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Putting ISO 9001:2000 to

Work for You


Center for Professional Management
September 16, 2003

Outline
ISO 9001:2000
The WIIFM Factor

Overview
Details
Transition
Implementation
Use

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Overview

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Background
There are several standards organizations
SAE, ASTM, ANSI, DIN, BSI
ISO
The International Organization for Standardization
From the Greek isos equal or standard

ISO 9001:2000 Quality Management


Systems - one of many ISO standards
Aggregation of Mil and Industry Reqs
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Definition
ISO 9001:2000 is A series of standards to insure that
necessary processes are in place, that
the processes identified as necessary
are appropriately coordinated, that they
are being performed consistently and
effectively and that there is objective
evidence of same.
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8 Quality Principles
1.
2.
3.
4.
5.
6.
7.
8.

Customer Focus
Leadership
Involvement of People
Process Approach
System Approach to Management
Continual Improvement
Factual Approach to Decision-Making
Mutually Beneficial Supplier Relationships
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5 Core Elements (Clauses)

Clause 4 Quality Management System


Clause 5 Management Responsibility
Clause 6 Resource Management
Clause 7 Product Realization
Clause 8 Measurement Analysis and
Improvement

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The Big 6

Required Procedures
4.2.3 Control of Documents
4.2.4 Control of Records
8.2.2 Internal Audit
8.3 Control of Non Conforming Product
8.5.2 Corrective Action
8.5.3 Preventive Action
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Transition From 1994 Standard


ISO 9001:2000
5 Core Elements
6 Reqd Procedures
Business System

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ISO 9000:1994
20 Core Elements
18 Reqd Procedures
Shop Floor Control
System

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90% + Fall Into 1 0f 4 Groups


Not ISO Registered
Registered to the 1994 Standard
ISO 9001:2000 or QS
Customer Requirement
Foundation for CE stamp

Did what we had to do to get ISO in on time

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Considerations Beyond ISO


As Example
Lean Manufacturing
Error proofing
5Ss

Sort
Shine
Set in Order
Standardize
Sustain

Employees properly trained


Use Visual Management techniques
Managers are committed to the programs success
Workplace is well ordered & adheres to procedures
New procedures become a habit

How do you keep these initiatives alive and well?


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...who wish to know about the world


must learn about it in its particular
details.
-- Heraclitus c. 500 B.C.

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The Details

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TLAs
ABC
BPI
BPM
BRP
CIP
CIT
CMM
CPM
CQI
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CRM
CRP
DRP
ERP
FBA
GMP
HMT
JAD
JIT

KPI
MBO
MRP
MES
OEE
QFD
QIT
QMS
QRP

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SCM
SPC
TCO
TOC
TQM
TPP
TPM
WCM

TLAs
ABC
BPI
BPM
BRP
CIP
CIT
CMM
CPM
CQI
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CRM
CRP
DRP
ERP
FBA
GMP
HMT
JAD
JIT

KPI
MBO
MRP
MES
OEE
QFD
QIT
QMS
QRP

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SCM
SPC
TCO
TOC
TQM
TPP
TPM
WCM

???
CMMS
SCADA
CFPR

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ISO
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ISO 9001:2000
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Additional Definition
ISO 9001:2000 is also

Model
Framework
Structure
Backbone

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ISO as Backbone Model


People

Methods

Mgt. Initiatives

Morale
Communications

Performance Measure
Quality Mgt.

Coaching&Mentoring

ERP System
Training&Devlpmnt

Company
Objectives

Company
Mission

ISO9001

Direction

Tooling
Production Lines

Vendor Certification

Computer Network

Chemicals
Components

Equipment
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Company

Material
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Further Definition
ISO 9001:2000 as Business
System outlines the following:
A Management System
A Process Control System
A Document Control System

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Characteristics
ISO 9001:2000

Completeness/Encompassing
Closed Loop System
Linked Inputs and Outputs
Internal Audits
Externally Audited
Global Recognition
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Model of a Process Based QMS


Continual Improvement of the Quality Management System

Management

Customers

Customers

Responsibility
Measurement,
Analysis &
Improvement

Resource
Management

Input

Requirements

Product
Realization

Key
Valueadding activity
Information flow

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Satisfaction

Product

Output

Source: ANSI/ASQ/ISO

ISO 9001:2000
-- Not a Silver Bullet

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All good tools can be used poorly and


often are. A lot of companies that have to
do ISO misuse ISO. They cause more
instead of less work, paperwork, training,
meetings, etc.
-- Lestie Carey

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Resource versus Requirement


ISO tells what to do to run a good
company To improve your business you
have to fill-in the how.
They should be business requirements
if they are not business requirements, they
should not be ISO requirements

