Implementing ISO 9001:2015 Quality Management System

Pelaksanaan Sistem Pengurusan Kualiti
MS ISO 9001:2015
bagi meningkatkan prestasi organisasi
16/4/2018 hak cipta Mbustaman IAB.KPM 1

Introducing Your
Workshop Facilitator
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*Image mbam
Fasilitator
MUHAMAD BUSTAMAN BIN ABDUL MANAF
PENSYARAH CEMERLANG (GRED DG 54)
Mata Pelajaran: Pengurusan
Certified as Specialist Trainer & Specialiast Coach-KPM
Jurulatih Pakar Negara – Latihan Pengurusan Pendidikan –KSM
16/4/2018

m bustaman/IAB/KPM/10 3
BIODATA
FASILITATOR
MUHAMAD BUSTAMAN BIN HAJI ABDUL MANAF
Pensyarah Cemerlang (MP: Pengurusan) (Gred 54), Instutut Aminuddin Baki, KPM
A. Pengalaman: Pensyarah di Institut Aminuddin Baki bermula dari tahun 1995.
1. Buku: 1. Pengurusan Kualiti ISO 9000 dalam pendidikan 2. Perancangan Strategik
B. Latihan Profesionalisme dalam bidang Pengurusan Strategik dan Pengurusan Kualiti:
Latihan Luar Negara:
i. Strategic Management & Leadership Skills: World Trade Institute, New York, USA (1996)
ii. Quality (TQM) in Education: SEAMEO Innotech, Manila (1998)
iii. Strategic Planning in Education: University of York, England (2000- 2004)
iv. Strategy Performance Measurement Systems: U of Adelaide, Australia (2005)
C. Mempunyai sijil profesional Juruaudit (Lead Auditor) ISO 9000 sejak 1997 dan Sijil Kejurulatihan MS ISO 9000 dari
MAMPU.
Berpengalaman menjadi juruaudit bersama dengan MAMPU serta memberi konsultasi dalam pembinaan dokumen
kualiti dan Audit Kualiti Dalaman .
D. Bidang kepakaran lain: Change Management, Benchmarking, Balanced Scorecard (KPI), Strategic Leadership Skills,
Leadership Coaching, Strategic Thinking Skills & Personal Balanced Scorecard.
E. Ahli panel Sistem Star Rating KPM 2008 & Ketua Pasukan 2010.
F. Timbalan Wakil Pengurusan Ssitem Pengurusan Kualiti MS ISO 9000 IAB.

OBJEKTIF
Pelaksanaan MS ISO 9001:2015 bagi
meningkatkan lagi kualiti pengurusan
organisasi.
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10
OBJEKTIFDi akhir Sesi Kursus ini, setiap Peserta
Akan :-
1. MEMAHAMI KONSEP SISTEM PENGURUSAN
KUALITI
2 . PELAKSANAAN STANDARD MS ISO 9001:2015

Lembaran Kerja (analisis jurang/Senarai semak
audit)
Klausa Status Pelaksanaan
(Analisis Jurang)
Isu/Penambahbaika
n

1. PENGENALAN KEPADA SISTEM
PENGURUSAN KUALITI (SPK)

APA ITU KUALITI
Keupayaan sesuatu produk
atau perkhidmatan memenuhi
kepuasan pelanggan
(pihak berkepentingan)
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Definisi Kualiti –ISO 9000
“ darjah dimana sekumpulan sifat produk atau
perkhidmatan yang wujud memenuhi keperluan-
keperluan” (3.1.1)
Sifat (3.5.1) bermaksud ciri-ciri yang membezakan sesuatu samada
sedia wujud yang atau diberikan, kualitatif atau kuantitatif atau
jumlah yang banyak dan terdapat banyak kelas sifat seperti fizikal,
deria, kelakuan,batas waktu, ergonomic dan fungsian.
Keperluan (3.1.2) adalah amalan yang biasa digunakan oleh syarikat,
pelanggannya dan atau pihak yang berminat.
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Latarbelakang ISO
• Because "International Organization for Standardization"
would have different acronyms in different languages
("IOS" in English, "OIN" in French for Organisation
internationale de normalisation), its founders decided to
give it also a short, all-purpose name”.
• “They choose "ISO", derived from the Greek isos,
meaning "equal". Whatever the country,
whatever the language, the short form of the
organization's name is always ISO”.

APA ITU ISO?
8
INTERNATIONAL ORGANISATION FOR STANDARDISATION
(ISO)
Badan bersekutu mengabungkan organisasi dari
seluruh dunia.
Ditubuhkan pada 27 Februari 1947 dan beribu pejabat
di Geneva Switzerland.
ISO 9000 kini digunakan di lebih 170 buah negara di
dunia.
1
7
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• International Organization for
Standardization ISO
Central Secretariat
Chemin de Blandonnet 8, Case Postale 401
CH – 1214 Vernier, Geneva, Switzerland
• www.iso.org

12
Sejarah Std. (QMS)
1987
1994
2000
2008
Revisions
2015
Latest Revisions 1
9
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Transition Period
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What is a Quality Management System (QMS)?
• A QMS is a tool to help an organisation to
manage quality.
• One thing a QMS isn’t is just the quality manual!
The quality manual is a means of recording how
quality is managed within your organisation so
everyone does their job in a consistent way,
delivering a consistent and quality product or
service.
• In other words, a quality manual reflects the
business and the quality management system.

What is QMS (SPK)?

Memahami Std ISO 9001: 2015
ISO 9001 adalah standard antarabangsa yang
menetapkan keperluan bagi sistem pengurusan kualiti
(SPK). Organisasi menggunakan standard untuk
menunjukkan keupayaan untuk menyediakan produk
dan perkhidmatan yang memenuhi keperluan
pelanggan dan keperluan undang-undang secara
konsisten.
ISO 9001 is the international standard that specifies requirements for a quality
management system (QMS). Organizations use the standard to demonstrate the ability
to consistently provide products and services that meet customer and regulatory
requirements.
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ISO 9000 Series
ISO 9000 - •Qualitymanagement systems — Fundamentals and vocabulary ISO
9000 provides an essential background for the proper understanding and
implementation of the ISO 9001 International Standard.
ISO 9001 – Quality Management Systems - Requirement
ISO 9001 specifies requirements aimed primarily at giving confidence in the
products and services provided by an organization and thereby improving
customer satisfaction.
ISO 9004 - Managing for the sustained success of an organization - Aquality
management approach
ISO 9004, Provides guidance for organizations that choose to progress beyond
the requirements of the ISO 9001 International Standard to address a broader
range of topics that can lead to continual improvement of the organization's
overall performance.
ISO 19011 – Auditing
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Faedah ISO 9001:2015
• a) meningkatkan keupayaan organisasi untuk
menyediakan secara tekal/konsisten produk
dan perkhidmatan yang berupaya memenuhi
keperluan pelanggan, serta keperluan
berkanun dan peraturan yang diguna pakai;
• b) memudahkan peluang untuk meningkatkan
kepuasan pelanggan;
• c) menyatakan risiko dan peluang yang
berkaitan dengan konteks dan matlamatnya;
• d) meningkatkan keupayaan untuk
menunjukkan keakuran terhadap keperluan
sistem pengurusan kualiti yang ditetapkan
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Steps to to implement ISO 9001 (Certification)
Step 1: Preparation
Get an Understanding of ISO 9001:2015/Awareness/ Top Management
Commitment
ISO 9001 Management Representative (Quality Champion/Manager)
Training
Get Buy-In
Step 2: Documentation
Which Documents are required by ISO 9001?
(1) Quality Policy
(2) Scope of the quality management system
(3) Process map (flowchart)
(4) Quality objectives
(5) Procedures
(6) Work Instructions
(7) Forms
Organisation-specific ISO 9001 Documentation
Customization of Templates

