Quality and Environmental Management System: ISO 9001 & ISO 14001

ISO 9001 & ISO 14001
Quality and Environmental

Management System
Public Surabaya
2014 October 13
PT TUV Rheinland Indonesia

2014
Outline 1-Days
Overview of ISO 9001 and 14001 New version
Somerset Hotel, October 13th, 2014
Time
Topic
Introduction to ISO 9001 and 14001 New version
09:00 10:00
Information about Annex XL

PDCA Cycle
Why it Change?
10.00 10.15
Coffee Break
10.15 12.00
Overview of ISO 9001:2015 (based on ISO DIS 9001:2014)

Main changes of ISO 9001:2015
Brief interpretation requirement of ISO 14001:2015
Plan, Do, Check and Action phase of requirement
12.00 13.00
Lunch Break
13.00 14.30
Overview of ISO 14001:2015 (based on ISO DIS 14001:2014)

Main changes of ISO 14001:2015
Brief interpretation requirement of ISO 14001:2015
Plan, Do, Check and Action phase of requirement
15.00 15.15
Coffee Break
15.15 16.30
Correlation between ISO 9001:2015 and ISO 14001:2015
16.30 17.00
Discussion (Question and Answer)
The schedule might change based on training condition,

Professional Training for Management and Technical Staff
F:\Outline 50001:2011
Overview ISO 9001 & ISO 14001
Overview
ISO 9001:2015* New version
and
ISO 14001:2015* New Version
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2014-1009
Agenda Pelatihan
Pengantar ISO 9001 dan 14001 versi 2015
Informasi tentang Annex XL
Siklus PDCA
Mengapa berubah? Sekilas tentang perubahan
Sekilas ISO 9001: 2015 (berdasarkan ISO DIS 9001: 2014)
Perubahan utama dari ISO 9001: 2015
Persyaratan interpretasi Singkat ISO 14001: 2015
Plan, Do, Check Action fase persyaratan
Sekilas ISO 14001: 2015 (berdasarkan ISO DIS 14001: 2014)
Perubahan utama dari ISO 14001: 2015
Persyaratan interpretasi Singkat ISO 14001: 2015
Plan, Do, Check Action fase persyaratan
Korelasi antara ISO 9001: 2015 dan ISO 14001: 2015
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Page 1
Pengantar ISO 9001 dan 14001 versi 2015
ISO 14001:2014 Environment Management Systems

Requirements with guidance for use
ISO 9001:2015 Quality management systems
requirement
Next for Heath and safety standard
OHSAS 18001:2007 ISO 45001:2016
2014-1009
ISO Standard
Kedepannya semua standard ISO mengadopsi Annex SL (Proposals
for management system standards )
Annex SL
High-level structure
Identical core text
Common terms and core definitions
P
D
C
A
Annex SL (High-level structure)

Introduction
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement
Appendix
Bibliography
2014-1009
10
4, 5
6, 7
Action Plan
Check Do
9
Page 2
Pertimbangan Perubahan Standard
Proses Peninjauan (Process Review) dari Komite Teknis

- Bertujuan untuk memastikan kesesuaian standard dengan perubahan dan
perkembangan industri.
- Diadakan minimum 5 Tahun sekali
Input dari System Users
- Hasil survey dan questionnaire (web-based 2010)
- Termasuk rekomendasi-rekomendasi yang diberikan oleh user dari hasil
interpretasi proses
Trend yang berlaku
- Untuk menyesuaikan dengan perkembangan dibidang management system
- Perkembangan pengetahuan dan teknologi
- Meningkatnya keragaman pengguna ISO 9001 and 14001
2014-10-09
Overview
Based on ISO/DIS 9001:2014
2014-1009
Page 3
Tujuan dari ISO 9001:2015
Untuk menyediakan kerangka kerja yang konsisten untuk 10

tahun ke depan
Untuk menjadi cukup generik, namun masih relevan untuk semua
jenis dan ukuran organisasi, terlepas dari industri atau sektor
mereka
Untuk tetap fokus pada proses manajemen yang efektif dalam
rangka mencapai hasil yang diinginkan
Untuk memperhitungkan perubahan implementasi QM dan
teknologi yang besar sejak revisi terakhir pada tahun 2000
2014-10-09
Tujuan dari ISO 9001:2015 (Lanjutan)
Untuk mencerminkan perubahan dalam kerja yang semakin

kompleks dan dinamis dalam lingkungan di mana organisasi
beroperasi
Untuk menerapkan struktur yang seragam, teks inti dan definisi
yang ditetapkan dalam Annex SL dari Petunjuk ISO (Struktur
Tingkat Tinggi) untuk memastikan kompatibilitas dengan sistem
manajemen ISO lain (misalnya ISO 14001)
Untuk mempermudah implementasi yang efektif dalam organisasi
Untuk menggunakan istilah istilah yang lebih sederhana untuk
memastikan pemahaman umum dan interpretasi yang konsisten
dari persyaratan
2014-10-09
Page 4
ISO 9001:2015 Timeline

