ISO 9001 2015 Translated into Plain English

ISO DIS 9001 2015 is an "Interim Working Draft". It's not the final version of the standard.
According to ISO, the final official version "is due to be published by 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 and describe the products
and services that will be included in your organization's QMS.

•  Use your scope document to explain that every ISO 9001 requirement
is mandatory and may only be excluded if it cannot be applied.

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

•  Maintain your organization's scope document.

4.4 Establish a QMS that complies with this standard

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

•  Determine the processes that your QMS needs.

•  Determine process sequences and interactions.

•  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 check your processes.

•  Determine opportunities to improve your processes.

•  Implement your process-based quality management system.

•  Support your process-based quality management system.

•  Improve your process-based quality management system.

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 an awareness of the process approach. 

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 provide compliant products and services. 

•  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. 

•  Make sure that it can be used to set quality objectives. 

•  Formulate your organization's quality policy.

•  Make a commitment to satisfy applicable requirements. 

•  Make a commitment to continual QMS improvement.

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 Control 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.

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 be sure that your
organization is capable of meeting customer requirements on
a consistent basis.
 

•  Provide the people that you need in order to be sure that your
organization is capable of meeting all applicable statutory and
regulatory requirements
on a consistent basis.
 

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 to 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 to achieve
conformity of products and services.
 

•  Provide the environment that your processes need.

7.1.5 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.
 

•  Determine your measurement traceability requirements.

•  Identify the measurement traceability resources that
customers and interested parties expect you to have.
 

•  Identify the measurement traceability resources
that governmental agencies expect you to have.
 

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 revision 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 all of 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 all 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 processes.

•  Prepare process implementation and control plans.

•  Use your plans to implement and control processes.

•  Control planned process changes and modifications.

•  Retain suitable process documents and records.

8.2 Clarify how product and service requirements will be managed

8.2.1 Clarify how communications with customers will be handled

•  Establish processes for communicating with customers.

•  Establish how customer enquires should be handled. 

•  Establish how orders and contracts should be handled. 

•  Establish how customer feedback should be handled. 

8.2.2 Clarify how product and service requirements will be specified

•  Establish a process for managing product and service requirements.

•  Implement your product and service requirement management process.

•  Maintain your product and service requirement management process.

8.2.3 Clarify how product and service requirements will be reviewed

•  Review product and service requirements before you accept an order.

•  Confirm all unwritten customer requirements before you accept them.

•  Clarify differences between your original proposal and the final order.

•  Resolve differences between your original proposal and the final order.

•  Retain and control documents that describe the results of your reviews.

8.3 Establish a process to design and develop products and services

8.3.1 Create a design and development process when necessary

•  Establish a design and development process (when necessary).

•  Establish a design and development process whenever product
and service requirements are unavailable or inadequate.
 

•  Implement a design and development process (when necessary).

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 participation. 

•  Consider design and development process interfaces. 

•  Consider design and development process responsibilities. 

•  Consider design and development process documentation. 

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.

8.3.4 Specify how design and development process will be controlled

•  Establish your design and development controls.

•  Ensure that your results are clearly defined. 

•  Ensure that your reviews are done as planned.

•  Ensure that output verifications are performed. 

•  Ensure that output validations are carried out. 

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 to design inputs and outputs.

•  Review changes made to design inputs and outputs.

•  Control changes made to design inputs and outputs.

8.4 Monitor and control externally provided products and services

8.4.1 Confirm that external products and services meet requirements

•  Confirm that externally provided processes,
products, and services meet requirements
.

•  Confirm that externally provided products and services
meet requirements if they are incorporated into your
organization's own products and services.
 

•  Confirm that externally provided processes and
functions
meet your organization's requirements.
 

•  Establish criteria to select and evaluate external providers.

8.4.2 Establish 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 verification requirements. 

•  Clarify your organization's competence requirements. 

•  Clarify your organization's methodological requirements. 

•  Clarify your organization's monitoring and control 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 process outputs and control their unique identity

•  Use suitable means to identify process outputs.

