Clauses of ISO 9001 | Quality Management System ISO 9001

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 9001 is 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 other management systems where the structure is the same, such as IATF 16949:2016(Automotive Quality Management System),  ISO 14001:2015 (Environmental Management System), and ISO 45001:2018 (Occupational Health and Safety Management).

ISO 9001 CLAUSES

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 clauses are 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

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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