PEMAHAMANSISTEMMANAJEMENMUTU - ISO 9000

ISO (International Organisation for Standardization)Federasi badan standarisasi nasional seluruh duniaSetiap negara diwakili oleh satu badan standarisasi nasional

MISI : Mengembangkan standarisasi guna memberi kemudahan dalampertukaran barang dan jasa secara internasional Membangun kerjasama dalam kegiatan di bidang intelektual,pengetahuan, teknologi dan ekonomi internasional

Hasil kerja ISO berupa kesepakatan internasional yang diterbitkansebagai Standar Internasional1979 ISO membentuk ISO/TC 176 untuk menyusun standar

sistem Jaminan Mutu1987 ISO/TC 176 menghasilkan ISO 90001994 Edisi kedua ISO 9000 diterbitkan

What are ISO Quality Standards ?What are ISO Quality Standards ?

ISO Quality Standards:ISO Quality Standards:Define the main feature and requirements of aDefine the main feature and requirements of aQA system.QA system.They are flexible and adaptable to the needs ofThey are flexible and adaptable to the needs ofdifferent organizations.different organizations.They from a basis a develop and establish aThey from a basis a develop and establish aQuality Management System for anQuality Management System for anorganization.organization.these standards are ISO 9000 series.these standards are ISO 9000 series.

EvolusiEvolusi StandarStandar MutuMutuMIL-Q-9858MIL-I-45208AQAP1, 4, 9

BS 4891BS 5179

Def. Stds.05 Series

Bs 57501979

Standar Mutu

ISO 90001987

ISO 90001994

ISO 90002000 Standar Mutu

Standar Nasional

Dipublikasikan 15.12.2000

StandarStandar ISOISO90009000 telahtelah diadopsidiadopsi oleholeh sebagiansebagian besarbesarnegaranegara--negaranegara diduniadidunia diantaranyadiantaranya ::

AmerikaAmerika SerikatSerikat ANSI/ASQC Q91ANSI/ASQC Q91AustraliaAustralia AS 3900AS 3900AustriaAustria NormNorm EN 29000EN 29000IndonesiaIndonesia SNI 19SNI 19--90009000JepangJepang JIS 9900JIS 9900JermanJerman DIN ISO 9000DIN ISO 9000MalaysiaMalaysia MS/ISO 9000MS/ISO 9000MEME EN 29000EN 29000New ZealandNew Zealand NZS 9000NZS 9000SingapuraSingapura SS ISO 9000SS ISO 9000

StandarStandar SistemSistem MutuMutu

UmumUmum (ISO 9000)(ISO 9000)

BerhubunganBerhubungan dengandengan industriindustri (QS 9000,(QS 9000,AQAP, AS 9000, TL 9000)AQAP, AS 9000, TL 9000)

BerhubunganBerhubungan dengandengan produkproduk (EN 45011, EN(EN 45011, EN45012)45012)

Beberapa Badan Sertifikasi dunia :

ABS Quality Standar Inc. USAUL (Underwriter Laboratories Inc.) USASICS (Sucofindo Intl Cert. Services) INDONESIASGS SWISSBVQI (Bureau Veritas Quality Intl) PERANCISLRQA (Lloyd Register Quality Ass.) INGGRISSIRIM MALAYSIAPSB SINGAPURATUV JERMANRWTUV JERMANSAI GLOBAL AUSTRALIA

MENGAPA MENERAPKAN ISO 9000MENGAPA MENERAPKAN ISO 9000

AdanyaAdanya permintaanpermintaan pasarpasar agaragar produsenprodusen memberikanmemberikanjaminanjaminan mutumutu atasatas produknyaproduknyaUntukUntuk memasukimemasuki pasarpasar globalglobalMeningkatkanMeningkatkan kepercayaankepercayaan dandan kepuasankepuasan pelangganpelangganSertifikatSertifikat ISO 9000ISO 9000 akanakan menaikkanmenaikkan citracitra dandan dayadaya saingsaingperusahaanperusahaanDapatDapat meningkatkanmeningkatkan produktifitasproduktifitas,, efisiensiefisiensi dandanefektifitasefektifitas operasioperasiMenekanMenekan biayabiaya atasatas material yangmaterial yang terbuangterbuang karenakarenamutunyamutunya yangyang tidaktidak sesuaisesuaiDapatDapat memperbaikimemperbaiki moralmoral pekerjapekerja melaluimelalui sistemsistem kerjakerjayangyang lebihlebih konsistenkonsisten

