Overview iso 9001 2015

Created, by Erfi Ilyas – email : erfiilyas@yahoo.com, blog: http://erfiilyas.blogspot.com
Overview ISO 9001:2015
Based on ISO/DIS 9001:2014 &
ISO DIS 9000:2014
Prepared by
Dr. Erfi Ilyas
Widyaiswara P4TK BMTI Bandung
Dosen Politeknik TEDC Bandung
Konsultan & Auditor ISO 9000
Bandung Management & Economic Center

Agenda
Latar Belakang Perubahan
Tujuan Perubahan
ISO 9001:2015 Timeline
Cakupan Perubahan
Proses Pengembangan Standar
High Level Structure

 Standar ISO harus ditinjau setiap lima tahun untuk
memastikan bahwa standar tetap up-to-date dan relevan
dengan perkembangan zaman.
 Tinjauan resmi menyeluruh yang dilakukan oleh seluruh
anggota organisasi ISO (National Member Bodies /NMBs)
terhadap standar ISO 9001 pada tahun 2012
menyimpulkan bahwa standar 9001 harus direvisi.
 Beberapa t ahun terakhir berbagai standar sistem
manajemen telah digunakan secara luas di seluruh dunia.
Sehingga organisasi yang menggunakan multi sistem
membutuhkan format dan bahasa yang relatif sama
diantara standar-standar tersebut.

 Input dari pengguna sistem (system user)
yang dilakukan melalui survey diseluruh
dunia, menghasilkan “key user input”
sebagai berikut:
• ISO 9001 harus dirubah agar tetap relevan
• Harus terintegrasi dengan standar sistem
manajemen yang lain seperti EMS
• Harus lebih bekerjasama dengan
ISO/CASCO dan IAF untuk memastikan
efisiensi dan efektifitas audit dan mengatasi
masalah dalam audit sertifikasi
• Harus mencakup “tools” dan “risk
management”

Tujuan Perubahan
 Memelihara relevansi standar dengan tuntutan perubahan
dan perkembangan lingkungan organisasi yang semakin
kompleks dan dinamis
 Untuk meningkatan efektifitas implementasi sistem dan
penilaian kesesuaian
 Meningkatkan kepercayaan terkait dengan kemampuan
organisasi dalam penyediaan produk dan jasa yang
memenuhi persyaratan serta kemampuan untuk
memuaskan pelanggan.
 Menyediakan kerangka kerja yang konsisten untuk jangka
panjang (10-25 tahun)

Tujuan Perubahan
 Menjadikan standar ISO 9001 lebih “generic” dan
lebih mudah diterapkan pada industri jasa.
 Memastikan standar ISO 9001 memenuhi
kebutuhan seluruh kelompok pengguna yang
potensial.
 Meningkatkan penekanan terhadap Manajemen
Risiko dalam mencapai tujuan
 Untuk meningkatkan “kompatabilitas” dengan
persyaratan sistem manajemen yang lain (ie. ISO
14001, OHSAS 18001/ISO 45001 melalui
penerapan struktur yang seragam (High Level
Structure)

Apa dan kenapa high-level structure? (Annex SL)
• Mandated by ISO’s Technical Management Board (TMB)
• High level structure, identical core text and common terms and
core definitions for use in all Management System Standards
• Purpose - Enhance the consistency and alignment of different
management system standards
• Organizations who implement a single system addressing
multiple standards (e.g. QMS, EMS, ISMS etc) will see the most
potential benefit
Kedepannya semua standar sistem manajemen akan mengadopsi
high-level structure.
High-level structure

High-level structure
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
4,5,6,7,
8
9
10

Proses pengembangan standar ISO 9000
WDs
Working
Draft
CD
Committee
Draft
DIS
Draft
International
standard
FDIS
Final Draft
International
Standard
International
Standard
ISO
9001
Ketentuan penetapan FDIS jadi
International Standard harus
disetujui oleh minimal 75%
anggota ISO