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Terms
Quality the degree to which a set of inherent
characteristics fulfills requirements.
Effective Plan-to-Actual performance
Efficiency amount of resources ut takes to
complete a task
Conformance fulfillment of a requirement.
Customer Satisfaction the customers
perception of the degree to which the customers
requirements have been fulfilled.
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Please Note
It should be Conformance versus
Compliance to standards
ISO 9001:2000 is a Registration as
opposed to being a Certification

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Transition
ISO 9001:2000 is Less Prescriptive
Focus Shifted From Documentation to Objective
Evidence
From Shop Floor Control to Mgt System
with Emphasis on:

Planning
Process
Being Effective
Visibility to Management
Customer Perspective
Causing Success & Insuring Success
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Changing Doctrines
1994 Dogma
Document What You Do and Do What You
Document
2000 Dogma
A Failure to Plan is a Plan to Fail

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Implementation
Implement ISO using the ISO conforming
processes

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Project Mgt 101


Identify Major Tasks & Activities
Categorize Work Content
Calculate Effort & Duration
Effort = Unit of work by category X the volume
required X the periodicity X the frequency
Duration accounts for availability of resources
Forecast variability using MVIs

Plan Backward from Finish Date


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Implementation
Build Nucleus of Support

Recruit Senior Sponsor


ID Peers

Open

Develop Resource Estimates

Cost
Effort
Staff Requirments

Pre

Establish Implementation
Project Management

Select/Appoint Implementation Project Manager


Draft Project Outline
Establish Project Timeline

Weeks
1-6

ID Registrar/Prime Resource

6 wks

Gap Analysis

Week 7

Presentation to Sr. Mgt.

Prelium timeline
Resource Reqs
Major content
Features and Benefits- What will be different

Week 8

Establish Terminology

Open a Glossary of Terms


Review Terms in Standards Review & Training

Week 9

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Selecting the audit firm

References
Bench Audit
Pricing
Gap Analysis as Test Drive

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Implementation
Review CAP

Review Corrective Action Procedure 8.5.2


Design Implementation Efforts to Insure that CAP is Used

Week 9

Define Individual Roles

ID probable cast

Week 9
Week 10

SR Mgt Approval
Schedule Dates

Gap analysis
Interim
Final Audit
Registration audit

Week 12

Lock-in timeline
Develop Promotions

Promotional Campaign
Materials

Negotiate Assignments

Recruit identified volunteers


Clear volunteer participation with area sprv/mgt
Review understanding of commitment (roles &
responsibilities) w/volunteers

Kick-off

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Week 11

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Implementation
Prelim Internal Audit Activities

ID Lead Internal Auditor(s)


Schedule Certification Classes
ID Resource to Assist Initial Internal Audit Efforts

Institute Document Control

Appoint administrator
Enter into vendor selection Resource/Software
Define Controlled Document & Protocol
Establish Quality Record Listing Format
Mark Non cntrld process maps for reference only

Schedule Standards Review


Publish Resource Names
Draft Quality Policy Statement
Draft Quality Objectives
Identify Key Processes
Develop Process Formats

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Establish Map Design


Develop Process Database

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Process Map Design


Quality

C
U
S
T
O
M
E
R

Mrkting

R&D

Mgt
Ops

Requirements

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Sales

Finance

MIS

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C
U
S
T
O
M
E
R
Satisfaction /
Fulfillment

Process Map Document Example

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Implementation
Process Map
Process Gap Analysis
Select/Appoint Mgt Rep
Devlelop Mgt Review Protocols

Impanel Mgt Board


Big 6 Procedures
Draft Quality Manual
Quality Record Database
Develop Training Program

Develop Training modules


Create Handouts
Determine Time Requirements
Schedule Training/Set Training Timeline

Review Work Instructions


Initiate Training
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Training Material Example

Stress Linkage with


Organizational Objectives
Corporate
Mission
Statement

Quality
Policy
Statement

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Dept
Mission
Statement

Area
Mission
Statement

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Functional
Quality
Objectives

Implementation
Initiate Internal Audits
Initialize System
First Interim External Audit
Make Necessary Adjustments
Communications Process
5.5.3

Draft Letters Introduction letter


ID all communications
Have communication meetins post minutes

Use System

Continue audits, Training, Promotions

Second Interim Audit


Fill-in Gaps
Registration Audit
Celebrate
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Audit Schedule/Layout Bad Example


