ISO Management System

(1)

SINTEGRAL C

lti

SINTEGRAL Consulting

ISO Management System

Phone (021) 726 4126

Fax (021) 726 4127

Grand Wijaya Center Blok H 9

Jl. Wijaya II, Jakarta Selatan

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,

Email: [email protected]

www.sintegral.com

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SINTEGRAL S

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Training and consulting for:

SINTEGRAL Services

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 Quality Management System ISO 9000

 Environmental Management System ISO 14000

 Food Safety Management System ISO 22000 and HACCP

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O

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d S f t OHSAS 18001

 Management System for Occupational and Safety OHSAS 18001

 Information Security Management System ISO 27001

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 Cosmetics – Good Manufacturing Practices (GMP) ISO 22716

 Automotive Quality Management ISO/TS 16949

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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

Visit Quality Club

https://groups.yahoo.com/neo/groups/QualityClub/info

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Quality Systems: Strategy for the future

ISO 9001 201

Qua ty Syste s St ategy o t e utu e

ISO 9001:2015

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International

Organization for

Standardization



Organisasi Standardisasi Internasional (non

governmental) yang beranggotakan 140 Dewan

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d di

i N

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l

Standardisasi Nasional



Sejak 1947 ISO telah menerbitkan 25.000 standar

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internasional

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ISO b

if t

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)

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 Adopsi standar ISO bersifat sukarela (voluntary)

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ISO 9001:2015

Q

S



Quality Management Standard ->

Menghasilkan Barang dan jasa yang

Berkualitas - > Customer satisfaction

Sejarah ISO 9001

1987-> ISO 9001:1987

Berkualitas

Customer satisfaction



Bukan standar produk

1994-> ISO 9001:1994

2000 > ISO 9001:2000



Bersifat umum (Generic)



Berlaku bagi semua jenis organisasi

2000-> ISO 9001:2000

2008-> ISO 9001:2008

Pre

s



Berlaku bagi semua jenis organisasi



Manufacturing, Service, Institution...Big

or small, Public or private,

2015-> ISO 9001:2015

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Benefits of Quality System ISO 9000

Improving the company’s image and credibility in

international markets which is essential for success in

export business

Enhancement of customer satisfaction

Improvement of your organization’s performance and

productivity

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Creating quality awareness and more work satisfaction

among personnel

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Reducing scrap, rework and customer complaints

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Struktur ISO 9001:2015

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f

1. Ruang Lingkup

2. Standar Acuan

3. Istilah dan Definisi

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 Si t

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M t d

P

4.4. Sistem Manajemen Mutu dan Proses

5. Kepemimpinan (Leadership)

5.1 Kepemimpinan dan Komitmen

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5.2 Kebijakan Mutu

5.3 Peran Organisasi, Tanggung Jawab dan Wewenang

6 Perencanaan Sistem Manajemen Mutu

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6. Perencanaan Sistem Manajemen Mutu

6.1 Penanganan Risiko dan Peluang

6.2 Sasaran Mutu dan Rencana Pencapaian

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Struktur ISO 9001:2015

7. Pendukung

7.1 Sumberdaya

7.2 Kompetensi

7.3 Pelatihan

7.4 Komunikasi

7 5 I f

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T d k

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7.5 Informasi yang Terdokumentasi

8. Operasi

8.1 Perencanaan dan Pengendalian Operasional

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8.2 Penetapan Persyaratan Produk dan Jasa

8.3 Desain dan Pengembangan Produk dan Jasa

8 4 Pengendalian Produk & Jasa yang disediakan Pihak Eksternal

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8.4 Pengendalian Produk & Jasa yang disediakan Pihak Eksternal

8.5 Produksi dan Penyediaan Jasa

8.6 Merilis Produk dan Jasa

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Struktur ISO 9001:2015

9. Evaluasi Kinerja

9.1 Pemantauan, Pengukuran, Analisis dan Evaluasi

9.2 Audit Internal

9.3 Management Review

10. Perbaikan

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10.1 Umum

10.2 Ketidaksesusaian dan Tindakan Koreksi

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10.3 Perbaikan Berkelanjutan

