Materi Sosialisasi New Version 2015
Short Description
pendidikan...
Description
ISO 9001 & ISO 14001
Quality and Environmental Management System
Public Surabaya 2014 October 13
© PT TUV Rheinland Indonesia 2014
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
Information about Annex XL PDCA Cycle Why it Change?
10.00 – 10.15
Coffee Break
10.15 – 12.00
Overview of ISO 9001:2015 (based on ISO DIS 9001:2014) Main changes of ISO 9001:2015 Brief interpretation requirement of ISO 14001:2015 Plan, Do, Check and Action phase of requirement
12.00 – 13.00
Lunch Break
13.00 – 14.30
Overview of ISO 14001:2015 (based on ISO DIS 14001:2014) Main changes of ISO 14001:2015 Brief interpretation requirement of ISO 14001:2015 Plan, Do, Check and Action phase of requirement
15.00 – 15.15
Coffee Break
15.15 – 16.30
Correlation between ISO 9001:2015 and ISO 14001:2015
16.30 – 17.00
Discussion (Question and Answer)
The schedule might change based on training condition,
PT TUV Rheinland Indonesia Professional Training for Management and Technical Staff
F:\Outline 50001:2011
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Overview ISO 9001 & ISO 14001
Overview ISO 9001:2015* New version and ISO 14001:2015* New Version 1
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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 2
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Overview ISO 9001 & ISO 14001
Pengantar ISO 9001 dan 14001 versi 2015
ISO 14001:2014 Environment Management Systems — Requirements with guidance for use ISO 9001:2015 Quality management systems – requirement Next for Heath and safety standard OHSAS 18001:2007 ISO 45001:2016
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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
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Annex SL (High-level structure) Introduction 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. Improvement Appendix Bibliography 2014-1009
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4, 5 6, 7
Action Plan Check Do 9
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Overview ISO 9001 & ISO 14001
Pertimbangan Perubahan Standard
Proses Peninjauan (Process Review) dari Komite Teknis - Bertujuan untuk memastikan kesesuaian standard dengan perubahan dan perkembangan industri. - Diadakan minimum 5 Tahun sekali Input dari System Users - Hasil survey dan questionnaire (web-based 2010) - Termasuk rekomendasi-rekomendasi yang diberikan oleh user dari hasil interpretasi proses Trend yang berlaku - Untuk menyesuaikan dengan perkembangan dibidang management system - Perkembangan pengetahuan dan teknologi - Meningkatnya keragaman pengguna ISO 9001 and 14001
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Overview ISO 9001:2015* New version Based on ISO/DIS 9001:2014
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Overview ISO 9001 & ISO 14001
Tujuan dari ISO 9001:2015
Untuk menyediakan kerangka kerja yang konsisten untuk 10 tahun ke depan Untuk menjadi cukup generik, namun masih relevan untuk semua jenis dan ukuran organisasi, terlepas dari industri atau sektor mereka Untuk tetap fokus pada proses manajemen yang efektif dalam rangka mencapai hasil yang diinginkan Untuk memperhitungkan perubahan implementasi QM dan teknologi yang besar sejak revisi terakhir pada tahun 2000
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Tujuan dari ISO 9001:2015 (Lanjutan)
Untuk mencerminkan perubahan dalam kerja yang semakin kompleks dan dinamis dalam lingkungan di mana organisasi beroperasi Untuk menerapkan struktur yang seragam, teks inti dan definisi yang ditetapkan dalam Annex SL dari Petunjuk ISO (Struktur Tingkat Tinggi) untuk memastikan kompatibilitas dengan sistem manajemen ISO lain (misalnya ISO 14001) Untuk mempermudah implementasi yang efektif dalam organisasi Untuk menggunakan istilah –istilah yang lebih sederhana untuk memastikan pemahaman umum dan interpretasi yang konsisten dari persyaratan
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Overview ISO 9001 & ISO 14001
ISO 9001:2015 Timeline 2013
2014
2015
June 2013 CD (Committee Draft)
April 2014 DIS (Draft International Standard)
July 2015 FDIS (Final Draft International Standard)
Plan : September 2015 Published International Standard 9
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ISO 9001:2015 Certification Transition Timeline
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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Overview ISO 9001 & ISO 14001
Perubahan yang signifikan pad ISO 9001:2015 a) untuk membuat standar yang lebih umum dan lebih mudah diterapkan oleh industri jasa, contoh : • Istilah “Product” diganti dengan “Product and services” b) Konteks organisasi • Dua Klausul baru berkaitan dengan organisasi 4.1 Understanding the organization and its context and 4.2 Understanding the needs and expectations of interested parties yang meminta organisasi untuk menentukan isu-isu dan persyaratan yang dapat berdampak pada perencanaan sistem manajemen mutu dan dapat digunakan sebagai masukan ke dalam pengembangan sistem manajemen mutu c. Process Approach (Pendekatan Proses) • Persyaratan mengenai Pendekatan proses dibuat lebih eksplisit dengan adanya klausul 4.4.2 Process Approch 11
