ISO

International Organization for

Standardization ( ISO)
• Headquartered in Geneva , Switzerland
• Developed guidelines for quality management
that were initially adopted in Europe.
• Initial publication in the year 1987 , the ISO
standards have been adopted by companies all
over the world
• Series of written standards laying down a quality
system.
• Basic elements of the system defined throug
documentation
• ISO (International Organization for
Standardization) is the source of the ISO
9000 and ISO 14000 families of quality
and environmental management standards
and some 15 000 International Standards
for business, government and society. ISO
is a network of national standards
institutes from 146 countries working in
partnership with international
organizations, governments, industry,
business and consumer representatives.
 HIGHLIGHTS OF ISO 9000
• Issued by independent ISO certified
auditors
• Registration increasingly driven by
customer requirements and competitive
measures not via official or statutory
mandate
• Certification verifies that your factory , your
laboratory or your office meets a set of
predetermined ( by ISO) Quality
Management requirements
• Documentation is central to ISO 9000
requirements for the purpose of planning ,
controlling , training and providing objective
evidence of compliance.
• ISO 9000 is not a product standard but a quality
system standard . It is designed and intended to
apply to virtually any product or service made by
any process anywhere in the world.
• ISO 9000 requires that Quality system monitor
conformance to requirements
• Obligates management to implement statistical
techniques when and as appropriate
 WHY ISO 9000??
• Helps Companies that market their products in
the European markets .
• Essential for Companies ( or vendors) supplying
to other companies that demand ISO 9000
certification.
• Necessary for companies whose competitors are
certified or are seeking ISO 9000 certification
• Companies with geographically scattered
facilities and global operations find it easier to
convince customers about their quality
standards if they have ISO 9000 certification
 HARMONIZED VERSIONS OF ISO 9000

NATION STANDARD
AUSTRALIA AS3900
BELGIUM NBNX50
CANADA CSAZ299
DENMARK DS/EN 29000
GERMANY DIN SO 9000
INDIA IS14000
SWEDEN SS ISO 9000
UK BS 5750
Companies do not get ISO
9000 certification . Instead
they get either an ISO 9001
ISO 9002 or ISO 9003
certification
 Quality System Models
• Generic models apply to virtually any facility producing any product
or service for any market .Mostly encourage the use of good
business practices and time proven quality methods.
• Contractual Models
• ISO 9001- Most comprehensive
- Covers facilities whose process includes
DESIGN/DEVELOPMENT
PRODUCTION/INSTALLATION/SERVICING
Contains 20 sections describing various elements of the quality
system
• ISO 9002 : More limited, Applies to facilities making products which
are designed and serviced by others , includes 18 of the 20 sections
found in ISO 9001
• ISO 9003 : Most limited , Applies only to facilities performing final
inspection and test functions , Includes 12 of the 20 sections found
in ISO 9001
QUALITY MANAGEMENT GUIDELINES
Facilities do not register to these guidelines . These are
mainly guidelines for facilities wishing to implement ISO
9000.Provides a clearer and more graphic illustration of
an integrated quality system than do the contractual
models
ISO 9004 for Manufacturing and service sector
ISO 9004-2 for service sector
ISO 9000 -3 A specialized set of guidelines for applying
ISO 9001 to facilities which develop and maintain
computer software
GUIDELINES FOR AUDITING
Audits ( or assessments) to obtain evidence about
the performance of the system against specified
requirements
Internal Assessment ( by OWN Facility Personnel)
Second Party Assessment ( by Customer)
Third Party Assessment by an Accredited Third
Party)
ISO 10011 SERIES
ISO 10011-1( 1990) “ AUDITING
ISO 10011-2( 1990) “ Qualification criteria for
Quality systems auditing “
ISO 10011-3(1990) “ Mgmt of Audit Programs”
• ISO 9000 guides you to “ document what
you do and the do what you documented”
• Creates an awareness and brings in the
discipline much needed for continuous
improvement and TQM.
• ISO 9000 specifies the way a Company
operates along with its quality standards ,
service levels , delivery performance and
so on .
• Helps a company to be in a customer
company's short list of suppliers firms.
• ISO 9000 and ISO 14000 - in brief
• The ISO 9000 and ISO 14000 families are
among ISO's most widely known
standards ever. ISO 9000 and ISO
14000 standards are implemented by
some 887 770 organizations in 161
countries. ISO 9000 has become an
international reference for quality
management requirements in business-to-
business dealings, and ISO 14000 is well
on the way to achieving as much, if not
more, in enabling organizations to meet
their environmental challenges.
SOURCE : http://www.iso.ch
• The ISO 9000 family is primarily
concerned with "quality management".
This means what the organization does to
fulfil:
• - the customer's quality requirements, and
- applicable regulatory requirements, while
aiming to
- enhance customer satisfaction, and
- achieve continual improvement of its
performance in pursuit of these objectives.
SOURCE : http://www.iso.ch
• The ISO 14000 family is primarily concerned
with "environmental management". This
means what the organization does to:
• - minimize harmful effects on the environment
caused by its activities, and to
- achieve continual improvement of its
environmental performance.
• The vast majority of ISO standards are highly
specific to a particular product, material, or
process. However, the standards that have
earned the ISO 9000 and ISO 14000 families a
worldwide reputation are known as "generic
management system standards".
SOURCE : http://www.iso.ch
• Generic" means that the same standards can be applied:
• - to any organization, large or small, whatever its product
- including whether its "product" is actually a service,
- in any sector of activity, and
- whether it is a business enterprise, a public
administration, or a government department.
• "Generic" also signifies that no matter what the
organization's scope of activity, if it wants to establish a
quality management system or an environmental
management system, then such a system has a number of
essential features for which the relevant standards of the
ISO 9000 or ISO 14000 families provide the requirements.
• "Management system" refers to the organization's structure for
managing its processes - or activities - that transform inputs of
resources into a product or service which meet the organization's
objectives, such as satisfying the customer's quality requirements,
complying to regulations, or meeting environmental objectives

