Overview of ISO 9001 and ISO 14001

BY
Kidambi Srinivasan

April 19, 2011

 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 some 887 770 organizations in 161

countries.

• ISO 9001 helps organizations to implement quality

management.

• ISO 14001 helps organizations to implement environmental

management.
 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.
 Quality management (cont.)

• Quality management also means what the

organization does to
• enhance customer satisfaction, and
• achieve continual improvement of its
performance.
 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.
 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.
 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.
 Management systems

• Management system means what the organization

does to manage its processes, or activities in order
that
• its products or services meet the organization’s
objectives, such as
• satisfying the customer's quality requirements,
• complying to regulations, or
• meeting environmental objectives
 Management systems

• To be really efficient and effective, the organization can

manage its way of doing things by systemizing it.
• Nothing important is left out.
• Everyone is clear about who is responsible for
doing what, when, how, why and where.
• Management system standards provide the
organization with an international, state-of-the-art
model to follow.
 Management systems (cont.)

• Large organizations, or ones with complicated

processes, could not function well without
management systems.
• Companies in such fields as aerospace,
automobiles, defence, or health care devices
have been operating management systems
for years.
• The ISO 9001 and ISO 14001 management
system standards now make these successful
practices available for all organizations.
 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.
 Processes, not products (cont.)

• Processes affect final products or services.

• ISO 9001 gives the requirements for what the
organization must do to manage processes
affecting quality of its products and services.
• ISO 14001 gives the requirements for what
the organization must do to manage
processes affecting the impact of its
activities on the environment.
 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,
 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 9001:2000 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.
 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.
Certification is a business decision

• Certification is a decision to be taken for

business reasons:
• if it is a contractual, regulatory, or market
requirement,
• If it meets customer preferences
• it is part of a risk management program, or
• if it will motivate staff by setting a clear goal.
 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.
 The ISO 9000 family

• ISO 9001 is the standard that gives the requirements

for a quality management system.
• ISO 9001:2000 is the latest, improved version.
• It is the only standard in the ISO 9000 family that can
be used for certification.
• There are 14 other standards in the family that can
help an organization on specific aspects such as
performance improvement, auditing, training…
 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…
The ISO Survey
 The ISO Survey (cont.)

• The worldwide total of certificates to ISO

9001:2000 at the end of 2005 was 776 608.
• There was an increase of 18 % over 2004
when the total was 660 132 certificates.
• Certificates had been issued in 161 countries
compared to 154 the previous year.
The ISO Survey (cont.)
 The ISO Survey (cont.)

• The worldwide total of ISO 14001 certificates

at the end of 2005 was 111 162.
• There was an increase of 24 % over 2004
when the total was 89 937.
• Certificates had been issued in 138 countries
compared to 127 the year before.
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.
Benefits of ISO 9001 and ISO 14001
(cont.)
• Model for satisfying customers and other
stakeholders.
• Build quality into products and services from
design onwards.
• Address environmental concerns of customers
and public, and comply with government
regulations.
• Integrate with global economy.
Benefits of ISO 9001 and ISO 14001
(cont.)
• Sustainable business
• Unifying base for industry sectors
• Qualify suppliers for global supply chains
• Technical support for regulations
Benefits of ISO 9001 and ISO 14001
(cont.)
• Transfer of good practice to developing
countries
• Tools for new economic players
• Regional integration
• Facilitate rise of services
 ISO
ISO 9001:2000
9001:2000
Sections
Sections –– New
New Version
Version
 Important changes
Criteria Previous version New Version
Main focus Products Customer satisfaction

Approach 20 quality elements Value adding processes

Product requirements Requirements specified by + Statutory & regulatory

customer / organization requirements

Involvement of people What to do, When, Whom & How to + Why it is to be done
do

Improvements Maintain the system requirements Continual improvements

should be achieved
 Objective
Introduce
Introducethe
theconcept
conceptof
ofnew
newISO
ISO9001
9001Standard
Standard

Highlight
Highlightimportant
importantareas
areasand
andchanges
changesof
ofthe
thenew
newstandard
standard

