ISO 9000

 ISO 9000 was created to produce an
international set of process quality standards
 ISO looks at the process and addresses the
methods used during the manufacturing
process instead of inspecting the final product
 Process well documented and agreed upon,
then the product will be good
 ISO 9001:2000 - one of the latest updates
• Focuses more on improving processes and
monitoring customer satisfaction

 Started with Britain's Ministry of Defense
seeking to reduce mistakes on the assembly
line during WWII - Lead to explosions
 Written procedures that were inspected to
ensure consistency
 Similar quality standards were sought after in
the 1960s by NASA and NATO
 These ideas lead to the BS 9000(Quality
Assurance for the Electronics Industry) in
1971
• Many revisions followed

 A world wide federation of national standard bodies
from 140 countries, one from each country
A non governmental organization (1947) in GENEVA
 Mission:
Development of standardisation & related activities in the
world
Felicitating international Developing co-operation in the
Exchange of goods & sphere of Scientific,Technological,
Services intellectual & economic activity

International
agreements
Published as
International Standards

Documented agreements
Technical specifications or precise criteria
Used consistently as rules or characteristics
Ensuring that materials, products, processes
and services are fit for their purpose
Eg: International optimal thickness of credit
card, phone card, smart card
optimum
thickness is 0.76mm used
worldwide

Standards
make life
simpler
Increase the
reliability and
effectiveness of
goods and services

 Non Harmonized Standards for similar
technologies leads to
“Technical barrier for trade”
 World standards
Rationalize the international trading process
(export and import)

 ISO Global market driven
 International standardization is well established
for many technologies
Sociology, services, company organization
and management, administration, transport
Health care technology
Environment, Health protection, Safety
Metrology and measurement, Physical
phenomena

Testing, Analytical Chemistry
Mechanical and fluid systems and components for
general use.
Measurement of fluid flow
Engineering of energy, heat transfer, electrical,
manufacturing, electronics, telecommunication,
audio& video, road vehicles, railways, aircraft and
space vehicles.
Information technology, office machine, image
technology, technology of food, chemical, paper
petroleum and related.

Ship building and marine structures
Materials handling equipment
Construction material and building
Packaging and distribution of goods
Clothing industry
Agriculture
Mining and minerals
Metallurgy

Industries of glass and ceramics, rubber and
plastic, paint and color
Engineering of civil, military
Domestic and commercial equipment
Entertainment and sports
For drug and pharmaceuticals : a) USFDA
approval, WHO approval etc . b) Nonetheless,
ISO certification is essential to establish QMS

 ISO continue to grow in all sector of
industrial activity due to
 Worldwide progress in trade
liberalization
 Interpenetration of sectors. eg.
Computer
 Worldwide communication system
 Global standards for emerging
technologies

 CURRENT: 1M ISO
certs.
 Top 10 countries for
registrations:
• China (approx. 27%)
• Italy
• UK
• Japan
• Spain
• USA (approx. 9%)
• Germany
• Australia
• France
• South Korea
14

Developing Countries:
To meet market competitiveness & export
capability
Standardization of infrastructure is a basic
condition.

 Facilitate trade, exchange & technology
transfer by the following
 Enhanced product quality & reliability at a
reasonable price
 Improved health, safety & environmental
protection
 Greater compatibility and inter-operability of
goods and services
 Simplification for improved usability
 Reduction in the number of models, wastes &
thus cost reduction

Increase distribution efficiency & ease of
maintenance
Consumer has confidence in products &
services that conform to ISO
Conformity assurance by
Manufactures declaration
or
Audits carried out by independent bodies (ISO
certification bodies)

 Technical work is decentralized
 2850 technical committees, sub
committees, working groups across the world
(Industry, research org., govt. authorities,
consumer bodies)
Equal partners in the resolution of global
standardization
(30,000 experts meet each year)

Standards are administrated through one
of the national standards bodies (In
India, it is BIS – Bureau of Indian
Standards)
Member body of ISO has secretariat of
standards committee with chairman &
members
A consensus for a problem is arrived (
Best for international application at that
time )

Central Secretarial in Geneva ensured
flow of documents in all directions,
clarify with Secretariat & Chairman
Submitted as draft International standards
to ISO Member bodies for approval &
printed
A dozen ISO meetings are taking place in
the world somewhere every working day
on an average.

