Interpretationanddocumentationiso9001 151210114259

British Standard Institution Learning Academy
ISO 9001:2015
INTERPRETATION &
DOCUMENTATION
COURSE
8-9 Oktober 15
Dewi Almitrasari
Lead Auditor & Trainer
Benefits to you!
Copyright 2015 BSI. All rights

reserved.
Welcome!

reserved.
Delegate Introductions
Introductions
Dewi Almitra Sari

reserved.
Course Aim
To gain an understanding of effective
quality management, by using a
systematic framework to:
A) Consistently provide products or
service that meet requirements
B) Enhance customer satisfaction
C) Develop effectiveness of
documentation system

reserved.
Learning Objectives
The
The history
history and
and
development
development of
of
ISO/FDIS
ISO/FDIS 9001
9001
What
What is
is a
a Quality
Quality
Management
Management System
System
(QMS)
(QMS)
The
The benefits
benefits of
of a
a QMS
QMS
Have
Have the
the skills
skills to
to develop
develop
documentation
:
documentation :
process
process mapping
mapping
documented
documented information
information
such
such as
as procedure
procedure and
and
supporting
supporting document
document
KNOWLEDGE
The
The terms
terms and
and
definitions
definitions used
used
Key
concepts,
Key concepts,
principles
principles and
and
structure
structure
The
The main
main requirements
requirements
of
of ISO/FDIS
ISO/FDIS 9001:2015
9001:2015
and
and how
how to
to implement
implement
SKILLS
QMS
QMS shall
shall establishing
establishing the
the
documented
documented information
information for
for
the
the effectiveness
effectiveness (Clause
(Clause 7.5,
7.5,
ISO
FDIS
9001:2015)
ISO FDIS 9001:2015)

reserved.
Solution & Result...

training journey to excellence... (2 days course)
Overview
Knowledge
Identificatio
n
The Need for

Quality
Management
System
Understanding the
requirements of
the
standard is your
essential starting
point to working
with
a management
system.
Develop your
expertise to
identify the
document and
other to
comply the
requirement
4
Documentati
on
Discover how
you
can develop the
documentation
system
1/20/17
reserved.
tion
Training
Agenda 2 days Course
duc
Intro
Module 2
Overview
Module 1
Principle of QMS
Terminology
(Workshop 1)
Concept of Quality
Module 9
Interpretation &
Documentation of
Performance Evaluation
Customer Satisfaction
Internal Audit
Management Review
Module 10
Interpretation &
Documentation of
Improvement
Improvement
Nonconformity & Corrective action
Continual Improvement)
Closing
Module 3
ISO 9001 - General
Historical of ISO 9001
ISO 9000, ISO 9001 &
ISO 9004
Module 8
Interpretation &
Documentation of
Operation
Planning and provision of services
((Workshop 5)
Control of external providers
Release & Control of Non Conforming
Module 7
Interpretation &
Documentation of
Resources
People
Infrastructure
Process Environment
Monitoring & Measurement
Knowledge Management)
Competence
Awareness
Copyright
2015 BSI. All rights
Documented Information(Workshop 4
reserved.
Module 4
Interpretation &
Documentation of
Context Organisation
Interested Party
Scope
Process Mapping (Workshop 2)
Module 5
Interpretation &
Documentation of
Leadership
Commitment
Quality Policy
Role & Responsibility
Module 6
Interpretation &
Documentation of
Planning
Risk Management
(Workshop 3)
Quality Objective
Management of Change
8
Time Table
08 October 2015
08.00 Opening & Introduction
08.20 Module 1 : Concept of Quality
09.00 Module 2 : QMS Overview & Workshop 1
09.40 Module 3 : QMS Historical
10.00 Break
10.15 Module 4 : Context Organisation & Workshop 2
12.00 Ishoma
13.00
Module 5 : Leadership
14.00 Module 6 : Planning and workshop 3

15.00
Break
15.15
Continued with module 6
16.30
End of Day 1 course

reserved.
Time Table
09 October 2015
08.00 Review of day 1 materi
08.15 Module 7 : Resources and workshop 4
10.00 Break
10.15 Continued with module 7
11.00 Module 8 : Operation
12.00 Ishoma
13.00
Continued with module 8 and workshop 5
15.00
Break
15.15
Module 9 : performance Evaluation
16.00 Module 10 : Improvement

16.30
End of course

reserved.
10
Course Structure
Materials:
Delegate workbook
Loan copy of ISO 9001
Course Format:
Activities
Classroom discussions

reserved.
11
British Standard Institution

Overview

reserved.
12
Who is BSI?
Leading Global Standards Creation Body: British, European, ISO, Public, Private
The UK National Standards Body: The source of British Standards
Specialist Focus on Standards Creation, Training and Certification
Global Network: 72,000 clients in 150 countries worldwide including governments, global brands and
SMEs
Experienced: The worlds first National Standards Body established in 1901 and a founding member of
ISO
Thought Leaders: Shaped the worlds most adopted standards, incl. ISO 9001, ISO 14001, OHSAS
18001
Trusted: Were a Royal Charter Company, reinvesting profits back into our business to improve our
clients experience

reserved.
1/20/17
13
BSIs end-to-end solutions make excellence a habit
Support
Assess
Embed
Share
Shape
Together with >10,000
independent experts,
BSI leads in the
development and
maintenance of global
standards
Public
Public Standards
Standards -- PAS
PAS
British Standards - BS
European
European Standards
Standards -EN
EN
ISO
ISO Standards
Standards
We share our
standards and
guidance documents
in many formats,
from paper to PDF or
organization-wide
licenses
Online Standards
Portal
Portal
Network
Network Licenses
Licenses
R i s k
S u s t
O p e r
M a n a
a i n a b
a t i o n
Our tutors transfer

