Lecture-7 & 8: Handbook for Understanding and Implementation of ISO 9 !

:" 8
#r$ %li &esar '(an )acult* %d+unct

ISO 9001:2008-The Focuses

, , , , , , , Customer satisfaction Continual Improvement Documentation Documents of all scope i.e., all you o,! "eco" s,! inte"nal au its,! nonconfo"min# p"o uct, ! co""ecti$e action, ! p"e$enti$e action. The standard that requires a %uality manual,! a statement of %uality policy, an ! %uality o&'ecti$es. Legal and regulatory issues (to ensure that activities are operated within the law)

ISO-9
, ,

!:"

8 pro-ides emp(asis on " .a+or Issues

("ocess acti$ities )ustome" satisfaction

/(ese again depends on )ustome"s "e%ui"ements

0ustomer re1uirement is not static /(is is 2(* 3.S *+uality ,ana#e ment System- (as to be impro-ed continuall*

, )ustome"s .e%ui"ements
1. /a" issues: , e$g$ 4roduct5Ser-ice re1uirements6 , Legal6 Healt(6 Safet* re1uirements6 , 4rice and deli-er* re1uirements 2. Fu00y issues: , e$g$ Implied re1uirements6 , 7eliabilit*6 .aintainabilit*6 Upgradeabilit*6 etc$ 1. Soft issues: , e$g$ #esign6 St*le6 etc$

8 8lements of ISO 9
, , 1 Scope

!:"

2 &ormati-e references

ISO-9001:2008 provides emphasis on 2 Major Issues

Process activities Customer satisfaction
These again depends on

Customers requirements

Customer re uirement is not stati! This is "h# $MS (Quality

Management System)
has to %e improved !ontinua&&#

Customers Requirements 1. Hard issue s: e'g' (rodu!t)Servi!e re uirements* +ega&* ,ea&th* Sa-et# re uirements* (ri!e and de&iver# re uirements . !u""y issue s: e'g' Imp&ied re uirements* .e&ia%i&it#* Maintaina%i&it#* /pgradea%i&it#* et!' #. Soft issue s: e'g' 0esign* St#&e* et!'

2.0 +uality ,ana#ement System *+,S2.1 3ene"al "e%ui"ements: It i entifies the co"e inte"nal p"ocesses t(at t(e organi9ation needs to address: - t(e s*stem and t(e products it produces :4roduct and 3% s*stem; -monitoring and control :30; -continual impro-ement of t(e processes :3I; $ 2.2 Documentation "e%ui"ements: , 1- 4.5.1 .anagement 7e-ie2s , 2- 5.2.2 0ompetence6 a2areness and training , 1- 6.1 4lanning of product reali9ation , 2- 6.2.2 7e-ie2 of re1uirements , 4- 6.1.1 #esign planning output , 5- 6.1.2 #esign and de-elopment inputs , 6- 6.1.1 #esign and de-elopment output , 8- 6.1.2 #esign and de-elopment re-ie2 , 9- 6.1.4 #esign and de-elopment -erification , 10- 6.1.5 #esign and de-elopment -alidation , 11- 6.1.6 #esign and de-elopment c(anges , 12- 6.2.1 4urc(asing process

, , , , , , , , , , , , , ,

11- 6.4.1 0ontrol of production and ser-ice pro-ision 1- 4.5.1 .anagement 7e-ie2s 2- 5.2.2 0ompetence6 a2areness and training 1- 6.1 4lanning of product reali9ation 2- 6.2.2 7e-ie2 of re1uirements 4- 6.1.1 #esign planning output 5- 6.1.2 #esign and de-elopment inputs 6- 6.1.1 #esign and de-elopment output 8- 6.1.2 #esign and de-elopment re-ie2 9- 6.1.4 #esign and de-elopment -erification 10- 6.1.5 #esign and de-elopment -alidation 11- 6.1.6 #esign and de-elopment c(anges 12- 6.2.1 4urc(asing process 11- 6.4.1 0ontrol of production and ser-ice pro-ision

