ISO 9001 2008*

TRANSLATED INTO PLAIN ENGLISH

* Based on final version of ISO 9001 2008 published November 15, 2008.

ISO 9001 2008 QUALITY MANAGEMENT REQUIREMENTS

• 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.

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.

ISO 9001 2008 QUALITY MANAGEMENT REQUIREMENTS

• 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.

• Enhance customer satisfaction by ensuring that
  customer requirements are being identified.

• Enhance customer satisfaction by ensuring
  that customer requirements are being met.

• 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.

5.4.1 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.

5.5.1 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.

5.6.1 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.

ISO 9001 2008 QUALITY MANAGEMENT REQUIREMENTS

• Identify the resources that your QMS needs.

• Provide the resources that your QMS needs.

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.

• 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.

• 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.

ISO 9001 2008 QUALITY MANAGEMENT REQUIREMENTS

• 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.

7.2.1 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.

7.3.1 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.

7.4.1 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.

7.5.1 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.

• 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.

ISO 9001 2008 QUALITY MANAGEMENT REQUIREMENTS

• 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.

8.2.1 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.

• Establish a nonconforming products procedure.

• Document your nonconforming products procedure.

• Implement your nonconforming products procedure.

• Maintain your nonconforming products procedure.

• 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.

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.

ISO 9001 2008 QUALITY MANAGEMENT REQUIREMENTS

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
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ISO 9000 Introduction

ISO 9000 2005 Principles

ISO 9001 2008 versus ISO 9001 2000

ISO 9001 2000 versus ISO 9001 1994

ISO 9000 2005 Plain English Definitions

Plain English Overview of ISO 9001 2008

ISO 9001 2000 Translated into Plain English

ISO 9001 1994 Translated into Plain English

How to Upgrade to the New ISO 9001 2008 Standard

How to Develop an ISO 9001 2008 Process-based QMS

ISO 9001 2008 Process-based QMS Development Plan

ISO 9001 2008 Internal Audit Program

ISO 9001 2008 Gap Analysis Tool

ISO's Process Approach

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Updated on May 29, 2009. On the Web since May 25, 1997.