This web page presents a Plain English overview of the new

ISO 9001 2015 quality management standard. For a more detailed

version, please see ISO DIS 9001 2015 Translated into Plain English.
Part 4. Context asks you to start by understanding your organization
and its context before you start to develop its process-based quality
management system (QMS). It asks you to consider the external and
internal issues that are relevant to your organization's purpose and
strategic direction and to think about the influence these issues could
have on its QMS and the results it intends to achieve.
This means that you need to understand your organization's external
environment, its culture, its values, its performance, and its interested
parties before you develop its QMS. Why? Because your QMS will
need to be able to manage all of these influences. Once youve
considered all of this, you're ready to define the scope of your
QMS and to begin its development.

Part 5. Leadership asks your organization's top management to

provide leadership for its QMS by showing that they support it, by
expecting people to focus on quality and on customers, by expecting
them to provide compliant products and services, and by expecting
them to manage risks and opportunities. Section 5 also expects top
management to establish a quality policy and to assign QMS roles,
responsibilities, and authorities.

Part 6. Planning asks you to plan the development of your QMS.

It asks you to address the risks and opportunities that could
influence your organization's QMS or disrupt its operation and
to consider how its context and its interested parties could affect
its QMS and the results it intends to achieve. Section 6 also asks
you to set quality objectives and to develop plans to achieve them.
Finally, it asks you to control changes to your QMS.

Part 7. Support asks you to support your QMS by managing

communications and by providing the necessary resources.

It asks you to provide competent people, to provide an appropriate
infrastructure and environment, to provide suitable monitoring and
measuring technologies, to provide the knowledge that is needed to
support process operations, and to provide documented information.
It asks you to start by figuring out how extensive your documented
information should be and then asks you to select and include all the
documentation your organization needs in order to ensure that its
processes are being carried out as planned and all the documentation
it needs in order to comply with the ISO 9001 standard. It asks you to
manage the creation and modification of this documentation and to
control how it is used.

Part 8. Operations asks you to develop, implement, and control

the operational processes that your organization needs in order
to provide products and services and to manage and control risks
and opportunities. It asks you to clarify how product and service
requirements will be managed and how communications with
customers will be handled.
Section 8 also asks you to establish a product and service design
and development process (when necessary), to monitor externally
provided products and services, to manage production and service
provision, to supervise product and service release, and to control
nonconforming process outputs, products, and services.

Part 9. Evaluation asks you to monitor, measure, analyze, and

evaluate the performance of your organization's QMS. It asks
you to monitor customer satisfaction, to evaluate monitoring and
measuring results, to audit conformance and performance, and
to review the suitability, adequacy, and effectiveness of your QMS.

Part 10. Improvement asks you to identify opportunities to improve

your organization's processes, products and services, and to enhance

customer satisfaction. It also asks you to control nonconformities, to
take corrective actions, and to enhance the suitability, adequacy, and
effectiveness of your QMS.

RELATED RESOURCES

ISO 9001 2015 Introduction

Quality Management Principles
ISO 19011 Internal Audit Library
Outline of ISO 9001 2015 Standard

ISO 9001 2015 versus ISO 9001 2008

Plain English ISO 9000 2015 Definitions
ISO's Process Approach in Plain English
ISO 9001 2015 Translated into Plain English
ISO 9004 2009 Translated into Plain English
Plain English Quality Management Checklist

This web page presents a Plain English outline of the new

ISO DIS 9001 2015 quality management standard. For a more
detailed version, see ISO 9001 2015 Translated into Plain English.

4. Context
4.1 Understand your organization and its unique context.
4.2 Clarify the needs and expectations of interested parties.
4.3 Define the scope of your quality management system.
4.4 Establish a QMS that complies with this standard.

5. Leadership
5.1 Provide leadership by focusing on quality and customers.
5.1.1 Provide leadership by encouraging a focus on quality.
5.1.2 Provide leadership by encouraging a focus on customers.
5.2 Provide leadership by establishing a suitable quality policy.
5.2.1 Provide leadership by formulating your quality policy.
5.2.2 Provide leadership by implementing your quality policy.
5.3 Provide leadership by defining roles and responsibilities.