Briefly
Brieflyintroduce
introducethe
thesystem
systemrequirements
requirementsof
ofthe
thenew
newstandard
standard
 What is ISO 9001: 2000
2nd
2ndrevision
revisionof
ofQuality
QualityManagement
ManagementSystem
SystemRequirement
RequirementStandard
Standardfrom
from
International
InternationalOrganization
Organizationfor
forStandards
Standards

Replacement
Replacementfor
forprevious
previousISO
ISO9001
9001/ /9002
9002and
and9003
9003standards
standardsof
of1994
1994

Introduced
Introducedconsiderable
considerableconceptual
conceptualchanges
changes

Applicable
Applicableto
toall
alltypes
typesof
ofOrganizations
Organizationswith
withpossible
possiblepermissible
permissible
omissions
omissionsof
ofcertain
certainrequirements
requirements
 New ISO 9001
Management
Responsibility

General Measurement, General

Resource
analysis &
requirements management QMS improvements
requirements

Product
Realization

Continual Improvement cycle

 ISO 9001:2000 – Model
Continual Improvement of
the Quality Management System

5.Management
Responsibility

CUSTOMERS
CUSTOMERS

Quality Management

Satisfaction
6. Resource 8. Measurement
Analysis and
Management Improvement

System

7. Product
Requirements Product Consumption
Realization
 Principles of new standard
r
meer
tom
CCuussto
us
foccus
fo LLeeaaddeerrsshhip
ip

l
MMuutu tuaal
bbeenneefifciciaial l eenntt
v olv eem
ssuupppplilieerr hhtt
In
Inv olv m
ship s e d o n n eig
e i g ooffppeeoopplele
tionnship
rreelalatio BBaased o
qquuaalilittyy
a n a g eem m eenntt
mman a g
ples
FFaacctu l
tuaal incci iples
pprrin
to
aapppprrooaacchh to
ionn
ddeeccisisio PPrroocceessss
king aapppprrooaacchh
mmaaking
SSyysstetemm
al
tinuual t
CCoonntin h to
aapppprrooaacch to
vveem eennt nt
im p
imp
ro
ro m MMaannaaggeem meent
Principles of new standard
Customer focus
•Organization depends customers
•Understand current & future customer needs.
•Meet / exceed customer expectations

Leadership
•Leaders establish purpose & direction of the organization
•Should create & maintain environment to achieve organization’s
objectives

Involvement of People
•People of all levels are essence of an organization
•Their full involvement for organization’s benefit

Process approach
Desired results are achieved more efficiently when activities and resources
are managed as process
Principles of new standard
System approach to Management
Identifying, understanding and managing interrelated process as a system
contributes to the organization’s effectiveness & efficiency

Continual improvements
Continual improvement of the organization’s overall performance should be
a permanent objective of the organization

Factual approach to decision making

Effective decisions are based on the analysis of data and information

Mutually beneficial supplier relationships

•An organization & its suppliers are interdependent
•Mutually beneficial relationship enhances the ability of both to create
value
 Expectations of the new
Avoid
Avoidthe
theapplication
applicationof
Standard
ofsystems
systemsthat
thatare
areseparate
separatefrom
fromthe
the
organization’s
organization’sbusiness
businessprocess
process

Enable
Enablethe
thedevelopment
developmentof ofaaQuality
Qualitysystem
systemthat
thatisisfully
fullyintegrated
integratedinto
into
the
thenormal
normaloperations
operationsof
oforganization’s
organization’sbusiness
business

Enable
EnableContinual
Continualimprovements
improvementsof
ofthe
thesystem
systemfor
forenhanced
enhancedcustomer
customer
satisfaction
satisfaction

Enable
Enablecompliance
complianceto
tostatutory
statutory&&regulatory
regulatoryrequirements
requirements
 Process approach
Process
Processdefinition
definition
Set
Setof
ofinterrelated
interrelatedor
orinteracting
interactingactivities
activitieswhich
whichtransforms
transformsinputs
inputs
into
intooutputs
outputs

