Quality Systems
International Standards for Quality
by
Randy Gooden and David Juriga
Background
ISO – International Organization for
Standardization
 Founded 1946 in Geneva, Switzerland
 Purpose – to promote international
standards to facilitate the exchange of
goods/services worldwide

Question

Why do you think it is necessary to have
ISO standards?
Reasons for a Quality System

Demand for quality from the customer
 Snowball effect – requires subcontractors
and suppliers to have built-in quality
 Helps to maintain market share
ISO 9000 Series of Standards

Designed to be generic and thus can be
tailored to any organization’s needs
 Simply requires an organization to say what
it is doing to ensure quality
 Documents what it says it is doing
Toyota Manufacturing

Perceived quality image
 Continuous improvement
 Employee participation
 Willingness to work in teams and share
ideas
 Continue to change
Toyota Achievements

Camry #1 selling car in U.S.
 TMMK’s assembly and powertrain ranked
#1 in North America for productivity by
Harbour Report
 ISO 14001 Certification
ISO 14001

Voluntary standard that deals with the
company’s environmental management
system.
 Verifies that each Toyota plant has a formal
environmental policy as well as a
management system
How Toyota Does It

Continuous improvement concepts
 Team member participation
 Using Kaizens (suggestion cards to improve
process)
 Rely on Toyota Production System
Kaizens

Last year had over 75,000 suggestions
– 7,000 team members
– 99.8% implementation of ideas
5 Standards in the Series

ISO 9000
 ISO 9001
 ISO 9002
 ISO 9003
 ISO 9004-1
ISO 9000

Quality Management & Quality Assurance
Standard Guidelines for Selection and Use
– Defines key terms
– Provides guidelines for tailoring ISO 9001, ISO
9002, and ISO 9003 standards
– Road map for entire series
ISO 9001

Quality Systems – a model for quality
assurance in design, development,
production, installation, and servicing
– Most comprehensive of standards
ISO 9002

Quality Systems – a model for quality
assurance in production, installation, and
servicing
– Does not focus on design
– Focuses on prevention, detection, and
correction standards
ISO 9003

Quality Systems – a model for quality
assurance in the final inspection and testing
– Least comprehensive
– Focuses on detection and control problems
ISO 9004 - 1

Quality Management and Quality System
Elements – guidelines
– Provides guidelines for developing and
implementing a quality system
Other Quality Systems

QS 9000
 TE 9000
 AS 9000
QS 9000

Characteristics
– Developed by General Motors, Ford, Chrysler
– Broader than ISO 9001
– Adds automotive/heavy trucking requirements
– Adds continuous improvement
– Establishes customer requirements unique to
Ford, General Motors, Chrysler
TE 9000

Characteristics
– Tooling and Equipment supplement
– Interprets QS 9000 as it relates to tooling and
equipment
AS 9000

Characteristics
– Aerospace industry
– Attempt to unify requirements of NASA, DoD,
and FAA
– Very similar to ISO 9000
Questions

When implementing a quality management
system, where do you first begin?
 What are some fundamental elements that
are necessary for a successful
implementation?
Implementing a Quality
Management System
1. Senior Management Commitment
•
•
CEO support
Committing necessary resources
2. Appointing Management Representative
•
•
Coordinates implementation
Contact person for everyone
Implementation Continued
3. Awareness
•
•
Everyone should understand the system
Training sessions
4. Appoint Implementation Team
•
Should be from all levels
5. Training
•
Should involve everyone (Teams,
supervisors)
Implementation Continued
6. Time Schedule
•
•
Schedule for implementation/registration
Should take less than 1.5 years
7. Select Element Owners
•
Owners for each of system elements
8. Review Present System
•
Should be first step in process
Implementation Continued
9. Write Documents
•
•
Written quality policy and procedure manuals
Everyone should be involved
10. Install New System
•
Integrate policies/procedures, work instructions
11. Internal Audit
•
Conduct audit of system – working effectively?
Implementation Continued
12. Management Review
•
To see if the system is achieving quality goals
13. Registration
•
•
•
Submit application
Choose registrar
Registrar audit
Documentation
1. Policy
•
•
Defines what will be done and why
Should be clear and easy to understand
2. Procedure
•
•
Describes methods that will be used to
implement and perform stated policies
Who, When, Where
Documentation Continued
3. Work Instructions
•
•
Department, machine, task – spells out how to
do job
Very detailed
4. Records
•
Documents that policies, procedures, and
work instructions have been followed
Elements of ISO/QS 9000
1. Management Responsibility
•
•
•
Quality Policy – short/concise statement that
defines organization’s objectives for quality
Responsibility & Authority – should be
defined for all personnel affecting quality
Management Review – to remain effective
(customer feedback, internal audits)
Elements
2. Quality System
•
•
•
Establish and maintain documents in QS
Policies, procedures, work instructions
Prevents problems (not detection)
3. Contract Review
•
Reviews contracts/PO’s – Are requirements
clearly defined?, Are there any unusual
quality requirements? Can we meet specs?
Elements
4. Design control
•
Establishes and maintains procedures to
control/verify that product design meets specs
5. Document and Data Control
•
Procedures and a master list is established to
control documents and data that affects
quality (blueprints, work instructions, task
procedures)
Elements
6. Purchasing
•
To establish and maintain documented
procedures to ensure that purchased materials
will conform to specs
7. Control of Customer-Supplied Products
•
•
Organization does not own item
Segregate so only used for that customer
Elements
8. Product Identification/Traceability
•
Identify product throughout all stages of
production, delivery, and installation
9. Process Control
•
•
Controlling processes – best way to prevent
problems
Monitoring systems/documented instructions
Elements
10. Inspection/Testing
•
•
•
Receiving – purchased items comply?
WIP – Early detection/Nonconformity
Final Inspection – final product meets specs?
11. Control of Inspection,Measuring, and Test
Equipment
•
Requires control, calibration, and
maintenance of all equipment
Elements
12. Inspection and Test Status
•
•
Look at product’s condition throughout production
Conforming to quality plan?
13. Control of Nonconforming Product
•
Identify, remove, and segregate
14. Corrective & Preventive Action
•
•
Should have documented procedures to detect
nonconformity
Be able to identify and fix problem
Elements
15. Handling, Storage, Packaging, Delivery
•
•
•
Incoming material/Finished goods – handled to
ensure protection from damage
Easily identify
Storage area secure
16. Control of Quality Records
•
•
Demonstrate achievement of required quality and
verify the effective and economical operation of the
quality system
Should be made available to customer
Elements
17. Internal Quality Audits
•
To ensure that quality system is working
according to plan
18. Training
•
•
Plant safety, technical skills, basic statistical
concepts.
Document that training requirements have
been fulfilled
Elements
19. Servicing
•
•
After-delivery service
Does service meet spec requirements
20. Statistical Techniques
•
Implement where suitable for
improvement/control of quality
Question