2013
2014
2015
June 2013 CD
(Committee Draft)
April 2014 DIS

(Draft International
Standard)
July 2015 FDIS

(Final Draft International
Standard)
Plan :
September 2015
Published International
Standard
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ISO 9001:2015 Certification

Transition Timeline
2015
2016
2017
2018
September 2015
Published International
Standard
Plan :
September 2015 start of 3 years transition period
to September 2018
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Page 5
Perubahan yang signifikan pad ISO 9001:2015

a) untuk membuat standar yang lebih umum dan lebih mudah diterapkan
oleh industri jasa, contoh :
Istilah Product diganti dengan Product and services
b) Konteks organisasi
Dua Klausul baru berkaitan dengan organisasi 4.1 Understanding the
organization and its context and 4.2 Understanding the needs and
expectations of interested parties yang meminta organisasi untuk
menentukan isu-isu dan persyaratan yang dapat berdampak pada
perencanaan sistem manajemen mutu dan dapat digunakan sebagai masukan
ke dalam pengembangan sistem manajemen mutu
c. Process Approach (Pendekatan Proses)
Persyaratan mengenai Pendekatan proses dibuat lebih eksplisit dengan
adanya klausul 4.4.2 Process Approch
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Perubahan yang signifikan pad ISO 9001:2015

d) Risk and Preventive Action (resiko dan tindakan pencegahan)
Klausul mengenai preventive action (8.5.3) diganti dengan persyaratan
identifikasi resiko (klausul 4.1 dan 6.1) bertujuan agar konsep pencegahan
dalam pengembangan dan implementasi perdasarkan pemikiran dan
pendekatan resiko
e) Documented information (Informasi terdokumentasi)
Mengganti istilah dokumen dan rekaman dengan Documented information
(Informasi terdokumentasi)
f) Control of external provision of products and services
pada klausul 8.4 secara jelas meminta organisasi mengendalikan penyediaan
barang dan jasa dari luar perusahaan baik pembelian dari pemasok, melalui
kontrak dengan perusahaan rekanan, melalui outsourcing proses ataupun
dengan cara lainnya.
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Page 6
Contoh Perubahan lainnya

Manual mutu: Spesifikasi mengenai isi manual mutu tetap berlaku, tetapi tidak ada
persyaratan khusus mengenai itu. (sub pasal 4.4, sub-klausul 7.5).
Manajer mutu / MR: Persyaratan tetap ada tentang fungsi mereka, tetapi tidak
posisi mereka dalam perusahaan. MR tidak perlu lagi menjadi "anggota manajemen"
(sub-clause. 5.3).
Melaksanaan sasaran mutu : Dokumentasi sekarang diperlukan ketika

merencanakan bagaimana tujuan kualitas yang ingin dicapai (sub-klausul 6.2).
Risiko: Organisasi harus mengidentifikasi risiko yang dapat mempengaruhi

pencapaian produk dan proses. Perusahaan harus merencanakan langkah-langkah
untuk mengatasi risiko ini dan mengevaluasi efektivitas mereka (sub-klausul 6.1).
Outsourcing: sekarang menjadi lebih explisit dengan adanya klasusul 8.4 Control
of external provision of products and services
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Risk
3.09
risk
effect of uncertainty on an expected result
Note 1 to entry: An effect is a deviation from the expected positive or
negative.
Note 2 to entry: Uncertainty is the state, even partial, of deficiency of
information (3.50) related to, understanding or knowledge (3.53) of, an event,
its consequence, or likelihood.
Note 3 to entry: Risk is often characterized by reference to potential events
(ISO Guide 73:209, 3.5.1.3) and consequences (as defined in ISO Guide
73:2009, 3.6.1.3), or a combination of these.
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Page 7
ISO Requirement
ISO 9001:2008
1.
2.
3.
4.
5.
6.
7.
8.
Scope
Normative references
Terms and definitions
Quality Management System
Management Responsibility
Resource management
Product Realization
Measurement, Analysis
and Improvement
ISO/DIS 9001:2014
0.1 General
0.2 The ISO standards for quality management
0.4 Plan-Do-Check-Act cycle
0.5 Risk-based thinking
0.6 Compatibility with other management system standards
1. Scope
2. Normative references
5. Leadership
6. Planning
7. Support
8. Operation
10. Continual improvement
Annex A (informative) Clarification of new structure,
terminology and concepts
Annex B (informative) Quality management principles
Annex C (informative) The ISO 10000 portfolio of quality
management standards
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ISO/DIS 9001:2014 Requirement

