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Quick Start Kit

Copyright 2002 The 9000 Store

Visit us at www.the9000store.com
 Table of Contents

Introduction ........................................................................... 2

Making the Decision: ISO 9001:2000 Registration ............... 4

Implementation Steps ........................................................... 6

Project Plan ........................................................................... 7

Scheduling and Conducting the Gap Analysis ...................... 9

The ISO Steering Team Meeting ........................................ 11

Holding Task Group Team Meetings .................................. 13

Project Plan: ISO 9001:2000............................................... 15

Planning Meeting Handouts ................................................ 16

Task Group Meeting............................................................ 22

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Copyright 2002 The ISO 9000 Store
 Introduction

This Quick Start Kit is designed to help you plan and manage your ISO
9001:2000 Project. You can use this manual and project management approach
with or without the ISO 9000 Store documents and tools that are referenced in
the manual.

To make your project efficient and effective we recommend using The ISO 9000
Store Documented Quality System and Training, and discuss how to use
those tools in this manual. All items in blue text are available at
www.the9000store.com. All products are available on CD-ROM or by download
and can be ordered online or by using our order form; for pricing and ordering
details see the order form at the end of this document.

The Documented Quality System includes an ISO 9001:2000 Quality Manual,

ISO 9001:2000 Quality System Procedures and all related forms for an ISO
9001:2000 Quality Management System. All of the documents in the
Documented Quality System are in Microsoft Word or Excel, and are very easy
to edit. You will make this system your own by reviewing and editing the
procedures, manual and forms. You will also be making changes to your existing
processes so you meet the requirements of the ISO 9001:2000 Standard. The
project plan in this kit will help you manage these changes.

Project Manager Training gives an in-depth training on the ISO 9001:2000

Standard. This training is for the project manager, management representative
and others that will be closely involved in the implementation of the QMS.

The Training Materials Package provides you with the materials you need to
train your employees on the ISO 9001:2000 Standard. It comes in two versions,
one for those that are familiar with ISO 9000:1994, and one for those that are
new to ISO 9000. It includes a PowerPoint presentation with speaker’s notes, a
trainers guide and student manual. A project manager or management
representative that has completed the Online Training will be able to give this
presentation.

Computer Based Employee Training Another option for training employees is

our Computer Based training. This is a one hour training session focusing on the
general requirements of ISO 9001:2000 and what it means to employees. Each
employee works through the training when it is convenient, takes a quiz and
prints a training certificate.

Documentation and Training Package Provides you with a package price for
the Documented Quality System, Project Manager Training, Gap Analysis and
Training Materials Package, and Internal Auditor Training Materials.

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Copyright 2002 The ISO 9000 Store
Internal Auditor Training Materials Package This package includes a Trainer’s
Guide, Presentations and Training Material to train your internal audit team. It is
a 12 hour course and includes practice auditing of procedures and records
provided with the material.

Visit our website www.the9000store.com for prices on all of these products.

Products are available for immediate order and download or delivery on CD-
Rom. You may purchase with a credit card, wire transfer, check or Corporate PO.

Contact us at The ISO 9000 Store on-line at www.the9000store.com

Phone: 952-250-7172

Fax: 801-457-9770

Page 3 of 10
Copyright 2002 The ISO 9000 Store
 Making the Decision:
ISO 9001:2000 Registration

Making the Decision: ISO 9001:2000 Registration

What can you really expect in return for your investment in an ISO 9001:2000
Quality Management System (QMS)? What happens when you have your QMS
in place and working for you? Feedback from ISO 9001:2000 Registered
companies shows what you can expect as the payoff from all of your hard work.

Because of the responsibilities called out in the ISO 9001:2000 Standard,

organizations often see an increased involvement of top management with
regards to the Quality Management System. This starts with the setting of the
Quality Policy and Quality Goals and Objectives. It continues with Management
Review looking at data from the QMS, and taking actions to make sure that
Quality Goals are met, new Goals are set, and continual improvement is
achieved.

With the QMS in place and working for you, the organization is focused towards
the Quality Goals. Management is provided with data on a continual basis and
able to see progress or lack of progress towards goals and take appropriate
action. The organized, scheduled process of conducting Management Review
ensures that this evaluation takes place. It provides the mechanism of reviewing
goals and performance against goals on a scheduled basis, and for taking action
based on the evaluation.

