Beruflich Dokumente
Kultur Dokumente
Public Surabaya
2014 October 13
Outline 1-Days
Overview of ISO 9001 and 14001 New version
Somerset Hotel, October 13th, 2014
Time
Topic
Introduction to ISO 9001 and 14001 New version
09:00 10:00
10.00 10.15
Coffee Break
10.15 12.00
12.00 13.00
Lunch Break
13.00 14.30
15.00 15.15
Coffee Break
15.15 16.30
16.30 17.00
F:\Outline 50001:2011
Overview
ISO 9001:2015* New version
and
ISO 14001:2015* New Version
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Agenda Pelatihan
Pengantar ISO 9001 dan 14001 versi 2015
Informasi tentang Annex XL
Siklus PDCA
Mengapa berubah? Sekilas tentang perubahan
Sekilas ISO 9001: 2015 (berdasarkan ISO DIS 9001: 2014)
Perubahan utama dari ISO 9001: 2015
Persyaratan interpretasi Singkat ISO 14001: 2015
Plan, Do, Check Action fase persyaratan
Sekilas ISO 14001: 2015 (berdasarkan ISO DIS 14001: 2014)
Perubahan utama dari ISO 14001: 2015
Persyaratan interpretasi Singkat ISO 14001: 2015
Plan, Do, Check Action fase persyaratan
Korelasi antara ISO 9001: 2015 dan ISO 14001: 2015
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ISO Standard
Kedepannya semua standard ISO mengadopsi Annex SL (Proposals
for management system standards )
Annex SL
High-level structure
Identical core text
Common terms and core definitions
P
D
C
A
10
4, 5
6, 7
Action Plan
Check Do
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Overview
ISO 9001:2015* New version
Based on ISO/DIS 9001:2014
2014-1009
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2014
2015
June 2013 CD
(Committee Draft)
Plan :
September 2015
Published International
Standard
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2015
2016
2017
2018
September 2015
Published International
Standard
Plan :
September 2015 start of 3 years transition period
to September 2018
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Manajer mutu / MR: Persyaratan tetap ada tentang fungsi mereka, tetapi tidak
posisi mereka dalam perusahaan. MR tidak perlu lagi menjadi "anggota manajemen"
(sub-clause. 5.3).
Outsourcing: sekarang menjadi lebih explisit dengan adanya klasusul 8.4 Control
of external provision of products and services
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Risk
3.09
risk
effect of uncertainty on an expected result
Note 1 to entry: An effect is a deviation from the expected positive or
negative.
Note 2 to entry: Uncertainty is the state, even partial, of deficiency of
information (3.50) related to, understanding or knowledge (3.53) of, an event,
its consequence, or likelihood.
Note 3 to entry: Risk is often characterized by reference to potential events
(ISO Guide 73:209, 3.5.1.3) and consequences (as defined in ISO Guide
73:2009, 3.6.1.3), or a combination of these.
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ISO Requirement
ISO 9001:2008
1.
2.
3.
4.
5.
6.
7.
8.
Scope
Normative references
Terms and definitions
Quality Management System
Management Responsibility
Resource management
Product Realization
Measurement, Analysis
and Improvement
ISO/DIS 9001:2014
0.1 General
0.2 The ISO standards for quality management
0.4 Plan-Do-Check-Act cycle
0.5 Risk-based thinking
0.6 Compatibility with other management system standards
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Continual improvement
Annex A (informative) Clarification of new structure,
terminology and concepts
Annex B (informative) Quality management principles
Annex C (informative) The ISO 10000 portfolio of quality
management standards
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Scope
7 Support
Normative references
7.1 Resources
Terms and definitions
7.1.1 General
Context of the organization
7.1.2 People
4.1 Understanding the organization and its
7.1.3 Infrastructure
context
7.1.4 Environment for the operation of
4.2 Understanding the needs and expectations
processes
of Interested parties
7.1.5 Monitoring and measuring resources
4.3 Determining the scope of the quality
7.1.6 Organizational knowledge
management system
7.2 Competence
4.4 Quality management system and its
7.3 Awareness
processes
7.4 Communication
5 Leadership
7.5 Documented information
5.1 Leadership Commitment
7.5.1 General
5.2 Quality policy
7.5.2 Creating and updating
5.3 Organizational roles, responsibilities and
authorities
6 Planning for the quality management system
Next slide : clause 8,9,10
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
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9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
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ISO 9001:2008
ISO 9001 : 2008
1. scope
1. scope
2. Normative Reference
2. Normative Reference
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Organizational context
Contoh dari Klausul 4.1 Understanding the organization and its context
Purpose: Motor manufacturer
Intended outcome: Production of motorcycles
Internal issues
Quality
Automation
Workforce
Design secrets
Capacity
Company culture
Innovation
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External issues
Quality
Customers
Fashion
New markets
Deadlines
Competition
Regulators
Utilities
Organizational context
Definitions
Interested party
3.02 - person or organization (3.01)
that can affect, be affected by, or
perceive themselves to be affected by a decision or activity.