Step 3: Implementation
One Step at a Time
Take one step at a time in your ISO 9001 implementation
process. We recommend that you start with the section on
Document Control than processes in the scope of practices.
Training and Work Instructions go Hand in Hand
Step 4: Internal Audit
The Auditor (train internal auditor)
Do internal audits
Step 5: Certification
Selecting the ISO 9001 Registrar
The ISO 9001 Certification Audit
Maintaining Certification

Apakah Badan Pensijilan ISO 9000?
CB 01 SIRIM QAS International Sdn.Bhd.
CB 02 Moody International Certification (Malaysia) Sdn.Bhd.
CB 03 CI International Certification Malaysia Sdn. Bhd.
CB 04 SGS (Malaysia) Sdn. Bhd.
CB 05 TUV NORD (Malaysia) Sdn. Bhd. [formerly known as RWTUV (Malaysia)
Sdn. Bhd.]
CB 06 Lloyd's Register of Shipping (M) Bhd.
CB 07 Independent European Certification (M) Sdn. Bhd.
CB 08 AJA EQS Certification (M) Sdn. Bhd.
CB 09 GLOBAL GROUP Asia Pacific Sdn. Bhd.
CB 10 Bureau Veritas Certification (Malaysia) Sdn. Bhd. [formerly known as BVQI
(Malaysia) Sdn. Bhd.]
CB 11 BM TRADA (Malaysia) Sdn.Bhd.
CB 12 NQA Certification Services (M) Sdn. Bhd.
CB 13 CARE Certification International (M) Sdn. Bhd.
CB 14 AGM Certification Sdn. Bhd.

Alignment
Information technology
-- Service management
(ITSMS)
Information security management
(ISMS)
Business Continuity Management Systems
(BCMS)
Environmental management systems
(EMS)
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Ciri – ciri
ISO 9001:2015
• 1. Forward Looking
Ciri ini terdapat dalam klausa 4, iaitu Context of
the organization, klausa ini menjelaskan
mengapa organisasi harus ada misi & visi.
Faktor DALAMAN,
Faktor LUARAN
Kenalpasti Isu Isu Utama-BKU

Ciri – ciri
ISO 9001:2015
• 2. Risk Based thinking
organisasi harus mengurus risiko sehingga di ISO
9001:2015 tidak ada lagi klausa tentang preventive
action, karena semua proses yang rekabentuk,
diterapkan risiko.
Minima ada tiga risiko yang harus diurus, iaitu
1. Kegagalan produk (produk dan servis).
2. Kerugian pelanggan (keselamatan dan ekonomis).
3. Kerugian organisasi .
klausa 6 tentang Perancangan: risiko harus dianalisa
atau dideterminasi bermula pada masa membuat
perancangan lagi.

Ciri – ciri
ISO 9001:2015
• 3. Compentency Based
klausa 7.2 tentang kompetensi. Untuk itu perlu langkah-langkah
untuk mengelolanya :
1. Melakukan identifikasi dan determinasi kompetensi yang
diperlukan.
2. Memastikan bahwa individu yang mempengaruhi kepuasan
pelanggan dan kualiti produk adalah kompeten.
3. Melakukan pembangunan staf (melalui latihan atau
pembinaan - cth coaching, supervisi) jika terjadi gap
kompetensi.
4. Bukti efektif dari kompetensi terkini (tidak cukup dan bukan
hanya sijil, perlu diperagakan/bultikan).

Ciri – ciri
ISO 9001:2015
• 4. Improvement driven
“ berkualiti dan memuaskan pelanggan hari ini, belum
tentu berkualiti dan memuaskan pelanggan hari esok”
Kepuasan pelanggan dan kualti produk adalah sesuatu
yang dinamis. Untuk itu, dalam ISO 9001 ada 3 komponen
besar, iaitu
1. Quality management principles
2. Quality management process
3. Control system berbasis PDCA (Plan-Do-Check-Action)
cycle.
Ketiga-tiganya harus ditetapkan dan diterapkan.

MQA code provides a guideline of
general requirements in the
following areas:
• Vision, mission and learning outcomes;
• Curriculum design and delivery;
• Student selection and support services;
• Assessment of students;
• Academic staff;
• Educational resources;
• Programme monitoring and review;
• Leadership, governance and administration; and
• Continual quality improvement.

© Ghani Jan 2016 - All rightsreserved 3
0
Penekanan ISO 2008 vs 2015
Key Words in ISO 9001 2008 2015
“Pelanggan” “Customer” 50 X
63 X
“Kepuasan Pelanggan”
“Customer Satisfaction”
8 X 27 X
“Top Management”
“ Leadership”
10 X 16 X
“Context” 0 10 X
“Interested Party (ies)” 0 14 X
“Plan”, “Planned”, “Planning” 36 X
50 X
“Quality Objective”
“Objective”
15 X 17 X
“Improve”,“Improvement” 24 X 41 X
“Process”, “Processes” 78 X
114 X
“Risk”, “Risk-Based Thinking” 2 X
© Ghani Jan 2016 - All rightsreserved
49 X
6
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49
Plan - Do - Check - Act
P
DC
A
Plan: Establish the
objectives &
processes necessary
to deliver results in
accordance with
customer
requirements & the
organization's
policies
Do: Implement the
processes
Check: Monitor &
Measure processes &
product against
policies, objectives &
requirements for the
product & report the
results.
Action: Take actions
to continually
improve process
performance.