Increased productivity results from the initial evaluation and improvement of

processes that occurs during the implementation process and from improved
training and qualification of employees. Better documentation or control of
processes leads to consistency in performance, and less scrap and rework.
Managers experience less late night troubleshooting calls; employees have more
information for troubleshooting problems on their own.

Customer satisfaction increases are seen as Goals and Objectives take the
customer needs into account. Customer needs are better understood as
customer feedback is sought, received and analyzed. Goals and objectives are
adjusted based on the information and the organization becomes more customer
driven. As goals focus on the customer, the organization spends less time
focusing on individual goals of departments and more time working together to
meet customer needs.

All of this leads to financial rewards, your reward for your hard work and
investment in the Quality Management System. In a study conducted by
researchers from UCLA results showed that “U.S. publicly held companies traded
on the New York Stock Exchange that receive certification under the ISO 9000
Quality Standard show significant improvement in financial performance
compared to those companies that have not pursued the standard.” *

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Copyright 2002 The ISO 9000 Store
 Making the Decision:
ISO 9001:2000 Registration

So work with enthusiasm and optimism, knowing that your organization will be
significantly improved by this ISO 9001:2000 implementation project. You are
contributing to the future success and profitability of your company.

Selling ISO 9001:2000 in your company: Use the PowerPoint presentation

“ Benefits of ISO 9000” that is provided with this kit. This is an excellent
presentation to give to management and to the people that will be involved in the
implementation project. It is important for everyone that will be working on this to
know why it is important to the company, and what it will do for them. The end of
the presentation also covers how The 9000 Store materials can simplify your
project and save costs on your implementation project. You can use the
presentation to present this option to your organization.

*For more detail on this study see

http://personal.anderson.ucla.edu/charles.corbett/papers/does_iso_9000_pay.pdf

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Copyright 2002 The ISO 9000 Store
 Implementation Steps

Implementation Steps

Quick Start steps to Implementation:

1. The Project Manager completes the Online Training Session or other

training.

2. The Project Manager prepares a Project Plan.

3. Management and the Project Manager identify an ISO 9001:2000 Steering

Team.

4. The Project Manager and others conduct a Gap Analysis with a Gap
Analysis Checklist.

5. The ISO 9000 Steering Team assign responsibilities for customizing or

developing each Quality System Procedure and the Quality Manual to a
Task Team or individual.

6. The Project Manager trains employees on ISO 9001:2000 using the

Training Materials Package, Custom Online Training or other training.

7. Team leaders hold team meetings to revise processes and procedures

based on the results of the Gap Analysis and the prepared Quality
System Procedure Templates.

8. The ISO 9001:2000 Steering Team reviews the procedures as they are
completed.

9. The Project Manager trains internal auditors using the Internal Auditor
Training Materials Package or other training program.

10. The system is used for several months while records are collected and
improvements are made.

11. The Registrar comes to audit.

This Kit outlines these steps in more detail, and provides forms and templates to
help you. This is a recommended plan, and you may change it to suit your
organization. All of the documents in the Documented Quality System are in
Microsoft Word or Excel, and are very easy to edit. You will make this system
your own by reviewing and editing the procedures, manual and forms. You will
also be making changes to your existing processes so you meet the
requirements of the ISO 9001:2000 Standard. This project plan will help you
manage these changes.

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Copyright 2002 The ISO 9000 Store
 The Project Plan

Project Plan
A. Determine the project goals (Use the Project Plan Template in Appendix A)
In order to start planning, you will need to determine what your goals are for the
project. Answer these questions:

1. When will you start your project?

Consider the start of your project as the date of the Gap Analysis. When
will you be ready to conduct the Gap Analysis?
Recommended steps to be completed before conducting the Gap
Analysis:
a. Identify one or more people to conduct the Gap Analysis; it is
helpful if they have some quality system experience or audit
experience.
b. Print the Gap Analysis Checklist.
c. Schedule the Gap Analysis, and communicate to all employees
what is being done, and why. You will want to be able to make the
employees comfortable with answering your auditor’s questions.
(The auditor is the person conducting the gap analysis. It may be
an audit team or one individual)

2. When does your company want to have an ISO 9001:2000 certificate in

hand?
The answer to this question will determine your timeline.
a. The shorter time frame allowed for the project, the more resources
the project will demand during implementation.
b. It is important to know what your goal is because other dates will be
determined by this information.
c. Find out if there are company goals, are there clients that are
requesting certification or other circumstances that will determine
the date? If you are transitioning from 1994 talk to your registrar.
Find out what goals they have for their clients to transition.
d. Your date may be revised later. You will use this as a target date,
and as we move along to the gap analysis and creating the task list
you will be able to determine if the date is realistic. It will depend on
what you currently have in place for your quality system, and how
many resources you have available for the project.

