This document provides a checklist for organizations transitioning from ISO 9001:2008 to ISO 13485:2016 and ISO 9001:2015. It contains tables to validate that an organization's integrated quality management system addresses new concepts in both standards. The tables list clauses from each standard and require evidence that requirements have been met without exceptions. It concludes that a recommendation for certification is dependent on submitting a corrective action plan to address any findings from the audit, or that a special on-site visit may be required if registration cannot be immediately recommended.
Quality Management Systems in different industries - from ISO 9001 to cGxPPauwels Consulting
油
This presentation is about the design and implementation of Quality Management Systems (QMS) in different industries.
In this presentation you will learn more about the history and development of quality management systems (QMS),
the importance and benefits of a QMS for various industries,
quality principles and Good Manufacturing Practices (GMP) in life sciences, the most important requirements of an ISO 9001 QMS,
the most important requirements of GMP regulations and how to develop and implement a QMS for various industries.
The speakers, Luc Marivoet and Luc Huybreghts, both work in very different industries. They both talked about quality management systems from their own experience and very different and interesting angles.
This presentation is ideal for all professionals who want to include quality management in their projects and daily activities and who want to take the overall quality level of their organization to the next level.
Do you have any questions regarding quality management or the implementation of a QMS for your organization? Don't hesitate and visit our website at www.pauwelsconsulting.com
ISO 9001:2008 is an international standard for quality management systems that was last updated in 2008. It aims to ensure organizations meet requirements, continually improve, and comply with laws and regulations. The standard outlines requirements for documentation, management responsibilities, resource management, product realization processes, measurement and improvement. It addresses customer focus, quality policy, objectives, planning, responsibilities, management review, training, infrastructure, purchasing, production, monitoring, auditing, data analysis, corrective and preventive actions.
This document discusses the changes between ISO 9001:2008 and ISO 9001:2015 quality management system standards. Some key changes include reorganizing clauses into a 10 clause structure for better alignment, adding requirements for determining organizational context and risks/opportunities, expanding the process approach, and changing terminology like replacing "preventative actions" with "risks and opportunities". Each clause is also analyzed in detail highlighting revisions and additional requirements in the 2015 version.
This document provides a gap analysis of an organization's quality management system against the requirements of the IATF 16949:2016 standard. It analyzes the organization's implementation of various clauses and requirements, identifying areas that need to be expanded, changed, or implemented for the first time to be fully compliant with the updated standard. The analysis is conducted clause by clause, with explanations of differences between the earlier and current requirements. It will help the organization prioritize and plan changes needed to meet the new standard.
This document provides a summary of the changes between the 2008 and 2015 versions of the ISO 9001 quality management system standard. It outlines the key changes to requirements, including an increased emphasis on risk-based thinking, leadership involvement, and flexibility in documenting processes. There is also a mapping of how requirements from the 2008 standard correspond to sections of the new 2015 version. Finally, there is a list of the minimum documented information now required by each clause of ISO 9001:2015.
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
Comparison of the two systems iso 9001 and iso 9004 clause 5Raffia Siddique
油
The document discusses ISO 9001 and ISO 9004 standards regarding management responsibility in quality management systems. It covers the key clauses in section 5, including management commitment, customer focus, quality policy, planning, responsibility, and management review. For each clause, it summarizes the requirements in ISO 9001 and provides additional guidance on how organizations can apply each clause according to ISO 9004.
This document provides an overview of ISO standards including ISO 9001 and ISO 14001. It discusses:
- The history and present scenario of ISO as an independent international standardization body with 162 member countries.
- The benefits of ISO standards in ensuring safety, reliability and quality for businesses and access to new markets.
- An overview of the key requirements of ISO 9001:2008 for quality management systems and ISO 14001 for environmental management systems.
- Updates and changes in ISO 9001:2015 and ISO 14001:2015 including greater emphasis on risk-based thinking and the Plan-Do-Check-Act cycle.
The document provides an overview of ISO 9001:2008, including its 8 quality management principles and the requirements of the standard. It discusses the benefits organizations can achieve by implementing the standard such as increased customer satisfaction, continual improvement processes, better integration and management of interrelated business functions, and gaining international recognition. The standard is designed to be applied generically in any organization to enhance performance and customer satisfaction.
This document provides an overview of the key changes between IATF 16949:2016 and ISO/TS 16949:2009. Some of the major changes include adopting a high level structure from ISO 9001:2015, with more explicit requirements for risk-based thinking and consideration of organizational context. There is also a greater emphasis on the role of top management and limiting the boundaries of the quality management system. Additional clauses were added related to issues like product safety, process effectiveness, and contingency planning. Finally, the document outlines how various clauses from ISO/TS 16949:2009 were either modified, carried over, or made new in IATF 16949:2016.