61
Do Check ActPLAN
Plan
4
Context of
organization
5
Leadership
6
Planning
8
Operation
9
Performance
and Evaluation
10
Improvement
4.1
Understanding
context
4.2
Interestedparties
4.3
Scope
4.4
QMS
5.1
Leadershipand
commitment
6.1
Actions to address
risks and
opportunities
6.2
Quality objectives
and planning
9.1
Monitoring,
measurement,
analysis and
evaluation
10.2
Nonconformityand
corrective action
10.3
Continual
improvement
5.3
Organizational
roles,
responsibilities
andauthorities
9.2
Internalaudit
9.3
Management
review
8.1
Operational
planningand
control
5.2
Policy
6.3
Planning of
changes
9.1.2
Customer
satisfaction
9.1.3
Analysis and
evaluation
See next slide
7
Support
7.1
Resources
7.3
Awareness
7.4
Communication
7.5
Documented
information
7.2
Competence
7.1.4
Environment for the
operation of
processes
7.1.5
Monitoringand
measuring resources
7.1.2
People
7.1.3
Infrastructure
7.1.6
Organizational
knowledge
10.1
General
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Proses/
Aktiviti
Titik Mula TitikAkhir
Kawalan dan tempat pemeriksaan yang munasabah untuk
memantau dan mengukur prestasi
PROSES
TERDAHULU /
SEBELUMNYA
Cth: Oleh pembekal
(dalaman & luaran),
Oleh pelanggan,
Oleh pihak-pihak
yangberminat
Sumber Input
PRINSIP,
TENAGA,
MAKLUMAT.
Cth: Dalam
bentukbahan,
sumber,
keperluan.
Input
PRINSIP,
TENAGA,
MAKLUMAT.
Cth: Dalam
bentukproduk,
perkhidmatan,
keputusan.
Output
PROSES
BERIKUTNYA
Cth: Pelanggan
(dalaman dan
luaran), Olehpihak-
pihak yang
berminat
Penerima
Output
PENDEKATAN PROSES
MS ISO 9001:2015
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53
KEMUDAHAN INFRASTRUKTUR DAN FIZIKAL
PERPUSTAKAAN PENGURUSAN SUMBER MANUSIAKOLEJ
KEDIAMAN
URUSAN PEJABAT BENDAHARI
K
E
P
E
R
L
U
A
N
P
E
L
A
N
G
G
A
N
&
S
H
1.10
PEPERIKSAAN K
E
P
U
A
S
A
N
P
E
L
A
N
G
G
A
N
1.
6
P
E
N
G
U
R
U
S
A
N
S
U
M
B
E
R
1.5
PENGURUSAN
REKOD
PELAJAR
1.7
PENYEDIAAN
INFRASTRUKTUR
1.8
PERANCANGAN
PENGAJARAN
1.9
PELAKSANAAN
PENGAJARAN
KAWALAN KETIDAKAKURAN
1.11
PENILAIAN
PERKHIDMATAN PENGAJARAN
PEMANTAUAN
PENGAJARAN
DAN PEMBELAJARAN
1.12
PENILAIAN
PENCAPAIAN PELAJAR
MENEPATI
KEPERLUAN
YA
1.13
PENGIJAZAHAN
PENGENALPASTIAN
TAHAP
PEMBELAJARAN
TIDAK
1.1
PELAN
STRATEGIK
1.2
PEMBENTUKA
N KURIKULUM
1.3
PENAWARAN
KURSUS
1.4
PENDAFTARAN
KURSUS
PROSES PENGURUSAN
MENEPATI
KEPERLUAN
TIDAK
YA
AUDIT DALAMAN TINDAKAN
PEMBETULAN DAN
PENCEGAHAN
SEMAKAN
PENGURUSAN
MAKLUMBALAS
PELANGGAN
Contoh Pemetaan Proses

13
PRINSIP-PRINSIP KUALITI
ISO 9001:2015
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One of the definitions of a “ principle ” is
that it is a basic belief, theory or rule that
has a major influence on the way in which
something is done.
“ Quality management principles ” are a set
of fundamental beliefs, norms, rules and
values that are accepted as true and can be
used as a basis for quality management.

ISO 9001 : 2015 dibina berlandaskan
7 prinsip pengurusan kualiti iaitu:
• Fokus Kepada Pelanggan – memahami dan memenuhi keperluan serta
meningkatkan kepuasan pelanggan
• Kepimpinan – wujudkan halatuju dan sasaran organisasi serta
persekitaran positif untuk mencapai objektif
• Penglibatan Manusia – menggunakan keupayaan mereka untuk
penambahbaikan dan faedah organisasi
• Pendekatan Proses – hasil dapat dicapai dengan lebih berkesan jika
aktiviti diurus sebagai proses dan sumber diperuntukkan dengan cekap
• Penambahbaikan – meningkatkan prestasi dan keupayaan organisasi
serta mestilah dijadikan objektif kekal organisasi
• Membuat Keputusan Berdasarkan Fakta –
keputusan yang berkesan adalah berdasarkan analisis data dan
maklumat
• Pengurusan Perhubungan – berkongsi kepakaran, sumber, maklumat
dan perancangan meningkatkan keupayaan kedua-dua pihak

© Ghani Jan 2016 - All rightsr eserved 23
Kesimpulan Prinsip
PRINSIP
1 Customer Focus / Fokus Pelanggan  Requirement
 Expectation
2 Leadership / Kepimpinan  Direction
 Motivation
3 Engagement of People /
Pembabitan Staf
 Participant
 Accountability
4 Process Approach / Pendekatan
Proses
 Efficiency
 Effectiveness
5 Improvement / Penambahbaikan  Product
 Process
6
Evidence Based Decision Making /
Membuat Keputusan berasaskan
Bukti
 Trends
 StatisticalApproach
7 Relationship Management /
Pengurusan hubungan
 Supplier
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0.3.3 Pemikiran Berasaskan
RISIKO menjadi ASAS
perubahan STD.
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Risk-Based Thinking
MSISO 9001:2015
ISO/TC 176/SC2
Document N1222, July 2014

Bahagian Kedua
Pemahaman Keperluan SPK MS ISO
9001:2015 dengan proses-proses
kerja organisasi dan analisis jurang

Klausa-klausa
ISO 9001:2015
Pendahuluan
1. Skop
2. Rujukan Normatif
3. Istilah dan Definisi
4. Konteks Organisasi
5. Kepimpinan
6. Perancangan
7. Sokongan
8. Operasi
9. Penilaian Prestasi
10.Penambahbaikan

Section 1- Scope
• Needs to demonstrate its ability to
meet customer/statutory/regulatory
requirements
• Aims to enhance customer
satisfaction
This Standard
specified
requirements
for a quality
management
system where
an organization
All requirements are generic and intended to be
applicable to all types of organizations, regardless
of type, size and product (or service) provided.
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8
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Section 3 – Terms & Definitions
CUSTOMER
Person or organisation that could or
does receive a product or a service
that is intended for or required by this
person or organisation
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3.02 – INTERESTED PARTY
Person or organization (3.01) that can affect, be
affected by, or perceive themselves to be
affected by a decision or activity.
3.01 – person or group of people that has its own
functions (3.25) with responsibilities, authorities
and relationships to achieve its objectives (3.08)
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3.06 - EFFECTIVENESS
Extent to which planned activities are
realized and planned results achieved.
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3.08 –
OBJECTIVE
Result to be
achieved.
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3.09 - RISK
Effect of
uncertainty on
an expected
result.
The effect can
be positive or
negative
consequence
- Risk is
characterized
by potential
events and
consequences.
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DOCUMENTED INFORMATION
Information required to be
controlled and maintained by an
organization and the medium on
which it is contained.
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Set of interrelated or interacting activities
which transforms inputs into outputs
PROCESS
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CORRECTIVE ACTION
• Action to eliminate the cause of a
nonconformity and to prevent recurrence.
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7
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18