1
2
3
4
Scope
7 Support
7.1 Resources
7.1.1 General
Context of the organization
7.1.2 People
4.1 Understanding the organization and its
7.1.3 Infrastructure
context
7.1.4 Environment for the operation of
4.2 Understanding the needs and expectations
processes
of Interested parties
7.1.5 Monitoring and measuring resources
4.3 Determining the scope of the quality
7.1.6 Organizational knowledge
management system
7.2 Competence
4.4 Quality management system and its
7.3 Awareness
processes
7.4 Communication
5 Leadership
7.5 Documented information
5.1 Leadership Commitment
7.5.1 General
5.2 Quality policy
7.5.2 Creating and updating
5.3 Organizational roles, responsibilities and
authorities
6 Planning for the quality management system
Next slide : clause 8,9,10
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
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Page 8
ISO/DIS 9001:2014 Requirement (Continued)

8 Operation
8.1 Operational planning and control
8.2 Determination of requirements for products and services
8.2.1 Customer communication
8.2.2 Determination of requirements related to products
and services
8.2.3 Review of requirements related to products and service
8.3 Design and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development Inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4 Control of externally provided products and services
8.4.1 General
8.4.2 Type and extent of control of external provision
8.4.3 Information for external providers
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and services
8.7 Control of nonconforming process outputs, products
and services
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9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
ISO Requirement (ISO/DIS 9001:2014)
Figure 1 - Model of a process-based quality

management system, showing the links to the
clauses of this International Standard
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Figure 2 - Schematic representation

of a single process within the
system
Page 9

ISO 9001:2015
ISO 9001:2008
ISO 9001 : 2008
ISO 9001 : 2015
1. scope
1. scope
2. Normative Reference
2. Normative Reference

Note : pengertian-pengertian dimasukan di
dalam standard (tidak hanya di ISO 9000:2005)
4. Quality Management Systems
4.1 General Requirement

context
4.2 Documentation Requirements
Tentang Documentasi ada di klausul 7.5

9001:2015
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of interested parties
management system
4.4 Quality management system

4.1 Understanding the organization and its context
The organization shall determine external and internal issues, that are relevant to its
purpose and its strategic direction and that affect its ability to achieve the intended
outcome(s) of its quality management system.
..
4.2 Understanding the needs and expectations of interested parties
The organization shall determine
a) the interested parties that are relevant to the quality management system, and
b) the requirements of these interested parties
..
4.3 Determining the scope of the quality management system
When determining this scope, the organization shall consider
a) the external and internal issues referred to in 4.1, and
b) the requirements referred to in 4.2
.
4.4 Quality management system
Same as 4.1 ISO 9001:2008
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Page 10
Organizational context
Contoh dari Klausul 4.1 Understanding the organization and its context
Purpose: Motor manufacturer
Intended outcome: Production of motorcycles
Internal issues
Quality
Automation
Workforce
Design secrets
Capacity
Company culture
Innovation
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External issues
Quality
Customers
Fashion
New markets
Deadlines
Competition
Regulators
Utilities
(Relevant) interested parties

Consumers
Employees
Owners/shareholders
Society
Regulator
Suppliers and partners
Definitions
Interested party
3.02 - person or organization (3.01)
that can affect, be affected by, or
perceive themselves to be affected by a decision or activity.
All parties
Interested parties
Relevant Interested parties
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Page 11

ISO 9001:2015
ISO 9001:2008
5. Management Responsibility
5. Leadership
5.1 Management commitment
5.1 Leadership and commitment
5.2 Customer focus
5.2 Policy
5.3 Quality policy
5.3 Organization roles, responsibilities and

authorities
5.4. Planning
6. Planning
5.6 Management Review
Management Reviewi ada di klausul 9.3

