quality management standards – iso 9001

7/26/2019 Quality Management Standards Iso 9001

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RAKIB ZAHOOR WANI

QUALITY MANAGEMENTSTANDARDS ISO9001:2000


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QMS FUNDAMENTALS

Strat!"# $%a&"t' !(a&) ar )ta*&")+, at t+ +"!+)t#(-.a/' &&) a/, ar a .art ( t+ #(-.a/")*%)"/)) .&a/)3 T+") #(/#.t ( )trat!"# $%a&"t' !(a&)") a &(!"#a& r)%&t ( t+ -(-/t t( !" $%a&"t' t+

t(. .r"(r"t' a-(/! t+ #(-.a/") !(a&)3 J. M. Juran, Juran on Quality by Design, The Free Press, 1992.

I/ t+ /,4 a ")"(/ 5"t+(%t t+ a*"&"t' t( 6#%t ").r(*a*&' a +a&&%#"/at"(/3

Stephen M. Case, Chairan, !"#Tie$arner, %The Min& o'the C.(.", )*usiness $ee+, February , 2--1, p. 1-.


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RELE7AN8E OF STANDARDS

Ar -a/a!-/t )ta/,ar,) )t"&& r&a/t"/ a 5(r&, ( a##&rat, t#+/(&(!' ra-.a/t !&(*a&"at"(/ ;


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RELE7AN8E OF STANDARDS

W )t"&& /, a )ta/,ar, t+at ,


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/(#(0!C(

T( )ta*&")+ -a/"/!%& )ta/,ar,) r$%"r) t+att+r ar %/"r)a& (r!a/"at"(/a& %/,a-/ta&)3S%#+ %/,a-/ta&) -%)t * #(/)ta/t4 a&t+(%!+t+ .ara,"!-) -a' )+"t >"334 t+ 5a' 5 -(,&

a/, a..&' t+ %/,a-/ta&) ar") 5"t+ t+ -()ta##.t, !&(*a& /(r-)?

H(5r4 /( -attr 5+at t+ .ara,"!- )+"t"/(&)4 t+() 5+( )&& a .r(,%#t at a &()) ( (/#/t .r ."# 5"&& /r -a= %. t+ &()) "/(&%-3 T+() 5+( ,( /(t =/(5 5+at t+"r#%)t(-r ra&&' /,) 5"&& )t"&& &() t( )(-(/&) 5+( ,()3


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/(#(0!C(

T+() 5+( ,( /(t #()t@r,%# t+"r .r(,%#t)#(/t"/%(%)&' 5"&& /t%a&&' &() t+"r -ar=t,(-"/a/#3 T+() 5+( ,( /(t .r"(,"#a&&'(r -(r .r(r-a/# (r t+ )a- .r"# 5"&&&() t+"r #(-.t"t" ,!3

T+%)4 t+ ,&(.-/t a/, a..&"#at"(/ ()ta/,ar,) t( /+a/# (r!a/"at"(/a&

,&(.-/t r-a"/) r&a/t "/ )."t ( t+(r5+&-"/!4 #(/)ta/t&' #+a/!"/! t5/t'@


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/(#(0!C(

I/ a#t4 "/tr/at"(/a& a/, /at"(/a& )ta/,ar,)ar /(5 "/ %) "/ (r 10 #(%/tr") t( (r-t+ (%/,at"(/ (r #t" $%a&"t'

-a/a!-/t )')t-)3 T+ /%-*r (A//%a& Q%a&"t' A5ar,) /(5 &")t) at &a)t119 .r(!ra-) 5(r&,5",3 I/ t+ U/"t,Stat)4 )tat@5", .r(!ra-) ar %/,r5a'"/ at &a)t C1 )tat)


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QMS M"D(#


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S(#(CT" "F ! QMS *!S(#(


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S" 9--132--- QMS


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S(CT" 1 SC"P(

Clause 1.1 General

The S4ope has been enhan4e&, an& there is no5 anee& 'or an organisation

%6 to &eonstrate its ability to pro7i&e 4onsistentlypro&u4t that eets 4ustoer an& appli4ableregulatory re8uireents, an& to in4lu&e pro4esses'or the 4ontinual ipro7eent o' the syste an&the pre7ention o' non4on'ority.)

ote3 n S" 9--13199 : Clause , the re8uireentsspe4i;e& are aie& priarily at a4hie7ing 4ustoersatis'a4tion only by pre7enting non4on'ority.


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8LAUSE 132 ALI8ATION

This re8uireent is /5 an& gi7es in'oration on the%perissible e


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SE8TION @ TERMS AND DEFINITIONS

The ter =organisation> ?4opany@ use& in S"9--132--- repla4es the ter =supplier>, that 5asuse& pre7iously to ean the unit to 5hi4h S"

9--1 applie&. The ter =supplier> is no5 use&instea& o' the pre7ious ter =sub4ontra4tor>.

