Klausul ISO 9001 2015 SINTEGRAL PDF

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Training and consulting services

SINTEGRAL C
Consulting
lti
ISO Management System
Phone (021) 726 4126
Fax (021) 726 4127
Grand Wijaya Center Blok H 9
Jl. Wijaya
j y II,, Jakarta Selatan
Email: [email protected]
www.sintegral.com
Pres
sentasi ISO9001-20
015/Nov15

1
Training and consulting services

SINTEGRAL S
Services
i
Training
g and consulting
g for:
Quality Management System ISO 9000
Environmental Management System ISO 14000
Food Safety Management System ISO 22000 and HACCP
Management
M t System
S t for
f Occupational
O ti l and
d Safety
S f t OHSAS 18001
Information Security Management System ISO 27001
Cosmetics Good Manufacturing Practices (GMP) ISO 22716
Automotive Quality Management ISO/TS 16949
Pres
sentasi ISO9001-20
015/Nov15

2
Training and consulting services

To maintain our clients, we provide focus group discussion through mailing list
such as Quality Club with 1.600 members
Visit Quality Club https://groups.yahoo.com/neo/groups/QualityClub/info
https://groups yahoo com/neo/groups/QualityClub/info
Pres
sentasi ISO9001-20
015/Nov15

3
Training and consulting services

Quality
Qua ty Syste
Systems:
s Strategy
St ategy for
o the
t e future
utu e

ISO 9001:2015
9001 201
Pres
sentasi ISO9001-20
015/Nov15

4
Training and consulting services

International
Organization for
Standardization
Organisasi Standardisasi Internasional (non
governmental) yang beranggotakan 140 Dewan
St d di
Standardisasi
i Nasional
N i l

Sejak 1947 ISO telah menerbitkan 25.000 standar


internasional
Pres

Ad
Adopsi
i standar
t d ISO bersifat
b if t sukarela
k l (voluntary)
( l t )
sentasi ISO9001-20
015/Nov15

5
Training and consulting services

ISO 9001:2015
Q
Quality Management Standard
S -> Sejarah ISO 9001
Menghasilkan Barang dan jasa yang
Berkualitas - > Customer satisfaction 1987-> ISO 9001:1987
1994-> ISO 9001:1994
Bukan standar produk
2000 > ISO 9001:2000
2000->
Bersifat umum (Generic)
2008-> ISO 9001:2008
Berlaku bagi semua jenis organisasi
Manufacturing, Service, Institution...Big 2015-> ISO 9001:2015
or small,, Public or private,
p ,
Pres
sentasi ISO9001-20

Geograpchical and socio-economic


differences
015/Nov15

6
Training and consulting services

Benefits of Quality System ISO 9000


Improving the companys image and credibility in
international markets which is essential for success in
export business
Enhancement of customer satisfaction
Improvement of your organizations performance and
productivity
Creating quality awareness and more work satisfaction
among personnel
Pres
sentasi ISO9001-20

Reducing scrap, rework and customer complaints


015/Nov15

7
Training and consulting services

Struktur ISO 9001:2015


1. Ruang Lingkup 2. Standar
S Acuan 3. Istilah dan Definisi
f
4. Konteks Organisasi
4.1 Memahami Organisasi dan Konteks Organisasi
4.2 Memahami Kebutuhan dan Harapan Pihak yang Berkepentingan
4.3 Menetapkan Ruang Lingkup Sistem Manajemen Mutu
4 4 Sistem
4.4. Si t M
Manajemen
j M t dan
Mutu d Proses
P
5. Kepemimpinan (Leadership)
5.1 Kepemimpinan
p p dan Komitmen
5.2 Kebijakan Mutu
5.3 Peran Organisasi, Tanggung Jawab dan Wewenang
Pres