9001:2015
23
Komunikasi ada di klausul 7.4 9001:2015
5.5 Authorities, Responsibility and

communication
2014-10-09
6.2 Quality objectives and planning to achieve

them

ISO 9001 versi terbaru ini mengharapkan Top Management lebih
berperan dan berkomitmen dalam quality management system
Kutipan dari ISO/DIS 9001:2014 Klausul 5.1
5.1.1 Leadership and commitment for the quality management system
Top management shall demonstrate leadership and commitment with respect to the
quality management system by:
a) taking accountability of the effectiveness of the quality management system;
b) ensuring that the quality policy and quality objectives are established for the quality
management system and are compatible with the strategic direction and the context of
the organization;
c) ensuring that the quality policy is communicated, understood and applied within the
organization;
d) ensuring the integration of the quality management system requirements into the
organizations business processes;
e. promoting awareness of the process approach;
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Page 12
Kutipan dari ISO/DIS 9001:2014 Klausul 5.1

5.1.1 Leadership and commitment for the quality management system
e. ensuring that the resources needed for the quality management system are available;
f. communicating the importance of effective quality management and of conforming to
the quality management system requirements;
g. ensuring that the quality management system achieves its intended results;
h. engaging, directing and supporting persons to contribute to the effectiveness of
the quality management system;
i. promoting continual improvement;
j. supporting other relevant management roles to demonstrate their leadership as it
applies to their areas of responsibility.
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5.2 c) be available to relevant interested parties, as

appropriate.
5.3 Top management shall ensure that the
responsibilities and authorities for relevant roles are
assigned, communicated and understood within the
organization.
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Page 13

ISO 9001:2008
ISO 9001:2015
5. Management Responsibility
6. Planning
5.1 Management commitment
5.2 Customer focus

them
5.3 Quality policy
5.4. Planning
5.5 Authorities, Responsibility and
communication
5.6 Management Review
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ISO 9001:2015
6. Planning
Menambahkan identifikasi resiko sebagai persyaratan
6.1.1 When planning for the quality management system, the organization shall consider the
issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and
opportunities that need to be addressed to:
a) give assurance that the quality management system can achieve its intended result(s);
b) prevent, or reduce, undesired effects;
c) achieve continual improvement.
6.1.2 The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
1. integrate and implement the actions into its quality management system processes (see
4.4);
2. evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities shall be proportionate to the potential impact on
the conformity of products and services.
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ISO 9001:2015
6. Planning
Klausul 5.4.1 dan 5.4.2 ISO 9001:2008
6.2.1 The organization shall establish quality objectives at relevant functions, levels and
processes.
The quality objectives shall:
be consistent with the quality policy, be measurable; take into account applicable requirements;
be relevant to conformity of products and services and the enhancement of customer satisfaction;
be monitored; be communicated; be updated as appropriate.
The organization shall retain documented information on the quality objectives
6.2.2 When planning how to achieve its quality objectives, the organization shall
determine:
what will be done; what resources will be required; who will be responsible;
when it will be completed; how the results will be evaluated.
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ISO 9001:2015
6. Planning
Meminta adanya rencana perubahan kebutuhan dan peluang untuk mempertahankan
dan meningkatkan kinerja dari sistem manajemen mutu
Where the organization determines the need for change to the quality management
system (see 4.4) the change shall be carried out in a planned and systematic manner.
The organization shall consider:
a) the purpose of the change and any of its potential consequences;
b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities.
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ISO 9001:2015
ISO 9001:2008
6. Resource Management
7. Support
6.1 General
7.1 Resources
6.2 Human Resource
7.2 Competence
5.3 Infrastructure
7.3 Awareness
6.4 Work Environment
7.4 Communication
Klausul 4.2.3 dan 4.2.4 ISO 9001:2008
Klausul 7 ini sama dengan klausul 6 di ISO 9001:2008 berisikan pengelolan dari
sumber daya (manusia, Infrastruktur dan lingkungan) ditambahkan dengan
pengendalian dokumen dan komunikasi
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ISO 9001:2015
7. Support
7.1 Resources
7.1.1 General
7.1.2 People Klausul 6.2.2 ISO 9001:2008
7.1.3 Infrastructure Klausul 6.3 ISO 9001:2008
7.1.4 Environment for the operation of processes Klausul 6.4 ISO 9001:2008
7.1.5 Monitoring and measuring resource Klausul 7.6 ISO 9001:2008
7.1.6 Knowledge Klausul 6.2.1 and 6.2.2 ISO 9001:2008
7.2 Competence Klausul 6.2.1 and 6.2.2 ISO 9001:2008
7.3 Awareness Klausul 6.2.2 d ISO 9001:2008
7.4 Communication Klausul 5.5.3 ISO 9001:2008
7.5 Documented information Klausul 4.2.1, 4.2.3 dan 4.2.4 ISO 9001:2008
7.5.1 General
7.5.3 Control of documented Information
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ISO 9001:2015
3.11
documented information
information (3.50) required to be controlled and maintained by an organization (3.01) and
the medium on which it is contained
Note 1 to entry: Documented information can be in any format and media and from any
source.
Note 2 to entry: Documented information can refer to:
- the quality management system (3.33), including related processes (3.12);
- information (3.50) created in order for the organization (3.01) to operate
(documentation);
- evidence of results achieved (records).
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ISO 9001:2008
ISO 9001:2015
7. Product Realization
8. Operation
7.1 Planning of product realization
7.2 Customer-related processes
8.2 Determination of requirements for products

