ISO 9001:2008 vs ISO 9001:2015

Sự khác biệt giữa ISO 9001:2008 và ISO 9001:2015

Sự khác biệt giữa ISO 9001:2008 và ISO 9001:2015
ISO 9001:2008 ISO 9001:2015 FDIS Remarks
0. Introduction 0. Introduction
1.1 General 1. Scope
1.2 Application 4.3 Determining the scope of the quality management system
2. Normative references 2. Normative references
3. Terms and definitions 3. Terms and definitions
4. Quality Management System 4. Context of the organization
4.1 General Requirements 4.4 Quality management system and its processes
4.2 Documentation Requirements 7.5 Documented information Reduced requirements for documentation
4.2.1 General 7.5.1 General
4.2.2 Quality Manual - Quality Manual not required
4.2.3 Control of Documents 7.5 Documented Information Records and Documents are now "Documented Information"
4.2.4 Control of Records 7.5 Documented Information Records and Documents are now "Documented Information"
5. Management Responsibility 5. Leadership
5.1 Management Commitment 5.1 Leadership and commitment
5.2 Customer Focus 5.1.2 Customer focus
5.3 Quality Policy 5.2 Quality policy
5.4 Planning 6. Planning
5.4.1 Quality Objectives 6.2 Quality objectives and planning to achieve them
5.4.2 Quality Management System Planning 6.3 Planning of change
5.5 Responsibility, Authority, and Communication 5.3 Organizational roles, responsibilities and authorities
5.5.1 Responsibility and Authority 5.3 Organizational roles, responsibilities and authorities
5.5.2 Management Representative - MR not required
5.5.3 Internal Communications 7.4 Communication
5.6 Management Review 9.3 Management Review
5.6.1 General 9.3.1 Management Review
5.6.2 Review Input 9.3.2 Management Review Inputs
5.6.3 Review Output 9.3.3 Management Review Outputs
6. Resource Management 7.1 Resources
6.1 Provision of Resources 7.1 Resources
6.2 Human Resources 7.1.2 People
6.2.1 General 7.2 Competence
6.2.2 Competence, Training, and Awareness 7.2 Competence and 7.3 Awareness
6.3 Infrastructure 7.1.3 Infrastructure
6.4 Work Environment 7.1.4 Environment for the operation of processes
7. Product Realization 8. Operation
7.1 Planning of Product Realization 8.1 Operational planning and control
7.2 Customer-Related Processes 8.2 Requirements for products and services
7.2.1 Determination of Requirements Related to the Product 8.2.2 Determining of requirements related to products and services
7.2.2 Review of Requirements Related to the Product 8.2.3 Review of requirements related to products and services
7.2.3 Customer Communication 8.2.1 Customer communication
7.3 Design and Development 8.3 Design and development of products and services
7.3.1 Design and Development Planning 8.3.2 Design and development planning
7.3.2 Design and Development Inputs 8.3.3 Design and development inputs
7.3.3 Design and Development Outputs 8.3.5 Design and development outputs
7.3.4 Design and Development Review 8.3.4 Design and development controls
7.3.5 Design and Development Verification 8.3.4 Design and development controls
7.3.6 Design and Development Validation 8.3.4 Design and development controls
7.3.7 Control of Design and Development Changes 8.3.6 Design and development changes
7.4 Purchasing 8.4 Control of externally provided processes, products and services
7.4.1 Purchasing Process 8.4.1 General
7.4.2 Purchasing Information 8.4.3 Information for external providers
7.4.3 Verification of Purchased Product 8.4.2 Type and extent of control and 8.6 Release of products and services
7.5 Production and Service Provision 8.5 Production and service provision
7.5.1 Control of Production and Service Provision 8.5.1 Control of production and service provision
7.5.2 Validation of Processes for Production and Service Provision 8.5.1 Control of production and service provision
7.5.3 Identification and Traceability 8.5.2 Identification and traceability
7.5.4 Customer Property 8.5.3 Property belonging to customers or external providers
7.5.5 Preservation of Product 8.5.4 Preservation
7.6 Control of Monitoring and Measuring Equipment 8.5.1 Control of production and service provision
8. Measurement, Analysis, and Improvement 9.1 Monitoring, measurement, analysis and evaluation
8.1 General 9.1.1 General
8.2 Monitoring and Measurement 9.1.1 General
8.2.1 Customer Satisfaction 9.1.2 Customer satisfaction
8.2.2 Internal Audit 9.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes 9.1.3 Analysis and evaluation
8.2.4 Monitoring and Measurement of Product 8.6 Release of products and services
8.3 Control of Nonconforming Product 8.7 Control of nonconforming outputs
8.4 Analysis of Data 9.1.3 Analysis and evaluation
8.5 Improvement 10. Improvement
8.5.1 Continual Improvement 10.3 Continual Improvement Continual deleted in CD, but is back in DIS and FDIS
8.5.2 Corrective Action 10.2 Nonconformity and corrective action
8.5.3 Preventive Action 6.1 Actions to address risks and opportunities PA is being replaced with risk based thinking

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