ISO 9001 2008 Translated into Plain English

ISO 9001 is a quality management standard. It applies to all types
of organizations. It doesn't matter what size they are or what they do.
It can help both product and service organizations achieve standards
of quality that are recognized and respected throughout the world.

This web page presents a detailed overview of ISO 9001 2008. It does not
present the entire detailed standard. If you need a detailed and complete
interpretation and explanation of the ISO 9001 standard, please consider
purchasing our new Title 20: ISO 9001 2008 Translated into Plain English.

Please note that ISO presents requirements in sections 4 to 8 of
ISO 9001 2008. Therefore, the following material begins with section 4.

4.2. DOCUMENT YOUR QUALITY MANAGEMENT SYSTEM (QMS)

4.2.1 MANAGE QUALITY MANAGEMENT SYSTEM DOCUMENTS

Develop documents for your organization's QMS.
Make sure that your organization's QMS documents
respect and reflect what you do and how you do it.

4.2.2 PREPARE QUALITY MANAGEMENT SYSTEM MANUAL

Establish a quality manual for your organization.
Maintain your organization's quality manual.

4.2.3 CONTROL QUALITY MANAGEMENT SYSTEM DOCUMENTS

Control your organization's QMS documents.
Control documents that are used as QMS records.

4.2.4 ESTABLISH QUALITY MANAGEMENT SYSTEM RECORDS

Establish your organization's QMS records.
Establish a procedure to control your QMS records.

5.3 SUPPORT YOUR QUALITY POLICY

Ensure that your organization's quality
policy serves its overall purpose.
Ensure that your quality policy makes
it clear that requirements must be met.
Ensure that your quality policy makes a commitment
to continually improve the effectiveness of your QMS.
Ensure that your quality policy supports
your organization's quality objectives.
Ensure that your quality policy is communicated
and discussed throughout your organization.
Ensure that your quality policy is periodically
reviewed to make sure that it is still suitable.

5.4 CARRY OUT YOUR QMS PLANNING

5.4.1 ESTABLISH QUALITY OBJECTIVES

Support the establishment of quality objectives.
Establish quality objectives for your organization.
Make sure that your quality objectives are effective.

5.4.2 PLAN QUALITY MANAGEMENT SYSTEM (QMS)

Plan the establishment of your QMS.
Plan the documentation of your QMS.
Plan the implementation of your QMS.
Plan the maintenance of your QMS.
Plan the continual improvement of your QMS.

5.5 ALLOCATE QMS RESPONSIBILITY AND AUTHORITY

5.5.1 DEFINE RESPONSIBILITIES AND AUTHORITIES

Ensure that QMS responsibilities and authorities are defined.
Ensure that QMS responsibilities and authorities are
communicated throughout your organization.

5.5.2 CREATE MANAGEMENT REPRESENTATIVE ROLE

Appoint a member of your organization's
management to oversee your QMS.
Give your management representative authority
over and responsibility for your organization's QMS.

5.5.3 SUPPORT INTERNAL COMMUNICATION

Ensure that appropriate communication processes
are established within your organization.
Ensure that internal communication
occurs throughout your organization.

5.6 PERFORM QMS MANAGEMENT REVIEWS

5.6.1 REVIEW QUALITY MANAGEMENT SYSTEM (QMS)

Carry out management reviews of your
organization's QMS at planned intervals.
Evaluate improvement opportunities.
Assess the need to make changes.
Maintain a record of your management reviews.

5.6.2 EXAMINE MANAGEMENT REVIEW INPUTS

Examine information about your QMS (inputs).

5.6.3 GENERATE MANAGEMENT REVIEW OUTPUTS

Generate management review decisions and
actions (outputs) to improve your organization.
Generate management review decisions and actions
(outputs) to change your general quality orientation.
Generate management review decisions and
actions (outputs) to address resource needs.

6.2 PROVIDE COMPETENT QMS PERSONNEL

6.2.1 ENSURE THE COMPETENCE OF WORKERS

Ensure the competence of anyone within your
QMS who could directly or indirectly affect your
ability to meet product requirements.

6.2.2 MEET COMPETENCE REQUIREMENTS

Identify the competence requirements of personnel
within your QMS who perform work that could directly
or indirectly affect your organization's ability to meet
product requirements.
Provide training, or take other suitable steps, to meet
your organization's QMS competence requirements.
Evaluate the effectiveness of your organization's
QMS training and awareness activities.
Maintain suitable records which show that
personnel within your QMS are competent.

7. REALIZATION REQUIREMENTS	7.1 CONTROL PRODUCT REALIZATION PLANNING
	Establish a product realization planning process. Use your product realization planning process to plan the realization of your organization's products. Prepare planning outputs that are suitable and consistent with your organization's methods. Develop the processes that you will need to use in order to realize products.