and services customers
7.3 Design and development

7.4 Purchasing
7.6 Control of monitoring and
measuring equipment
8.3 Design and development of products and

services
8.4 Control of external provision of
products and services
8.6 Release of products or services
8.7 Control of nonconforming process outputs,
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Page 17
8. Operation
Klausul 7.1 ISO 9001:2008

8.2 Determination of requirements for products and services customers
8.2.2 Determination of requirements related to the products and services
8.2.3 Review of requirements related to the products and services
Hampir
Sama dengan
Klausul
7.2
ISO 9001:2008
Dalam 8.1 terdapat penegasan mengenai harusnya pengandalian outsource process dan
merefer ke klausul 8.4
Dalam klausul 8.2 diinfromasikan dalam catatan bahwa persyaratan tambahan mungkin
saja datang dari interested parties
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8.3 Design and development of products and services
8.4 Control of external provision of products and services
8.4.1 General
Klausul 7.3 ISO 9001:2008

Klausul 7.4 ISO
9001:2008 tetapi
juga termasuk
pengendalian
outsource
Catatan
Dalam 8.4 pengendalian bukan hanya untuk supplier tetapi juga rekanan/subcon
(outsource process)
Dalam 8.5 lebih menekankan pada pengembangan barang dan jasa
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Klausul 7.5.1&2
8.5.2 Identification and traceability Klausul 7.5.3 ISO 9001:2008
8.5.3 Property belonging to customers or external providers Klausul 7.5.4
8.5.4 Preservation
Klausul 7.5.5
8.5.5 Post delivery activities Persyaratan berkaitan dengan pasca delivery
8.6 Release of products or services Klausul 8.2.4 ISO 9001:2008

8.7 Control of nonconforming process outputs, Klausul 8.3 ISO 9001:2008
Catatan
Dalam 8.5.6 organisasi diminta untuk melakukan perubahan yang
terencana dan sistematik , meninjau konsekuensi dari perubahan dan
mengambil tindakan yang dibutuhkan untuk memastikan interritas dari
barang dan jasa terpelihara (berkaitan dengan klausul 6.3 ISO/DIS
9001:2014)
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ISO Requirement
ISO 9001:2008
8. Measurement, analysis and
improvement
ISO 9001:2015
8.1 General
9.1 Monitoring, measurement, analysis And

evaluation
8.2 Monitoring and measurement
9.2 Internal audit

8.3 Control of nonconforming

product
8.4 Analysis of data
10. Improvement
8.5 Improvement

10.2 Improvement
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9.1 Monitoring, measurement, analysis
and evaluation
9.1.1 General Klausul 8.1 ISO 9001:2008 (penetapan untuk metode
pemantauan pengukuran dan evaluasinya)
9.1.2 Customer satisfaction Klausul 8.2.1 ISO 9001:2008
9.1.3 Analysis and evaluation of data Klausul 8.4 ISO 9001:2008
9.2 Internal audit Klausul 8.2.2 ISO 9001:2008 (konsep risk based auditing)
9.3 Management review Klausul 5.6 ISO 9001:2008 (penambahan input
mengenai isu dari supplier atau outsource process)
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10. Improvement
Klausul 8.5.2 ISO 9001:2008
10.2 Continual improvement Klausul 8.5.1 ISO 9001:2008

