ISO
INTERNATIONAL
ORGANIZATION FOR
STANDARDIZATION
I.S.O. or ISO?
• ISO is not an acronym, but was derived from a
Greek word “isos” meaning “equal”. The relation
to standards is that if two objects meet the same
standard, they should be equal.
• The International Organization for
Standardization is a voluntary organization
whose members are recognized standard
authorities, each one representing one country.
• The American National Standards Institute (ANSI)
is the United States Representative to ISO.
• ISO Main Headquarters in located in Geneva,
Switzerland.
Some History
• (AQAP) Allied Quality Assurance
Publication..WW11. A series of publications on
everything from production efficiency to selection
of suppliers.
• AQAP Series was adopted by the UK Ministry of
Defense for the British Arms Forces.
• A trickle down effect was more organizations
began to require Quality Assurance Programs
from their Suppliers.
• 1979 British Standard (BS) 5750 adopted based
largely on the AQAP Series. The British version
addressed the diversity issues emerging in the
requirements for different organizations.
More History
• BS 5750 was so effective, it was
adopted with very little changes by
ISO in 1987 as ISO 9000.
• The formation of the European Union
and the perception that it (ISO) was
required in order to do business with
Europe, lead to the widespread
acceptance of the ISO series.
MIL-Q-9858 & MIL-I-45208
USA
• ONE SIZE FITS ALL APPROACH
• NO ALLOWANCE FOR INNOVATIONSPROCESS MATURITY
• POTENTIAL CUSTOMER COST SAVINGS
LOST
• DETAILED DESIGN SPECS REPLACED
WITH PERFORMANCE-BASED SPECS.
• IN 1996, THESE MODELS WERE
SUPERCEDED WITH ANSI/ASQC Q-9000
SERIES
Commercial- Military
Integration
1994-Acquisition Reform
• Reduce total ownership costs
• Reduce acquisition time
• Promote standardization of
materials, facilities,and engineering
practices to improve military
readiness
Defense Standardization
Program
• Gov’t unique specifications were a
barrier to commercial-military
integration
• Cancelled or inactivated thousands
of documents
• Greater reliance on the use of nongovernment standards
Every ISO Member Body is
responsible for:
• Informing potentially interested parties in the
country of relevant international standardization
opportunities/initiatives
• Ensuring that a concerted view of the country’s
interest is presented during international
negotiations leading to standards agreement
• Providing their share of financial support for the
central operations of ISO, through the payment of
membership dues
• Representing vendors, manufacturers,
consumers, professionals and government of it’s
country
Other Members
• Correspondent Member-usually an
organization in a country which does not yet have a fully
developed national standards activity. Do not take an active
part in the technical and policy development work, but are
kept fully informed about the work of interest to them
• Subscriber Membership-established for
countries with very small economies. Subscribers members
pay reduced membership fees that nevertheless allow them
to maintain contact with international standardization.
How is it financed?
• Membership dues-80%
• Sales of Standards and other Publications-20%
• Subscriptions are expressed in units and
calculated in Swiss francs
• Factors affecting dues: gross national product
(GNP) and Value of imports and exports
• Others expenditures: Voluntary time and travel
for approx. 30,000 experts (several hundred
million Swiss francs per year)
Who does the work?