6 Perencanaan Sistem Manajemen Mutu


6.
sentasi ISO9001-20

6.1 Penanganan Risiko dan Peluang


6.2 Sasaran Mutu dan Rencana Pencapaian
015/Nov15

6.3 Perubahan Yang Terencana


8
Training and consulting services

Struktur ISO 9001:2015


7. Pendukung
7.1 Sumberdaya
7.2 Kompetensi
7.3 Pelatihan
7.4 Komunikasi
7 5 Informasi
7.5 I f i yang Terdokumentasi
T d k t i
8. Operasi
8.1 Perencanaan dan Pengendalian
g Operasional
p
8.2 Penetapan Persyaratan Produk dan Jasa
8.3 Desain dan Pengembangan Produk dan Jasa
Pres

8 4 Pengendalian Produk & Jasa yang disediakan Pihak Eksternal


8.4
sentasi ISO9001-20

8.5 Produksi dan Penyediaan Jasa


8.6 Merilis Produk dan Jasa
015/Nov15

8.7 Pengendalian Proses, Produk dan Jasa yang Tidak Sesuai


9
Training and consulting services

Struktur ISO 9001:2015


9. Evaluasi Kinerja
9.1 Pemantauan, Pengukuran, Analisis dan Evaluasi
9.2 Audit Internal
9.3 Management Review

10. Perbaikan
10.1 Umum
10.2 Ketidaksesusaian dan Tindakan Koreksi
Pres
sentasi ISO9001-20

10.3 Perbaikan Berkelanjutan


015/Nov15

10
Training and consulting services
Plan Do Check Act
4 9
5 6 7 8 10
Context of Performance
Leadership Planning Support Operation Improvement
organization and Evaluation

4.1 7.1 8.1 91


9.1
5.1
5 1 6.1
6 1 10 1
10.1
Understanding Resources Operational Monitoring,
Leadership and Actions to General
context planning and measurement,
commitment address risks and analysis and
opportunities 7.1.2 control
evaluation
4.2 People 10.2
5.2 8.2
Interested parties Nonconformity
Policy 6.2 Requirements
q for 9.1.2 and corrective
7.1.3
7 13 products and Customer
Quality objectives action
Infrastructure services satisfaction
4.3 5.3 and planning
Scope Organizational
roles, 7.1.4 8.3 10.3
6.3 Environment for the 9.1.3
responsibilities Design and Continual
4.4 Planning of operation of Analysis and
and authorities development of improvement
QMS changes processes evaluation
products and
services
7.1.5 9.2
Monitoring and 8.4 Control of Internal audit
measuring externally
resources provided
p
processes, 9.3
7.1.6 products and Management
Organizational services review
knowledge
8.5
Pres

7.2 Production and


sentasi ISO9001-20

C
Competence
t service provision

7.3
Awareness 8.6
Production and
service provision
7.4
015/Nov15

Communication
8.7
7.5 Control of
Documented nonconforming
information outputs 11
Training and consulting services

4 Klausul 4.1
Context of
organization Organisasi harus menetapkan isu eksternal dan internal
41
4.1
yang
y g relevan dengan
g tujuan
j dan arah organisasi
g yang
y g
Understanding
context
strategis.

4.2 Konteks internal misalnya isu-isu nilai, budaya,


Interested parties
pengetahuan dan kinerja organisasi.
4.3
Scope
Konteks eksternal misalnya
y isu-isu yyang
g berkaitan
4.4
QMS dengan aspek hukum, teknologi, persaingan, pasar,
budaya, sosial dan ekonomi serta lingkungan, baik
internasional nasional maupun regional
internasional, regional.

Klausul 4.2
Pres
sentasi ISO9001-20

Mengidentifikasi pihak-pihak yang berkepentingan


(interested parties) dan persyaratan mereka
015/Nov15

12
Training and consulting services

4 Klausul 4.3
Context of
organization
Ruang lingkup sistem manajemen mutu harus
41
4.1
Understanding
didokumentasikan dengan mempertimbangkan:
context
Isu internal dan eksternal
4.2
Interested parties persyaratan pihak
pihak-pihak
pihak yang berkepentingan
4.3 Produk dan jasa yang dihasilkan
Scope