the knowledge and
skills needed to
embed excellence
In-Company
In-Company Training
Training
Public Training
Training
Public
Internal
Internal &
& Lead
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Auditor
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Training
Self
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Assessment
tools
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g e m e
i l i t y
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Our assessors give

you proven ways to
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& CE
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marking
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We support you with

the knowledge and
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Training
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n t S t a n d a r d s
S t a n d a r d s
r f o r m a n c e S t a n d a r d s

reserved.
14
Standardisasi
Sertifikasi
International Accreditation Forum
Certified once, accepted everywhere
UK
Accreditation Body
USA
Accredit
s
Certification Body
Organization

reserved.
15
BSI Standards World Standards

Since 1901 BSI has worked with industry to build consensus and develop standards of
excellence
Year
British
Standard
ISO Standard
1987
BS 5750
ISO 9001 (Quality Management)
1992
BS 7750
ISO 14001 (Environmental Management)
1995
BS 7799
ISO/IEC 27001 (Information Security)
1996
BS 8800
OHSAS 18001 / AS/NZS 4801 (Occupational Health & Safety)
2000
BS 8600
ISO 10002 (Customer Satisfaction)
2002
BS 15000
ISO/IEC 20000 (IT Service Management)
2002
TS 16949
ISO/TS 16949 (Automotive)
2009
BS 16001
ISO 50001 (Energy Management)
2009
BS 5750 (based)
AS 9100 (Aerospace)
2012
BS 25999
ISO 22301 (Business Continuity)
2012
BS 8901
ISO 20121 (Sustainable Events)

reserved.
16
1
Concept of Quality

reserved.
MUTU
18
reserved.
18
Quality ? Mutu ?
Quality
Management /
Manajemen Mutu
Quality
Control/
Kendali
Mutu

reserved.
Quality
Assurance /
Jaminan Mutu
19
Apa itu Mutu?

Kaoru Ishikawa
(1915 1989)
Mutu berarti kepuasan pelanggan
Philip Bayard
Crosby (19262001):
Mutu berarti kesesuaian terhadap

persyaratan
Joseph Moses
Juran (1904
2008)
Mutu berarti kesesuaian dengan

penggunaan
William Edwards
Deming (19001993)
Memenuhi dan melebihi harapan dan

kebutuhan pelanggan, dan
peningkatan berkelanjutan

reserved.
20
Evolusi Sistem Manajemen Mutu

Evolusi Sistem Manajemen Mutu
(ISO 9001:2015)
(ISO 9001:2015)
ZERO DEFECT CONTINUOSLY &

ZEROPARTIES
DEFECT SATISFCATION
CONTINUOSLY &
INTERESTED
INTERESTED PARTIES SATISFCATION
Q Performance
Q Performance
CUSTOMERS SATISFCATION CONSISTENTLY

CUSTOMERS SATISFCATION CONSISTENTLY
ZERO DEFECT CONTINUOSLY &
ZERO
DEFECT SATISFCATION
CONTINUOSLY &
CUSTOMERS
CUSTOMERS SATISFCATION
ZERO DEFECT CONTINUOSLY
ZERO DEFECT CONTINUOSLY
SUSTANAIBILITY
SUSTANAIBILITY
(ISO 9001:2008)
(ISO 9001:2008)
QUALITY
MANAGEMENT
Quality
Quality
Assurance
Assurance
PERFORMANC E
Quality Control
Quality Control
ZERO DEFECT
ZERO DEFECT
Quality Inspection
Quality Inspection
COMPLIANC
E
Non Quality Culture

Non Quality Culture
Time
Time

reserved.
21
comprehensive portfolios ensure your corporate reputation remains

secure

reserved.
22
Key terms and definitions

BS EN ISO 9000
BSI British Standards
Management ?
Coordinated activities to direct and
control an organization
Quality Management ?
Management with regard to quality
Quality Management System
?
Management system with regard to
quality

reserved.
Quality
management
systems
Fundamental
s
and
vocabulary
23
Workshop 1a
Terms and Definitions
15 minutes
Click here to
start

reserved.
24
Sistem manajemen
Integrasi dari keseluruhan sistem
manajemen yang meliputi struktur

organisasi, rencana kegiatan,
tanggung jawab, prosedur, proses dan
sumber daya untuk pengembangan,
penerapan, pencapaian dan
pemeliharaan kebijakan atau arah VISI
perusahaan/organisasi.

reserved.
25
VISI & MISI
Kemana tujuan kita ?
KEBIJAKAN
Uraian dari visi & misi ?
SASARAN/TARGET
STRATEGI
Plan
Do
Indikator pencapaian visi & misi ?

Rencana
Manajemen Mutu
PROGRAM
SISTEM DOKUMENTASI Metode pencapaian sasaran : prosedur,
juklak, juknis, form dll
Action Check
PENERAPAN
PEMANTAUAN,
EVALUASI & TINDAK
LANJUT
reserved.
26
Mengapa kita
perlu sistem ?

reserved.
27
Integrasi = Keterkaitan
SASARAN MUTU
PROSES
DOKUMENTASI
TUJUAN

reserved.
28
HARAPAN
CUSTOME
R
KEBIJAKAN &
SASARAN, PROGRAM
Personel
Peralatan
Tg. Jawab&wewenang
Kompetensi/Kualifikasi
Pelatihan
Record
Ketersediaan
PROSES
PLAN
DO
Informasi/Metode
Material
Kebutuhan
Ketersediaan
Kemampuan
Pemeliharaan
Kondisi
Spesifikasi
Ketersediaan
Penyimpanan
Pengadaan
Kondisi lingkungan
Penetapan
Pengelolaan
Kebutuhan
Spesifikasi
Akurat
Analisa
Komunikasi
Ketersediaan

reserved.
ACTION CHECK
29
Pengukuran efektifitas sistem manajemen mutu
Sasaran mutu
organisasi
Hasil
pencapaian
Peningkatan
% 100
0
75
50

