ISO 9001 2008

• Establish your organization's process-based QMS.

• Document your organization's process-based QMS.

• Implement your organization's process-based QMS.

• Maintain your organization's process-based QMS.

• Improve your organization's process-based 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.

• 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 policy serves its 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 your organization's 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 actually occurs.

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 to improve your organization.

• Generate management review decisions and actions to change your general quality orientation.

• Generate management review decisions and actions to address resource needs.

• 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.

• 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 unique 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 products.

• 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.

• Identify the monitoring, measurement, and analytical processes that you need 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.

Introduction to Standard

Quality Management Principles

ISO 9001 2008 versus ISO 9001 2000

Plain English Quality Management Definitions

How to Upgrade to the New Quality Standard

Quality Management Gap Analysis Tool

How to Develop a Process-based QMS

Process-based QMS Development Plan

Quality Management Audit Program

Process Approach to Management

Frequently Asked Questions

Knowledge and Skills QMS Auditors Should Have

Introduction to ISO 9004 2009 Quality Management

Overview of the ISO 9004 2009 Quality Standard

ISO 9004 2009 Translated into Plain English

Auditing Guidelines

Risk Management Guidelines

Business Continuity 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