Quality Management System
(ISO 9001:2015)
4 3 3 5 7 3 3
Clauses Clauses Clauses Clauses Clauses Clauses Clauses
3. Terms and definitions
2. Normative references
10. Improvement
4. Context of the
9. Performance
5. Leadership
organization
8. Operation
6. Planning
7. Support
evaluation
1. Scope
2 Sub- 4 Sub- 4 Sub- 9 Sub- 21 Sub- 8 Sub- 2 Sub-
Clauses Clauses Clauses Clauses Clauses Clauses Clauses
4 Context of the
Organization
4.1 Understanding the 4.2 Understanding the 4.3 Determining the 4.4 Quality
organization and its needs and expectations scope of the quality management system
context of interested parties management system and its processes
4.4.1 The organization shall
establish, implement, maintain
and continually improve
4.4.2 To the extent necessary,
the organization shall:
5. Leadership
5.3. Organizational roles,
5.1. Leadership and
5.2. Policy responsibilities and
commitment
authorities
5.1.1 General 5.2.1 Establishing the
(4 Points) quality policy (4Points)
5.2.2 Communicating
5.1.2 Customer the quality policy (3
focus (10 points) Points)
6 Planning
6.1 Actions to address risks and 6.2 Quality objectives and
6.3 Planning of changes
opportunities planning to achieve them
6.1.1 When planning for the 6.2.1 The organization shall
quality management establish quality objectives
system, the organization at relevant functions, levels
shall consider the issues and processes for QMS
6.2.2 When planning how to
6.1.2 The organization shall achieve its quality
plan: objectives, the organization
shall determine:
7 Support
7.4 7.5 Documented
7.1 Resources 7.2 Competence 7.3 Awareness
Communication information
7.1.1 General 7.5.1 General
7.5.2 Creating and
7.1.2 People
updating
7.5.3 Control of
7.1.3 Infrastructure
Documented Information
7.1.4 Environment for the
operation of processes
7.1.5 Monitoring and
measuring resources
7.1.6 Organizational
knowledge
8 Operation
8.1 Operational 8.3 Design and 8.6 Release of 8.7 Control of
8.2 Requirements for 8.4 Control of externally provided 8.5 Production and
planning and development of products products and Nonconforming
products and services processes, products and services service provision
control and services services Outputs
8.5.1 Control of 8.7.1 The organization
8.2.1 Customer
8.3.1 General 8.4.1 General production and service shall deal with
communication
provision nonconforming outputs
8.2.2 Determining the 8.7.2 The organization
8.3.2 Design and 8.4.2 Type and extent of 8.5.2 Identification and
requirements for shall retain documented
development planning control traceability
products and services information that
8.2.3 Review of the 8.5.3 Property belonging
8.3.3 Design and 8.4.3 Information for
requirements for to customers or external
development inputs external providers
products and services providers
8.2.4 Changes to
8.3.4 Design and
requirements for 8.5.4 Preservation
development controls
products and services
8.3.5 Design and 8.5.5 Post-delivery
development outputs activities
8.3.6 Design and
8.5.6 Control of changes
development changes
9 Performance
evaluation
9.1 Monitoring,
measurement, analysis 9.2 Internal audit 9.3 Management review
and evaluation
9.2.1 The organization
9.1.1 General shall conduct internal 9.3.1 General
audits
9.1.2 Customer 9.2.2 The organization 9.3.2 Management
satisfaction shall: review inputs
9.1.3 Analysis and 9.3.3 Management
evaluation review outputs
10 Improvement
10.2 Nonconformity 10.3 Continual
10.1 General
and corrective action improvement
10.2.1 When a nonconformity occurs
10.2.2 The organization shall retain
documented information as evidence