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Do

_Check

_Act

Plan

5 Leadership

6 Planning

8 Operation

9 Performance

and Evaluation

10 Improvement

5 1 6 1 8.1 9 19.1

7 Support

7.1 _{10 1}

4 Context of

organization

4.1 5.1 Leadership and commitment 6.1 Actions to address risks and

opportunities 6.2 evaluation Monitoring, measurement, analysis and evaluation 10.2 Nonconformity and corrective 8.1 Operational planning and control 5.2 Policy 9.1.2 7.1 Resources 7.1.2 People 7 1 3 10.1 General 8.2 Requirements for Understanding context 4.2 Interested parties Quality objectives and planning and corrective action 10.3 Continual improvement 5.3 Organizational roles, responsibilities and authorities 6.3 Planning of changes Customer satisfaction 9.1.3 Analysis and evaluation 7.1.4

Environment for the operation of 7.1.3 Infrastructure q products and services 8.3 Design and development of 4.3 Scope 4.4 QMS 9.2 Internal audit changes _processes evaluation

7.1.5 Monitoring and measuring resources development of products and services 8.4 Control of externally provided QMS Pre s 9.3 Management review 7.2 C t 7.1.6 Organizational knowledge p processes, products and services 8.5 Production and s entasi ISO90 0 1 -2 0 7.3 Awareness 7.4

Competence _{service provision}

8.6 Production and service provision

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Klausul 4.1

Organisasi harus menetapkan isu eksternal dan internal

yang relevan dengan tujuan dan arah organisasi yang

4 Context of

organization

4 1

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g

j

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y

g

strategis.

4.1 Understanding

context

4.2 Interested parties

 Konteks internal misalnya isu-isu nilai, budaya,

Interested parties

4.3 Scope

pengetahuan dan kinerja organisasi.

 Konteks eksternal misalnya isu-isu yang berkaitan

4.4 QMS

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dengan aspek hukum, teknologi, persaingan, pasar,

budaya, sosial dan ekonomi serta lingkungan, baik

internasional nasional maupun regional

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Klausul 4.2

internasional, nasional maupun regional.

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Mengidentifikasi pihak-pihak yang berkepentingan

(interested parties) dan persyaratan mereka

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4 Context of

organization

4 1

Klausul 4.3

Ruang lingkup sistem manajemen mutu harus

didokumentasikan dengan mempertimbangkan:

4.1 Understanding

context

4.2 Interested parties

didokumentasikan dengan mempertimbangkan:

 Isu internal dan eksternal

 persyaratan pihak pihak yang berkepentingan

Interested parties

4.3 Scope

 persyaratan pihak-pihak yang berkepentingan

 Produk dan jasa yang dihasilkan

 justifikasi apabila terdapat persyaratan standar ISO

4.4 QMS

 justifikasi apabila terdapat persyaratan standar ISO

9001 yang tidak relevan

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Klausul 4.4

Proses-proses dalam organisasi harus diidentifikasi yang

mencakup:

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mencakup:

 Input dan output proses

 Urutan dan interaksi antarproses

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 Urutan dan interaksi antarproses

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5 Leadership

6 Planning

8 Operation

9 Performance

and Evaluation

10 Improvement

5 1 6 1 8.1 9 19.1

7 Support

7.1 _{10 1}

4 Context of

organization

4.1 5.1 Leadership and commitment 6.1 Actions to address risks and

opportunities 6.2 evaluation Monitoring, measurement, analysis and evaluation 10.2 Nonconformity and corrective 8.1 Operational planning and control 5.2 Policy 9.1.2 7.1 Resources 7.1.2 People 7 1 3 10.1 General 8.2 Requirements for Understanding context 4.2 Interested parties Quality objectives and planning and corrective action 10.3 Continual improvement 5.3 Organizational roles, responsibilities and authorities 6.3 Planning of changes Customer satisfaction 9.1.3 Analysis and evaluation 7.1.4