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Copyright 2002 The ISO 9000 Store
 The Project Plan

B. Identify Project Responsibilities

It is important to determine who will be leading this project. Are you the person
leading the charge? If so, you would be the project manager. You do not need to
identify the management representative at this point. You will need to clarify who
makes up "Top Management". The standard has requirements to be fulfilled by
Top Management, and the sooner they are involved in this project the better.

1. Who is your project manager?

2. Who makes up Top Management at your organization?
3. Who should be on the ISO 9001:2000 Steering Team? (This team will play
an important role in planning, coordinating and providing resources for the
ISO 9001:2000 project. See Appendix B for team responsibilities.)

C. Begin to fill in the Project Timeline

1. When will you conduct your Gap Analysis and how long will it take to
complete?
a. A Gap Analysis can typically take anywhere from 2 days to 5 days
to perform. It will depend on the size of your organization, the
number of auditors, the state of your current quality system and the
experience of your auditors.

2. Planning Meetings to assign Task Teams.

a. This will take one or two meetings. The project manager and top
management should be involved. (See section 2 “Planning and
Holding the Planning Meetings”)

3. Target a date for Introductory training for all employees.

a. You will want your employees to be aware of the project, what will
need to be done, who will be involved, and why you are
implementing ISO 9001:2000. Choose a date that is after the
meeting discussed above.
b. That way you can decide if some people that will be involved in the
project need more detailed training, and you can let employees
know who will be working on the project. Use the Training
Materials Package or . Computer Based Employee Training.
c. Plan training before the Task Team meetings so individuals
involved in the task groups are trained before their first meeting.
4. Send out Employee Newsletter #1, included at the end of this Quick Start
Kit, to inform employees of the upcoming ISO 9001:2000 implementation
project.

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Copyright 2002 The ISO 9000 Store
 The Gap Analysis

Scheduling and Conducting the Gap Analysis

A. Schedule the Gap

1. Review the project plan:

a. Who did you identify to conduct the gap?
b. Schedule the Gap Analysis, and communicate to all employees
what is being done, and why. You will want to be able to make the
employees comfortable with answering your auditor's questions.
c. You may want to consider sending out a newsletter to inform
employees that the Gap will be performed, by whom, when and
why the Gap is being performed. Use the Employee Newsletter #2
at the end of this Quick Start Kit.

2. The audit schedule

a. Determine if you will audit by process/procedure or by area of the
facility. Our approach is usually to audit by area of the facility.
b. Divide the facility into manageable areas. Schedule time to audit
each section of the standard that applies to the area.
c. If you are using an audit team, assign the team to cover the various
areas of the facility.
d. Arrange your Gap Analysis checklists so each auditor will have the
sections of the standard that are applicable in the areas they will
cover.
e. Arrange your checklists so each auditor will have the sections of
the standard that are applicable in the areas they will cover.

B. Conducting the Audit

1. Follow the schedule that you have prepared. Go into each area of the
facility to evaluate the current quality system. Focus on what is in place,
and what is not in place. Remind auditors that you are not focusing on
compliance or non compliance to the current system, but on the design of
the current system, and how it matches the ISO 9001:2000 requirements.
2. Take notes on what is in place, and what will need to be developed and
changed. Take complete notes, reference documents and examples.

C. Reporting

1. Summarize the audit findings in the form of a task list. You will usually
identify several categories of tasks.

· Processes that comply with the standard and are documented.

· Processes that comply with the standard and must be documented.
· Processes that do not comply with the standard and must be
redesigned.
· Processes required by the standard that are not currently in place.

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Copyright 2002 The ISO 9000 Store
 The Gap Analysis

For each requirement (or set of requirements) of the standard you will
want to identify the status of the current system. The ISO 9001:2000
Steering Team will use this information as they assign responsibility and
timelines to Teams. Task Teams will be assigned responsibility for
development of a procedure.

