AWARENESS FOR :

QMS ISO 9001 : 2015,

EMS ISO 14001 : 2015,
OHS MS ISO 45001 : 2018,
RISK MS ISO 31000 : 2018

1
SKILL & PROFIENCY :
Agustin Nugrahesti (H-E-S-T-I)
Environmental Engineer, Bachelor Degree (S.T) and
Master of Engineer, Gadjah Mada University Master Degree (M. Eng)

ISO/TS 16949 Automotive Management System, Advanced

ISO 9001 Quality Management System, Advanced

ISO 14001 Environmental Management System, Advanced

OHSAS 18001 Safety Health Management System, Advanced

ISO 45001 Occupational Health & Safety Management System

ISO 37001 Anti Bribery Management System, Awareness

Conoco Phillips Project at Suban Palembang & Matak, Natuna

Alkana Co Ltd. Vietnam and Malaysia

QHSE Objective Strategy & KPI set-up, Advanced

Sony Green Partner & Green Services System, Advanced

Restriction of Hazardous Substance RoHS, Advanced

Integrated Management System Implementation, Advanced

Waste Water Treatment Process & Plant, Advanced

Housekeeping & Safety

Emergency Exits

Evacuation Procedures

Start/Finish/Break

Dietary & Medical

Toilets & Facilities

Mobile Phones

Other Issues
 5
Let’s get started

Get Ready! Introductions

Materials Mobiles & Email

Breaks Facilities
 Perkenalan

Perkenalkan diri Saudara dengan menyebutkan :

 Nama lengkap & panggilan

 Pekerjaan / Background pendidikan
 Ekspektasi harapan mengikuti pelatihan
 Buku bacaan yang sedang dibaca / disukai
 Tujuan Pelatihan
1. Peserta seminar mengenal konsep dasar Sistem
Manajemen Mutu ISO 9001:2015 & ISO 31000

2. Peserta seminar mengenal konsep dasar Sistem

Manajemen Lingkungan ISO 14001:2015.

3. Peserta seminar mengenal konsep dasar Sistem Manajemen

Keselamatan & Kesehatan Kerja ISO 45001:2018

4. Peserta mengenal konsep Sistem Manajemen Mutu (Q),

Sistem Manajemen Lingkungan (E), Sistem Manajemen
Keselamatan & Kesehatan Kerja secara terintegrasi.
 8

Benefit of an IMS – Drivers for Change

COMMUNITY COMMERCIAL INCREASED

ATTITUDE ADVANTAGE REGULATORY
REQUIREMENTS

COST SAVINGS CORPORATE IMAGE

ISO 9001, ISO 14001 & ISO 45001 –
Manfaat Integrasi

• Mengurangi duplikasi
• Mengurangi potensi konflik antara sistem yang berbeda.
• Meningkatkan pemahaman akan persyaratan.

Sistem
Sistem
Manajemen Manajemen Sistem
Manajemen K3
Lingkungan Mutu

Integrated QHSE
 MATRIX
CORRELATION
INTEGRATED MANAGEMENT
SYSTEM
Format Stuktur Klausul Baru Sistem Manajemen
ISO 9001, 14001, 45001 vs ISO 31000:2018
Salah satu perubahan besar dalam versi baru ISO 9001: 2015,
ISO 14001:2015, ISO 45001:2018 adalah strukturnya disebut
Struktur Tingkat Tinggi (High Level Structure).
Sekarang ada 10 bagian (bukan 8) di Standar;
Persyaratan itu sendiri diatur dalam Bagian 4 - 10

− Bagian 1 - Ruang Lingkup − Bagian 6 – Perencanaan

− Bagian 2 - Acuan Normatif
− Bagian 3 - Istilah Definisi
− Bagian 4 - Konteks Organisasi
− Bagian 5 - Kepemimpinan
− Bagian 7 - Dukungan
− Bagian 8 - Operasional
− Bagian 9 - Evaluasi Kinerja
− Bagian 10 - Perbaikan
− Lampiran A dan B
QMS ISO 9001:2015

QMS ISO 9001:2015

QUALITY MANAGEMENT SYSTEM / EMS 9001 : 2015
 Kerangka Manajemen Mutu ISO 9001:2015

“Some things change and

some remain the same”

Persyaratan Baru
• Pemahaman terhadap konteks bisnis organisasi (Clause 4)
• Mengelola risiko dan peluang (Clause 6.1)
• Mengendalikan lingkungan untuk operasi dari proses (Clause
7.1.4)
• Mengelola pengetahuan organisasi (Clause 7.1.6)
• Mengendalikan layanan penyedia eksternal - produk, layanan,
dan proses (Clause 8.4)
Quality Management Systems
A Quality Management System is defined as:
“Co-ordinated activities to direct and control an
organisation with regard to quality.”