Environment for the operation of 7.1.3 Infrastructure q products and services 8.3 Design and development of 4.3 Scope 4.4 QMS 9.2 Internal audit changes _processes evaluation

8.6 Production and service provision 0 15 /N o v 15 Communication 8.7

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Kl

l 5 1 1

5 Leadership

5 1

Klausul 5.1.1

Manajemen puncak harus menunjukkan kepemimpinan &

komitmen terhadap penerapan sistem manajemen mutu:

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5.1 Leadership and commitment 5.2 Policy

bertanggung jawab penuh atas penerapan sistem manajemen

 memastikan kebijakan mutu dan sasaran mutu ditetapkan

 Memastikan sistem manajemen mutu terintegrasi ke dalam

proses bisnis organisasi

5.3

Organizational roles, responsibilities and

authorities

proses bisnis organisasi.

 mempromosikan process approach dan risk based thinking

 memastikan kecukupan sumberdaya guna penerapan sistem

manajemen mutu

 mengkomunikasikan pentingnya manajemen mutu yang

efektif dan pemenuhan persyaratan sistem manajemen mutu

 memastikan sistem manajemen mutu mencapai hasil yang

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diinginkan.

 turut serta dan memberi arahan kepada personil agar

berkontribusi terhadap penerapan sistem manajemen mutu

yang efektif

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yang efektif

 mempromosikan improvement

 mendukung peran jajaran manajemen dalam memperagakan

kepemimpinan mereka di area tanggung jawabnya

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Kl

l 5 1 2

5 Leadership

5 1

Klausul 5.1.2

Fokus pelanggan dengan cara :

 memenuhi persyaratan pelanggan, perundang-undangan dan

peraturan lain yang berlaku

5.1 Leadership and

commitment 5.2 Policy

peraturan lain yang berlaku

 menetapkan risiko dan peluang yang berpengaruh terhadap

kesesuaian produk dan jasa telah ditetapkan.

 fokus meningkatkan kepuasan pelanggan

5.3

Organizational roles, responsibilities and

authorities

fokus meningkatkan kepuasan pelanggan

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5 Leadership

5 1

Klausul 5.2

 Manajemen puncak harus menetapkan kebijakan

mutu

5.1 Leadership and commitment 5.2 Policy

mutu

Klausul 5.3

5.3 Organizational roles, responsibilities and authorities

 Manajemen puncak harus memastikan bahwa

tanggung jawab dan wewenang telah ditetapkan,

dikomunikasikan dan dipahami

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6 Planning

8 Operation

9 Performance

and Evaluation

10 Improvement

6 1 8.1 9 19.1

7 Support

7.1 _{10 1}

4 Context of

organization

4.1

5 Leadership

5 1 6.1 Actions to address risks and

opportunities 6.2 evaluation Monitoring, measurement, analysis and evaluation 10.2 Nonconformity and corrective 8.1 Operational planning and control 9.1.2 7.1 Resources 7.1.2 People 7 1 3 10.1 General 8.2 Requirements for Understanding context 4.2 Interested parties 5.1 Leadership and commitment 5.2 Policy Quality objectives and planning and corrective action 10.3 Continual improvement 6.3 Planning of changes Customer satisfaction 9.1.3 Analysis and evaluation 7.1.4

Environment for the operation of 7.1.3 Infrastructure q products and services 8.3 Design and development of 4.3 Scope 4.4 QMS 5.3 Organizational roles, responsibilities and authorities 9.2 Internal audit changes _processes evaluation