Identify
Identifythe
the
Identify
Identifythe
the Establish
Establish Ensure
Ensure
Identify
Identifythe
the Interactions
Interactions
Inputs
Inputs&& measuring
measuring continual
continual
processes
processes to
toother
other
outputs
outputs criteria
criteria improvements
improvements
processes
processes

Do
Doitit for
forall
all value
value adding
adding processes
processes
 Process approach –
Continual improvements of Process
Understandings &
meeting requirements
PLAN

Continual improvements
Processes in terms
of Processes based on
Of Added Value PDCA Cycle
objective measurements
DO
ACTION

Measure results of process

Performance and effectiveness
- Objective Measurements
CHECK
 Example - Purchasing Process
Inputs
Inputs Purchasing
Purchasing Outputs
Outputs
•• Required
Requireditem
item//
Procedure
Procedure •• Receipt
Receiptof
of
quantity
quantity//date
date Material
Materialon
on
•• Applicable right
rightcondition
condition
Applicable
specs •• Right
RightQuality
Quality
specs
•• Supplier Right
RightQuantity
Quantity
Suppliersource
source Interactions
Interactionsto
to
•• Suppliers ••Storage •• Right
RightTime
Time
Suppliers Storage
capability
capabilityto
to ••Inspection
Inspectionand
and
meet
meetour
our Testing
Testing
requirements
requirements ••Manufacturing
Manufacturing
••Finance
Finance
Performance
PerformanceMeasurements
Measurements
••Delivery
Deliverystatus
status––On-time,
On-time,On
Onspec,
spec,
NCP
NCPetc
etc
••Supplier
Supplierevaluation
evaluation
 System Requirements /
Structure of the Standard
4 Quality 5 Management 6 Resource 7 Product 8 Measurement
Management Responsibility Management Realization Analysis &
System improvement

Management
General Commitment Provision of Planning General
requirements resources

Customer focus Customer Monitoring &

Documentation Human related measurement
Requirements resources processes
Quality policy
Control of NCP
Infrastructures Design &
development
Planning Analysis of data
Work
environment Purchasing
Responsibility, Improvements
authority & Production &
communication service
provision
Management
Reviews
4 - Quality management system
Identification
Continual of processes
improvements required

4.1 General
requirements Criteria and

Monitoring and methods to ensure

Measuring of Operation & control

processes
Availability of
information &
resources for
operation & control
4 - Quality management system
4.2 Document requirements

Quality Policy

Quality Objectives

Quality Manual

Procedures required by the Standard

Procedures required for planning, operation & control of Organization activities

Records
 5 - Management Responsibility
5.1 5.2 5.3 5.4 5.6 5.7
Management Customer Quality Planning Responsibility Management
commitment focus policy authority & Review
communicate

Quality Responsibility & General

objectives authority
Review
QMS planning Management inputs
representative
Review
Internal outputs
communication
 5 - Management Responsibility
Development,
Development,implementation
implementationand
andcontinually
continually
improvement
improvementof
ofQMS
QMS

Establishment
Establishmentof
of
•Quality
•QualityPolicy
Policy
•Quality Objectives
•Quality Objectives
Top
Top
Management’s
Management’s Identification
Identificationof
ofCustomer
Customerrequirements
requirements
commitment
commitment

Communication
Communicationof
ofimportance
importanceof
of
••Appointment •Regulatory
•Regulatory&&statutory
statutoryrequirements
AppointmentofofManagement
Management •Meeting
requirements
Representative
Representative •Meetingcustomer
customerrequirements
requirements
•Quality
•QualityPolicy
Policy&&Quality
Qualityobjectives
objectives
••Conducting
ConductingManagement
ManagementReviews
Reviews •Responsibilities
•Responsibilities&&authorities
authorities
••Providing
Providingrequired
requiredresources
resources
 5 - Management Responsibility

Evidence
Evidencemust
mustbe
beprovided
providedto
toshow
showthat
thatthe
theManagement
Managementisiscommitted
committedto
tothe
the
above
aboverequirements
requirements

