ISO 9001 2000

TRANSLATED INTO PLAIN ENGLISH

ISO 9001 2000 is now obsolete. See ISO 9001 2008.

ISO 9001 2000: 4 Systemic Requirements

4.1
Establish
your quality management system (QMS)

Develop your quality management system

	Identify the processes that make up your quality system.
	Describe your quality management processes.

Implement your quality management system

	Use quality system processes.
	Manage process performance.

Improve your quality management system

	Monitor process performance.
	Improve process performance.

4.2
Document
your quality management system (QMS)

4.2.1 Develop quality system documents

	Develop documents to implement your quality system.
	Develop documents that reflect what your organization does.

4.2.2 Prepare quality system manual

	Document your procedures.
	Describe how your processes interact.
	Define the scope of your quality system.

4.2.3 Control quality system documents

	Approve documents before you distribute them.
	Provide the correct version of documents at points of use.
	Review and re-approve documents whenever you update them.
	Specify the current revision status of your documents.
	Monitor documents that come from external sources.
	Prevent the accidental use of obsolete documents.
	Preserve the usability of your quality documents.

4.2.4 Maintain quality system records

	Use your records to prove that requirements have been met.
	Develop a procedure to control your records.
	Ensure that your records are useable.

ISO 9001 2000: 5 Management Requirements

5.1
Support
quality

Promote the importance of quality

	Promote the need to meet customer requirements.
	Promote the need to meet regulatory requirements.
	Promote the need to meet statutory requirements.

Develop a quality management system

	Support the development of a quality system.
	Formulate your organization's quality policy.
	Set your organization's quality objectives.
	Provide quality resources.

Implement your quality management system

	Provide resources to implement your quality system.
	Encourage personnel to meet quality system requirements.

Improve your quality management system

	Perform quality management reviews.
	Provide resources to improve the quality system.

5.2
Satisfy your customers

Identify customer requirements

Expect your organization to identify customer requirements.

Meet your customers' requirements

Expect your organization to meet customer requirements.

Enhance customer satisfaction

Expect your organization to enhance customer satisfaction.

5.3
Establish a quality policy

Define your organization's quality policy

	Ensure that it serves your organization's purpose.
	Ensure that it emphasizes the need to meet requirements.
	Ensure that it facilitates the development of quality objectives.
	Ensure that it makes a commitment to continual improvement.

Manage your organization's quality policy

	Communicate your policy to your organization.
	Review your policy to ensure that it is still suitable.

5.4
Carry out quality planning

5.4.1 Formulate your quality objectives

	Ensure that objectives are set for functional areas.
	Ensure that objectives are set at organizational levels.
	Ensure that objectives facilitate product realization.
	Ensure that objectives support the quality policy.
	Ensure that objectives are measurable.

5.4.2 Plan your quality management system

	Plan the development of your quality management system.
	Plan the implementation of your quality management system.
	Plan the improvement of your quality management system.
	Plan the modification of your quality management system.

5.5
Control your quality system

5.5.1 Define responsibilities and authorities

	Clarify responsibilities and authorities.
	Communicate responsibilities and authorities.

5.5.2 Appoint management representative

	Oversee your quality management system.
	Report on the status of your quality management system.
	Support the improvement of your quality management system.

5.5.3 Support internal communications

	Ensure that internal communication processes are established.
	Ensure that communication occurs throughout the organization.

5.6
Perform management reviews

5.6.1 Review quality management system

	Evaluate the performance of your quality system.
	Evaluate whether your quality system should be improved.

5.6.2 Examine management review inputs

	Examine audit results.
	Examine product conformity data.
	Examine opportunities to improve.
	Examine feedback from customers.
	Examine process performance information.
	Examine corrective and preventive actions.
	Examine changes that might affect your system.
	Examine previous quality management reviews.

5.6.3 Generate management review outputs

	Generate actions to improve your quality system.
	Generate actions to improve your products.
	Generate actions to address resource needs.

ISO 9001 2000: 6 Resource Requirements

6.1
Provide quality resources

Identify quality resource requirements

	Identify resources needed to support the quality system.
	Identify resources needed to improve customer satisfaction.