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Perubahan yang signifikan pad ISO 9001:2015 d) Risk and Preventive Action (resiko dan tindakan pencegahan) • Klausul mengenai preventive action (8.5.3) diganti dengan persyaratan identifikasi resiko (klausul 4.1 dan 6.1) bertujuan agar konsep pencegahan dalam pengembangan dan implementasi perdasarkan pemikiran dan pendekatan resiko e) Documented information (Informasi terdokumentasi) • Mengganti istilah dokumen dan rekaman dengan Documented information (Informasi terdokumentasi) f) Control of external provision of products and services • pada klausul 8.4 secara jelas meminta organisasi mengendalikan penyediaan barang dan jasa dari luar perusahaan baik pembelian dari pemasok, melalui kontrak dengan perusahaan rekanan, melalui outsourcing proses ataupun dengan cara lainnya.
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Overview ISO 9001 & ISO 14001
Contoh Perubahan lainnya Manual mutu: Spesifikasi mengenai isi manual mutu tetap berlaku, tetapi tidak ada persyaratan khusus mengenai itu. (sub pasal 4.4, sub-klausul 7.5).
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).
Melaksanaan sasaran mutu : Dokumentasi sekarang diperlukan ketika merencanakan bagaimana tujuan kualitas yang ingin dicapai (sub-klausul 6.2).
Risiko: Organisasi harus mengidentifikasi risiko yang dapat mempengaruhi pencapaian produk dan proses. Perusahaan harus merencanakan langkah-langkah untuk mengatasi risiko ini dan mengevaluasi efektivitas mereka (sub-klausul 6.1).
Outsourcing: sekarang menjadi lebih explisit dengan adanya klasusul 8.4 ‘Control of external provision of products and services’ 13
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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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Overview ISO 9001 & ISO 14001
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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ISO/DIS 9001:2014 Requirement 1 2 3 4
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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Overview ISO 9001 & ISO 14001
ISO/DIS 9001:2014 Requirement (Continued) 8 Operation 8.1 Operational planning and control 8.2 Determination of requirements for products and services 8.2.1 Customer communication 8.2.2 Determination of requirements related to products and services 8.2.3 Review of requirements related to products and service 8.3 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 8.4 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 8.5 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 8.6 Release of products and services 8.7 Control of nonconforming process outputs, products and services 17
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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 Requirement (ISO/DIS 9001:2014)
Figure 1 - Model of a process-based quality management system, showing the links to the clauses of this International Standard
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Figure 2 - Schematic representation of a single process within the system
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Overview ISO 9001 & ISO 14001
ISO Requirement (ISO/DIS 9001:2014) ISO 9001:2015
ISO 9001:2008 ISO 9001 : 2008
ISO 9001 : 2015
1. scope
=
1. scope
2. Normative Reference
=
2. Normative Reference
3. Terms and definitions
=
3. Terms and definitions Note : pengertian-pengertian dimasukan di dalam standard (tidak hanya di ISO 9000:2005)
4. Quality Management Systems
4. Context of the organization
4.1 General Requirement
4.1 Understanding the organization and its context
4.2 Documentation Requirements
Tentang Documentasi ada di klausul 7.5 9001:2015
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4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the quality management system 4.4 Quality management system
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ISO Requirement (ISO/DIS 9001:2014) 4. Context of the organization 4.1 Understanding the organization and its context The organization shall determine external and internal issues, that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended outcome(s) of its quality management system. ……….. 4.2 Understanding the needs and expectations of interested parties The organization shall determine a) the interested parties that are relevant to the quality management system, and b) the requirements of these interested parties ……….. 4.3 Determining the scope of the quality management system When determining this scope, the organization shall consider a) the external and internal issues referred to in 4.1, and b) the requirements referred to in 4.2 ………. 4.4 Quality management system Same as 4.1 ISO 9001:2008
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Overview ISO 9001 & ISO 14001
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
(Relevant) interested parties • Consumers • Employees • Owners/shareholders • Society • Regulator • Suppliers and partners
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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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Overview ISO 9001 & ISO 14001
ISO Requirement (ISO/DIS 9001:2014) ISO 9001:2015
ISO 9001:2008 5. Management Responsibility
5. Leadership
5.1 Management commitment