"l& ters3 sub:4ontra4tor : : A supplier : : : : : : : :A4ustoer

e5 ters supplier : : : : : : A organisation : : : : A4ustoer


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SE8TION C @ QUALITY MANAGEMENT SYSTEM

There is ore ephasis on the nee& to4ontinually ipro7e a QMS.

The organisation shall establish documentimplement maintain and continually improve a!"#. This should be achieved by identiyingrelevant processes determining the sequence

and criteria o these processes ensuringinormation is available on the processes and bymeasuring and monitoring these processes.


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SE8TION @ MANAGEMENT RESONSIBILITY

8&a%) 3 1 Ma/a!-/t #(--"t-/t

More ephasis is pla4e& on Top Manageent 4oitent by3

a$ communicating to the organisation the importance omeeting customer as %ell as regulatory and legal requirements;

establishing the quality policy and quality ob&ectives;

conducting management revie%s;

ensuring the availability o necessary resources.

8&a%) 32 8%)t(-r (#%)

This re8uireent rein'or4es the in7ol7eent o' Top Manageent,

5hi4h shoul&3 ' ensure that customer needs and expectations are

determined converted into requirements and ul(lled %ith theaim o achieving customer satisaction.


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SE8TION @ MANAGEMENT RESONSIBILITY

8&a%) 3 Q%a&"t' .(&"#'

This re8uireent has been enhan4e& to ensure that Top Manageentestablishes its poli4y 'or 8uality. Parti4ular attention shoul& be gi7en to3

B )%*@#&a%) >*?:

%there shoul& be a 4oitent to eeting re8uireents an& to

4ontinual ipro7eent) an&

B )%*@#&a%) >#?:

% a 'rae5or+ shoul& be pro7i&e& 'or establishing an& re7ie5ing 8ualityobe4ti7es)

8&a%) 3C31 Q%a&"t' (*#t")

There is a re8uireent that3 %Quality obe4ti7es are establishe& at rele7ant 'un4tions an& le7els

5ithin the organisation, 5hi4h shoul& be easurable an& 4onsistent 5iththe 8uality, in4lu&ing the 4oitent to 4ontinual ipro7eent.)


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SE8TION @ MANAGEMENTRESONSIBILITY

8&a%) 3C32 Q%a&"t' -a/a!-/t )')t-) .&a//"/!

This re8uireent has been re7ise& 'or 4larity an& to ensure that anaging4hange is in4lu&e& in planning.

)lanning shall cover:

a$ the planning o the !"#;

b$ the integrity o the !"#

)lanning shall ensure that change is conducted in a controlled manner and thatthe integrity o the !"# is maintained during this change.

8&a%) 33 Ma/a!-/t R.r)/tat"

%Top "anagement shall appoint a member o the management %hoirrespective o other responsibilities shall have responsibility and authority or:

a$ ensuring the processes o !"# are established and maintained; b$ reporting to Top "anagement on the perormance o the !"# including

needs or improvement;

c$ promoting a%areness o customer requirements throughout theorganisation.


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SE8TION @ MANAGEMENTRESONSIBILITY

8&a%) 33C I/tr/a& 8(--%/"#at"(/

This is a /5 re8uireent that re8uires the organisation3

to establish and maintain procedures or internal communication bet%eenthe various levels and unctions regarding the !"# and its efectiveness.

8&a%) 3 Ma/a!-/t R"5 (phasis is pla4e& on the organisation establishing a QMS pro4e&ure 'or

Manageent /e7ie5. Further te


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SE8TION @ RESOUR8E MANAGEMENT

8&a%) 31 r(")"(/ ( r)(%r#)

This re8uireent 'urther 4lari;es the re8uireent 'or an organisation to3

' determine and provide resources needed to establish and maintain the

!"# in order to address customer satisaction.

8&a%) 3232 8(-.t/#'4 a5ar/)) a/, tra"/"/!4The s4ope o' training re8uireents has been enhan4e& to in4lu&e not only

training nee&s but 4opeten4e an& a5areness. Pro4e&ures an& syste le7elpro4e&ures are re8uire& to3

a$ determine competency and training needs;

b$ provide training to address identi(ed needs; c$ evaluate the efectiveness o training at de(ned intervals;

d$ ensure employees are a%are o the importance o their activities;

e$ maintain appropriate records o education training s*ill and experience.


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SE8TION @ RESOUR8E MANAGEMENT

8&a%) 3 I/ra)tr%#t%r

The organiEation shall3

' identiy provide and maintain the acilities it needs toachieve the conormity o productincluding:

a$ %or*space and associated acilities; b$ equipment hard%are and sot%are;

c$ supporting services.

