Professional Documents
Culture Documents
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
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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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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ISO 9000:1994
20 Core Elements
18 Reqd Procedures
Shop Floor Control
System
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Sort
Shine
Set in Order
Standardize
Sustain
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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
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
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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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
Center for Professional
Management
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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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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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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Implementation
Build Nucleus of Support
Open
Cost
Effort
Staff Requirments
Pre
Establish Implementation
Project Management
Weeks
1-6
ID Registrar/Prime Resource
6 wks
Gap Analysis
Week 7
Prelium timeline
Resource Reqs
Major content
Features and Benefits- What will be different
Week 8
Establish Terminology
Week 9
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References
Bench Audit
Pricing
Gap Analysis as Test Drive
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Implementation
Review CAP
Week 9
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
Kick-off
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Week 11
Implementation
Prelim Internal Audit Activities
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
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C
U
S
T
O
M
E
R
Mrkting
R&D
Mgt
Ops
Requirements
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Sales
Finance
MIS
C
U
S
T
O
M
E
R
Satisfaction /
Fulfillment
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Implementation
Process Map
Process Gap Analysis
Select/Appoint Mgt Rep
Devlelop Mgt Review Protocols
Quality
Policy
Statement
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Dept
Mission
Statement
Area
Mission
Statement
Functional
Quality
Objectives
Implementation
Initiate Internal Audits
Initialize System
First Interim External Audit
Make Necessary Adjustments
Communications Process
5.5.3
Use System
1
0
1
1
4.2.1 General
5 - MANAGEMENT RESPONSIBILITY
5.1 Management commitment
5.4 Planning
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1
2
1
3
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
Regulatory Affairs
OPERATIONS
Manufacturing Management
Production Management
- Production Line Operation
- Maintenance
- Material Handling
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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
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
Conforms?
(8.1)
No
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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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C
U
S
T
O
M
E
R
Mrkting
R&D
Board
Mgt
Ops
Requirements
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Sales
Finance
MIS
C
U
S
T
O
M
E
R
Satisfaction /
Fulfillment
Maturation
ISO 9001:2000 Evolves
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ISO Take-Aways
Structured Management
Major Constituents Addressed
Customers
Employees
Suppliers
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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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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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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Cause Success
Thank You APICS
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