Ref: ISO 9000

18
What is Quality?
“The totality of characteristics of an entity that bear on it’s ability to
satisfy stated and implied needs”
“Degree to which a set of inherent characteristics fulfils requirements”
ISO 9000
“Conformance to requirements”
Crosby
“Fitness for use”
Joe Juran

19
 Benefits of a Quality
Management System

• There are benefits for:

• The organisation
• The organisation’s employees
• The organisation’s customers and other interested parties

20
 Evolution of the Standard

1994
2000

Revision
1987 History

2008
5th
Edition
2015

21
 High Level Structure
Organisations implementing multiple management systems
(e.g. quality, environmental, information security) can
achieve better integration and easier implementation

• A new common format has been developed for use in all

management system standards:
• standardised core text and structure for multiple ISO
management systems for integration
• standardised core definitions

The high level structure and common text is public information and can be found in
Annex SL of the www.iso.org/directives

22
Annex SL – How it works

Annex SL
Discipline Discipline
Common
Specific Specific
Structure
Standard Standard
Terms and
(ISO9001) (ISO14001)
Text

Discipline
Specific
Standard
(ISO45001)

23
 2015
– Anne
xA
ISO 9001:2015 – Annex A
• Structure and terminology
• Products and services
• Understanding the needs and expectations of interested parties
• Risk-based thinking
• Applicability
• Documented information
• Organisational knowledge
• Control of externally provided processes products and services

24
 2015
0.3.1 Process Approach – S ec t
ion 0
.3

25
 Plan-Do-Check-Act Cycle

6 5
9

4 10

26
27
DEFINISI – MUTU

*) 3.1.1 iso 9001:2015 QMS

Fundamental dan Vocabulary

“ Tingkat sejauhmana suatu set karakteristik

bawaan memenuhi persyaratan-persyaratan “ *)

Struktur Seri ISO 9000

ISO 9000 - Dasar-dasar dan Kosakata

ISO 9001 - Persyaratan

ISO 9004 - Petunjuk untuk Peningkatan

Kinerja 28
 ACTIVITYY GROUP :
DEFINISI – RANTAI PASOKAN

Pemasok, Kriteria
Interested parties
(External PROSES (stakeholder, customer,
Provision) (video) government, etc)

INPUT OUTPUT

Setiap kali muncul istilah Produk ini berarti juga Jasa/Pelayanan.

PRODUK : Hasil yang diinginkan dari suatu proses realisasi atau Hasil
yang diminta Pelanggan.
PROSES : Satu set aktifitas yang berinteraksi atau berhubungan yang
merubah bentuk masukan menjadi keluaran.
Aktifitas ini akan memerlukan alokasi sumber daya.

Sistem adalah,,,,,Proses adalah,,,,,Aktivitas

29
 5 GROUP WORKSHOP PUBLIC

Group 1 : HOTEL / Penginapan

Group 2 : TIKETING / TRAVEL AGENT

Group 3 : BENGKEL Mobil / Motor

Group 4 : RESTORAN / Café / Rumah Makan

Group 5 : ZOO / Dunia Fantasi / Taman Safari

PROCESS MODEL EXAMPLE (PEMETAAN BISNIS
PROSES)

MANAGEMENT
STRATEGIC PLANNING COMPLIANCE MANAGEMENT
PROCESSES

CORE
SALES SCHEDULING DELIVERY INVOICING PROCESSES

HUMAN RESOURCE MANAGEMENT FINANCIAL MANAGEMENT

SUPPORT
PROCESSES
INFRASTRUCTURE MANAGEMENT FACILITIES MANAGEMENT
 PDCA
PLAN DO CHECK ACT
Sections

 
  PLAN DO CHECK ACT
Clauses

       

       

33
EMS ISO 14001:2015

EMS ISO
14001:2015
ENVIRONMENTAL MANAGEMENT SYSTEM / EMS 14001 : 2015
 35
ISO Series of International
Standards
SAGE formed six sub-groups who extended their
brief of evaluating the need for standards, and began
drafting standards.