Improvement melalui :
a) hasil analisis data;
b) perubahan dalam konteks organisasi; (4.1)
c) perubahan dalam risiko yang diidentifikasi (lihat 6.1), dan
d) peluang baru
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Tambahan Annex mengenai Quality management systems dalam ISO 9001:2008 akan tetapi
Ada perubah menjadi 7 Prisnsip Management System
8 Prinsip
Sistem manajemen Pada
ISO 9000:2005
QMP 1 - Customer focus
QMP 2 - Leadership
QMP 3 - Involvement of people
QMP 4 - Process approach
QMP 5 - System approach to management
QMP 6 - Continual improvement
QMP 7 - Factual approach to decision making
QMP 8 - Mutually beneficial supplier relationships
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7 Prinsip
Sistem manajemen Pada
ISO/DIS 9001:2015
QMP 1 Customer Focus
QMP 2 Leadership
QMP 3 Engagement of People
QMP 4 Process Approach
QMP 5 Improvement
QMP 6 Evidence-based Decision Making
QMP 7 Relationship Management
Overview
Based on ISO/DIS 14001:2015
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Page 21
Overview
Meningkatkan hubungan antara lingkungan dan prioritas bisnis.

Peningkatan transparansi dan akuntabilitas dalam pengelolaan lingkungan.
Menggarisbawahi kontribusi positif dari standar sistem manajemen
lingkungan.
Klarifikasi persyaratan untuk peningkatan kinerja lingkungan.
Penguatan hubungan antara pengelolaan lingkungan dan bisnis inti pada
tingkat strategis.
Memudahkan Implementasi ISO 14001, terutama di perusahaan-perusahaan
kecil dan menengah.
Menyoroti konsep Life Cycle Assessments (LCL) dan mempertimbangkan
rantai nilai (Value Chain) dengan pandangan terhadap identifikasi dan
penilaian dampak lingkungan dari produk.
Menampung persyaratan berkaitan dengan komunikasi eksternal.
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Overview
Sekarang di fase ini
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Page 22
Overview
Model of ISO 14001 : 2015

45
2014-10-09
Overview
Clause of ISO 14001:2015 (Based on ISO/DIS 14001:2014)
1
2
3
4
Scope
Context of the organization
context
management system
4.4 Environment management Systems
5 Leadership
5.2 Environment policy
authorities
6 Planning
6.1 Actions to address risks associate with threats and
opportunities
6.1.1 General
6.1.2 Significant environment aspect
6.1.1 Complience obligatory
6.1.4 risks assosiate with threats and opportunities
6.1.5 Planning to take action
6.2 Environment objectives and planning to achieve them
6.2.1 Environment objectives
6.2.2 Planning action to achieve environmental objective
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7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5.1 General
7.5.3 Control of documented information
8 Operation
8.2 Emergency Preparadness and response
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Evaluation of complience
9.2 Internal audit
10 Improvement
Page 23
Overview
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Overview
48
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Page 24
Contoh dari Klausul 4.1 Understanding the organization and its context
Purpose: Motor manufacturer
Intended outcome: Production of motorcycles
Internal issues
Environment
raw
material
design
normal/abnormal
process
etc
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External issues
Environment
Supplier
disaster
Utilities supply
etc
(Relevant) interested parties

Consumers
Employees
Owners/shareholders
Society
Regulator
Suppliers and partners
Perubahan pada ISO 14001:2015 (ISO/DIS 14001:2014)
Tidak ada muncul management representative pada persyaratan akan
tetapi fungsinya masih tetap ada
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Page 25
Overview
Pada klausul 6.1.2 sudah memasukan konsep life cycle perspective
51
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Overview
Konsep risk berkaitan dengan environmrental impact
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Page 26
Overview
Pada klausul 7.4.3 EMS meminta organisasi mengomunikasikan keluar
informasi yang relefan berkaitan dengan sistem managemen
lingkungannya
53
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Overview
Untuk operasional persyaratannya masih tetap sama dengan klausul 4.4.6 ISO
14001:2004 hanya dipertegas kembali berkaitan kontrol proses yang dioutsourcekan
Kitipan dari kalusul 8
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Page 27
Overview
Untuk operasional persyaratannya diminta mempertimbangkan perspektif
Berkaitan life cycle produk/jasa
55
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Correspondence between ISO 9001:2015 and ISO 14001:2015
56
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Page 28
Correspondence between ISO 9001:2015 and ISO 14001:2015
57
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DIS ISO 9001:2014
1 Scope
2 Normative references
DIS ISO 14001:2014

