International Organization

International Organization
for Standardization
for Standardization

www.iso.org
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www.iso.org Running title of presentation 1
 Overview of ISO
9001 and ISO
14001

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 ISO 9000

ISO is the International Organization for standardization

headquartered in Geneva, Switzerland.
"ISO" is not an acronym.
ISO is a non-governmental organization started its
operation in 1947.
The mission of ISO is to promote the development of
standardization and related activities in the world with a
view to facilitating the international exchange of goods and
services and to developing cooperation in the spheres of
intellectual, scientific, technical and economic activity.

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 ISO 9000

ISO 9000 is a Quality Management System

Voluntary certification
Not a product certification
Not a life time certification
Revised every 5 years. Latest is ISO 9000:2000
ISO has no authority to enforce implementation of
standards

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 ISO 9000:2000

ISO 9000 series

ISO 9000:2000 Fundamentals and vocabulary
ISO 9001:2000 QMS Requirements
ISO 9004:2000 QMS guidelines for
performance improvement

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 ISO 9001 and ISO 14001 in brief

ISO 9001 and ISO 14001 are among ISO's most well
known standards ever.

They are implemented by more than a million

organizations in some 175 countries.

ISO 9001 helps organizations to implement quality

management.

ISO 14001 helps organizations to implement

environmental management.

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 Quality management

ISO 9001 is for quality management.

Quality refers to all those features of a product (or service) which are
required by the customer.
Quality management means what the organization does to
ensure that its products or services satisfy the customer's quality
requirements and
comply with any regulations applicable to those products or services.
enhance customer satisfaction, and
achieve continual improvement of its performance.

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 Environmental management

ISO 14001 is for environmental management.

This means what the organization does to:
minimize harmful effects on the environment
caused by its activities,
to conform to applicable regulatory
requirements, and to
achieve continual improvement of its
environmental performance.

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 Generic standards

ISO 9001 and ISO 14001 are generic standards.

Generic means that the same standards can be
applied:
to any organization, large or small, whatever its
product or service,
in any sector of activity, and
whether it is a business enterprise, a public
administration, or a government department.

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 Generic standards (cont.)

Generic also signifies that

no matter what the organization's scope of activity
if it wants to establish a quality management
system, ISO 9001 gives the essential features
or if it wants to establish an environmental
management system, ISO 14001 gives the
essential features.

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 Processes, not products

Both ISO 9001 and ISO 14001 concern the way

an organization goes about its work.
They are not product standards.
They are not service standards.
They are process standards.
They can be used by product manufacturers
and service providers.

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 Certification and registration

Certification is known in some countries as

registration.
It means that an independent, external body
has audited an organization's management
system and verified that it conforms to the
requirements specified in the standard (ISO 9001
or ISO 14001).
ISO does not carry out certification and does
not issue or approve certificates,

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 Accreditation

Accreditation is like certification of the certification body.

It means the formal approval by a specialized body - an
accreditation body - that a certification body is competent
to carry out ISO 9001:2008 or ISO 14001:2004
certification in specified business sectors.
Certificates issued by accredited certification bodies - and
known as accredited certificates - may be perceived on
the market as having increased credibility.
ISO does not carry out or approve accreditations.

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 Certification not a requirement

Certification is not a requirement of ISO 9001

or ISO 14001.
The organization can implement and benefit from
an ISO 9001 or ISO 14001 system without having
it certified.
The organization can implement them for the
internal benefits without spending money on a
certification programme.

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 ISO does not certify

ISO does not carry out ISO 9001 or ISO 14001

certification.
ISO does not issue certificates.
ISO does not accredit, approve or control the
certification bodies.
ISO develops standards and guides to
encourage good practice in accreditation and
certification.

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 The ISO 9000 family

ISO 9001 is the standard that gives the

requirements for a quality management system.
ISO 9001:2008 is the latest, improved version.
It is the only standard in the ISO 9000 family that
can be used for certification.
There are 16 other standards in the family that
can help an organization on specific aspects such
as performance improvement, auditing, training…

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 The ISO 14000 family

ISO 14001 is the standard that gives the requirements for

an environmental management system.
ISO 14001:2004 is the latest, improved version.
It is the only standard in the ISO 14000 family that can
be used for certification.
The ISO 14000 family includes 21 other standards that
can help an organization specific aspects such as
auditing, environmental labelling, life cycle analysis…

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 8 QUALITY MANAGEMENT
PRINCIPLES( As per ISO 9000 Standard )
• 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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 QMS DOCUMENTATION

Quality Policy
Quality Objectives
QMS Procedures
Work Instructions
Records

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 Quality Audit
To check practice against procedure
To document any non Conformity
First party audit (Internal audit)
Second party audit
Third party audit
Compliance audit
Surveillance audit

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 The ISO Survey

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 The ISO Survey (cont.)

