Comparison between ISO 9001:2008 and ISO 9001:2015



ISO 9001:2008ISO 9001:2015Remarks
0. Introduction0. Introduction
1.1 General1 Scope
1.2 Application4.3 Determining the scope of the quality management system
2. Normative references2 Normative references
3. Terms and definitions3 Terms and definitions
4. Quality Management System4 Context of the organization
4.1 General Requirements4.4 Quality management system and its processes
4.2 Documentation Requirements7.5 Documented informationReduced requirements for documentation
4.2.1 General7.5.1 General
4.2.2 Quality ManualQuality Manual not required(external link)
4.2.3 Control of Documents7.5 Documented InformationRecords and Documents are now “Documented Information(external link)
4.2.4 Control of Records7.5 Documented InformationRecords and Documents are now “Documented Information(external link)
5. Management Responsibility5 Leadership
5.1 Management Commitment5.1 Leadership and commitment
5.2 Customer Focus5.1.2 Customer focus
5.3 Quality Policy5.2 Policy
5.4 Planning6 Planning
5.4.1 Quality Objectives6.2 Quality objectives and planning to achieve them
5.4.2 Quality Management System Planning6.3 Planning of changes
5.5 Responsibility, Authority, and Communication5.3 Organizational roles, responsibilities and authorities
5.5.1 Responsibility and Authority5.3 Organizational roles, responsibilities and authorities
5.5.2 Management RepresentativeMR not required(external link)
5.5.3 Internal Communications7.4 Communication
5.6 Management Review9.3 Management Review
5.6.1 General9.3.1 General
5.6.2 Review Input9.3.2 Management Review Inputs
5.6.3 Review Output9.3.3 Management Review Outputs
6. Resource Management7.1 Resources
6.1 Provision of Resources7.1 Resources
6.2 Human Resources7.1.2 People
6.2.1 General7.2 Competence
6.2.2 Competence, Training, and Awareness7.2 Competence and 7.3 Awareness
6.3 Infrastructure7.1.3 Infrastructure
6.4 Work Environment7.1.4 Environment for the operation of processes
7. Product Realization8 Operation
7.1 Planning of Product Realization8.1 Operational planning and control
7.2 Customer-Related Processes8.2 Requirements for products and services
7.2.1 Determination of Requirements Related to the Product8.2.2 Determining of requirements related to products and services
7.2.2 Review of Requirements Related to the Product8.2.3 Review of requirements related to products and services
7.2.3 Customer Communication8.2.1 Customer communication
7.3 Design and Development8.3 Design and development of products and services
7.3.1 Design and Development Planning8.3.2 Design and development planning
7.3.2 Design and Development Inputs8.3.3 Design and development inputs
7.3.3 Design and Development Outputs8.3.5 Design and development outputs
7.3.4 Design and Development Review8.3.4 Design and development controls
7.3.5 Design and Development Verification8.3.4 Design and development controls
7.3.6 Design and Development Validation8.3.4 Design and development controls
7.3.7 Control of Design and Development Changes8.3.6 Design and development changes
7.4 Purchasing8.4 Control of externally provided processes, products and services
7.4.1 Purchasing Process8.4.1 General
7.4.2 Purchasing Information8.4.3 Information for external providers
7.4.3 Verification of Purchased Product8.4.2 Type and extent of control and 8.6 Release of products and services
7.5 Production and Service Provision8.5 Production and service provision
7.5.1 Control of Production and Service Provision8.5.1 Control of production and service provision
7.5.2 Validation of Processes for Production and Service Provision8.5.1 Control of production and service provision
7.5.3 Identification and Traceability8.5.2 Identification and traceability
7.5.4 Customer Property8.5.3 Property belonging to customers or external providers
7.5.5 Preservation of Product8.5.4 Preservation
7.6 Control of Monitoring and Measuring Equipment8.5.1 Control of production and service provision
8. Measurement, Analysis, and Improvement9.1 Monitoring, measurement, analysis and evaluation
8.1 General9.1.1 General
8.2 Monitoring and Measurement9.1.1 General
8.2.1 Customer Satisfaction9.1.2 Customer satisfaction
8.2.2 Internal Audit9.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes9.1.3 Analysis and evaluation
8.2.4 Monitoring and Measurement of Product8.6 Release of products and services
8.3 Control of Nonconforming Product8.7 Control of nonconforming outputs
8.4 Analysis of Data9.1.3 Analysis and evaluation
8.5 Improvement10 Improvement
8.5.1 Continual Improvement10.3 Continual improvementContinual deleted in CD, but is back in the revised standard(external link)
8.5.2 Corrective Action10.2 Nonconformity and corrective action
8.5.3 Preventive Action6.1 Actions to address risks and opportunitiesPA is being replaced with risk based thinking(external link)


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