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Understanding ISO 9001Understanding ISO 9001New Trends in IE
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Most of the ISO Standards relate to products and
services.
The ISO 9000 and ISO 14000 families are among
ISO's best no!n standards ever. ISO 9000ISO 9000relates to "ualit# Management S#stem.
ISO 14000ISO 14000relates to $nvironmental Management
S#stem.
ISO 9001%&000 and ISO 14001% &004 areimplemented b# over a million organiations in
1() countries.
ISO CertificationISO Certification
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ISO 9000 FamilyISO 9000 Family
The ISO 9000 famil# addresses *"ualit#
management*.
This means !hat the organiation does to
fulfill% the customer's +ualit# re+uirements, and
applicable regulator# re+uirements, !hile
aiming to
enhance customer satisfaction, and
achieve continual improvement of its
performance in pursuit of these ob-ectives.
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ISO 9000 FamilyISO 9000 Family
ISO 9000ISO 9000 "ualit# Management S#stems%
/undamentals and ocabular#
ISO 9001ISO 9001 "ualit# Management S#stems%
e+uirements ISO 9004ISO 9004 "ualit# Management S#stems%
2uidance for 3erformance Improvements
ISO 19011ISO 19011 2uidelines on "ualit# and$nvironmental uditing
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In the Global EconomyIn the Global Economy
The positive roles pla#ed in globaliation b# ISO5s
standards for +ualit# and environmental
management s#stems include the follo!ing%
a unif#ing base for global businesses and suppl#
chains 6 such as the automotive and oil and gas
sectors
a technical support for regulation 6 as, for
e7ample, in the medical devices sector
a tool for ma-or ne! economic pla#ers to increase
their participation in global suppl# chains, in
e7port trade and in business process outsourcing8
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In the Global EconomyIn the Global Economy
a tool for regional integration 6 as sho!n b#their adoption b# ne! or potential members ofthe $uropean nion
in the rise of services in the global econom# 6nearl# :& ; of ISO 9001%&000 certificates and&9 ; of ISO 14001%&004 certificates in &00(!ent to organiations in the service sectors,and
in the transfer of good practice to developingcountries and transition economies
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What is Qality!What is Qality!
The ability of aThe ability of a
product or service toproduct or service to
consistently meet orconsistently meet or
exceed customerexceed customer
expectations.expectations.
QUALITYQUALITY
Degree ofexcellence
!ustomer!ustomersatisfactionsatisfaction
"#$%&"#$%&D#'#!TD#'#!T
(()tness)tness
for use*for use*
((doingdoingright theright the
)rst time+)rst time+
all theall the
time*time*
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Qality "efinedQality "efined
QUALITYQUALITYis the degree to !hich a set of
inherent characteristics fulfills
re+uirements.
CharacteristicCharacteristic6 distinguishing
feature
RequireentRequireent6 need or e7pectationthat is stated, generall# implied or
obligator#
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"imensions of Qality"imensions of Qality
Performance
Aesthetics
Special features
Conformance
Safety
Reliability
Durability
Perceived
quality
Service after
sale
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Qality #anagement System $Q#S%Qality #anagement System $Q#S%
S!steS!ste6 set of interrelated or interacting
elements
"ana#eent S!ste"ana#eent S!ste6 a s#stem to
establish polic# and ob-ectives and toachieve those ob-ectives
Qua$it! "ana#eent S!steQua$it! "ana#eent S!ste6 a
management s#stem to direct and control
an organiation !ith regard to +ualit#
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#odel of &rocess'(ased Q#S#odel of &rocess'(ased Q#S
Customers
Customers
C%ntinua$ I&r%'eent %( the
Qua$it! "ana#eent S!ste
ManagementResponsibility
ResourceManagement
Measurement,analysis andimprovement
ProductRealiation
$e,uirements Product
-atisfaction
Input %utput
Key
Value-adding activitiesInformation flow
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Qality #anagement System $Q#S%Qality #anagement System $Q#S%
ISO 9001%&000 specifies re+uirements for a
+ualit# management s#stem !here an
organiation
needs to demonstrate its abilit# to consistentl#provide product that meets customer and
applicable regulator# re+uirements, and
aims to enhance customer satisfaction through
the effective application of the s#stem, includingprocesses for continual improvement of the
s#stem and the assurance of conformit# to
customer and applicable regulator#
re+uirements.
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Qality #anagement &rinci)lesQality #anagement &rinci)les
The +ualit# management s#stem standards of theISO 9000%&000 and ISO 9000%&00< series arebased on the eight +ualit# managementprinciples.