The worldwide total of certificates to ISO

9001:2001 at the end of 2007 was 951 486.
This was increase of 6 % over 2006 when the
total was 896 929 certificates.
Certificates had been issued in 175 countries
compared to 170 the previous year.

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 The ISO Survey (cont.)

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 The ISO Survey (cont.)

The worldwide total of ISO 14001 certificates at

the end of 2007 was 154 572.
This was an increase of 21 % over 2006 when
the total was 128 211.
Certificates had been issued in 148 countries
compared to 140 the year before.

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 Benefits of ISO 9001 and ISO 14001

International, expert consensus on state-of-the-art

practices for quality and environmental
management.
Common language for dealing with customers
and suppliers worldwide in B2B.
Increase efficiency and effectiveness.
Model for continual improvement.

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 More information

ISO 9000/ISO 14000 section on ISO Web site:

www.iso.org
ISO Management Systems magazine
www.iso.org/ims
IMS Alerts free electronic newsletter
www.iso.org/imsalerts

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 Resources

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 SIX SIGMA

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 Six Sigma
• Six Sigma is a business improvement approach
that seeks to find and eliminate causes of defects
and errors in manufacturing and service processes
by focusing on outputs that are critical to customers
and results in a clear financial return for the
organization.
• Used by companies including Motorola, Allied Signal,
Texas Instruments, and General Electric.

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 Chapter 15 Quality Management

Six Sigma
Defects are any mistakes or errors that are passed on
to the customer (many people also use the term
nonconformance).

Defects per unit (DPU)=Number of defects discovered

Number of units processed

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 Chapter 15 Quality Management

Six Sigma
• The Six Sigma concept characterizes quality
performance by defects per million
opportunities (dpmo), computed as DPU 
1,000,000 opportunities for error (or, as is
often used in services, errors per million
opportunities – epmo).

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 Chapter 15 Quality Management

Six Sigma
• A DPU measure might be lost bags per customer.
However, customers may have different numbers of bags;
thus the number of opportunities for error is the average
number of bags per customer.
• If the average number of bags per customer is 1.6, and
the airline recorded 3 lost bags for 8,000 passengers in
one month (note: 12,800 opportunities for error in one
month), then
epmo = (3/8,000 DPU)  1,000,000/1.6 = 234.375

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 Chapter 15 Quality Management

Six Sigma’s DMAIC Process

1. Define: identify customers and their priorities; identify
and define a suitable project; identify CTQs (critical to
quality characteristics).
2. Measure: determine how to measure the process and
how it is performing; identify key internal processes
that influence CTQs and measure current defects.
3. Analyze: determine likely causes of defects and
understand why defects are generated by identifying
key variables that cause process variation.

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 Chapter 15 Quality Management

Six Sigma’s DMAIC Process

4. Improve: identify means to remove causes of
defects; confirm key variables; modify the
process to stay within acceptable range.
5. Control: determine how to maintain
improvements; put tools in place to ensure that
key variables remain within acceptable ranges
under the modified process.

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 Managing for Quality

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 QUALITY

Quality consists of the capacity to satisfy wants

(Deming)

Quality is fitness for use (Juran)

Quality is conformance to requirements (Crosby)

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 The Big Man W. Edwards Deming
Ph.D. in Physics
Western Electric in 1920’s, 30’s.
WWII taught Quality Control for war effort
Ignored after the war
Japan wanted to learn from the US

Deming went to help with census

Started teaching them quality control
1951 Deming Prize for high level of achievement in quality
practices
1980 NBC “If Japan Can…Why Can’t We?” US discovers

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Exhibit Extra The Deming Cycle