1 Scope
2 Normative references
3 Terms and definitions
3 Terms and definitions
4 Context of the organization
4 Context of the organization

context
management system
4.4 Quality management system and its

context
4.3 Determining the scope of the Environment
management system
4.4 Environment management Systems
processes
5 Leadership
5 Leadership
5.2 Quality policy
5.2 Environment policy

authorities
6 Planning for the quality management system

authorities
6 Planning
6.1 Actions to address risks assosiate with threats and
opportunities
6.1.1 General
6.1.2 Significant environment aspect
6.1.1 Compliance obligatory
6.1.4 risks assosiate with threats and opportunities
6.1.5 Planning to take action

them
6.2 Environment objectives and planning to achieve them

6.2.1 Environment objectives
6.2.2 Planning action to achieve environmental
objective

58
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Page 29
DIS ISO 9001:2014
DIS ISO 14001:2014
7 Support
7 Support
7.1 Resources
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation
of processes
7.1.5 Monitoring and measuring
resources
7.1.6 Organizational knowledge
7.2 Competence
7.2 Competence
7.3 Awareness
7.3 Awareness
7.4 Communication
7.4 Communication
7.5.1 General
7.5.1 General
7.5.3 Control of documented
7.5.3 Control of documented
information
information
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DIS ISO 9001:2014
8 Operation
8.2 Determination of requirements for products and services
DIS ISO 14001:2014

8 Operation
8.2 Emergency Preparadness and response
8.2.2 Determination of requirements related to products
8.3
8.4
8.5
8.6
8.7
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2014-10-09
and services
8.2.3 Review of requirements related to products and
service
Design and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development Inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
Control of externally provided products and services
8.4.1 General
Production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external
providers
8.5.4 Preservation
8.5.5 Post-delivery activities
Release of products and services
Control of nonconforming process outputs, products
and services
Page 30
DIS ISO 9001:2014

9.1 Monitoring, measurement,
analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
10 Improvement
10.1 Nonconformity and corrective
action
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DIS ISO 14001:2014

9.1 Monitoring, measurement, analysis
and evaluation
9.1.1 General
9.1.2 Evaluation of complience
9.2 Internal audit
10 Improvement
Attach ISO 31000 Risk Management
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Attach
63
Documented Information on DIS ISO 9001:2014

4.3 The scope shall be available as documented information.
5.2 Quality policy be available as documented information
6.2 Quality objectives and planning to achieve them The organization shall
retain documented information on the quality objectives
7.1.5 Monitoring and measuring resource The organization shall retain
appropriate documented information as evidence of fitness for purpose of
monitoring and measuring devices.
7.1.5 verified or calibrated at specified intervals or prior to use against
measurement standards traceable to international or national measurement
standards. Where no such standards exist, the basis used for calibration or
verification shall be retained as documented information
7.2 Competence d) retain appropriate documented information as evidence
of competence.
8.1 Operational planning and control retain documented information to the
extent necessary to have confidence that the processes have been carried out as
planned
8.2.3 Review of requirements related to the products and services
Documented information describing the results of the review shall be maintained.
8.3.3, 8.3.5, 8.3.6 design and development
8.4 Control of externally provided products and services (8.4.1)
2014-10-09
Attach
64
8.5.1 Control of production and service provision the availability of documented

information that defines the characteristics of the products and services
8.5.1 Development processes the necessary documented information on the
application of development processes, the outputs and their suitability
the availability of documented information that defines the activities to be performed
and the results to be achieved;
8.5.2 Identification and traceability Where traceability is a requirement, the
organization shall control the unique identification of the process outputs, and retain
any documented information necessary to maintain traceability.
8.5.6 Control of changes The organization shall retain documented information
describing the results of the review of changes, the personnel authorizing the change, and
any necessary actions
8.6.1 Control of production of products and provision of services the availability of
documented information that describes the characteristics of the products and services
the availability of documented information that describes the activities to be performed and
the results achieved, as necessary
8.6.2 Identification and traceability Where traceability is a requirement, the
organization shall control the unique identification of the process 856
outputs, and maintain it as documented information
8.6.6 Control of changes Documented information describing the results of the review
of changes, the personnel authorizing the change and any necessary actions shall be
maintained
2014-10-09
Page 32
Attach
65
8.6 Release of products and services Documented information shall provide

traceability to the person(s) authorizing release of products and services for
delivery to the customer
8.7 Control of nonconforming process outputs, products and services
Documented information shall indicate the person(s) authorizing release of
products and services for delivery to the customer
9.1 Monitoring, measurement, analysis and evaluation (general) The
organization shall retain appropriate documented information as evidence of the
results.
9.2 Internal Audit retain documented information as evidence of the
implementation of the audit programme and the audit results
9.3 Management review he organization shall retain documented
information as evidence of the results of management reviews
The organization shall retain documented information as evidence of
a) the nature of the nonconformities and any subsequent actions taken; and
b) the results of any corrective action.
2014-10-09
Attach
66
8.1 Operational planning and control The organization shall maintain