Clause/Section 4 :
Context Of The Organization
Understand your organization and its unique context
Memahami organisasi anda dan konteks yangunik
Clarify the needs and expectations of interested parties
Menjelaskan keperluan dan harapan pihak yang berkepentingan
Define the scope of your quality management system
Tentukan skop sistem pengurusan kualiti anda
Develop a QMS and establish documented information
Membangunkan QMS dan mewujudkan maklumat didokumenkan
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Tentukan Isu-isu
Luaran & Dalaman
77
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Konteks Organisasi
Konteks
Organisasi
Dua keperluan
baru telah
ditambah dalam
standard ISO
9001:2015 iaitu:
4.1
Memahami
organisasi
dan
konteksnya
4.2 Memahami
keperluan dan
harapan pihak
yang
berkepentingan.
90
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Klausa 4.0: Konteks Organisasi

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Strategic Planning Model
A B C D E
• Environmental
Scan
Assess
• Organisation
background
information
• Stakeholders Analysis
• Strategic issues
• Mission & Vision
• Values / Guiding
Principles
• Strategic
Goals/KRA
• Specific
Objectives/Outcome
s
• Performance
Measurement/KPI
• Targets / Standards of
Performance
• Initiatives / Projects
• KPI Data Dictionary
Build Cascade
• Communicating the plan
• Performance
Management
• Review Progress –
Balanced Scorecard
• Take Corrective
Actions
Do Evaluate
Where we are Where we want to be How we will do it How are we doing
• Gaps
• Allingment
• Action Plans
• Operational Plan
(include budget planning)
• Continual
Improvement
Readiness
Collect
current data
OUTPUT
Strategic thinking
skills

"Konteks organisasi"
135
Konteks luaran termasuk *
persekitaran budaya, sosial, politik, undang-undang, peraturan,
kewangan, teknologi, ekonomi, semula jadi dan berdaya saing,
sama ada antarabangsa, kebangsaan, serantau atau tempatan;
hubungan dengan, dan persepsi / nilai pihak berkepentingan luar
Konteks dalaman termasuk *
budaya korporat; tadbir urus, struktur organisasi, peranan dan
kebertanggungjawaban; dasar, objektif, dan strategi
sumber (modal, masa, orang, proses, sistem teknologi);
sistem maklumat, aliran maklumat dan proses membuat
keputusan (kedua-dua rasmi dan tidak rasmi)
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Assessment Model:
S W O T/SWOC
Build
External Assessment: Political, economic
factor, competitor’s, social trends, technology,
regulatory environment. (PESTEL)
Internal Assessment: Organizational assets,
resources, people, culture, systems,
partnerships, suppliers, . . .
• Easy to Understand
• Apply at any organizational level
• Needs to be Analytical and
Specific
• Be honest about your
weaknesses
Good Points Possible Pitfalls
SWOT SWOT

95
Analisis Persekitaran Luaran:
Teknik Analisis PEST
– Political
– Legislation and Regulation
– International relations, world peace
– Economic
– Economic cycles, recession, boom
– Currency rates, interest rates, tariff/taxes/quotas
– Capital, labour and commodity markets
– Social
– Demographics, foreigners
– Tastes, fashion, perception, worldview
– Environmental awareness
– Technological
– Process effect development
– Product capability
– ICT
hak cipta Mbustaman IAB.KPM16/4/2018

Standard ini memerlukan organisasi untuk menentukan isu-
isu dalaman dan luaran. (SWOT Analysis &PESTEL)
Isu apa?
 Isu-isu yang
 relevan dengan tujuan,
 hala tuju strategik dan
 yang memberi kesan kepada keupayaan untuk mencapai
keputusan yang diingini itu.
Apa yang perlu dilakukan?
Organisasi perlu memantau dan
mengkaji semula maklumat mengenai isu-isu ini.
96
4.2 Memahami organisasi dan konteksnya.
9
6
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Siapakah pihak yang berminat?
Biasanya, ini termasuk:
98
 Pemegang Saham
 pemilik
 pengurusan
 pekerja
 kesatuan sekerja
 Pembekal
 rakan-rakan
 Pelanggan
 agensi kerajaan
 Media
 Persatuan
 mana-mana orang atau organisasi lain yang berminat dgn
organisasi
9
8
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keupayaan organisasi untuk menyediakan produk dan
perkhidmatan yang memenuhi keperluan pelanggan dan
keperluan perundangan yang berkenaan secara konsisten, juga
melibatkan KESAN (EFFECT) dan KEBARANGKALIAN KESAN
(POTENTIAL EFFECT) , maka organisasi hendaklah menentukan:
 Pihak yang berminat yang berkaitan dengan sistem
 Syarat-syarat (Keperluan – Requirement) pihak yang berminat
Memantau dan mengkaji semula maklumat mengenai pihak
yang berminat dan keperluan yang berkaitan mereka.
99
Memahami Keperluan dan Harapan Pihak
yang berminat
9
9
16/4/2018

Contoh:
InterestedParty
Internalor
External Reason forInterest
Customers External Direct recipient of our [Products or Services ]
Employees Internal Responsible for realization of our [Products or Services ]
Endusers External Our products may be resold by our direct customers or other
end users, who are directly impacted by the quality of our
[Products or Services ].
Suppliers
(vendors)
External Provide supporting services or raw materials
Regulators External Dictate controlling regulations that impact on the
management system and our [Products or Services ].
Public External While a low risk, failure of our [Products or Services ] could
impact on public safety.
Certification
Bodies
External Assess conformity of [Short Client Name] to ISO 9001 and so
must be kept notified of changes to the QMS.
Competitors External Provide challenges to our ability to provide [Products or
Services to customers. 102
1
16/4/2018

4.3. Scope: What does the ISO
9001:2015 standard state?
Section 4.3 of the standard details the requirements for
determining the scope of the Quality Management System.
In a note about the QMS, it is stated that the QMS can include
the whole organization, specifically identified functions of the
organization, specifically identified sections of the organization,
or one or more functions across a group of organizations. To
start, there are three considerations to be included when
determining the scope:
External and internal issues that are relevant to the purpose of
the organization, the strategic direction, and the ability to
achieve intended results
Requirements of relevant interested parties
The product and service of the organization

4.3
sample scope ISO 9001:2015
XYZ Manufacturing located in London, England, producing
machined components in the aerospace and automotive
industry within Europe.
XYZ Consultants located in offices in Europe, Asia, and North
American provide Information Technology Support to companies
in any industry.
XYZ Computing provides software development services to
companies in the automotive and heavy machinery industries
within North and South America.
XYZ Industries is a division of XYZ International that operates in
Indonesia and provides paper products to the Asian market

106
Contoh Polisi Kualiti
Contoh Pernyataan Dasar Kualiti
1. “KV X berazam dan beriltizam memberi perkhidmatan
pendidikan teknikal dan vokasional yang berkualiti tinggi bagi
memenuhi kepuasan pelanggan dan keperluan negara
melalui proses PdP yang berkualiti dan amalan pengurusan
yang bertaraf dunia”
2. Dasar kualiti Institut Aminuddin Baki adalah untuk menyediakan
program latihan dalam bidang pengurusan dan kepimpinan pendidikan
yang berkualiti bagi memenuhi keperluan pelanggan melalui
pelaksanaan MS ISO 9001: 2015.