May 2013 CD
(Committee Draft)
February 2014 DIS
(Draft International Standard)
July 2015 FDIS
(Final Draft International Standard)
September 2015 Published IS
(International Standard)
201520142013
+ Transition period
for certification

September 2015
Publisged International
Standard
September 2015 start of 3 years transition
period to September 2018
201720162015 2018

Cakupan Perubahan
Perubahan pada standar ISO 9001:2015 mencakup
perubahan terminologi dan konten persyaratan

ISO 9001:2008 ISO 9001:2015
Products Products and service
Exclusions Not used
Documentation, records Documented information
Work environment Environment for the operation of process
Purchased product Externally provided products and services
Suplier External provider
Management
responsibility
Leadership
Continual improvement Improvement
Major differences in terminology between ISO 9001:2008 and
ISO 9001:20015
Perubahan Terminologi

Perubahan yang signifikan pada ISO 9001:20015
1. Mengadopsi high-level structure & terminologi dari Annex SL
(Pedoman terpadu untuk pengembangan seluruh standar ISO
yang baru). Sehingga jumlah klausul berubah jadi 10 dari
sebelumnya sebelumnya 8.
2. Risk-based thinking lebih eksplisit dan menjadi bagian persyaratan
Risk-based thinking  mempertimbangkan risiko secara
kualitatif (dan, tergantung pada konteks organisasi, secara
kuantitatif) pada saat menetapkan ketegasan dan tingkat
formalitas yang diperlukan untuk merencanakan dan
mengendalikan sistem manajemen mutu, serta kegiatan
dan kompnen prosesnya.
Risk  Pengaruh ketidakpastian terhadap hasil yang
diharapkan (effect of uncertainty on an expected result)

3. Istilah dokumen (document) dan rekaman (record) diganti dengan
informasi terdokumentasi (documented information).
4. Quality management principles (QMP) berubah menjadi 7 dari
sebelumnya 8.
5. Tidak ada lagi persyaratan khusus untuk Management
representative (MR) atau Wakil Manajemen Mutu.
6. Tidak ada lagi persyaratan yang spesifik untuk tindakan
pencegahan (preventive action), tetapi diakomodir pada klausul
tentang memahami organisasi dan konteksnya (4.1) dan tindakan
untuk menghadapi risiko dan peluang (6.1)
7. Tidak ada persyaratan yang spesifik untuk pedoman mutu (quality
manual).

8. Kegiatan oursourcing lebih eksplisit diatur dalam klausul tersendiri
(klausul 8.4)
9. Istilah dan definisi diuraikan secara lengkap pada klausul 3, tidak
hanya menyebutkan ISO 9000 seperti pada versi sebelumnya
10. Memberikan penekanan pada pencapaian nila bagi organisasi
dan pelanggannya serta memberikan perhatian lebih pada proses
pemenuhan persyaratan produk dan jasa serta kepuasan
pelanggan
12. Memperkenalkan dua klausul baru yaitu klausul 4.1 tentang
Understanding the organization and its context dan klausul 4.2
tentang Understanding the needs and expectations of interested
parties .
11 Program pencapaian sasaran mutu lebih eksplisit diatur dalam
klausul tersendiri (Klausul 6.2.2)

2008
0. Introduction
1. Scope
2015
0. Introduction
1. Scope
4. Quality Management System
4.1 General requirements
4.2 Documentation requirement
4. Context of the organization
4.1 Understanding the organization
and its context
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the
quality manageent systems
4.4 Quality management systems and
its processes
Lihat klausul 7.5
ISO 9001:2008 vs ISO 9001:2015

5. Management responsibility
5.1 Management commitmen
5.2 Customer fpcus
5.3 Quality policy
5.4 Planning
5. Leadership
5.1 Leadership and commitment
5.2 Quality policy
5.3 Organizational roles,
responsibilities and authorities
6. Planning for the quality
management system
6.1 Actions to address risks and
opportunities
6.2 Quality objectives and planning to
achieve them.
6.3 Planning of changes
5.5 Responsibility, authority and
communication
5.6 Management review
Lihat klausul 5.3 dan 7.4
Lihat klausul 9.3
ISO 9001:2008 vs ISO 9001:2015