7.2 CONTROL CUSTOMER-RELATED PROCESSES

7.2.1 IDENTIFY YOUR UNIQUE PRODUCT REQUIREMENTS

Identify the requirements that your
customers want you to comply with.
Identify the requirements that are dictated
by your product's intended use or purpose.
Identify the requirements that are imposed
on your products by external agencies.
Identify any additional requirements that are
important to your organization and must be met.

7.2.2 REVIEW CUSTOMERS' PRODUCT REQUIREMENTS

Review your customers' product requirements.
Maintain a record of your product requirement reviews.
Control changes in customers' product requirements.

7.2.3 COMMUNICATE WITH YOUR CUSTOMERS

Establish customer communication arrangements.
Implement customer communication arrangements.

7.3 CONTROL PRODUCT DESIGN AND DEVELOPMENT

7.3.1 PLAN PRODUCT DESIGN AND DEVELOPMENT

Plan the design and development of your products.
Control the design and development of your products.
Update your planning outputs whenever product design
and development progress makes this necessary.

7.3.2 IDENTIFY DESIGN AND DEVELOPMENT INPUTS

Define product design and development inputs.
Maintain a record of design and development inputs.
Review your product design and development inputs.

7.3.3 GENERATE DESIGN AND DEVELOPMENT OUTPUTS

Produce product design and development outputs.
Approve product design and development
outputs before they are formally released.
Verify that product design and development outputs
meet design and development input requirements.

7.3.4 CARRY OUT DESIGN AND DEVELOPMENT REVIEWS

Perform systematic design and development reviews
throughout the design and development process.
Maintain a record of design and development reviews.

7.3.5 PERFORM DESIGN AND DEVELOPMENT VERIFICATIONS

Carry out design and development verifications.
Maintain a record of design and development verifications.

7.3.6 CONDUCT DESIGN AND DEVELOPMENT VALIDATIONS

Perform design and development validations.
Maintain a record of design and development validations.

7.3.7 MANAGE DESIGN AND DEVELOPMENT CHANGES

Identify changes in design and development.
Record changes in design and development.
Review changes in design and development.
Verify changes in design and development.
Validate changes in design and development.
Approve changes in design and development
before you implement these changes.

7.4 CONTROL PURCHASING AND PURCHASED PRODUCTS

7.4.1 ESTABLISH CONTROL OF YOUR PURCHASING PROCESS

Establish criteria that you can use to control suppliers.
Evaluate your suppliers' ability to supply products
that meet your organization's requirements.
Select suppliers that are capable of supplying products
that meet your organization's specified requirements.
Make sure that purchased products meet
specified purchase requirements.

7.4.2 SPECIFY YOUR PURCHASING REQUIREMENTS

Describe your purchasing requirements.
Ensure that purchasing requirements are adequately
specified before you discuss them with suppliers.

7.4.3 VERIFY YOUR PURCHASED PRODUCTS

Establish product verification or inspection methods in order
to ensure that purchased products meet purchase requirements.
Implement product verification or inspection methods in order
to ensure that purchased products meet purchase requirements.

7.5 CONTROL PRODUCTION AND SERVICE PROVISION

7.5.1 ESTABLISH CONTROL OF PRODUCTION AND SERVICE

Carry out production under controlled conditions.
Carry out service provision under controlled conditions.

7.5.2 VALIDATE PRODUCTION AND SERVICE PROVISION

Validate production and service provision processes
whenever process outputs cannot be measured, monitored,
or verified until after the product is in use or the service
has been delivered (such a process is often referred
to as a special process).
Establish arrangements to control special processes.

7.5.3 IDENTIFY AND TRACK YOUR PRODUCTS

Establish the unique identity of your
organization's products (if appropriate).
Identify the monitoring and measurement
status of your organization's products.

7.5.4 PROTECT PROPERTY SUPPLIED BY CUSTOMERS

Identify property supplied to you by customers.
Verify property supplied to you by customers.
Protect property supplied to you by customers.
Safeguard property supplied to you by customers.

7.5.5 PRESERVE YOUR PRODUCTS AND COMPONENTS

Make sure that your products and components
continue to conform to requirements while they
are being processed internally.
Make sure that your products and components
continue to conform to requirements while they
are being delivered to the intended destination.

