08/08/2019 AS9100D Translated into Plain English

This page presents a detailed overview of AS9100D and provides a PDF sample of our approach.

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.
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• 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 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 requirement

must be applied unless you can explain why it does not apply.

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

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• 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

• Identify quality management system (QMS) requirements.

• Identify your statutory and regulatory QMS requirements.

• Identify your customers' particular QMS requirements.

• Determine the processes that your QMS needs to have.

• 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 evaluate your processes.

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

• 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

• Establish QMS documents and records (documented information).

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• Establish documents and records that define the scope of your QMS.

• Establish documents and records that describe your interested parties.

• Establish documents and records needed to support process operations.

• Manage QMS documents and records (documented information).

• Retain your organization's quality management records.

• Maintain your organization's quality management documents.

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.

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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 measure conformance and performance.

• Expect personnel to take appropriate action when necessary.

• 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.

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• Apply your organization's quality policy.

5.3 Provide leadership by defining roles and responsibilities

• Appoint a member of management to oversee your organization's QMS.

• Assign responsibilities and authorities to your management representative.

• Give management representative unrestricted access to top management.

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

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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.

• Document your quality objectives.

• Communicate 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
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7.1 Support your QMS by providing the necessary resources

7.1.1 Provide internal and external resources for your QMS

• Consider QMS resource needs and requirements.

• 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

• Determine the people needed to ensure that QMS is implemented effectively.

• Identify the people that you need in order to operate your QMS processes.

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

• Provide the people needed to ensure that QMS is implemented effectively.

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

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

• Maintain the infrastructure that your processes need.

7.1.4 Provide the appropriate environment for your processes

• Determine the environment that your processes need.

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• 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.

• Maintain 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.

• Maintain suitable monitoring and measuring resources.

7.1.5.2 Provide suitable measurement traceability resources

• Determine your measurement traceability requirements.

• Maintain a register of monitoring and measuring equipment.

• Establish a recall process for monitoring and measuring equipment.

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.

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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.

• Periodically review the competence of people who affect your QMS.

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.

• Support your QMS by managing feedback about your QMS.

• Support your QMS by managing internal feedback about your QMS.

• Support your QMS by managing external feedback about your QMS.

7.5 Support your QMS by controlling documented information

7.5.1 Include the documented information that your QMS needs

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• Figure out how extensive documented QMS information should be.

• Consider activities when you establish documents and records.

• Consider personnel when you establish documents and records.

• Consider processes when you establish documents and records.

• Consider products when you establish documents and records.

• Consider services when you establish documents and records.

• Consider size when you establish documents and records.

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

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

• Select all 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.
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• 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.

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• Use your plans to implement and control operational processes.

• Retain operational process planning documents and records.

8.1.1 Establish an operational risk management process

• Plan your operational risk management process.

• Develop a process to manage your operational risks.

• Implement your operational risk management process.

• Assign operational risk management responsibilities.

• Manage your product and service management risks.

• Apply the actions that must be taken to mitigate the operational

risks that exceed the limits set by your risk acceptance criteria.

• Control the risks that remain after you’ve implemented

actions to mitigate unacceptable operational risks.

• Control your operational risk management process.

8.1.2 Establish a configuration management process

• Plan your configuration management process.

• Implement your configuration management process.

• Use your configuration management process to identify and

control your organization’s product and service attributes.

• Control your configuration management process.

8.1.3 Establish product safety management processes

• Plan your product safety management processes.

• Develop your product safety management processes.

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• Implement your product safety management processes.

• Control your product safety management processes.

8.1.4 Establish counterfeit part management processes

• Plan your counterfeit part management processes.

• Develop your counterfeit part management processes.

• Implement your counterfeit part management processes.

• Control your counterfeit part management processes.

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 accepting an order.

• Clarify all differences between your original proposal and final order.
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• Confirm that you can meet specified 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

• Control documents that record changes in product and service requirements.

• Amend all relevant documented information to reflect

changes in customers' 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.

• Maintain your organization's design and development process.

8.3.2 Plan product and service design and development activities

• Plan your design and development stages and controls.

• Consider product and service needs and complexities.

• Consider design and development process complexities.

8.3.3 Determine product and service design and development inputs

• Clarify your product and service design and development inputs.

• Specify your product and service design and development inputs.

• Define product and service design and development resource needs.

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• Control your design and development input documents and records.