6. Resources Management
6.1 Provision of resources
6.2 Human resources
7. Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
6.3 Infrastructure
6.4 Working environment
Lihat klausul 7.1 untuk infrastructure
Lihat klausul 7.1 untuk workplace
criteria
ISO 9001:2008 vs ISO 9001:2015

7. Prodoct realization
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and
measuring equipment
8. Operation
8.1 Operation planning and control
8.2 Determination of requirements for
products and services
8.3 Design and development of
8.4 Control of externally provided
8.5 Production and service provision
8.6 Release of products and srvices
8.7 Control of nonconforming process
outputs, products and services
ISO 9001:2008 vs ISO 9001:2015

8. Measurment, analysis and
improvement
8.1 General
8.2 Monitoring and measurement
9. Perfoermance evaluation
9.1 Monitoring, measurement, analysis
and evaluation
9.2 Internal audit
8.3 Control of nonconforming product
8.4 Analysis data
8.5 Improvement
Lihat klausul 8.7
Lihat klausul 9.1
10. Improvement
10.1 General
10.2 Nonconformity and corrective
action
10.3 Continual improvement
ISO 9001:2008 vs ISO 9001:2015

ISO 9001:2008
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to management
6. Continual improvement
7. Factual approach to decision
making
8. Mutually benefial suplier relationship
ISO 9001:2015
1. Customer Focus
2. Leadership
3. Engagement of People
4. Process Approach
5. Improvement
6. Evidence-based Decision Making
7. Relationship Management
Quality Management Principles

Process Approach
4.1, 4.2, 4.3
Establish context,
define relevant
interested parties
& scope of QMS
Customers &
other
relevant
interested
parties
10. Continual improvement
Customers
Satisfaction
5. Leadership
8. Operation
6. Planning 9. Performance
evaluation
4.4 QMS-general &
Process Approach
7. Supprot processes
Requirements
Products &
Service
Inputs Outputs
*
*

Process Approach
Interactionwithotherprocesses
Interactionwithotherprocesses
Do – Carry out the
process
Plan the process–
(Extent of planning
depends on RISK
Act – incorporate
improvements as
necessary
Check – monitor/measure
process performance
INPUTS OUTPUTS
Schematic representation of a single process within the system

Plan
 What to do?
 How to do?
Do
Do what was
planned
Check
Did things happen
According to plan?
Act
How to improve
Next time?
Roda Deming (PDCA Cycle)

Plan
Establish the objectives of the system and its
component processes, and the resources needed
to deliver results in accordance with customers’
requirements and the organization’s policies.
Do
Implement what was planned
Monitor and (where applicable) measure processes
and the resulting products and services against
policies, objectives and requirements, and report
the results
Check
Take actions to improve process performance, as
necessaryAct
Roda Deming (PDCA Cycle)

Clause 4: Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested
parties
4.3 Determining the scope of the quality management
system
4.4 Quality management system and its processes
Inti Perubahan
 Klausul 4.1 dan 4.2 merupakan klausul baru
 Klausul 4.1 memberi penekanan pada organisasi agar
menetapkan, memantau dan meninjau isu-isu internal dan
eksternal yang berpengaruh terhadap kemampuan organisasi
dalalam mencapai hasil yang diinginkan.

Clause 4: Context of the organization
Inti Perubahan
 Klausul 4.2 memberi penekanan agar organisasi menetapkan
“interested parties” yang relevan dengan organisasi berikut
persyaratan dari “interested parties” tersebut
 Klausul 4.3 dan 4.4 relatif sama dengan klausul 4.2 dan 4.1 ISO
9001:2008
Definisi
context of the organization (business environment) : combination
of internal and external factors and conditions that can have an
effect on an organization's approach to its products, services and
investments and interested parties.
interested party: person or organization that can affect, be affected
by, or perceive themselves to be affected by a decision or activity

Clause 5: Leadership
5.1 Leadership and commitment
5.1.1 Leadership and commitment for the quality
management system
5.1.2 Customer focus
5.2 Quality policy
5.3 Organizational roles, responsibilities and authorities
Inti Perubahan
 Isi Klausul 5 ini pada dasarnya relatif sama dengan klausul 5.1,
5.2, 5.3, dan 5.5 pada ISO 9001:2008. Namun pada standar
versi terbaru ini, “top management” diharapkan lebih
menunjukkan kepemimpinan dan komitment terkait dengan
sistem manajemen mutu.