reserved.
25
30
2
Management Principle

reserved.
Key concepts : Management Principles
Customer
Focus
Leadership
Engagemen
t of People
Process
Approach

reserved.
Improveme
nt
Evidencebased
Decision
Making
Relationshi
p
Manageme
nt
32
Menetapkan harapan pelanggan

sekarang dan akan datang
Organisasi tergantung
pada pelanggan
Persyaratan Pelanggan
Prinsip 1:
Customer Focus /
Fokus Pelanggan
Kepuasasn Pelanggan !
reserved.
33
Pemimpin harus menetapkan

keseragaman tujuan dan arah organisasi.
Harus menciptakan kesadaran semua
orang untuk ikut serta terlibat mencapai
sasaran
Prinsip 2:
Leadership /
Kepemimpina
n
reserved.
34
Setiap orang di setiap level adalah bagian

penting dari organisasi.
Keterlibatan penuh dari karyawan sangat
menguntungkan bagi organisasi.
Prinsip Ke-3
Engagement of
people

reserved.
35
Hasil yang diinginkan dapat dicapai lebih efisien bila

sumber daya dan kegiatan yang terkait dikelola sebagai
suatu proses.
Identifikasi, pemahaman dan pengelolaan suatu sistem
dari proses-proses yang saling berhubungan untuk
mencapai sasaran yang ditetapkan meningkatkan
efektifitas dan efisiensi organisasi.
Prinsip Ke-4
Pendekatan
proses
reserved.
36
Key concepts : Process Approach

A Coherent System:
(Interactions)
Understandi
ng
requirement
s
(Outputs)
(Inputs)
Process
Intended
results
Processes adding value
Processes providing effective performance
Improvements (through evaluation) of
data/information
PDCA (process) methodology (Fig. 2)
reserved.
Activities
understood
and managed as
interrelated
processes
Consistent,
predictable results
Meeting
requirements
Customer
satisfaction
37
Peningkatan
berkelanjutan
haruslah menjadi sasaran tetap dari
organisasi
Prinsip Ke-5
Peningkatan

reserved.
38
Pengukuran efektifitas sistem manajemen mutu
Sasaran mutu
organisasi
Hasil
pencapaian
Peningkatan
% 100
0
75
50

reserved.
25
39
Prinsip Ke 6
Pendekatan Fakta/bukti untuk
keputusan
Keputusan yang efektif adalah yang

berdasarkan pada analisa terhadap data dan
informasi.

reserved.
40
Organisasi
dan
pemasoknya
selalu
tergantung satu sama lain dan hubungan
yang saling menguntungkan meningkatkan
kemampuan dari kedua belah pihak untuk
menghasilkan nilai tambah yang lebih
besar.
Prinsip Ke-7
Relationship Management

reserved.
41
Workshop 1b
Quality Management
Principle
15 minutes
Click here to
start

reserved.
42
3
ISO 9000 Family

reserved.
ISO 9001 History
D
D&
&
D
D
BSI
Pellentesque mollis
felis dolor, quis
aliquet sapien
dapibus tempus
lectus. Nulla sed
posuere velit, ut
gravida nibh.
BSI
BS 5750: Part 1 : 1987

ISO 9001 1987
EN 29001 - 1987
BS 5750: Part 2 : 1987

ISO 9002 1987
EN 29002 - 1987
Quality systems
British Standard
Quality systems
British Standard
Quality systems
British Standard
BS 5750: Part 3 : 1987

ISO 9003 1987
EN 29003 - 1987
Part 1. Specification for final inspection

and test
Part 1. Specification for production

and installation
Part 1. Specification for design/development,

production, installation and servicing

reserved.
44
ISO Standards for Quality Management

BS EN ISO 9001
BS EN ISO 9000
BSI British
Standards
BS EN ISO 9004
BSI British
Standards
BSI Standards Publication

Quality
Manageme
nt
systems
Requiremen
ts
Quality
managemen
t
systems
Fundamental
s
and
vocabulary

reserved.
Managing for
the
sustained
success of an
organization
A quality
management
approach
45
Evolusi Seri ISO 9000

Sejarah perubahan ISO 9001:
BS 5750
Part 2:1979
1st edition :
ISO 9001:1987
ISO 9002:1987
ISO 9003:1987
2nd edition :
ISO 9001:1994
ISO 9002:1994
ISO 9003:1994
3rd edition :
ISO 9001:2000
BS EN ISO 9001
BSI Standards Publication
Quality Management
systems Requirements

reserved.
e
l
e
se
.
p
e
4th edition :
5th edition :
ISO 9001:2008 ISO 9001:2015
BS EN ISO 9000
BSI British
Standards
Quality management
systems
Fundamentals
and vocabulary
BS EN ISO 9004
BSI British
Standards
Managing for the
sustained success of
an
organization A
quality
management
approach
46
Accredited Certification
International Accreditation ForumEstablishe

Certified once, accepted everywhere
s
Accreditation Body
Accredit
s
Certification Body
Multilateral Recognition Arrangements

Mandatory Documents
UKAS, or
equivalent local
national body
BSI, or esteemed
competitor
Personnel
Certification Body
Certificate
s
Auditor
User
Organization
Train
s
eg IRCA
Accredit
s
Training Course,
Tutor,
Training Body
Audits

reserved.
47
Nama Perusahaan
dan alamat
Ruang Lingkup
aktifitas
Tanggal penerbitan
dan masa berlakuk
sertifikat
Badan sertifikasi
dan lembaga yang
mengakreditasi
reserved.
48
CERTIFICATION PROCESS ISO 9001

