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Welcome to
Guidance to Achieve Sustained
Success
ISO 9004:2018
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Internal Quality Auditing
Based on
ISO 19011:2018
Brief introduction
Name : DESTI HILVAWATY
Mobile phone: 08112544560
Experience :
PT. Inkomas Lestari, Jakarta (1993 -1995) , as Chemistry Analyst
PT. Mutuagung Lestari, Jakarta (1995 – 2002)
as Chief of Laboratory
as Auditor of Quality System Audit and QA Coordinator
PT. TÜV International Indonesia, Jakarta (2002 – 2010)
as Project engineer (Auditor) of Management System
PT. SAI Global Indonesia, Jakarta (2010 – 2020)
as Auditor of Management System Audit (ISO 9001)
as Auditor of ABMS (Anti Bribery Management System) ISO
37001:2016
Current: Freelance auditor, trainer and consultant
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The ISO 9001 Family
ISO 9000:2015
• Identifies the fundamentals and vocabulary for Quality
Management Systems (QMS).
ISO 9001:2015 Quality Management Systems - Requirements
• Specifies requirements for a QMS where capability to provide
product that meets customer and regulatory requirements
needs to be demonstrated.
ISO 9004:2018
• Provides guidance to organisations to support the achievement
of sustained success by a quality management approach.
Discussion Topic
ISO 9004 : 2018 – Introduction of ISO 9004 : 2018
ISO 9004 : 2018 – Quality of an Organization & Sustained Success
ISO 9004 : 2018 – Leadership & Process Management
ISO 9004 : 2018 – Improvement, Learning, & Innovation
ISO 9001 : 2015 – Risk Control
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ISO 9004 : 2018
Introduction
• Introduction
• Introduction
• Introduction
MATRIKS BETWEEN ISO 9004:2009 & ISO 9004:2018
ISO 9004 : 2009 ISO 9004 : 2018
1. Scope 1. Scope
2. Normative references 2. Normative references
3. Terms and definition 3. Terms and definition
4. Managing for the sustained success of an 4. Quality of an organization and sustain
organization success
5. Strategy and policy 5. Context of an organization
6. Resource management 6. Identity of an organization
7. Process management 7. Leadership
8. Monitoring, measurement, and analysis 8. Process management
9. Improvement, innovation and learning 9. Resource management
Annex A Self assessment tool 10. Analysis and evaluation of an organization
performance
Annex B Quality management principles 11. Improvement, learning and innovation
Annex C Correspondence ISO 9004&9001 Annex A : Self assessment
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ISO 9004 :2018 – What does it do ?
• ISO 9004:2018 provides guidance to
organisations to support the achievement of
sustained success by a quality management
approach
• Applicable to any organisation, regardless of
size, type and activity
• Not intended for certification, regulatory or
contractual use
Quality Management Principles
“A quality management principle is a comprehensive and
fundamental rule/belief, for leading and operating an
organisation, aimed at continually improving
performance over the long term by focusing on customers
while addressing the needs of all other stakeholders”
International Standards Organisation
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Historical
ISO 9004:2018 is
a quality management standard.
It was first published in 1994, updated in 2000 and
again in 2009. The last revision in 2018.
This current version was officially published on April 20,
2018 and is the fourth edition of the ISO 9004 standard.
It cancels and replaces all previous editions.
Historical
2000
1994
Revision
History
2009
2018
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Historical
This fourth edition cancels and replaces the third
edition (ISO 9004:2009), which has been technically
revised.
The main changes compared to the previous edition
are as follows:
alignment with the concepts and terminology of ISO
9000:2015 and ISO 9001:2015;
focus on the concept of “quality of an organization”
focus of the concept of “identity of an
organization”.
Purpose
Help organizations who are customers of ISO 9001 obtain
sustained benefit from a more broad-based and in-depth
QMS implementation.
First Priority
Current customers of 9001:
Organizations just getting started on 9001
Second Priority
Organizations who are not customers of 9001 who
want to go farther in QMS implementation than
9001
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ISO 9004 : 2018
Quality of an Organization and
Sustained Success
Sustained Success
Sustained Success
Sustained Success
Sustained Success
4.1 Quality of an Organisation
The quality of an organization is the degree to which the inherent
characteristics of the organization fulfil the needs and expectations of its
customers and other interested parties, in order to achieve sustained success.