6. Planning
6.1 Define actions to manage risks and address opportunities.
6.1.1 Consider risks and opportunities when you plan your QMS.
6.1.2 Plan how youre going to manage risks and opportunities.
6.2 Set quality objectives and develop plans to achieve them.
6.2.1 Establish quality objectives for all relevant areas.
6.2.2 Develop plans to achieve objectives and evaluate results.
6.3 Control changes to your quality management system.

7. Support

7.1 Support your QMS by providing the necessary resources.

7.1.1 Provide internal and external resources for your QMS.
7.1.2 Provide suitable people for your QMS and your processes.
7.1.3 Provide the infrastructure that your processes must have.
7.1.4 Provide the appropriate environment for your processes.
7.1.5 Provide suitable monitoring and measuring resources.
7.1.6 Provide knowledge to facilitate process operations.
7.2 Support your QMS by ensuring that people are competent.
7.3 Support your QMS by explaining how people can help.
7.4 Support your QMS by managing your communications.
7.5 Support your QMS by controlling documented information.
7.5.1 Include the documented information that your QMS needs.
7.5.2 Manage the creation and revision of documented information.
7.5.3 Control the management and use of documented information.
7.5.3.1 Control your organization's QMS documents and records.
7.5.3.2 Control how QMS documents and records are controlled.

8. Operations
8.1 Develop, implement, and control your operational processes.
8.2 Clarify how product and service requirements will be managed.
8.2.1 Clarify how communications with customers will be handled.
8.2.2 Clarify how product and service requirements will be specified.
8.2.3 Clarify how product and service requirements will be reviewed.
8.3 Establish a process to design and develop products and services.

8.3.1 Create a design and development process when necessary.

8.3.2 Plan product and service design and development activities.
8.3.3 Determine product and service design and development inputs.
8.3.4 Specify how design and development process will be controlled.
8.3.5 Clarify how design and development outputs will be produced.
8.3.6 Review and control all design and development changes.
8.4 Monitor and control externally provided products and services.
8.4.1 Confirm that external products and services meet requirements.
8.4.2 Establish controls for externally provided products and services.
8.4.3 Discuss your organizations requirements with external providers.
8.5 Manage and control production and service provision activities.
8.5.1 Establish controls for production and service provision.
8.5.2 Identify process outputs and control their unique identity.
8.5.3 Protect property owned by customers and external providers.
8.5.4 Preserve outputs during production and service provision.
8.5.5 Clarify and comply with all post-delivery requirements.
8.5.6 Control changes for production and service provision.
8.6 Implement arrangements to control product and service release.
8.7 Control nonconforming process outputs, products, and services.

9. Evaluation
9.1 Monitor, measure, analyze, and evaluate your QMS performance.
9.1.1 Plan how youre going to monitor, measure, analyze, and evaluate.
9.1.2 Obtain customer information and monitor customer satisfaction.

9.1.3 Analyze and evaluate monitoring and measurement results.

9.2 Use internal audits to examine conformance and performance.
9.2.1 Audit your quality management system at planned intervals.
9.2.2 Develop an internal audit program for your organization.
9.3 Review the suitability, adequacy, and effectiveness of your QMS.
9.3.1 Plan and perform management reviews at planned intervals.
9.3.2 Generate management review outputs and document results.

10. Improvement
10.1 Determine improvement opportunities and make improvements.
10.2 Control nonconformities and take appropriate corrective action.
10.2.1 Correct nonconformities and address causes and consequences.
10.2.2 Document your nonconformities and the actions that are taken.
10.3 Enhance the suitability, adequacy, and effectiveness of your QMS.

If you'd like to see how we've translated each of the above

sections into
Plain English, please check out our more detailed ISO 9001 webpage.

RELATED RESOURCES

ISO 9001 2015 Introduction

Quality Management Principles
Overview of ISO 9001 2015 Standard
Plain English Internal Audit Standard
ISO 9001 2015 versus ISO 9001 2008

Plain English ISO 9000 2015 Definitions

ISO's Process Approach in Plain English
ISO 9001 2015 Translated into Plain English
ISO 9004 2009 Translated into Plain English
Plain English Quality Management Checklist

Updated on May 15, 2015. First published on November 25, 2014.