• A highly decentralized hierarchy of some 2850 technical
committees, subcommittees and working groups. Hence
the 30000 experts. The premise is that equal partners come
together in the resolution of global standardization
problems
• Qualified representatives of;
industry
research institutes
government authorities
consumer bodies
international organizations from all over the world
The Goal of ISO
• Enhanced product Quality and Reliability at a
reasonable price
• Improved health and safety and environmental
protection and reduction of waste-(ISO 14000)
• Greater compatibility and interoperability of
goods and services
• Reduction in the number of models and thus,
reduction in costs
• Increased distribution efficiency and ease of
maintenance
• Simplification for improved usability
ISO and WTO
• Strategic partnership-common goal of
promoting free and fair global trading
• WTO agreements require underpinning by
technical agreements (ISO)
• ISO recognized by WTO for special
technical support in relationship to new
and expanded WTO programs
Regional Partners
• ISO has recognized regional standards
organizations representing:
 Africa
 The Arab Countries
 Commonwealth of Independent States
 Europe
 Latin America
 The Pacific area
 South-East Asia Nations
(Some) ISO “Achievements”
•
ISO Film Speed Code-among
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photographic equipment standards, it has
been adopted worldwide to make things
simpler for the user
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Internationally Standardized
Freight Container-air, sea
railways,highways packages interface
efficiently. Other standardized documents
identifying sensitive or hazardous
cargoes making international trade
cheaper, faster and safer.
•
conveys a clear cut message in a multilingual world. These symbols are
displayed in automobiles over the world,
no matter where they were produced.
Telephone & Banking Cardsstandardization of the format means that
they can be used worldwide
Paper Sizes-With ISO 216, standard
paper sizes allow economies of scale
with cost benefits to both producers and
consumers
Symbols for Automobile
Controls-well designed symbol
12,000 International
Standards-more than 300,000
pages in English and French with
terminology provided for other
languages
•
Others:
Automobile bumper heights, sizes and
colors of road signs, hygiene and toxicity
in the food industry, nut /bolts
combinations, light measurement in
photography, child resistant
packaging,standards for monitoring the
state of the environment and standards
for safety of machinery and protective
clothing
ISO 9000 Series
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ISO 9001-applies to organizations that design, develop, produce,
install and service product (Tenergy Water, for instance)
20 sets of Quality System Requirements (Elements)
ISO 9002-applies to organizations that produce, install and service
product
19 sets of Quality System Requirements (Elements)
ISO 9003-applies to organizations that assure Quality through
Final Inspection and Testing.
16 sets of Quality System Requirements (Elements)
(missing 4.4, 4.6, 4.9 and 4.19)
What exactly is ISO 9001?
• A series of Standardized Quality
System “Frameworks” which are
designed to detect and prevent
Quality problems.
• There are 20 Elements in the ISO
9001 Standard. Each element
outlines Quality issues which the
company is required to address as
part of the Quality System in order to
be certified or compliant.
The Elements
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1. Management Responsibility
2. Quality System
3. Contract Review
4. Design Control
5. Document and Data Control
6. Purchasing
7. Control of Customer
Supplied Product
8. Product Identification and
Traceability
9. Process Control
10. Inspection and Testing
11. Control of Inspection,
Measuring & Test
Equipment
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12. Inspection & Test Status
13. Control Of Nonconforming
Product
14. Corrective & Preventive
Action
15. Handling, Storage,
Packaging, Preservation &
Delivery
16. Control of Quality Records
17. Internal Quality Audits
18. Training
19. Servicing
20. Statistical Techniques
4.1 Management
Responsibility
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Commitment
Overall Plan
Steering Committee
Quality Objectives
Management Review
Appoint a senior executive ( The management
Representative) to manage the quality system and
give him/her the necessary authority to
maintain it
Management Responsibility
2
• Define a Quality Policy. Policy should describe
company’s attitude towards Quality
• Identify and provide resources for people to
manage, perform and verify Quality System work
• Define Quality System responsibilities; insure
Quality System personnel have the authority to
carry out these responsibilities and ensure that
interactions between these personnel are clearly
specified. Document this well.
• Define a procedure that Senior Managers can use
to review the effectiveness of the Quality System
4.2 Quality System
• Develop the Quality System
• A manual that describes it
• Procedures, processes that are consistent
with Quality Policy
• Quality plans to show how you intend to
fulfill quality system requirements
• Develop plans for product, processes,
projects and Customer Contracts
4.3 Contract Review
• Determine Requirements
• Procedure to ensure that all contractual
requirements are acceptable before
agreement to provide product to customer
• System for documenting review of
customer contracts and sales orders
• Procedure to amending contracts and
ensuring changes are communicated
throughout the organization
4.4 Design Control
• Procedures to control the design and
development process
• Identify groups involved and communication
methods
• Procedure to control design outputs
• Design outputs at all stages verified
• Design modifications-how are changes
implemented?