It is up to the organization to determine what is relevant to achieve sustained
success. The term “quality of an organization” is derived from the definition
of “quality” given in ISO 9000:2015, 3.6.2 (“the degree to which a set of
inherent characteristics of an object fulfils requirements”).
The organization should apply all of the quality management principles (see
ISO 9000:2015) to achieve sustained success. Particular attention should be
given to the principles of “customer focus” and “relationship management”
to meet the different needs and expectations of interested parties.
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Sustained Success
The needs and expectations of individual interested parties can be
different, aligned to, or in conflict with those of other interested parties,
or can change quickly. The means by which the needs and expectations
of interested parties are expressed and met can take a wide variety of
forms, for example co-operation, negotiation, outsourcing, or by
terminating an activity; consequently, the organization should give
consideration to the interrelationships of its interested parties when
addressing their needs and expectations.
Activity 1 :
Using the Quality Management Principles
Objective:
Each quality management principle has a specific intent, intended to benefit an organisation in some aspect
of their operations, to enable the organisation to meet the needs and expectations of all interested parties.
1. Customer Focus
2. Leadership
3. Engagement of People
4. Process Approach
5. Evidence-based Decision Making
6. Improvement
7. Relationship Management
(hanya ada satu definisi yang benar untuk setiap prinsip)
Task:
Individually, attempt to match each definition given below with a specific quality management principle.
Note there is only one correct definition for each principle.
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DEFINISI SISTEM MANAJEMEN MUTU PRINSIP
Keputusan yang diambil berdasarkan analisis dan evaluasi data dan informasi lebih mungkin
untuk menghasilkan hasil yang diinginkan.
Untuk sukses yang berkelanjutan, organisasi akan mengelola hubungan mereka dengan pihak
pemangku kepentingan, seperti para pemasok.
Hal ini penting untuk organisasi yang semua orang kompeten, diberdayakan dan terlibat dalam
memberikan nilai tambah bagi organisasi
Pemimpin di semua tingkatan menetapkan kesatuan tujuan dan arah dan menciptakan kondisi
dimana orang terlibat dalam mencapai sasaran mutu organisasi.
Organisasi yang sukses memiliki focus berkelanjutan pada pengembangan.
Fokus/utama dari manajemen mutu adalah untuk memenuhi kebutuhan pelanggan dan
berusaha untuk melebihi harapan pelanggan.
Hasil konsisten yang dapat diprediksi tercapai lebih efektif dan efisien bila kegiatan dipahami
dan dikelola sebagai proses yang saling terkait, yang berperan sebagai system yang jelas.
Sustained Success
4.2 Managing for the sustained success of an organization
Ability
Result of the ability of an
organization to achieve and
maintain its objective in the
long term
Achieve Maintain
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ISO 9004 : 2018
Leadership
Leadership
Leadership
Leadership
Leadership
7. Leadership
General
To achieve sustained success, top management should demonstrated
leadership and commitment within the organization
Policy and Strategy
Establishing the organization’s policy include commitment to satisfy
the need and expectation of interested parties and to promote the
improvement
Objective
Should be quantified (S.M.A.R.T)
Communication
The effective communication of policies and strategy, with relevant
objectives.
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Context of an Organization
8. Process Management ~~~
Refer to Business Process (mind mapping model process)
Context of an Organization
9. Resource Management
Resources support the operation of all process and are critical
for ensuring effective & efficient performance and its
sustained success
10. Analysis, Evaluation of an Organization Performance
organization performance
11. Improving, Learning and Innovation
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ISO 9004 : 2018
Improvement, Learning & Innovation
Improvement, Learning, & Innovation
Improvement, Learning& Innovation
Improvement, Learning, & Innovation
Improvement, Learning
& Innovation
Improvement
Make or become Better
Oxford Dictionary
Organization performance improvement can be made through organization capabilities, strategic intent (vision,
mission, policy and objectives), products, processes and systems.