5.1 Leadership and commitment
5.2 Customer focus
5.2 Policy
5.3 Quality policy
5.3 Organization roles, responsibilities and authorities
5.4. Planning
6. Planning
5.6 Management Review
6.1 Actions to address risks and opportunities
Management Reviewi ada di klausul 9.3 9001:2015
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Komunikasi ada di klausul 7.4 9001:2015
5.5 Authorities, Responsibility and communication
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6.2 Quality objectives and planning to achieve them 6.3 Planning of changes
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ISO Requirement (ISO/DIS 9001:2014) ISO 9001 versi terbaru ini mengharapkan Top Management lebih berperan dan berkomitmen dalam quality management system Kutipan dari ISO/DIS 9001:2014 Klausul 5.1 5.1.1 Leadership and commitment for the quality management system Top management shall demonstrate leadership and commitment with respect to the quality management system by: a) taking accountability of the effectiveness of the quality management system; b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the strategic direction and the context of the organization; c) ensuring that the quality policy is communicated, understood and applied within the organization; d) ensuring the integration of the quality management system requirements into the organization’s business processes; e. promoting awareness of the process approach;
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Overview ISO 9001 & ISO 14001
ISO Requirement (ISO/DIS 9001:2014)
Kutipan dari ISO/DIS 9001:2014 Klausul 5.1 5.1.1 Leadership and commitment for the quality management system e. ensuring that the resources needed for the quality management system are available; f. communicating the importance of effective quality management and of conforming to the quality management system requirements; g. ensuring that the quality management system achieves its intended results; h. engaging, directing and supporting persons to contribute to the effectiveness of the quality management system; i. promoting continual improvement; j. supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
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ISO Requirement (ISO/DIS 9001:2014)
5.2 c) be available to relevant interested parties, as appropriate. 5.3 Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.
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Overview ISO 9001 & ISO 14001
ISO Requirement (ISO/DIS 9001:2014) ISO 9001:2008
ISO 9001:2015
5. Management Responsibility
6. Planning
5.1 Management commitment
6.1 Actions to address risks and opportunities
5.2 Customer focus
6.2 Quality objectives and planning to achieve them
5.3 Quality policy
6.3 Planning of changes
5.4. Planning 5.5 Authorities, Responsibility and communication 5.6 Management Review
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ISO Requirement (ISO/DIS 9001:2014) ISO 9001:2015 6. Planning 6.1 Actions to address risks and opportunities Menambahkan identifikasi resiko sebagai persyaratan 6.1 Actions to address risks and opportunities 6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to: a) give assurance that the quality management system can achieve its intended result(s); b) prevent, or reduce, undesired effects; c) achieve continual improvement. 6.1.2 The organization shall plan: a) actions to address these risks and opportunities; b) how to: 1. integrate and implement the actions into its quality management system processes (see 4.4); 2. evaluate the effectiveness of these actions. Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.
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Overview ISO 9001 & ISO 14001
ISO Requirement (ISO/DIS 9001:2014) ISO 9001:2015 6. Planning 6.2 Quality objectives and planning to achieve them Klausul 5.4.1 dan 5.4.2 ISO 9001:2008 6.2 Quality objectives and planning to achieve them 6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes. The quality objectives shall: be consistent with the quality policy, be measurable; take into account applicable requirements; be relevant to conformity of products and services and the enhancement of customer satisfaction; be monitored; be communicated; be updated as appropriate. The organization shall retain documented information on the quality objectives 6.2.2 When planning how to achieve its quality objectives, the organization shall determine: what will be done; what resources will be required; who will be responsible; when it will be completed; how the results will be evaluated.
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ISO Requirement (ISO/DIS 9001:2014) ISO 9001:2015 6. Planning 6.3 Planning of changes Meminta adanya rencana perubahan kebutuhan dan peluang untuk mempertahankan dan meningkatkan kinerja dari sistem manajemen mutu 6.3 Planning of changes Where the organization determines the need for change to the quality management system (see 4.4) the change shall be carried out in a planned and systematic manner. The organization shall consider: a) the purpose of the change and any of its potential consequences; b) the integrity of the quality management system; c) the availability of resources; d) the allocation or reallocation of responsibilities and authorities.