4.4
justifikasi apabila terdapat persyaratan standar ISO
QMS 9001 yang tidak relevan

Klausul 4.4
Proses-proses dalam organisasi harus diidentifikasi yang
Pres

mencakup:
sentasi ISO9001-20

Input dan output proses


Urutan dan interaksi antarproses
015/Nov15

Sumber daya, tanggung jawab dan aspek risiko


13
Training and consulting services
Plan Do Check Act
4 9
5 6 7 8 10
Context of Performance
Leadership Planning Support Operation Improvement
organization and Evaluation

4.1 7.1 8.1 91


9.1
5.1
5 1 6.1
6 1 10 1
10.1
Understanding Resources Operational Monitoring,
Leadership and Actions to General
context planning and measurement,
commitment address risks and analysis and
opportunities 7.1.2 control
evaluation
4.2 People 10.2
5.2 8.2
Interested parties Nonconformity
Policy 6.2 Requirements
q for 9.1.2 and corrective
7.1.3
7 13 products and Customer
Quality objectives action
Infrastructure services satisfaction
4.3 5.3 and planning
Scope Organizational
roles, 7.1.4 8.3 10.3
6.3 Environment for the 9.1.3
responsibilities Design and Continual
4.4 Planning of operation of Analysis and
and authorities development of improvement
QMS changes processes evaluation
products and
services
7.1.5 9.2
Monitoring and 8.4 Control of Internal audit
measuring externally
resources provided
p
processes, 9.3
7.1.6 products and Management
Organizational services review
knowledge
8.5
Pres

7.2 Production and


sentasi ISO9001-20

C
Competence
t service provision

7.3
Awareness 8.6
Production and
service provision
7.4
015/Nov15

Communication
8.7
7.5 Control of
Documented nonconforming
information outputs 14
Training and consulting services

5
Klausull 5.1.1
Kl 511
Leadership Manajemen puncak harus menunjukkan kepemimpinan &
komitmen terhadap penerapan sistem manajemen mutu:
51
5.1
Leadership and
b t
bertanggung j
jawabb penuh
h atas
t penerapan sistem
i t manajemen
j
commitment
memastikan kebijakan mutu dan sasaran mutu ditetapkan
5.2
Policy
Memastikan sistem manajemen mutu terintegrasi ke dalam
proses bisnis organisasi.
organisasi
5.3
Organizational roles,
mempromosikan process approach dan risk based thinking
responsibilities and
authorities
memastikan kecukupan sumberdaya guna penerapan sistem
manajemen mutu
mengkomunikasikan pentingnya manajemen mutu yang
efektif dan pemenuhan persyaratan sistem manajemen mutu
memastikan sistem manajemen
j mutu mencapai
p hasil yyang
g
diinginkan.
turut serta dan memberi arahan kepada personil agar
berkontribusi terhadap penerapan sistem manajemen mutu
Pres

yang efektif
sentasi ISO9001-20

mempromosikan improvement
mendukung peran jajaran manajemen dalam memperagakan
kepemimpinan mereka di area tanggung jawabnya
015/Nov15

15
Training and consulting services

5
Klausull 5.1.2
Kl 512
Leadership Fokus pelanggan dengan cara :
memenuhi persyaratan pelanggan, perundang-undangan dan
51
5.1 peraturan lain yang berlaku
Leadership and
commitment menetapkan risiko dan peluang yang berpengaruh terhadap
5.2
kesesuaian produk dan jasa telah ditetapkan.
Policy fokus meningkatkan kepuasan pelanggan
5.3
Organizational roles,
responsibilities and
authorities
Pres
sentasi ISO9001-20
015/Nov15

16
Training and consulting services

5 Klausul 5.2
Leadership
Manajemen puncak harus menetapkan kebijakan
51
5.1 mutu
Leadership and
commitment

5.2
Policy Klausul 5.3
5.3 Manajemen puncak harus memastikan bahwa
Organizational roles,
responsibilities and
authorities
tanggung jawab dan wewenang telah ditetapkan,
dikomunikasikan dan dipahami
Pres
sentasi ISO9001-20
015/Nov15