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Copyright 2002 The ISO 9000 Store
 The Planning Meeting

The ISO Steering Team Meeting

A. Planning your ISO Steering Team meeting

1. Determine who should attend. Include top management. Answer these

questions:
a. Who will be able to decide which employees will be assigned
tasks?
b. Will they know whether the employees' workload will be able to
accommodate the assigned tasks?
c. Who is responsible for resources and can make resources
available to the ISO 9001:2000 project?
d. This group should continue meeting as the “ISO 9001:2000
Steering Team”
2. Create an Agenda, items to include:
a. Explain the “Implementation Steps” to the group using the
PowerPoint presentation “ ISO 9001:2000 Implementation”
b. Use the meeting handout in Appendix B
c. Use the PowerPoint presentation “ ISO 9000 Implementation Tips
and Techniques” to give the team an overview of the dos and
don’ts of implementation.
d. Assign the tasks to individuals or teams. (Use tables from Appendix
B)
§ Review the responsibilities to make sure that they are well
dispersed, not assigned heavily to one group or one
individual.
§ For each team identify a team leader. It works very well to
have a member of the ISO Steering Team as a leader for
each of the Task Group teams. It provides good
communication between the teams and the ISO Steering
Team throughout the project.
e. Determine resources required for completion of the tasks.
§ Will teams or individuals need assistance with other
responsibilities during the ISO 9001:2000 project?
§ What kind of technical guidance will be needed to allow
these teams or individuals to complete the tasks efficiently
and effectively?
1. Assistance from the management representative?
2. Prepared materials?
3. Special Training?
f. Assign dates to tasks. (Use table from Appendix B)
§ Stagger start dates according to resources available.
§ Determine which tasks you need to complete in the
beginning to allow others to build on, for example:
Management Responsibility. Complete the Quality Policy
and Quality Goals as well as identifying key processes and
their interrelation early on in the project.

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Copyright 2002 The ISO 9000 Store
 The Planning Meeting

§ Estimate the amount of time needed to complete each task

based on the amount of resources available to the task.

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Copyright 2002 The ISO 9000 Store
 The Task Group Meeting

Holding Task Group Team Meetings

The team leader is responsible for scheduling the first team meeting according to
the plan on the Gantt chart.

1. An agenda is provided in Appendix C:

a. Discuss Responsibilities of the ISO 9001:2000 Steering Team and
Implementation steps using the PowerPoint presentation
“ Implementation of ISO 9001:2000” included with this Quick Start
Kit.
b. Use the Task Group Team Handout in Appendix C
c. Hand out the Quality System Procedure that the team will be
responsible for. ( If using the prepared procedures)
d. Hand out the section of the Gap Analysis that applies to the team.
e. Determine resources required for completion of the tasks.
§ Will teams or individuals need assistance with other
responsibilities during the ISO 9001:2000 project?
§ What kind of technical guidance will be needed to allow
these teams or individuals to complete the tasks efficiently
and effectively?
1. Assistance from the management representative?
2. Prepared materials?
3. Special Training?
2. Assign dates to tasks from the Gap Analysis using the start and finish date
on the Gantt chart. The team leader should print copies of the section of
the Gap Analysis that are relevant to the team.
a. Explain to the team that the Procedure and your process must
match. Some of your processes (the way you do things) will need to
be changed to meet requirements of the standard, and parts of the
procedure will need to be edited to accurately describe what you
do.
§ If you are not using the prepared procedures this team will
be responsible for developing and documenting the new
procedure for a section of the standard.
b. List the requirements from the Gap Analysis Checklist that you
are not currently meeting. These will need to be evaluated to
determine if you will change your process to match the procedure,
or alter your process to meet the standard and edit the procedure.
c. List the requirements from the Gap Analysis Checklist that you
are meeting. Evaluate these against the procedure to see if edits
are needed to the Procedure, or if the process documented in the
procedure will work better for you.
§ Or if not using the prepared procedures, identify the
requirements of the standard that you will need to address to
be incompliance.

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Copyright 2002 The ISO 9000 Store
 The Task Group Meeting

d. Schedule next meeting. During the next meetings you will work on
the tasks that you have listed above.
e. Once the process has been determined the procedure will need to
be finalized and sent for approval by the ISO 9001:2000 Steering
Team.

