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SOLUSI MANAJEMEN
MADANI www.solusimadani.com
8 Hal Baru di Sistem
Manajemen Mutu
ISO 9001:2015
8 Something New on Quality Management
System ISO 9001:2015
Ekhsan Hari Nuryanto
SOLUSI MANAJEMEN
MADANI www.solusimadani.com
Struktur & Terminologi Structure & Terminology
1
ISO 9001:2008 ISO 9001:2015
8 Klausul
Exclusion
MR
Document, record
Work Environment
Monitoring & Measuring
Equipment
Purchased Products
Supplier
10 Klausul
Not Used
Not Used
Doc. information
Env. for operation
Monitoring & Measuring
Resources
Externally provided
Externally povider
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MADANI www.solusimadani.com
Produk & Layanan Products & Services
2
Kualitas produk & layanan tidak dapat dipisahkan. Produk
berwujud atau tidak berwujud dapat memiliki beberapa
layanan terkait atau layanan dapat memiliki beberapa
produk terkait.
SOLUSI MANAJEMEN
MADANI www.solusimadani.com
Pemahaman Kebutuhan & Harapan Para Pihak Terkait Understanding of Needs & Expectations of Interested Parties
3
Tujuan dari setiap organisasi adalah adanya keberlangsungan usaha. Kemampuan untuk beradaptasi ditunjukkan dari kemampuan untuk memahami kebutuhan dan harapan para pihak terkait.
SOLUSI MANAJEMEN
MADANI www.solusimadani.com
Pemikiran Berbasis Resiko Risk Based Thinking
4
Setiap strategi harus
mempertimbangkan kekuatan, risiko
yang muncul dari kelemahan &
ancaman, serta peluang.
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Penerapan Applicability
5
Penerapan persyaratan dilihat dari ukuran & kompleksitas organisasi, adopsi model manajemen, jangkauan aktivitas, serta sifat dari resiko dan peluang.
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Informasi Terdokumentasi Documented Information
6
Dalam era digital dan paperless, Organisasi lebih flexibel
dalam mendefinisikan informasi apa saja yang harus
terdokumentasi, bentuk dokumentasinya dan bagaimana
cara memelihara serta menahan informasi tersebut.
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Pengetahuan Organisasi Organizational Knowledge 7
Pengetahuan hasil pembelajaran dari dalam organisasi harus dijaga dan didorong ke seluruh personil sehingga akan semakin memperkuat organisasi.
SOLUSI MANAJEMEN
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Pengendalian proses, barang &
jasa yang disediakan eksternal Control of Externally provided process, products & services
8 Segala proses diluar bisnis inti organisasi dapat
diserahkan ke pihak eksternal asalkan pengendaliannya
tetap dilaksanakan demi tercapaianya kualitas dan
kepuasan pelanggan.
SOLUSI MANAJEMEN
MADANI www.solusimadani.com
4. CONTEXT OF THE ORGANIZATION 4.1 Understanding the organization & its
context 4.2 Understanding the needs & expectation
of interested parties 4.3 Determining the scope of the quality
management system 4.4 Quality management system & its
process
5. LEADERSHIP 5.1 Leadership & commitment
5.1.1Leadership & commitment for QMS 5.1.2 Customer focus
5.2 Policy 5.3 Organizational roles, responsibility &
authorities
6. PLANNING 6.1 Action to address risks & opportunities
6.2 Quality Objectives & planning to
achieve them 6.3 Planning of changes
NEW NEW NEW
4.2.2 Quality manual 4.1 General Rquirement
5. MANAGEMENT RESPONSIBILITY 5.1 Management commitment 5.4.2 Quality Management system planning 5.1.2 Customer focus 5.3 Policy 5.5.1 Responsibility & authority
NEW NEW 5.4.1 Quality objectives
5.4.2 Quality management system planning
ISO 9001:2008 ISO 9001:2015
SOLUSI MANAJEMEN
MADANI www.solusimadani.com
7. SUPPORT 7.1 Resources 7.1.1 General 7.1.2 People
7.1.3 Infrastructure 7.1.4 Environment for the operation process
7.1.5 Monitoring & measuring resources
7.1.6 Organizational knowledge 7.2 Competence
7.3 Awareness 7.4 Communication
7.5 Documented information
8. OPERATION
8.1 Operational planning & control 8.2 Requirements for products & services
8.2.1 Customer communication 8.2.2 Determining the requirement
8.2.3 Review of the requirement 8.2.4 Change to requirement
6. RESOURCES MANAGEMENT 6.1 Provision of resources 6.2.1 Human Resources - General
6.3 Infrastructure 6.4 Working environment 7.6 Control of monitoring & measuring equipment NEW 6.2.2 Competence, training & awareness
5.5.3 Internal Communication 4.2.3 Control of document 4.2.4 Control of records 7. PRODUCT REALIZATION
7.1 Planning product realization 7.2 Customer related process 7.2.3 Customer communication 7.2.1 Determination of requirements related to product
7.2.3 Review of requirements related to product
ISO 9001:2008 ISO 9001:2015
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8.3 Design & Development of products & services
8.4 Control of externally provided process, products & services
8.5 Production & service provision 8.6 Release of products & services
8.7 Control of non conforming output
9. PERFORMANCE EVALUATION
9.1 Monitoing, Measurement, analysis & evaluation
9.2 Internal Audit 9.3 Management review
10 IMPROVEMENT
10.1 general 10.2 nonconformity & corrective action
10.3 Continual Improvement
7.3 Design & Development 7.4.1 Purchasing Process
7.5 Production & service provision NEW 8.3 Control of nonconforming product 8. MEASUREMENT, ANALYSIS & IMPROVEMENT
8.2.3 Monitoring & measurement of process 8.2.2 Internal Audit 5.6 Management review 8.5 Improvement
8.5.2 Corrective Action 8.5.4 Continual improvement
ISO 9001:2008 ISO 9001:2015
Siap untuk bertransisi?
SOLUSI MANAJEMEN
MADANI www.solusimadani.com
Ekhsan Hari Nuryanto
Konsultan profesional yang berpengalaman lebih dari 10
tahun dibidang manajemen mutu, keselamatan &
kesehatan kerja, lingkungan, peningkatan produktivitas,
perbaikan kinerja, dll. Lebih lanjut bisa dihubungi di
[email protected] atau 081261725676.
