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PEMAHAMAN

SISTEM
MANAJEMEN
MUTU - ISO 9000

ISO (International Organisation for Standardization)


Federasi badan standarisasi nasional seluruh dunia
Setiap negara diwakili oleh satu badan standarisasi nasional
MISI :
Mengembangkan standarisasi guna memberi kemudahan dalam
pertukaran barang dan jasa secara internasional
Membangun kerjasama dalam kegiatan di bidang intelektual,
pengetahuan, teknologi dan ekonomi internasional
Hasil kerja ISO berupa kesepakatan internasional yang diterbitkan
sebagai Standar Internasional
1979 ISO membentuk ISO/TC 176 untuk menyusun standar
sistem Jaminan Mutu
1987 ISO/TC 176 menghasilkan ISO 9000
1994 Edisi kedua ISO 9000 diterbitkan

What are ISO Quality Standards ?


ISO Quality Standards:
Define the main feature and requirements of a
QA system.
They are flexible and adaptable to the needs of
different organizations.
They from a basis a develop and establish a
Quality Management System for an
organization.
these standards are ISO 9000 series.

MIL-Q-9858
MIL-I-45208

AQAP
1, 4, 9

Evolusi Standar Mutu


Def. Stds.
05 Series

BS 4891
BS 5179

Bs 5750
1979
Standar Nasional

Dipublikasikan 15.12.2000

ISO 9000
1987
ISO 9000
1994

Standar Mutu

ISO 9000
2000

Standar Mutu

Standar ISO9000 telah diadopsi oleh sebagian besar


negara-negara didunia diantaranya :
Amerika Serikat
ANSI/ASQC Q91
Australia
AS 3900
Austria
Norm EN 29000
Indonesia
SNI 19-9000
Jepang
JIS 9900
Jerman
DIN ISO 9000
Malaysia
MS/ISO 9000
ME
EN 29000
New Zealand
NZS 9000
Singapura
SS ISO 9000

Standar Sistem Mutu


Umum (ISO 9000)
Berhubungan dengan industri (QS 9000,
AQAP, AS 9000, TL 9000)
Berhubungan dengan produk (EN 45011, EN
45012)

Beberapa Badan Sertifikasi dunia :


ABS Quality Standar Inc.
UL (Underwriter Laboratories Inc.)
SICS (Sucofindo Intl Cert. Services)
SGS
BVQI (Bureau Veritas Quality Intl)
LRQA (Lloyd Register Quality Ass.)
SIRIM
PSB
TUV
RWTUV
SAI GLOBAL

USA
USA
INDONESIA
SWISS
PERANCIS
INGGRIS
MALAYSIA
SINGAPURA
JERMAN
JERMAN
AUSTRALIA

MENGAPA MENERAPKAN ISO 9000


Adanya permintaan pasar agar produsen memberikan
jaminan mutu atas produknya
Untuk memasuki pasar global
Meningkatkan kepercayaan dan kepuasan pelanggan
Sertifikat ISO 9000 akan menaikkan citra dan daya saing
perusahaan
Dapat meningkatkan produktifitas, efisiensi dan
efektifitas operasi
Menekan biaya atas material yang terbuang karena
mutunya yang tidak sesuai
Dapat memperbaiki moral pekerja melalui sistem kerja
yang lebih konsisten

SEJARAH PERUBAHAN ISO 9001


Pencegahan
Peningkatan
berkesinambungan

Konsistensi

ISO 9001 : 87

ISO 9001 : 94

ISO 9001 : 2000

ISO 9000 bersifat generik, dapat diaplikasikan


pada bidang manufaktur dan jasa.
Standar ISO 9000 telah diadopsi oleh sebagian
besar negara-negara didunia,
diantaranya :
Amerika Serikat
Australia
Austria
Indonesia
Jepang
Jerman
Malaysia
New Zealand
Singapura

ANSI/ASQC Q91
AS 3900
Norm EN 29000
SNI 19-9000
JIS 9900
DIN ISO 9000
MS/ISO 9000
NZS 9000
SS ISO 9000

KEKUATAN STANDAR ISO 9000


Standar ISO 9000 menekankan pada pencegahan
terhadap penyimpangan dengan :
Menetapkan dengan jelas tanggung jawab dan
wewenang dari personil yang pekerjaannya
mempengaruhi mutu
Mendokumenkan prosedur dan rencana mutu untuk
mengatur berbagai operasi dan proses produksi
Melakukan tindakan perbaikan jika ditemukan
penyimpangan dan melakukan verifikasi terhadap
keefektifan dari tindakan perbaikan tersebut
Efektifitas penerapan sistem mutu dapat diketahui
melalui audit dan manajemen review

SIKLUS PDCA & ISO 9001:2000

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ISO 9001:2000
8 Prinsip Manajemen Mutu

02/13/2008

8 Prinsip Manajemen Mutu

13

Definisi dari Mutu:


Derajat terpenuhinya persyaratan
oleh karakteristik dasar
(degree to which a set of inherent

characteristics fulfils
requirements)

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

ISO 9000:2000 defines grade as


follows:
Category or rank given to different
quality requirements for products,
processes or systems having the
same functional use
Grade is inherent in the product and
may be altered by change in
specification.
Whereas quality is dependent upon how
well the product satisfies the need.

