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Plain English Overview
* Based on the final official version of ISO 9001 2008. |
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This page
presents a plain English overview of the
ISO 9001 2008
Quality Management Standard. To see a more
detailed version,
please visit
ISO 9001 2008 Translated into Plain English.
NOTE: ISO presents its requirements in
sections 4 to 8 of
ISO 9001 2008. Therefore,
the following material begins with section 4.
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4. General Requirements |
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4.1 |
• 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. |
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4.2 |
4.2.1 Manage QMS documents. 4.2.2 Prepare QMS manual. 4.2.3 Control QMS documents. 4.2.4 Establish QMS records. |
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5. Management Requirements |
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5.1 |
• Support the development of your QMS. • Support the implementation of your QMS. • Support efforts to continually improve your QMS. |
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5.2 |
• Identify customer requirements. • Meet your customers' requirements. |
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5.3 |
• 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. |
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5.4 |
5.4.1 Establish your quality objectives. 5.4.2 Plan your quality management system. |
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5.5 |
5.5.1 Define responsibilities and authorities. 5.5.2 Create management representative role. 5.5.3 Support internal communication. |
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5.6 |
5.6.1 Review quality management system. 5.6.2 Examine management review inputs. 5.6.3 Generate management review outputs. |
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6. Resource Requirements |
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6.1 |
• Identify the resources that your QMS needs. • Provide the resources that your QMS needs. |
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6.2 |
6.2.1 Ensure the competence of workers. 6.2.2 Meet competence requirements. |
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6.3 |
• Identify your infrastructure needs. • Provide needed infrastructure. • Maintain your infrastructure. |
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6.4 |
• Identify needed work environment. • Manage needed work environment. |
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7. Realization Requirements |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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8. Remedial Requirements |
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8.1 |
• Identify monitoring, measurement, and analytical processes. • Plan monitoring, measurement, and analytical processes. • Implement monitoring, measurement, and analytical processes. |
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8.2 |
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. |
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8.3 |
• Establish a nonconforming products procedure. • Document your nonconforming products procedure. • Implement your nonconforming products procedure. • Maintain your nonconforming products procedure. |
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8.4 |
• Define your QMS information needs. • Collect data about your organization's QMS. • Provide information by analyzing your QMS data. |
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8.5 |
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. |
If you'd
like to see how we've
translated each of these ISO 9001
sections
into plain and simple English, please see our detailed
ISO
9001 2008 page.
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Please consider purchasing
our
Title 20:
Our Title 20 provides a detailed, accurate, and complete
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Check
our Title 20 Table of Contents. Title 20 can be delivered to you as an email attachment. |
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