8&a%) 3C W(r= /"r(/-/t

This is a 7ery general re8uireent3

The organisation shall identiy and manage the human andphysical actors o the %or* environment needed to achieveconormity o product.

t is not 4lear ho5 a %5or+ en7ironent % is &e;ne&.


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SE8TION @ RODU8T REALIZATION

ote3 The title o' Pro4ess Control as tra&itionallyre'erre& to in S" 9--13199 has been repla4e& 5iththe title %Pro&u4t /ealisation).

This is 8uite a 4ople< se4tion, an& organisations 5illnee& to 4onsi&er 4are'ully 5hether they 5ish toin4lu&e any %.r-"tt, 6#&%)"(/) in their QMS?see 4lause 1.2@. !n organisation 5oul& ha7e to

usti'y any peritte& e


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8&a%) 31 &a//"/! ( ra&")at"(/ .r(#)))

Pro&u4t realisation is that se8uen4e o' pro4esses an& sub:pro4esses re8uire& to a4hie7e the pro&u4t, an& the 4lausespe4i;es the re8uireents to be et to a4hie7e this.

8&a%) 32 8%)t(-r@r&at, .r(#)))

This is &i7i&e& into sub:4lauses3

3231 +etermination o requirements related to the product

3232 ,evie% o requirements related to the product

323 -ustomer communicationThis sub:4lause is essentially a /5 re8uireent, the

organisation being re8uire& to ipleent eGe4ti7e liaison 5ith4ustoers, 5ith the ai o' eeting 4ustoer re8uireents.


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8&a%) 3 D)"!/ a/,J(r ,&(.-/t


331 +esign and development planning

332 +esign and development inputs

33 +esign and development outputs 33C +esign and development revie%

33 +esign and development veri(cation

33 +esign and development validation

33 -ontrol o design and development changes

8&a%) 3C %r#+a)"/!


3C31 )urchasing process

3C32 )urchasing inormation

3C3 eri(cation o purchased product


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8&a%) 3 r(,%#t"(/ a/, )r"# (.rat"(/)


331 -ontrol o production and services

332 alidation o process or production and service provision

33 /denti(cation and traceability 33C -ustomer property

33 )reservation o product

8&a%) 3 8(/tr(& ( -(/"t(r"/! a/, -a)%r"/! ,"#)

e5 re8uireents 'or so't5are &e7elope& 'or tests has been

a&&e&3 #ot%are used or monitoring and measuring o speci(ed

requirements shall be validated prior touse.


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S(CT" H : M(!SI/(M(T, !!#SS!D MP/"0(M(T

8&a%) 31 G/ra&

This 4lause re8uires that a easureent, onitoring, analysisan& improvement processes ust be

use& as a eans o' &eonstrating that the QMS, pro4esses an&

pro&u4t an&Kor ser7i4e 4on'ors to spe4i;e& re8uireents. The organisation shall identiy and use appropriate statistical

tools.

The results o data analysis and improvement activities shall beused as input to the management revie% process

8&a%) 323131 8%)t(-r Sat")a#t"(/This re8uireent is /5 an& ephasises that a pro4ess 'or

obtaining an& onitoring in'oration an& &ata on 4ustoersatis'a4tion SHALL be ipleente&.


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8&a%) 323 Ma)%r-/t a/, -(/"t(r"/! ( .r(#)))

This re8uireent is essentially the sae, ho5e7er it pla4es ore ephasison the etho& use& 'or the easureent o' pro4esses ne4essary to eet4ustoer re8uireents.

n parti4ular, %Measureent results SL!## be use& to aintain an&Koripro7e those pro4esses).

8&a%) 3C A/a&')") ( ,ata

n a&&ition to the tra&itional statisti4al te4hni8ue re8uireent o' the 199stan&ar&, this 4lause

'o4uses on the analysis o' appli4able &ata as one eans o' &eterining5here QMS ipro7eents 4an be a&e.

%The organisation SL!## analyse appli4able &ata to pro7i&e in'oration on3

a@ 4ustoer satis'a4tion, an& &issatis'a4tionb@ 4on'oran4e to 4ustoer re8uireents an&

4@ 4hara4teristi4s o' pro4esses, pro&u4ts an&Kor ser7i4es)

&@ supplier


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C#!IS( H..1 C"TI!# MP/"0(M(T

This re8uireent is 8uite 4lear3

%The organisation shall 4ontinually ipro7e the

QMS. The organisation shall establish a systele7el pro4e&ure that &es4ribes the use o' 8ualitypoli4y, obe4ti7es, internal au&it results, analysis o'&ata, 4orre4ti7e an& pre7enti7e a4tion an&anageent re7ie5 to 'a4ilitate 4ontinualipro7eent.)

quality management standards – iso 9001

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