Clauses of ISO 9001 | Quality Management System
ISO 9001
September 15, 2022 / Management Standards / By TQP
ISO 9001:2015 Quality Management System standard consists of 10
clauses. First three clauses (1 to 3) provides a background to the standard,
and seven main clauses (4 to 10) describes the ISO 9001 requirements.
ISO 9001 is the most recognized standard that defines the Quality
Management System (QMS) requirements and 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).
Table of Contents
1. ISO 9001 CLAUSES
2. Clause 1: Scope
3. Clause 2: Normative references
4. Clause 3: Terms and definitions
5. CLAUSES OF ISO 9001 | QUALITY MANAGEMENT SYSTEM REQUIREMENTS
6. Clause 4: Context of the organization
7. Clause 5: Leadership
8. Clause 6: Planning
9. Clause 7: Support
10. Clause 8: Operation
11. 9 Performance evaluation
12. Clause 10: Improvement
12.1. Difference in clauses – ISO 9001:2008 and ISO 9001:2015
12.1.1. You’ll also like:
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 PDCA model.
Clause 4: Context of the organization
ISO 9001 clause 4 have 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 have 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 & 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 have 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 Remarks
version
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 Leadership Change
Cl. 6 Planning
Cl. 6 Resource Management Cl. 7 Support Change
Cl. 7 Product realization Cl. 8 Operation Change
Cl. 8 Measurement, analysis, and Cl. 9 Performance evaluation Change
improvement Cl. 10 Improvement
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CLAUSES OF IATF 16949:2016