This document outlines and compares the structure and requirements of three international standards - ISO 9001 for quality management systems, ISO 14001 for environmental management systems, and OHSAS 18001 for occupational health and safety management systems. While the standards have different focuses, they have similar high-level requirements for topics such as leadership commitment, policy development, planning, implementation, monitoring and improvement. The document lists the section titles and compares the corresponding requirements across the three standards.
This document provides a clause-by-clause comparison of the changes between ISO 9001:2008 and ISO 9001:2015. Some of the key changes include: reducing documentation requirements; introducing terms like "documented information", interested parties, and risk-based thinking; removing requirements for things like quality manuals and management representatives; combining some clauses; and emphasizing leadership involvement, risk management, and customer focus. The new standard is more principles-based and focuses on effectiveness of quality management systems rather than documentation and procedures.
Correlation matrix with TS 16949-Iatf 16949prateek verma
油
This document provides a correlation matrix comparing the clauses between IATF 16949:2016 and ISO/TS 16949:2009. It shows that IATF 16949:2016 contains additional requirements compared to ISO 9001:2015, with some clauses being modified from ISO/TS 16949:2009. The matrix lists each clause, indicates if it is from ISO 9001:2015, additional for IATF, or modified from the previous automotive standard. This allows understanding the changes and relationship between the new and previous automotive quality management system standards.
Changes ISO 9001-2008 to ISO 9001-2015.pdfRealDairy2
油
The document provides an overview of the notable changes between ISO 9001:2008 and ISO 9001:2015. Some of the key changes include adopting a common 10-clause structure across all ISO management system standards, placing more emphasis on leadership involvement and risk-based thinking, and introducing requirements for determining organizational context and interested party needs. The new version aims to make the standard more compatible with services and non-manufacturing users, strengthen the process approach, and increase flexibility for documented information.
Mario Machado introduces himself and his qualifications and experience in workplace health and safety. He provides background on the new ISO 45001 standard which replaces ISO 18001 and aligns with other ISO standards. The new standard focuses on risk-based thinking, leadership engagement, and consultation/participation of workers. It also includes key changes like expanded definitions, requirements for determining scope and understanding organizational context, and planning actions to address risks and opportunities. The summary outlines the document's sections on the ISO 45001 structure and alignment with the PDCA cycle.
ISO9001Revision Aligning QMS policy and objectives with the strategy of the o...Kumaran637735
油
The document provides a summary of notable changes between ISO 9001:2008 and ISO 9001:2015. Key changes include adopting a common 10-clause structure across all ISO management system standards, increased emphasis on leadership and risk-based thinking, and replacing terms like "document" and "record" with "documented information". The new version aims to better address the needs of different organization types and contexts through a more flexible and holistic approach.
The intention of this presentation is to: Provide a summary of notable change...Kumaran637735
油
The document provides a summary of notable changes between ISO 9001:2008 and ISO 9001:2015. Key changes include adopting a common 10-clause structure across all ISO management system standards, increased emphasis on leadership and risk-based thinking, and replacing terms like "document" and "record" with "documented information". The new version aims to better address the needs of different organization types and contexts through a more flexible and explicit process approach.
The document summarizes key aspects of ISO quality standards including ISO 9000, ISO 14000, and environmental management systems. It provides an overview of what ISO standards are, their history and purpose in ensuring quality management systems. Key points covered include the requirements of ISO 9000 like management responsibility, quality planning, and internal audits. Advantages of ISO certification are improved marketability, reliability and customer satisfaction. ISO 14000 and environmental management systems are introduced as relating to managing environmental responsibilities through a plan-do-check-act model and standards like ISO 14001.
ISO 90012008 Understanding and Internal Auditing.pptFirozKhan158275
油
This document provides an overview of quality management systems and ISO 9001 certification. It discusses what ISO and ISO 9001 are, how ISO 9001 can help businesses, common misunderstandings about the standard, and the requirements and processes involved in achieving certification. The roles and responsibilities of different parties in the certification process are also outlined.