8.3.4 Specify how design and development process is 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.

• Control how design and development progression is authorized.

• Document product and service design and development activities.

8.3.4.1 Control design and development verification and validation

• Plan your design verification and validation testing activities.

• Control your design verification and validation testing activities.

• Review your design verification and validation testing activities.

• Document your design verification and validation testing activities.

8.3.5 Clarify how design and development outputs are managed

• 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 process.

• Ensure that outputs include or refer to the appropriate acceptance criteria.

• Ensure that outputs can be used to validate proposed products and services.

• Ensure that outputs specify any critical items that must be accommodated.
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• Ensure that outputs facilitate and support product and service management.

• Ensure that outputs are approved by authorized persons prior to release.

• Control design and development output documents and records.

8.3.6 Review and control design and development changes

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

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

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

8.4 Monitor and control external processes, products, and services

8.4.1 Evaluate and select external providers of processes, products, and services

• Accept responsibility for externally provided processes, products, and services.

• Identify risks related to the external provision of processes, products, and services.

• Define data and criteria to manage external process, product, and service providers.

• Establish controls for all externally provided processes, products, and services.

• Control the use of externally provided processes, products, and services.

8.4.1.1 Establish control over the management of your external providers

• Assign responsibility and authority for deciding if external providers are used.

• Develop a process to manage, monitor, and control use of external providers.

• Establish and maintain a register of external provider performance and status.

• Periodically review performance and conformance of each external provider.

• Define the actions to take when external providers fail to meet requirements.

8.4.2 Establish external provider controls and carry out external verifications
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• Establish controls for external providers and external outputs.

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

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

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

• Establish external process, product, and service verification activities.

• Plan your external process, product, and service verification activities.

• Establish a process to evaluate the accuracy of test data and test reports.

• Perform routine external process, product, and service verification activities.

• Accept processes, products, and services only if they meet requirements.

• Monitor your external process, product, and service verification activities.

• Review your external process, product, and service verification activities.

8.4.3 Discuss requirements with external process, product, and service providers

• Define what you expect from external providers.

• Identify your organization's process requirements.

• Identify your organization's product requirements.

• Identify your organization's service requirements.

• Identify your organization's special requirements.

• Identify your organization's equipment requirements.

• Identify your organization's information requirements.

• Identify your organization's procedural requirements.

• Identify your organization's interaction requirements.

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• Identify your organization's notification requirements.

• Identify your organization's methodological requirements.

• Identify your organization's design and development requirements.

• Identify your organization's verification and validation requirements.

• Identify your organization's production and fabrication requirements.

• Identify your organization's testing and inspection requirements.

• Identify your organization's part and component requirements.

• Identify your organization's special outsourcing requirements.

• Identify your organization's particular supply chain requirements.

• Identify your organization's external staff awareness requirements.

• Identify your organization's competence and skill requirements.

• Identify your organization's monitoring and control requirements.

• Identify your organization's quality management requirements.

• Identify your organization's documentation requirements.

• Discuss your organization's expectations 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 for production.

• Use documented information to control production.

• Use monitoring and measurement to control production.

• Use suitable process environments to control production.

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• Use competent qualified personnel to control production.

• Use workmanship criteria to control production.

• Use accountability to control production.

• Implement controlled conditions for service provision.

• Use documented information to control service provision.

• Use monitoring and measurement to control service provision.

• Use suitable process environments to control service provision.

• Use competent qualified personnel to control service provision.

• Use workmanship criteria to control service provision.

• Use accountability to control service provision.

• Implement controlled conditions for delivery process.

• Use documented information to control delivery process.

• Use monitoring and measurement to control delivery process.

• Use suitable process environments to control delivery process.

• Use competent qualified personnel to control delivery process.

• Implement controlled conditions for post-delivery process.

• Use documented information to control post-delivery process.

• Use monitoring and measurement to control post-delivery process.

• Use suitable process environments to control post-delivery process.

• Use competent qualified personnel to control post-delivery process.

8.5.1.1 Control your equipment, tools, and software programs

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• Validate equipment, tools, and software prior to release for production.

• Maintain equipment, tools, and software used during production.

8.5.1.2 Validate and control your organization's special processes

• Validate processes if outputs cannot be properly verified.

• Control processes when outputs cannot be properly verified.

8.5.1.3 Verify that production process outputs meet requirements

• Establish suitable production process verification activities.

• Implement your production process verification activities.

• Document your production process verification activities.