17
Training and consulting services
Plan Do Check Act
4 9
5 6 7 8 10
Context of Performance
Leadership Planning Support Operation Improvement
organization and Evaluation

4.1 7.1 8.1 91


9.1
5.1
5 1 6.1
6 1 10 1
10.1
Understanding Resources Operational Monitoring,
Leadership and Actions to General
context planning and measurement,
commitment address risks and analysis and
opportunities 7.1.2 control
evaluation
4.2 People 10.2
5.2 8.2
Interested parties Nonconformity
Policy 6.2 Requirements
q for 9.1.2 and corrective
7.1.3
7 13 products and Customer
Quality objectives action
Infrastructure services satisfaction
4.3 5.3 and planning
Scope Organizational
roles, 7.1.4 8.3 10.3
6.3 Environment for the 9.1.3
responsibilities Design and Continual
4.4 Planning of operation of Analysis and
and authorities development of improvement
QMS changes processes evaluation
products and
services
7.1.5 9.2
Monitoring and 8.4 Control of Internal audit
measuring externally
resources provided
p
processes, 9.3
7.1.6 products and Management
Organizational services review
knowledge
8.5
Pres

7.2 Production and


sentasi ISO9001-20

C
Competence
t service provision

7.3
Awareness 8.6
Production and
service provision
7.4
015/Nov15

Communication
8.7
7.5 Control of
Documented nonconforming
information outputs 18
Training and consulting services

6 Klausul 6.1
Planning

Risk management
6.1
Actions to address risks
and opportunities Klausul ini mensyaratkan organisasi mengidentifikasi
risiko dan peluang, mengambil tindakan untuk mitigiasi
62
6.2
Objectives and planning
risiko dan evaluasi tindakan yang telah diambil/

6.3
Planning of changes Klausul 6.2

Organisasi harus menentukan sasaran mutu pada fungsi


dan tingkatan yang relevan. Sasaran mutu harus terukur
(SMART)
Pres
sentasi ISO9001-20

Kl
Klausul
l 6.3
63
Perubahan-perubahan harus terkontrol (change
management)
015/Nov15

19
Training and consulting services
Plan Do Check Act
4 9
5 6 7 8 10
Context of Performance
Leadership Planning Support Operation Improvement
organization and Evaluation

4.1 7.1 8.1 91


9.1
5.1
5 1 6.1
6 1 10 1
10.1
Understanding Resources Operational Monitoring,
Leadership and Actions to General
context planning and measurement,
commitment address risks and analysis and
opportunities 7.1.2 control
evaluation
4.2 People 10.2
5.2 8.2
Interested parties Nonconformity
Policy 6.2 Requirements
q for 9.1.2 and corrective
7.1.3
7 13 products and Customer
Objectives and action
Infrastructure services satisfaction
4.3 5.3 planning
Scope Organizational
roles, 7.1.4 8.3 10.3
6.3 Environment for the 9.1.3
responsibilities Design and Continual
4.4 Planning of operation of Analysis and
and authorities development of improvement
QMS changes processes evaluation
products and
services
7.1.5 9.2
Monitoring and 8.4 Control of Internal audit
measuring externally
resources provided
p
processes, 9.3
7.1.6 products and Management
Organizational services review
knowledge
8.5
Pres

7.2 Production and


sentasi ISO9001-20

C
Competence
t service provision

7.3
Awareness 8.6
Production and
service provision
7.4
015/Nov15

Communication
8.7
7.5 Control of
Documented nonconforming
information outputs 20
Training and consulting services

7
Support Klausul 7.1
7.1 Sumber daya harus cukup tersedia untuk penerapan
Resources
sistem manajemen mutu yang meliputi :
7.1.2
People
internal resources
7.1.3
Infrastructure
external providers
people
7.1.4
Environment for the
operation of processes

monitoring and measuring resources


7.1.5

organizational knowledge required to ensure the


Monitoring and
measuring resources

716
7.1.6
processes p
p provide conforming
gpproducts and services
Organizational
knowledge
external communication
7.2
Klausul 7.2
Pres