Pe 6421 chapter 3 iso 9000 quality system oct 13 2014Charlton Inao
油
This document provides an overview of ISO 9000 quality standards. It begins with an introduction to ISO and the history and benefits of the ISO 9000 family of standards. The core standards - ISO 9000, 9001, 9004 and 19011 - are described. Key requirements of ISO 9001:2008 are outlined, including the quality management principles of customer focus, leadership, engagement, process approach, system approach, continual improvement, evidence-based decision making and mutually beneficial supplier relationships. The document then covers quality system documentation and auditing requirements. It concludes with an outline of the course contents to help participants understand and implement an ISO 9001 compliant quality management system.
The document provides an overview of the history and key changes between versions of the ISO 9001 quality management standard. Some of the major changes in ISO 9001:2015 include a new structure consisting of 10 clauses focused on risk-based thinking, greater emphasis on leadership and engagement from top management, and flexibility in how organizations design their quality management system. The core quality management principles remain the same with some rewording and consolidation.
Comparison of the two systems iso 9001 and iso 9004 clause 5Raffia Siddique
油
The document discusses ISO 9001 and ISO 9004 standards regarding management responsibility in quality management systems. It covers the key clauses in section 5, including management commitment, customer focus, quality policy, planning, responsibility, and management review. For each clause, it summarizes the requirements in ISO 9001 and provides additional guidance on how organizations can apply each clause according to ISO 9004.
This document provides an overview of ISO standards including ISO 9001 and ISO 14001. It discusses:
- The history and present scenario of ISO as an independent international standardization body with 162 member countries.
- The benefits of ISO standards in ensuring safety, reliability and quality for businesses and access to new markets.
- An overview of the key requirements of ISO 9001:2008 for quality management systems and ISO 14001 for environmental management systems.
- Updates and changes in ISO 9001:2015 and ISO 14001:2015 including greater emphasis on risk-based thinking and the Plan-Do-Check-Act cycle.
The document provides an overview of ISO 9001:2008, including its 8 quality management principles and the requirements of the standard. It discusses the benefits organizations can achieve by implementing the standard such as increased customer satisfaction, continual improvement processes, better integration and management of interrelated business functions, and gaining international recognition. The standard is designed to be applied generically in any organization to enhance performance and customer satisfaction.
This document provides an overview of the key changes between IATF 16949:2016 and ISO/TS 16949:2009. Some of the major changes include adopting a high level structure from ISO 9001:2015, with more explicit requirements for risk-based thinking and consideration of organizational context. There is also a greater emphasis on the role of top management and limiting the boundaries of the quality management system. Additional clauses were added related to issues like product safety, process effectiveness, and contingency planning. Finally, the document outlines how various clauses from ISO/TS 16949:2009 were either modified, carried over, or made new in IATF 16949:2016.
This document outlines and compares the structure and requirements of three international standards - ISO 9001 for quality management systems, ISO 14001 for environmental management systems, and OHSAS 18001 for occupational health and safety management systems. While the standards have different focuses, they have similar high-level requirements for topics such as leadership commitment, policy development, planning, implementation, monitoring and improvement. The document lists the section titles and compares the corresponding requirements across the three standards.
This document provides a clause-by-clause comparison of the changes between ISO 9001:2008 and ISO 9001:2015. Some of the key changes include: reducing documentation requirements; introducing terms like "documented information", interested parties, and risk-based thinking; removing requirements for things like quality manuals and management representatives; combining some clauses; and emphasizing leadership involvement, risk management, and customer focus. The new standard is more principles-based and focuses on effectiveness of quality management systems rather than documentation and procedures.
Correlation matrix with TS 16949-Iatf 16949prateek verma
油
This document provides a correlation matrix comparing the clauses between IATF 16949:2016 and ISO/TS 16949:2009. It shows that IATF 16949:2016 contains additional requirements compared to ISO 9001:2015, with some clauses being modified from ISO/TS 16949:2009. The matrix lists each clause, indicates if it is from ISO 9001:2015, additional for IATF, or modified from the previous automotive standard. This allows understanding the changes and relationship between the new and previous automotive quality management system standards.
Changes ISO 9001-2008 to ISO 9001-2015.pdfRealDairy2
油
The document provides an overview of the notable changes between ISO 9001:2008 and ISO 9001:2015. Some of the key changes include adopting a common 10-clause structure across all ISO management system standards, placing more emphasis on leadership involvement and risk-based thinking, and introducing requirements for determining organizational context and interested party needs. The new version aims to make the standard more compatible with services and non-manufacturing users, strengthen the process approach, and increase flexibility for documented information.