<$! .anagement 0ommitment

a; #emonstrate a commitment to meet custome" "e%ui"ements and meet statutor* and regulator* re1uirements= &- Define the %uality policy of t(e organi9ation and ensure t(at it is un e"stoo an maintaine = c- Define t(e %uality o&'ecti$es of t(e organi9ation and see t(at t(e* are successfully eploye = - 7nsure t(at *our compan* "e#ula"ly "e$ie8 the ope"ation of the mana#ement system to dri-e ongoing de-elopment and impro-ement of t(e operations of t(e organi9ation= and e- 7nsure t(at a e%uate "esou"ces a"e a$aila&le to implement and maintain t(e s*stem$

! " ? @ <

+uality o&'ecti$es .e$ie8 of the ope"ation of the mana#ement system :$aila&ility of "esou"ces

>ritten6 understood or maintained #efined and deplo*ed in 2ork s*stem #one regularl* 8nsured in ade1uate

4.2 )ustome" focus

, , , , /op management is to ensure t(at custome" nee s an e9pectations a"e p"ime issue of its &usiness consi e"ation$ :naly0e an "esea"ch 8hat custome"s 8ant :and e-en 2(at t(e* cannot t(ink but still 2ould like; Desi#n +:, +) an +I acco" in#ly :ct acco" in#ly to implement the esi#ns

/( e 0om p a n * is 0om m it t ed

Indicator )ompany;s commitment to meet custome" "e%ui"ements +uality policy

Status Has in >ritten form

7emark

4.1 +uality policy

This is a policy that states /o8 "e%ui"e %uality 8ill &e ma e an thei" satisfaction , , , , , eli$e"e to custome" fo"

1.The %uality policy must &e efine &y top mana#ement. 2.+uality policy must &e app"op"iate fo" capacity of the o"#ani0ation an to the nee s of its custome"s 1. It must &e ocumente an un e" fo"mal cont"ol. 2. The policy nee s to &e communicate an un e"stoo th"ou#hout the o"#ani0ation. 4. It is usually an e9pecte that e$e"y mem&e" of staff 8ill ha$e clea" un e"stan in# a&out the %uality policy an ho8 to apply it in "especti$e &o y;s ay to ay 8o"<.

$.% Planning
(&anning -a&&s into 1 !ategories 2 a) Planning to fulfill t &e qualit y o'(ectives * 34'5'16 %6 Planning to fulfill )roduct requirements 7 c) Planning to ensure t&e integrit y of t&e management system 34'5'26' $ua&it# o%je!tives have to %e de-ined and dep&o#ed at a&& "relevant functions and levels" o- the organi8ation' Managem ent m us t de-ine "hat &eve&s are re&evant and then ens ure that pro!ess es e9is t "hi!h "i&& ensure that the o%je!tives are a!hieved'

$.$ Res)onsi'ility* aut&ority and communication

+veryone in an organi8ation ,or-s and t&at affects quality* and e--e!tive intera!tion %et"een -un!tions and operations is the :e# to su!!ess' ;&& various -un!tions i- per-ormed right&#* "ithin an# organi8ation* - e--e!tive -u&-i&&ment o- !ustomer* organi8ationa& and so!ieta& re uirements are satis-a!tori&# met'Partici)atory quality ,or- !an !reate satis-a!tion o- organi8ation 7 !ustomers

Typical hierarchy of documents

$.$. Management re)resentative

The management re)resentative is the person "ho has %een de&egated authorit# -rom top management to ensure that the system is proper&# im)lemented and effectively maintained '
.as-s of t&e m anagement re)resentative: 1' The management representativ e reports to to) management on ho" the s#stem is "or:ing' 2' The management representativ e must collect data/information on t&e effectiveness of t&e system and identify t&ose areas ,&ere im)rovement is )ossi'le or c&allenged. The top management team !an
then imp&ement those improvements or adjust approa!hes and monitor their e--e! tiveness'

