ISO 9001:2015 Quality Management System standard consists of 10 clauses. The first three clauses (1 to 3) provide a background to the standard, and seven main clauses (4 to 10) describe the ISO 9001 requirements.
ISO 9001is the most recognized standard that defines the Quality Management System (QMS) requirements and the base standard for IATF 16949 (Automotive Quality Management System standard).
ISO 9001:2015 standard is based on the high-level structure (HLS) and integrates with othermanagement systemswhere the structure is the same, such as IATF 16949:2016(Automotive Quality Management System), ISO 14001:2015 (Environmental Management System), andISO 45001:2018(Occupational Health and Safety Management).
Table of Contents
ISO 9001 CLAUSES
Clauses of ISO 9001 are:
- Clause 1: Scope
- Clause 2: Normative references
- Clause 3: Terms and definitions
- Clause 4: Context of the organization
- Clause 5: Leadership
- Clause 6: Planning
- Clause 7: Support
- Clause 8: Operation
- Clause 9 Performance evaluation
- Clause 10: Improvement
Clause 1: Scope
Clause 2: Normative references
Clause 3: Terms and definitions
CLAUSES OF ISO 9001 | QUALITY MANAGEMENT SYSTEM REQUIREMENTS
The seven mandatory ISO 9001 standard clausesare clauses 4 to 10. All these clauses are arranged according to the PDCA model.
Clause 4: Context of the organization
ISO 9001 clause 4 has four sub-clauses- 4.1,4.2,4.3, and 4.4
- 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 processes
Clause 5: Leadership
ISO 9001 clause 5 has three sub-clauses- 5.1,5.2, and 5.3
- 5.1 Leadership and Commitment
- 5.1.1 General
- 5.1.2 Customer focus
- 5.2 Policy
- 5.2.1 Establish the quality policy
- 5.2.1 Communicating the Quality Policy
- 5.3 Organizational roles, responsibilities, and authorities
Clause 6: Planning
ISO 9001 clause 6 have three sub-clause- 6.1,6.2, and 6.3
- 6.1 Actions to address risks and opportunities
- 6.2 Quality objectives and planning to achieve them
- 6.3 Planning of changes
Clause 7: Support
ISO 9001 clause 7 have five sub-clause- 7.1,7.2,7.3,7.4, and 7.5
- 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
- 7.3 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
Clause 8: Operation
ISO 9001 clause 8 have seven sub-clause- 8.1,8.2,8.3,8.4,8.5,8.6, and 8.7
- 8.1 Operational planning and control
- 8.2 Requirements for products and services
- 8.2.1 Customer communication
- 8.2.2 Determining the requirements for products and services
- 8.2.3 Review of the requirements for products and services
- 8.2.4 Changes to requirements for products and services
- 8.3 Design & Development of products & services
- 8.3.1 General
- 8.3.2 Design & Development planning
- 8.3.3 Design & Development Inputs
- 8.3.4 Design & Development Control
- 8.3.5 Design & Development Outputs
- 8.3.6 Design & Development Changes
- 8.4 Control of externally provided processes, products and services
- 8.4.1 General
- 8.4.2 Type and Extent of control
- 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 customer 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 Outputs
Clause 9: Performance Evaluation
ISO 9001 clause 9 have three sub-clause- 9.1,9.2, and 9.3
- 9.1 Monitoring, measurement, analysis and evaluation
- 9.1.1 General
- 9.1.2 Evaluation of Compliance
- 9.1.3 Analysis and Evaluation
- 9.2 Internal audit
- 9.3 Management review
- 9.3.1 General
- 9.3.2 Management review inputs
- 9.3.3 Management Review Outputs
Clause 10: Improvement
ISO 9001 clause 10 has three sub-clause- 10.1,10.2, and 10.3
- 10.1 General
- 10.2 Nonconformity and corrective actions
- 10.3 Continual improvement
Difference in clauses – ISO 9001:2008 and ISO 9001:2015
There is no change in the first three clauses of the latest ISO 9001:2015 standard and are the same as those in ISO 9001:2008, but there is a considerable difference from the fourth clause onwards.
| Clause | As per ISO 9001:2008 old version | Clause | As per ISO 9001:2015 new version | Remarks |
| Cl. 0 | Introduction | Cl. 0 | Introduction | |
| Cl. 1 | Scope | Cl. 1 | Scope | Same |
| Cl. 2 | Normative References | Cl. 2 | Normative References | Same |
| Cl. 3 | Terms and Definitions | Cl. 3 | Terms and Definitions | Same |
| Cl. 4 | Quality Management System | Cl. 4 | Context of the organization | Change |
| Cl. 5 | Management Responsibility | Cl. 5 Cl. 6 | Leadership Planning | Change |
| Cl. 6 | Resource Management | Cl. 7 | Support | Change |
| Cl. 7 | Product realization | Cl. 8 | Operation | Change |
| Cl. 8 | Measurement, analysis, and improvement | Cl. 9 Cl. 10 | Performance evaluation Improvement | Change |
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