ISO 9001 2015 Translated into Plain English

ISO FDIS 9001 2015 is the "Final Draft" of the new quality management standard.
However, in spite of what it's called, the FDIS version is not actually the final standard.
Minor clerical changes are still permitted and certainly will be made but no further technical
changes will be allowed. Once these minor changes are made, the final official standard
will be published (which, according to ISO, will be sometime before the end of 2015).

4. Context

4.1 Understand your organization and its unique context

•  Identify and understand your organization's context.

• Identify and understand your organization's context before
you establish its quality management system (QMS).

• Consider the external issues that are relevant to your organization's
purpose and strategic direction and think about the influence these
issues could have on its QMS and the results it intends to achieve.

• Consider the internal issues that are relevant to your organization's
purpose and strategic direction and think about the influence these
issues could have on its QMS and the results it intends to achieve.

•  Monitor information about your organization's context.

• Consider the impact changes in context could have on
your organization's quality management system (QMS).

4.2 Clarify the needs and expectations of interested parties

•  Identify the parties who affect or could affect your QMS.

•  Consider how interested parties affect or could affect your ability
to provide products and services that meet customer requirements.

•  Consider how interested parties affect or could affect your ability to provide
products and services that meet statutory and regulatory requirements.

•  Clarify and understand their unique needs and expectations.

•  Monitor and review information about your interested parties.

4.3 Define the scope of your quality management system

•  Clarify boundaries and think about what your QMS should apply to.

•  Use boundary and applicability information to define your scope.

•  Consider your organization's context when you define your scope.

•  Document the scope of your quality management system (QMS).

•  Use your scope document to describe the boundaries of
your organization's QMS and to explain what it applies to.

•  Use your scope document to identify the types of products
and services that will be included in your organization's QMS.

•  Use your scope document to explain that every ISO 9001 requirement
must be applied unless you can explain why it doesn't apply in your case.

•  Maintain the document that defines the scope of your QMS.

•  Control your organization's QMS scope document.

4.4 Develop a QMS and establish documented information

4.4.1 Establish a QMS that complies with this standard

•  Develop a process-based quality management system (QMS).

•  Determine the processes that your QMS needs.

•  Determine methods needed to manage processes.

•  Determine resources needed to support processes.

•  Determine process responsibilities and authorities.

•  Determine risks and opportunities for each process.

•  Determine methods needed to evaluate processes.

•  Implement your process-based quality management system.

•  Apply criteria needed to operate and control your processes.

•  Apply methods needed to operate and control your processes.

•  Maintain your process-based quality management system.

•  Improve your process-based quality management system.

4.4.2 Maintain QMS documents and retain QMS records

•  Maintain documents needed to support process operations.

•  Control documents which support process operations.

•  Retain records which show that plans are being followed.

•  Control records which show that plans are being followed. 

5. Leadership

5.1 Provide leadership by focusing on quality and customers

5.1.1 Provide leadership by encouraging a focus on quality

•  Accept responsibility for your QMS.

•  Demonstrate a commitment to your QMS.

•  Ensure that a quality policy is developed. 

•  Ensure that quality objectives are established. 

•  Ensure that requirements are built into processes. 

•  Ensure that your QMS achieves all intended results. 

•  Communicate your commitment to the QMS.

•  Explain why quality management is important. 

•  Expect managers to be accountable for their QMS. 

•  Encourage your personnel to support their QMS. 

•  Promote the use of risk-based thinking. 

5.1.2 Provide leadership by encouraging a focus on customers

•  Expect personnel to focus on customers.

•  Expect personnel to manage all relevant requirements. 

•  Expect personnel to manage relevant risks and opportunities. 

•  Expect personnel to focus on enhancing customer satisfaction. 

5.2 Provide leadership by establishing a suitable quality policy

5.2.1 Provide leadership by formulating your quality policy

•  Develop an appropriate quality policy.

•  Make sure that it supports your organization's purpose. 

•  Make sure that it deals with your organization's context.

•  Formulate your organization's quality policy.

•  Make a commitment to satisfy applicable requirements. 

•  Make a commitment to continual QMS improvement.

•  Implement your organization's quality policy.

•  Maintain your organization's quality policy.

5.2.2 Provide leadership by implementing your quality policy

•  Document your organization's quality policy.

•  Communicate your organization's quality policy.