1' ,e)she must a&so ensure that a, areness a'out customer requirements is actively )romoted t&roug&out t&e organi"ation' ;n#

deviation or short!oming shou&d %e %rought to top management -or -u&-i&&ment'

5' The management representativ e has to loo- after t&e internal audit )rogram* all t&ird0)arty certification issues* and any e1ternal enquiries a'out t&e system '

2eing a management re)resentative s&ould not 'e a full0time (o'3 .emem%er ever#one is responsi%&e -or the ua&it# at respe!tive "or:' 4n a ,ell managed organi"ation t&ere s&ould 'e little need for a formal Quality 5e)artment and the most ua&it# issues "i&& %e !ontro&&ed %# individua& persons and their departments'

4.4.1 Inte"nal communication

, , , %ll emplo*ees s(ould kno2 2(at t(e customer and (is5(er organi9ation 2ants$ One of t(e main purposes of establis(ing an effecti-e management s*stem is to ha$e a means fo" communicatin# o"#ani0ational an custome" "e%ui"ements to staff. The ISO stan a" "e%ui"es that this info"mation is sha"e .

$.6 Management revie,

1 . )o n s i e " t ( e s u i t a &i li t y o f t h e %u a l i t y po l i c y

2 . .e $ i e 8 t ( e %u a l i t y o &'e c t i $ e s a n t h e i " m e a s u "e m e n t a n t u n e u p t h e po l i c y

:c t io n it e m s f"o m p"e $ io u s m e e t in #s fo ".e $ie 8 t he %ualit y o &'e c t i$e s 0u s t om er feed b a ck #a ta on ( o2 p r oces s es a r e p er form in g a n d ( o2 2ell p r od u cts a n d 5 or s er-ices a r e 7es u lts of in ter n a l a u d its 4os iti-e %-a ila b le 4os iti-e
:4r ogres s is good ;

St at us

&ega ti-e Un a -a ila b le

/( ere a r e p r ogr es s b u t m ore dr i-es a re n eces s a r *

&ega ti-e
:4oor or n o p rogr es s ;

4r e-en ti-e a n d cor r ecti-e a ction s

%ction -! %ction -" %ction -?

8ffect i-e

Aet t o b e im p ro-ed

In effecti-e

Im p en d in g c( a n ges 2( ic( cou ld a ffect t( e op er a t ion of t( e m a n a gem en t s *s t em

0( a n ge-! 0( a n ge-" 0( a n ge-?

7ecom m en d a tion s for s *s tem 6 p r oces s or p r od u ct im p r o-em en t 2( ic( n eed t o b e con s id er ed b * t op m a n a gem en t
7ecom m en d a tion -! 7ecom m en d a tion -" 7ecom m en d a tion -?

5. .esou"ce mana#ement , 5.1 Specifies ("o$ision of .esou"ces *Shoul ha$e o"#ano#"am sho8in# an 'ustifyin# positions, actual num&e" of "esou"ces an 'o& specifications fo" each, 5.2 Specifies ho8 to han le issues of staff competency and t(e records re1uired to demonstrate t(ose competencies= , :8ducation6 training6 I36 age and actual le-el of skill to perform gi-en tasks5responsibilities of t(e +ob6 success and failure6 measures taken for impro-ement.onitor and e-aluate t(roug( documentation; , 5.1 defines t(e infrastructure issues 2(ic( must be addressed6 :Infrastructure: Structure t(at facilitates production and ser-ice suc( as building6 road6 po2er & 2ater suppl* telecom com net2ork6 etc$; , and 5.2 specifies t(e re1uired 2ork en-ironment$ >ork en-ironment s(ould co-er suc( issues as a- assu"in# le#al compliance 2it( (ealt( and safet* re1uirements6 , &- identif*ing and controlling an* special en$i"onmental "e%ui"ements6 , c- ensuring t(at house<eepin# is "easona&le for t(e t*pe of 2ork being performed$ 6. ("o uct "eali0ation /(e term co-ers all acti-ities starting f"om initial custome" contact to post- eli$e"y maintenance. 6.1 (lannin# of p"o uct "eali0ation /(is co-ers all t(e t(ings 2(ic( used to be called smart planning or 1ualit* planning$ It addresses (o2 t(e organi9ation makes appropriate arrangements for meeting customer re1uirements$ It is in fact a 3% planning