Renewal Certification Process
Receive
Manual &
Procedure
Min. 3 weeks before audit
Stage 1
Audit
PreAudit
Corrective
Action
OPTIONAL
major
Corrective
Actions
6-monthly
Surveillance
Audit
Stage 2
Audit
major
major N
Follow-up
audit

reserved.
Y
Corrective
Actions
3 year
Max.
3
months
Corrective
Actions
Max.
3
months
Follow-up
audit
49
Clause of ISO 9001:2015

1
1
Scope
Planning
Normative references
Support
Terms and definitions
Operation
Context of the
organization
Performance evaluation
5
5
Leadership
10
1/20/17
10

reserved.
Improvement
50
1) Scope
this particular Management System Standard (MSS) is

addressed, and this includes the intended result(s) of the
application of this Standard. These have already in the main
been addressed through the promotion of the process
approach, namely:
Consistent provision of products and services that meet
customer and applicable statutory and regulatory
requirements (legal requirements)
Intended outcome is that which is intended as a result of
the application of the standard, or process etc.
Expected outcome is that which is expected by interested
parties
2) Normative
references
cites ISO 9000:2015 Quality Management

Systems Fundamentals and vocabulary
as indispensable for its application
3) Terms and
definitions

reserved.
51

reserved.
52
4
Context of Organisation
Clause 4 - ISO 9001:2015

reserved.
Clause 4: Context of the Organization

(1)
Understanding the
organization and its context

reserved.
54
Understand the Context of your

Organization
Determine:
Purpose
and
strategic
direction
Applicabili
ty
Products
and
services
Intended
result(s)
of QMS
External
and
internal
issues
Organization
Boundarie
s and
applicabili
ty (Scope)
Requireme
nts of
these
interested
parties
reserved.
Interested
parties
relevant
to the
QMS
55

(2)
4.2. Understanding
the
and expectations
of
Citizens
Theneeds
Organization
Competitors
interested
parties
Management
Customers
Media
Distributors
Shareholders
Investors
Owners
Insurers
Government
Regulators
Recovery service
suppliers
Top Management
Those accountable
for Quality policy
and implementation
Commentators
Trade groups
Neighbors
Those who implement

and maintain the
QMS
Pressure groups
Those who maintain

QMS and risk
procedures
Other response
agencies
Other Staff
Staff dependents
Contractors

reserved.
Emergency services
Transport services
56

(3)
4.3. Determining the scope of the
QMS
4.4. QMS and its Processes

reserved.
57
4.4. QMS and its Processes
Organisasi harus:
mengidentifikasi proses-proses yang diperlukan
Peta
Proses
menetapkan tahapan dan interaksi dari proses-proses

menetapkan kriteria dan metoda untuk menjamin operasi dan
pengendalian
menjamin ketersediaan dari sumber daya dan informasi
memonitor, mengukur dan menganalisa proses-proses
menerapkan tindakan yang dibutuhkan untuk mencapai hasil yang
direncanakan dan peningkatan berkesinambungan.

reserved.
58

reserved.
59
Key concepts : Process

With who?
(responsibilities,
authorities)
With what?
(resources)
Inputs?
(what,
from
whom)
PROCESS
Outputs?
(what,
to whom)
What results?
(monitoring, measurements,
performance indicators)
How done?
(criteria, methods/controls
documentation)

reserved.
60
Key concepts Process Approach

A Coherent System:
(Interactions)
Understandi
ng
requirement
s
(Outputs)
(Inputs)
Process
Intended
results
Processes adding value
Processes providing effective performance
Improvements (through evaluation) of
data/information
PDCA (process) methodology (Fig. 2)
reserved.
Activities
understood
and managed as
interrelated
processes
Consistent,
predictable results
Meeting
requirements
Customer
satisfaction
61
Representation of the structure of this

International Standard in the PDCA cycle
Quality Management System
(4)
Organization
and its context
(4)
Support and
Operation
( 7,8)
Do
Plan
Customer
requirement
s
Planning (6)
Leadership
(5)
Act
Needs and
expectations
of relevant
interested
parties (4)
Performanc
e evaluation
(9)
Check
Improveme
nt (10)

reserved.
Customer
satisfaction
Results of
the QMS
Products
and
services
62
Contoh Generik Business Process

Calon Mahasiswa
Bagian Administrasi dan

Akademik Kemahasiswaan
Pendidikan &
Pengajaran
Workshop
Fungsi
Perbaikan dan
Perawatan
Laboratorium
Fungsi
MIS
Perpustakaan
Penelitian dan
Pengabdian Pada
Masyarakat
Fungsi
Publikasi
Fungsi
Penjaminan
Mutu
Bg Umum,
Administrasi
dan keuangan
Lulusan,Industri,
Masyarakat
Business process mapping sebagai peta aliran fungsi untuk menjelaskan interaksi antar
fungsi dan menjadi fondasi dalam menetapkan key performance indikator yang efektif
dengan berlandaskan kaidah next process is our customer dan kaidah quality built by
every proceses within organization

reserved.
63
Contoh Generik Context Diagram

Perpustakaan
Laboratorium
Workshop
Review dan
Improvement
Process
PEN-01
PEN-03
Prosedur Proses
Prosedur Pelaksanaan
dan Evaluasi Ujian
Semester
Belajar Mengajar
UPT Perbaikan
dan Perawatan
Unit MIS
Bagian Akademik
dan Administrasi
Kemahasiwaan
PEN-04
Prosedur Bimbingan dan
Administrasi Tugas Akhir
Unit
Publikasi
P3M
Bg Umum,
Administrasi
dan keuangan
Context Diagram adalah menjadi landasan penyusunan prosedur yang efektif.