• Plan: study current situation

• Do: implement plan on trial basis
• Study: determine if trial is working correctly
• Act: standardize improvements
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 Quality Philosophy
“A product or service possesses quality if it helps somebody
and enjoys a good and sustainable market.”
Variation is the cause of poor quality
The Process
Product/service design
Manufacture/service delivery
Test
Sales
Market surveys
Redesign and improvement

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 Improve Quality

Costs decrease because of less

Chain Reaction rework, fewer mistakes, delays,
better use of time & materials

Productivity Improves

Capture market with better

quality and price

Stay in business

Provide jobs and

more jobs

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 Deming’s 14 Points
1. Create a vision and demonstrate commitment

1. Long-term vision
2. Companies purpose is to serve their customers and employees,
not simply for profit
3. Invest in innovation, training, research
4. Improve competitive position
5. Top management is responsible for this
6. Effective leadership begins with commitment

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 14 Points

2. Learn the New Philosophy

1. Quota-driven, adversarial management won’t work

2. That ignores importance of quality improvement
3. Labor and management have to cooperate to improve the
customers’ satisfaction
4. Keep training people – turnover does exist
3. Understand Inspection

1. Routine inspection – let someone else fix it

2. Increases costs in the end (no rework in services)
3. Inspect your own work and fix it

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 4. Don’t Buy on the Cost per Part Basis

Don’t buy from several for competition

Increases variability
Work with suppliers in long-term relationships
Improve quality with your suppliers
Also get volume discounts, fewer setups
Supplier-customer bond

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 5. Improve Constantly and Forever
Reduce causes of variation
Engage all employees
How to do jobs more efficiently
More effectively
Continuous Process Improvement now is
mandatory

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 6. Institute Training

People are a valuable resource and want to do a good job

They need training to know how to do a good job
Invest in their future
Training should include tools for

Diagnosing
Analyzing
Solving quality problems
Identify improvement opportunities

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 7. Institute Leadership

The job of management is leadership, not

supervision.
If supervisors don’t know the job, they can’t lead
Focus on getting product “out the door”
Good supervisors are coaches, not prison guards

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 8. Drive Out Fear

Managers and workers must have mutual respect,

2 way communication
Pointing out quality problems and will everybody
will work effectively

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 9. Optimize the Efforts of Teams
People have to understand what customers want
No barrires should be there between R&D, Sales,
Admin, Production….
Team should tackle the problem

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 10. Eliminate Exhortations
Do you work better with a poster on the wall?
Slogans assume quality problems caused by people
Deming thinks the system is responsible for problems
Workers demoralized when they cannot fix defects,
and yet are held accountable
Workers’ attempts to fix problems only cause more
variation

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 11. Eliminate Numeric Quotas
They do not encourage improvement

If you do improve it, they’ll just raise the quota

Risk of missing quotas
Once you meet the standard, why try harder?
Arbitrary (random) goals are demoralizing without a plan of how
you can reach those goals
Variability in system year-to-year
Use statistical method to improve quality

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 12. Remove Barriers to Pride in Workmanship

People are treated like a commodity

Work nights to make up for cut positions
Don’t make your people compete against each
other
Behavior driven by what boss wants, not Quality

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 13 Education & Self-Improvement

Not job-specific
Many benefits, some specific to job, others broader
An org not only need good people but also people who
improve with eduction

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 14. Commitment from Top

Accomplish the Transformation

Start the cultural change with top management
People will be skeptical until they start to see
change

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 Joseph Juran

Joined Western Electric in 1920s.

1951 – Quality contol handbook
Taught quality principles to Japanese in 1950s

Quality directed by senior management

Train whole mgt hierarchy in quality
Strive for evolutionary changes in Quality
Report progress to executive levels
Involve the workforce in quality
Quality part of reward/recognition structure

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 Quality Trilogy

Quality Planning
Preparing to meet quality goals, Identify customer,
determine there need, translate those need into our
language, develop a pdt that can respond those
needs and optimize the pdt feature to meet cm need.
Quality control
Meeting quality goals during operations, Develop a
process which is able to produce pdt, optimise the
process

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 Quality improvement
Breaking through to unprecedented levels of
performance, prove that the process can produce
the product under operating condition and optimize
the process

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 Philip Crosby

Corporate VP for Quality at International

Telephone and Telegraph, ITT for 14 years.
Quality is Free – 1 million copies sold.
He talked about 4 absolutes of quality (the
definition, the system, the performance standard
and the measurement)

