ISO9001 Awareness

7/25/2019 ISO9001 Awareness

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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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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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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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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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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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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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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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).& =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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).: "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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).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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).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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).) 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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).).: 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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).? Management esponsibilit#

).?.1 2eneral Top management must revie! "MS

at planned intervals to ensure

continued suitabilit#, ade+uac# andeffectiveness.


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).?.& 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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).?.: 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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?.& 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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?.: 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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?.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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(.& =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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(.&.& 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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(.&.& 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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(.&.: 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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(.: 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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(.:.& 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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(.:.: 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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(.:.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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(.:.) 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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(.:.? 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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(.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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(.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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(.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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(.) 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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(.).& 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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(.).: 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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(.).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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(.).) 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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(.? =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

Clase 8.0 #easrement +nalysis andClase 8.0 #easrement +nalysis and


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Im)roementIm)roement


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Documents

ISO9001 Awareness