7. Customer0related )rocesses

Main # )oints of customer-re&ated pro!ess

1' Identify )roduct

-Identification of )roduct: !irst get t&e ans,er

;re the re uirement !&ear&# understood< Is !apa%i&it# and in-rastru!ture enough or the re uired !apa%i&it# !an %e a! uired "ithin the time< Can supp&# the produ!t on time<

requirements . .&e revie, of requirements and #.Managing customer communications.

.&e revie, of requirements: S&ould 'e done 'efore order finali"ation Managing Customers: Customer s&ould 'e comm unicated frequently notifying c&anges and )rogresses

7$? #esign and #e-elopment 6.1.1 #esign and de-elopment planning 6.1.2 #esign and de-elopment inputs 6.1.1 #esign and de-elopment outputs 6.1.2 #esign and de-elopment re-ie2 6.1.4 #esign and de-elopment -erification 6.1.5 #esign and de-elopment -alidation 6.1.6 0ontrol of design and de-elopment c(anges Desi#n an e$elopment inputs , a- /(e functional and performance re1uirements for t(e design , &- %n* statutor* or regulator* re1uirements 2(ic( ma* be rele-ant to t(e product or ser-ice , c- %n* useful (istor* 2(ic( can be included from past eBperience in designing similar items including , Clessons learnedC from past acti-ities , - Ot(er re1uirements suc( as , -customer re1uirements for packaging6 , -disposal after use6 , -rec*cling of materials6 , -process re1uirements6 , -storage and maintenance re1uirements6 , -interc(angeabilit*6 , -upgradeabilit*6 etcetera$

6.1.1 Desi#n an e$elopment outputs , &eBt to Input de-elopment6 #esign output is t(e most essential information to be recorded and it must contain or reference information 2(ic( does four t(ings: , i. :pp"o$al *be appro-ed prior to release;6 , ii. contain rele-ant information for t(e purc(asing6 production and ser-icing re1uirements of t(e product6 , iii. pro-ide criteria against 2(ic( t(e product can be -erified6 , i$. address an* safet* aspects associated 2it( t(e use of t(e product$ 6.1.2 Desi#n an e$elopment "e$ie 8 , i. e-aluation of t(e abilit* of t(e design to meet t(e re1uirements6 and , ii. identification of an* problems6 and finall* , iii. appropriate action to follo2-up and resol-e an* issues identified during t(e re-ie2$ , 6.1.4 Desi#n an e$elopment $e"ification , 4erforming alternati-e calculations6 , 0omparing t(e ne2 design 2it( a similar pro-en design6 , Undertaking tests5trials6 , 7e-ie2ing t(e documents before release$ 6.1.5 Desi#n an e$elopment $ali ation /(is is t(e second part of design proof$ In t(e -alidation it s(ould be demonstrated t(at design output meets t(e design input$ 6.1.6 )ont"ol of esi#n an e$elopment chan#es #esign c(ange acti-it* must ensure t(at c(anges are identified6 -erified and -alidated and appro-ed prior to t(eir introduction$ /(e impact of eac( c(ange on t(e entire suppl* c(ain6 including alread* deli-ered product6 is to be e-aluated$ 7ecords of all t(is acti-it* must be maintained$ 8. easurement! analysis and improvement 8.1 3ene"al , 4roducts 1ualit* & attributes :at different stages of formation; , %cti-ities like process controls and test and inspection procedures , 4erformances of persons & management , 0ompliance status 8.2 ,onito"in# an measu"ement , 8$"$! 0ustomer satisfaction :/(e met(ods used to measure and monitor customer satisfaction and dissatisfaction mig(t be an*t(ing from: 3uestionnaires based 0ustomer sur-e*s or blind customer response studies$ /o be conducted b* independent sur-e*s b* companies50onsultants; ,