ISO 9000:2000 defines the Quality


Management as:

coordinated activities to direct


and control an organisation with
regard to quality

8 Prinsip Manajemen Mutu


Fokus Pelanggan
Kepemimpinan
Keterlibatan Karyawan
Pendekatan Proses
Pendekatan Sistim pada manajemen
Perbaikan Berkesinambungan
Pendekatan factual untuk pengambilan
keputusan
Hubungan dengan rekanan yang saling
menguntungkan

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Fokus Pelanggan
Organisasi bergantung pada pelanggannya dan
karenanya hendaknya memahami kebutuhan kini dan
mendatang pelanggannya (current & future customer
needs), hendaknya memenuhi dan berusaha
melampaui harapan pelanggan (customer
expectations).
Determine customer
needs & expectation
Requirements
Prinsip 1
Customer satisfaction

Kepemimpinan
Pemimpin menetapkan kesatuan tujuan dan
arah organisasi. Mereka hendaknya
menciptakan dan memelihara lingkungan
intern tempat karyawan dapat melibatkan
dirinya secara penuh dalam pencapaian
sasaran organisasi (organizations objectives)
Prinsip 2

Keterlibatan Karyawan
Karyawan pada seluruh tingkatan organisasi
adalah inti sebuah organisasi dan pelibatan
penuh mereka kemungkinkan kemampuannya
dipakai untuk manfaat organisasi

Prinsip 3

Pendekatan Proses
Hasil yang dikehendaki tercapai lebih
efisien bila kegiatan (activities) dan
sumber daya (resources) terkait dikelola
sebagai suatu proses

Prinsip 4

Proses:
Controls
(mis. prosedur)
Input

Aktivitas
Proses
+
Sumber daya

Output

Pendekatan Sistim pada Manajemen


Mengetahui, memahami dan mengelola
proses yang saling terkait sebagai
sistem memberi sumbangan pada
keefektifan dan efisiensi organisasi
dalam mencapai sasarannya

Prinsip 5

Proses - memahami interaksi


Proses
A

Masukan
Keluaran
Pengendalian

Proses
C
Proses
B

Proses
D

Perbaikan Berkesinambungan
Perbaikan berlanjut organisasi secara
menyeluruh hendaknya dijadikan
sasaran (objectives) tetap dari
organisasi
Quality Improvement:
part of quality
Management focusing on
increasing effectiveness
and efficiency
(ISO 9000:2000)

Prinsip 6

Pengambilan Keputusan
dengan Pendekatan Fakta
Keputusan yang efektif didasarkan
pada analisis data dan informasi.

Principle 7

Hubungan yang saling


menguntungkan dengan rekanan
Sebuah organisasi dan pemasoknya saling
bergantung dan suatu hubungan yang saling
menguntungkan meningkatkan kemampuan
keduanya untuk menciptakan nilai (value) .

Prinsip 8

Quality Management System (QMS) model

C
U
S
T
O
M
E
R

Quality Management System


Continual Improvement

R
e
q
u
i
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m
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Management
responsibility

Resource
management

Input

Measurement, analysis,
improvement

Product
realisation

Product
Output

S
a
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i
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f
a
c
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i
o
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U
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T
O
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E
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Total Quality Management (TQM)


Award Model
for
Performance Measurement

Quality Award Models

Malcolm Baldrige National Quality Award


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

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

The award places equal emphasis on:

the excellence of what is done


the results which are achieved

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

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

Malcolm Baldrige National


Quality Award (MBNQA)

Award Categories
t

1994
Manufacturing
Service
Small Business
2 winners per category

2001

Business
Service
Small Business
Education
Health Care

3 winners per category

MBNQA Winners
t

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


Corp., and Globe Metallurgical Inc.

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

1990Cadillac Motor Car Division, IBM Rochester, Federal Express Corp., and
Wallace Co. Inc.

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

1992AT&T Network Systems Group/ Transmission Systems Business Unit, Texas


Instruments Inc. Defense Systems & Electronics Group, AT&T Universal Card
Services, The Ritz-Carlton Hotel Co., and Granite Rock Co.

1993Eastman Chemical Co. and Ames Rubber Corp

1994AT&T Consumer Communications Services, GTE Directories Corp., and


Wainwright Industries Inc.

Service
Manufacturing
Small Business

MBNQA Winners
t

1995Armstrong World Industries Building Products Operation and Corning


Telecommunications Products Division

1996ADAC Laboratories, Dana Commercial Credit Corp., Custom Research


Inc., and Trident Precision Manufacturing Inc.

19973M Dental Products Division, Solectron Corp., Merrill Lynch Credit


Corp., and Xerox Business Services

1998Boeing Airlift and Tanker Programs, Solar Turbines Inc., and Texas
Nameplate Co., Inc.