3. Discuss the Next agenda:

g. Read The 9000 Store Procedure (Or for the team responsible for
the quality manual read The 9000 Store Quality Manual and
compare to current processes.
§ If not using The 9000 Store procedures, outline a new
process to meet the requirements of the standard.
h. Assign tasks for implementing changes in your processes and
editing prepared procedure.
i. Set next agenda
j. Schedule next meeting

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Copyright 2002 The ISO 9000 Store
 Appendix A
The Project Plan

Project Plan: ISO 9001:2000

Project goals:

Start Date:

Target Registration Date:

Responsibilities:
Project Manager:

Management Representative:

Top Management:

ISO 9001:2000 Steering Team

Project timeline:

Step Schedule Date Completion Date

1. Project Manger
completes Online
Training
2. Conduct Gap
Analysis
3. Hold ISO Steering
Team Meeting
4. Introductory
Training
5. Hold Task Team
Meetings
6. System Complete
7. Registration Audit
8. Certificate
Received

Appendix A
Copyright 2002 The ISO 9000 Store
www.iso9000store.com
 Appendix B
ISO 9001:2000 Planning Meeting

ISO Steering Team Meeting Handouts

Agenda:

1. Review the “Implementation Steps”

2. PowerPoint presentation “ Implementation of ISO 9001:2000”
3. Assign individuals to teams for each task group. Determine resources
required for completion of the tasks.
a. Will teams or individuals need assistance with other responsibilities
during the ISO 9001:2000 project?
b. What kind of technical guidance will be needed to allow these
teams or individuals to complete the tasks efficiently and
effectively?
§ Assistance from the management representative?
§ Prepared materials?
§ Special Training?
4. Assign dates to tasks
a. Stagger start dates according to resources available.
b. Determine which tasks you need to complete in the beginning to
allow others to build on, for example: Management Responsibility
and Document Control should start early in the project. Complete
the Quality Policy and Quality Goals as well as identifying key
processes and their interrelation early on in the project.
c. Estimate the amount of time needed to complete each task based
on the amount of resources available to the task. Refer to the Gap
Analysis results to determine how much work each team has to
complete.
5. Schedule employee training sessions using the Training Materials
Package
a. All employees need training on the ISO 9001:2000 Standard.
Providing the training early on in the project makes everyone aware
of the projects and its goals.

*Keep minutes of all of the ISO 9001:2000 Planning and Steering Team
meetings. This helps demonstrate top management involvement in the
development of the ISO 9001:2000 Quality Management System. Record
attendees.

Appendix B
Copyright 2002 The ISO 9000 Store
www.iso9000store.com
 Appendix B
ISO 9001:2000 Planning Meeting

Implementation Steps

1. The team of people assigned responsibility will use The 9000 Store
Procedures, Quality Manual and Forms as a foundation for the process to
address the requirements of the standard. The team will use the task list to
identify what areas need changes to processes.

2. Each responsible team will evaluate the process presented in the procedure,
determine if any changes are necessary for your organization, and make edits
to the procedure and forms.

3. The team will finalize the procedure and send it to the ISO 9001:2000
Steering Team for review and approval.

4. The team will train employees that are affected by or have responsibility for
the procedure.

5. The employees will start following the documented process and maintaining
records.

ISO 9001:2000 Steering Team Responsibilities

1. Identify team members for each procedure.

2. Assign target start date and completion date for each team.
3. Identify training needs for employees and schedule training sessions for
ISO 9001:2000
4. Meet on a regular basis to evaluate progress, answer questions for the
teams and evaluate resource needs for the implementation.
5. Review and approve procedures as they are finalized.
6. Evaluate and choose a Registrar

Appendix B
Copyright 2002 The ISO 9000 Store
www.iso9000store.com
 Appendix B
ISO 9001:2000 Planning Meeting

Task Assignments

Task Group Team Members Team Leader

Quality Manual

Document Control

Control of Quality Records

Management Responsibility

Competence, Awareness and

Training

Infrastructure

Planning of Product Realization

Processes

Customer Related Processes

Design and Development

Purchasing

Control of Production and Service

Provision

Appendix B
Copyright 2002 The ISO 9000 Store
www.iso9000store.com
 Appendix B
ISO 9001:2000 Planning Meeting

Task Group Team Members Team Leader

Identification and Traceability

Customer Property

Preservation of Product

Control of Measuring and

Monitoring Devices
Monitoring, Measuring and
Analysis of Customer Satisfaction

Internal Audits
Monitoring, Measuring and
Analysis of Product and
Realization Processes
Control of Nonconforming Product

