Overview ISO 9001-2015

Created, by Erfi Ilyas email : [email protected], 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 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

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)

2015 2014 2013

+ Transition period for certification



September 2015

Publisged International Standard

September 2015 start of 3 years transition period to September 2018

2017 2016 2015 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 In

tera

ctio

n w

ith

oth

er

pro

ce

sse

s In

tera

ctio

n w

ith o

the

r pro

ce

sse

s

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 organizations 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

necessary Act

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 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


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

Overview ISO 9001-2015

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