1. =ustomer focus&. >eadership
:. Involvement of people
4. 3rocess approach
). S#stems approach to management?. =ontinual improvement
(. /actual approach to decision maing
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*he ISO 9000 &rocess +))roach*he ISO 9000 &rocess +))roach
There are five sections in the standard that specif#
activities that need to be considered !hen a
compan# implement its s#stem %
1. Overall re+uirements for the +ualit#
management s#stem and documentation
&. Management responsibilit#, focus, polic#,
planning and ob-ectives
:. esource management and allocation
4. 3roduct realiation and process management,
and
). Measurement, monitoring, anal#sis and
improvement.
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ISO 9001 ,e-irementsISO 9001 ,e-irements
The standard has < clauses%
=lause 1.0 Scope
=lause &.0 @ormative eferences
=lause :.0 Aefinitions=lause 4.0 "ualit# Management S#stems
=lause ).0 Management esponsibilit#
=lause ?.0 esource Management,
=lause (.0 3roduct andBor Service ealiation
=lause
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ISO 9001 ,e-irementsISO 9001 ,e-irements
)r%cess a&&r%ach)r%cess a&&r%achrefers to the application of a
s#stem of processes !ithin an organiation,
together !ith their identification and interactions
and the managing of these processes
This approach emphasies the importance of%
nderstanding and fulfilling re+uirements
The need to consider processes in terms of value
added
Obtaining results of process performance and
effectiveness
=ontinual improvement on processes based on
ob-ective measure
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Clase 1.0 Sco)eClase 1.0 Sco)e
The purpose of the standard is for the
organiation to demonstrate its abilit# to provide
a product that meets customer and regulator#
re+uirements and achieves customer
satisfaction
This purpose is accomplished b# evaluating and
continuall# improving the s#stem, rather than the
product.
The re+uirements of the standard are intended
to be applicable to all t#pes and sies of
organiations
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Clase /.0 ormatie ,eferenceClase /.0 ormatie ,eference
ISO 9000:2000 Quality Management
Systems - Fundamentals and vocabularyis
a normative reference that provides
applicable concepts and definitions.
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Clase 2.0 *erms and "efinitionsClase 2.0 *erms and "efinitions
/or the purposes of this standard, the terms and
definitions given in ISO 9000%&000 appl#.
In addition the suppl# chain is defined as%
Supplier Organiation =ustomer Must be properl# understood and accuratel#
applied.
uditors and others involved in the "MS
implementation and improvement are e7pectedto demonstrate good understanding of
definitions.
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Clase 3.0 Qality #anagementClase 3.0 Qality #anagement
SystemsSystems
4.1 2eneral e+uirements
The organiation shall establish, document,
implement, and maintain a "MS and continuall#
improve its effectiveness
It shall%
a. Identif# needed processes such as
management activities, provision of resources,
product realiation, and measurement
b. Aetermine their se+uence and interaction
c. Aetermine criteria and methods for effective
operation and control of these processes
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Clase 3.0 Qality #anagementClase 3.0 Qality #anagement
SystemsSystems
d. $nsure the availabilit# of resources andinformation necessar# to support and monitorthese processes
e. Monitor, measure, and anal#e these
processes, andf. Implement actions to achieve planned results
and continual improvement of theseprocesses
Outsourced processes that affect the +ualit# ofthe product shall be identified and included inthe s#stem.
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Clase 3.0 Qality #anagementClase 3.0 Qality #anagement
SystemsSystems
4.& Aocumentation e+uirements
4.&.1 2eneral
Aocumentation shall include
a. statements of +ualit# polic# and +ualit#ob-ectives
b. a +ualit# manual
c. re+uired documented procedures
d. needed documents to ensure effectiveplanning, operation, and control of
processes
e. re+uired records
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Clase 3.0 Qality #anagementClase 3.0 Qality #anagement
SystemsSystems
4.&.& "ualit# Manual
+ualit# manual shall be established and
maintained that includes%
a. the scope of the "MS !ith details and-ustification for an# e7clusions
b. the documented procedures or
reference to them, and
c. a description of the interaction amongthe "MS processes
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Clase 3.0 Qality #anagementClase 3.0 Qality #anagement
SystemsSystems
4.&.: =ontrol of Aocuments Aocuments re+uired b# the "MS shall be
controlled. documented procedure shall be in place
to define controls needed to%a. pprove documents prior to use
b. evie!, update, and reapprove asnecessar#
c. Identif# the current revision status
d. $nsure that current versions areavailable at the point of use
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Clase 3.0 Qality #anagementClase 3.0 Qality #anagement
SystemsSystems
e. $nsure that documents are legible andreadil# identified
f. Identif# and distribute documents ofe7ternal origin, and
g. 3rovide for the prompt removal ofobsolete documents and suitabl#identif# an# that ma# be retained
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Clase 3.0 Qality #anagementClase 3.0 Qality #anagement
SystemsSystems
4.&.4 =ontrol of ecords Rec%rdsRec%rdsare a special form of
documentation. The# shall be established and maintained
to provide evidence of conformit# tore+uirements, and effective operation ofthe "MS.