Corrective Action and Preventive

Action

Appendix B
Copyright 2002 The ISO 9000 Store
www.iso9000store.com
 Appendix B
ISO 9001:2000 Planning Meeting

Project Gantt Chart

(Change headings to the Months you expect your project to run- identify when each team will start and stop,
shade the time that each team will run)
Task Group Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9

Document Control

Control of Quality Records

Management Responsibility

Competence, Awareness and

Training
Infrastructure

Planning of Product Realization

Processes
Customer Related Processes

Design and Development

Purchasing

Control of Production and Service

Provision
Identification and Traceability

Customer Property

Appendix B
Copyright 2002 The ISO 9000 Store
www.iso9000store.com
 Appendix B
ISO 9001:2000 Planning Meeting

Task Group Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9

Preservation of Product

Control of Measuring and

Monitoring Devices
Monitoring, Measuring and Analysis
of Customer Satisfaction
Internal Audits

Monitoring, Measuring and Analysis

of Product and Realization
Processes
Control of Nonconforming Product

Corrective Action and Preventive

Action

Appendix B
Copyright 2002 The ISO 9000 Store
www.iso9000store.com
 Appendix B
Task Team Meeting

Task Team Meeting

Agenda:

1. Review the Implementation Steps and Responsibilities of the ISO

9001:2000 Steering Team. Use the PowerPoint presentation “ ISO
9001:2000 Implementation”
2. Review procedure that the team will be responsible for.
3. Review the section of the Gap Analysis that applies to the team.
4. Determine resources required for completion of the tasks.
a. Will the team need assistance with other responsibilities during the
ISO 9001:2000 project?
b. What kind of technical guidance will be needed to allow the team to
complete the tasks efficiently and effectively?
1. Assistance from the management representative?
2. Prepared materials?
3. Special Training?
5. Assign dates to tasks from Gap Analysis using the start and finish date
on the Gantt chart.
6. Schedule next meeting.
7. Next agenda:
1. Read The 9000 Store Procedure and compare to current
processes.
2. Assign tasks for implementing changes in your processes
and editing prepared procedure.

Implementation Steps

1. The team assigned responsibility for each procedure will use the The
9000 Store Procedure as a foundation for the process to address the
requirements of the standard. The team will use the task list to identify
what areas need changes to processes.

2. Each responsible team will evaluate the process presented in the

procedure, determine if any changes are necessary for your organization,
and make edits to the procedure and forms.

