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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.
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.
Page 2 of 10
Page 3 of 10
Implementation Steps
Implementation Steps
4. The Project Manager and others conduct a Gap Analysis with a Gap
Analysis Checklist.
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.
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 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.
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.
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
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.
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 goals:
Start Date:
Responsibilities:
Project Manager:
Management Representative:
Top Management:
Project timeline:
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
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Appendix B
ISO 9001:2000 Planning Meeting
Agenda:
*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.
Appendix B
Copyright 2002 The ISO 9000 Store
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Appendix B
ISO 9001:2000 Planning Meeting
Task Assignments
Quality Manual
Document Control
Management Responsibility
Infrastructure
Purchasing
Customer Property
Appendix B
Copyright 2002 The ISO 9000 Store
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Appendix B
ISO 9001:2000 Planning Meeting
Preservation of Product
Internal Audits
Monitoring, Measuring and
Analysis of Product and
Realization Processes
Control of Nonconforming Product
Appendix B
Copyright 2002 The ISO 9000 Store
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Appendix B
ISO 9001:2000 Planning Meeting
Document Control
Management Responsibility
Purchasing
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
Appendix B
Copyright 2002 The ISO 9000 Store
www.iso9000store.com
Appendix C
Task Group Team Meeting
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.
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.
Appendix C
Copyright 2002 The ISO 9000 Store
www.iso9000store.com
Appendix C
Task Group Team Meeting
Appendix C
Copyright 2002 The ISO 9000 Store
www.iso9000store.com
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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 $
www.iso9000store.com
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
Data Management
TT2000 x TrainingTrack 2000 $
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249.00
Sub-total
Select shipping method:
$
UPS Ground 5.00
$
UPS Overnight 15.00
$
UPS 2nd Day Air 12.00
$
UPS International Air 45.00
Tax 6.5% (Minnesota only)
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