108
Objektif Kualiti
Pengurusan Atasan organisasi hendaklahlah menyediakan
objektif-objektif kualiti yang :
 Selaras dengan Polisi Kualiti (consistent with the quality
policy)
 Sesuai pada peringkat/bahagian yang berkaitan (at
relevant functions and level)
 Bercirikan SMART
 Menyatakan hasil akhir yang ingin dicapai.
“Something Sought, Or Aimed For, Related To Quality”

Objektif Kualiti IAB
Objektif Sistem Pengurusan Kualiti adalah:
(a) Melaksanakan100% program latihan yang dijadualkan dalam
Perancangan Program Latihan IAB kecuali berlaku perkara-perkara yang di
luar kawalan IAB.
(b) Memastikan sekurang-kurangnya Sembilan Puluh Peratus (90%) peserta
kursus berpuas hati dengan program latihan IAB.
(c) Memastikan skor prestasi pensyarah mencapai tahap prestasi
sekurangkurangnya Lapan Puluh Peratus (80%).
(d) Mengeluarkan Sijil kepada peserta-peserta selepas program latihan
dilaksanakan mengikut tempoh berikut:
i) Sijil Kehadiran – 3 Minggu
ii) Sijil Pencapaian – Semasa Majlis Penyampaian Sijil.
(e) Semua aduan pelanggan dan peserta kursus akan dilayan sebagaimana
yang tercatat dalam Piagam Pelanggan.

4.4

Kepimpinan
(klausa 5.0)
Operasi
Klausa 8.0)
Penambahbaikan
(Klausa 10)
Kawalan proses NC &
Pembetulan.
Penambahbaikan
Sokongan
(klausa 7.0)
Perancangan
Operasi &
kawalan
Input
Keperluan
Latihan
Keperluan utk
kursus
Rekabentuk
&
Pembangunan
kursus
Kawalan sumber luaran
Pengambilan
Peserta
Kursus
Pengendalian
Kursus
Penilaian
Kursus
Persekitaran utk
Operasi proses
Infrastruktur
Sumber
Manusia
Maklumat
didokumentasi
Kompetensi
Kesedaran
Penilaian Prestasi
(klausa 9)
Pemantauan, pengukuran,
Analisis dan penilaian
Audit Dalaman
Semakan Pengurusan
Klausa 4.0: Hala Tuju Organisasi
Perancangan
(klausa 6.0)
Komunikasi
Tindakan susulan
Perancangan
Strategik
Penyelidikan
& Penerbitan
Konsultasi

114
KEDIAMAN
K
E
P
E
R
L
U
A
N
P
E
L
A
N
G
G
A
N
1.10
PEPERIKSAAN K
E
P
U
A
S
A
N
P
E
L
A
N
G
G
A
N
1.
6
P
E
N
G
U
R
U
S
A
N
S
U
M
B
E
R
1.5
PENGURUSAN
REKOD
PELAJAR
1.7
PENYEDIAAN
INFRASTRUKTUR
1.8
PERANCANGAN
PENGAJARAN
1.9
PELAKSANAAN
PENGAJARAN
1.11
PENILAIAN
PEMANTAUAN
PENGAJARAN
DAN PEMBELAJARAN
1.12
PENILAIAN
PENCAPAIAN PELAJAR
MENEPATI
KEPERLUAN
YA
1.13
PENGIJAZAHAN
PENGENALPASTIAN
TAHAP
PEMBELAJARAN
PROSES SOKONGAN
TIDAK
1.1
PELAN
STRATEGIK
1.2
PEMBENTUKA
N KURIKULUM
1.3
PENAWARAN
KURSUS
1.4
PENDAFTARAN
KURSUS
PROSES PENGURUSAN
PROSES TERAS
MENEPATI
KEPERLUAN
TIDAK
YA
PEMBETULAN DAN
PENCEGAHAN
SEMAKAN
PENGURUSAN
MAKLUMBALAS
PELANGGAN
Pemetaan Proses

Questions to ask:
 What are the inputs to the process?
 Where do the inputs come from?
 What are the outputs to the process?
 Where do the outputs go to?
 Is there an effective inter-relationship between
processes?
 Who plans the process?
 Who conducts the process?
 Are responsibilities and authorities defined?
 Who monitors and measures the process?
 What resources are required for the process? -
Materials, people, information, environment,
infrastructure, etc.

 What documented information is required for the
operation and control over the process?
 What competences & training are required?
 What awareness and knowledge is required?
 What methods are used to control and run the process?
 What are the risks and opportunities for the process?
 What happens when the process goes wrong or does not
yield the correct output or result?
 How can the process be improved?
 Is the process part of the management review process?
 Is the process subject to internal audit?

Clause/Section 5 :
LEADERSHIP
focusing on quality and customers
Pelanggan, kehendak berkanun dan peraturan yg berkenaan
establishing a suitable quality policy
mewujudkan dan menyampaikan dasar kualiti yang sesuai utktujuan
dan konteksorganisasi
defining roles and responsibilities
menentukan peranan dan tanggungjawab
16/4/2018

"Tanggungjawab
Pengurusan" kini
digantikan dengan
"Kepimpinan"
151
Akauntabiliti
Polisi &
ObjektifQ
Integrasi
PromosiPA
&RBT
Sumber
Komunikasi
Pastikan
SPK
berkesan
Pembabitan,
Arahan
dan
Sokongan
Penambahbaikan
Sokongan
Kepemimpinan
1
16/4/2018

Top management must:
• have accountability for the effectiveness of their organisation’s quality
management system;
• ensure that their organisation’s quality policy and quality objectives are
consistent with the organisation’s overall strategic direction and the
context in which the organisation is operating;
• work alongside their people in the organisation in order to ensure that the
quality objectives are achieved;
• ensure that the quality policy is communicated, understood and applied
across the organisation;
• make sure that the quality management system is achieving the results
that are intended;
• lead people to contribute to the effective operation of the system;
• drive continual improvement and innovation and develop leadership in
their managers

The top management is required to ensure that:
• the requirements set out in ISO 9001:2015 are met;
• QMS processes are delivering their intended
outcomes;
• reporting on the operation of the QMS and identifying
any opportunities for improvement is taking place;
• a customer focus is promoted throughout the
organisation;
• whenever changes to the QMS are planned and
implemented, the integrity of the system is
maintained.