Provide quality system resources

	Provide resources needed to support the quality system.
	Provide resources needed to improve customer satisfaction.

6.2
Provide quality personnel

6.2.1 Use competent personnel

	Ensure that your personnel have the right experience.
	Ensure that your personnel have the right education.
	Ensure that your personnel have the right training.
	Ensure that your personnel have the right skills.

6.2.2 Support competence

	Define acceptable levels of competence.
	Identify training and awareness needs.
	Deliver training and awareness programs.
	Evaluate effectiveness of training and awareness.
	Maintain a record of competence.

6.3
Provide quality infrastructure

Identify infrastructure needs

	Identify building needs.
	Identify workspace needs.
	Identify hardware needs.
	Identify software needs.
	Identify utility needs.
	Identify equipment needs.
	Identify support service needs.

Provide needed infrastructure

	Provide needed buildings.
	Provide needed workspaces.
	Provide needed hardware.
	Provide needed software.
	Provide needed utilities.
	Provide needed equipment.
	Provide needed support services.

Maintain your infrastructure

	Maintain your buildings.
	Maintain your workspaces.
	Maintain your hardware.
	Maintain your software.
	Maintain your utilities.
	Maintain your equipment.
	Maintain your support services.

6.4
Provide quality environment

Identify needed work environment

Identify factors needed to ensure products meet requirements.

Manage needed work environment

Manage factors needed to ensure products meet requirements.

ISO 9001 2000: 7 Realization Requirements

7.1
Control realization planning

Plan product realization processes

	Define product quality objectives and requirements.
	Identify product realization needs and requirements.

Develop product realization processes

	Develop product realization documents.
	Develop product realization record keeping systems.
	Develop methods to control quality during product realization.

7.2
Control customer processes

7.2.1 Identify customers' product requirements

	Identify the requirements that customers want you to meet.
	Identify the requirements that are dictated by the product's use.
	Identify the requirements that are imposed by external agencies.
	Identify the requirements that your organization wishes to meet.

7.2.2 Review customers' product requirements

	Review requirements before you accept orders from customers.
	Maintain a record of your product requirement reviews.
	Control changes in product requirements.

7.2.3 Communicate with your customers

	Develop a process to control communications with customers.
	Implement your customer communications process.

7.3
Control product development

7.3.1 Plan design and development

	Define your product design and development stages.
	Clarify design and development responsibilities and authorities.
	Manage interactions between design and development groups.
	Update your design and development plans as changes occur.

7.3.2 Define design and development inputs

	Specify product design and development inputs.
	Record product design and development input definitions.
	Review product design and development input definitions.

7.3.3 Generate design and development outputs

	Create product design and development outputs.
	Approve design and development outputs prior to release.
	Use design and development outputs to control product quality.

7.3.4 Carry out design and development reviews

	Perform product design and development reviews.
	Record product design and development reviews.

7.3.5 Perform design and development verifications

	Carry out product design and development verifications.
	Record product design and development verifications.

7.3.6 Conduct design and development validations

	Perform product design and development validations.
	Record product design and development validations.

7.3.7 Manage design and development changes

	Identify changes in product design and development.
	Record changes in product design and development.
	Review changes in product design and development.
	Verify changes in product design and development.
	Validate changes in product design and development.
	Approve changes before they are implemented.

7.4
Control purchasing function

7.4.1 Control purchasing process

	Ensure that purchased products meet requirements.
	Ensure that suppliers meet requirements.

7.4.2 Document product purchases

	Describe the products being purchased.
	Specify the requirements that must be met.

7.4.3 Verify purchased products

	Verify purchased products at your own premises.
	Verify purchased products at suppliers' premises (when required).

7.5
Control operational activities

7.5.1 Control production and service provision

	Control production and service processes.
	Control production and service information.
	Control production and service instructions.
	Control production and service equipment.
	Control production and service measurements.
	Control production and service activities.

7.5.2 Validate production and service provision

	Prove that special processes can produce planned outputs.
	Prove that process personnel can produce planned results.
	Prove that process equipment can produce planned results.

7.5.3 Identify and track your products

	Establish the identity of your products (when appropriate).
	Maintain the identity of your products (when appropriate).
	Identify the status of your products (when appropriate).
	Record the identity of your products (when required).