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6 Planning

Klausul 6.1

Risk management

6.1

Actions to address risks and opportunities

6 2

Klausul ini mensyaratkan organisasi mengidentifikasi

risiko dan peluang, mengambil tindakan untuk mitigiasi

risiko dan evaluasi tindakan yang telah diambil/

6.2

Objectives and planning

6.3

Planning of changes

risiko dan evaluasi tindakan yang telah diambil/

Klausul 6.2

Organisasi harus menentukan sasaran mutu pada fungsi

dan tingkatan yang relevan. Sasaran mutu harus terukur

Pre s

(SMART)

Kl

l 6 3

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Klausul 6.3

Perubahan-perubahan harus terkontrol (change

management)

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management)

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8 Operation

9 Performance

and Evaluation

10 Improvement

9 1 9.1 8.1

7 Support

7.1 _{10 1}

4 Context of

organization

4.1

5 Leadership

5 1

6 Planning

6 1 evaluation Monitoring, measurement, analysis and evaluation 10.2 Nonconformity and corrective 8.1 Operational planning and control 9.1.2 7.1 Resources 7.1.2 People 7 1 3 10.1 General 8.2 Requirements for Understanding context 4.2 Interested parties 5.1 Leadership and commitment 5.2 Policy 6.1 Actions to address risks and

opportunities 6.2 and corrective action 10.3 Continual improvement Customer satisfaction 9.1.3 Analysis and evaluation 7.1.4

Environment for the operation of 7.1.3 Infrastructure q products and services 8.3 Design and development of 4.3 Scope 4.4 QMS 5.3 Organizational roles, responsibilities and authorities Objectives and planning 6.3 Planning of changes 9.2 Internal audit evaluation processes 7.1.5 Monitoring and measuring resources development of products and services 8.4 Control of externally provided QMS changes Pre s 9.3 Management review 7.2 C t 7.1.6 Organizational knowledge p processes, products and services 8.5 Production and s entasi ISO90 0 1 -2 0 7.3 Awareness 7.4

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7

7.1 Resources

7 Support

Klausul 7.1

Sumber daya harus cukup tersedia untuk penerapan

sistem manajemen mutu yang meliputi :

7.1.2 People

7.1.3 Infrastructure

sistem manajemen mutu yang meliputi :

 internal resources

 external providers

7.1.4 Environment for the operation of processes

 external providers

 people

 monitoring and measuring resources

7.1.5 Monitoring and measuring resources

7 1 6

 monitoring and measuring resources

 organizational knowledge required to ensure the

processes provide conforming products and services

Pre s 7.2 Competence 7.1.6 Organizational knowledge

p

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 external communication

Klausul 7.2

s entasi ISO90 0 1 -2 0 7.3 Awareness 7.4 Communication

 Kompetensi personil harus ditetapkan

 Kompetensi berdasarkan pendidikan, pelatihan dan

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pengalama kerja

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7

7.1 Resources

7 Support

Klausul 7.3 dan 7.4

 Personil yang bekerja dibawah kendali organisasi harus

memahami sistem manajemen organisasi

7.1.2 People 7.1.3 Infrastructure

memahami sistem manajemen organisasi

 Saluran komunikasi internal dan eksternal harus

ditetapkan

7.1.4 Environment for the operation of processes

p

Klausul 7.5.

7.1.5 Monitoring and measuring resources 7 1 6

Klausul 7.5.



Dokumen yang beredar harus terkontrol: SOP,

Working Instruction, formulir, dll.

Pre s 7.2 Competence 7.1.6 Organizational

knowledge



Pengendalian dokumen internal dan eksternal



Media dokumen termasuk kertas, video, sample, foto,

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

Providing people with the information they need

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Do

_Check

_Act

Plan

8 Operation

9 Performance

and Evaluation

10 Improvement

9 1 9.1 8.1 _{10 1}

4 Context of

organization

4.1

5 Leadership

5 1

6 Planning

6 1

7 Support

7.1 evaluation Monitoring, measurement, analysis and evaluation 10.2 Nonconformity and corrective 8.1 Operational planning and control 9.1.2 10.1 General 8.2 Requirements for Understanding context 4.2 Interested parties 5.1 Leadership and commitment 5.2 Policy 6.1 Actions to address risks and