Auditors
Auditorscould
couldspeak
speakto
toand
andaudit
auditTop
TopManagement
Management(E.g.
(E.g.MD
MD/ /Directors)
Directors)to
to
establish
establishtheir
theircommitment
commitmentto tothe
themanagement
managementsystem
system

New
Development
6 - Resource Management
6.1 6.2 6.3 6.4
Infrastructures
Provision of Human Work
resources Resources Environment

General

Competence,
awareness &
training
 6 - Resource Management
Resources
Resourcesrequired
requiredto
to
Implementing,
Implementing,monitoring
monitoring&&continual
continual
improvements
improvements
Enhance
EnhanceCustomer
Customersatisfaction
satisfactionby
bymeeting
meeting
customer requirements
customer requirements

Human
HumanResources
Resources
Resource
Resource
Management
Management Infrastructures
Infrastructures
Infrastructures
Infrastructuresneeded
neededtotoachieve
achieveproduct
product
conformity
conformity

Work
Workenvironment
environment
Work
Workenvironment
environmentneeded
neededtotoachieve
achieveproduct
product
conformity
conformity
Enhanced 6 - Human Resources
Competent
Competenton
onthe
thebasis
basisofofappropriate
appropriateeducation,
education,
skill and experience
skill and experience

Define
Definecompetencies
competenciesfor
forpeople
peopleperforming
performingwork
work
affecting
affectingproduct
productquality
quality

6.2
6.2 Human
Human Provide
Providetraining
trainingor
oractions
actions
Resources
Resources

Evaluate
Evaluateeffectiveness
effectivenessofofthe
thetraining
training/ /actions
actions

Employees
Employeesshould
shouldaware
awareimportance
importanceofofthe
theactivity
activity
being
beingperformed
performed
 7 - Product Realization
7.1 7.2 7.3 7.4 7.5 7.6

Planning of Customer Design and Purchasing Production & Control of

related development service monitoring
product measuring
realization processes provision
devices

Identification of Design planning Purchasing Control

customer process
requirement
Design inputs Validation of
Purchasing processes
Review of Design outputs information
customer Identification &
requirement traceability
Design review Verification of
purchased
products
Customer Design verification Customer
communication property

Design validation Preservation of

product

Design Changes
 7 - Product Realization
Quality
Qualityobjectives
objectivesofofProducts
Products––Specs
Specs

Processes,
Processes,procedures
procedurestotorealize
realizeproduct
product
7.1
7.1
Planning
PlanningofofProduct
Product
realization
realization Verification,
Verification,validation,
validation,monitoring,
monitoring,
inspection
inspectionand
andtesting
testingofofproduct
product

Record
Recordtotodemonstrate
demonstrateconformance
conformance
 7 - Product Realization
Identification
IdentificationofofCustomer
Customer/ /Market
Market
requirements
requirements
•Specified
•Specifiedby bycustomer
customer
•Requirements
•Requirementstaken
takenfor
forgranted
granted
•Statutory
•Statutory/ /Regulatory
Regulatoryrequirements
requirements
7.2
7.2
Customer
Customerrelated
related
processes Review
Reviewofofrequirements
requirementsrelated
relatedproduct
processes––(Sales)
(Sales) prior
product
priortotoacceptance
acceptance/ /commitment
commitmenttoto
customers
customers --ability
abilitytotomeet
meetcustomer
customer
requirements
requirements

Effective
Effectivecommunication
communicationwith
withcustomer
customerininrelation
relationtoto
•Product
•Productinformation
information
•Sales
•Sales orderhandling
order handling
•Customer feedback
•Customer feedback
•Customer
•Customercomplaints
complaints
 7 - Product Realization
Planning
Planning
•Effective
•Effective&&efficient
efficient
•Expectations
•Expectationsofofinterested
interestedparties
parties
•EHS
•EHS

7.3
7.3
Design
Designand
and
Development
Development––
(Product) Design
Designinputs
inputsand
andoutputs
outputs
(Product)

