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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

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

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Latar Belakang Perubahan


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.

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Latar Belakang Perubahan


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
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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)

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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)
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High-level structure
Kedepannya semua standar sistem manajemen akan mengadopsi
high-level structure.
Apa dan kenapa high-level structure? (Annex SL)

Mandated by ISOs 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

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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,
10

8
9

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Proses pengembangan standar ISO 9000

International
Standard

FDIS
DIS
CD
WDs
Working
Draft

Final Draft
International
Standard

ISO
9001

Draft
International
standard

Committee
Draft

Ketentuan penetapan FDIS jadi


International Standard harus
disetujui oleh minimal 75%
anggota ISO

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ISO 9001:2015 Timeline


2013

2014

2015

May 2013 CD
(Committee Draft)

February 2014 DIS

+ Transition period
for certification

(Draft International Standard)

July 2015 FDIS


(Final Draft International Standard)

September 2015 Published IS


(International Standard)
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ISO 9001:2015 Timeline

2015

2016

2017

2018

September 2015
Publisged International
Standard

September 2015 start of 3 years transition


period to September 2018
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Cakupan Perubahan
Perubahan pada standar ISO 9001:2015 mencakup
perubahan terminologi dan konten persyaratan

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Perubahan Terminologi
Major differences in terminology between ISO 9001:2008 and
ISO 9001:20015
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

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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)
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Perubahan yang signifikan pada ISO 9001:20015


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


representative (MR) atau Wakil Manajemen Mutu.

Management

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).

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Perubahan yang signifikan pada ISO 9001:20015


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

11 Program pencapaian sasaran mutu lebih eksplisit diatur dalam


klausul tersendiri (Klausul 6.2.2)
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 .
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ISO 9001:2008 vs ISO 9001:2015


2008

2015

0. Introduction

0. Introduction

1. Scope

1. Scope

2. Normative references

2. Normative references

3. Terms and definitions

3. Terms and definitions

4. Quality Management System

4. Context of the organization

4.1 General requirements

4.1 Understanding the organization


and its context

4.2 Documentation requirement

Lihat klausul 7.5


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
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ISO 9001:2008 vs ISO 9001:2015


5. Management responsibility

5. Leadership

5.1 Management commitmen

5.1 Leadership and commitment

5.2 Customer fpcus

5.2 Quality policy

5.3 Quality policy

5.3 Organizational roles,


responsibilities and authorities

5.4 Planning

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

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ISO 9001:2008 vs ISO 9001:2015


6. Resources Management

7. Support

6.1 Provision of resources

7.1 Resources

6.2 Human resources

7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information

6.3 Infrastructure

Lihat klausul 7.1 untuk infrastructure

6.4 Working environment

Lihat klausul 7.1 untuk workplace


criteria

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ISO 9001:2008 vs ISO 9001:2015


7. Prodoct realization

8. Operation

7.1 Planning of product realization

8.1 Operation planning and control

7.2 Customer-related processes

8.2 Determination of requirements for


products and services

7.3 Design and development


7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and
measuring equipment

8.3 Design and development of


products and services
8.4 Control of externally provided
products and services
8.5 Production and service provision
8.6 Release of products and srvices
8.7 Control of nonconforming process
outputs, products and services

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ISO 9001:2008 vs ISO 9001:2015


8. Measurment, analysis and
improvement

9. Perfoermance evaluation

8.1 General

9.1 Monitoring, measurement, analysis


and evaluation

8.2 Monitoring and measurement

9.2 Internal audit


9.3 Management review

8.3 Control of nonconforming product

Lihat klausul 8.7

8.4 Analysis data

Lihat klausul 9.1

8.5 Improvement

10. Improvement
10.1 General

10.2 Nonconformity and corrective


action
10.3 Continual improvement

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Quality Management Principles


ISO 9001:2008

ISO 9001:2015

1. Customer focus

1. Customer Focus

2. Leadership

2. Leadership

3. Involvement of people

3. Engagement of People

4. Process approach

4. Process Approach

5. System approach to management


6. Continual improvement

5. Improvement

7. Factual approach to decision


making

6. Evidence-based Decision Making

8. Mutually benefial suplier relationship

7. Relationship Management

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Process Approach
4.1, 4.2, 4.3
Establish context,
define relevant
interested parties
& scope of QMS

10. Continual improvement

*
5. Leadership

Customers &
other
relevant
interested
parties

Requirements

4.4 QMS-general &


Process Approach

6. Planning

Inputs

9. Performance
evaluation

8. Operation

Outputs

Customers
Satisfaction

Products &
Service

7. Supprot processes
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Act incorporate

Plan the process

improvements as
necessary

(Extent of planning
depends on RISK

INPUTS

Do Carry out the

OUTPUTS

process

Check monitor/measure
process performance

Schematic representation of a single process within the system

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Interaction with other processes

Interaction with other processes

Process Approach

Roda Deming (PDCA Cycle)

Act
How to improve
Next time?

Check
Did things happen
According to plan?

Plan
What to do?
How to do?

Do
Do what was
planned

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Roda Deming (PDCA Cycle)

Plan
Do

Establish the objectives of the system and its


component processes, and the resources needed
to deliver results in accordance with customers
requirements and the organizations policies.
Implement what was planned

Check

Monitor and (where applicable) measure processes


and the resulting products and services against
policies, objectives and requirements, and report
the results

Act

Take actions to improve process performance, as


necessary

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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.
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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
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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.
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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.
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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
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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

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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)
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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
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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
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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.

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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.

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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 organizations 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
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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
9.3 Management review

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.

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Clause 10: Improvement


10.1
10.2
10.3

General
Nonconformity and corrective action
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.
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The ISO 10000 portfolio of quality management standards


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

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The ISO 10000 portfolio of quality management standards


Standard

Content

ISO 10008

Customer satisfaction Guidelines for business-toconsumer electronic commerce

ISO 10008

Customer satisfaction Guidelines for business-toconsumer 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

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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)
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TERIMAKASIH




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