All parties
Interested parties
Relevant Interested parties
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ISO 9001:2008
5. Management Responsibility
5. Leadership
5.2 Policy
5.4. Planning
6. Planning
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ISO 9001:2015
5. Management Responsibility
6. Planning
5.4. Planning
5.5 Authorities, Responsibility and
communication
5.6 Management Review
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ISO 9001:2008
6. Resource Management
7. Support
6.1 General
7.1 Resources
7.2 Competence
5.3 Infrastructure
7.3 Awareness
7.4 Communication
7.5 Documented information
Klausul 4.2.3 dan 4.2.4 ISO 9001:2008
Klausul 7 ini sama dengan klausul 6 di ISO 9001:2008 berisikan pengelolan dari
sumber daya (manusia, Infrastruktur dan lingkungan) ditambahkan dengan
pengendalian dokumen dan komunikasi
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ISO 9001:2015
7. Product Realization
8. Operation
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8. Operation
8.1 Operational planning and control
Hampir
Sama dengan
Klausul
7.2
ISO 9001:2008
Dalam 8.1 terdapat penegasan mengenai harusnya pengandalian outsource process dan
merefer ke klausul 8.4
Dalam klausul 8.2 diinfromasikan dalam catatan bahwa persyaratan tambahan mungkin
saja datang dari interested parties
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Catatan
Dalam 8.4 pengendalian bukan hanya untuk supplier tetapi juga rekanan/subcon
(outsource process)
Dalam 8.5 lebih menekankan pada pengembangan barang dan jasa
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ISO Requirement
ISO 9001:2008
8. Measurement, analysis and
improvement
ISO 9001:2015
9. Performance evaluation
8.1 General
10. Improvement
8.5 Improvement
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9.2 Internal audit Klausul 8.2.2 ISO 9001:2008 (konsep risk based auditing)
9.3 Management review Klausul 5.6 ISO 9001:2008 (penambahan input
mengenai isu dari supplier atau outsource process)
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10. Improvement
10.1 Nonconformity and corrective action
Klausul 8.5.2 ISO 9001:2008
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8 Prinsip
Sistem manajemen Pada
ISO 9000:2005
QMP 1 - Customer focus
QMP 2 - Leadership
QMP 3 - Involvement of people
QMP 4 - Process approach
QMP 5 - System approach to management
QMP 6 - Continual improvement
QMP 7 - Factual approach to decision making
QMP 8 - Mutually beneficial supplier relationships
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7 Prinsip
Sistem manajemen Pada
ISO/DIS 9001:2015
QMP 1 Customer Focus
QMP 2 Leadership
QMP 3 Engagement of People
QMP 4 Process Approach
QMP 5 Improvement
QMP 6 Evidence-based Decision Making
QMP 7 Relationship Management
Overview
ISO 14001:2015* New version
Based on ISO/DIS 14001:2015
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Overview
ISO 14001:2015* New version
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Overview
ISO 14001:2015* New version
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Page 22
Overview
ISO 14001:2015* New version
2014-10-09
Overview
ISO 14001:2015* New version
Clause of ISO 14001:2015 (Based on ISO/DIS 14001:2014)
1
2
3
4
Scope
Normative references
Terms and definitions
Context of the organization
4.1 Understanding the organization and its
context
4.2 Understanding the needs and expectations
of Interested parties
4.3 Determining the scope of the quality
management system
4.4 Environment management Systems
5 Leadership
5.1 Leadership Commitment
5.2 Environment policy
5.3 Organizational roles, responsibilities and
authorities
6 Planning
6.1 Actions to address risks associate with threats and
opportunities
6.1.1 General
6.1.2 Significant environment aspect
6.1.1 Complience obligatory
6.1.4 risks assosiate with threats and opportunities
6.1.5 Planning to take action
6.2 Environment objectives and planning to achieve them
6.2.1 Environment objectives
6.2.2 Planning action to achieve environmental objective
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7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