3 categories
 Member body:
It is a national body. Only one body in
each country is admitted. Gives financial
support to ISO through fees. Has full
right on technical and policy committee.
 Subscriber membership:
A country with small economy. Pay small
fees. Nevertheless can main contact
with ISO.

 Correspondence member:
A organization in a country not fully
developed for national standards
activity.
Receive information required.

 Central Secretariat in Geneva
(Switzerland)
Its activity & technical work financed by
o Member subscription (80%)
o Sale of standards & publication (20%)
(Total several million Swiss francs)
 ISO member bodies: Have to meet their
own expenditure

 International Electrochemical Commission (IEC) – Non
governmental
 International Telecommunication Union (ITU) – Members are
governments
b) For promotion of free & fair global trade. & other WTO
programmes.
 Partnership of WTO
c) Regional partners:
Regional standards organization of Africa, Arab countries,
Common Wealth independent states, Europe, Latin America,
Pacific area and south east Asia nations
Commitment is regional bodies participate and adopt ISO
standards
(central secretariat liaises with 500 international and regional
organizations)

Quality management principles
1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based
7. Decisionmaking
8. Relationshipmanagement
• No requirements
• Ideas useful in guiding
organizations’actions
• Used as a basisfor
developingISO 9001

1. Person or people
2. Organization
3. Activity
4. Process
5. System
6. Requirement
7. Result
8. Data, information
and document
9. Customer
10.Characteristic
11.Determination
12.Action
13.Audit

Elected
1. President
Appointed
2. Vice president (policy)
3. Vice president (Technical
Management)
4. Treasurer
5. Acting secretary general
8.PRINCIPAL OFFICERS OF ISO:

Dynamic process
Requirement of standard is expressed by
industry
Communicated to national member body
Proposed as new work item to ISO
Once agreed , technical scope defined (I phase)

Working group of technical experts should agree
the standard by the various countries involved
Countries may negotiate detailed specifications
within the standard (II phase consensus building
phase)
Formal approval of draft International standard.
(2/3 of ISO members participated in the
development should approve + approved by 75%
of all members by vote) – Final Phase.

Standards revised at intervals of no
more than 5 years (Sometimes earlier)
to meet
o Technological evolution
o New methods and materials
o New quality and safety requirements
Right now 12,000 International
standards covering various
technologies.

 ISO film speed for photographic equipment.
User friendly
 Format for Telephone and banking cards. It
can be used worldwide
 ISO 9000 describes the concept and
terminology and ISO 9001 lays down
requirement of QMS:
Several businesses are implementing ISO
9000 – which provides framework for QM &
QA. ISO 1400 series provide framework for
environmental management.

 Internationally standardized freight
container and standardized documents.
International trade cheaper, faster and
safety
 Universal system of measurement (SI
units) made shopping, trade harmonized
throughout the world and technological
developments made easy.
Paper sizes standardized

 Well designed symbol (Automobile
Control) displayed in cars around the world
Gives clear cut message in a multilingual world
Safety of wire ropes for oil rigs, fishing
vessels, mines
 ISO international codes for country
names, currencies and languages
Universally understandable for documentation
ISO standards for ISO metric screw threads
to replace easily damaged nuts & bolts

Implemented > 43,000 organization in 158
countries.
A worldwide overview of ISO 9000 and ISO
14000 related developments available in the
bimonthly journal (ISO – Management
System)
ISO Bulletin
ISO Annual reports
ISO catalogue (List of published ISO
standards) are also available

ISONET (ISO information network)
Assist customer to retrieve information
required on ISO standards and No. of
recognized standards agreed within
other international technical
organization.

Members of this network is ISO member
Act as International
reference about standards,
technical regulation and
certification system
operate in that country
Provides its own nationals
information on national,
foreign, and international
technical rules
ISO 9000 : 1994
Valid up to 30th Dec.2003
only
Current is ISO 9000 : 2000 family.