The six sub-group areas were:

• Environmental Management System
• Environmental Auditing
• Environmental Labelling
• Environmental Performance Evaluation
• Life Cycle Assessment
• Environmental Aspects in Product Standards
 36

The
ISO14001:2015
Model
 37

Ikhtisar dari ISO14001:2015

• Standards seri ISO14000
• Sistem Manajemen Lingkungan
• Tinjauan Lingkungan Awal ( Pemetaan Awal)
Environmental Management 38

System Structure
and Integration
Clausul 7.5 Informasi Terdokumentasi
maintain means : dipelihara
“maintain” documented information :
“retain” documented information

retain means disimpan atau dipertahankan

 ISO 45001:2018 – kini diterbitkan

• Diterbitkan oleh ISO pada tanggal 12 Maret 2018

• Standar tersebut sudah tersdia dan dapat dibeli di SAI Global InfoStore

Standar Internasional pertama untuk sistem manajemen Kesehatan dan

Keselamatan Kerja telah diterbitkan. Standar tersebut dikembangkan untuk
mengatasi peningkatan jumlah cedera, sakit, dan kematian yang berkaitan
dengan pekerjaan di seluruh dunia.
OHMS ISO 45001:2015

OHS MS ISO 45001:2018

OCCUPATIONAL HEALTH & SAFETY
MANAGEMENT SYSTEM
 Benefits of an OHSMS

• An effective OHSMS enables an organisation to:

• Evaluate how well they are meeting compliance

obligations

• Protect workers’ health and safety

• Assist with the strategic direction of the organisation

• Continually improve OHS performance

• Improve commercial advantage

 ISO 45001 - Prinsip Dasar

• Hasil yang Diinginkan:

o Peningkatan terus menerus terhadap kinerja K3
o Pemenuhan persyaratan hukum dan persyaratan lainnya
o Pencapaian sasaran K3
o Hal yang Penting – Model Plan, Do, Check, and Act (Rencanakan,
Kerjakan, Cek, dan Tindak lanjuti)

“ 23% responden menyatakan bahwa 2 faktor teratas yang

memengaruhi pelatihan mengenai migrasi adalah sumber daya
” terhadap standar tersebut
internal; dan pemahaman
Mengapa Menggunakan ISO 45001?

• Integrasi – Manfaat
• Penerapan internasional -
lintas lokasi dan rantai pasok
• Dikenali secara global
• Dapat diterapkan untuk
organisasi apa saja
Menurut ILO, terdapat 2,34 juta kematian pada tahun
2013 yang diakibatkan oleh aktivitas pekerjaan
 Langkah-Langkah untuk Sertifikasi

Tidak perlu panik! Periode migrasi

1. Pahami perubahan dan area fokus yang baru

2. Edukasi Tim Manajemen Puncak Anda dan pihak yang relevan lainnya

3. Analisis Kesenjangan / Gap Analysis dan Rencana Tindakan

4. Hubungi Badan Sertifikasi

1 Pahami Perubahan dan
Area Fokus yang Baru

• Kepemimpinan
• Pemikiran berbasis risiko
• Konsultasi dan partisipasi pekerja
• Pekerja dan pihak yang terkait
 Health Hazards
• Chemical
• inks & paints (irritants)
• solvents (asthma)
• oils & lubricants (skin diseases)
• Physical
• radiation (cancer)
• noise (hearing loss)
• drills (vibration white finger)
• Ergonomic
• poor posture (back pain)
• repetitive work (WRULD)
• poor lighting (eye sight)
• Biological
• bacteria (infections)
• moulds, yeast & fungi (asthma)
• viruses (infections)
• Psycho-social
• work/life balance (stress)
• family problems (alcohol abuse)
• lifestyle (smoking)
52
 Safety Hazards
• Chemical • Biological
• spills (slips & trips) • loss of containment
• splashes (burns) (infection)
• fumes (eye injuries) • air conditioning (Legionella)
• Physical • human to human and
indirect transmission
• electricity (electrocution) (infection)
• machinery (entrapment)
• trailing leads (slips & trips)
• Psycho-social
• losing concentration
through fatigue (ignoring
key controls)
• Ergonomic
• overstretching (falls) • working with public
(violence)
• awkward postures (musculoskeletal)
• twisting & dropping loads (fractures) 53
 Typical Risk Assessment Steps
ISO 31000 & ISO 45001