opportunities 6.2 7.1 Resources 7.1.2 People 7 1 3 and corrective action 10.3 Continual improvement Customer satisfaction 9.1.3 Analysis and evaluation q products and services 8.3 Design and development of 4.3 Scope 4.4 QMS 5.3 Organizational roles, responsibilities and authorities Objectives and planning 6.3 Planning of changes 7.1.4 Environment for the

operation of 7.1.3 Infrastructure 9.2 Internal audit evaluation development of products and services 8.4 Control of externally provided QMS changes processes 7.1.5 Monitoring and measuring resources Pre s 9.3 Management review p processes, products and services 8.5 Production and 7.2 C t 7.1.6 Organizational knowledge s entasi ISO90 0 1 -2 0 service provision 8.6 Production and service provision 7.3 Awareness 7.4 Competence

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8 Operation

8.1

Klausul 8.1

 Organisasi wajib melakukan kontrol proses

8.1 Operational planning and control 8.2 Requirements for

 Proses termasuk proses outsourcing

Klausul 8.2.1

q products and services 8.3 Design and development of

 Customer communications; customer property, and

contingency actions

Klausul 8 2 2

development of products and services 8.4 Control of externally provided

Klausul 8.2.2

 Menetapkan persyaratan pelanggan; termasuk

peraturan perundang-undangan dan peraturan

Pre s p processes, products and services 8.5 Production and

p

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organisasi

Klausul 8.2.3

s entasi ISO90 0 1 -2 0 service provision 8.6 Production and service provision

 Melakukan review terhadap persyaratan barang dan

jasa untuk memastikan organisasi dapat memenuhi

persyaratan yang ditetapkan atau tidak

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8 Operation

8.1

Klausul 8.3

Proses desain dan pengembangan harus terkendali

 perencanaan desain

 input desain

 kontrol desain

 output desain

 perubahan desain

Klausul 8.4

Organisasi harus memastikan bahwa barang yang dibeli

sesuai dengan persyaratan yang telah ditentukan

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8 Operation

8.1

Klausul 8.5.1

 Organisasi harus memastikan proses produksi dan

g

p

jasa berlangsung dalam kondisi terkendali

Klausul 8.5.2

 Persyaratan identifikasi dan mampu telusur

Klausul 8.5.3

 Persyaratan properti pelanggan

Klausul 8.5.4

 Persyaratan preservasi (penyimpanan)

Klausul 8.5.5

 Persyaratan proses pengiriman dan after sales

Klausul 8.5.6

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8 Operation

8.1

Klausul 8.6

 Peryaratan untuk rilis produk dan jasa

 Evidence of conformity with the acceptance criteria

 Traceability to the person authorizing the release

Klausul 8.7

 nonconforming outputs shall be controlled.

Pre s p processes, products and services 8.5 Production and s entasi ISO90 0 1 -2 0 service provision 8.6 Production and service provision

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8 Operation

9 Performance

and Evaluation

10 Improvement

9 1 9.1 8.1 _{10 1}

4 Context of

organization

4.1

5 Leadership

5 1

6 Planning

6 1

7 Support

operation of 7.1.3 Infrastructure 9.2 Internal audit evaluation development of products and services 8.4 Control of externally provided QMS changes processes 7.1.5 Monitoring and measuring resources Pre s 9.3 Management review p processes, products and services 8.5 Production and 7.2 C t 7.1.6 Organizational knowledge s entasi ISO90 0 1 -2 0 service provision 8.6 Production and service provision 7.3 Awareness 7.4 Competence 0 15 /N o v 15 8.7 Communication

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9 Performance

evaluation

9 1

Klausul 9.1.1

 Organisasi harus melakukan evaluasi terhadap kinerja

sistem manajemen mutu

9.1.2 9.1 Monitoring, measurement, analysis

and evaluation

sistem manajemen mutu

Klausul 9.1.2

9.1.2

Customer satisfaction

9.1.3

Analysis and evaluation

Klausul 9.1.2

 Kepuasan pelanggan harus dimonitor

9.2 Internal audit

Klausul 9.1.3

 Organisasi harus melakukan analisa dan evaluasi data

f

Pre

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9.3

Management review

dan informasi yang berasal dari proses pemantauan

dan pengukuran.

