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Project Manager’s Guide

ISO 9001:2000 Implementation

Copyright 2002 The ISO 9000 Store

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Table of Contents

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

Implementation Steps.........................................................................3

Project Plan.........................................................................................4

Scheduling and Conducting the Gap Analysis....................................6

The Planning Meetings.......................................................................8

Holding Task Group Team Meetings..................................................9

Project Plan: ISO 9001:2000..............................................Appendix A

Planning Meeting Handouts................................................Appendix B

Task Group Meeting...........................................................Appendix C

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

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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


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

Page 5 of 10

Project PlanA. 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 ResponsibilitiesIt 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 groupsa. 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 AnalysisA. 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 schedulea. 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 MeetingsA. 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.

Estimate the amount of time needed to complete each task based on the amount of resources available to the task.

The Planning Meeting

The Task Group Meeting

Holding Task Group Team MeetingsThe 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?


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 agendai. Schedule next meeting

Appendix AThe 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 Date1. Project Manger

completes Online Training

2. Conduct Gap Analysis

3. Hold Planning Meeting

4. Introductory Training

5. Hold Task Group Meetings

6. System Complete7. Registration Audit8. Certificate

Appendix ACopyright 2002 The ISO 9000 Store


Appendix AThe Project Plan

Received

Appendix ACopyright 2002 The ISO 9000 Store


Appendix BISO 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 Packagea. 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 BCopyright 2002 The ISO 9000 Store




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 9001:20004. 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




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




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




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




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 ProcessesControl of Nonconforming Product

Corrective Action and Preventive Action



Appendix CTask Group Team Meeting

Task Group MeetingAgenda:

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?


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.


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 CCopyright 2002 The ISO 9000 Store


Appendix CTask 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 CCopyright 2002 The ISO 9000 Store



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ISO 9001:2000 Documentation

200 x ISO 9001:2000 Documented Quality Management System

$ 497.00

200-CD xISO 9001:2000 Documented Quality Management System - CD

$ 503.00

QMSLicense x Additional Site License for Quality Management System

$ 450.00

QM-001 x ISO 9001:2000 Quality Manual $ 50.00

QM-001-CD x ISO 9001:2000 Quality Manual on CD-Rom $ 55.00

Form x ISO 9001:2000 Forms Package $ 50.00

GAP x ISO 9001:2000 Gap Analysis Checklist $ 25.00

250 x Simple ISO 9001:2000 Conversion Template - Downloadable

$ 145.00

IAC x Internal Audit Package (Procedure, 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

P-622 x Competence, Awareness and Training Procedure $ 30.00

P-630 x Infrastructure Procedure $ 30.00

P-710 x Planning of Product Realization 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

P-750 x Control of Production & Service Provision Procedure $ 30.00

P-753 x Identification & Traceability Procedure $ 10.00

P-754 x Customer Property Procedure $ 10.00

P-755 x Preservation of Product Procedure $ 10.00

P-760 x Control of Measuring & Monitoring Devices Procedure $ 21.00


P-821 x Monitoring, Measuring & Analysis of Customer Satisfaction

$ 30.00

P-822 x Internal Audit Procedure $ 30.00

P-824 x Monitoring, Measuring & Analysis of Product & Realization Procedure

$ 30.00

P-830 x Control of Nonconforming Product Procedure $ 25.00

P-850 x Corrective & Preventive Action Procedures $ 30.00

Complete Documentation & Training Package

290 x Complete ISO 9001:2000 Documentation and Training $ 994.00

290-CD xComplete ISO 9001;2000 Documentation and Training on CD

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ISO 9001:2000 Training

120 x ISO 9001:2000 Online Training $ 125.00

125 x License for additional student for Online ISO 9001:2000 Training

$ 75.00

100 x Introduction to ISO 9001:2000 Training Package $ 175.00

100-P x Transition to ISO 9001:2000 Training Package in Portuguese

$ 197.00

110 x License for 15 Additional Student Manuals $ 15.00

112 x ISO 9001:2000 Internal Auditor Training Package $ 450.00

112-CD xISO 9001:2000 Internal Auditor Training Package on CD

$ 455.00

130 x Customized Employee ISO 9001:2000 Training on CD $ 500.00

135 x General ISO 9001:2000 Employee Training CD $ 350.00

104 x Transition to ISO 9001-2000 Training Package $ 175.00

100-CD x Introduction to ISO 9001:2000 Training Package on CD $ 180.00

104-CD x Transition to ISO 9001:2000 Training Package on CD $ 180.00

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