• Design inputs identified, documented, reviewed,
flaws and deficiencies are resolved
Design Control 2
• 4.4.1 General
• 4.4.2 Design and
development
planning
• 4.4.3
Organizational and
Technical
Interfaces
• 4.4.4 Design Input
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Design Output
Design review
Design verification
Design validation
Design Changes
4.5 Document & Data
Control
• Develop procedures to control
quality system documents, records
and data
• Procedures to review, approve and
manage all quality system
documents, records and data
• Procedures to control changes to
documents and data
4.6 Purchasing
• Supplier Selectionbased on capability,
performance history
• Customer
Requirements
Flowdown
• Ensure P.O.’s
document precisely
what to buy
• Purchase Order
change control
• Procedures to verify
the acceptability of
purchases to you and
the Customer
• List of Approved
Suppliers-procedure
to add or delete from
the list
• Use of approved
Suppliers
4.7 Control of Customer
Supplied Product
• Correct & undamaged when received
• Record & report to Customer
damage, etc.
• Traceable ownership
• Identification and Use
• Protect and Maintain (how & who)
• Dispose as Customer directs
4.8 Product Identification
and Traceability
• Identify and document products at every
step from purchase through all stages of
handling, storage, production, delivery,
installation and servicing
• Prevent product mixing
• Trace product or product batches by
means of unique identifiers and record
keeping
4.9 Process Control
• Develop procedures to plan, monitor
and control production, installation
and servicing processes
• Develop a record keeping system
that monitors and controls process
personnel and equipment
• Insure that all important processes
qualities are monitored and recorded
4.10 Inspection & Testing
• Quality Plan-decide where, when and
how-(incoming, in-process and final
inspections)
• How records are maintained
• Identification (Acceptance/Rejection)
• Disposition (Acceptance/Rejection)
• Procedures to ensure product meets
all requirements prior to shipping
4.11 Control of Inspection,
Measuring & Test Equipm’t
• Develop procedures to control,
calibrate and maintain inspection,
measuring/test equipment (hardware
and software)
• Ensure measurement equipment is
appropriate, effective and secure
• Calibration procedures for all quality
measuring and test equipment
4.12 Inspection & Test
Status
• Identify conformance statusaccept/reject at all points of
production process
• The test status of the product is
documented and respected
throughout the production,
installation and service process
4.13 Control of
Nonconforming Product
• Prevent from
unintended use
• Documented
• Identify and segregate
• Disposition by
qualified personnel
(MRB)
• Observe contractural
or regulatory
limitations
• Identify root cause of
defect
• Record of
dispositions
• Reinspect/retest after
rework and repair
4.14 Corrective and
Preventive Action
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Implement at root cause of defect
Identify effectivity-date, lot, batch
Identify responsibility for the problem
Commensurate with the magnitude of
problem and risks encountered
• Anticipate problems-preventive action
• Ensure effectivity of corrective/preventive
actions
4.15 Handling, Storage,
Packaging, Preservation &
Delivery
• Methods to prevent damage or
deterioration through all stages of
production
• Designate storage areas
• Periodic assessment of material in storage
• Identify shelf-life sensitive items
• Protect to destination when required
4.16 Control of Quality
Records
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What records are “Quality Records”?
How long to retain, where, how?
Define storage conditions
Customer availability
Hard copy or electronic media
Protect from unauthorized access
and subsequent alteration
4.17 Internal Quality Audits
• What we say we do
• Measure performance
of the Quality System
• Scheduled events
performed by qualified
auditors independent
of their functions
• Objective evidence
• Report to
management for
review
• Discuss with auditee
• Timely and
appropriate corrective
action
• Follow up for
effectiveness
4.18 Training
• Identify needs
• Who to train?