ISO 9001 : 87

ISO 9001 : 94

ISO 9001 : 2000

Konsistensi

Pencegahan

Peningkatanberkesinambungan

SEJARAH PERUBAHAN ISO 9001

ISO 9000ISO 9000 bersifatbersifat generikgenerik,, dapatdapat diaplikasikandiaplikasikanpadapada bidangbidang manufakturmanufaktur dandan jasajasa..StandarStandar ISO 9000ISO 9000 telahtelah diadopsidiadopsi oleholeh sebagiansebagianbesarbesar negaranegara--negaranegara diduniadidunia,,diantaranyadiantaranya ::

AmerikaAmerika SerikatSerikat ANSI/ASQC Q91ANSI/ASQC Q91AustraliaAustralia AS 3900AS 3900AustriaAustria Norm EN 29000Norm EN 29000IndonesiaIndonesia SNI 19SNI 19--90009000JepangJepang JIS 9900JIS 9900JermanJerman DIN ISO 9000DIN ISO 9000MalaysiaMalaysia MS/ISO 9000MS/ISO 9000New ZealandNew Zealand NZS 9000NZS 9000SingapuraSingapura SS ISO 9000SS ISO 9000

KEKUATAN STANDAR ISO 9000KEKUATAN STANDAR ISO 9000

StandarStandar ISO 9000ISO 9000 menekankanmenekankan padapada pencegahanpencegahanterhadapterhadap penyimpanganpenyimpangan dengandengan ::MenetapkanMenetapkan dengandengan jelasjelas tanggungtanggung jawabjawab dandanwewenangwewenang daridari personilpersonil yangyang pekerjaannyapekerjaannyamempengaruhimempengaruhi mutumutuMendokumenkanMendokumenkan prosedurprosedur dandan rencanarencana mutumutu untukuntukmengaturmengatur berbagaiberbagai operasioperasi dandan prosesproses produksiproduksiMelakukanMelakukan tindakantindakan perbaikanperbaikan jikajika ditemukanditemukanpenyimpanganpenyimpangan dandan melakukanmelakukan verifikasiverifikasi terhadapterhadapkeefektifankeefektifan daridari tindakantindakan perbaikanperbaikan tersebuttersebutEfektifitasEfektifitas penerapanpenerapan sistemsistem mutumutu dapatdapat diketahuidiketahuimelaluimelalui auditaudit dandan manajemenmanajemen reviewreview

SIKLUS PDCA & ISO 9001:2000

ISO9001

P D

CA

PENING

KATAN

02/13/200802/13/2008 8 Prinsip Manajemen Mutu8 Prinsip Manajemen Mutu 1313

ISO 9001:2000ISO 9001:20008 Prinsip Manajemen Mutu8 Prinsip Manajemen Mutu

DefinisiDefinisi daridari MutuMutu::

DerajatDerajat terpenuhinyaterpenuhinya persyaratanpersyaratanoleholeh karakteristikkarakteristik dasardasar

((degree to which a set of inherentdegree to which a set of inherentcharacteristics fulfilscharacteristics fulfils

requirementsrequirements))

(ISO 9000 : 2000, Quality management systems(ISO 9000 : 2000, Quality management systems --fundamentals and vocabulary)fundamentals and vocabulary)

ISO 9000:2000 defines grade asISO 9000:2000 defines grade asfollows:follows:

Category or rank given to differentCategory or rank given to differentquality requirements for products,quality requirements for products,processes or systems having theprocesses or systems having thesame functional usesame functional use

Grade is inherent in the product andGrade is inherent in the product andmay be altered by change inmay be altered by change inspecification.specification.

Whereas quality is dependent upon howWhereas quality is dependent upon howwell the product satisfies the need.well the product satisfies the need.

ISO 9000:2000 defines the QualityISO 9000:2000 defines the QualityManagement as:Management as:

coordinated activities to directcoordinated activities to directand control an organisation withand control an organisation withregard to qualityregard to quality

FokusFokus PelangganPelangganKepemimpinanKepemimpinanKeterlibatanKeterlibatan KaryawanKaryawanPendekatanPendekatan ProsesProsesPendekatanPendekatan SistimSistim padapada manajemenmanajemenPerbaikanPerbaikan BerkesinambunganBerkesinambunganPendekatanPendekatan factualfactual untukuntuk pengambilanpengambilankeputusankeputusanHubunganHubungan dengandengan rekananrekanan yangyang salingsalingmenguntungkanmenguntungkan