Competence
sentasi ISO9001-20

7.3
Awareness Kompetensi personil harus ditetapkan
7.4
Communication Kompetensi
p berdasarkan p
pendidikan,, p
pelatihan dan
015/Nov15

7.5
pengalama kerja
Documented information
21
Training and consulting services

7
Support Klausul 7.3 dan 7.4
7.1 Personil yang bekerja dibawah kendali organisasi harus
Resources
memahami sistem manajemen organisasi
7.1.2
People
Saluran komunikasi internal dan eksternal harus
7.1.3
Infrastructure ditetapkan
p
7.1.4
Environment for the
operation of processes
Klausul 7.5.
7.1.5
Monitoring and
measuring resources
Dokumen yang beredar harus terkontrol: SOP,
Working Instruction, formulir, dll.
716
7.1.6


Organizational
knowledge Pengendalian dokumen internal dan eksternal
7.2
Competence Media dokumen termasuk kertas, video, sample, foto,
Pres
sentasi ISO9001-20

7.3
Awareness
dll
7.4 Providing people with the information they need
Communication
015/Nov15

7.5
Documented
information
22
Training and consulting services
Plan Do Check Act
4 9
5 6 7 8 10
Context of Performance
Leadership Planning Support Operation Improvement
organization and Evaluation

4.1 7.1 8.1 91


9.1
5.1
5 1 6.1
6 1 10 1
10.1
Understanding Resources Operational Monitoring,
Leadership and Actions to General
context planning and measurement,
commitment address risks and analysis and
opportunities 7.1.2 control
evaluation
4.2 People 10.2
5.2 8.2
Interested parties Nonconformity
Policy 6.2 Requirements
q for 9.1.2 and corrective
7.1.3
7 13 products and Customer
Objectives and action
Infrastructure services satisfaction
4.3 5.3 planning
Scope Organizational
roles, 7.1.4 8.3 10.3
6.3 Environment for the 9.1.3
responsibilities Design and Continual
4.4 Planning of operation of Analysis and
and authorities development of improvement
QMS changes processes evaluation
products and
services
7.1.5 9.2
Monitoring and 8.4 Control of Internal audit
measuring externally
resources provided
p
processes, 9.3
7.1.6 products and Management
Organizational services review
knowledge
8.5
Pres

7.2 Production and


sentasi ISO9001-20

C
Competence
t service provision

7.3
Awareness 8.6
Production and
service provision
7.4
015/Nov15

Communication
8.7
7.5 Control of
Documented nonconforming
information outputs 23
Training and consulting services

8 Klausul 8.1
Operation
Organisasi wajib melakukan kontrol proses
8.1
Operational
planning and
Proses termasuk proses outsourcing
control

8.2
Klausul 8.2.1
Requirements
q for
products and
services Customer communications; customer property, and
8.3
contingency actions
Design and
development of
products and Klausul 8.2.2
822
services

8.4 Control of Menetapkan persyaratan pelanggan; termasuk


externally
provided
p peraturan p
p perundang-undangan
g g dan p peraturan
processes,
products and organisasi
services

8.5 Klausul 8.2.3


Pres

Production and
sentasi ISO9001-20

service provision
Melakukan review terhadap persyaratan barang dan
8.6
Production and jasa untuk memastikan organisasi dapat memenuhi
service provision
persyaratan yang ditetapkan atau tidak
015/Nov15

8.7
Control of
nonconforming
outputs 24
Training and consulting services

8 Klausul 8.3
Operation
Proses desain dan pengembangan harus terkendali
8.1
Operational
planning and
perencanaan desain
control

8.2
input desain
Requirements
q for
products and
services kontrol desain
8.3
Design and
output desain
development of
products and
services
perubahan desain
8.4 Control of
externally
provided
p Klausul 8.4
processes,
products and
services Organisasi harus memastikan bahwa barang yang dibeli
8.5 sesuai dengan persyaratan yang telah ditentukan
Pres