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 Philip Crosby
Quality means conformance to requirements, not
elegance
Either you meet the requirements or not
Determine requirements up front, and very carefully
There is no such thing as a “quality” problem
There are accounting, mfg, design problems
Quality originates in those depts., not in QC
There is no “economics of quality”

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 Crosby Philosophy
Only quality cost is non-conformance
15-20% of sales on quality costs
Well-run, it can be 2.5%
Measure & publicize cost of poor quality
Provides visible signs of improvement
Zero Defects
Do it right the first time, prevent defects, don’t fix them
Human errors from lack of attention, because we assume errors are
inevitable

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 Chapter 15 Influential Leaders in Quality Management

Philip B. Crosby
• Wrote Quality is Free in 1979, which brought quality to the
attention of top corporate managers in the U.S.
• Crosby’s Absolutes of Quality Management include:
 Quality means conformance to requirements, not elegance.
 There is no such thing as a quality problem.
 There is no such thing as the economics of quality; doing the
job right the first time is always cheaper.
 The only performance measurement is the cost of quality,
which is the expense of nonconformance.
 The only performance standard is Zero Defects (ZD).

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 Crosbys 14 steps
Management Commitment
Q Improvement Team
Q Measurement
Cost of Quality
Q Awareness
Corrective Action
Zero defect planning
Supervisor training

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 ZD Day
Goal Setting
Error Cause removal
Recognition
Quality Council
Do it over again

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 QULAITY LEADERSHIP
Creating a vision
Commitment
Initiating cultural change
Strategic quality planning
Recognition & rewards
Empowerment

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 ACCEPTANCE SAMPLING

When the quantity to be inspected is huge a sample

from the lot is taken and based on the sample
inspection result a decision to accept or reject the
entire lot is taken. This is is called acceptance
sampling
Single sampling plan
Double sampling plan
Multiple sampling plan

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 ACCEPTANCE SAMPLING
Producer’s risk (Alpha risk)
Possible rejection of a lot that ought to be accepted
Consumer’s risk (Beta risk)
Possible acceptance of a lot that ought to be rejected
Acceptable Quality Level (AQL)
Maximum proportion of defectives that a consumer finds definitely
acceptable
Lot Tolerance Percent defectives (LTPD)
The proportion of defectives that the consumer finds definitely unacceptable

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 Acceptance Sampling vs. SPC
Sampling to accept or reject the immediate lot of
product at hand (Acceptance Sampling).
Determine quality level
Ensure quality is within predetermined (agreed)
level

Sampling to determine if the process is within

acceptable limits - Statistical Process Control
(SPC)

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 Acceptance Sampling
Advantages Disadvantages
Economy
Risks of accepting “bad”
Less handling damage lots and rejecting “good”
lots
Fewer inspectors
Upgrading of the inspection job Added planning and
documentation
Applicability to destructive
testing Sample provides less
Entire lot rejection (motivation
information than 100-
for improvement) percent inspection

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 A Single Sampling Plan

A Single Sampling Plan simply requires two

parameters to be determined:

n the sample size (how many units to sample

from a lot)

1. c the maximum number of defective items

that can be found in the sample before the lot
is rejected.

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 RISK

RISKS for the producer and consumer in sampling plans:

Acceptable Quality Level (AQL) Max. acceptable
percentage of defectives defined by producer.
 (Producer’s risk) The probability of rejecting a good lot.
Lot Tolerance Percent Defective (LTPD) Percentage of
defectives that defines consumer’s rejection point.
 (Consumer’s risk) The probability of accepting a bad lot.

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 AWARDS

Deming Award (Individual, Co. and Factory Price)

Malcom Baldgridge Award
European Foundation for Quality Management
Australian Award

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 Deming Price Checklist
Awarded by JUSE – 1950 – Overall Perf of CO.

Corporate Policy (Deployment)

Org and Admin (SQC in cross functional )
Education and Training (QCC activities)
Implementation (Collecting Info, Analysis,
Standardization, Control, Assurance)
Effect
Planning for future

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 Malcom Award-1987-US co.
Awareness of Quality, Understanding reqt of Q, Sharing Info

Evaluated on 1000 points category

Leadership 95
Info and Analysis 75
Process Mgmt 140
Business result 180
Customer Focus 300

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 THANK U

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