• Who will provide
the training?
• How will training
be provided?
• Quality system
training
• What is training
schedule?
• How will training
effectiveness be
measured?
• What training
records will be
generated?
4.19 Servicing
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Installation
Returned product-not defective
Technical information
Trained personnel
Procedures, materials, equipment
Train customer personnel
4.20 Statistical Techniques
• Establish, control & verify process
capability
• Measure product characteristics
• Defined by qualified personnel
• Documented procedures
WHY DO WE NEED IT?
• can be Customer driven.
• Inspires more confidence in products
and services that conform to the
same standards
• Improves internal controls
• Increases employee involvement
• provides a competitive edge
Benefits for me?
• Potential increase in business
volume which means job stability
• Outlet for ideas affecting Quality
• More control of your job
• Decrease in uncertainty of
expectations
• Less stress
Does it change how we do
things?
• No, in most cases. It means we
document what we are already doing.
• “Document what you do and do what
you say you do.”
• There would be some areas that will
require written procedures to meet
certain specific requirements.
The Process(in a nutshell)
• Create procedures • Independent third
that meet the ISO
party audit
Model for a Quality
conducted by a
Management
Registrar for
System
certification
• Train internal
• Maintain quality
auditors to perform
system. Audited
system audits.
every six months
to remain certified
ISO 9001:2000 Process
Model
ISO 9001:2000
• Why are standards
being revised?
• What are the major
changes?
• What do we do
now?
When will it happen?
• Final standard release is scheduled for
December 15, 2000.
• In three (3) years from the actual
publication release, ISO 9002 and ISO
9003 and all associated guidelines will be
history.
• ISO 9001 Quality Management Systems
will have to be amended to comply with
the new standard.
Why the need for change?
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ISO required 5-year standards review
Difficult for small businesses
Oriented towards manufacturing
Proliferation of guideline standards
Need to reduce documentation
Some Changes
• ISO 9001-ISO 9002-ISO 9003 (3 Stds)
will become ISO 9001:2000 (1Std)
• 20 Sections(Elements) Structure will
become main 5 Sections based on 8
Principles
• From a Quality Management System
to a Business Management System
KEY NEW REQUIREMENTS
• Process
oriented/continual
improvement
• Increased emphasis
on role of Top
Management
• Consideration of legal
and regulatory
requirements
• Establishment of
measurable
objectives/planning
• Determination of
training effectiveness
• Measurement and
analysis of system
performance (process
and product)
• Monitoring of
information and
customer satisfaction
dissatisfaction
• Increased attention to
resource availability
Let’s make believe
• Contract Review-procedures to assure your
customer needs and expectations are converted
to Customer Requirements
• Established employee awareness and training
programs
• Defined processes for evaluating the training
program’s effectiveness
• Defined processes for internal communication
More make believe
• Defined processes for communicating with
Customers regarding: product information, order
handling, and processing, customer complaints
and customer feedback.
• Added employee communication and training
processes to create awareness of Customer
requirements and importance of meeting them
• Defined processes to measure Customer
satisfaction, which may include existing
Customer complaint process
A few more
• Defined processes for collection and
analysis of quality performance data, and
use of the data to facilitate continual
improvement
• Established Quality objectives and plans
to support the Quality Policy
• Specific quality policy language to include
a commitment to continual improvement
Principle 1-Customer
Focused Organization
Quality
Management
Principles
APPLICATION FOR
ISO 9001 (1994
EDITION)
QUALITY
MANAGEMENT
APPLICATION
(ADDITIVE TO ISO
9001)
Principle 1 - Customerfocused organization
Assure conformance to defined
customer requirements.
Understand current and
future customers needs and
expectations.
Measure customer
satisfaction and act on it.
Organizations depend on their
customers and therefore
should understand current
and future customer needs,
meet customer requirements
and strive to exceed customer
expectations.
