Plain English Overview of ISO 9001 2000

 ISO 9001 2000 is now obsolete. Please see ISO 9001 2015.

This web page presents a plain English overview
of the ISO 9001 2000 Quality Management Standard.
It is based on the final official version of this standard.

4 Systemic requirements

4.1 Establish your quality system
Develop your quality management system
Implement your quality management system
Improve your quality management system

4.2 Document your quality system
4.2.1 Develop quality system documents
4.2.2 Prepare quality system manual
4.2.3 Control quality system documents
4.2.4 Maintain quality system records

5 Management requirements

5.1 Support quality
Promote the importance of quality
Develop a quality management system
Implement your quality management system
Improve your quality management system

5.2 Satisfy your customers
Identify customer requirements
Meet your customers' requirements
Enhance customer satisfaction

5.3 Establish a quality policy
Define your organization's quality policy
Manage your organization's quality policy

5.4 Carry out quality planning
5.4.1 Formulate your quality objectives
5.4.2 Plan your quality management system

5.5 Control your quality system
5.5.1 Define responsibilities and authorities
5.5.2 Appoint management representative
5.5.3 Support internal communications

5.6 Perform 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 quality resources
Identify quality resource requirements
Provide quality system resources

6.2 Provide quality personnel
6.2.1 Use competent personnel
6.2.2 Support competence

6.3 Provide quality infrastructure
Identify infrastructure needs
Provide needed infrastructure 
Maintain your infrastructure

6.4 Provide quality environment
Identify needed work environment
Manage needed work environment

7 Realization requirements

7.1 Control realization planning
Plan product realization processes
Develop product realization processes

7.2 Control customer processes
7.2.1 Identify customers' product requirements
7.2.2 Review customers' product requirements
7.2.3 Communicate with your customers

7.3 Control product development
7.3.1 Plan design and development
7.3.2 Define 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 function
7.4.1 Control purchasing process
7.4.2 Document product purchases
7.4.3 Verify purchased products

7.5 Control operational activities
7.5.1 Control production and service provision
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 devices
Identify monitoring and measuring needs
Select monitoring and measuring devices
Calibrate monitoring and measuring devices
Protect monitoring and measuring devices
Validate monitoring and measuring software
Use monitoring and measuring devices

8 Remedial requirements

8.1 Perform remedial processes
Plan remedial processes
Implement remedial processes

8.2 Monitor and measure quality
8.2.1 Monitor and measure customer satisfaction
8.2.2 Plan and perform regular internal audits
8.2.3 Monitor and measure quality processes
8.2.4 Monitor and measure product characteristics

8.3 Control nonconforming products
Develop a procedure to control nonconforming products
Identify and control your nonconforming products
Re-verify nonconforming products that were corrected
Control nonconforming products after delivery or use
Maintain records of nonconforming products

8.4 Analyze quality information
Define quality management information needs
Collect quality management system data
Provide quality management information

8.5 Make quality improvements
8.5.1 Improve quality management system
8.5.2 Correct actual nonconformities
8.5.3 Prevent potential nonconformities

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First published on January 10, 2001. Updated on November 30, 2014.

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