01Identify the hazards

02 Identify the people at risk

03 Assess the risks (quantify/qualify)

04 Evaluate the control measures

05 Record and review when required

54
 55

Pengenalan dan klausul 1 sampai 3

• Klausual 1: Ruang Lingkup – Menyediakan konteks & latar belakang

• Klausul 2: Referensi Normatif – Tidak ada referensi normative

• Klausul 3: Istilah dan Definisi

• Shall
• Should
• May
• Can
 Struktur dari Standar ISO 45001:2018
(dan Struktur Tingkat Tinggi dengan Annex SL)

1. Ruang Lingkup
2. Referensi Normatif
3. Istilah dan Definisi
4. Konteks Organisasi
5. Kepemimpina dan partisipasi pekerja
6. Perencanaan
7. Dukungan
8. Operasional
9. Evaluasi Kinerja
10. Peningkatan / Perbaikan
• Annex A 56
 57

An OHS Focused Process Approach

PEOPLE (WHO) MATERIALS, EQUIPMENT AND PHYSICAL
• Competence ENVIRONMENT (WHAT & WHERE)
• Skills • Defined & Approved
• Knowledge • Maintained & Tested
• Training • Hierarchy of control applied
• Aptitude/ability • Hardware/software
• Organizational culture
OUTPUTS
INPUTS Process Activities • Finished Goods or Services
• OHS Hazards or • Results
• Objectives
Tasks • Data
• Requirements • Unharmed workers
• Specifications • Suitably/acceptably
• Legal Requirements controlled hazards

METHODS (HOW) MEASURES (RESULTS)

• Risks Assessed • Defined & accurate
• Sequence Steps • Performance Trends
• Documentation (Maintained) • Audits
• Documentation (Retained) • Corrective Action

Turtle Diagram image adapted from ‘Process Auditing and Techniques – JP Russell Quality Progress, June 2008’
 PDCA Model

Context of the Planning

organisation (Clause 6) Scope OHSMS
(Clause 4.1) (Clause 4.3 & 4.4)
Plan
Needs &
Expectations
(Clause 4.2) Support
(Clause 7)
Leadership
Act and Worker Do
participation
Improvement (Clause 5) Operation
(Clause 10) (Clause 8)

Check
Performance
Evaluation
(Clause 9)
Reference adapted from ISO 45001:2018, Introduction 0.4

58
 Pemikiran Berbasis Risiko /
Risk Based Thinking

• Explicit requirement in ISO 45001:2018

• Clause 4: Determine the business risks which can affect ability
in OHS performance

• Clause 6: Plan how to address these risks and OHS risks

• Note: Annex A4 provides some additional insight into concept

59
 Introduction

• Risk: Effect of uncertainty

• Management: Using resources to achieve

required outcomes

• Risk Management: Being smart about making

decisions
 Risk Based Thinking

Ensures an organisation:
• Considers risk throughout all aspects of its operations

• Takes preventive action as part of strategic planning

“ Individuals think about

risk automatically or at a

subconscious level”
 Annex SL - Risk Requirements

Annex SL Provides a universal framework for all management system

standards.
Contains a number of elements dedicated to the subject of risk.
• Clause 4: Context of the Organisation
• Clause 6: Planning
Individual management system standards have incorporated
additional risk management requirements relevant to the scope of the
standard.
“ Risk management is a universal
theme across all disciplines and

standards”
 Risk Management Standards

• ISO 31000: Risk Management – Principles and Guidelines

• ISO/IEC 31010: Risk Assessment Techniques

• ISO Guide 73: Risk Management – Vocabulary

• ISO/TR 31004: Risk Management – Guidance for the

Implementation of ISO 31000
Structure of ISO 31000