Prosedur yang efektif adalah prosedur yang dibangun bukan berdasarkan klausul ISO tapi sebuah prosedur
yang disusun dari nature of business proses organisasi yang disempurnakan untuk memastikan compliance
dengan ISO Requirement.

reserved.
64
Business Process
SP-01
Planning
CP-01
PP-01
WI-XX-01
(Penerimaan
Mhs baru )
Order Processing
Litbang
SP-02
CP-02
RID-01
Umum
WI-XX-02
(Pembuatan
Kartu Tanda
Peserta Test)
Logistics
SP-03
QA, MR

reserved.
65

reserved.
66
Structure of quality management system and documentation

Sample 1
<Process >
< Procedure>
< W.I. >
ISO 9001 Quality Management System
Human resource
management process
Sales marketing process
Production
management process
Equipment control
procedure procedure
Purchasing
Production procedure
Inspection procedure
Purchasing information control

instruction
Supplier evaluation criteria
Products inspection criteria
Purchasing criteria
Inquiry, negotiation and
comparison of price
Design and research

process
Financial management
process

reserved.
67
Contoh
MATRIKS KORESPONDENSI "DOKUMENTASI - STANDARD"
No
Departemen/
Proses
Nama
Dok.
No
Dok.
Klausul ISO 9001

Prosedu
Regulasi
r

reserved.
68
5
Leadership
Clause 5 - ISO 9001:2015

reserved.
5.1. Leadership and

commitment
Leadership and
commitment for the
quality management
system
Customer focus
5. Leadership
5.2. Quality policy
5.3. Organizational
roles,
responsibilities and
authorities

reserved.
70
5.1 LEADERSHIP & COMMITMENT

reserved.
71
FOKUS KE PELANGGAN
Persyaratan pelanggan dan peraturan
yang berlaku telah ditetapkan, dipahami
dan dipenuhi secara konsisten
Top manajemen
harus menjamin:
Resiko dan peluang yang dapat

berakibat pada pelayanan & produk
serta kemampuan untuk untuk
meningkatkan kepuasan pelanggan
telah ditetapkan
Fokus untuk meningkatkan kepuasan
pelanggan selalu dipelihara/dijaga
reserved.
72
5.2 Kebijakan Mutu

reserved.
73
5.3. PERANAN ORGANISASI, TANGGUNG JAWAB

DAN WEWENANG

reserved.
74
6
Planning
Clause 6 - ISO 9001:2015

reserved.
Clause 6: Planning for the QMS

6.1. Actions to address risks and opportunities
6.2. Quality objectives and planning to achieve
them
6.3. Planning of changes
4.1
Issues
6.1
Determine risks and opportunities
9.2
6.1
Plan actions to address risks and opportunities

reserved.
76
One can slice and dice these multiple

dimensions of risk*
Equity Risk
Market Risk
Credit Risk
Specific
Risk
Trading Risk
Interest Rate Risk

Currency Risk
Gap Risk
General
Market
Risk
Commodity Risk
Operational
Risk
Risks
Reputational
Risk
Business and
strategic risks
Counterparty
Risk
Transaction Risk
Issuer Risk
Portfolio
Concentration
Risk

reserved.
Issue Risk
77
Threat map

reserved.
78
Business Risk Assessment Process
Identify
Risk
Understand
and analyse
the business
Focus on
strategic
issues
Assessment
of Controls
Business
Management
Assess
business
risk
Assess
implemented
risk control
Strategy
Planning
Implementation
Monitoring
Improvement
Prioritising
of critical
risk
Improved
internal
control
Assessment
of Risk

reserved.
Managed
Business
79
Risk context, assessment and treatment

Relevant
Issues
(from
context)
red = -ve
green =
+ve
Risk
Identification
Risk Analysis
Risk
Evaluation
Impact significant
but likelihood
unknown (high
uncertainty)
Unable to
qualify as
likelihood
unknown
Risk Treatment
Residual risk
Subscribe to Economic
indicators service for
horizon scanning
economic conditions and
global trends
Unknown
pending horizon
scan. Re-evaluate
on report receipt.
Tolerate risk.
Transfer
emergency funds
to holding
company
Neighbourh
ood
disruption in
street
cabling
New fibre
technology
available
Workforce
retention
Share
holders:
Stock
market
crash
Economic
Significant
effect on profit
objectives and
liquidity if
share price
collapses

reserved.
80
SAMPLE - LIST OF RISK ITEMS

Design Engineering Risks
Procurement Risks
HSE Risks
FEED Docs in ITB Docs are not RFQ & RFP documents are HSE Project Plan
detail and incomplete additional not clear such as : Scope of Implementation. High
some procentage for Bill of
Supply, Data Sheet, Bill of
standard will impact to
Quantity calculation may
Quantity, Specification, Test project cost and schedule
required.
Witness, Chemical
/Oil/Grease Supply, Spare
Part For Commissioning & 2
Years Operations, engineering
document should be supply,
Fabrication Schedule,
Packaging Specification,
General Condition, etc are not
clear.
Plot Plan, P&ID, One Line
Diagram & Hazardous Area
Change
Critical Items and Very tight

Schedule that need special
attentions
Inaccurate assumptions on
technical issues in planning
stage
Surveys incomplete
Increase in material cost due Environmental analysis

to market forces
(AMDAL) incomplete
Project Management Risks
Organizational
Risks
Project purpose and need is not Inexperienced staff Refer To Legal

well-defined
assigned
Analysis on Draft of
Contract from Legal
Department or Refer
to Analysis from
Contract Engineer
Risk Register and Risk

Project scope, schedule,
Losing critical staff
Management Execution are objectives, cost, and deliverables at crucial time of
not well done since
are not clearly defined or
the project
Engineering Design Stage. understood
Unreasonably high expectations Insufficient time to
from stakeholders
plan
Political Situation is unstable, Environmental regulation or Vendor or contractor delays

