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Project Manager’s Guide

ISO 9001:2000 Implementation

Copyright 2002 The ISO 9000 Store

Visit us at www.iso9000store.com
Table of Contents

.............................................................................................................................................1
Introduction..........................................................................................................................2
Implementation Steps...........................................................................................................4
Project Plan..........................................................................................................................6
Scheduling and Conducting the Gap Analysis.....................................................................8
The Planning Meetings......................................................................................................10
Holding Task Group Team Meetings.................................................................................12
Project Plan: ISO 9001:2000.............................................................................................14
Planning Meeting Handouts...............................................................................................16
Task Group Meeting..........................................................................................................22

Page 1 of 10
Introduction

This project manager’s guide 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.iso9000store.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.

Online 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.

Custom Online Training Another option for training employees is our custom
online training. This is a one hour training session focusing on the general
requirements of ISO 9001:2000 and what it means to employees. We customize
the session with your quality policy, goals and specifics to your organization.
Each employee works through the training when it is convenient, takes a quiz
and prints a training certificate.

Complete Documentation and Training Package Provides you with a package
price for the Documented Quality System, Online Training, Gap Analysis and
Training Materials Package.

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.

Page 2 of 10
Page 3 of 10
Implementation Steps

Implementation Steps

Basic 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 Procedure and the Quality Manual to a 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 Procedures.

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 guide 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

Page 4 of 10
Implementation Steps

requirements of the ISO 9001:2000 Standard. This project plan will help you
manage these changes.

Page 5 of 10
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 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.
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 groups
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 to conduct the training sessions.
c. Plan training before the task group meetings so individuals involved
in the task groups are trained before their first meeting.
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.

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.
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 Group Teams will be assigned responsibility for
development of a procedure.
The Planning Meeting

The Planning Meetings
A. Planning your 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 (see handout in
Appendix B)
b. Discuss Responsibilities of the ISO 9001:2000 Steering Team (see
handout in Appendix B)
c. 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.
d. 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?
e. 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.
The Planning Meeting

 Estimate the amount of time needed to complete each task
based on the amount of resources available to the task.
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. Explain the “Implementation Steps” to the group (use the Task
Group Team Handout in Appendix C)
b. Discuss Responsibilities of the ISO 9001:2000 Steering Team (use
the Task Group Team Handout in Appendix C)
c. Hand out the 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.
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:

f. Read ISO 9000 store Procedure (Or for the team responsible for
the quality manual read The ISO 9000 Store Quality Manual and
compare to current processes.
 If not using the procedures, outline a new process to meet
the requirements of the standard.
g. Assign tasks for implementing changes in your processes and
editing prepared procedure.
h. Set next agenda
i. Schedule next meeting
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 Planning
Meeting
4. Introductory
Training
5. Hold Task Group
Meetings
6. System Complete
7. Registration Audit
8. Certificate

Appendix A
Copyright 2002 The ISO 9000 Store
www.iso9000store.com
Appendix A
The Project Plan
Received

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

Planning Meeting Handouts

Agenda:

1. Review the “Implementation Steps” (see handout attached)
2. Discuss Responsibilities of the ISO 9001:2000 Steering Team (see handout attached)
3. Assign individuals to teams for each task group. (Use tables from Appendix B)
4. 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?
5. Assign dates to tasks. (Use table from Appendix B)
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.
6. 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 ISO 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

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 Team Members Team Leader

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 C
Task Group Team Meeting

Task Group Meeting
Agenda:

1. Review the “Implementation Steps” to the group
2. Review Responsibilities of the ISO 9001:2000 Steering Team
3. Review procedure that the team will be responsible for.
4. Review the section of the Gap Analysis that applies to the team.
5. 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?
6. Assign dates to tasks from Gap Analysis using the start and finish date
on the Gantt chart.
7. Schedule next meeting.
8. Next agenda:
1. Read ISO 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 ISO 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 C
Copyright 2002 The ISO 9000 Store
www.iso9000store.com
Appendix C
Task Group 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.

Appendix C
Copyright 2002 The ISO 9000 Store
www.iso9000store.com
www.iso9000store.com

ISO 9000 Store Order Form

Do
wn CD-
Product loa Ro Quan Tota
ID d m Item Price tity l
ISO 9001:2000 Documentation
ISO 9001:2000 Documented Quality $
200 x Management System 497.00
ISO 9001:2000 Documented Quality $
200-CD x Management System - CD 503.00
QMSLice Additional Site License for Quality $
nse x Management System 450.00
$
QM-001 x ISO 9001:2000 Quality Manual 50.00
QM-001- ISO 9001:2000 Quality Manual on CD- $
CD x Rom 55.00
$
Form x ISO 9001:2000 Forms Package 50.00
$
GAP x ISO 9001:2000 Gap Analysis Checklist 25.00
Simple ISO 9001:2000 Conversion $
250 x Template - Downloadable 145.00
Internal Audit Package (Procedure, $
IAC x Checklist, Forms) 50.00
Individual Procedures:
$
P-423 x Document Control Procedure 30.00
$
P-424 x Control of Quality Records Procedure 15.00
$
P-500 x Management Responsibility Procedure 35.00
Competence, Awareness and Training $
P-622 x Procedure 30.00
$
P-630 x Infrastructure Procedure 30.00
Planning of Product Realization $
P-710 x Procedure 30.00
$
P-720 x Customer Related Processes Procedure 30.00
$
P-730 x Design and Development Procedure 35.00
$
P-740 x Purchasing Procedure 21.00
Control of Production & Service $
P-750 x Provision Procedure 30.00
$
P-753 x Identification & Traceability Procedure 10.00
P-754 x Customer Property Procedure $
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10.00
$
P-755 x Preservation of Product Procedure 10.00
Control of Measuring & Monitoring $
P-760 x Devices Procedure 21.00
Monitoring, Measuring & Analysis of $
P-821 x Customer Satisfaction 30.00
$
P-822 x Internal Audit Procedure 30.00
Monitoring, Measuring & Analysis of $
P-824 x Product & Realization Procedure 30.00
Control of Nonconforming Product $
P-830 x Procedure 25.00
Corrective & Preventive Action $
P-850 x Procedures 30.00

Complete Documentation & Training Package
Complete ISO 9001:2000 $
290 x Documentation and Training 994.00
Complete ISO 9001;2000 $
290-CD x Documentation and Training on CD 997.00
ISO 9001:2000 Training
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120 x ISO 9001:2000 Online Training 125.00
License for additional student for $
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Introduction to ISO 9001:2000 Training $
100 x Package 175.00
Transition to ISO 9001:2000 Training $
100-P x Package in Portuguese 197.00
License for 15 Additional Student $
110 x Manuals 15.00
ISO 9001:2000 Internal Auditor Training $
112 x Package 450.00
ISO 9001:2000 Internal Auditor Training $
112-CD x Package on CD 455.00
Customized Employee ISO 9001:2000 $
130 x Training on CD 500.00
General ISO 9001:2000 Employee $
135 x Training CD 350.00
Transition to ISO 9001-2000 Training $
104 x Package 175.00
Introduction to ISO 9001:2000 Training $
100-CD x Package on CD 180.00
Transition to ISO 9001:2000 Training $
104-CD x Package on CD 180.00

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