ISO 9000
International
Quality Standards
QUALITY
MANAGEMENT
Larry
W. Jacobs
Much of the material covered
herein is adapted from "A Manager’s View of ISO
9000 Quality System Registration," International
Quality Systems
ISO 9000
DEFINITION
ISO 9000 IS
A SERIES OF INTERNATIONAL STANDARDS, CONFORMANCE TO WHICH
PROVIDES ASSURANCE TO AN ORGANIZATION’S MANAGEMENT AND
CUSTOMERS THAT A SYSTEM FOR QUALITY MANAGEMENT IS ESTABLISHED AND
IS IN EFFECT. THE STANDARDS FOCUS ON DOCUMENTATION OF OPERATIONAL
PROCEDURES AND MANAGEMENT PRACTICES TO FULFILL CUSTOMER
EXPECTATION
CONFORMANCE TO THE
STANDARDS IS ASSURED VIA AN INTERNATIONAL SYSTEM OF THIRD PARTY
ACCREDITATION AND REGISTRATION BODIES
Importance of
ISO 9000 Standards
Competing Globally
ISO 9000 FAMILY -
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
Widespread Acceptance
‘Demonstrated
Compliance’ is fast becoming an expectation
Over 100,000
registrations world-wide
QS-9000
verbatim reproduction
of ISO 9001
specific additions
production part
approval,
requirements for
specific manufacturers
TE-9000
- tooling and capital equipment
Others...
ISO Standards
An Approach to
using the Standards
Overview
of Quality Management and
Direction
for choosing standard
TERMINOLOGY
ISO
9000-1AND ISO 9004 -1 RECOMMENDATIONS: "should"
ISO
9001,9002,9003 - REQUIREMENTS: "shall"
THE QUALITY
ASSURANCE STANDARDS
ISO
9001 - MOST COMPREHENSIVE
ISO
9002 - IDENTICAL TO ISO 9001 EXCEPT FOR CONTROL OF
DESIGN
ISO
9003 - FOCUS IS ON FINAL INSPECTION AND TEST
PHILOSOPHY OF
THE STANDARDS
SAY WHAT
YOU DO
DO WHAT
YOU SAY
RECORD
WHAT YOU DID
CHECK ON
THE RESULTS
ACT ON
THE DIFFERENCE
STRUCTURE OF ISO
9001 - THE HEART OF THE STANDARD IS IN CLAUSE 4
4.1
Management Responsibility
4.1.1
Quality Policy
4.1.2
Organization
4.1.2.1
Responsibility and authority
4.1.2.2
Resources
4.1.2.3
Management Representative
4.1.3
Management review
4.2 Quality
System
4.2.1
General
4.2.2
Quality System Procedures
4.2.3
Quality Planning
4.3
Contract Review
4.3.1
General
4.3.2
Review
4.3.3
Amendment to a contract
4.3.4
Records
4.4 Design
Control
4.4.1
General
4.4.2
Design and development planning
4.4.3
Organizational and technical interface
4.4.4
Design input
4.4.5
Design output
4.4.6
Design review
4.4.7
Design verification
4.4.8
Design validation
4.4.9
Design changes
4.5
Document and data control
4.5.1
General
4.5.2
Document and data approval and issue
4.5.3
Document and data changes
4.6
Purchasing
4.6.1
General
4.6.2
Evaluation of subcontractors
4.6.3
Purchasing data
4.6.4
Verification of purchased product
4.6.4.1
Supplier verify at subcontractor’s premises
4.6.4.2
Customer verify subcontracted product
4.7 Control
of customer-supplied product
4.8 Product
identification and traceability
4.9 Process
control
4.10
Inspection and testing
4.10.1
General
4.10.2
Receiving inspection and testing
4.10.3
In-process inspection and testing
4.10.4
Final inspection and testing
4.10.5
Inspection and test records
4.11
Control of inspection, measuring and test equipment
4.11.1
General
4.11.2
Control procedure
4.12
Inspection and test status
4.13
Control of nonconforming product
4.13.1
General
4.13.2
Review and disposition
4.14
Corrective and preventive action
4.14.1
General
4.14.2
Corrective action
4.14.3
Preventive action
4.15
Handling, storage, packaging, preservation and delivery
4.15.1
General
4.15.2
Handling
4.15.3
Storage
4.15.4
Packaging
4.15.5
Preservation
4.15.6
Delivery
4.16
Control of quality records
4.17
Internal quality audits
4.18
Training
4.19
Servicing
4.20
Statistical techniques
4.20.1
Identification of need
4.20.2
Procedures
4.1 MANAGEMENT
RESPONSIBILITY
Establish
and communicate a quality policy
Set
quality objectives
Identify
responsibilities related to the quality system
Allocate
resources
Appoint
management representative
Conduct
management reviews
QUALITY POLICY
Describe goals,
priorities of company in a clear, straightforward
manner
Make it so that
employees can relate the Quality Policy to their
daily work
Recognize the needs of
Customers (internal as well as external)
Identify
responsibilities
QUALITY POLICY?
