4.1
Develop
your QMS

•  Establish your organization's quality management system.

•  Document your organization's quality management system.

•  Implement your organization's quality management system.

•  Maintain your organization's quality management system.

•  Improve your organization's quality management system.

4.2
Document
your QMS

4.2.1 Manage quality management system documents.

4.2.2 Prepare quality management system manual.

4.2.3 Control quality management system documents.

4.2.4 Establish quality management system records.

5.1
Show your
commitment
to quality

•  Support development of your quality management system.

•  Support implementation of your quality management system.

•  Support efforts to improve your quality management system.

5.2
Focus on
customers

•  Identify customer requirements.

•  Meet your customers' requirements.

5.3
Support your
quality policy

•  Ensure that quality policy expects requirements to be met.

•  Ensure that quality policy makes a commitment to improve.

•  Ensure that quality policy actively supports quality objectives.

•  Ensure that quality policy is communicated and discussed.

•  Ensure that quality policy is periodically reviewed.

5.4
Carry out your
QMS planning

5.4.1 Establish your quality objectives.

5.4.2 Plan your quality management system.

5.5
Allocate QMS responsibility
and authority

5.5.1 Define responsibilities and authorities.

5.5.2 Create management representative role.

5.5.3 Support internal communication.

5.6
Perform QMS
management
reviews

5.6.1 Review quality management system.

5.6.2 Examine management review inputs.

5.6.3 Generate management review outputs.

6.1
Provide required
QMS resources

•  Identify the resources that your QMS needs.

•  Provide the resources that your QMS needs.

6.2
Provide competent
QMS personnel

6.2.1 Ensure the competence of workers.

6.2.2 Meet competence requirements.

6.3
Provide necessary
infrastructure

•  Identify your infrastructure needs.

•  Provide needed infrastructure.

•  Maintain your infrastructure.

6.4
Provide suitable
work environment

•  Identify needed work environment.

•  Manage needed work environment.

7.1.1 Establish a project management process.

7.1.2 Establish a risk management process.

7.1.3 Establish a configuration management process.

7.1.4 Establish a work transfer control process.

7.2.1 Identify your product requirements.

7.2.2 Review customers' product requirements.

7.2.3 Communicate with your customers.

7.3.1 Plan product design and development.

7.3.2 Identify design and development inputs.

7.3.3 Generate design and development outputs.

7.3.4 Carry out design and development reviews.

7.3.5 Perform design and development verifications.

7.3.6 Conduct design and development validations.

7.3.6.1 Manage design and development verification and validation testing.

7.3.6.2 Document design and development verifications and validations.

7.3.7 Manage design and development changes.

7.4.1 Establish control of your purchasing process.

7.4.2 Specify your purchasing requirements.

7.4.3 Verify your purchased products.

7.5.1 Establish control of production and service.

7.5.1.1 Verify that production process meets requirements.

7.5.1.2 Control changes in your production process.

7.5.1.3 Control equipment, tools, and software programs.

7.5.1.4 Provide post-delivery support.

7.5.2 Validate production and service provision.

7.5.3 Identify and track your products.

7.5.4 Protect property supplied by customers.

7.5.5 Preserve your products and components.

•  Identify monitoring and measuring needs.

•  Select monitoring and measuring equipment.

•  Establish monitoring and measuring processes.

•  Calibrate monitoring and measuring equipment.

•  Protect your monitoring and measuring equipment.

•  Confirm suitability of monitoring and measuring software.

8.1
Establish monitoring
and measurement
processes

•  Identify monitoring, measurement, and analytical processes.

•  Plan monitoring, measurement, and analytical processes.

•  Implement monitoring, measurement, and analytical processes.

8.2
Carry out monitoring
and measurement
activities

8.2.1 Monitor and measure customer satisfaction.

8.2.2 Plan and perform regular internal audits.

8.2.3 Monitor and measure your QMS processes.

8.2.4 Monitor and measure product characteristics.

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

•  Define your QMS information needs.

•  Collect data about your organization's QMS.

•  Provide information by analyzing your QMS data.

8.5
Make improvements
and take remedial
actions

8.5.1 Improve the effectiveness of your QMS.

8.5.2 Correct nonconformities to prevent recurrence.

8.5.3 Prevent the occurrence of nonconformities.