Review
Reviewand
andverification,
verification,validation
validationand
andcontrol
controlofofchanges
changes
•Accuracy
•Accuracy
•Potential
•Potentialhazards
hazards&&faults
faults
•Corrections
•Corrections
•Evaluations
•Evaluationsagainst
againstlessons
lessonslearned
learned
 7 - Product Realization
Degree
Degreeofofcontrol
controldepends
dependson
oneffects
effectsofof
subsequent
subsequentprocesses
processesand
andeffect
effecton
onfinal
final
product
product
7.4
7.4
Purchasing
Purchasing
Purchasing
Purchasingisisdone
doneinin Supplier
Supplierevaluation
evaluation
controlled
controlledmanner
mannertoto
ensure
ensurethat
thatpurchased
purchased
products
products conformstoto
conforms
specific
specificrequirements
requirements

Verification
Verificationofofpurchased
purchasedproduct
product––Inspection
Inspection
and testing
and testing
 7 - Product Realization
Product
Productcharacteristics
characteristics
(Specs) Procedures
(Specs) Proceduresand
and work
workinstructions
instructions

Suitable
Suitableequipments
equipmentstotomanufacture.
manufacture.
7.5 Monitoring
7.5 Monitoring and inspection&&testing
and inspection testing
Production
Productionand
andservice
service
provision
provision
Product
Productrelease,
release,delivery
deliveryand
andpost
postdelivery
delivery
Manufacturing
Manufacturing/ /service
service
provision
provisionunder
under
controlled
controlledcondition
conditiontoto Process
ensure Processvalidation
validation
ensureconformity
conformityofof
product
product
Identification
Identificationand
andtraceability
traceability

Customers
Customersproperty
property
Material
Materialsupplied
suppliedby
bycustomers
customers––e.g..
e.g..33rdparty
rd
partyblending
blending
 7 - Product Realization

7.6
7.6 Control
Controlof
ofmonitoring
monitoringand
andmeasuring
measuringdevices
devices
Control
Controland
andCalibration
Calibrationofofequipments
equipmentsused
usedfor
formonitoring,
monitoring,inspection
inspectionand
andtesting
testing
 8 - Measurement, analysis
and improvement 8.3 Control
8.1 8.2 8.4 8.5
of non
General Monitoring & conforming Analysis of Improvement
measurements product data

Customer Continual
satisfaction improvements

Internal audits Corrective action

Measurement of
processes Preventive
action
Measurement of
product
 8 - Measurement, analysis
and improvement
To
Todemonstrate
8.1
8.1-demonstrate
-To
Todemonstrate
demonstrate
•Conformity
•Conformityofofthe
theproduct
product
•Conformity
•ConformitytotoQMS
QMSrequirements
requirements
•Continually
•Continually improvementsand
improvements andthe
theeffectiveness
effectivenessof
ofthe
thesystem
system

8.2
8.2-- Monitoring
Monitoringand
andMeasurements
Measurements
•Customer
•Customersatisfaction
satisfaction/ /perception
perception
•Internal
•Internalaudits
audits - -conformity
conformityplanned
plannedarrangements
arrangementsofofQMS
QMSand
andISO9001
ISO9001
•Monitoring
•Monitoringand
andmeasurements
measurementsof ofprocesses
processes––totodetermine
determine/ /demonstrate
demonstrateability
abilityofof
processes
processestotoachieve
achieverequired
requiredresults
results
•Monitoring
•Monitoringand
andmeasurements
measurementsof
ofproduct
product––Conformity
Conformitytotoproduct
productrequirements
requirements

8.3
8.3--Control
Controlof
ofNCP
NCP
•Tooassure
•T
assurethat
thatNCP
NCPare
areidentified
identifiedand
andcontrolled
controlledto
toprevent
preventunintended
unintendeduse
use/ /
delivery
delivery
 8 - Measurement, analysis
and improvement
8.4
8.4--Analysis
Analysisof
ofdata
data
Collection
Collectionand
andanalysis
analysisofofdata
datagenerated
generatedthrough
throughQMS
QMSactivities
activities
to
toverify
verifysuitability,
suitability,effectiveness
effectivenessand
andcontinual
continualimprovement
improvementof
ofthe
the
system
system
Analysis shall provide information related to