Clause 6: Planning for the quality management system
6.1 Action to address risks and oppurtunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
Inti Perubahan
 Klausul 6.1 merupakan klausul baru yang memberikan
penekanan agar dalam proses perencanaan organisasi harus
mempertimbangkan isu-isu terkait “dengan context of the
organization” dan persyaratan “interested parties” untuk
kemudian menetapkan risiko dan peluang yang harus dihadapi
 Isi Klausul 6.2 dan 6.3 relatif sama dengan klausul 5.4 pada ISO
9001:2008. Perubahannya adalah adanya penegasan bahwa
setiap sasaran mutu (quality objective) harus dilengkapi dengan
program untuk mencapainya.

Clause 7: Supprot
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 meauring resources
7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information

Clause 7: Supprot
Inti Perubahan
 Isi Klausul 7.1, kecuali klausul 7.1.6 relatif sama dengan klausul
6.1, 6.2, 6.3, 6.4, dan 7.6 pada ISO 9001:2008. Berisi
persyaratan tentang penyediaan sumber daya, sumberdaya
manusia, infra truktur, lingkungan kerja, dan sumberdaya
pemantauan dan pengukuran.
 Klausul 7.1.6 merupakan klausul baru yang mensyaratkan agar
organisasi menetapkan “knowledge” yang diperlukan untuk
menjalankan proses dan mencapai kesesuaian produk dan jasa.
 Klausul 7.2 dan 7.3 relatif sama dengan klausul 6.2.1 dan 6.2.2
pada ISO 9001:2008. Sementara klausul 7.3 relatif sama
dengan klausul 5.5.3 ISO 9001:2008
 Klausul 7.5 relatif sama dengan klausul 4.2.1, 4.2.3 dan 4.2.4
pada ISO 9001:2008

Clause 7: Supprot
Definisi
Knowledge: available collection of information being a justified
belief and having a high certainty to be true.
Information: meaningful data (facts about an object)
Documented information : information required to be controlled
and maintained by an organization and the medium on which it is
contained
Documented procedures (ISO 9001:2008)  to maintain
documented information (ISO 9001:2015)
Record (ISO 9001:2008)  to retain doumented information
(ISO 9001:2015)

Clause 8: Operation
8.1 Operation planning and control
8.2 Determination of requirements for products and service
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
services.
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

Clause 8: Operation
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 Informatioan for external providers
8.5 Production and services 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

Clause 8: Operation
Inti Perubahan
 Isi Klausul 8.1 relatif sama dengan klausul 7.1 sementara
klausul 8.2 relatif sama dengan klausul 7.2 pada ISO 9001:2008.
 Klausul 8.3 relatif sama dengan klausul 7.3 pada ISO 9001:2008
 Klausul 8.4 relatif sama dengan klausul 7.4 ISO 9001:2008
dengan tambahan bahwa pengendalian bukan hanya untuk
pemasok tetapi juga termasuk rekanan/subcon untuk outsourcing
 Klausul 8.5, kecuali 8.5.5 dan 8.5.6 relatif sama dengan klausul
7.5 ISO 9001:2008. Untuk klausul 8.5.3 ada penambahan bahwa
organisasi juga harus peduli dengan “property” external provider
disamping “property” pelanggan.