War, Riot, Embargo
local regulation is not Clear
or Changed
Changes to Capacity, Materials Economic is Unstable,
Construction Waste
Estimating and/or scheduling
or Specification
Depression, Inflasion,
Treatment Availability
errors
Currency Rate is unstable, Oil
Price is unstable or increase.
SIL, HAZID & HAZOP Study
Disaster, Climate, High/Low Availability of project data Unplanned work that must be
have potensial to add more
Tide and Other Nature
and mapping at the
accommodated
materials, instrument &
Conditions.
beginning of the
equipments.
environmental study is
insufficient
Basic Engineering Design Data Massive Development or
New information after
Lack of
& Detail Engineering Design
Massive Construction in some Environmental Document is coordination/communication
Data are wrong.
country or Province that
completed may require rerequires a lot of Cosntruction evaluation or a new
materials
document (i.e. utility
relocation beyond
document coverage)
Unanticipated
project manager
workload
Internal red tape
causes delay
getting approvals,
decisions
Functional units
not available,
overloaded
P&ID and Plot Plan Review

Meeting are not so carefully
Overlapping of one
or more projects
Loading & Unloading and

Transportation Plan which
Terms &
Conditions
Contract Risks
New
alternatives
required
support
Copyright
2015
BSI. All Underestimated
rights
toreserved.
avoid, mitigate or
resources or overly optimistic
Lack of specialized
staff or Skilled MP
resources are
limited.
81

reserved.
82

reserved.
83

reserved.
84
The FMEA Form
Identify failure modes

and their effects
Identify causes of the

failure modes
and controls

reserved.
A Closer Look
Prioritize
Determine and assess

actions
85
Workshop 3
Risk Management
45 minutes
Click here to
start

reserved.
86
6.2. Quality objectives and

planning to achieve them

reserved.
87
Objective and Effort of the whole

institution
Current
Current
Situation
Situation
Risk
Analysis
progressing
Risk A
Objectives A
Risk B
Objectives B
Risk C
Objectives C
Future
Future
Situation
Situation
Vision
Mission
Institusional
objectives
Performance
indicators
reserved.
88
6.3. Planning of Changes

Planning/implementing QMS changes (6.3),
Controlling operational changes, planned and
unintentional (8.1)
Addressing unplanned changes affecting products &
services (8.5.6)
See also 7.1.6 Organizational knowledge - for
addressing changing needs and trends, with respect
to knowledge

reserved.
89
7
Resources
Clause 7 - ISO 9001:2015

reserved.
Clause 7: Support
7.1 Resources
Determine and provide the necessary resources

including people, infrastructure, operational processes,
and knowledge
7.2 Competence
Identify and maintain competence
7.3 Awareness
Make objectives known, and ensure awareness of QMS
7.4 Communication
What, when, how, who, and to whom
7.5 Documented information
Reflects variety of sources and need to back up

information
reserved.
91
7.1. Sumber daya /

Resources
7.1.1. Organisasi harus menetapkan
dan menyediakan sumber daya yang
diperlukan
7.1.2 Sumber
Daya Manusia
organisasi harus
menyediakan orang-orang
yang diperlukan untuk
efektifitas operasi dari
sistem manajemen mutu,
termasuk proses yang
diperlukan.
7.1.3
Infrastruktur
Organisasi harus menetapkan,

menyediakan dan memelihara
infrastruktur untuk operasi dari
proses dalam mencapai
kesesuaian produk dan jasa.
Infrastruktur dapat mencakup:
bangunan dan utilitas
terkait;
peralatan termasuk
perangkat keras dan
perangkat lunak;
transportasi;
teknologi informasi dan
komunikasi.
reserved.
7.1.4 Lingkungan
Kerja
Organisasi harus
menetapkan,
menyediakan dan
memelihara lingkungan
operasi dari proses untuk
mencapai kesesuaian
produk dan jasa.
Lingkungan dapat mencakup
fisik, sosial, psikologis,
lingkungan dan faktor
lainnya (seperti suhu,
kelembaban, ergonomi dan
kebersihan
92
7.1.5 Monitoring and measuring resources

Dimana pemantauan atau pengukuran yang digunakan untuk bukti
kesesuaian produk dan jasa dengan persyaratan yang ditentukan, organisasi
harus menentukan sumber daya yang dibutuhkan untuk memastikan
kevalidan dan kehandalan dari hasil pemantauan dan pengukuran.
Organisasi harus memastikan bahwa sumber daya yang disediakan:
cocok untuk jenis tertentu kegiatan pemantauan dan pengukuran yang
dilakukan;
dipelihara untuk memastikan kesesuaian tujuan mereka.
These need to be determined/provided to ensure valid and reliable

results. Controls will include: suitable resources, maintenance,
documented information, measurement traceability (if required)
including: verification, calibration status, adjustment safeguards, and
appropriate corrective action on equipment malfunction.

reserved.
93
7.1.6. Organisational Knowledge

Defined as available collection of information (meaningful data
facts about an object) being a justified belief and having a high
certainty to be true.
This can include information such as intellectual property and
lessons learned.
The requirement here is to determine, maintain and make
available (extent necessary) the knowledge necessary for the
operation of its processes, AND to achieve conformity of products
and services.
Knowledge necessary to address changing needs and trends will
also need considering, and how to acquire or access any
additional knowledge necessary.
Sources: (Internal) learning from failure/success, capturing
knowledge of experts, etc. (External) academia, standards,
conferences, customers, external providers etc.
reserved.
94
Other support
Kompetensi (7.2)
Organisasi harus:
menentukan kompetensi yang
diperlukan untuk orang (s) yg.
melakukan pekerjaan di bawah
kendalinya dapat mempengaruhi
kinerja mutu;
memastikan bahwa orang-orang ini
kompeten atas dasar pendidikan,
pelatihan, atau pengalaman;
di mana berlaku, mengambil tindakan
untuk memperoleh kompetensi yang
diperlukan, dan mengevaluasi
efektivitas tindakan yang diambil;
menyimpan informasi terdokumentasi
sebagai bukti kompetensi.
CATATAN tindakan Berlaku dapat meliputi,
misalnya, penyediaan pelatihan, mentoring,
atau re-assigment orang saat ini bekerja;
atau mempekerjakan / mengontrak orang
yang kompeten.
Kepedulian (7.3)
Komunikasi (7.4)
Orang yang
melakukan
pekerjaan di bawah
kendali organisasi
harus peduli
terhadap:
Organisasi harus menetapkan