8.2.2 Inte"nal au it *I:, /(e internal audit is a mandator* process to -erif*6 on a regular basis6 2(et(er t(e s*stem is continuing o2n processes and procedures and t(ose of t(e standard$

I: chec<s:
, , , , , operating documentation6 processes and results$ /(e fre1uenc* of I% depends on t(e importance of t(e acti-ities5processes and t(e results of pre-ious audits$ I% s(ould be performed b* people independent of t(e acti-it*$

8.2.1 ("ocesses ,onito"in# an measu"ement , processD E input F acti-it* F output , .easure and .onitor input parameters , .easure and monitor mac(ine parameters , .easure and monitor ambient factors and parameters , .easure and monitor (andling5ser-icing parameters , .easure and monitor output parameters 8.2.2 ,onito"in# an measu"ement of p"o uct , Is measurement and monitoring of product mandated by the standard? , If yes then compare with the standard , If no then develop own standard for measurement. , 7at(er t(an emplo*ing independent bod* Self- inspection and self- test are perfectl* oka*$

8.1 )ont"ol of nonconfo"min# p"o uct , i; nonconforming product or ser-ice is identified and segregated :if possible;= , ii; all t(e rele-ant aut(orities5officials bot( inside and outside t(e organi9ation to be informed= , iii; #ecide 2(at is to be done 2it( non-conformed or defected items: , a; re2ork back to specification= , b; use Cas isC= , c; regard and specif* for an alternate use= or , d; scrap and t(en sale or dispose as per rule$

8.% 9nalysis of data

Most organi8ations spend a great dea& o- time in !o&&e!ting data and then do not hing "ith it' This is the :file and forget: syndrome; Management shou&d !o&&e!t data and ana&#8e to understand: 16 to "hat e9tent Customer satis-a!tion has o!!urred' 26 to "hat e9tent the produ!ts have Con-ormed to the re uirements set' 16 nature and trends opro!esses and produ!t in!&uding opportunities =-or preventive a!tion' %) Supp&iers -itness

The anal yses can be sophi sti cated or as simple as the organization chooses.

8.4 Imp"o$ement 8.4.1 )ontinual imp"o$ement

Item , .anagement commitment to t(e 1ualit* polic* , 3ualit* ob+ecti-es , 7esults from internal audits , #ata anal*sis , 0orrecti-e and pre-enti-e action .anagement re-ie2

>(at to be done /o be maintained or upgraded /o be specified5clarified5impro-ed e-er* time /o be e-aluated /o be continuall* done /o be taken e-er* time /o be done periodicall* & regularl*$

8.$.

Corrective action
.e!ords o- !orre!ti ve a!tion that must %e :ept* and it must in!&ude:
a6 the date)time o- the event2 ') the item* produ!t or pro!ess invo&ved2 !6 the nature o- the pro%&em: the !ause the a!tion ta:en to res o&ve the issue2 an# preventive a!tion p&anned) thought appropriate2 d6 the resu&ts o- an# -o&&o"-up a!tion ta:en to revie" the e--e!tiveness o- the !orre!tive and) or preventive a!tions ta:en'

1' >hen thi ngs go "rong* stop it %eing !onti nued 2' ;!t to resist the pro%&em re!urring and !onti nue a!ting unti & pro%&em is -i9ed satis-a!tori&# 1' ?eep the .e!ords o-