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9 Performance

evaluation

9 1

Klausul 9.2

 Audit internal harus dilakukan secara berkala

P

dit h

dib

t d

di

hk

9.1.2 9.1 Monitoring, measurement, analysis and evaluation

 Program audit harus dibuat dan disahkan

 Audit internal harus dilaksanakan oleh auditor internal

yang independen dan berkualifikasi

9.1.2

9.1.3

yang independen dan berkualifikasi

 Laporan audit harus tersedia yang berisi tindakan

perbaikan

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9 Performance

evaluation

9 1

Klausul 9.3 Management review

 Management review (tinjauan manajemen) harus dilakukan secara

berkala.

9.1.2 9.1 Monitoring, measurement, analysis and evaluation

 Agenda pembahasan management review meliputi

1. perubahan isu eksternal dan internal

2 i f

i ki

j d

f ktifit

i t

j

t

9.1.2

9.1.3

2. informasi kinerja dan efektifitas sistem manajemen mutu,

3. kepuasan pelanggan dan feedback pihak yang

berkepentingan

9.2 Internal audit

4. tingkat pemenuhan sasaran mutu

5. ketidaksesuaian dan tindakan koreksi

6. hasil pemantauan dan pengukuran

Pre s 9.3 Management review

p

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7. hasil audit

8. kinerja proses dan kesesuaian produk dan jasa

9 ki

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9. kinerja external provider

10. kecukupan sumber daya

11. efektivitas tindakan yang diambil terhadap risiko dan peluang

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12. peluang untuk perbaikan kinerja

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8 Operation

9 Performance

and Evaluation

10 Improvement

9 1 9.1 8.1 _{10 1}

4 Context of

organization

4.1

5 Leadership

5 1

6 Planning

6 1

7 Support

operation of 7.1.3 Infrastructure 9.2 Internal audit evaluation development of products and services 8.4 Control of externally provided QMS changes processes 7.1.5 Monitoring and measuring resources Pre s 9.3 Management review p processes, products and services 8.5 Production and 7.2 C t 7.1.6 Organizational knowledge s entasi ISO90 0 1 -2 0 service provision 8.6 Production and service provision 7.3 Awareness 7.4 Competence 0 15 /N o v 15 8.7 Communication

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10 Improvement

10 1

Klausul 10.1

 Organisasi harus mengambil tindakan improvemnet yang

diperlukan guna memenuhi persyaratan pelanggan dan

meningkatkan kepuasan pelanggan

10.2 Nonconformity and corrective action

10.1

General

meningkatkan kepuasan pelanggan.

 CATATAN: Contoh improvement misalnya tindakan koreksi,

korektif, perbaikan kontinyu, langkah perubahan (misalnya

corrective action

10.3

Continual improvement

korektif, perbaikan kontinyu, langkah perubahan (misalnya

terobosan), inovasi atau re-organisasi

Klausul 10.2

 Tindakan perbaikan harus dilakukan bila terjadi ketidaksesuaian

(nonconformity)

Klausul 10 3

Pre

s

Klausul 10.3

 Organisasi harus meningkatkan kesesuaian, kecukupan dan

efektivitas sistem manajemen mutu secara terus-menerus

(continual improvement).

s entasi ISO90 0 1 -2 0

(continual improvement).

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Thank You

Zulkifli Nasution 0818 772411

zulnasution@yahoo com

[email protected]

Pre s

SINTEGRAL Consulting

www sintegral com

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