Production and
sentasi ISO9001-20

service provision

8.6
Production and
service provision
015/Nov15

8.7
Control of
nonconforming
outputs 25
Training and consulting services

8
Operation Klausul 8.5.1
8.1 Organisasi
g harus memastikan p
proses p
produksi dan
Operational
planning and jasa berlangsung dalam kondisi terkendali
control

8.2
Requirements
q for
Klausul 8.5.2
products and
services Persyaratan identifikasi dan mampu telusur
8.3
Design and Klausul 8.5.3
development of
products and
services Persyaratan properti pelanggan
8.4 Control of
externally
provided
p
Klausul 8.5.4
processes,
products and
services
Persyaratan preservasi (penyimpanan)
8.5 Klausul 8.5.5
Pres

Production and
sentasi ISO9001-20

service provision
Persyaratan proses pengiriman dan after sales
8.6
Production and
service provision Klausul 8.5.6
015/Nov15

8.7 Persyaratan management of change


Control of
nonconforming
outputs 26
Training and consulting services

8 Klausul 8.6
Operation
Peryaratan untuk rilis produk dan jasa
8.1
Operational
planning and
Evidence of conformity with the acceptance criteria
control

8.2
Traceability to the person authorizing the release
Requirements
q for
products and
services

8.3
Design and
Klausul 8.7
development of
products and
services
nonconforming outputs shall be controlled.
8.4 Control of
externally
provided
p
processes,
products and
services

8.5
Pres

Production and
sentasi ISO9001-20

service provision

8.6
Production and
service provision
015/Nov15

8.7
Control of
nonconforming
outputs 27
Training and consulting services
Plan Do Check Act
4 9
5 6 7 8 10
Context of Performance
Leadership Planning Support Operation Improvement
organization and Evaluation

4.1 7.1 8.1 91


9.1
5.1
5 1 6.1
6 1 10 1
10.1
Understanding Resources Operational Monitoring,
Leadership and Actions to General
context planning and measurement,
commitment address risks and analysis and
opportunities 7.1.2 control
evaluation
4.2 People 10.2
5.2 8.2
Interested parties Nonconformity
Policy 6.2 Requirements
q for 9.1.2 and corrective
7.1.3
7 13 products and Customer
Objectives and action
Infrastructure services satisfaction
4.3 5.3 planning
Scope Organizational
roles, 7.1.4 8.3 10.3
6.3 Environment for the 9.1.3
responsibilities Design and Continual
4.4 Planning of operation of Analysis and
and authorities development of improvement
QMS changes processes evaluation
products and
services
7.1.5 9.2
Monitoring and 8.4 Control of Internal audit
measuring externally
resources provided
p
processes, 9.3
7.1.6 products and Management
Organizational services review
knowledge
8.5
Pres

7.2 Production and


sentasi ISO9001-20

C
Competence
t service provision

7.3
Awareness 8.6
Production and
service provision
7.4
015/Nov15

Communication
8.7
7.5 Control of
Documented nonconforming
information outputs 28
Training and consulting services

9
Performance Klausul 9.1.1
evaluation
Organisasi harus melakukan evaluasi terhadap kinerja
91
9.1
Monitoring,
sistem manajemen mutu
measurement, analysis
and evaluation

9.1.2 Klausul 9.1.2


Customer satisfaction

Kepuasan pelanggan harus dimonitor


9.1.3
Analysis and evaluation

9.2
Klausul 9.1.3
Internal audit
Organisasi harus melakukan analisa dan evaluasi data
9.3
Management review
dan informasi
f yang berasal dari proses pemantauan
dan pengukuran.
Pres
sentasi ISO9001-20
015/Nov15

29
Training and consulting services

9
Performance Klausul 9.2
evaluation
Audit internal harus dilakukan secara berkala
Program
91
9.1
Monitoring, P audit
dit h
harus dib
dibuatt d
dan di
disahkan
hk
measurement, analysis
and evaluation
Audit internal harus dilaksanakan oleh auditor internal
9.1.2 yang independen dan berkualifikasi
Customer satisfaction