Principle 2-Leadership
Principle 2 - Leadership
Leaders establish unity of
purpose and direction of the
organization. They should
create and maintain the
internal environment in which
people can become fully
involved in achieving the
organization's objectives.
Set policy and verifiable
objectives, deploy policy,
provide resources and
establish an environment for
Quality.
Establish vision, direction
and shared values. Set
challenging targets and
goals and implement
strategies to achieve them.
Coach, facilitate, and
empower people.
Principle 3-Involvement of
People
Principle 3 - Involvement of
People
People at all levels are the
essence of an organization
and their full involvement
enables their abilities to be
used for the organization's
benefit.
Establish competency levels,
train & qualify personnel.
Provide clear authority and
responsibility.
Create personal ownership of
an organizations targets and
goals, by using it’s peoples
knowledge and experience,
and through training achieve
involvement in operational
decisions and process
improvement.
Principle 4-Process
Approach
Principle 4 - Process
Approach
A desired result is
achieved more efficiently
when related resources
and activities are
managed as a process.
Establish, control and
maintain documented
processes.
Explicitly identify
internal/external
customers and suppliers
of processes. Focus on
the use of resources in
process activities,
leading to effective use
of people, equipment,
methods and materials.
Principle 5-System
Approach to Management
Principle 5 - System
Approach to
Management
Identifying,
understanding and
managing a system of
interrelated processes
for a given objective
improves the
organization’s
effectiveness and
efficiency.
Establish and maintain a
suitable and effective
documented Quality
System.
Identify a set of
processes in a system.
Understand their
interdependencies.
Align the processes
with the organizations
goals and targets.
Measure results
against key objectives.
Principle 6-Continual
Improvement
Principle 6 - Continual
Improvement
Continual improvement
should be a permanent
objective of the
organization.
Through management
review, internal/external
audits and
corrective/preventive
actions, continually improve
the effectiveness of the
Quality System.
Set realistic and
challenging improvement
goals, provide resources
and give people the tools,
opportunities and
encouragement to
contribute to the continual
improvement of the
processes.
Principle 7-Factual
Approach To Decision
Making
Principle 7 - Factual
Approach to Decision
Making
Effective decisions are
based on the analysis
of data and information.
Management decisions and
actions on the Quality
System are based on the
analysis of the factual data
and information gained
from reports on audits,
corrective action,
nonconforming product,
customer complaints and
other sources.
Decisions and actions are
based on the analyses of
data and information to
maximize productivity and to
minimize waste and rework.
Effort is placed on minimizing
cost, improving performance
and market share through the
use of suitable management
tools and technology.
Principle 8-Mutually
beneficial supplier
relationships
Principle 8 - Mutually
Beneficial Supplier
Relationships
An organization and its
suppliers are
interdependent, and a
mutually beneficial
relationship enhances the
ability of both to create
value.
Adequately define and
document requirements to
be met by subcontractors.
Review and evaluate their
performance to control the
supply of quality products
and services.
Establish strategic
alliances or partnerships,
ensuring early
involvement and
participation defining
requirements for joint
development and
improvement of
products, processes and
systems. Develop
mutual trust, respect and
commitment to customer
satisfaction and
continual improvement.
Main reasons for failing/not
pursuing ISO Certification
• Lack of commitment-usually CEO support
and the steering committee participation
• Lack of project organization and involvement
• Distribution of workload
• Employee involvement
• Clear definition of tasks and skills
• Too much detail in documentation
THE PROBLEM
• ISO 9001 1994 version-20 elements for (3?)
years, then convert? Most of our written
procedures are formatted to the 1994
version.
• ISO 9001:2000-Rewrite procedures in the
new format.
• Leave procedures as is. Create new ones
for additional requirements. Use
conversion chart for Audit purposes.
• Contract with a accredited facility to drive
the ISO effort.
“WE” CAN DO THIS