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Our 5-Step Approach
Simplify your ISO 9000 implementation with our 5-Step
Approach! Follow the five steps below and use our
ISO 9000 Starter Package (or the ISO 9000 Combination
Package) and you will be surprised how simple the ISO
9001:2000 implementation can be.
Step 1: Preparation
This step is the preparation for your ISO 9000
implementation. It’s not difficult but it’s important and
should not be missed.
Get an Understanding of ISO 9001:2000
ISO 9001:2000 is a world-wide accepted
standard for quality management requirements. As such, ISO
9001:2000 focuses on a large variety of business activities
– not merely on quality testing! Implementing ISO 9001:2000
will affect virtually all business processes.
Note: "ISO 9000", "ISO 9001" and "ISO 9001:2000" all mean
the same: the ISO 9001:2000 standard.
click for explanation
For some good overview, please review the
following:
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Our ISO 9000 Starter Package
and our ISO 9000 Combination Package contain a good summary and
overview of ISO 9001:2000.
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http://www.iso.ch
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In addition, we recommend that you
obtain the actual ISO 9001:2000 standard (see our
Resources section) and review it.
ISO 9000 Management Representative
First, appoint the ISO 9000 “Management Representative”.
This is typically a quality manager or senior manager of the
company; it needs to be somebody who has sufficient
authority to change the way that the company works. This
person is responsible for the ISO 9000 implementation.
A “Role Description” for the Management Representative is
included with our ISO 9000 Starter Package and our
ISO 9000 Combination Package. We wrote this page as if
you, the reader, will be the Management Representative.
Larger companies may appoint a Management Representative for
each physical location or for each business unit; a
corporate Management Representative would then coordinate
among all local Management Representatives. Note that our
Quality Manuals are based on a system of local and corporate
Management Representatives (which can very easily be
modified to a single Management Representative).
Training
Next, the Management Representative needs to get some
training. A Training Plan for Management Representatives is
included with our ISO 9000 Forms Collection.
Please see our Resources section for
training videos, training classes and good books for
self-study.
Also, studying a sample of good ISO
9001:2000 documentation is an excellent training tool. For
this purpose, we highly recommend you carefully review our
ISO 9000 Implementation Manual (which includes many
explanations) and the detailed customization instructions
that are included.
Get Buy-In
Further, you should ensure that the company executives
completely support the ISO 9000 effort. You may need to
explain to them the advantages, requirements and costs. See
our Resources section for useful information.
Finally, you should inform all employees. It’s important
that the employees don’t feel threatened by ISO 9000. In our
ISO 9000 Starter Package and our ISO 9000 Combination
Package you’ll find a brief Employee Intro To ISO
9000, as well as an ISO 9000 Summary; also our Resources
section contains useful information.
Step 2: Quality Manual,
Quality Policy and Procedures
Developing the various documents required
by ISO 9001:2000 is for most companies the most difficult
part of the ISO 9001:2000 implementation. The main reasons
are that these documents have to meet the rather
hard-to-understand requirements of the ISO 9001:2000
standard, and that writing these documents is at the
beginning of the ISO 9001:2000 implementation thus
presenting a big initial hurdle.
However, we make it easy for you!
Use our ISO 9000 Implementation Manual (or the ISO 9000
Streamlining Manual if your company already has some form of
quality management system in place) and the many useful
forms in our ISO 9000 Forms Collection as templates and you
can complete this crucial step quickly and at minimal cost!
(Note: the ISO 9000 Implementation Manual is included in our
featured ISO 9000 Starter Package; our ISO 9000 Combination
Package contains both, the ISO 9000 Implementation Manual
and the ISO 9000 Streamlining Manual.)
Which Documents are required?
(1) Quality Manual
(2) Six Quality Procedures
(3) Quality Policy
(4) Quality Objectives
(5) Process Flowchart
In addition, ISO 9001:2000 indirectly
requires the following:
(6) Work Instructions
Work Instructions are detailed step by step instructions on
how to perform a particular work process. ISO 9001:2000 does
not include an absolute requirement for Work Instructions;
however, section 7.5.1 requires Work Instructions where they
add value to the company.
(7) Forms
ISO 9001:2000 does not specifically require forms but they
can be considered both work instructions (before they are
filled in) and records (after they are filled in). For this
reason, good forms save time and provide many more benefits.
Choose the right Template
The secret to easy ISO 9001:2000
implementation is the use of good templates. Good templates
will not only help you develop a business-friendly ISO
9001:2000 system, they will also make the development of all
required documentation a rather easy task.
