Klausul ISO 9001 2015 SINTEGRAL PDF
Klausul ISO 9001 2015 SINTEGRAL PDF
Klausul ISO 9001 2015 SINTEGRAL PDF
SINTEGRAL C
Consulting
lti
ISO Management System
Phone (021) 726 4126
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Email: [email protected]
www.sintegral.com
Pres
sentasi ISO9001-20
015/Nov15
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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
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015/Nov15
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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
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sentasi ISO9001-20
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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
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International
Organization for
Standardization
Organisasi Standardisasi Internasional (non
governmental) yang beranggotakan 140 Dewan
St d di
Standardisasi
i Nasional
N i l
Ad
Adopsi
i standar
t d ISO bersifat
b if t sukarela
k l (voluntary)
( l t )
sentasi ISO9001-20
015/Nov15
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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
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Training and consulting services
10. Perbaikan
10.1 Umum
10.2 Ketidaksesusaian dan Tindakan Koreksi
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sentasi ISO9001-20
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Plan Do Check Act
4 9
5 6 7 8 10
Context of Performance
Leadership Planning Support Operation Improvement
organization and Evaluation
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 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.
Klausul 4.2
Pres
sentasi ISO9001-20
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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
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 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
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Training and consulting services
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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
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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
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sentasi ISO9001-20
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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
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 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
Kl
Klausul
l 6.3
63
Perubahan-perubahan harus terkontrol (change
management)
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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
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 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
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
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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
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7.5
Documented
information
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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
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 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
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
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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
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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 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
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
9.2
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.
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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
9.2
Internal audit
9.3
Management review
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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
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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
Klausul 10.3
10 3
Organisasi harus meningkatkan kesesuaian, kecukupan dan
efektivitas sistem manajemen mutu secara terus-menerus
Pres
(continual improvement).
sentasi ISO9001-20
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Training and consulting services
Thank You
Zulkifli Nasution 0818 772411
zulnasution@yahoo com
[email protected]
SINTEGRAL Consulting
www sintegral com
www.sintegral.com
Pres
sentasi ISO9001-20
015/Nov15
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