Developed to assist organization of all types and sizes
to implement and operate effective Quality
Management System (QMS)

ISO 9000 : 2000 9001 9004
Fundamentals
and terminology
of QMS
Requirements of QMS
by which organization
demonstrates its ability to
fulfill.
 Customer requirement
 Regulatory requirement
 Enhanced customer
satisfaction
It can be used for internal
application by
organization or for
certification or for
contractual purpose.
It focuses mainly on
effectiveness of QMS in
meeting customer
requirements
Guidelines for efficiency
and effectiveness of
QMS.
Standard for continual
improvement of
performance of
organization and
satisfaction of customer
and other related bodies.
It makes organization to
move beyond ISO 9001.
Not for certification or
contractual purpose

ISO 9001 : 2000 REQUIREMENTS
FOR QUALITY MANAGEMENT
SYSTEMS:
1. Organization demonstrates its ability to
fulfill.
1. Customer requirement
2. Regulatory requirements including
ISO 14000 (environmental
management)
3. Enhanced customer satisfaction

ISO standards : Highly specific to a particular
products martial or process
ISO 9001 Constant and conforming
products
ISO 14001 Prevention of pollution
OHSAS 18001 Safe working condition
ISO 50001 Efficient energy usage
ISO 20000 safe food
2. It is truly said
 First do the requirement
 Second do the possible
 Finally do all the impossible and
achieve success

Generic = Same standards can be applied to
any organisation large or small engaged in
production or service say
Business enterprise / Public administration /
Govt. dept.
MS = What it does to manage the
processes or activities
In ISO: 9000: 2000 version : 8 quality
management principles for continuous
improvement

 Customer focused organization
 Leadership
 Involvement of people
 Process approach
 Systems approach
 Continual improvement (Step by step
improvement)
 Factual approach to decision making
 Mutually beneficial suppliers relationship

 Quality: Totally of the product characteristic
and futures fulfill the implied and stated needs
of the customer.
Characteristic = functional like good color,
cost effectiveness, durable
Features = Non functional like servicing
etc., supply of spare parts (Sensitive & vital
area)
 Quality Assurance: Quality is to be sustained -
--- difficult (?) ----respond to changing
environment ---- today’s customer delight will
become routine tomorrow

How ISO achieve quality and assure quality:
a) Process approach:
Procedure Process
Dictates what should be done Indicates what is to be achieved
Task oriented Best result oriented
Different objectives Everybody towards same objective
(TQM)
Work in isolation Encourages synergy
Compliance may not guarantee
desired achievement
When followed, guarantee success
Inhibits innovation Encourages innovation
Individuals not counted Empowers individuals
We do what we do Bound to improve (re-engineering)

Eg:
 Story of Japanese Railway Booking
Clerk
 Success of British airways
Spontaneity , concern for others
problem solving
 Federal express courier service of
America (Chopper Service)
 Bank: Issue of Draft

b)Process based Quality Management System
Continual Improvement
of QMS
Management
Responsibilit
y
Measurement
analysis and
improvement
Resource
Management
Product
Realisation
Product
Customers
Requirements
Customer
Satisfaction
Input
Value adding activities
Information flow
Strategic decision to promote and sustain business

c) Interaction of Processes within the
system:
For efficient and effective functioning:
Organisation identifies and manages with
resources number of linked activities.
Each activity is a process, the output of
one process is input for another
Interactions and management of process
is called “Process approach”. Many
process constitute a system when use
within a
In QMS: the process approach emphasize

Understanding and meeting requirements
 Need to consider the process in terms
of added value
 Obtaining results of performance and
effectiveness
 Continual improvement of process
QMS is influenced by objectives, product,
process, size and structure of organization.
Hence QMS and its documentation need
not be same / uniform

d) Follow methodology of
“Plan – Do – Check – Act” (PDCA) to
process
Plan = Establish objectives and process
to deliver results as per customer and
legal requirements and organisational
policy
Do = Implement the process
Check = Monitor and measure process
and product and report the result
Act = Take actions to continually
improve

e) Compatibility with other management
systems : Although ISO 9001 does not
include requirements specific to other
management systems, it enables to
align or integrate the QMS with
environment management,
occupational, health and safety
management, financial management or
risk management.

f) Getting ISO Certification does not mean
that you have achieved excellence
Internal Audit
Certification
Surveillance Audit
Certification continued

g) ISO 9000 makes organisation to set
goal and its continual improvement
h) Customer perception changes
periodically ISO makes continual
improvement to enhance customer
satisfaction
i) ISO Certification is meant for that
organisation, big or small for its QMS.
Not necessary for uniform QMS or
Documentation. Need not to be
compared.