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Overview ISO 9001 & ISO 14001
ISO Requirement (ISO/DIS 9001:2014) ISO 9001:2015
ISO 9001:2008 6. Resource Management
7. Support
6.1 General
7.1 Resources
6.2 Human Resource
7.2 Competence
5.3 Infrastructure
7.3 Awareness
6.4 Work Environment
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 Requirement (ISO/DIS 9001:2014) ISO 9001:2015 7. Support 7.1 Resources 7.1.1 General 7.1.2 People Klausul 6.2.2 ISO 9001:2008 7.1.3 Infrastructure Klausul 6.3 ISO 9001:2008 7.1.4 Environment for the operation of processes Klausul 6.4 ISO 9001:2008 7.1.5 Monitoring and measuring resource Klausul 7.6 ISO 9001:2008 7.1.6 Knowledge Klausul 6.2.1 and 6.2.2 ISO 9001:2008 7.2 Competence Klausul 6.2.1 and 6.2.2 ISO 9001:2008 7.3 Awareness Klausul 6.2.2 d ISO 9001:2008 7.4 Communication Klausul 5.5.3 ISO 9001:2008 7.5 Documented information Klausul 4.2.1, 4.2.3 dan 4.2.4 ISO 9001:2008 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented Information
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Overview ISO 9001 & ISO 14001
ISO Requirement (ISO/DIS 9001:2014) ISO 9001:2015 3.11 documented information information (3.50) required to be controlled and maintained by an organization (3.01) and the medium on which it is contained Note 1 to entry: Documented information can be in any format and media and from any source. Note 2 to entry: Documented information can refer to: - the quality management system (3.33), including related processes (3.12); - information (3.50) created in order for the organization (3.01) to operate (documentation); - evidence of results achieved (records).
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ISO Requirement (ISO/DIS 9001:2014) ISO 9001:2008
ISO 9001:2015
7. Product Realization
8. Operation
7.1 Planning of product realization
8.1 Operational planning and control
7.2 Customer-related processes
8.2 Determination of requirements for products and services customers
7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring and measuring equipment
8.3 Design and development of products and services 8.4 Control of external provision of products and services 8.5 Production and service provision 8.6 Release of products or services 8.7 Control of nonconforming process outputs, products and services
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Overview ISO 9001 & ISO 14001
ISO Requirement (ISO/DIS 9001:2014)
8. Operation 8.1 Operational planning and control
Klausul 7.1 ISO 9001:2008 8.2 Determination of requirements for products and services customers 8.2.1 Customer communication 8.2.2 Determination of requirements related to the products and services 8.2.3 Review of requirements related to the products and services
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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ISO Requirement (ISO/DIS 9001:2014) 8.3 Design and development of products and services 8.4 Control of external provision of 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
Klausul 7.3 ISO 9001:2008 Klausul 7.4 ISO 9001:2008 tetapi juga termasuk pengendalian outsource
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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Overview ISO 9001 & ISO 14001
ISO Requirement (ISO/DIS 9001:2014) 8.5 Production and service provision Klausul 7.5.1&2 8.5.1 Control of production and service provision 8.5.2 Identification and traceability Klausul 7.5.3 ISO 9001:2008 8.5.3 Property belonging to customers or external providers Klausul 7.5.4 8.5.4 Preservation Klausul 7.5.5 8.5.5 Post delivery activities Persyaratan berkaitan dengan pasca delivery 8.5.6 Control of changes
8.6 Release of products or services Klausul 8.2.4 ISO 9001:2008 8.7 Control of nonconforming process outputs, Klausul 8.3 ISO 9001:2008 products and services Catatan Dalam 8.5.6 organisasi diminta untuk melakukan perubahan yang terencana dan sistematik , meninjau konsekuensi dari perubahan dan mengambil tindakan yang dibutuhkan untuk memastikan interritas dari barang dan jasa terpelihara (berkaitan dengan klausul 6.3 ISO/DIS 9001:2014) 37
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ISO Requirement ISO 9001:2008 8. Measurement, analysis and improvement
ISO 9001:2015 9. Performance evaluation
8.1 General
9.1 Monitoring, measurement, analysis And evaluation
8.2 Monitoring and measurement
9.2 Internal audit 9.3 Management review
8.3 Control of nonconforming product 8.4 Analysis of data
10. Improvement
8.5 Improvement
10.1 Nonconformity and corrective action 10.2 Improvement
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Overview ISO 9001 & ISO 14001
ISO Requirement (ISO/DIS 9001:2014) 9. Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General Klausul 8.1 ISO 9001:2008 (penetapan untuk metode pemantauan pengukuran dan evaluasinya) 9.1.2 Customer satisfaction Klausul 8.2.1 ISO 9001:2008 9.1.3 Analysis and evaluation of data Klausul 8.4 ISO 9001:2008
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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ISO Requirement (ISO/DIS 9001:2014)
10. Improvement 10.1 Nonconformity and corrective action Klausul 8.5.2 ISO 9001:2008
10.2 Continual improvement Klausul 8.5.1 ISO 9001:2008 Improvement melalui : a) hasil analisis data; b) perubahan dalam konteks organisasi; (4.1) c) perubahan dalam risiko yang diidentifikasi (lihat 6.1), dan d) peluang baru
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Overview ISO 9001 & ISO 14001
