ISO 9001 2000

TRANSLATED INTO PLAIN ENGLISH

ISO 9001 2000 is now obsolete. See ISO 9001 2015.

 Praxiom Research Group Limited

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 30, 2014.

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