SZNS ISO 9001:2015 Quality Management Systems – Requirements

E405.21

This standard specifies requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.

 Supersedes SZNS ISO 9001:2008    Quality Management System- Requirements.

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Description

This standard specifies requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.

 Supersedes SZNS ISO 9001:2008    Quality Management System- Requirements.

TABLE OF CONTENTS

Contents  Page
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Context of the organization 1
4.1 Understanding the organization and its context 1
4.2 Understanding the needs and expectations of interested parties 1
4.3 Determining the scope of the quality management system 2
4.4 Quality management system and its processes 2
5 Leadership 3
5.1 Leadership and commitment 3
    5.1.1 General 3
    5.1.2 Customer focus 3
5.2 Policy 3
    5.2.1 Establishing the quality policy 3
    5.2.2 Communicating the quality policy 3
5.3 Organizational roles, responsibilities and authorities 4
6 Planning 4
6.1 Actions to address risks and opportunities 4
6.2 Quality objectives and planning to achieve them 5
6.3 Planning of changes 5
7 Support 5
7.1 Resources 5
   7.1.1 General 5
   7.1.2 People 5
   7.1.3 Infastructure 6
    7.1.4 Environment for the operation of processes 6
    7.1.5 Monitoring and measuring resources 6
    7.1.6 Organizational knowledge 6
7.2 Competence 7
7.3 Awareness 7
7.4 Communication 7
7.5 Documented information 7
   7.5.1 General 7
   7.5.2 Creating and updating 8
   7.5.3 Control of documented information 8
8 Operation 8
8.1 Operational planning and control 8
8.2 Requirements for products and services 9
   8.2.1 Customer communication 9
   8.2.2 Determining the requirements for products and services 9
   8.2.3 Review of the requirements for products and services 9
   8.2.4 Changes to requirements for products and services 10
8.3 Design and development of products and services 10
   8.3.1 General 10
   8.3.2 Design and development planning 10
   8.3.3 Design and development inputs 10
   8.3.4 Design and development controls 11
   8.3.5 Design and development outputs 11
   8.3.6 Design and development changes 11
8.4 Control of externally provided processes, products and services 11
   8.4.1 General 11
   8.4.2 Type and extent of control 12
   8.4.3 Information for external providers 12
8.5 Production and service provision 13
   8.5.1 Control of production and service provision 13
   8.5.2 Identification and traceability 13
   8.5.3 Property belonging to customers or external providers 13
   8.5.4 Preservation 13
   8.5.5 Post-delivery activities 14
   8.5.6 Control of changes 14
8.6 Release of products and services 14
8.7 Control of nonconforming outputs 14
9 Performance evaluation 15
9.1 Monitoring, measurement, analysis and evaluation 15
   9.1.1 General 15
   9.1.2 Customer satisfaction 15
   9.1.3 Analysis and evaluation 15
9.2 Internal audit 15
9.3 Management review 16
   9.3.1 General 16
   9.3.2 Management review inputs 16
   9.3.3 Management review outputs 16
10 Improvement 17
10.1 General 17
 10.2 Nonconformity and corrective action 17
 10.3 Continual improvement 17
Annex A (informative) Clarification of new structure, terminology and concepts 18
Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176 22
Bibliography 26

Additional information

Format

PDF, Hardcopy