8 Prinsip Manajemen Mutu8 Prinsip Manajemen Mutu

PrinsipPrinsip StandarStandar yangyang BaruBaru

Berdasarkan

pada delapanPrinsip

Manajemen Mutu

Berdasarkan

pada delapanPrinsip

Manajemen Mutu

KepemimpinanKepemimpina

n

PendekatanProses

PendekatanProses

Keterlibatankaryawan

Keterlibatankaryawan

Pendekatan

Sistem pada

Manajemen

Pendekatan

Sistem pada

ManajemenPerbaikanyang terus-

menerus

Perbaikanyang terus-

menerus

Pendekatan

yang faktualpada

Pengambilan

Keputusan

Pendekatan

yang faktualpada

Pengambilan

Keputusan

Hubungansaling

menguntung

kan denganpemasok

Hubungansaling

menguntung

kan denganpemasok

Fokus padapelanggan

Fokus padapelanggan

OrganisasiOrganisasi bergantungbergantung padapada pelanggannyapelanggannya dandankarenanyakarenanya hendaknyahendaknya memahamimemahami kebutuhankebutuhan kinikini dandanmendatangmendatang pelanggannyapelanggannya ((current & future customercurrent & future customerneedsneeds),), hendaknyahendaknya memenuhimemenuhi dandan berusahaberusahamelampauimelampaui harapanharapan pelangganpelanggan ((customercustomerexpectationsexpectations).).

Determine customerneeds & expectation

Requirements

Customer satisfactionPrinsip 1

FokusFokus PelangganPelanggan

KepemimpinanKepemimpinan

PemimpinPemimpin menetapkanmenetapkan kesatuankesatuan tujuantujuan dandanaraharah organisasiorganisasi.. MerekaMereka hendaknyahendaknyamenciptakanmenciptakan dandan memeliharamemelihara lingkunganlingkunganinternintern tempattempat karyawankaryawan dapatdapat melibatkanmelibatkandirinyadirinya secarasecara penuhpenuh dalamdalam pencapaianpencapaiansasaransasaran organisasiorganisasi ((organizationorganizations objectivess objectives))

Prinsip 2

KeterlibatanKeterlibatan KaryawanKaryawanKaryawanKaryawan padapada seluruhseluruh tingkatantingkatan organisasiorganisasiadalahadalah intiinti sebuahsebuah organisasiorganisasi dandan pelibatanpelibatanpenuhpenuh merekamereka kemungkinkankemungkinkan kemampuannyakemampuannyadipakaidipakai untukuntuk manfaatmanfaat organisasiorganisasi

Prinsip 3

PendekatanPendekatan ProsesProses

HasilHasil yangyang dikehendakidikehendaki tercapaitercapai lebihlebihefisienefisien bilabila kegiatankegiatan ((activitiesactivities)) dandansumbersumber dayadaya ((resourcesresources)) terkaitterkait dikeloladikelolasebagaisebagai suatusuatu prosesproses

Prinsip 4

ProsesProses::

AktivitasProses

+Sumber daya

Input Output

Controls(mis. prosedur)

PendekatanPendekatan SistimSistim padapada ManajemenManajemen

MengetahuiMengetahui,, memahamimemahami dandan mengelolamengelolaprosesproses yangyang salingsaling terkaitterkait sebagaisebagaisistemsistem memberimemberi sumbangansumbangan padapadakeefektifankeefektifan dandan efisiensiefisiensi organisasiorganisasidalamdalam mencapaimencapai sasarannyasasarannya

Prinsip 5

ProsesProses -- memahamimemahami interaksiinteraksi

ProsesProsesAA

ProsesProsesDD

ProsesProsesBB

ProsesProsesCC

MasukanMasukanKeluaranKeluaranPengendalianPengendalian

PerbaikanPerbaikan BerkesinambunganBerkesinambungan

PerbaikanPerbaikan berlanjutberlanjut organisasiorganisasi secarasecaramenyeluruhmenyeluruh hendaknyahendaknya dijadikandijadikansasaransasaran (objectives)(objectives) tetaptetap daridariorganisasiorganisasi

Prinsip 6Quality Improvement:part of qualityManagement focusing onincreasing effectivenessand efficiency(ISO 9000:2000)

Pengambilan KeputusanPengambilan Keputusandengan Pendekatan Faktadengan Pendekatan Fakta

KeputusanKeputusan yangyang efektifefektif didasarkandidasarkanpadapada analisisanalisis datadata dandan informasiinformasi..