ISO Requirement (ISO/DIS 9001:2014) Tambahan Annex mengenai Quality management systems dalam ISO 9001:2008 akan tetapi Ada perubah menjadi 7 Prisnsip Management System
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
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Overview ISO 14001:2015* New version Based on ISO/DIS 14001:2015
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Overview ISO 9001 & ISO 14001
Overview ISO 14001:2015* New version
• Meningkatkan hubungan antara lingkungan dan prioritas bisnis. • Peningkatan transparansi dan akuntabilitas dalam pengelolaan lingkungan. • Menggarisbawahi kontribusi positif dari standar sistem manajemen lingkungan. • Klarifikasi persyaratan untuk peningkatan kinerja lingkungan. • Penguatan hubungan antara pengelolaan lingkungan dan bisnis inti pada tingkat strategis. • Memudahkan Implementasi ISO 14001, terutama di perusahaan-perusahaan kecil dan menengah. • Menyoroti konsep Life Cycle Assessments (LCL) dan mempertimbangkan rantai nilai (Value Chain) dengan pandangan terhadap identifikasi dan penilaian dampak lingkungan dari produk. • Menampung persyaratan berkaitan dengan komunikasi eksternal.
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Overview ISO 14001:2015* New version
Sekarang di fase ini
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Overview ISO 9001 & ISO 14001
Overview ISO 14001:2015* New version
Model of ISO 14001 : 2015 45
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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 9001 & ISO 14001
Overview ISO 14001:2015* New version
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Overview ISO 14001:2015* New version
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Overview ISO 9001 & ISO 14001
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
(Relevant) interested parties • Consumers • Employees • Owners/shareholders • Society • Regulator • Suppliers and partners
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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 9001 & ISO 14001
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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Correspondence between ISO 9001:2015 and ISO 14001:2015
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Correspondence between ISO 9001:2015 and ISO 14001:2015
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Correlation between ISO 9001:2015 and ISO 14001:2015 DIS ISO 9001:2014 1 Scope 2 Normative references
DIS ISO 14001:2014 1 Scope 2 Normative references
3 Terms and definitions
3 Terms and definitions
4 Context of the organization
4 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 Quality management system and its
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 Environment management system 4.4 Environment management Systems
processes 5 Leadership
5 Leadership
5.1 Leadership Commitment
5.1 Leadership Commitment
5.2 Quality policy
5.2 Environment policy
5.3 Organizational roles, responsibilities and authorities 6 Planning for the quality management system 6.1 Actions to address risks and opportunities
5.3 Organizational roles, responsibilities and authorities 6 Planning 6.1 Actions to address risks assosiate with threats and opportunities 6.1.1 General 6.1.2 Significant environment aspect 6.1.1 Compliance obligatory 6.1.4 risks assosiate with threats and opportunities 6.1.5 Planning to take action
6.2 Quality objectives and planning to achieve them
6.2 Environment objectives and planning to achieve them 6.2.1 Environment objectives 6.2.2 Planning action to achieve environmental objective
6.3 Planning of changes 58
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Overview ISO 9001 & ISO 14001
Correlation between ISO 9001:2015 and ISO 14001:2015
DIS ISO 9001:2014
DIS ISO 14001:2014
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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Correlation between ISO 9001:2015 and ISO 14001:2015 DIS ISO 9001:2014 8 Operation 8.1 Operational planning and control 8.2 Determination of requirements for products and services 8.2.1 Customer communication
DIS ISO 14001:2014 8 Operation 8.1 Operational planning and control 8.2 Emergency Preparadness and response
8.2.2 Determination of requirements related to products
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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Overview ISO 9001 & ISO 14001
Correlation between ISO 9001:2015 and ISO 14001:2015
DIS ISO 9001:2014 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 Nonconformity and corrective action 10.2 Continual improvement
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DIS ISO 14001:2014 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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Attach – ISO 31000 – Risk Management
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Overview ISO 9001 & ISO 14001
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Documented Information on DIS ISO 9001:2014 4.3 The scope shall be available as documented information. 5.2 Quality policy be available as documented information 6.2 Quality objectives and planning to achieve them The organization shall retain documented information on the quality objectives 7.1.5 Monitoring and measuring resource The organization shall retain appropriate documented information as evidence of fitness for purpose of monitoring and measuring devices. 7.1.5 verified or calibrated at specified intervals or prior to use against measurement standards traceable to international or national measurement standards. Where no such standards exist, the basis used for calibration or verification shall be retained as documented information 7.2 Competence d) retain appropriate documented information as evidence of competence. 8.1 Operational planning and control retain documented information to the extent necessary to have confidence that the processes have been carried out as planned 8.2.3 Review of requirements related to the products and services Documented information describing the results of the review shall be maintained. 8.3.3, 8.3.5, 8.3.6 design and development 8.4 Control of externally provided products and services (8.4.1) 2014-10-09