documented information to the extent necessary to have confidence that the
processes have been carried out as planned
9.1 Monitoring, measurement, analysis and evaluation, general The organization
shall retain appropriate documented information as evidence of the monitoring,
measurement, analysis and evaluation results.
9.1.2 Evaluation of Compliance The organization shall retain documented
information as evidence of the compliance evaluation result(s)
9.2 Internal audit The organization shall retain documented information as
evidence of the implementation of the audit programme and the audit results
9.3 Management review The organization shall retain documented information as
evidence of the results of management reviews
10.1 Nonconformity and corrective action The organization shall retain
documented information as evidence of:
the nature of the nonconformities and any subsequent actions taken;
the results of any corrective action.
2014-10-09
Page 33
Attach
67
6.1 Actions to address risk associated with threats and opportunities

The organization shall maintain documented information to the extent necessary to
have confidence that the process has been carried out as planned
6.1.2 Significant environmental aspects The organization shall maintain
documented information of its:
criteria used to determine its significant environmental aspects;
environmental aspects and associated environmental impacts;
significant environmental aspects.
6.1.3 Compliance obligations The organization shall maintain documented
information of its compliance obligations.
6.1.4 Risk associated with threats and opportunities The organization shall
maintain documented information of the risk associated with threats and
opportunities that needs to be addressed
7.4 Communication The organization shall retain documented information as
evidence of its communications, as appropriate
2014-10-09
Questions & Answers
Thank You
68
2014-10-09
Page 34

Quality and Environmental Management System: ISO 9001 & ISO 14001

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Quality and Environmental Management System: ISO 9001 & ISO 14001

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ISO 9001 & ISO 14001

Quality and Environmental

PT TUV Rheinland Indonesia

Information about Annex XL

Overview of ISO 9001:2015 (based on ISO DIS 9001:2014)

Overview of ISO 14001:2015 (based on ISO DIS 14001:2014)

Correlation between ISO 9001:2015 and ISO 14001:2015

Discussion (Question and Answer)

The schedule might change based on training condition,

PT TUV Rheinland Indonesia

Overview ISO 9001 & ISO 14001

PT TUV Rheinland Indonesia

PT TUV Rheinland Indonesia

PT TUV Rheinland Indonesia

Overview ISO 9001 & ISO 14001

Pengantar ISO 9001 dan 14001 versi 2015

ISO 14001:2014 Environment Management Systems

PT TUV Rheinland Indonesia

Annex SL (High-level structure)

PT TUV Rheinland Indonesia

PT TUV Rheinland Indonesia

Overview ISO 9001 & ISO 14001

Pertimbangan Perubahan Standard

Proses Peninjauan (Process Review) dari Komite Teknis

PT TUV Rheinland Indonesia

PT TUV Rheinland Indonesia

PT TUV Rheinland Indonesia

Overview ISO 9001 & ISO 14001

Tujuan dari ISO 9001:2015

Untuk menyediakan kerangka kerja yang konsisten untuk 10

PT TUV Rheinland Indonesia

Tujuan dari ISO 9001:2015 (Lanjutan)

Untuk mencerminkan perubahan dalam kerja yang semakin

PT TUV Rheinland Indonesia

PT TUV Rheinland Indonesia

Overview ISO 9001 & ISO 14001

ISO 9001:2015 Timeline

April 2014 DIS

July 2015 FDIS

PT TUV Rheinland Indonesia

ISO 9001:2015 Certification

PT TUV Rheinland Indonesia

PT TUV Rheinland Indonesia

Overview ISO 9001 & ISO 14001

Perubahan yang signifikan pad ISO 9001:2015

PT TUV Rheinland Indonesia

Perubahan yang signifikan pad ISO 9001:2015

PT TUV Rheinland Indonesia

PT TUV Rheinland Indonesia

Overview ISO 9001 & ISO 14001

Contoh Perubahan lainnya

Melaksanaan sasaran mutu : Dokumentasi sekarang diperlukan ketika

Risiko: Organisasi harus mengidentifikasi risiko yang dapat mempengaruhi

PT TUV Rheinland Indonesia

PT TUV Rheinland Indonesia

PT TUV Rheinland Indonesia

Overview ISO 9001 & ISO 14001

PT TUV Rheinland Indonesia

ISO/DIS 9001:2014 Requirement

PT TUV Rheinland Indonesia

PT TUV Rheinland Indonesia

Overview ISO 9001 & ISO 14001

ISO/DIS 9001:2014 Requirement (Continued)