•  Apply your organization's quality policy.

5.3 Provide leadership by defining roles and responsibilities

•  Assign QMS roles, responsibilities, and authorities.

•  Communicate QMS roles, responsibilities, and authorities.

6. Planning

6.1 Define actions to manage risks and address opportunities

6.1.1 Consider risks and opportunities when you plan your QMS

•  Plan the development of your organization's QMS.

•  Identify the risks and opportunities that could influence the
performance of your organization's QMS or disrupt its operation.
 

• Consider how your organization's context could affect
how well its QMS is able to achieve intended results.
 

• Consider how your organization's interested parties could
affect how well its QMS is able to achieve intended results.
 

•  Figure out what you need to do to address the risks and
opportunities that could influence the performance of your
organization's QMS or disrupt its operation.

6.1.2 Plan how you’re going to manage risks and opportunities

•  Consider your organization's risk treatment options.

•  Define actions to address risks and opportunities.

•  Define actions that you can take to address the risks
and opportunities that could influence the performance
of your QMS or disrupt or damage its operation.

6.2 Set quality objectives and develop plans to achieve them

6.2.1 Establish quality objectives for all relevant areas

•  Clarify criteria for setting quality objectives.

•  Set quality objectives in all relevant areas.

•  Communicate your quality objectives.

•  Document your quality objectives.

•  Monitor your quality objectives.

•  Update your quality objectives.

6.2.2 Develop plans to achieve objectives and evaluate results

•  Establish plans to achieve quality objectives.

•  Plan how you're going to evaluate your results.

6.3 Plan changes to your quality management system

•  Plan changes to your quality management system.

•  Consider the purpose of the changes you intend to make.

•  Consider responsibilities and authorities whenever you make changes.

•  Consider the consequences that changes could potentially produce.

•  Consider the availability of resources whenever you make changes.

•  Consider the integrity of your QMS whenever you make changes.

7. Support

7.1 Support your QMS by providing the necessary resources

7.1.1 Provide internal and external resources for your QMS

•  Determine the resources that your QMS needs.

•  Provide the resources that your QMS needs.

7.1.2 Provide suitable people for your QMS and your processes

•  Provide the people that your QMS needs to be effective.

•  Provide the people that you need in order to operate processes. 

•  Provide the people that you need in order to control your processes. 

7.1.3 Provide the infrastructure that your processes must have

•  Determine the infrastructure that your processes need.

•  Identify the infrastructure that your organization needs
in order to support process operations and achieve
conformity of products and services.
 

•  Provide the infrastructure that your processes need.

7.1.4 Provide the appropriate environment for your processes

•  Determine the environment that your processes need.

•  Identify the environment that your organization needs
in order to support process operations and achieve
conformity of products and services.
 

•  Provide the environment that your processes need.

7.1.5 Provide monitoring, measuring, and traceability resources

7.1.5.1 Provide suitable monitoring and measuring resources

•  Determine monitoring and measuring resource requirements.

•  Identify the monitoring and measuring resources that you
need in order to be sure that you can provide products
and services that meet all relevant requirements.
 

•  Provide suitable monitoring and measuring resources. 

7.1.5.2 Provide suitable measurement traceability resources

•  Determine your measurement traceability requirements.

•  Provide suitable measurement traceability resources.

7.1.6 Provide knowledge to facilitate process operations

•  Determine the knowledge that your organization needs to have.

•  Acquire the knowledge that your organization needs to have.

•  Make organizational knowledge available to the extent necessary.

•  Monitor relevant trends and changes in knowledge and information.

•  Maintain the organizational knowledge that has been acquired.

7.2 Support your QMS by ensuring that people are competent

•  Identify those under your control who do work that affects quality.

•  Clarify your organization's quality competence requirements.

•  Acquire competence whenever shortcomings are discovered.

•  Document the competence of those whose work affects quality.

•  Evaluate the effectiveness of actions taken to acquire competence.

7.3 Support your QMS by explaining how people can help

•  Make personnel aware of your organization's QMS.

•  Share information about your QMS with the people who
carry out work that is under your organization's control.

7.4 Support your QMS by managing your communications

•  Support your QMS by managing QMS communications.

•  Figure out how internal communications will be handled.

•  Figure out how external communications will be handled.

7.5 Support your QMS by controlling documented information

7.5.1 Include the documented information that your QMS needs

•  Figure out how extensive documented QMS information should be.