Clause/Section 6 :
PLANNING
Define actions to manage risks and address opportunities
Perancangan Menentukan tindakan untuk menangani risiko dan peluang
Set quality objectives and develop plans to achieve them
Menetapkan objektif kualiti dan membangunkan rancangan untuk mencapainya
Control changes to your quality management system
Kawalan Perubahan untuk sistem pengurusan kualitianda
Perancangan manusia itu USAHA,
Perancangan ALLAH itu TAKDIR!!
16/4/2018

1
“risk-based thinking”
2
3
“saya berubah, kita mengubah”
“WE positively CHANGE”
86
1
2
16/4/2018

KJADUAL KEMUNGKINAN
Penilaian Kemungkinan Penerangan
5 Sangat Kerap Selalu berlaku (81% - 100%)
4 Kerap Berlaku berulang kali (56% - 80%)
3 Sederhana Kerap Kadang-kadang berlaku (45% - 55%)
2 Tak Kerap Jarang berlaku (1% - 44%)
1 Tidak Mungkin Berlaku Tidak mungkin berlaku ( < 1% )
1
2
16/4/2018

JADUAL AKIBAT / KESAN
Penilaian Keparahan Penerangan
5 Ketakakuran Besar Kegagalan Sistem
4 Ketakakuran Sederhana
Mendapat teguran audit yang boleh
menyebabkan kegagalan sistem pada masa
hadapan dan memerlukan tindakan pembetulan
tanpa berlengah-lengah
3 Ketakakuran Kecil
Mendapat teguran audit yang memerlukan
tindakan pembetulan
2 Perlu Penambahbaikan Pernah mendapat teguran audit
1 Penambahbaikan
Inisiatif sendiri untuk penambahbaikan
berdasarkan penanda aras
1
2
16/4/2018

2
16/4/2018

Jadual Tindakan
ARAS RISIKO SKALA TINDAKAN DAN SKALA MASA
TINGGI 15-25 Memerlukan tindakan
pembetulan tanpa berlengah-
lengah
SEDERHANA 4-12 Memerlukan tindakan
pembetulan
RENDAH 1-3 Inisiatif sendiri berdasarkan
penanda aras
1
2
16/4/2018

Contoh…..
Risiko Kemungkinan Keparahan PenilaianRisiko ArasRisiko Mitigasi
Pelajar tidak mendapat
tempat latihan industri
2 4 8 Sederhana
Pelajar ditempatkan di
r
akan industri,
pusat penyelidikan dan pusat pengajian.
Tindakan direkod dalam Borang Taksiran
Risiko dalam tempoh 2 minggu.
Majikan tidak memberi
latihan yang sewajarnya
2 4 8 Sederhana
Perbincangan bersama majikan,
penempatan semula pelajar atau
penangguhan latihan. Tindakan direkod
dalam Borang Taksiran Risiko dalam
tempoh 2 minggu.
Pelajar tidak mencapai
tahap keperluan latihan
1 5 5 Sederhana
Perbincangan bersama pelajar,
penempatan semula pelajar atau
penangguhan latihan. Tindakan direkod
dalam Borang Taksiran Risiko dalam
tempoh 2 minggu.
Proses penilaian tidak dapat
dilaksanakan kerana
kekangan kewangan dan
lokasi
1 3 3 Rendah
Penilaian dilaksanakan atas
talian/panggilan telefon, pembentangan
laporan latihan. Tindakan direkod dalam
Borang Taksiran Risiko dalam tempoh 2
minggu.
145
2
16/4/2018

6.2: Apabila merancang bagaimana untuk
mencapai Objektif Kualiti, hendaklah
menentukan:
Sumber apa yang
diperlukan
Siapa yg
bertanggungjawab
Bila ia akan
disiapkan
Apa yang akan
dilakukan
what will be done
129
what resources will be required
who will be responsiblewhen it will be completed
Bagaimana
keputusan akan
diniilai
how the results will be evaluated
16/4/2018

16/4/2018
Strategic Planning Model
A B C D E
• Environmental
Scan
Assess
• Organisation
background
information
• Stakeholders Analysis
• Strategic issues
• Mission & Vision
• Values / Guiding
Principles
• Strategic
Goals/KRA
• Specific
Objectives/Outcome
s
• Performance
Measurement/KPI
• Targets / Standards of
Performance
• Initiatives / Projects
• KPI Data Dictionary
Build Cascade
• Communicating the plan
• Performance
Management
• Review Progress –
Balanced Scorecard
• Take Corrective
Actions
Do Evaluate
Where we are Where we want to be How we will do it How are we doing
• Gaps
• Allingment
• Action Plans
• Operational Plan
(include budget planning)
• Continual
Improvement
Readiness
Collect
current data
OUTPUT
Strategic thinking
skills

Action Plan Framework
What will
be done
Who will be
resposible
What
resources
will be
required
When it will
be
completed
How the
results will
be
evaluated
(KPI)
Expected
results
(Output/out
comes)

6.3: Perancangan Perubahan
Apabila menentukan keperluan untuk perubahan kepada SPK,
perubahan tersebut hendaklah dijalankan dengan cara dirancang
dgn mengambil kira:
Perubahan
Tujuan dan
potensi
kesan
IntergritiSPK
Ketersediaan
sumber
Peruntukan
semula
T/Jwb &
Kuasa
132
the purpose of the changes and
their potential consequences
the integrity of the qms
the availability of resources
the allocation or reallocation of
responsibilities and authorities
16/4/2018

89
1
3
16/4/2018

Clause/Section 7 : SUPPORT
Support your QMS by / Menyokong QMS anda dengan :
providing the necessary resources
menyediakan sumber yang diperlukan (eg. Staf, Infra, Environment (5S),
Kalibrasi.
ensuring that people are competent
memastikan bahawa staff adalah kompeten
Awareness
Mengetahui Dasar, Objektif, Sumbangan mrk, Implikasi jika TIDAK patuh
SPK
managing your communications
menguruskan komunikasi anda, perkara apa, bila, dgn siapa, Bgaimana,
Siapa
1
3
16/4/2018

1
2
3
4
5
91
1
3
16/4/2018

Versi standard 2008 mempunyai dua terma
berasingan: "dokumen" dan "rekod".
Dalam Versi 2015 pula ia telah digabungkan
bersama-sama dan dipanggil "maklumat
didokumenkan".
150
Kawalan Dokumen & Rekod - Fleksibel
4
MAINTAIN KEKALKAN Dokumen
RETAIN SIMPAN Rekod
1
16/4/2018

