ISO 9001 2000 in Plain English

ISO9001 applies to all types of organizations. It doesn't matter
what size they are or what they do. It can help both product and
service oriented organizations achieve standards of quality
that are recognized and respected throughout the world.

ISO 9001 2000 has replaced the old ISO 9001 1994 standard.
In addition, the old ISO 9002 1994 and ISO 9003 1994 quality
standards have been discontinued. They are now obsolete!

If you're now ISO 9001 1994 certified, you're going to have
to update your quality management system in order to meet
the new ISO 9001 2000 requirements. And if you're now
ISO 9002 or ISO 9003 certified, you're going to have
to become ISO 9001 2000 certified !

These web pages present a detailed introduction to the final version of
ISO 9001 2000. However, they do not present the entire detailed standard.
If you need a detailed and complete interpretation of ISO 9001 2000, please
consider purchasing Title 20: ISO 9001 2000 Translated into Plain English.
Or contact Praxiom Research Group Limited for more information.

Please note that ISO presents requirements in sections 4 to 8 of ISO 9001:2000.
Therefore, the following material begins with section 4. Sections 1 to 3 cover
a variety of introductory and legalistic topics. These additional topics are
discussed in our Title 20: ISO 9001 2000 Translated into Plain English.

ISO9001 QUALITY MANAGEMENT STANDARD IN PLAIN ENGLISH

ISO 9001: 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.

ISO9001 QUALITY MANAGEMENT STANDARD IN PLAIN ENGLISH

ISO 9001: 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.

ISO9001 QUALITY MANAGEMENT STANDARD IN PLAIN ENGLISH

ISO 9001: 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.

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