SOURCE : http://www.iso.ch
ISO is not an auditor, assessor, registrar, or
certifier of management systems, products,
services, materials or personnel, nor does it
endorse or control any such activities performed
by other parties. ISO develops International
Standards but does not operate any schemes for
assessing conformity with them. ISO 9001:2000
and ISO 14001:2004 certificates are issued
independently of ISO by more than 750
certification bodies worldwide, although the
organization does develop voluntary standards
and guidelines to encourage good practice by
these certification bodies and by the accreditation
bodies that approve the latter as competent.

SOURCE : http://www.iso.ch
• ISO has no “ISO 9001:2000 logo” or
“ISO 14001:2004 logo”. In addition,
you are not allowed to use ISO’s logo,
which is copyrighted. ISO will take
whatever actions it considers
necessary to prevent the misuse of its
logo.
SOURCE : http://www.iso.ch
• You can’t use ISO’s logo, nor adapt or
modify it. If you adapt your organization’s
existing logo to communicate its
certification, or if you have a new logo
designed to convey this, they should not
be capable of being mistaken for the ISO
logo. If you want to use the logo of your
certification body, you will need to ask for
the latter’s authorization.
SOURCE : http://www.iso.ch
• The terms “ISO certified” and “ISO
certification” should not be used
because they carry the potential for
misleading people into thinking that
it is ISO which has carried out the
certification. Use instead “ISO
9001:2000 certified”, “ISO
9001:2000 certification”, “ISO
14001:2004 certified”, or “ISO
14001:2004 certification”.
SOURCE : http://www.iso.ch
• It is okay to state either that your
organization has been “certified” or
“registered” because their meanings
are equivalent for practical purposes,
but inaccurate to state that it has
been “accredited” (unless your
organization is a
certification/registration body).
SOURCE : http://www.iso.ch
• ISO 9001:2000 and ISO 14001:2004 give
generic requirements for management systems,
not requirements for specific products or
services. ISO 9001:2000 and ISO 14001:2004
certifications are not product certifications or
product guarantees. Great care must therefore
be taken in the wording of any references to
them which appear in product-related
information, including advertisements, or on
any other medium, in order to avoid giving the
impression that they are product certifications
or product guarantees. In particular, ISO
9001:2000 and ISO 14001:2004 certification
marks of conformity are not to be displayed on
products, on product labels, on product
packaging, or in any way that may be
interpreted as denoting product conformity.
SOURCE : http://www.iso.ch
• ISO 9001:2000 and ISO 14001:2004
certificates are issued for scopes of
activity, which are specified on the
certificate. You should be just as
specific when publicizing that
certification. Do not misrepresent the
scope (the extent) of the certification
as far as either activity or geographic
location is concerned.
SOURCE : http://www.iso.ch
SIX SIGMA MANAGEMENT TECHNIQUE
• Latest and highest form of quality management
and surpasses ISO 9000.
• Six sigma means faultless quality right across the
company management
• The Greek letter sigma is the statistical short
hand for standard deviation. It really refers to the
extent to which a process is capable of
deviating from preset specifications without
causing errors. The higher the sigma rating the
greater is this capability.
• Six sigma allows variation of up to six times the
standard deviation without causing flaws.
• Six sigma philosophy is the same as that of TQM –
reducing defects . The following table gives defect
rate per million :