Mario Machado introduces himself and his qualifications and experience in workplace health and safety. He provides background on the new ISO 45001 standard which replaces ISO 18001 and aligns with other ISO standards. The new standard focuses on risk-based thinking, leadership engagement, and consultation/participation of workers. It also includes key changes like expanded definitions, requirements for determining scope and understanding organizational context, and planning actions to address risks and opportunities. The summary outlines the document's sections on the ISO 45001 structure and alignment with the PDCA cycle.
ISO9001Revision Aligning QMS policy and objectives with the strategy of the o...Kumaran637735
油
The document provides a summary of notable changes between ISO 9001:2008 and ISO 9001:2015. Key changes include adopting a common 10-clause structure across all ISO management system standards, increased emphasis on leadership and risk-based thinking, and replacing terms like "document" and "record" with "documented information". The new version aims to better address the needs of different organization types and contexts through a more flexible and holistic approach.
The intention of this presentation is to: Provide a summary of notable change...Kumaran637735
油
The document provides a summary of notable changes between ISO 9001:2008 and ISO 9001:2015. Key changes include adopting a common 10-clause structure across all ISO management system standards, increased emphasis on leadership and risk-based thinking, and replacing terms like "document" and "record" with "documented information". The new version aims to better address the needs of different organization types and contexts through a more flexible and explicit process approach.
The document summarizes key aspects of ISO quality standards including ISO 9000, ISO 14000, and environmental management systems. It provides an overview of what ISO standards are, their history and purpose in ensuring quality management systems. Key points covered include the requirements of ISO 9000 like management responsibility, quality planning, and internal audits. Advantages of ISO certification are improved marketability, reliability and customer satisfaction. ISO 14000 and environmental management systems are introduced as relating to managing environmental responsibilities through a plan-do-check-act model and standards like ISO 14001.
ISO 90012008 Understanding and Internal Auditing.pptFirozKhan158275
油
This document provides an overview of quality management systems and ISO 9001 certification. It discusses what ISO and ISO 9001 are, how ISO 9001 can help businesses, common misunderstandings about the standard, and the requirements and processes involved in achieving certification. The roles and responsibilities of different parties in the certification process are also outlined.
Pe 6421 chapter 3 iso 9000 quality system oct 13 2014Charlton Inao
油
This document provides an overview of ISO 9000 quality standards. It begins with an introduction to ISO and the history and benefits of the ISO 9000 family of standards. The core standards - ISO 9000, 9001, 9004 and 19011 - are described. Key requirements of ISO 9001:2008 are outlined, including the quality management principles of customer focus, leadership, engagement, process approach, system approach, continual improvement, evidence-based decision making and mutually beneficial supplier relationships. The document then covers quality system documentation and auditing requirements. It concludes with an outline of the course contents to help participants understand and implement an ISO 9001 compliant quality management system.
The document provides an overview of the history and key changes between versions of the ISO 9001 quality management standard. Some of the major changes in ISO 9001:2015 include a new structure consisting of 10 clauses focused on risk-based thinking, greater emphasis on leadership and engagement from top management, and flexibility in how organizations design their quality management system. The core quality management principles remain the same with some rewording and consolidation.
This document provides an overview of the IT-ITES/BPM industry in India. It discusses that India has become a global hub for digital talent, accounting for 75% of the world's digital workforce. The IT/ITeS industry has significantly contributed to India's economic growth, transforming the country's image globally and fueling social transformation. The industry is growing with a focus on business processes, security, privacy and customer satisfaction. The size of the Indian IT/BPM industry was estimated at around $191 billion in FY20 and is projected to reach $350 billion by 2025.
This document discusses electrical safety standards. It covers common electrical hazards like electric shock, burns, falls and explosions. It discusses identifying hazards, safe work practices, personal protective equipment, lockout/tagout procedures, training requirements and safety for working on energized equipment. The standards specify requirements for electrical installations, utilization systems, wiring design, grounding, receptacles, flexible cords, boxes/fittings, damp locations and portable equipment handling. Personnel working with electricity must be trained on safety practices related to their job assignments.
Transform your space into a sanctuary with SPL Interiors where comfort meet...SPL Interiors
油
A bedroom is more than just a place to sleep; it's where you find comfort and a sense of peace. It's the room that feels like a hug after a busy day. The bed, soft and inviting, is where you can sink into relaxation, with pillows that cradle your head and blankets that make you feel cozy and safe. It's a place where you can let go of the world and just be.
You might have a dresser or a closet, a place to tuck away clothes and personal items, but its also where you keep the little things that make you feel at homelike a favorite book on the nightstand or a candle that smells like calm. Soft lighting adds warmth, and windows let in just enough natural light during the day to keep things bright but not too harsh.