Dokumen wajib
Dokumen/Prosedur Wajib Klausa
Menentukan Skop Sistem Pengurusan Kualiti (SPK)
# terdapat di dalam Manual Pengurusan SPK
4.3
Polisi/Dasar Kualiti 5.2
Objektif Kualiti dan Perancangan untuk
Mencapainya
6.2
Kawalan terhadap proses luaran yang dibekalkan,
produk dan perkhidmatan
8.4
NEW
NEW
139
1
16/4/2018

D
NEW
NEW
NEW
NEW
NEW
NEW
140
okumen bukan mandatori
Dokumen/Prosedur Tidak Wajib Klausa
Memahami organisasi dan konteksnya
Memahami keperluan dan jangkaan pihak yang berkepentingan
4.1, 4.2
Prosedur untuk menangani risiko dan peluang 6.1
Prosedur Latihan, Kecekapan dan Kesedaran Changed!? 7.2,73
Prosedur Maklumat yang didokumenkan 7.5
Prosedur Reka Bentuk dan Pembangunan Produk dan
Perkhidmatan
8.3
Prosedur Pemantauan & Pengukuran Kepuasan Pelanggan 9.1.2
Prosedur Audit Dalaman Changed!? 9.2
Prosedur Kajian Pengurusan Changed!? 9.3
Prosedur Ketidakpatuhan dan Tindakan Pembetulan Changed!? 10.2
1
16/4/2018

118
Menyimpan Maklumat yang
didokumenkan
4.3 Scope of the QMS 8.4 Control of externally provided products and
services
4.4 QMS and its Processes 8.5.1 Production and Service provision
5.2 QMS Policy 8.5.2 Identification and traceability
6.2 QMS Objectives 8.5.6 Control of Changes
7.1.5 Monitoring & measuring resources 8.7 Control of non conforming processes
7.2 Evidence of Competence 9.1 Control of monitoring, measurement, analysis
and evaluation
7.5 Documented Information determined by the
organization as being necessary for the
effectiveness of the QMS
9.2 Evidence of the audit programme(s) and the
auditresults
8.1 Operational Planning andControl 9.3 Evidence of the results of Management Reviews
8.2 Determination of Requirements for Products
and Services
10.1 Evidence of the nature of the nonconformities
and any subsequent actions taken
8.3.5 Design & Development 10.3 Evidence of continual improvementhak cipta Mbustaman IAB.KPM
1
4
16/4/2018

142
PROSEDUR KUALITI
• Kawalan DokumenPK 01
PK 02
• Audit DalamPK 03
• Kajian Semula PengurusanPK 04
• Tindakan Pembetulan, Pencegahan dan
Penambahbaikan
PK 05
• Kawalan Perkhidmatan Yang Tidak AkurPK 06

143
PROSEDUR KUALITI
• Aduan dan Maklum Balas PelangganPK 07
• Pelaksanaan P & PPK 08
• Pengurusan PanitiaPK 09
• Penyediaan Jadual WaktuPK 10
• Pengurusan PeperiksaanPK 11
• Pencerapan P&PPK 12

144
PROSEDUR KUALITI
• Pembangunan StafPK 13
• Perolehan, Pembayaran dan Pengurusan StokPK 14
• Pengurusan MesyuaratPK 15
• Semakan Hasil Kerja MuridPK 16
• PenyenggaraanPK 17
• Pengurusan Pusat Sumber Sekolah (PSS)PK 18

Clause/Section 8 : OPERATION /
OPERASI
Develop, implement,
and control operational
processes
Determine and
document product and
service requirements
Establish a process to
design and develop
products and services
Monitor and control
external processes,
products, and services
Manage and control
production and service
provision activities
Implement
arrangements to control
product and service
release
Control nonconforming
outputs and document
actions taken
2
3 4
5
61
7
16/4/2018

Pematuhan
Keyakinan
Clause/Section 8 : OPERATION / OPERASI
1 Menentukan
Keperluan
pelangan
Mewujudkan
Kriteria
Menentukan
Sumber
Melaksanakan
Kawalan
Menentukan &
Memastikan
Maklumat yg
didokumenkan Perancangan
Operasi dan
Kawalan
Proses
Peneri
maan
16/4/2018

94
2 Komunikasi
dengan
Pelanggan
Menentukan
keperluan
yang
berkaitan
Semakan
Keperluan
berkaitan
Perubahan
kepada
Keperluan
Keperluan
untuk Produk
&
Perkhidmatan
Perund
angan
Peratur
an
• Maklumat yg berkaitan
• Pertanyaan, kontrak,
pesanan, termasuk
perubahan
• Maklumbalas, termasuk
aduan
• Kawal harta pelanggan
• Luar jangka
• Keperluan yg ditetapkan
oleh Pelanggan,
penghantaran dan aktiviti
slps penghantaran
• Keperluan yg TIDAK
dinyatakan
• Keperluan Organisasi
• Perundangan & Peraturan 1
16/4/2018

3
Rekabentuk
dan
Pembangunan
Produk &
Perkhidmatan
Umum , wujud, laksana, simpan proses rekabentuk
& pembangunan
Perancangan Rekabentuk & Pembangunan
Input Rekabentuk & Pembangunan
Kawalan Rekabentuk & Pembangunan
Output Rekabentuk & Pembangunan
Perubahan Rekabentuk & Pembangunan
4
1
2
3
5
6
16/4/2018

KAWALAN
terhadap
proses luaran
yang
dibekalkan
Produk &
Perkhidmatan
Umum , mematuhi keperluan,
menentukan kawalan
Jenis dan Tahap Kawalan,
Keberkesanan, Pengesahan
Maklumat untuk Pembekal Luar
1
2
3
4
16/4/2018

5
Pengeluaran
dan
Penyedian
Kawalan Pengeluaran dan Penyediaan
Perkhidmatan
Identifikasi dan kemudahkesanan
Harta Milik Pelanggan atau Pembekal Luar
Pemeliharaan / Preservation
Aktiviti Selepas Penghantaran
Kawalan Perubahan
Pelepasan Produk & Perkhidmatan
1
2
3
4
Perkhidmatan
5
6
716/4/2018