komunikasi internal dan
eksternal yang relevan
dengan sistem manajemen
mutu termasuk:
pada apa yang akan
dikomunikasikan;
kapan berkomunikasi;
dengan siapa
berkomunikasi;
bagaimana berkomunikasi.
kebijakan mutu;
sasaran mutu yang
relevan;
kontribusi mereka
terhadap efektivitas
SMM, termasuk
manfaat dari
peningkatan kinerja
mutu;
implikasi
ketidaksesuaian
persyaratan sistem
manajemen mutu

reserved.
95
7.5. Documented Information

reserved.
96
Pengendalian dokumen
menyetujui dokumen akan kecukupannya sebelum diterbitkan,
meninjau dan memperbaharui seperlunya dan menyetujui ulang
dokumen,
memastikan perubahan dan status revisi terkini,
versi relevan dari dokumen yang berlaku tersedia di tempat
pemakaian,
dapat dibaca dan mudah dikenali,
Pengendalian dokumen yang berasal dari
luar
mencegah pemakaian tak disengaja dari dokumen obsolete
(kadaluarsa)

reserved.
97

Pengendalian Rekaman
Identifikasi rekaman
Cara penyimpanan
Cara perlindungan
Cara pengambilan
Masa retensi
Cara pembuangan rekaman.
Rekaman harus terbaca, dapat dikenali dan mudah
ditemukan.
98
1/20/17
reserved.
98
Workshop 4
Documentation
30 minutes
Click here to
start

reserved.
99
8
Operational
Clause 8 - ISO 9001:2015

reserved.
Clause 8: Operation
Operational planning
and control
Requirements for products and
services
Design and development of products
and services
Control of externally provided products and
services
Production and service
provision, including
release
Control of nonconforming
process
reserved.
10
1
8.1. Operational
planning and control
8.1 Perencanaan dan Pengendalian Operasional
Merencanakan, menerapkan
dan mengendalikan proses
realisasi produk.
Perencanaan realisasi
produk harus taat azas
dengan persyaratan
Menetapkan :
Kriteria proses
Kriteria keberterimaan produk dan

pelayanan
kebutuhan sumber daya
Pengendalian proses antara lain aktifitas

verifikasi, validasi, monitoring,
measurement inspeksi dan test yang
diperlukan spesifik teradap produk dan
kriteria keberterimaan produk;
Informasi dokumen yang diperlukan

termasuk rekaman diperlukan untuk
menyediakan bukti bahwa proses-proses
realisasi dan produk yang dihasilkan
memenuhi persyaratan
Pengendalian perubahan
Pengendalian outsource

reserved.
10
2
8.2. Requirement for product and

Services

reserved.
10
3

Services

reserved.
10
4

Services

reserved.
10
5
8.3. Design & Development

8.3.3. MASUKAN DISAIN &
PENGEMBANGAN
Persyaratan Pelanggan &
Pasar
Peraturan
Disain sebelumnya
Sumber daya (material,
peralatan, Skill yang
diminta, Evaluasi &
pemeriksaan)
8.3.4. PENGENDALIAN
DISAIN &
PENGEMBANGAN
Evaluasi kemampuan
pemenuhan persyaratan
VERIFIKASI (Self-checking,
Pemeriksaan oleh
personel/Team yang
independent , Metode
pembanding (Kalkulasi atau
evaluasi design yang serupa),
Test, simulasi atau uji coba
8.3.2. PERENCANAAN
DISAIN &
PENGEMBANGAN
VALIDASI, Memastikan
sesuai dengan keinginan
Tahapan proses
Identifikasi masalah dan

tindak lanjut
tinjauan, verifikasi &

validasi untuk setiap desain
8.3.5. KELUARAN DISAIN &

PENGEMBANGAN
Sesuai Masukan
Dapat diproses secara efektif
dan efesien
8.3.6. . PENGENDALIAN PERUBAHAN

Identifikasi
Pengendalian dokumen terkait
tanggung jawab &

wewenang
Informasi harus akurat & benar

Komunikasi yang efektif
komunikasi dengan bagian

terkait
Perubahan harus diverifikasi dan validasi

reserved.
10
6
8.4. Control of externally provided products and

services

reserved.
10
7

services

reserved.
10
8

services

reserved.
10
9
8.5.1. Pengendalian penyediaan produk dan

pelayanan

reserved.
11
0
Workshop 5
Process Identification
30 minutes
Click here to
start

reserved.
11
1
8.5.2. Identifikasi & Mampu Telusur
Organisasi harus:
identifikasi produk dengan cara sesuai diseluruh
realisasi produk , jika diperlukan
identifikasi status produk berkaitan dengan persyaratan
pengukuran dan pemantauan
mengendalikan dan merekam identifikasi khas dari
produk, bila mampu telusur dipersyaratkan

reserved.
11
2
8.5.3. property belonging to Customers or External

providers
harus:
diidentifikasi
diverifikasi
dilindungi dan dijaga
milik pelanggan atau provider eksternal yang hilang, rusak atau
karena suatu hal tak layak pakai harus direkam dan dilaporkan
Property mencakup intelektual property

reserved.
11
3
8.5.4. Preservasi
Preservasi kesesuaian produk selama proses internal dan

penyerahan
Mencakup:
identifikasi
penanganan
pengemasan
penyimpanan
perlindungan
bagian-bagian yang menjadikan produk