Decor adds that personal touchwhether its a plant in the corner, art on the walls, or a rug that feels nice underfoot. Its where you can get away from everything, to recharge or reflect, and to make the space feel completely yours. A bedroom is the ultimate safe haven, designed for comfort, rest, and a sense of belonging.
Approaches_to_teaching_Grammar.ppt
**Approaches to Teaching Grammar**
This presentation explores various methods and strategies for teaching grammar effectively in language learning. It covers traditional and modern approaches, including:
- **Deductive vs. Inductive Methods** Teaching rules explicitly versus allowing learners to discover them.
- **Grammar-Translation Method** A classical approach focusing on written language and direct rule application.
- **Communicative Approach** Teaching grammar through real-life communication and interaction.
- **Task-Based Learning** Integrating grammar into meaningful tasks rather than isolated drills.
- **Implicit vs. Explicit Instruction** The role of subconscious learning versus direct grammar explanations.
By comparing these methods, the presentation provides insights into choosing the most effective approach based on learners' needs and contexts.
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"This portfolio includes various projects, ranging from villa designs, commercial spaces, and interior design. Each project is created with a focus on details and tailored to meet the client's needs."
What is 3D Visualization? A Simple Guide for BeginnersZealous Services
油
Explore how 3D visualization transforms ideas into reality from architectural designs to product concepts. This guide dives into its wide-ranging applications, essential tools, and step-by-step processes, making it easy for both beginners and professionals to master. Whether youre creating immersive environments, crafting product prototypes, or enhancing customer experiences, 3D visualization bridges the gap between imagination and execution. Perfect for designers, marketers, and innovators alike discover how this powerful technology brings your concepts to life with stunning precision and creativity. Lets step into the future of design!
Nature Inspired Innovation : Designing The Future Using Lessons From The Pastjejchudley
油
In an era dominated by technological revolution, design thinking's impact on economic and cultural success is undeniable.
However, its focus on 'designing for the user' often neglects the broader real-world implications of the complex systems within which the things we design are used.
In this talk, we will advocate for embracing evolutionary and ecological theories as a toolkit for understanding and designing for our dynamic and interconnected world.
By exploring questions about innovation speed, efficiency, and societal impacts through this lens, attendees will gain insights into enhancing UX design, fostering creative problem-solving, and developing impactful, innovative solutions.
From this presentation you will learn:
- How a better understanding of natural biological systems will help to improve their design practice
- The importance of considering the context of how and where your designs will be used
- How to think about your work in different ways that will enable them to take different approaches to problem solving
- How to adopt systems thinking approaches to help you design more impactful, innovative and effective design solutions.
5. ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
0 Introduction 0 Introduction 0 Introduction
0.1 General 0.1 Background 0.1 Background
0.2 Quality management principles
0.2 Aim of an environmental
management system
0.2 Aim of an OH&S management
system
0.3 Process approach 0.3 Success factors 0.3 Success factors
0.3.1 General ッ ッ
0.3.2 Plan-Do-Check-Act cycle ッ ッ
0.3.3 Risk-based thinking ッ ッ
0.4 Relationship with other
management system standards
0.4 Plan-Do-Check-Act model 0.4 Plan-Do-Check-Act cycle
ッ
0.5 Contents of this International
Standard
0.5 Contents of this International
Standard
11. ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
3 Terms and definitions 3 Terms and definitions 3 Terms and definitions
ッ
3.1 Terms related to
organization and leadership
ッ
ッ 3.2 Terms related to planning ッ
ッ
3.3 Terms related to support
and operation
ッ
ッ
3.4 Terms related to
performance evaluation and
improvement
ッ
13. ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
4 Context of the organization 4 Context of the organization 4 Context of the organization
4.1 Understanding the organization
and its context
4.1 Understanding the organization
and its context
4.1 Understanding the organization
and its context
4.2 Understanding the needs and
expectations of interested parties