7.5.4 Protect property supplied by customers

	Identify property supplied to you by your customers.
	Verify property supplied to you by your customers.
	Safeguard property supplied to you by your customers.

7.5.5 Preserve your products and components

	Preserve products and components during internal processing.
	Preserve products and components during final delivery.

7.6
Control monitoring devices

Identify monitoring and measuring needs

Identify the monitoring and measuring that should be done.

Select monitoring and measuring devices

Select devices that meet your monitoring and measuring needs.

Calibrate monitoring and measuring devices

	Perform calibrations.
	Record calibrations.

Protect monitoring and measuring devices

	Protect your devices from unauthorized adjustment.
	Protect your devices from damage or deterioration.

Validate monitoring and measuring software

	Validate monitoring and measuring software before you use it.
	Revalidate monitoring and measuring software when necessary.

Use monitoring and measuring devices

Use devices to ensure that your products meet requirements.

ISO 9001 2000: 8 Remedial Requirements

8.1
Perform remedial processes

Plan remedial processes

	Plan how remedial processes will be used to assure conformity.
	Plan how remedial processes will be used to improve the system.

Implement remedial processes

	Use remedial processes to demonstrate conformance.
	Use remedial processes to improve quality management system.

8.2
Monitor and measure quality

8.2.1 Monitor and measure customer satisfaction

	Identify ways to monitor and measure customer satisfaction.
	Monitor and measure customer satisfaction.
	Use customer satisfaction information.

8.2.2 Plan and perform regular internal audits

	Set up an internal audit program.
	Develop an internal audit procedure.
	Plan your internal audit projects.
	Perform regular internal audits.
	Solve problems discovered during audits.
	Verify that problems have been solved.

8.2.3 Monitor and measure quality processes

	Use suitable methods to monitor and measure your processes.
	Take action when your processes fail to achieve planned results.

8.2.4 Monitor and measure product characteristics

	Verify that product characteristics are being met.
	Keep a record of product monitoring and measuring activities.

8.3
Control nonconforming products

Develop a procedure to control nonconforming products

	Define how nonconforming products should be identified.
	Define how nonconforming products should be handled.

Identify and control your nonconforming products

	Eliminate or correct product nonconformities.
	Prevent the delivery or use of nonconforming products.
	Avoid the inappropriate use of nonconforming products.

Re-verify nonconforming products that were corrected

Prove that corrected products now meet requirements.

Control nonconforming products after delivery or use

Control events when you deliver or use nonconforming products.

Maintain records of nonconforming products

	Describe your product nonconformities.
	Describe the actions taken to deal with nonconformities.

8.4
Analyze quality information

Define quality management information needs

	Define the information you need to evaluate your quality system.
	Define the information you need to improve your quality system.

Collect quality management system data

	Monitor and measure the suitability of your quality system.
	Monitor and measure the effectiveness of your quality system.

Provide quality management information

	Provide information about your customers.
	Provide information about your suppliers.
	Provide information about your products.
	Provide information about your processes.

8.5
Make quality improvements

8.5.1 Improve quality management system

	Use your audits to generate improvements.
	Use your quality data to generate improvements.
	Use your quality policy to generate improvements.
	Use your quality objectives to generate improvements.
	Use your management reviews to generate improvements.
	Use your corrective actions to generate improvements.
	Use your preventive actions to generate improvements.

8.5.2 Correct actual nonconformities

	Review your nonconformities.
	Figure out what causes your nonconformities.
	Evaluate whether you need to take corrective action.
	Develop corrective actions to prevent recurrence.
	Take corrective actions when they are necessary.
	Record the results that your corrective actions achieve.
	Examine the effectiveness of your corrective actions.

8.5.3 Prevent potential nonconformities

	Detect potential nonconformities.
	Identify the causes of potential nonconformities.
	Study the effects of potential nonconformities.
	Evaluate whether you need to take preventive action.
	Develop preventive actions to eliminate causes.
	Take preventive actions when they are necessary.
	Record the results that your preventive actions achieve.
	Examine the effectiveness of your preventive actions.

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First published on January 10, 2001. Updated on November 23, 2011.

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