Principle 7

HubunganHubungan yangyang salingsalingmenguntungkanmenguntungkan dengandengan rekananrekanan

SebuahSebuah organisasiorganisasi dandan pemasoknyapemasoknya salingsalingbergantungbergantung dandan suatusuatu hubunganhubungan yangyang salingsalingmenguntungkanmenguntungkan meningkatkanmeningkatkan kemampuankemampuankeduanyakeduanya untukuntuk menciptakanmenciptakan nilainilai (value)(value) ..

Prinsip 8

CUSTOMER

CUSTOMER

Managementresponsibility

Resourcemanagement

Measurement, analysis,improvement

ProductProductrealisation

Quality Management SystemContinual Improvement

Requirements

Satisfaction

InputOutput

QualityQuality Management System (Management System (QMS) modelQMS) model

Total Quality Management (TQM)Award Model

forPerformance Measurement

Malcolm Baldrige National Quality Award(MBNQA)

European Quality Award (EQA) Deming Application Prize National & Regional Awards

Quality Award Models

t Quality Award it is a competition it is not a level of conformance, like ISO 9000 the key elements are:

collecting evidence against the Excellence model scoring the evidence against the Excellence model

t The award places equal emphasis on: the excellence of what is done the results which are achieved

structured approach identified strengths & areas for improvement helps management understand TQM helps develop, manage & integrate improvement

activities enable progress to be measured & recognised identifies best practice facilitates comparisons

Benefits of Self-Assessment using an Award Model (1)

Malcolm Baldrige NationalQuality Award (MBNQA)

Award Categories

t 1994 Manufacturing Service Small Business

2 winners per category

t 2001 Business Service Small Business Education Health Care

3 winners per category

MBNQA Winnerst 1988Motorola Inc., Commercial Nuclear Fuel Division of Westinghouse Electric

Corp., and Globe Metallurgical Inc.

t 1989Milliken & Co. and Xerox Corp. Business Products and Systems

t 1990Cadillac Motor Car Division, IBM Rochester, Federal Express Corp., andWallace Co. Inc.

t 1991Solectron Corp., Zytec Corp., and Marlow Industries

t 1992AT&T Network Systems Group/ Transmission Systems Business Unit, TexasInstruments Inc. Defense Systems & Electronics Group, AT&T Universal CardServices, The Ritz-Carlton Hotel Co., and Granite Rock Co.

t 1993Eastman Chemical Co. and Ames Rubber Corp

t 1994AT&T Consumer Communications Services, GTE Directories Corp., andWainwright Industries Inc.

Service

ManufacturingSmall Business

MBNQA Winners

t 1995Armstrong World Industries Building Products Operation and CorningTelecommunications Products Division

t 1996ADAC Laboratories, Dana Commercial Credit Corp., Custom ResearchInc., and Trident Precision Manufacturing Inc.

t 19973M Dental Products Division, Solectron Corp., Merrill Lynch CreditCorp., and Xerox Business Services

t 1998Boeing Airlift and Tanker Programs, Solar Turbines Inc., and TexasNameplate Co., Inc.

t 1999STMicroelectronics, Inc.-Region Americas, BI, The Ritz-Carlton HotelCo., L.L.C., and Sunny Fresh Foods

t 2000Dana Corp.-Spicer Driveshaft Division, KARLEE Company, Inc.,Operations Management International, Inc., and Los Alamos National Bank

Service

ManufacturingSmall Business

MBNQA CRITERIA

Organizational Profile :Environment, Relationships, and Challenges

1Leadership

2StrategicPlanning

3Customer andMarket Focus

7BusinessResults

5Human

ResourcesFocus

6Process

Management

4Measurement, Analysis, and Knowledge Management

Malcolm Baldridge Criteria for Performance Excellence Framework : A Systems Perspective

Changing Award Criteria

t 1991 Leadership, 100 Information and Analysis, 70 Strategic Quality Planning, 60 Human Resource Util., 150 Quality Assurance of

Products/Services, 140 Quality Results, 180

Customer Satisfaction, 300

t 1994 Leadership, 95 Information and Analysis, 75 Strategic Quality Planning, 60 Human Resource Devel., 150 Management of Process

Quality, 140 Quality and Operational

Results, 180 Customer Focus/Satis., 300

Changing Award Criteria

t 1995 Leadership, 90 Information and Analysis, 75 Strategic Planning, 55 Human Resource Devel. and

Management , 140 Process Management, 140 Business Results, 250 Customer Focus/Satisfaction,

250

t 2001 Leadership, 120 Information and Analysis, 90 Strategic Planning, 85 Human Resource Focus, 85