151
KEDIAMAN
K
E
P
E
R
L
U
A
N
P
E
L
A
N
G
G
A
N
1.10
PEPERIKSAAN K
E
P
U
A
S
A
N
P
E
L
A
N
G
G
A
N
1.
6
P
E
N
G
U
R
U
S
A
N
S
U
M
B
E
R
1.5
PENGURUSAN
REKOD
PELAJAR
1.7
PENYEDIAAN
INFRASTRUKTUR
1.8
PERANCANGAN
PENGAJARAN
1.9
PELAKSANAAN
PENGAJARAN
1.11
PENILAIAN
PEMANTAUAN
PENGAJARAN
DAN PEMBELAJARAN
1.12
PENILAIAN
PENCAPAIAN PELAJAR
MENEPATI
KEPERLUAN
YA
1.13
PENGIJAZAHAN
PENGENALPASTIAN
TAHAP
PEMBELAJARAN
PROSES SOKONGAN
TIDAK
1.1
PELAN
STRATEGIK
1.2
PEMBENTUKA
N KURIKULUM
1.3
PENAWARAN
KURSUS
1.4
PENDAFTARAN
KURSUS
PROSES PENGURUSAN
PROSES TERAS
MENEPATI
KEPERLUAN
TIDAK
YA
PEMBETULAN DAN
PENCEGAHAN
SEMAKAN
PENGURUSAN
MAKLUMBALAS
PELANGGAN
Pemetaan Proses

Kawalan proses,
produk dan
perkhidmatan dari
pembekal luar
Kriteria
Pemilihan
Kriteria
Penilaian
Pemilihan
Pemantauan
Prestasi
Penilaian
Semula
Verifikasi
152
1
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153
Pengurusan Pengetahuan
a) melindungi organisasi daripada kerugian,
kehilangan pengetahuan, contohnya
• Melalui staff turnover;
• Kegagalan untuk merakam dan berkongsi maklumat;
b) menggalakkan organisasi untuk
memperoleh pengetahuan, contohnya
• Belajar dari pengalaman;
• Mentor;
• Penandaarasan.
Dalam 7.1.6, Keperluan untuk menentukan dan menguruskan pengetahuan yang
disenggarakan oleh organisasi, untuk memastikan operasi proses dan bahawa ia boleh
mencapai pematuhan produk dan perkhidmatan.
Keperluan mengenai pengetahuan organisasi telah diperkenalkan untuk tujuan:
1
5
16/4/2018

98
• 8.7 - Control of Nonconforming outputs, products and services
• Correction / Pembetulan
• Segregation, Containment, Return or Suspension ( Pengasingan,
Pembendungan, pemulangan atau pengantungan penyediaan
produk & perkhidmatan)
• Informing the Customer / Pemakluman kepada Pelanggan
• Obtaining Authorization For Release / Mendapat kebenaran untuk
penerimaan di bawah komsesi.
Kawalan Ketidakpatuhan Keluaran, Produk & Perkhidmatan
1
16/4/2018

Clause/Section 9 :
EVALUATION
Monitor, measure,
analyze, and evaluate
QMS performance
Use internal audits to
examine conformance
and performance
Carry out management
reviews and document
your results
1
5
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Clause 9 – Performance Evaluation
1
0
0
9.1.3 – Analysis and Evaluation
Demonstrate Conform© Gihtayni ,JanE20n16h- Aall rnighcts reeserCvedustomer Satisfaction…
9.1.2 – Customer Satisfaction
Monitor Customer Perception
What, Methods, When and How
9 – Performance Evaluation
9.1.1- General
1
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9.2.1 - PlannedAudits
1- Organization’s Requirements
2- Requirements of ISO9001
9.2 – Internal Audits
10
1
1
5
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9.2 – Internal Audits
a.Plan, Establish, Maintain with defined Frequency, method,
responsibilities, reporting
b. Define the criteria and scope
c.Use of Independent Auditors
d.Reporting of Results to Management
e- Taking Actions Without Undue Delay
f- Maintain and Retain Documented Information
10
2
1
5
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Clause 9.3 – Management Review
9.3 Management Review
9.3.1- Inputs
9.3.2- Outputs
1
5
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Reviews at Planned Intervals
Ensue its continuing suitability,
adequacy and effectiveness
a) Status of actions from previous
reviews
b) Changes / Strategic Direction
ManagementReview
Inputs
10
4
1
6
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c) Information on Quality
Performance
• Nonconformities and
CARs
• Monitoring and
Measurement Results
• Audit Results
• Customer Satisfaction
• Issues with Relevant
Parties /External
Providers
• Adequacy of resources
• Process Performance
• Conformity of Products
Management
Review
Inputs
10
5
1
6
16/4/2018

a)Continual Improvement
Opportunities
b)Any change needed for QMS,
including resources
Retain document information
as evidence of results of
management review.
Management
Review
Outputs
1
6
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Clause/Section 10 : IMPROVEMENT
Determine improvement
opportunities and make
improvements
Control nonconformities
and take appropriate
corrective action
Enhance the suitability,
adequacy, and
effectiveness of your QMS
Ketakakuran
&
Tindakan
Pembetulan
163
Penambahbaikan
Berkala
Kenalpasti
Kaedah
16/4/2018

10: PENAMBAHBAIKAN
Hendaklah mengenalpasti kaedah untuk melakukan
penambahbaikan ke arah peningkatan kepuasan pelanggan
Penambahbaikan proses ke arah mencegah
ketakakuran dengan melakukan proses inovatif &
kreatif (KIK)
Penambahbaikan produk & perkhidmatan ke arah
menepati keperluan yang telah diketahui dan
dijangka seperti melakukan tindakan pembetulan
yang efektif
Penambahbaikan hasil pelaksanaan Sistem
Pengurusan Kualiti (SPK)
16/4/2018

Penambahbaikan (samb…)
Mengambil tindakan
untuk mengawal dan
memperbetulkannya
Menangani
akibatnya
16/4/2018

Penambahbaikan (samb…)
Kenalpasti
Ketakakuran
Tindakan
Pembetulan
PUNCA
Analisa
166
Selesai
dan
Keberkesanan
Keputusan
PelanTindakan
Menilai tindakan yang perlu untuk menghindar
punca ketakakuran
16/4/2018

16/4/2018

O ra n g I sl a m
a d a l a h o r a n g y a n g
h a r i i n i l e b i h b a i k
d a r i p a d a k e m a r i n
d a n h a r i e s o k nya
l e b i h baik
d ar i h ar i ini.
16/4/2018

PENAMBAHBAIKAN
169
CONTOH:
- Bengkel ISO bagi staf baru Perpustakaan
- Kajian Proses Kerja Semasa Bersama
Staf
- Kajian Kepuasan Pengguna (CSI)
- Kumpulan Inovatif & Kreatif (ICC) @ KIK
- Kajian Kepuasan Staf (ESI)
- Standard People Practice (SPP)
- Program 5S
- Kaizen
16/4/2018

Kata-kata Imam Syafie
• Bila kamu tidak tahan penatnya belajar, maka
kamu akan menanggung perihnya kebodohan
• Ilmu itu bukan yang dihafal tetapi yang
memberi manfaat

171
TERIMA KASIH
Untuk bantuan lanjut:
Muhd Bustaman Abdul Manaf
Institut Aminuddin Baki (CGH
Kementerian Pendidikan Malaysia.
Email: mbustaman@iab.edu.my
Tel: 019-9890524

172
SEKIAN,
TERIMA KASIH

Implementing ISO 9001:2015 Quality Management System

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