1

1
0

1
1

4 - QUALITY MANAGEMENT SYSTEM


4.1 General requirements

4.2.1 General

4.2.2 Quality manual

4.2.3 Control of documents

4.2.4 Control of records

4.2 Documentation requirements

5 - MANAGEMENT RESPONSIBILITY
5.1 Management commitment

5.2 Customer focus

5.3 Quality policy

5.4.1 Quality objectives

5.4.2 Quality management system planning

5.5.1 Responsibility and authority

5.5.2 Management representative

5.5.3 Internal communication

5.4 Planning

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1
2

1
3

Audit Schedule/Layout Good Example


4.1

4.2

4.2.1

4.2.2

4.2.1

4.2.3

4.2.4

5.1

5.2

5.3

5.4.1

MANAGEMENT
Strategic Planning
Operating Committee

X
X

QUALITY SYSTEMS
Quality Systems Management

Quality Control Management


- Line Inpection
- Receiving Inspection
- Analytical Lab
Quality Assurance

Regulatory Affairs
OPERATIONS
Manufacturing Management
Production Management
- Production Line Operation
- Maintenance
- Material Handling

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Using the System

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ISOs Approach
Familiar PDCA Cycle
Plan

Act

Do

Check
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Juran Approach
Conforming
Product / Service

Requirement

Yes
Plan

Do

Check

Conforms?
No

Corrective
Action

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Remedial
Action

Feedback Loop

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ISO Overlay
Requirement
(1.1,4.1,7.2.2)

Conforming
Product / Service
Yes

Plan
(5.4,7.1,7.3.1,
8.5.3)

Corrective
Action
(8.5.2)

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Do
(5.5.1,5.6,6,7.2,
7.3.2-7,7.4,7.5)

Remedial
Action
(8.3)

Check
(7.6,8.2)

Feedback Loop

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Conforms?
(8.1)
No

Signs ISO IS Sub Optimized


ISO requires us to do this.
People with ISO in their job titles
Activities that were done for ISO (e.g.,
flowcharts, work instructions, etc.) but are
not referred to or used otherwise

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Good Practice
Good Companies use Major Events to
Provide Improvement in Specific, Usually
Predefined, Areas of the Business

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Best Practice
Great Companies Use Major Events as a
Place Marker from which to Examine
Thinking

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Selling ISO to Senior Management


ISO as a Resource NOT a Requirement
Major part of ROI comes from all the other
projects working as they should
Sarbanes - Oxley

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Near Flawless Execution Requires Robust


Policy, Procedures and Practices

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Process Map with Board


Quality

C
U
S
T
O
M
E
R

Mrkting

R&D

Board
Mgt
Ops

Requirements

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Sales

Finance

MIS

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C
U
S
T
O
M
E
R
Satisfaction /
Fulfillment

Maturation
ISO 9001:2000 Evolves

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Role of the Individual

Desire to have a positive impact


Effort to get ISO up and running
Diligence
Change of mindset

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Critical Success Factors

Link Inputs and Outputs


Include Everyone
Design Ongoing Involvement
Promote Institutional Memory

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ISO Take-Aways
Structured Management
Major Constituents Addressed
Customers
Employees
Suppliers

Common Understandings Enforced


Functions Linked
Process Reinforcement
Communications Integrated
Participation at All Levels
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Resources - Pocket Guides


Goal/QPC Memory Joggers

9000:2000
Memory Jogger
Project Management
Creativity Tools

ASQ/J.P. Russell
Process Auditing
Techniques
Internal Auditing Pocket
Guide
ISO 2000 Lesson Guide

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An Audit of the System, not


the People Quality
Pursuit, Inc.
Cracking the Case of ISO
9001:2000 for Service
Cianfrani, West
Cracking the Case of ISO
9001:2000 for
Manufacturing
- Cianfrani, West
ISO 9001:2000 Revision
Highlights - Graebig

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Resources - Books
American National Standard
Quality Management
Systems-Requirements
ANSI/ISO/ASQ Q9001-2000
- ASQ
Demystifying ISO
9001:2000 Paradis,
Trubiano
The Route to Registration
BSI, CEEM
ISO 9000 Requirements
Kanholm
ISO 9001:2000 Standard
Paraphrased Peach,
Wilson
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The Management Review


Handbook Robitalle
The Painless ISO
9001:2000 Transition
Robitalle
Quality Audits for ISO
9001:2000 OHanlon
How to Audit the ProcessBased QMS Arter,
Cianfrani, West
ISO 9001:2000 Explained
Cianfrani, Tsiakals, West
ISO 9000 - Johnson

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Resources - Web Sites


ISO - http://www.iso.ch/iso/en/ISOOnline.frontpage
Magical Demystifying tour http://www.iso.ch/iso/en/iso9000-14000/tour/magic
al.html

ASQ - http://www.asq.org/
Standards - http://standardsgroup.asq.org/

BSI - http://www.bsi-global.com/index.xalter

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ISO as Resource
ISO 9001:2000 is a business management
system that can be used by managers:
As a robust outline of good practice
coordinated procedures
As a means for insuring consistent interdepartmental cross-functional support
As a way to maintain management
oversight and participation at ALL levels
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Use ISO 9001:2000


As A Resource
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Success does not just


happen Success is
caused

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Cause Success
Thank You APICS

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