The# must remain legible, readil#identifiable, and retrievable.
documented procedure is re+uired todefine controls needed for identification,storage, protection, retrieval, retentiontime and disposition.
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Clase 4.0 #anagementClase 4.0 #anagement
,es)onsibility,es)onsibility
).1 Management =ommitment
Top management must provide evidence of itscommitment to development, implementationand continual improvement of the "MS.
=ommitment must be demonstrated b#%
a. communicating to the organiation theimportance of meeting customer, statutor#and regulator# re+uirements
b. establishing a +ualit# polic#c. ensuring +ualit# ob-ectives are established
d. conducting management revie!s
e. ensuring resource availabilit#
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Clase 4.0 #anagementClase 4.0 #anagement
,es)onsibility,es)onsibility
).& =ustomer /ocus
T%& ana#eentT%& ana#eentrefers to the person or
group of people !ho directs and controls an
organiation. Top management must ensure that customer
re+uirements are determined and are met
!ith the aim of enhancing customer
satisfaction.
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Clase 4.0 #anagementClase 4.0 #anagement
,es)onsibility,es)onsibility
).: "ualit# 3olic# The +ualit# polic# must%
a. be appropriate to the purpose oforganiation.
b. include a commitment to compl# !ith "MSre+uirements.
c. include a commitment to continuall#improve "MS effectiveness.
d. provide a frame!or forestablishingBrevie!ing +ualit# ob-ectives.
e. be communicated and understood !ithinthe organiation.
f. be revie!ed for continuing suitabilit#.
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Clase 4.0 #anagementClase 4.0 #anagement
,es)onsibility,es)onsibility
).4 "ualit# 3lanning
).4.1 "ualit# Ob-ectives Must be established at relevant
functions and levels !ithin theorganiation.
Must include those needed to meetre+uirements for product.
Must be measurable.
Must be consistent !ith the +ualit#polic#.
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Clase 4.0 #anagementClase 4.0 #anagement
,es)onsibility,es)onsibility
).4.& "ualit# Management S#stem3lanning
Top management must ensure% 3lanning is carried out to meet
re+uirements of 4.1 and +ualit#ob-ectives.
Integrit# of "MS is maintained !henchanges to "MS are planned and
implemented.
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Clase 4.0 #anagementClase 4.0 #anagement
,es)onsibility,es)onsibility
).) esponsibilit#, uthorit# and =ommunication).).1 esponsibilit# and authorit#
Top management must ensure thatresponsibilities, authorities and their
interrelations are defined andcommunicated
).).& Management epresentative Must be appointed b# top
management Must be a member of management $nsures "MS is established,
implemented, maintained
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Clase 4.0 #anagementClase 4.0 #anagement
,es)onsibility,es)onsibility
).).: Internal communication
Top management must ensure that =ommunication processes are
established !ithin the organiation. =ommunication taes place
regarding effectiveness of the "MS.
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Clase 4.0 #anagementClase 4.0 #anagement
,es)onsibility,es)onsibility
).? Management esponsibilit#
).?.1 2eneral Top management must revie! "MS
at planned intervals to ensure
continued suitabilit#, ade+uac# andeffectiveness.
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Clase 4.0 #anagementClase 4.0 #anagement
,es)onsibility,es)onsibility
).?.& evie! Input evie! must include assessing
opportunities for improvement andneed for changes to "MS, including
+ualit# polic# and ob-ectives. Include information on results of
audits, customer feedbac, processperformance and product conformit#,status of preventive and corrective
actions, follo!up actions fromprevious revie!s, planned changesthat could affect the "MS andrecommendations for improvement.
l
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Clase 4.0 #anagementClase 4.0 #anagement
,es)onsibility,es)onsibility
).?.: evie! Output Include an# decisions and actions
related to%
a. improvement of effectiveness of
"MS and its processesb. improvement of product related to
customer re+uirements, and
c. resources needed
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ClaseClase 5.0 ,esorce #anagement5.0 ,esorce #anagement
?.1 3rovision of esources
Aetermine and provide resources needed to%
a. implement and maintain "MS and
=ontinuall# improve effectiveness of"MS.
b. enhance customer satisfaction b#
meeting customer re+uirements.