Process Management, 85 Business Results, 450 Customer and Market Focus,

85

Changing Award Criteria

t 2003 - 20051. Leadership, 1202. Strategic Planning, 853. Customer & Market Focus, 854. Measurement, Analysis & Knowledge Management, 905. Human Resources Focus, 856. Process Management, 857. Business Results, 450

Categories and Items MBNQA1. Leadership

1.1. Organizational Leadership

1.2. Social Responsibility

2. Strategic Planning2.1. Strategy Development

2.1. Strategy Deployment

3. Customer and Market Focus3.1. Customer and Market Knowledge

3.2. Customer Relationships and Satisfaction

12070

50

8540

45

8540

45

Categories and Items MBNQA4. Measurement, Analysis and Knowledge

4.1. Measurement and Analysis of Organizational Performance

4.2. Information and Knowledge Management

5. Human Resources Focus5.1. Work Systems

5.2. Employee Learning and Motivation

5.3. Employee Well-Being and Satisfaction

6. Process Management6.1. Value Creating Processes

6.2. Support Processes & Operational Planning

9045

45

8535

25

25

8545

40

Categories and Items MBNQA

7. Business Results7.1. Product and Service Outcomes

7.2. Customer- Focused Results

7.3. Financial and Market Results

7.4. Human Resources Results

7.5. Organizational Effectiveness Results

7.6. Leadership and Social Responsibility Results

450100

70

70

70

70

70

TOTAL POINTS 1000

The whole categories will measure with :

1.Approach

2.Deployment

3.Results

4.Improvement

CATEGORY OF MBNQA

A-D and Rt Approach

how the application addresses the item appropriateness effectiveness evidence of innovation

t Deployment extent to which approach is applied use of approach in business requirements use of approach by all appropriate units

t Results outcomes current performance levels performance levels relative to comparisons/benchmarks rate and breadth of performance improvements demonstration of sustained improvement

European Foundation for QualityManagement (EFQM)

t European Foundation for QualityManagement (EFQM) 1999Self-assessment is a comprehensive,systematic & regular review of anorganisation's activities & results referencedagainst the EFQM excellence model

European Foundation for QualityManagement (EFQM)

Quality awards

The European Quality Award model

Leadership

10%

Peoplemanagement

9%

Policy andstrategy

8%

Resources

9%

Processes

14%

Peoplesatisfaction

9%

Customersatisfaction

20%

Impact onsociety

6%

Businessresults

15%

Enablers - 50% Results - 50%

TQM: EFQM Model

TQM: EFQM ModelCriterion 1: Leadership (100 pts, 10%)

How leaders develop & facilitate theachievement of the mission & vision, developvalues required for long term success &implement these via appropriate actions &behaviours, & are personally involved inensuring that the organisation's managementsystem is developed & implemented

How the organisation implements its mission &vision via a clear stakeholder focused strategy,supported by relevant policies, plans,objectives, targets & processes

TQM: EFQM ModelCriterion 2: Policy & Strategy (80 pts, 8%)

How the organisation manages, develops &releases the knowledge & full potential of itspeople at an individual, team-based &organisational level, & plans these activities inorder to support its policy & strategy & theeffective operations of its processes

TQM: EFQM ModelCriterion 3: People Management (90 pts, 9%)

How the organisation plans & manages itsexternal partnerships & internal resources inorder to support its policy & strategy & theeffective operation of its processes

TQM: EFQM ModelCriterion 4: Resources (90 pts, 9%)

How the organisation designs, manages &improves its processes in order to support itspolicy & strategy & fully satisfy, & generateincreasing value for, its customers & otherstakeholders

TQM: EFQM ModelCriterion 5: Processes (140 pts, 14%)

What the organisation is achieving in relation toits external customers

a) the customer's perception of the organisations

producers, services & customers relationships

b) additional measures relating to the satisfaction of

the organisations customers

TQM: EFQM ModelCriterion 6: Customer Satisfaction (200 pts, 20%)

What the organisation is achieving in relation toits people

a) the peoples perception of the organisation

b) additional measures relating to people satisfaction

TQM: EFQM ModelCriterion 7: People Satisfaction (90 pts, 9%)

What the organisation is achieving in relation tolocal, national & international society asappropriate

a) the perception of the community at large of the

organisations impact on society

b) additional measures relating to the organisations

impact on society

TQM: EFQM ModelCriterion 8: Impact on Society (60 pts, 6%)

What the organisation is achieving in relation toits planned performance

a) financial measures of the organisations success

b) non-financial measures of the organisations

success

TQM: EFQM ModelCriterion 9: Business Results (115pts, 15%)