Sigma Defect rate PPM

Six σ 3.4
Five σ 233
Four σ 6210
Three σ 66807
Two σ 308537
One σ 690000
PROBABILITY MODEL : SELECTING PREVENTIVE MAINTENANCE POLICY

Objective : Whether to follow breakdown or preventive Maintenance policy

Steps:
Step 1: Data are collected on :
1. Preventive Maintenance servicing cost
2. Breakdown cost
3. Probability of breakdown
Step 2: Cumulative expected no. of breakdowns B in M months
Bn = N { ∑ Pn } + Bn-1 P1 + Bn-2 P2 +…B1Pn-1
N= No. of units on machine / equipment
P= Probability of breakdown during a given month after maintenance
n= Maintenance period in which maintenance is performed
Step 3 : After calculating expected number of breakdowns B n for various preventive
maintenance policies, cost of preventive maintenance and expected cost of
breakdown maintenance and total maintenance cost per month is determined
Step 4 : Policy which minimizes total maintenance cost per month is the choice
• PQR company has kept records of breakdowns of its
machines for a 300 day work year as shown below :

No. of breakdowns Frequency in days

0 40
1 150
2 70
3 30
4 10
The firm estimates that each breakdown
costs Rs 650 /- and is considering
adopting a preventive maintenance
program which could cost Rs 200 / - per
day and limit the number of breakdowns to
an average of one per day. What is the
expected annual savings from preventive
maintenance program.
No. of Frequency Prob.dist of Expected
breakdowns of breakdowns value of
breakdow P(x) breakdowns
ns f(x)
0 40 40/300=0.133 0

1 150 150/300=0.5 0.50

2 70 70/300=0.233 0.466

3 30 30/300=0.1 0.3

4 10 10/300=0.033 0.132

Total 300 1.00 1.4

Total No. of breakdowns per day =1.4
Cost of breakdown = 1.4* 650 = 910/-
Cost of preventive maintenance Programme per day =
Rs200+ 650= 850

Expected annual savings from preventive maintenance

Programme= (910-850)*300
=60*300
=Rs18000/-
It costs Rs 4000 to perform preventive maintenance on a
group of 10 machines . If one of the machines break down
between preventive maintenance inspection the
breakdown maintenance costs Rs 8000/- . The break
down history on machines is given below:
Weeks between Probability of
preventive breakdown
maintenance (n)
1 0.1
2 0.2
3 0.3
4 0.4
If only costs are considered how often
should preventive maintenance be
performed to minimize the total
maintenance cost .
• The probability of failure Pn of an equipment in
the nth period after maintenance has been
estimated as follows:
Cost of preventive maintenance = Rs150/-
Cost of breakdown maintenance = Rs1000/-
Determine the optimum frequency of preventive
maintenance
n 1 2 3 4
Pn 0.1 0.2 0.4 0.3