8 Hal Baru Sistem Manajemen Mutu ISO 9001:2015: 1. Struktur & terminologi 2. Produk & layanan 3. Pemahaman kebutuhan & harapan para pihak terkait 4. Pemikiran berbasis risiko 5. Penerapan 6. Informasi terdokumentasi 7. Pengetahuan organisasi 8. Pengendalian proses, barang, & jasa yang disediakan eksternal

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8 Hal Baru di Sistem
Manajemen Mutu
ISO 9001:2015
8 Something New on Quality Management
System ISO 9001:2015
Ekhsan Hari Nuryanto

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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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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.

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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.

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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 Knowledge7
Pengetahuan hasil pembelajaran dari
dalam organisasi harus dijaga dan
didorong ke seluruh personil sehingga
akan semakin memperkuat organisasi.

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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.

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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 9001:2008ISO 9001:2015

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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 9001:2008ISO 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 9001:2008ISO 9001:2015
Siap untuk bertransisi?

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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
ekhsan@solusimadani.com atau 081261725676.