ISO

ISO 9001
9001 :: 2000
2000
Objective

Introduce
Introducethe
theconcept
conceptof
ofISO
ISO9001
9001Standard
Standard

Highlight
Highlightimportant areasof
importantareas ofISO
ISO9001
9001Standard
Standard

Briefly
Brieflyintroduce
introducethe
thesystem requirementsof
systemrequirements ofISO
ISO9001
9001Standard
Standard
What is ISO 9001: 2000

Quality
QualityManagement
ManagementSystem
SystemRequirement
RequirementStandard
Standardfrom
from
International
InternationalOrganization
Organizationfor
forStandards
Standards

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

Introduced
Introducedconsiderable
considerableconceptual
conceptualchanges
changes

Applicable
Applicableto
toall
alltypes
typesof
ofOrganizations
Organizationswith
withpossible
possible
permissible
permissibleomissions
omissionsof
ofcertain
certainrequirements
requirements
 ISO 9001:2000

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 ISO 9001:2000

r
CCuussto meer
tom p
us
foccus
fo LLeeaaddeerrsshhi ip

l
MMuutu tuaal
bbeenneefifciciaial l eenntt
v o lvlveem
ssuupppplileierr hhtt
In
Inv o m
ship s e d o n n eig
e i g ooffppeeoopplele
ionnship
rreelalatito a
BBased o
qquuaaliltityy
a n a g eem m eenntt
m a
man ples g
FFaacctu l
tuaal incci iples
pprrin
to
aapppprrooaacchh to
ionn
ddeeccisisio PPrroocceessss
king aapppprrooaacchh
mmaaking
SSyysstetemm
to
al
inuual
CCoonntitn aapppprrooaacchh to
n
p ro vveem meenntt MMaannaaggeem meen
im
imp ro tt
Principles of ISO 9001:2000
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 ISO 9001:2000
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 ISO 9001:2000

Avoid
Avoidthe
theapplication
applicationof
ofsystems
systemsthat
thatare
areseparate
separatefrom
fromthe
the
organization’s
organization’sbusiness
businessprocess
process

Enable
Enablethe
thedevelopment
developmentofofaaQuality
Qualitysystem
systemthat
thatisisfully
fullyintegrated
integrated
into
intothe
thenormal
normaloperations
operationsof
oforganization’s
organization’sbusiness
business

Enable
EnableContinual
Continualimprovements
improvementsof
ofthe
thesystem
systemfor
forenhanced
enhanced
customer
customersatisfaction
satisfaction

Enable
Enablecompliance
complianceto
tostatutory
statutory&&regulatory
regulatoryrequirements
requirements
 Process approach

Process
Processdefinition
definition
Set
Setof
ofinterrelated
interrelatedor
orinteracting
interactingactivities
activitieswhich
whichtransforms
transforms
inputs
inputsinto
intooutputs
outputs

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

Do
Doititfor
forall
all value
valueadding
addingprocesses
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
 E.g. - Purchasing Process

Inputs
Inputs Purchasing
Purchasing Outputs
Outputs
•• Required
Requireditem
item/ /
Procedure
Procedure •• Receipt
ReceiptofofMaterial
Material
quantity
quantity/ /date
date on
onright
rightcondition
condition
•• Applicable •• Right
RightQuality
Applicablespecs
specs Quality
•• Supplier Right
RightQuantity
Quantity
Suppliersource
source
Interactions •• Right
RightTime
•• Suppliers
Suppliers Interactionstoto Time
capability
capabilitytotomeet
meet ••Storage
Storage
our
ourrequirements
requirements ••Inspection
Inspectionand
andTesting
Testing
••Manufacturing
Manufacturing
••Finance
Finance

Performance
PerformanceMeasurements
Measurements
••Delivery
Deliverystatus
status––On-time,
On-time,On
Onspec,
spec,NCP
NCP
etc
etc
••Supplier
Supplierevaluation
evaluation
 System Requirements / Structure of
the Standard

4 Quality 5 Management 6 Resource 7 Product 8

Management Responsibility Management Realization Measurement
System Analysis &
improvement

Management
General Commitment Provision of Planning
General
requirements resources

Customer focus Customer Monitoring &

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

Identification
Identification
Continual
Continual ofofprocesses
processes
improvements
improvements required
required

4.1 General
requirements Criteria
Criteriaand
and
Monitoring methods
methodstotoensure
Monitoringand
and ensure
Measuring Operation
Operation&&control
Measuringofof control
processes
processes
Availability
Availabilityofof
information
information&&
resources
resourcesfor
for
operation
operation&&control
control
Quality management system - 4

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
 Management Responsibility - 5

5.1 5.2 5.3 5.4 5.5 5.6

Management Customer Quality Planning Responsibility Management
commitment focus policy authority & Review
communicate

Quality Responsibility General

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

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

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

Evidence
Evidencemust
mustbe
beprovided
providedto
toshow
showthat
thatthe
theManagement
Managementisiscommitted
committed
to
tothe
theabove
aboverequirements
requirements

Auditors
Auditorscould
couldspeak
speaktotoand
andaudit
auditTop
TopManagement
Management(E.g.
(E.g.MD
MD/ /
Directors)
Directors)totoestablish
establishtheir
theircommitment
commitmenttotothe
themanagement
managementsystem
system
Resource Management - 6

6.1 6.2 6.3 6.4

Infrastructures
Provision of Human Work
resources Resources Environment

General

Competence,
awareness &
training
Resource Management - 6

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
Managemen
Managemen
tt Infrastructures
Infrastructures
Infrastructures
Infrastructuresneeded
neededtotoachieve
achieveproduct
product
conformity
conformity

Work
Workenvironment
environment
Work
Workenvironment
environmentneeded
neededtotoachieve
achieveproduct
product
conformity
conformity
Enhanced
Human Resources - 6