Res%urcesRes%urcesma# be people, infrastructure,!or environment, information, suppliers,
natural resources, and financial
resources.
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ClaseClase 5.0 ,esorce #anagement5.0 ,esorce #anagement
?.& Cuman esources?.&.1 2eneral
3ersonnel performing !or affecting product+ualit# must be competent on basis ofappropriate education, training, sills ande7perience
?.&.& =ompetence, !areness and Training The organiation must%
a. Aetermine necessar# competence ofpersonnel
b. 3rovide training or other actions to satisf#
needs.c. $valuate effectiveness of actions taen.
d. $nsure personnel are a!are of relevanceand importance of their !or and ho! the#contribute to +ualit# ob-ectives.
e. Maintain records of education, training, sills
and e7perience
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ClaseClase 5.0 ,esorce #anagement5.0 ,esorce #anagement
?.: Infrastructure The organiation shall determine, provide,
and maintain infrastructure needed toachieve conformit# to product re+uirements.
Infrastructure includes, as applicable%a. buildings, !orspace, utilities
b. process e+uipment Dhard!are andsoft!areE
c. supporting services Dsuch as transport orcommunicationE
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ClaseClase 5.0 ,esorce #anagement5.0 ,esorce #anagement
?.4 For $nvironment The organiation shall determine and
manage the !or environment needed toachieve conformit# to product re+uirements.
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.1 3lanning of 3roduct ealiation 3lanning of realiation processes must be
consistent !ith other processes of the "MS. 3lanning must include determining%
a. 3roduct +ualit# ob-ectives andre+uirements.
b. @eed to establish processes, documents,resources specific to the product.
c. e+uired verification, validation,monitoring, inspection and test activitiesspecific to product and the criteria forproduct acceptance.
d. ecords as evidence that realiationprocess and product meet re+uirements.
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.& =ustomerelated 3rocesses(.&.1 Aetermination of e+uirementselated to The 3roduct
The organiation shall determine%
a. customer specified re+uirementsincluding deliver# and post deliver#re+uirements
b. re+uirements not stated b#customer but necessar#
c. product statutor# or regulator#re+uirements, and
d. an# additional re+uirementsdetermined b# the organiation
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.&.& evie! of e+uirements elated toThe 3roduct
evie! re+uirements prior tocommitment to suppl# product.
evie! to ensure that%a. product re+uirements are defined
b. differences bet!een past andcurrent re+uirements are resolved,and
c. The organiation has the abilit# tomeet defined re+uirements
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.&.& evie! of e+uirements elated toThe 3roduct
evie! records and actions to bemaintained.
If customer re+uirements are notdocumented, organiation mustconfirm before acceptance.
Aocuments must be amended toreflect changes and relevant
personnel made a!are of thechanges.
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.&.: Cust%er C%unicati%n Aetermine and implement
arrangements for communicating !ithcustomers on%
a. product informationb. in+uiries, contracts, or orderhandling, including amendments,and
c. customer feedbac, including
customer complaints
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.: Aesign and Aevelopment(.:.1 Aesign and Aevelopment 3lanning
Auring this stage, the organiationshall determine the%
a. design and development stagesb. revie!, verification, and
validation that are appropriate toeach stage
c. responsibilities and authorities
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.:.& Aesign and Aevelopment Inputs Inputs include%
a. functional and performancere+uirements
b. applicable statutor# andregulator# re+uirements
c. information derived fromprevious similar designs, and
d. other essential re+uirements
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.:.: Aesign and Aevelopment Outputs Outputs shall%
a. meet the input re+uirements
b. 3rovide appropriate information for
purchasing, production, andservice provision
c. =ontain reference productacceptance criteria, and
d. Specif# the characteristics of the
product that are essential for itssafe and proper use
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.:.4 Aesign and Aevelopment evie! evie!s shall be performed to%
a. evaluate the abilit# of the results tomeet re+uirements
b. identif# an# problem and proposenecessar# actions is assessment such as /M$,
reliabilit# prediction, and simulationtechni+ues can be undertaen to
determine potential failures inproducts or processes
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.:.) Aesign and Aevelopment erification erification shall be performed to
ensure that outputs have met the inputre+uirements.
ecords of the results of theverification and an# necessar# actionsshall be maintained.