4.2 Understanding the needs and
expectations of interested parties
4.2 Understanding the needs and
expectations of workers and other
interested parties
4.3 Determining the scope of the
quality management system
4.3 Determining the scope of the
environmental management system
Determining 4.3 the scope of the
OH&S management system
4.4 Quality management system and
its processes
4.4 Environmental management
system
4.4 OH&S management system
17. ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
6 Planning 6 Planning 6 Planning
6.1 Actions to address risks and opportunities 6.1 Actions to address risks and opportunities 6.1 Actions to address risks and opportunities
ッ 6.1.1 General 6.1.1 General
ッ 6.1.2 Environmental aspects
6.1.2 Hazard identification and assessment of
OH&S risks
ッ ッ 6.1.2.1 Hazard identification
ッ ッ
6.1.2.2 Assessment of OH&S risks and other
risks to the OH&S management system
ッ ッ
6.1.2.3 Identification of OH&S opportunities
and other opportunities
ッ 6.1.3 Compliance obligations
6.1.3 Determination of applicable legal
requirements and other requirements
ッ 6.1.4 Planning action 6.1.4 Planning to take action
6.2 Quality objectives and planning to
achieve them
6.2 Environmental objectives and planning to
achieve them
6.2 OH&S objectives and planning to achieve
them
ッ 6.2.1 Environmental objectives 6.2.1 OH&S objectives
ッ
6.2.2 Planning actions to achieve
environmental objectives
6.2.2 Planning to achieve OH&S objectives
6.3 Planning of changes ッ ッ
19. ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
7 Support 7 Support 7 Support
7.1 Resources 7.1 Resources 7.1 Resources
7.1.1 General ッ ッ
7.1.2 People ッ ッ
7.1.3 Infrastructure ッ ッ
7.1.4 Environment for the
operation of processes
ッ ッ
7.1.5 Monitoring and
measuring resources
ッ ッ
7.1.5.1 General ッ ッ
7.1.5.2 Measurement
traceability
ッ ッ
7.1.6 Organizational
knowledge
ッ ッ
20. ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
7.2 Competence 7.2 Competence 7.2 Competence
7.3 Awareness 7.3 Awareness 7.3 Awareness
7.4 Communication 7.4 Communication
7.4 Information and
communication
ッ 7.4.1 General ッ
ッ 7.4.2 Internal communication ッ
ッ 7.4.3 External communication ッ
7.5 Documented information 7.5 Documented information 7.5 Documented information
7.5.1 General 7.5.1 General 7.5.1 General
7.5.2 Creating and updating 7.5.2 Creating and updating 7.5.2 Creating and updating
7.5.3 Control of documented
information
7.5.3 Control of documented
information
7.5.3 Control of documented
information
22. ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
8 Operation 8 Operation 8 Operation
8.1 Operational planning and
control
8.1 Operational planning and
control
8.1 Operational planning and
control
ッ ッ 8.1.1 General
ッ ッ 8.1.2 Hierarchy of controls
8.2 Requirements for products and
services
8.2 Emergency preparedness and
response
8.2 Management of change
8.2.1 Customer communication ッ ッ
8.2.2 Determining the requirements
for products and services
ッ ッ
8.2.3 Review of the requirements
for products and services
ッ ッ
8.2.4 Changes to requirements for
products and services
ッ ッ
23. ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
8.3 Design and development of products
and services
ッ 8.3 Outsourcing
8.3.1 General ッ ッ
8.3.2 Design and development planning ッ ッ
8.3.3 Design and development inputs ッ ッ
8.3.4 Design and development controls ッ ッ
8.3.5 Design and development outputs ッ ッ
8.3.6 Design and development changes ッ ッ
8.4 Control of externally provided
processes, products and services
ッ 8.4 Procurement
8.4.1 General ッ ッ
8.4.2 Type and extent of control ッ ッ
8.4.3 Information for external providers ッ ッ
24. ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
8.5 Production and service provision ッ 8.5 Contractors
8.5.1 Control of production and
service provision
ッ ッ
8.5.2 Identification and traceability ッ ッ
8.5.3 Property belonging to
customers or external providers
ッ ッ
8.5.4 Preservation ッ ッ
8.5.5 Post-delivery activities ッ ッ
8.5.6 Control of changes ッ ッ
8.6 Release of products and services ッ
8.6 Emergency preparedness and
response
8.7 Control of nonconforming
outputs
ッ ッ
28. ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
10 Improvement 10 Improvement 10 Improvement
10.1 General 10.1 General
10.1 Incident, nonconformity
and corrective action
10.2 Nonconformity and
corrective action
10.2 Nonconformity and
corrective action
10.2 Continual improvement
ッ ッ
10.2.1 Continual
improvement objectives
ッ ッ
10.2.2 Continual
improvement process
10.3 Continual improvement 10.3 Continual improvement ッ
29. PDCA and ISO Clause Structure
0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
ACT
10 Improvement
CHECK
9 Performance
evaluation
DO
8 Operation
PLAN
4 Context of the organization
5 Leadership
6 Planning
7 Support