Improvement has to be part of organization culture as it is on of the “ 7 management system principle”. The key
to successful improvement is empowerment of people.
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Improvement, Learning
& Innovation
Learning
Gain Knowledge of or skill in
Oxford Dictionary
The organization where people continually expand their capacity to create the results they truly desire, where
new expansive patterns of thinking are nurtured, where collective aspiration is set free, and where people are
continually learning to learn together” Peter Senge, 1990
According to Kaplan and Norton, Learning is more than training, it’s includes mentoring and tutoring process,
such as easy communication all over employee will possibly make them help each other when needed.
Improvement, Learning
& Innovation
Peter Senge’s, 1990
Learning Organization
System thinking.
Conceptual frame work that allows people to study performance of the organization as a whole and of its various
component.
Personal Mastery.
Staff training and development.
Mental Model.
Changing the assumption of individual and organization so they intend to espouse theory, which are what they
intend to follow, which are what they actually do.
Shared Vision.
Motivating the staff to learn, as it creates the common identity that provides focus and energy for learning.
Team Learning.
Development of open communication, shared meaning and shared understanding.
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Improvement, Learning
& Innovation
Innovation
Bring new methods, ideas etc; make changes
Oxford Dictionary
Customer need and expectation is a very wide and fluctuate variance, innovation is required by organization to
continually meet those needs and expectation and maintain it’s performance.
Innovation successful key is the balance between
Urgency of changes needed Vs Resource for Development
ISO 9004 : 2018
Risk Control
Risk Control
Risk Control
Risk Control
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Risk Control
Business Situation
Threat Threat Internal
Threat Org. Threat Threat
External
Threat Threat
Risk Control
Risk = Threat
Risk Risk
ISO 31000:2018
Identification Management
Identify
Effect of uncertainty
Action
on objectives Assess
Likelihood
Consequence
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Risk Control
Risk Risk Assessment
Management
Integrate them
With QMS System
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ISO 9004 : 2018
WORKSHOP
Prinsip Sistem Manajemen Mutu
Kebutuhan & Harapan
Pihak Pemangku Kepentingan
Activity 1 :
Using the Quality Management Principles
Objective:
Each quality management principle has a specific intent, intended to benefit an organisation in some aspect
of their operations, to enable the organisation to meet the needs and expectations of all interested parties.
1. Customer Focus
2. Leadership
3. Engagement of People
4. Process Approach
5. Evidence-based Decision Making
6. Improvement
7. Relationship Management
(hanya ada satu definisi yang benar untuk setiap prinsip)
Task:
Individually, attempt to match each definition given below with a specific quality management principle.
Note there is only one correct definition for each principle.
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DEFINISI SISTEM MANAJEMEN MUTU PRINSIP
Keputusan yang diambil berdasarkan analisis dan evaluasi data dan informasi lebih mungkin
untuk menghasilkan hasil yang diinginkan.
Untuk sukses yang berkelanjutan, organisasi akan mengelola hubungan mereka dengan pihak
pemangku kepentingan, seperti para pemasok.
Hal ini penting untuk organisasi yang semua orang kompeten, diberdayakan dan terlibat dalam
memberikan nilai tambah bagi organisasi
Pemimpin di semua tingkatan menetapkan kesatuan tujuan dan arah dan menciptakan kondisi
dimana orang terlibat dalam mencapai sasaran mutu organisasi.
Organisasi yang sukses memiliki focus berkelanjutan pada pengembangan.
Fokus/utama dari manajemen mutu adalah untuk memenuhi kebutuhan pelanggan dan
berusaha untuk melebihi harapan pelanggan.
Hasil konsisten yang dapat diprediksi tercapai lebih efektif dan efisien bila kegiatan dipahami
dan dikelola sebagai proses yang saling terkait, yang berperan sebagai system yang jelas.
Activity 2 : Memenuhi Kebutuhan & Persyaratan
PIHAK YANG KEBUTUHAN & PERSYARATAN CARA STRATEGI
BERKEPENTINGAN
(INTERESTED PARTIES)
(PIHAK2 BERKEPENTINGAN) PEMENUHAN
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