•  Consider your activities when you establish documents and records.

•  Consider your personnel when you establish documents and records.

•  Consider your processes when you establish documents and records.

•  Consider your products when you establish documents and records.

•  Consider your services when you establish documents and records.

•  Consider your size when you establish documents and records.

•  Select all the documents and records that your QMS needs.

•  Select all the internal documents and records that your QMS needs.

•  Select all the external documents and records that your QMS needs.

7.5.2 Manage the creation and revision of documented information

•  Manage the creation and updating of documented information.

•  Make sure that your organization’s QMS documents
and records are properly identified and described.

•  Make sure that your organization’s QMS documents
and records are properly formatted and presented.

•  Make sure that your organization’s QMS documents
and records are properly reviewed and approved.

7.5.3 Control the management and use of documented information

7.5.3.1 Control your organization's QMS documents and records

•  Select the QMS documents and records that you need.

•  Select all the documentation that you need in order to
protect the confidentiality, integrity, and use of information.

•  Select all of the documentation that is required by ISO 9001.

•  Control the QMS documents and records that you need.

•  Control all the internal documentation that your QMS needs.

•  Control all the external documentation that your QMS needs.

7.5.3.2 Control how QMS documents and records are controlled

•  Control how QMS documents and records are controlled.

•  Control how QMS documents and records are created.

•  Control how QMS documents and records are identified.

•  Control how QMS documents and records are distributed.

•  Control how QMS documents and records are accessed.

•  Control how QMS documents and records are retrieved.

•  Control how QMS documents and records are stored.

•  Control how QMS documents and records are used.

•  Control how QMS documents and records are changed.

•  Control how QMS documents and records are protected.

•  Control how QMS documents and records are preserved.

8. Operations

8.1 Develop, implement, and control your operational processes

•  Plan the implementation and control of operational processes.

•  Prepare operational process implementation and control plans.

•  Use your plans to implement and control operational processes.

•  Control planned operational process changes and modifications.

•  Retain suitable operational process documents and records.

8.2 Determine and document product and service requirements

8.2.1 Communicate with customers and manage customer property

•  Communicate with customers.

•  Provide information to customers. 

•  Obtain information from customers. 

•  Manage customer property. 

•  Control property supplied by customers. 

8.2.2 Clarify all product and service requirements and capabilities

•  Determine requirements for products and services offered to customers.

•  Verify that you are capable of meeting product and service requirements.

8.2.3 Review product and service requirements and record results

8.2.3.1 Verify requirements before you accept orders from customers

•  Review product and service requirements before you accept orders.

•  Clarify differences between original proposals and the final orders.

•  Confirm that you can meet product and service requirements.

8.2.3.2 Document your review of product and service requirements

•  Document the results of product and service requirement reviews.

•  Document any new or changed product and service requirements.

8.2.4 Amend documents when product and service requirements change

•  Amend all relevant documented information to reflect
changes in customers' product and service requirements.

•  Retain and control documents and records that describe
new or modified product and service requirements.

8.3 Establish a process to design and develop products and services

8.3.1 Create an appropriate design and development process

•  Establish an appropriate design and development process.

•  Implement an appropriate design and development process.

8.3.2 Plan product and service design and development activities

•  Plan your design and development stages and controls.

•  Consider design and development process complexities. 

•  Consider design and development process requirements. 

•  Consider design and development process expectations. 

•  Consider design and development process participation. 

•  Consider design and development process interfaces. 

•  Consider design and development process responsibilities. 

•  Consider design and development process documentation. 

•  Consider design and development process resources. 

8.3.3 Determine product and service design and development inputs

•  Clarify your product and service design and development inputs.

•  Define product and service design and development resource needs.

•  Control your design and development input documents and records.

8.3.4 Specify how design and development process will be controlled

• Control product and service design and development activities.

•  Control how design and development results are defined. 

•  Control how design and development reviews are carried out.

•  Control how design and development validations are performed. 

•  Control how design and development verifications are done. 

• Document product and service design and development activities.

8.3.5 Clarify how design and development outputs will be produced

•  Control product and service design and development outputs.

•  Ensure that outputs can be compared against input requirements. 

•  Ensure that outputs are capable of supporting product provision. 

•  Ensure that outputs include or refer to acceptance criteria. 