8 Operation
8.1 Operational planning and control
8.2 Emergency Preparadness and response
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Evaluation of complience
9.2 Internal audit
9.3 Management review
10 Improvement
10.1 Nonconformity and corrective action
10.2 Continual improvement
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Overview
ISO 14001:2015* New version
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Overview
ISO 14001:2015* New version
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Organizational context
Contoh dari Klausul 4.1 Understanding the organization and its context
Purpose: Motor manufacturer
Intended outcome: Production of motorcycles
Internal issues
Environment
raw
material
design
normal/abnormal
process
etc
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External issues
Environment
Supplier
disaster
Utilities supply
etc
Organizational context
Perubahan pada ISO 14001:2015 (ISO/DIS 14001:2014)
Tidak ada muncul management representative pada persyaratan akan
tetapi fungsinya masih tetap ada
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Overview
ISO 14001:2015* New version
Perubahan pada ISO 14001:2015 (ISO/DIS 14001:2014)
Pada klausul 6.1.2 sudah memasukan konsep life cycle perspective
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Overview
ISO 14001:2015* New version
Perubahan pada ISO 14001:2015 (ISO/DIS 14001:2014)
Konsep risk berkaitan dengan environmrental impact
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Overview
ISO 14001:2015* New version
Perubahan pada ISO 14001:2015 (ISO/DIS 14001:2014)
Pada klausul 7.4.3 EMS meminta organisasi mengomunikasikan keluar
informasi yang relefan berkaitan dengan sistem managemen
lingkungannya
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Overview
ISO 14001:2015* New version
Perubahan pada ISO 14001:2015 (ISO/DIS 14001:2014)
Untuk operasional persyaratannya masih tetap sama dengan klausul 4.4.6 ISO
14001:2004 hanya dipertegas kembali berkaitan kontrol proses yang dioutsourcekan
Kitipan dari kalusul 8
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Overview
ISO 14001:2015* New version
Perubahan pada ISO 14001:2015 (ISO/DIS 14001:2014)
Untuk operasional persyaratannya diminta mempertimbangkan perspektif
Berkaitan life cycle produk/jasa
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processes
5 Leadership
5 Leadership
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7 Support
7 Support
7.1 Resources
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation
of processes
7.1.5 Monitoring and measuring
resources
7.1.6 Organizational knowledge
7.2 Competence
7.2 Competence
7.3 Awareness
7.3 Awareness
7.4 Communication
7.4 Communication
7.5 Documented information
7.5 Documented information
7.5.1 General
7.5.1 General
7.5.2 Creating and updating
7.5.2 Creating and updating
7.5.3 Control of documented
7.5.3 Control of documented
information
information
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8.3
8.4
8.5
8.6
8.7
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and services
8.2.3 Review of requirements related to products and
service
Design and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development Inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
Control of externally provided products and services
8.4.1 General
8.4.2 Type and extent of control of external provision
8.4.3 Information for external providers
Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external
providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
Release of products and services
Control of nonconforming process outputs, products
and services
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Attach
63
Attach
64
Page 32
Attach
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Attach
Documented Information on DIS ISO 9001:2014
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Attach
Documented Information on DIS ISO 9001:2014
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Thank You
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