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.:.? Aesign and Aevelopment alidationalidation% ensures that the product is capable of
meeting re+uirements for the specifiedapplication or intended use
shall be completed prior to the deliver#or implementation of the product
(.:.( =ontrol of Aesign and Aevelopment
=hanges
The changes shall be revie!ed, verified,validated, and approved beforeimplementation.
The revie! shall include evaluation ofthe effect of changes on constituent
parts and product alread# delivered.
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.4 3urchasing
(.4.1 3urchasing 3rocess $nsure purchased product conforms !ith
specified purchase re+uirements.
T#pe and e7tent of control depends oneffect of purchased product on productrealiation and final product.
$valuate and select suppliers based onabilit# to suppl# product that meets
re+uirements. $stablish criteria for selection, evaluation,
reevaluation. Maintain records of results of evaluation
and actions taen.
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.4.& 3urchasing Information
Aescribe product to be purchased,
including%
a. re+uirements for approval of product,
procedures, processes and e+uipment
b. re+uirements for +ualification of
personnel, and
c. "ualit# management s#stem
re+uirements
$nsure ade+uac# of specified purchase
re+uirements prior to their communication
to supplier.
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.4.: erification of 3urchased 3roduct
erif# that purchased product meetsspecified re+uirements b# inspectionor other means.
Specif# verification arrangement andmethod of product release inpurchasing information !hereorganiation or its customer intends to
perform verification at supplierspremises.
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.) 3roduction and Service 3rovision
(.).1 =ontrol of 3roduction and Service
3rovision 3lan and carr# out production and service
provisions under controlled conditions.
=ontrolled conditions shall include%a. availabilit# of product characteristic
description information
b. availabilit# of !or instructions
c. use of suitable e+uipment
d. availabilit# and use of suitable monitoring andmeasurement devices
e. implementation of monitoring andmeasurement, and
f. implementation of release, deliver# and postdeliver# activities
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.).& alidation of 3rocesses for 3roduction andService 3rovision
If output of a process for production andservice provision cannot be verified b#subse+uent monitoring and measurement,it must be validated.
Include an# process !here deficienciesma# become apparent onl# after product isin use or service is delivered.
alidation must demonstrate abilit# ofthese processes to achieve plannedresults.
$stablish arrangements for theseprocesses.
l d l
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.).: Identification of Traceabilit# Identif# product b# suitable means
throughout product realiation !hereappropriate.
Identif# product status !ith respect tomonitoring and measurementre+uirements.
=ontrol and record the uni+ueidentification of the product Fhere
traceabilit# is a re+uirement.
Cl 0 d , li i
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.).4 =ustomer 3ropert# $7ercise care !ith customer propert#. Identif#, verif# and safeguard =ustomer
propert# provided for use or to be
incorporated into the product. eport to customer lost, damaged or
other!ise unsuitable customer propert#and maintain records.
Cl 6 0 & d , li i
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.).) 3reservation of 3roduct 3reserve conformit# of product during
internal processing and deliver# tointended destination.
3reservation includes%a. Identification
b. handling
c. pacaging
d. storage
e. protection 3reservation also applies to constituent
parts of product.
Cl 0 d li iCl 6 0 & d , li i
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Clase 6.0 &rodct ,eali7ationClase 6.0 &rodct ,eali7ation
(.? =ontrol of Monitoring and Measuring Aevices Aetermine monitoring and measurement to be
undertaen and measurement devices needed toprovide evidence of conformit# of product tore+uirements.
$stablish processes to ensure monitoring andmeasurement can be carried out and are carriedout in a !a# consistent !ith monitoring andmeasurement re+uirements.
ssess and record validit# of previous measuringresults !hen e+uipment is found not to conform tore+uirements.
=onfirm abilit# of computer soft!are to satisf#intended application !hen used in monitoring andmeasurement of specified re+uirements.
Cl 6 0 & d , li iCl 6 0 & d t , li ti
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(.? =ontrol of Monitoringand Measuring Aevices
Fhere necessar# to ensure valid results, measuringe+uipment must be%
a. calibrated or verified at specified intervals, or prior to
use against standard traceable to international ornational standard. Fhere no standard e7ists, basisof calibration or verification must be recorded.
b. ad-usted or read-usted as necessar#
c. identified to allo! calibration status to be determined
d. safeguarded against ad-ustments that !ouldinvalidate measurement results
e. protected from damage and deterioration duringhandling, maintenance, storage
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Clase 8.0 #easrement +nalysis and y
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Clase 8.0 #eas e e t alys s a d y
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y y
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y y
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y y
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yy
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