•  Ensure that outputs can be used to validate proposals. 

•  Control design and development output documents and records.

8.3.6 Review and control all design and development changes

•  Identify changes made during or subsequent to design and development.

•  Review changes made during or subsequent to design and development.

•  Control changes made during or subsequent to design and development.

8.4 Monitor and control external processes, products, and services

8.4.1 Confirm that external products and services meet requirements

•  Establish controls for external processes, products, and services.

•  Control your externally provided processes, products, and services.

•  Determine criteria to select, evaluate, and monitor external providers.

•  Use criteria to select external process, product, and service providers. 

•  Use criteria to monitor the performance of your external providers. 

•  Use criteria to evaluate your organization's external providers. 

8.4.2 Develop controls for externally provided products and services

•  Consider controls for external providers,
processes, products, and services.

•  Consider the potential impact that externally provided processes,
products, and services could have on your organization's ability
to consistently meet external requirements.
 

•  Consider the controls that external process, product, and service
providers have implemented and think about how effective their
controls actually are.
 

•  Develop controls for external providers,
processes, products, and services.

•  Implement controls for external providers,
processes, products, and services.

8.4.3 Discuss your organization’s requirements with external providers

•  Clarify what you expect from external providers.

•  Clarify your organization's process requirements. 

•  Clarify your organization's product requirements. 

•  Clarify your organization's service requirements. 

•  Clarify your organization's equipment requirements. 

•  Clarify your organization's interaction requirements. 

•  Clarify your organization's competence requirements. 

•  Clarify your organization's methodological requirements. 

•  Clarify your organization's monitoring and control requirements. 

•  Clarify your organization's verification or validation requirements. 

•  Discuss your organization's requirements with external providers.

8.5 Manage and control production and service provision activities

8.5.1 Establish controls for production and service provision

•  Implement controlled conditions.

•  Implement controlled conditions for production. 

•  Implement controlled conditions for service provision. 

•  Implement controlled conditions for delivery process. 

•  Implement controlled conditions for post-delivery process.

8.5.2 Identify your outputs and control their unique identity

•  Use suitable means to identify outputs.

•  Identify outputs throughout production. 

•  Identify outputs throughout service provision. 

•  Control the unique identify of your outputs.

•  Control output identity if traceability is required. 

8.5.3 Protect property owned by customers and external providers

•  Identify property belonging to customers and external providers.

•  Verify property belonging to customers and external providers.

•  Protect property belonging to customers and external providers.

•  Monitor property belonging to customers and external providers.

•  Document property belonging to customers and external providers.

8.5.4 Preserve outputs during production and service provision

•  Preserve outputs during production and service provision.

•  Consider using suitable identification methods to preserve outputs. 

•  Consider using suitable packaging methods to preserve outputs. 

•  Consider using suitable handling methods to preserve outputs. 

•  Consider using suitable storage methods to preserve outputs. 

•  Consider using suitable transmission methods to preserve outputs. 

•  Consider using suitable transportation methods to preserve outputs. 

8.5.5 Clarify and comply with all post-delivery requirements

•  Clarify your organization's post-delivery requirements.

•  Identify the activities that must be carried out after product delivery. 

•  Identify the activities that must be carried out after service delivery. 

•  Comply with your organization's post-delivery requirements.

8.5.6 Control changes for production and service provision

•  Review changes in production and service provision.

•  Document review results, actions taken, and authorizations. 

•  Control changes in production and service provision.

8.6 Implement arrangements to control product and service release

•  Establish planned arrangements to verify products at each stage.

•  Verify that product requirements were met at appropriate stages.

•  Establish planned arrangements to verify services at each stage.

•  Verify that service requirements were met at appropriate stages.

8.7 Control nonconforming outputs and document actions taken

8.7.1 Identify and control nonconforming output to prevent unintended use

•  Identify outputs that do not conform to their requirements.

•  Evaluate nonconforming outputs and examine their impact.

•  Take appropriate action to control nonconforming outputs.

•  Verify conformity when nonconforming outputs are corrected.

8.7.2 Document nonconforming outputs and the actions that are taken

•  Document your organization's nonconforming outputs.

•  Document the actions and decisions taken to prevent
the unintended use or delivery of nonconforming outputs
.

