ISO 9001 2008

Plain English Overview

ISO 9001 2008 is now obsolete. See the NEW ISO 9001 2015 standard.

4. General Requirements

4.1
Develop
your 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.

4.2
Document
your QMS

4.2.1 Manage QMS documents.

4.2.2 Prepare QMS manual.

4.2.3 Control QMS documents.

4.2.4 Establish QMS records.


5. Management Requirements

5.1
Show your
commitment
to quality

  Support the development of your QMS.

  Support the implementation of your QMS.

  Support efforts to continually improve your QMS.

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. Resource Requirements

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. Realization Requirements

7.1
Control product
realization
planning

  Establish a product realization planning process.

  Plan the realization of your organization's products.

  Prepare product realization planning outputs.

  Develop your product realization processes.

7.2
Control customer
related processes

7.2.1 Identify your product requirements.

7.2.2 Review customers' product requirements.

7.2.3 Communicate with your customers.

7.3
Control your
product design
and development

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.

7.3.7 Manage design and development changes.

7.4
Control purchasing 
and purchased
products

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
Control production
and service
provision

7.5.1 Establish control of production and service.

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.

7.6
Control monitoring 
and measuring
equipment

  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. Remedial Requirements

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.

ISO 9001 2008 is now obsolete. See the NEW ISO 9001 2015 standard.

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