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8.5.1 Control of production and service provision the availability of documented information that defines the characteristics of the products and services 8.5.1 Development processes the necessary documented information on the application of development processes, the outputs and their suitability the availability of documented information that defines the activities to be performed and the results to be achieved; 8.5.2 Identification and traceability Where traceability is a requirement, the organization shall control the unique identification of the process outputs, and retain any documented information necessary to maintain traceability. 8.5.6 Control of changes The organization shall retain documented information describing the results of the review of changes, the personnel authorizing the change, and any necessary actions 8.6.1 Control of production of products and provision of services the availability of documented information that describes the characteristics of the products and services the availability of documented information that describes the activities to be performed and the results achieved, as necessary 8.6.2 Identification and traceability Where traceability is a requirement, the organization shall control the unique identification of the process 856 outputs, and maintain it as documented information 8.6.6 Control of changes Documented information describing the results of the review of changes, the personnel authorizing the change and any necessary actions shall be maintained 2014-10-09
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8.6 Release of products and services Documented information shall provide traceability to the person(s) authorizing release of products and services for delivery to the customer 8.7 Control of nonconforming process outputs, products and services Documented information shall indicate the person(s) authorizing release of products and services for delivery to the customer 9.1 Monitoring, measurement, analysis and evaluation (general) The organization shall retain appropriate documented information as evidence of the results. 9.2 Internal Audit retain documented information as evidence of the implementation of the audit programme and the audit results 9.3 Management review he organization shall retain documented information as evidence of the results of management reviews 10.1 Nonconformity and corrective action The organization shall retain documented information as evidence of a) the nature of the nonconformities and any subsequent actions taken; and b) the results of any corrective action.
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Attach Documented Information on DIS ISO 9001:2014 •
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8.1 Operational planning and control The organization shall maintain documented information to the extent necessary to have confidence that the processes have been carried out as planned 9.1 Monitoring, measurement, analysis and evaluation, general The organization shall retain appropriate documented information as evidence of the monitoring, measurement, analysis and evaluation results. 9.1.2 Evaluation of Compliance The organization shall retain documented information as evidence of the compliance evaluation result(s) 9.2 Internal audit The organization shall retain documented information as evidence of the implementation of the audit programme and the audit results 9.3 Management review The organization shall retain documented information as evidence of the results of management reviews 10.1 Nonconformity and corrective action The organization shall retain documented information as evidence of: the nature of the nonconformities and any subsequent actions taken; the results of any corrective action. 2014-10-09
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Attach Documented Information on DIS ISO 9001:2014 •
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6.1 Actions to address risk associated with threats and opportunities The organization shall maintain documented information to the extent necessary to have confidence that the process has been carried out as planned 6.1.2 Significant environmental aspects The organization shall maintain documented information of its: criteria used to determine its significant environmental aspects; environmental aspects and associated environmental impacts; significant environmental aspects. 6.1.3 Compliance obligations The organization shall maintain documented information of its compliance obligations. 6.1.4 Risk associated with threats and opportunities The organization shall maintain documented information of the risk associated with threats and opportunities that needs to be addressed 7.4 Communication The organization shall retain documented information as evidence of its communications, as appropriate
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