3. The team will finalize the procedure and send it to the ISO 9001:2000
Steering Team for review and approval.

4. The team will train employees that are affected by or have responsibility
for the procedure.

5. The employees will start following the documented process and

maintaining records.
 Appendix B
Task Team Meeting

ISO 9001:2000 Steering Team Responsibilities

1. Identify team members for each procedure.

2. Assign target start date and completion date for each team.
3. Identify training needs for employees and schedule training sessions:
a. Employee Introduction to ISO 9001:2000 using the Training
Materials Package
b. Internal Auditor Training using the Internal Auditor Training
Materials Package
4. Meet on a regular basis to evaluate progress, answer questions for the
teams and evaluate resource needs for the implementation.
5. Review and approve procedures as they are finalized.
Introduction to ISO 9001:2000
Employee Newsletter #1
Welcome to ISO 9001:2000
Our Company is working on becoming
ISO 9001:2000 Registered. ISO
9001:2000 is a Quality Management
System that outlines some basic good
business practices that we need to have
in place.
By implementing a Quality Management
System that complies with ISO
9001:2000 we will be able to make our
company run more efficiently, increase
our customers’ satisfaction and
communicate to potential customers that
we have good quality processes in place.
Surveyed ISO 9001 Registered
Companies state that they have:
· Higher customer satisfaction
· Increased profitability because of
efficiencies
· Market advantages
· Improved communications
· Higher job satisfaction
What will employees need to do for
the ISO 9001:2000 Quality
Management System?
First Management will be identifying
our “ Key Processes”. Those are the
processes that affect the quality of our
product and our services. Then they will
identify how we will control these
processes to make sure that we are all
doing them the same way, and the best
way our organization has identified.
Controlling the process means
documenting the work instructions,
training employees or finding other ways
Watch for our next newsletter for more introduction to ISO 9001:2000, what it will mean
to you and your coworkers.
to make sure that the process is done
consistently no matter who is doing it.
This means that employees may be
required to have certain training, or to
follow specific work instructions.
Employees will also need to be aware of
how their job affects the quality of our
product and customer satisfaction.
ISO 9001 Highlights: Things that you
will be hearing about as we proceed
with this project… .
Our Quality Policy
We will identify our Quality Policy, and
will be communicating it to all
employees. It is important that all of us
are aware of what this statement says
about our company’s vision is for
meeting customers’ expectations and for
quality.
Registration Audit
To become ISO 9001:2000 registered,
we will be audited by a Registrar. This
Registration Audit will be done after we
have set up processes to meet all the
requirements of the standard. The
Registrar will send an auditor or audit
team to come in to our facilities and
evaluate the processes we have set up.
They will check to see if the processes
meet the requirements of the standard,
and to see if we are following the
processes. If everything looks good, we
will be recommended for Registration!
Introduction to ISO 9001:2000
Employee Newsletter #2
Welcome to ISO 9001:2000
Coming Soon: Gap Analysis
The next step in our ISO 9001:2000
Project is to conduct a “ Gap Analysis”.
This is an evaluation of our current
processes to see what we have in place
that already meets the requirements of
ISO 9001:2000, and what we will need
to do to meet the rest of the
requirements.
People from our company will be
coming to all departments and asking
how you do things. They will want to
see procedures and records so they can
evaluate the current method of doing
things against the requirements of the
standard. This information will help us
plan our ISO 9001:2000 Project.
Introducing our Quality Policy
Top Management has developed a
Quality Policy to describe our
commitment to providing quality
products and service to our customers.
How does your work contribute to
meeting our quality policy? Each and
every individual has an impact on
quality of the product and service we
deliver.
“ Insert your quality policy here”
Watch for our next newsletter for more introduction to ISO 9001:2000, what it will mean
to you and your coworkers.
After the Gap Analysis…
When we have completed the Gap
Analysis we will put together a plan to
address the requirements of ISO
9001:2000. This plan will include
outlining new ways of doing things, and
documenting procedures and work
instructions.
Many employees will be involved in this
effort. We have established a Steering
Team to lead the effort. The Steering
team will be creating Point Teams to
identify how to meet requirements in
different areas, and documenting the
new way of doing things in Procedures
and Work Instructions.
ISO 9001 Highlights: Things that you
will be hearing about as we proceed
with this project… .
Procedures
Procedures will be written to describe
how a process is done. For example, a
Purchasing Procedure will be written to
describe the overall purchasing process.
When detailed instructions are needed, a
Work Instruction will be written.
Work Instructions
Work Instructions are written to describe
how to do a task or process. In the
example above, a procedure is written
describing the overall purchasing
process. A work instruction would be
written to describe how to enter orders
into the purchasing system.
Introduction to ISO 9001:2000
Employee Newsletter #3

ISO 9001:2000: Introduction to the Requirements

Introduction to the Requirements of Procedures

ISO 9001:2000
The ISO 9001 Standard is organized in
five sections or ‘Clauses”. Today we are
going to look at the requirements in
Clause 4: General Requirements. The
reason we are starting at “ 4” is because
the first three clauses do not have actual
requirements; they are more of an
introduction to the standard. The
requirements are in clauses 4 through 8,
where we will focus.
Clause 4: General Requirements
Clause 4.0 gives us the requirements for
the foundation or establishment of the
Quality Management System (QMS). It
tells us to document, implement and
maintain the QMS, and continually
improve its effectiveness. This section
also requires that we write a quality
manual and procedures required by the
standard. The Quality Policy that we
introduced in our last newsletter is
required by this clause as well.
Once we have written these documents
this clause requires us to control them.
Controlling a document means making
sure that the current, correct copy is
available to employees, and old copies
are removed from use right away.
Document control is a very important
part of ISO 9000.
Our organization is writing procedures
that explain our processes.
We look at each business process, make
sure that it meets the requirements of the
standard and decide if we need to
document it in a procedure.
We will write a procedure to make sure
that everyone does the process in the
same way, and the correct way.
Procedures are an important tool for us
to make sure that we have carefully
planned how we want to do things, and
follow that plan. Procedures are
approved by management, and then
controlled so employees know that when
they follow the procedure they are doing
things the correct and approved way.
Procedures are also a good tool for
training people on processes. By using
our procedures we can improve the
consistency and quality of our products.

Watch for our next newsletter for more introduction to ISO 9001:2000, what it will mean
to you and your coworkers.