What are some of the benefits associated
with quality?
Results of Quality Systems

Reduced operating costs
 Fewer audits –(by the customer and
internally)
 Improved quality (internally/externally)—
this helps promote a perceived quality
image
Suggestions for Writing
Documentation
Keep it short and simple. Don’t “overdocument”
 Flowchart a process, if appropriate.
 Keep the audience in mind:
 Make the meaning very clear; have
someone else read it and explain to you
what it said.
 Make the text grammatically correct

Suggestions for Writing
Documentation

Search out errors in spelling and
punctuation.
 Avoid jargon
 Separate ideas into sentences or paragraphs.
 Ask the user to help write the
documentation.
For Every Task, Identify

Who is responsible for making sure that it is
done?
 Standards to be met / completion
 What resources are needed?
 What records are kept?
 What to do if it doesn’t work.
 Pretest procedures. Have those who will use
them try them and provide feedback.
Writing Documentation
Quality Manual
Step 1
 Use the format that can be used throughout the
documentation hierarchy.
Step2
 Helpful if documents follow the numbering
systems of the 20 elements.
Step3
 Simplicity & ease of use should determine the
structure to be used.
Writing Documentation
Quality Manual
To do this you should do the following:
A) Cover Page (Title, Organization Name, Location)
B) Table of Contents: (Revision Number or letter for
each document, location)
C) Quality Policy Statement
D) A Distribution Page (controlled and uncontrolled
copies
Outline Quality Manual

Quality Policy
 Quality Organization
 Statement of Authorization and
Responsibility
 Distribution List of Controlled Copies
 Quality System
 Procedures Index
 Form Index (Included or Referenced)
Outline Quality Procedure

Cover Sheet
 Table of Contents (with current revision
level)
 Purpose/Objective: Aim of the procedure
 Scope: What the procedure does or doesn’t
do
 Responsibilities: who (by job function) has
the responsibility for the task or actions
Outline Quality Procedure

Reference: To all documents covered under
the procedure
 Definitions: Of key terms and acronyms
 Procedure: Description of the action or task
to be carried out, by whom and in what
sequence
 Documentation: What documentation is
needed
Work / Job Instructions

Start from existing writing work / job
instructions
 Consider using the team approach
 Verify existing instructions
 Adopt improved practice, if necessary
 Flowchart complex operations
 Verify instructions are being followed
 Use work instructions for training
Internal Audits
Five Objectives





Determine that it actually conforms to the
documentation quality system.
Initiate corrective action activities in response to
deficiencies.
Follow up on noncompliance items of previous
audits.
Provide continued improvement in the system
through feedback to management.
Cause the auditee to think about the process,
thereby creating possible improvements
Internal Audits
How to do it

Develop an overall plan
 Identify the activities to be audited
 Schedule audits
 Establish the qualifications of audit
personnel
 Experience
Internal Audits
How to do it

Training
 Availability
 Conduct the audit
 Submit audits to management
 Take corrective action
Registration
Two parts
 Selecting Registrar
 Registration Process
Four criteria’s for selecting a
Registrar

Qualification / Experience
 Certificate Recognition
 Registration Process
 Cost & time constraints
Six Basic Steps of
Registration

Application for Registration
 Document Review
 Reassessment
 Assessment
 Registration
 Follow up Surveillance
Thank you for your attention