9001:2000 by a company insider as opposed to
an external consultant in most cases is not only
cheaper but it also results in a more efficient
quality management system. We recommend
appointing a manager as
the ISO 9001 management
representative who has sufficient authority to
make internal changes, then provide this
individual with training in the ISO 9001:2000
standard (there are many good public classes
available), then give this
individual the
resources to acquire a good template or sample
for an ISO 9001 quality manual and for ISO 9001
procedures, and ensure that all functions in the
company allocate enough time to work with the
ISO 9001
management representative.
► Tip:
Choose your
ISO 9000 registrar carefully! We recommend that
you compare different ISO 9001 registrars and
pay
particular attention towards auditor
background (for example, some may consider former military auditors
to be rigid
and inflexible in their
interpretation of the standard) and towards
attitude towards sharing ideas (in order to
ensure
objectivity, auditors are not allowed to
consult; however, some registrars permit their
auditors to share their
experiences).
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