!orre!tive a!tion

8.$.# Preventive action

(reventi ve a!tion is a&& a%out tr#i ng to error-proothe s#stem' @Q9A It is an integra& part oua&it# p&anni ng Process ca)a'ility studies !an %e !arried out to ensure that the re uired produ!t spe!i-i!ations are a!hieva%&e %# the p&anned method ooperation'
; do!umented pro!edure must in!&ude - o&&o" ing 4 spe!i- i! pro!ess operations : a) identifying )otential )ro'lems* and o- !ourse " h# the# ma# happen2 ') decide ,&at t&e ris- is * and " hether an#thing shou&d %e done a%out it2 c) i- something is to %e done* figure out ,&at to do2 d) :eep re!ords o- ever#thing that has %een done B in!&uding those situations " here nothing is done2 e ) !he!: %a!: and see i- the a!tion ta:en " or:ed* and monitor " hen a!tion " asnCt ta:en to ma:e sure that the de!ision " as va&id'

Thi" -(a"ty .e#ist"ation

/(e registration :or certification; process means: emplo*ing an eBternal organi9ation or t(at audits *our compan*Cs acti-ities and processes against t(e re1uirements of ISO 9 ! and *our documented management s*stem$ /(ird part* auditing is often called e9te"nal au it*7:-.

What are done in 3rd party audit?

The audit pro!ess !onsists o- 2 major a!tivities: 1' 0es: audit: ;uditors !ompare the !ompan#Cs do!umented s#stem "ith the re uirements o- the standard o- ISO-9001' This produ!es an audit report 2' Comp&ian!e audit: ;uditors are on site ta&:ing to sta--* as:ing uestions a%out "hat the# do and ho" the# do it* "hat do!uments the# have to have* "hat re!ords the# maintain* and "ho has a&& this stu--' The auditors "i&& %e -o&&o"ing a predetermined p&an* an advan!e !op# o- "hi!h "i&& %e given to the areaCs management representative' 1' Samp&e ;udit: On!e !omp&ian!e audit is !omp&eted* the ;uditors !he!: departmenta& a!tivities on samp&ing %asis'

Once t(e main audit is successfull* completed6 The <ey issues 8hich the e9te"nal au ito"s *7:- 8ill &e "e$ie8in# an see<in# o&'ecti$e e$i ence of compliance : , :"e all the "ele$ant "e%ui"ements of ISO 9001 &ein# met= , Is the"e clea" e$i ence that staff <no8 thei" "ole in ope"atin# the system= , :"e "eco" s #ene"ate as "e%ui"e an sto"e p"ope"ly= , Is the inte"nal au it p"ocess "o&ust an effecti$e= , Is the"e an a e%uately "esou"ce an effecti$e co""ecti$e an p"e$enti$e action p"o#"am in place= , Is the mana#ement "e$ie8 p"ocess soli an ope"atin# effecti$ely= , Do %uality o&'ecti$es emonst"ate imp"o$ement in the mana#ement system=

T"ainin#, )hec<in# an )e"tification , %ll Staff 2ill be trained as 2(at to do for respecti-e documentation , /3. team 2ill be trained as (o2 to be fit 2it( t(e procedures , /(e Internal auditors 2ill be trained as (o2 to c(eck during and post implementation period$ , *ou 2ill encounter sur-eillance audits on a regular basis G probabl* about e-er* siB mont(s$ , On a sample basis6 auditors 2ill re-isit -arious parts of t(e compan* for s(ort follo2-up audits to ensure t(at t(e s*stem remains full* operational$ , /(en *ou 2ill be certified
Management Orientation 2asic 5ocument Pre)aration Formation o- T$M Team
Dmp&o# ee ;"are ness Trainin g

4m)lementation

T$M Team Training

T$M Tria& (ra!ti!e E training -or a&&

emp&o#ees

Interna& ;uditing E I; Sta-Training

0es: audit and Comp&ian!e audit

Survei&&an!e ;udit -or si9 months

>ot <=

<=

Samp&e ;udit Certi-i!ation