9. Evaluation

9.1 Monitor, measure, analyze, and evaluate QMS performance

9.1.1 Plan how to monitor, measure, analyze, and evaluate

•  Plan how you're going to monitor, measure,
analyze, and evaluate your organization's QMS
.

•  Monitor, measure, analyze, and evaluate
QMS
performance and effectiveness.

9.1.2 Find out how well customer needs and expectations are being met

•  Establish methods that you can use to monitor customer perceptions.

•  Monitor how well customer needs and expectations are being fulfilled.

9.1.3 Evaluate performance, effectiveness, conformity, and satisfaction

•  Analyze your monitoring and measurement results.

•  Analyze and evaluate appropriate data and information. 

•  Use your analytical results to evaluate performance. 

•  Use your analytical results to evaluate effectiveness. 

•  Use your analytical results to evaluate conformity. 

•  Use your analytical results to evaluate satisfaction. 

9.2 Use internal audits to examine conformance and performance

9.2.1 Audit your quality management system at planned intervals

•  Conduct internal conformance audits at planned intervals.

•  Determine if your organization's QMS meets requirements. 

•  Examine the effectiveness of your organization's QMS. 

9.2.2 Develop an internal audit program for your organization

•  Plan the development of your internal audit program (or programme).

•  Develop a program that can find out if your QMS meets requirements. 

•  Develop a program that can determine if your QMS is effective. 

•  Establish your organization's internal audit program.

•  Establish internal audit planning requirements. 

•  Establish internal audit reporting requirements. 

•  Establish internal audit responsibilities. 

•  Establish internal audit schedules. 

•  Establish internal audit methods.

9.3 Carry out management reviews and document your results

9.3.1 Review suitability, adequacy, effectiveness, and direction

•  Review your organization's QMS at regular intervals.

•  Review the suitability of your organization's QMS. 

•  Review the adequacy of your organization's QMS. 

•  Review the effectiveness of your organization's QMS. 

•  Review the direction of your organization's QMS. 

9.3.2 Plan and perform management reviews at planned intervals

•  Plan your organization's management review activities.

•  Schedule your organization's reviews at planned intervals.

•  Review your organization's quality management system.

9.3.3 Generate management review outputs and document results

•  Generate suitable management review outputs.

•  Document the results of your management reviews.

10. Improvement

10.1 Determine improvement opportunities and make improvements

•  Consider ways of enhancing customer satisfaction.

•  Consider opportunities to support innovation.

•  Consider opportunities to take corrective action.

•  Consider opportunities to transform your operations.

•  Consider opportunities to make incremental changes.

•  Determine and select opportunities for improvement.

•  Identify opportunities to meet customer requirements.

•  Consider opportunities to enhance customer satisfaction.

•  Meet customer requirements and enhance satisfaction.

10.2 Control nonconformities and take appropriate corrective action

10.2.1 Correct nonconformities and address causes and consequences

•  React to your organization's nonconformities.

•  Control and correct your nonconformities.

•  Evaluate the need to eliminate causes.

•  Develop corrective actions to address causes.

•  Implement corrective actions to address causes.

•  Review the effectiveness of your corrective actions.

10.2.2 Document your nonconformities and the actions that are taken

•  Document your organization's nonconformities.

•  Document the actions taken to address nonconformities.

•  Document your organization's corrective action results.

10.3 Enhance the suitability, adequacy, and effectiveness of your QMS

•  Consider evaluation, analytical, and management review outputs.

•  Use results to confirm that unmet QMS needs must be addressed.

•  Improve the suitability, adequacy, and effectiveness of your QMS.

Also see ISO 13485 2015 and ISO 14001 2015 (in Plain English).

 
Attention

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main points. It does not present detail. To get the complete
Plain English standard,
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RELATED RESOURCES

ISO 9001 2015 Introduction

Quality Management Principles

Quality Management Checklist

Outline of ISO 9001 2015 Standard

Overview 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 9004 2009 Quality Management Library

OTHER STANDARDS

Auditing Standard

Risk Management Standard

Business Continuity Standard

IT Service Management Standard

Environmental Management Standard

Management System Auditing Standard

Occupational Health and Safety Standard

Software Quality Management Standard

Information Security Management Standard

Supply Chain Security Management Standard

Medical Device Quality Management Standard

Medical Device Risk Management Standard

Aerospace Quality Management Standard

Food Safety Management Standard


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 Updated on August 20, 2015. First published on November 25, 2014.

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