reserved.
11
4
8.5.5. Post Delivery Activities

reserved.
11
5
8.5.6. Control of Changes

reserved.
11
6
8.6. Release of Product and Services

reserved.
11
7
8.7. Control of NonConforming

Output

reserved.
11
8
9
Performance Evaluation
Clause 9 - ISO 9001:2015

reserved.
Clause 9 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation
What needs to be monitored and measured, how and when
9.2 Internal audit
To establish whether the QMS conforms to requirements

and is effectively implemented and maintained
9.3 Management review
Top management must regularly review the QMS

reserved.
12
0

9.1. Monitoring,
measurement, analysis and
evaluation
What needs to be monitored and measured,

how and when
9.1.3
(Analysis and
evaluation)
9.1.2
(Customer
satisfaction)
9.1.1
(General)

reserved.
12
1
9.1.2. Customer
Satisfaction
UNANTICIPATED
DESIRED
EXPECTED
BASIC
Standar minimun
yg diterima
Nilai rata-rata
(sama seperti
jasa lainnya)
Apa yang
diinginkan
pelanggan
Melebihi apa
yang
diinginkan
pelanggan
Faktor Kepuasan
Faktor loyalitas pelanggan
reserved.
12
2

9.2. Internal Audit
To establish whether the QMS conforms to
requirements and is effectively implemented and
maintained
At
Atplanned
planned
intervals
intervals
(status
(statusand
and
importance)
importance)
Ensure
Ensure
system
system
conforms
conformsto
to
planned
planned
arrangement
arrangement
ss
Ensure
Ensure
system
system
conforms
conformsto
to
ISO
9001
ISO 9001
Effectively
Effectively
implement
implement
ed
edand
and
maintained
maintained
Follow-up
Follow-up
actions
actions
Audit
Auditcriteria,
criteria,scope,
scope,frequency,
frequency,methods
methodsdefined
definedin
indocumented
documented
information
information

reserved.
12
3
9.3. Management Review
Sistem harus ditinjau oleh top managemen :

dalam interval yang direncanakan
untuk menjamin berlanjutnya kesesuaian, kecukupan dan
keefektivan
untuk menilai kesempatan untuk peningkatan dan
kebutuhan untuk perubahan sistem, kebijakan dan sasaran
mutu

reserved.
12
4
Management Review
WHAT NEEDS
TO CHANGE?
CONSIDER:
Previous actions/
status
External/
internal issues
Opportunities (C.I)
N/Cs,
corrective actions
Monitoring/
Measurement
REVIEW
REVIEW
Changes to QMS
Audit results
Customer satisfaction
External providers
Adequacy of
resources
Resource needs
Process performance
Risks and
opportunities
Continual
improvement (C.I)
Doc. Information

reserved.
12
5
1
0
Improvement
Clause 10- ISO 9001:2015

reserved.
Clause 10: Improvement

Improvement
Nonconformity and
corrective action
Continual improvement

reserved.
12
7
Improvement

reserved.
12
8
What to
evaluate ?
Policy
Critical Success
Factor
How to
evaluate ?
Data collected
Analyze
Responsibility
Measurement
Frequency
Program
Method
Action
Corrective
Correction
Improvement
reserved.
12
9
Nonconformity and corrective

action

reserved.
13
0
QUALITY PROBLEM
CORRECTIVE ACTION
Operational Cost
Coordination between function
Customer satisfaction Result
Caused identification
Non conformity
Analysis & corrective action plan
Performance
Follow up
Health & Safety
Implementation monitoring,
efficiency and evaluation on its
effectiveness
PREVENTIVE ACTIONS
POTENTIAL
Caused identification
PROBLEMS
Analysis & preventive action plan

Implementation
Implementation monitoring,
efficiency and evaluation on its
effectiveness (Management Review)
reserved.
CONTINUAL
IMPROVEMENT
13
1

reserved.
13
2
Review and Final Questions

reserved.
13
3

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British Standard Institution Learning Academy

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Dewi Almitra Sari

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Solution & Result...

The Need for

14.00 Module 6 : Planning and workshop 3

Continued with module 6

End of Day 1 course

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Continued with module 8 and workshop 5

Module 9 : performance Evaluation

16.00 Module 10 : Improvement

Copyright 2015 BSI. All rights

Copyright 2015 BSI. All rights

British Standard Institution

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The UK National Standards Body: The source of British Standards

Specialist Focus on Standards Creation, Training and Certification

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BSIs end-to-end solutions make excellence a habit

Our tutors transfer

Our assessors give

We support you with

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BSI Standards World Standards

ISO 9001 (Quality Management)

ISO 14001 (Environmental Management)

ISO/IEC 27001 (Information Security)

OHSAS 18001 / AS/NZS 4801 (Occupational Health & Safety)

ISO 10002 (Customer Satisfaction)

ISO/IEC 20000 (IT Service Management)

ISO/TS 16949 (Automotive)

ISO 50001 (Energy Management)

ISO 22301 (Business Continuity)

ISO 20121 (Sustainable Events)

Copyright 2015 BSI. All rights

Copyright 2015 BSI. All rights

Apa itu Mutu?

Mutu berarti kepuasan pelanggan

Mutu berarti kesesuaian terhadap

Mutu berarti kesesuaian dengan

Memenuhi dan melebihi harapan dan

Copyright 2015 BSI. All rights

Evolusi Sistem Manajemen Mutu

ZERO DEFECT CONTINUOSLY &

CUSTOMERS SATISFCATION CONSISTENTLY

Non Quality Culture

Copyright 2015 BSI. All rights

comprehensive portfolios ensure your corporate reputation remains

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Key terms and definitions

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Terms and Definitions

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manajemen yang meliputi struktur

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VISI & MISI

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