j)ISO is meant for service also.
7) QMS – REQUIREMENTS (ISO:9001:2000)
a. General:
Organisation shall establish, document, implement and
maintain a quality management system and
continually improve its effectiveness.
Ensure availability of resources
Monitor, measure and analyse the process
Implement actions necessary to achieve planned results
and continual improvement

b) QMS Documentation requirements: shall include
 Documented statement of quality policy and
quality objectives
 A quality manual ( Scope and Documented
procedures, description of interaction
between processes)
 Documented procedures (SOP)
 Documents (Hard copy, e.mail, types
installed) for effective planning, operation and
control of process (what to do?, when to do?,
where and how to do?)
 Records required (Out of a procedure or
event, evidence of conformity)

 Control of document and records
o to approve documents adequacy for use
o to ensure, update and reappove
o to identify changes and current revising
o to remain legible and identifiable
o to prevent use of obsolete documents
o to identify and control external document
documented procedure is for identification,
storage, protection, retrieval, retention and
disposition of records.

c) Management responsibility
Top management shall provide evidence of
the commitment for
 Communicating the importance of
customer, statutory or regulatory
requirements
 Establishing quality policy
 Ensuring quality objective established
 Conducting management reviews
 Ensuring resources

Appropriate to the organisation,
communicated understood with
in the organisation, reviewed for
continuing
Quality Policy

Quality objectives: established at relevant functions
and levels within the organisation. It shall be
measurable.
 Top management shall
o Ensure responsibilities and authorities defined
and communicated
o Appoint a management representative
a) To ensure QMS established
implemented and maintained
b) To report performance of QMS
c) promote awareness of
consumer requirement within
organisation.
o Ensure appropriate internal communication
o Conduct management review at planned
intervals

Inputs are Outputs are
Audit result
Customer feed back
Process performance
Product conformity
Preventive / corrective
action
Follow up action
Changes that affect QMS
Recommendation for
improvement
Improvement of
effectiveness of QMS and
its processes
Improvement of
resources
Improvement of product
related to customer
requirement

d) Resource management:
To Maintain QMS & continual
improvement
Financial resources
To enhance customer
satisfaction
Eg. Budget
Human resources:
To be competent (based on education,
training, skill and experience)
Eg. Appointment of highly qualified people
Necessary competency is given by training
and evaluate the effectiveness
Maintain appropriate records of training
imparted and evaluation.

Infrastructure:
Required building, work space and
associated utilities, process equipment
(hardware/software) and supporting
services (transport/communication)
Work environment: conformity to
product requirement. (Regulatory
requirement)

e) Product realization:
 Planning : required verification, inspection
and record maintained.
 Determination of product requirement
(customer / regulators) and review of
requirements
 Customer communication: product
information, customer feed back
including complaints
 Effective design and development
 Provide appropriate information for
purchasing, production and service provision.

 Specifying characteristic of the product for
safe and proper use.
 Design and developmental review,
verification and validation.
 Maintenance of records
 Purchase as per requirements and all
purchasing information.
 Verification of purchased product.
 Control of production and service provision.
Equipment, SOP, personnel, monitoring and
measuring devices, delivery and post delivery
activity, validation

 Identification and traceability
 Customer property: shall
exercise care when it is under the
organisation control
 Preservation of the product.
 Control of monitoring and measuring
devices (Calibration).

f) Measurement, analysis and improvement
 Customer satisfaction study
 Internal audit at planned intervals: Auditors shall not
audit their own work. To ensure QMS is implemented
and maintained.
 Monitoring and measurement of processes and
products.
 Control of non conformity product and records
maintained; if corrected, re-verification.
Analysis of data regarding customer satisfaction
conformity of product requirements suppliers, non
conformity and corrective action taken.

 Continual improvement:
o Effectiveness of QMS is improved through
quality policy, quality objectives, audit
result data analysis, corrective and
preventive action, management review
 Preventive action: to eliminate potential
non conformities to prevent occurrence
which will cause potential problem;
procedures and records maintained
 Corrective action: to eliminate causes of
non conformation to prevent recurrence:
Procedures and records maintained.

 Certifying agencies are available Lead auditor
inspects and raises non conformities. Certification
given for a specific period. However checked every
year any violation, certification is withdrawn.
Various appreciations
a) Mr. M.L. Gupta, Director, Export Inspection council
wrote in ISO 9000 news article as
“ ISO 9000 is a proactive system of QM”
b) Wieslaw .V, director of marketing protector, wrote in
ISO 9000 news articles as
“It helped management to establish a transparent
internal organisation clear to all employees.

ISO:9000 family means organization of
a product or service assuring
continued quality assurance to
customer delight.
It is going to take a shape in
public, private, government
organization (product/service) as a
quality circle.

ISO 9000

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