"The college
of business supports the concept of quality and the importance of
maintaining student satisfaction"
ANOTHER QUALITY
POLICY
"Our policy is for management
to provide the training and leadership to all employees in the
art of continuous improvement to constantly seek improved quality
at reduced costs that still exceed the expectations of our
customers."
ISO 9000 AND TQM
ISO 9000 establishes
minimum requirements
Except for process
quality and corrective and preventive action,
ISO 9000 is far short of the Baldrige model of TQM
ISO 9000 system is
essential to development of more progressive system
Bridge between
traditional ‘output’ focus and TQM system
that focuses on ‘process’
ISO 9000 is a
milestone in progress towards TQM
United States
Approach
American
National Accreditation Program for Registrars of
Quality Systems
American National
Standards Institute - ANSI
Registrar
Accreditation Board - RAB
American Society for
Quality Control - ASQC
About
50 U.S. Registrars
About
50% accredited under U.S. program
The Registration
Process
Prepare for registration
Pre-assessment
Formal registration process
Introductory visit
Formal assessment
is quality system, as
documented, adequate to satisfy the requirements and
scope of the chosen standard?
is there evidence that
employees are consistently following documented
procedures?
- is the quality system, as designed,
documented, and implemented, effective in meeting
customer requirements and preventing nonconformance?
Registration
Process continued
company may use registration
mark in general literature and descriptions of company in
advertising
may not put mark on products
or otherwise imply that products are registered
Regular surveillance audits
complete reassessment in
(usually) 3 years
Implementing ISO
9000 Registration
Two major principles:
Use experience,
systems, procedures you already have in place
Everything you do
should make long-term good business sense
INTERNAL
PREPARATION
Achieve commitment
2. Plan and organize
3. Define and Analyze
Processes
4. Develop Quality Plans
identify
quality requirements
translate
requirements into process characteristics
identify
control measures for characteristics
map
measures to processes
verify
adequacy of measures
modify
measures
5. Design/Refine the
Quality System
6. Document the Quality
System
Create/refine
procedures
create documentation
review and approve
documentation
create/refine Quality
Manual
conduct management
review
7.Implement Quality System
ensure employee
competencies
implement new/refined
procedures, instructions
track performance
revise procedures,
instructions
conduct management
review
8. Conduct Pre-Assessment
Motivations,
Benefits, Costs, and Savings
Deloitte &
Touche Survey, September 1993
Primary Motivations
Customer
Demands (60% primary/ 83% top 3)
Quality
Benefits (22%/62%
Market
Advantage (18%/77%)
Corporate
Mandate(9% primary)
Part of Larger
Strategy(9%)
Selling in EU
(9%)
Benefits
Higher perceived quality
(34%/76%)
Improved customer
satisfaction (27%/66%)
Fewer customer audits
(9%/41%)
Competitive Edge (22%/69%)
Increased Market Share
(5%/22%)
Better Documentation
(32%/73%)
Better Quality Awareness
(26%,75%)
Improved Productivity
(16%/53%)
Positive Cultural Change
(15%/47%)
What Caused
Benefits?
Process Control
Average Annual
Savings
>
$50M sales - 70% of registration cost annually
<
$50M sales - 50% of registration cost annually
30% of
all companies reported recovering cost in one year or less
20% of
all companies report that it would take more than 10 years