Both our ISO 9000 Implementation Manual
and our ISO 9000 Streamlining Manual contain and fully
integrate the following documents: Quality Manual, Six
Quality Procedures, Quality Policy, Quality Objectives,
Process Flowchart. In addition, several Work
Instructions and additional Procedures are included.
Both our ISO 9000 Implementation Manual
and our ISO 9000 Streamlining Manual come with comprehensive
customization instructions that make it really easy to
develop the required documentation.
Please use our product pages to chose the ideal manual for
you (for first time ISO 9001:2000 implementation you will
likely choose the ISO 9000 Implementation Manual - either
alone or packaged in our ISO 9000 Starter Package or
ISO 9000 Combination Package).
Easy Documentation Development
It is particularly easy to develop the
entire documentation required by ISO 9001:2000 if you
customize the ISO 9000 Implementation Manual or the ISO 9000
Streamlining Manual using the included detailed
customization instructions. Just follow them step by
step, and you will achieve your own, complete ISO 9001:2000
documentation quickly and easily.
Once done, get your Quality Manual approved by the president
of your company.
Step 3: Implementation,
Training and Work Instructions
Now it’s time to implement your ISO 9000 system. During this
phase you introduce the new requirements of your Quality
Manual, you train employees, and you get them to adjust
their way of working to any new requirements. This step will
be much easier if you did a good job in Step 1!
One
Step at a Time
Take one step at a time in your implementation process. You
may want to start with the section on Document Control.
Explain the requirements in a meeting or memo, or have the
appropriate department managers explain to their staff.
Training and Work Instructions go
Hand in Hand
As you implement ISO 9000, virtually all employees have to
change to some extent the way they work. At the same time,
ISO 9000 calls for standardization and for work
instructions. Our Quality Manuals point out where work
instructions are required. We recommend that you assign the
writing of work instructions to those who actually do the
work. Instruct them to write up the best way of doing the
work. If your Quality Manual calls for a change in their
work, introduce those new requirements and make the
employees incorporate them into their work instructions.
Review the work instructions to make sure that they meet the
requirements of your Quality Manual.
Step 4: Internal Audits
Internal audits are performed by somebody within your
company (or by a subcontractor). The job of the auditor is
to verify that your company meets the requirements of ISO
9000 as they are described in your Quality Manual.
The Auditor
In most cases the ISO 9000 Management Representative is also
responsible for internal audits. In this case, the
Management Representative audits the entire company except
his/her own work, and another employee audits the work of
the Management Representative. Our ISO 9000 Forms Collection contains
an invaluable Audit Checklist.
Larger companies often appoint and train several internal
auditors. This is an excellent opportunity for
cross-training and for staff of different departments to
learn what other departments are doing.
Audits as
Training Tool
We recommend that you start Step 4 even before Step 3 is
complete. Audits are an excellent way of training; they will
help with your implementation efforts!
Once you have performed a complete internal audit that
didn’t uncover any significant problems, you are probably
ready for the certification audit!
Step 5: Certification
Now it’s time to select your registrar! There are many
companies offering certification services but be careful:
some are not accredited! Start your search on the Internet
and compare the different registrars. Our ISO 9000 Forms Collection
contains a Registrar Evaluation Form; our ISO 9000 Starter
Package and our ISO 9000 Combination Package also contain very useful Audit
Preparation Tips.
Reaping the Marketing Benefits
Once you successfully passed the certification audit, you
should leverage your certification in marketing. You may
want to prepare a press release, send notification cards to
your customers, print your certification mark on business
cards and letterhead, add the certification to your
advertisement, display a banner outside your office building
and last but not least, recognize your employees for the
hard work they put into this effort. Our ISO 9000 Starter
Package and our ISO 9000 Combination Package
includes valuable ISO 9000 Marketing Tips.
Life after Certification
Remember, ISO 9001 :2000 certification is not the end, and your registrar
will want to perform a surveillance audit once or twice a
year. Your ISO 9000 system is designed to continually
improve itself. Make sure it remains implemented, continue
your internal audits, and we are convinced you’ll see your
company’s performance improvements at the bottom line!
In section 8.5.1, ISO 9001 :2000 requires
to "continually improve the effectiveness of the quality
management system". Most auditors would expect you to revise
your ISO 9000 Quality & Procedures Manual as your ISO
9000
Quality System matures and the detailed explanations of the
initial Quality & Procedures Manual are no longer needed.
The ISO 9000 Streamlining Manual is ideal to meet this
improvement requirement. In addition, you will benefit from
even more streamlined and efficient processes.
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