•  Identify process outputs throughout production. 

•  Identify process outputs throughout service provision. 

•  Control the unique identify of process outputs.

•  Control output identity if traceability is a requirement. 

8.5.3 Protect property owned by customers and external providers

•  Identify property owned by your customers and external providers.

•  Verify property owned by your customers and external providers.

•  Protect property owned by your customers and external providers.

•  Monitor property owned by your customers and external providers.

8.5.4 Preserve outputs during production and service provision

•  Preserve process 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. 

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 unplanned changes related to production and service provision.

•  Document review results, actions taken, and who authorized change. 

•  Control unplanned changes related to 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 process outputs, products, and services

•  Identify nonconforming process outputs, products, and services.

•  Control nonconforming process outputs, products, and services.

•  Control the unintended use or delivery of outputs, products,
and services that do not conform to requirements.

•  Document the actions and decisions taken to prevent the
unintended use or delivery of outputs, products, and services
that do not conform to requirements.

•  Prevent nonconforming process outputs, products, and services.

9. Evaluation

9.1 Monitor, measure, analyze, and evaluate QMS performance

9.1.1 Plan how you’re going to monitor, measure, analyze, and evaluate

•  Plan how to monitor, measure, analyze, and evaluate your QMS.

•  Monitor, measure, analyze, and evaluate your organization's QMS.

•  Monitor the performance and effectiveness of your QMS. 

•  Measure the performance and effectiveness of your QMS. 

•  Analyze the performance and effectiveness of your QMS. 

•  Evaluate the performance and effectiveness of your QMS. 

9.1.2 Obtain customer information and monitor customer satisfaction

•  Establish methods for obtaining and using customer information.

•  Obtain information about the opinions and perceptions of customers.

•  Monitor the perceptions, opinions, and attitudes of your customers.

9.1.3 Analyze and evaluate your monitoring and measurement results

•  Analyze and evaluate the data and information you have collected.

•  Use analytical results and evaluations to generate relevant outputs.

•  Use outputs to show that requirements are being met. 

•  Use outputs to demonstrate that your plans are working. 

•  Use outputs to assess performance, compliance, and effectiveness. 

•  Use outputs to identify QMS improvement needs and opportunities. 

•  Use outputs to evaluate the performance of your QMS processes.

•  Use outputs to provide inputs for management review process.

9.2 Use internal audits to examine conformance and performance

9.2.1 Audit your quality management system at planned intervals

•  Conduct internal QMS audits at planned intervals.

•  Find out 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.

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

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

•  Establish your organization's internal audit program.

•  Establish internal audit responsibilities. 

•  Establish internal audit planning requirements. 

•  Establish internal audit reporting requirements. 

•  Establish internal audit schedules. 

•  Establish internal audit methods.

9.3 Review the suitability, adequacy, and effectiveness of your QMS

9.3.1 Plan and perform management reviews at planned intervals

•  Plan your management review activities.

•  Schedule QMS reviews at planned intervals. 

•  Review your organization's QMS at regular intervals.

•  Review QMS suitability, adequacy, and effectiveness. 

9.3.2 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.

•  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 outputs to confirm that QMS improvement opportunities exist.

•  Select methodologies to analyze causes and support improvement.

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

 
 
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OTHER ISO 9001 PAGES

ISO 9001 2015 Introduction

Quality Management Principles

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

OTHER STANDARDS

Auditing Guidelines

Risk Management Guidelines

Business Continuity Requirements

Service Management Requirements

Management System Auditing Guidelines

Occupational Health and Safety Requirements

Software Quality Management Requirements

Information Security Management Requirements

Information Security Management Code of Practice

Supply Chain Security Management Requirements

Medical Device Quality Management Requirements

Medical Device Risk Management Requirements

Aerospace Quality Management Requirements

Environmental Management Requirements

Food Safety Management Requirements


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 Updated on December 11, 2014. First published on November 25, 2014.

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