1999STMicroelectronics, Inc.-Region Americas, BI, The Ritz-Carlton Hotel


Co., L.L.C., and Sunny Fresh Foods

2000Dana Corp.-Spicer Driveshaft Division, KARLEE Company, Inc.,


Operations Management International, Inc., and Los Alamos National Bank

Service
Manufacturing
Small Business

MBNQA CRITERIA
Malcolm Baldridge Criteria for Performance Excellence Framework : A Systems Perspective

Organizational Profile :
Environment, Relationships, and Challenges

2
Strategic
Planning

5
Human
Resources
Focus
7
Business
Results

1
Leadership
3
Customer and
Market Focus

6
Process
Management

4
Measurement, Analysis, and Knowledge Management

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

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

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 - 2005
1. Leadership, 120
2. Strategic Planning, 85
3. Customer & Market Focus, 85
4. Measurement, Analysis & Knowledge Management, 90
5. Human Resources Focus, 85
6. Process Management, 85
7. Business Results, 450

Categories and Items MBNQA


120

1. Leadership
1.1. Organizational Leadership

70

1.2. Social Responsibility

50

85

2. Strategic Planning
2.1. Strategy Development

40

2.1. Strategy Deployment

45

85

3. Customer and Market Focus


3.1. Customer and Market Knowledge

40

3.2. Customer Relationships and Satisfaction

45

Categories and Items MBNQA


90

4. Measurement, Analysis and Knowledge


4.1. Measurement and Analysis of Organizational Performance 45
4.2. Information and Knowledge Management

45

5. Human Resources Focus

85

5.1. Work Systems

35

5.2. Employee Learning and Motivation

25

5.3. Employee Well-Being and Satisfaction

25

6. Process Management

85

6.1. Value Creating Processes

45

6.2. Support Processes & Operational Planning

40

Categories and Items MBNQA


450

7. Business Results
7.1. Product and Service Outcomes

100

7.2. Customer- Focused Results

70

7.3. Financial and Market Results

70

7.4. Human Resources Results

70

7.5. Organizational Effectiveness Results

70

7.6. Leadership and Social Responsibility Results

70

TOTAL POINTS

1000

CATEGORY OF MBNQA
The whole categories will measure with :
1.Approach
2.Deployment
3.Results
4.Improvement

A-D and R
t

Approach

how the application addresses the item


appropriateness
effectiveness
evidence of innovation

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

Results

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

European Foundation for Quality


Management (EFQM)

European Foundation for Quality


Management (EFQM)
t

European Foundation for Quality


Management (EFQM) 1999
Self-assessment is a comprehensive,
systematic & regular review of an
organisation's activities & results referenced
against the EFQM excellence model

TQM: EFQM Model


Quality awards
People
satisfaction
9%

People
management
9%
Leadership
10%

Policy and
strategy
8%
Resources
9%

Enablers - 50%

Processes
14%

Customer
satisfaction
20%
Impact on
society
6%

Results - 50%

The European Quality Award model

Business
results
15%

TQM: EFQM Model


Criterion 1: Leadership (100 pts, 10%)

How leaders develop & facilitate the


achievement of the mission & vision, develop
values required for long term success &
implement these via appropriate actions &
behaviours, & are personally involved in
ensuring that the organisation's management
system is developed & implemented

TQM: EFQM Model


Criterion 2: Policy & Strategy (80 pts, 8%)

How the organisation implements its mission &


vision via a clear stakeholder focused strategy,
supported by relevant policies, plans,
objectives, targets & processes

TQM: EFQM Model


Criterion 3: People Management (90 pts, 9%)

How the organisation manages, develops &


releases the knowledge & full potential of its
people at an individual, team-based &
organisational level, & plans these activities in
order to support its policy & strategy & the
effective operations of its processes

TQM: EFQM Model


Criterion 4: Resources (90 pts, 9%)

How the organisation plans & manages its


external partnerships & internal resources in
order to support its policy & strategy & the
effective operation of its processes

TQM: EFQM Model


Criterion 5: Processes (140 pts, 14%)

How the organisation designs, manages &


improves its processes in order to support its
policy & strategy & fully satisfy, & generate
increasing value for, its customers & other
stakeholders

TQM: EFQM Model


Criterion 6: Customer Satisfaction (200 pts, 20%)

What the organisation is achieving in relation to


its 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 Model


Criterion 7: People Satisfaction (90 pts, 9%)

What the organisation is achieving in relation to


its people

a) the peoples perception of the organisation

b) additional measures relating to people satisfaction

TQM: EFQM Model


Criterion 8: Impact on Society (60 pts, 6%)

What the organisation is achieving in relation to


local, national & international society as
appropriate

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 Model


Criterion 9: Business Results (115pts, 15%)

What the organisation is achieving in relation to


its planned performance

a) financial measures of the organisations success

b) non-financial measures of the organisations


success