Clause 8: Operation
Inti Perubahan
 Klausul 8.5.5 dan 8.5.6 merupakan klausul baru. Klausul 8.5.5.
memberikan penekanan pada organisasi agar memenuhi
persyaratan kegiatan “post-delivery” yang berhubungan dengan
produk dan jasa. Sementara klausul 8.5.6 mengharuskan
organisasi untuk meninjau dan mengendalikan perubahan
esensial yang tidak direncanakan terkait dengan produksi dan
penyediaan jasa.

Clause 8: Operation
Inti Perubahan
 Isi Klausul 8.6 relatif sama dengan klausul 8.2.4 ISO 9001:2008.
 Isi klausul 8.7 relatif sama dengan klausul 8.3 ISO 9001:2008
Definisi
outsource (verb) : make an arrangement where an external
organization performs part of an organization’s function or process.
design and development : set of processes that transforms
requirements for an object into more detailed requirements
Product : output that is a result of activities where none of them
necessarily is performed at the interface between the provider and
the customer .
Service : intangible output that is the result of at least one activity
necessarily performed at the interface between the provider and the
customer

Clause 9: Performance Evaluastion
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
Inti Perubahan
 Tidak ada perubahan yang berarti . Klausul 9.1 relatif sama
dengan klausul 8.1 , 8.2.1 dan 8.4 ISO 9001:2008.
Klausul 9.2 relatif sama dengan klausul 8.2.2 ISO 9001:2008 dan
klausul 9.3 relatif sama dengan klausul 5.6 ISO 9001:2008.

Clause 10: Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Inti Perubahan
 Tidak ada perubahan yang berarti . Klausul 10.2 relatif sama
dengan klausul 8.5.2 ISO 9001:2008 dan klausul 10.3 relatif
sama dengan klausul 8.5.1 ISO 9001:2008.
 Terdapat penekanan berkenaan dengan “improvement” dimana
organisasi harus menetapkan dan memilih peluang untuk
perbaikan dan melaksanakan kegiatan yang diperlukan guna
memenuhi persyaratan pelanggan dan memperkuat kepuasan
pelanggan.

Standard Content
ISO 9000 Quality Management System - Fundamental and
Vocabulary
ISO 9004 Managing for the sustained success of an organization –
A quality management approach.
ISO 10001 Customer satisfaction – Guidelines for codes of conduct
ISO 10002 Customer satisfaction – Guidellines for handling
complaints
ISO 10003 Customer satisfaction – Guidelines for external dispute
resolution
ISO 10004 Guidelines for monitoring and measuring customer
satisfaction
ISO 10005 Guidelines for quality plans
ISO 10006 Guidlines for quality management in projects
ISO 10007 Guidelines for configuration management
The ISO 10000 portfolio of quality management standards

Standard Content
ISO 10008 Customer satisfaction –Guidelines for business-to-
consumer electronic commerce
ISO 10008 Customer satisfaction –Guidelines for business-to-
consumer electronic commerce
ISO 10012 Guidance for management of measurement processes
ISO/TR 10013 Guidelines for quality management system
documentation
ISO 10014 Guidelines for realizing financial and economic benefits
ISO 10015 Guidance for training
ISO /TR 10017 Guidance on statistical techniques
ISO 10018 Guidelines on people involvement and competence
ISO 10019 Guidelines for the selection of quality management
system consultants
ISO 19011 Guidelines for auditing management systems
The ISO 10000 portfolio of quality management standards

Barangsiapa yang diwaktu sorenya merasakan
kelelahan karena bekerja, berkarya dengan
tangannya sendiri,
maka di waktu sore itu pulalah ia terampuni
dosanya
(HR Thabrani dan Baihaqi)

TERIMAKASIH
ُ‫ه‬ُ‫ت‬‫ا‬َ‫ك‬َ‫ر‬َ‫ب‬َ‫و‬ ِ‫اهلل‬ ُ‫ة‬َ‫م‬ْ‫ح‬َ‫ر‬َ‫و‬ ْ‫م‬ُ‫ك‬ْ‫ي‬َ‫ل‬َ‫ع‬ ُ‫م‬َ‫ال‬َّ‫لس‬ْ‫ا‬

Overview iso 9001 2015

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