8.5.2 Maintain and control the unique identity of your outputs

• Establish suitable means for identifying production and service outputs.

• Specify the unique identity of outputs whenever conformity must be ensured.

• Identify outputs whenever product or service conformity must be ensured.

• Identify the monitoring and measurement status of outputs during production.

• Control the unique identity of your outputs when traceability is a requirement.

• Retain the documents and records that are needed to facilitate traceability.

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.

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• 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.

• Preserve outputs in accordance with specifications and legal requirements.

• Preserve outputs by setting up suitable cleaning and sanitization practices.

• Preserve outputs by setting up suitable arrangements to control foreign objects.

• Preserve outputs by setting up suitable handling methods and storage facilities.

• Preserve outputs by setting up suitable marking methods and labeling practices.

• Preserve outputs by setting up shelf life controls and by rotating your stock.

8.5.5 Clarify and comply with all post-delivery requirements

• Clarify your organization's post-delivery requirements and commitments.

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

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

• Meet your organization's post-delivery requirements and commitments.

8.5.6 Control changes in production and service provision

• Plan changes in production and service provision.

• Control changes in production and service provision.

• Review changes in production and service provision.

8.6 Implement arrangements to control product and service release

• Implement planned arrangements to verify products at appropriate stages.

• Verify that product requirements were met at all appropriate stages.

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• Identify the people who may authorize the release of products to customers.

• Release products only if verifications are finished or if authorized to do so.

• Implement planned arrangements to verify services at appropriate stages.

• Verify that service requirements were met at all appropriate stages.

• Identify the people who may authorize the release of services to customers.

• Release services only if verifications are finished or if authorized to do so.

8.7 Control nonconforming outputs and document actions taken

8.7.1 Identify and control nonconforming output to prevent unintended use

• Plan how you intend to control nonconforming outputs.

• Identify outputs that do not conform to their requirements.

• Evaluate nonconforming outputs and examine their impact.

• Take appropriate action to control nonconforming outputs.

8.7.2 Document your 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 you're going to monitor, measure, analyze, and evaluate

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

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

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9.1.2 Monitor customers' perceptions and improve customer satisfaction

• Determine methods for obtaining customer information.

• Determine methods for monitoring customer perceptions.

• Determine methods for improving customer satisfaction.

9.1.3 Evaluate satisfaction, effectiveness, performance, and conformance

• Analyze your monitoring and measurement results.

• Analyze and evaluate appropriate data and information.

• Use your analytical results to evaluate satisfaction.

• Use your analytical results to evaluate effectiveness.

• Use your analytical results to evaluate performance.

• Use your analytical results to evaluate conformance.

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 QMS meets requirements.

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

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• Establish your organization's internal audit program.

• Establish internal audit responsibilities and authorities.

• Establish internal audit methodologies and techniques.

• Establish internal audit planning requirements.

• Establish internal audit reporting expectations.

• Establish internal audit schedules.

• Implement your organization's internal audit program.

• Define the scope of each internal audit.

• Specify audit criteria for each internal audit.

• Select impartial and objective internal auditors.

• Carry out internal audits and planned intervals.

• Report internal audit results to management.

• Correct nonconformities and take corrective action.

• Maintain your organization's internal audit program.

• Retain documented information about your audit program.

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.

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• 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 continually improve.

• Consider opportunities to take corrective action.

• Consider opportunities to correct nonconformities.

• Consider opportunities to generate breakthroughs.

• Consider opportunities to transform your operations.

• Consider opportunities to make incremental changes.

• Determine and select opportunities for improvement.

• Identify opportunities to meet customer requirements.

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• Identify opportunities to enhance customer satisfaction.

• Meet customer requirements and enhance satisfaction.

10.2 Control nonconformities and take appropriate corrective action

10.2.1 Develop and implement corrective action management processes

• Define your corrective action management processes.

• React to your organization's nonconformities.

• Control and correct your nonconformities.

• Evaluate the need to eliminate causes.

• Develop corrective actions to address causes.

• Take corrective actions to deal with causes.

• Review the effectiveness of 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

• Identify quality management system improvement opportunities.

• Determine if there are needs or opportunities that should be addressed.

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

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This page summarizes the AS9100D standard. It highlights the

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Introduction to AS9100D
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Process Approach in Plain English
ISO's Quality Management Principles

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Updated on November 7, 2018. First published on August 20, 2017.

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