•Customer satisfaction / perception

•Conformity to specs, requirements
•Trends of processes and products
•Opportunities for preventive actions
•Suppliers
 8 - Measurement, analysis
and improvement
8.5
8.5--Improvements
Improvements
Continual
ContinualImprovements
Improvements
•QMS
•QMSneeded
neededto
tobe
becontinually
continuallyimproved
improved

Corrective
Correctiveaction
action
•Actions
•Actionsto
toprevent
preventrecurrence
recurrenceofofNCP,
NCP,NCRNCRetc
etc
•Includes
•Includesreviews,
reviews,determination
determinationofofcauses,
causes,need
needof
ofaction,
action,
implementation
implementation of action, review of action and maintenanceof
of action, review of action and maintenance ofrelevant
relevant
records
records

Preventive
Preventiveaction
action
•Actions
•Actionsagainst
againstpotential
potentialnon
nonconformities
conformitiestotoavoid
avoidtheir
theiroccurrence
occurrence
•Includes
•Includesidentification
identificationof
ofpotential
potentialnon
nonconformities,
conformities,cause,
cause,need
needfor
for
action,
action,implementation
implementationof ofaction,
action,review
reviewof
ofaction
actionand
andmaintenance
maintenanceofof
records
records
 Criteria for measurements
––Satisfaction
Satisfactionsurveys
surveysfor
forcustomers
customersand
andother
otherinterested
interestedparties
parties
•Feedback
•Feedbackononproducts
products
•Customer
•Customer&&market
marketrequirements
requirements

––Financial
Financialmeasurements
measurements
•Prevention
•Preventioncost
cost
•Non
•Nonconforming
conforming/ /failure
failurecost
System
System cost
•Lifecycle
•Lifecyclecost
cost
performance
performance
Self
Self
assessment
assessment

––Internal
Internalaudits
audits
•Effectiveness
•Effectiveness&&efficiency
efficiencyofofprocesses
processes
•Opportunities
•Opportunitiesfor forimprovements
improvements
•Use
•Useofofdata
data/ /information
information
•Effective
•Effective&&efficient
efficientuseuseofofresources
resources
•Adequacy,
•Adequacy, accuracy
accuracyand andperformance
performanceofofmeasurements
measurements
•Relationships
•Relationshipswithwithcustomers/
customers/suppliers/
suppliers/other
otherinterested
interestedparties
parties
 Criteria for measurements
––Process
Processcapability
capability/ /process
process
validation
validation
Processes
Processes ––Reaction
Reactiontimetime
––Cycle
Cycletime
time/ /throughput
throughput(Capacity)
(Capacity)
––Utilization
Utilizationofoftechnology
technology
––Waste
Wastereduction
reduction
––Cost
Costreduction
reduction

Products
Products

––Inspection
Inspectionand
andtesting
testingofofincoming,
incoming,ininprocess
processand
andfinal
finalproduct
product
––Product
Productverification
verification
––Product
Productvalidation
validation
Pros and Cons
More
Morebusiness
businessoriented.
oriented.Less
Lessprocedure
procedure oriented
oriented

Company
Companywide
wideinvolvement
involvement

Mutual
Mutualbenefit
benefitto
toall
allinterested
interestedparties
parties

Customer
Customerfocus
focusthan
thanproduct
productfocus
focus

Continual
Continualimprovements
improvements

Less
Lessemphasis
emphasison
ondocumentation
documentation

Demanding
Demandingmore
moreresources
resources??
??
Challenges in implementing new
standard
Management Support

Encouragement

New ISO

Communication

Other employee Support

 ISO 9001:2000
Transition Process
1st
1stvisit
visit 2nd
2ndvisit
visit 3rd
3rdvisit
visit 4th
4thvisit
visit

Review
Reviewof of Review
Reviewofof Review
Reviewof
of Review
Reviewof
of
QMS
QMS && Measurement,
Measurement, Management
Management Resource
Resource
Product
Product analysis
analysis&& responsibility
responsibility management
management
realization
realization improvements
improvements

22 years
years
Thank You