7.6 CONTROL MONITORING AND MEASURING EQUIPMENT

Identify your organization's monitoring
and measuring needs and requirements.
Select equipment that can meet your organization's
monitoring and measuring needs and requirements.
Establish monitoring and measuring processes.
Calibrate your monitoring and measuring equipment
whenever necessary to ensure that results are valid.
Protect your monitoring and measuring equipment.
Confirm that monitoring and measuring software
is capable of doing the job you want it to do.
Evaluate the validity of previous measurements
whenever you discover that your measuring or
monitoring equipment is out-of-calibration.

8. REMEDIAL REQUIREMENTS	8.1 ESTABLISH MONITORING AND MEASUREMENT PROCESSES
	Identify the monitoring, measurement, and analytical processes that your organization needs to have in order to be able to demonstrate conformity and make improvements. Plan how monitoring, measurement, and analytical processes will be used to demonstrate conformity and make improvements. Implement your organization's monitoring, measurement, and analytical processes.

8.2 CARRY OUT MONITORING AND MEASUREMENT ACTIVITIES

8.2.1 MONITOR AND MEASURE CUSTOMER SATISFACTION

Establish methods that you can use to monitor
and measure customer satisfaction (perceptions).
Monitor and measure customer satisfaction.

8.2.2 PLAN AND PERFORM REGULAR INTERNAL AUDITS

Establish an internal audit procedure.
Carry out internal audits of your QMS.
Take action to address audit results.

8.2.3 MONITOR AND MEASURE YOUR QMS PROCESSES

Select suitable methods to monitor and measure
the processes that make up your organization's QMS.
Monitor and measure your QMS processes.
Take appropriate action whenever your QMS
processes fail to achieve planned results.

8.2.4 MONITOR AND MEASURE PRODUCT CHARACTERISTICS

Monitor your organization's product characteristics.
Measure your organization's product characteristics.

8.5 MAKE IMPROVEMENTS AND TAKE REMEDIAL ACTIONS

8.5.1 IMPROVE THE EFFECTIVENESS OF YOUR QMS

Continually improve the effectiveness of your QMS.
Use information to improve the effectiveness of your QMS.

8.5.2 CORRECT NONCONFORMITIES TO PREVENT RECURRENCE

Establish a corrective action procedure.
Document your corrective action procedure.
Implement your corrective action procedure.
Maintain your corrective action procedure.

8.5.3 PREVENT THE OCCURRENCE OF NONCONFORMITIES

Establish a preventive action procedure.
Document your preventive action procedure.
Implement your preventive action procedure.
Maintain your preventive action procedure.

This page summarizes the ISO 9001 2008 standard.
It highlights the main points. It does not present detail.

If you need a detailed and complete interpretation
of ISO 9001 2008, please consider purchasing our
Title 20: ISO 9001 2008 Translated into Plain English.

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interpretation of ISO 9001 2008. It uses language that is
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Updated on January 5, 2010. On the Web since May 25, 1997.

4. GENERAL REQUIREMENTS	4.1 DEVELOP YOUR QUALITY MANAGEMENT SYSTEM (QMS)
	Establish your organization's QMS. Document your organization's QMS. Implement your organization's QMS. Maintain your organization's QMS. Improve your organization's QMS.

5. MANAGEMENT REQUIREMENTS	5.1 SHOW YOUR COMMITMENT TO QUALITY
	*Support the development* of your organization's QMS. Support the implementation of your organization's QMS.** Support efforts to continually improve the effectiveness of your organization's QMS.

	5.2 FOCUS ON YOUR CUSTOMERS
	Enhance customer satisfaction by ensuring that customer requirements are being identified. Enhance customer satisfaction by ensuring that customer requirements are being met.

6. RESOURCE REQUIREMENTS	6.1 PROVIDE REQUIRED QMS RESOURCES
	Identify the resources that your QMS needs. Provide the resources that your QMS needs.

	6.3 PROVIDE NECESSARY INFRASTRUCTURE
	Identify the infrastructure that your organization needs in order to ensure that product requirements are met. Provide the infrastructure that your organization needs in order to ensure that product requirements are met. Maintain the infrastructure that your organization needs in order to ensure that product requirements are met.

	6.4 PROVIDE SUITABLE WORK ENVIRONMENT
	Identify the work environment that your organization needs in order to ensure that product requirements are met. Manage the work environment that your organization needs in order to ensure that product requirements are met.

	8.3 IDENTIFY AND CONTROL NONCONFORMING PRODUCTS
	Establish a nonconforming products procedure. Document your nonconforming products procedure. Implement your nonconforming products procedure. Maintain your nonconforming products procedure.

	8.4 COLLECT AND ANALYZE QUALITY MANAGEMENT DATA
	Figure out what kind of data you need to collect about your organization's QMS. Collect data about your organization's QMS. Provide information by analyzing your QMS data.

ISO 9001 2008*