AS/NZS ISO 9001:2016
Quality management systems - Requirements
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, and aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements in this standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. Identical to and reproduced from ISO 9001:2015.
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AS/NZS ISO 9001:2016 Requirements
Preface
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
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
5 Leadership
5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus
5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7 Support
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
8 Operation
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 and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and 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 customers 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
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
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
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Annex A (informative) Clarification of new structure, terminology and concepts
Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176
Bibliography
Amendment 1
Amendment control sheet
Previous versions
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Related Information
Electricity Industry Participation Code Amendment (Requirements and Processes for Audits) 2016
Ministry: Ministry of Business Innovation and Employment - Records & Library Services
Section: 13
Citation context:Schedule 10.3, clause 3 amended: In Schedule 10.3, clause 3, replace "AS/NZS ISO 9001:2000" with "AS/NZS ISO 9001:2008 or AS/NZS ISO 9001:2016" in each place.
Electricity Industry Participation Code Amendment (Requirements and Processes for Audits) 2016
Ministry: Ministry of Business Innovation and Employment - Records & Library Services
Section: 15
Citation context:New clause 4A of Schedule 10.3 inserted: In Schedule 10.3, after clause 4, insert: "4A Incorporation of AS/NZS ISO 9001:2008 and AS/NZS ISO 9001:2016 by reference "(1) The New Zealand Standards AS/NZS ISO 9001:2008 and AS/NZS ISO 9001:2016 are incorporated by reference in this Code in accordance with section 32 of the Act. "(2) Subclause (1) is subject to Schedule 1 of the Act, which includes a requirement that the Authority must give notice in the Gazette before an amended AS/NZS ISO 9001:2008 or AS/NZS ISO 9001:2016 becomes incorporated by reference in this Code. "(3) Clause 10.10 does not apply in relation to the incorporation by reference of AS/NZS ISO 9001:2008 or AS/NZS ISO 9001:2016."
Electricity Industry Participation Code Amendment (Requirements and Processes for Audits) 2016
Ministry: Ministry of Business Innovation and Employment - Records & Library Services
Section: 14
Citation context:Schedule 10.3, clause 4 amended: In Schedule 10.3, clause 4, replace "AS/NZS ISO 9001:2000" with "AS/NZS ISO 9001:2008 or AS/NZS ISO 9001:2016" in each place.
Electricity Industry Participation Code Amendment (Requirements and Processes for Audits) 2016
Ministry: Ministry of Business Innovation and Employment - Records & Library Services
Section: 16
Citation context:Schedule 10.4, clause 17 amended: In Schedule 10.4, clause 17, replace "AS/NZS ISO 9001:2000" with "AS/NZS ISO 9001:2008 or AS/NZS ISO 9001:2016".
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AS/NZS ISO 9001:2016 Requirements
Preface
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
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
5 Leadership
5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus
5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7 Support
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
8 Operation
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 and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and 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 customers 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
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
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
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Annex A (informative) Clarification of new structure, terminology and concepts
Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176
Bibliography
Amendment 1
Amendment control sheet
Previous versions
AS/NZS ISO 9001:2016
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.