Competent
Competentononthe
thebasis
basisofofappropriate
appropriate
education, skill and experience
education, skill and experience

Define
Definecompetencies
competenciesfor
forpeople
peopleperforming
performing
work
workaffecting
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
the
activity
activitybeing
beingperformed
performed
 Product Realization - 7

7.1 7.2 7.3 7.4 7.5 7.6

Planning Customer Design and Purchasing Production Control of

related development & service monitoring
of 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 Customer
communication verification property

Design validation Preservation of

product

Design Changes
 Product Realization - 7

Quality
Qualityobjectives
objectivesofofProducts
Products––Specs
Specs

Processes,
Processes,procedures
procedurestotorealize
realize
product
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
 Product Realization - 7
Identification
IdentificationofofCustomer
Customer/ /Market
Market
requirements
requirements
•Specified
•Specifiedbybycustomer
customer
•Requirements
•Requirementstaken
takenfor
forgranted
granted
•Statutory / Regulatory requirements
•Statutory / Regulatory requirements
7.2
7.2
Customer
Customerrelated
related
processes Review
Reviewofofrequirements
requirementsrelated
processes––(Sales)
(Sales) product
related
productprior
priortotoacceptance
acceptance/ /
commitment
commitmenttotocustomers
customers --ability
abilitytoto
meet
meetcustomer
customerrequirements
requirements

Effective
Effectivecommunication
communicationwith
withcustomer
customerininrelation
relationtoto
•Product
•Productinformation
information
•Sales
•Sales orderhandling
order handling
•Customer feedback
•Customer feedback
•Customer
•Customercomplaints
complaints
Product Realization - 7

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
 Clause 7.3 Design Process
Design plan
7.3.1

Design Review
7.3.4
C
U
U
S Design Input Design Output
Design Process S
T 7.3.2 7.3.3 E
O
Design verification R
M
7.3.5 S
E
R Design validation
7.3.6
Design changes
7.3.7
Product Realization - 7

Degree
Degreeofofcontrol
controldepends
dependson
oneffects
effectsofof
subsequent
subsequentprocesses
processesand
andeffect
effecton
onfinal
final
product
product
7.4
7.4
Purchasing
Purchasing
Purchasing
Purchasingisisdone
done
inincontrolled
controlledmanner
manner Supplier
Supplierevaluation
evaluation
totoensure
ensurethat
that
purchased
purchasedproducts
products
conforms
conformstotospecific
specific
requirements
requirements

Verification
Verificationofofpurchased
purchasedproduct
product––
Inspection
Inspectionand
andtesting
testing
 Product Realization - 7
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
and
service
serviceprovision
provision
Product
Productrelease,
release,delivery
deliveryand
andpost
postdelivery
delivery
Manufacturing
Manufacturing/ /
service
serviceprovision
provision
under
undercontrolled
controlled Process
condition Processvalidation
validation
conditiontotoensure
ensure
conformity
conformity ofproduct
of product
Identification
Identificationand
andtraceability
traceability

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

7.6
7.6 Control
Controlof
ofmonitoring
monitoringand
andmeasuring
measuringdevices
devices
Control
Controland
andCalibration
Calibrationofofequipments
equipmentsused
usedfor
formonitoring,
monitoring,inspection
inspectionand
and
testing
testing
 Measurement, analysis - 8
and improvement

8.1 8.2 8.3 8.4 8.5

Control of
General Monitoring & non Analysis of Improvement
measurements conforming data
product

Customer Continual
satisfaction improvements

Internal audits Corrective

action

Measurement of
processes Preventive
action
Measurement of
product
Measurement, analysis - 8
and improvement
To
8.1demonstrate
8.1
To -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
NCPproducts
productsare
areidentified
identifiedand
andcontrolled
controlledto
toprevent
prevent
unintended
unintendeduse
use/ /delivery
delivery
Measurement, analysis - 8
and improvement

8.4
8.4--Analysis
Analysisof
ofdata
data
Collection
Collectionand
andanalysis
analysisofofdata
datagenerated
generatedthrough
throughQMS
QMS
activities
activitiesto
toverify
verifysuitability,
suitability,effectiveness
effectivenessand
andcontinual
continual
improvement
improvementof ofthe
thesystem
system

Analysis shall provide information related to

•Customer satisfaction / perception

•Conformity to specs, requirements
•Trends of processes and products
• Opportunities for preventive actions
•Suppliers
Measurement, analysis - 8
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 of
relevant records
relevant records

Preventive
Preventiveaction
action
•Actions
•Actionsagainst
againstpotential
potentialnon
nonconformities
conformitiestotoavoid
avoidtheir
their
occurrence
occurrence
•Includes
•Includesidentification
identificationof
ofpotential
potentialnon
nonconformities,
conformities,cause,
cause,need
need
for action, implementation of action, review of action and
for action, implementation of action, review of action and
maintenance
maintenanceof ofrecords
records
 Criteria for measurements
––Satisfaction
Satisfactionsurveys
surveysfor
forcustomers
customersand
andother
otherinterested
interested
parties
parties
•Feedback
•Feedbackononproducts
products
•Customer
•Customer&&market
marketrequirements
requirements
––Financial
Financialmeasurements
measurements
•Prevention
•Preventioncost
cost
System
System •Non
•Nonconforming
conforming/ /failure
failurecost
cost
performanc
performanc •Lifecycle
•Lifecyclecost
cost
ee
Self
Selfassessment
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
processvalidation
validation
––Reaction
Reactiontimetime
Processes
Processes ––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

More
Moreresource
resourcedemanding
demanding ??
??
Challenges in implementing
ISO 9001:2000
Management Support

Encouragement

ISO 9001:2000

Communication

Other employee Support

Thank You