Laporan audit harus tersedia yang berisi tindakan


9.1.3
Analysis and evaluation
perbaikan

9.2
Internal audit

9.3
Management review
Pres
sentasi ISO9001-20
015/Nov15

30
Training and consulting services

9
Performance Klausul 9.3 Management review
evaluation
Management review (tinjauan manajemen) harus dilakukan secara
91
9.1
berkala.
Monitoring,
measurement, analysis Agenda pembahasan management review meliputi
and evaluation
1. perubahan isu eksternal dan internal
9.1.2
Customer satisfaction 2 informasi
2. i f i ki
kinerja
j ddan efektifitas
f ktifit sistem
i t manajemen
j mutu,
t
3. kepuasan pelanggan dan feedback pihak yang
9.1.3 berkepentingan
Analysis and evaluation
4. tingkat pemenuhan sasaran mutu
9.2
Internal audit 5. ketidaksesuaian dan tindakan koreksi
6. hasil p
pemantauan dan p
pengukuran
g
9.3
Management review 7. hasil audit
8. kinerja proses dan kesesuaian produk dan jasa
Pres

9 kinerja
9. ki j external
t l provider
id
sentasi ISO9001-20

10. kecukupan sumber daya


11. efektivitas tindakan yang diambil terhadap risiko dan peluang
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12. peluang untuk perbaikan kinerja


13. status tindak lanjut dari management review yang lalu,
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Training and consulting services
Plan Do Check Act
4 9
5 6 7 8 10
Context of Performance
Leadership Planning Support Operation Improvement
organization and Evaluation

4.1 7.1 8.1 91


9.1
5.1
5 1 6.1
6 1 10 1
10.1
Understanding Resources Operational Monitoring,
Leadership and Actions to General
context planning and measurement,
commitment address risks and analysis and
opportunities 7.1.2 control
evaluation
4.2 People 10.2
5.2 8.2
Interested parties Nonconformity
Policy 6.2 Requirements
q for 9.1.2 and corrective
7.1.3
7 13 products and Customer
Objectives and action
Infrastructure services satisfaction
4.3 5.3 planning
Scope Organizational
roles, 7.1.4 8.3 10.3
6.3 Environment for the 9.1.3
responsibilities Design and Continual
4.4 Planning of operation of Analysis and
and authorities development of improvement
QMS changes processes evaluation
products and
services
7.1.5 9.2
Monitoring and 8.4 Control of Internal audit
measuring externally
resources provided
p
processes, 9.3
7.1.6 products and Management
Organizational services review
knowledge
8.5
Pres

7.2 Production and


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C
Competence
t service provision

7.3
Awareness 8.6
Production and
service provision
7.4
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Communication
8.7
7.5 Control of
Documented nonconforming
information outputs 32
Training and consulting services

10
Klausul 10.1
Improvement Organisasi harus mengambil tindakan improvemnet yang
diperlukan guna memenuhi persyaratan pelanggan dan
10 1
10.1 meningkatkan kepuasan pelanggan.
pelanggan
General

CATATAN: Contoh improvement misalnya tindakan koreksi,


10.2 Nonconformity and
corrective action korektif, perbaikan kontinyu, langkah perubahan (misalnya
terobosan), inovasi atau re-organisasi
10.3
Continual improvement Klausul 10.2
Tindakan perbaikan harus dilakukan bila terjadi ketidaksesuaian
(nonconformity)

Klausul 10.3
10 3
Organisasi harus meningkatkan kesesuaian, kecukupan dan
efektivitas sistem manajemen mutu secara terus-menerus
Pres

(continual improvement).
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33
Training and consulting services

Thank You
Zulkifli Nasution 0818 772411
zulnasution@yahoo com
[email protected]

SINTEGRAL Consulting
www sintegral com
www.sintegral.com
Pres
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015/Nov15

34

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