ISO 9001 2008

Plain English Overview

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.

4. General Requirements

4.1
Develop
your QMS

• 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.

4.2
Document
your QMS

4.2.1 Manage QMS documents.

4.2.2 Prepare QMS manual.

4.2.3 Control QMS documents.

4.2.4 Establish QMS records.

5. Management Requirements
5.1 Show your commitment to quality	• Support the development of your QMS. • Support the implementation of your QMS. • Support efforts to continually improve your QMS.
5.2 Focus on customers	• Identify customer requirements. • Meet your customers' requirements.
5.3 Support your quality policy	• 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.
5.4 Carry out your QMS planning	5.4.1 Establish your quality objectives. 5.4.2 Plan your quality management system.
5.5 Allocate QMS responsibility and authority	5.5.1 Define responsibilities and authorities. 5.5.2 Create management representative role. 5.5.3 Support internal communication.
5.6 Perform QMS 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 required QMS resources	*• Identify* the resources that your QMS needs. • Provide the resources that your QMS needs.**
6.2 Provide competent QMS personnel	6.2.1 Ensure the competence of workers. 6.2.2 Meet competence requirements.
6.3 Provide necessary infrastructure	• Identify your infrastructure needs. • Provide needed infrastructure. • Maintain your infrastructure.
6.4 Provide suitable work environment	• Identify needed work environment. • Manage needed work environment.

7. Realization Requirements
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.
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.
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.
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.
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.
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.

8. Remedial Requirements
8.1 Establish monitoring and measurement processes	*• Identify* monitoring, measurement, and analytical processes. • Plan monitoring, measurement, and analytical processes. • Implement monitoring, measurement, and analytical processes.**
8.2 Carry out monitoring and measurement activities	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.
8.3 Identify and control nonconforming products	*• Establish* a nonconforming products procedure. • Document your nonconforming products procedure. • Implement your nonconforming products procedure. • Maintain your nonconforming products procedure.**
8.4 Collect and analyze quality management data	• Define your QMS information needs. • Collect data about your organization's QMS. • Provide information by analyzing your QMS data.
8.5 Make improvements and take remedial actions	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.

How to Order	Our Products	Our Prices	Our Guarantee
Home Page	Table of Contents	Our License	Our Customers
PRAXIOM RESEARCH GROUP LIMITED 9619 - 100A Street, Edmonton, Alberta, T5K 0V7, Canada Telephone: 780-461-4514 info@praxiom.com
Updated on October 23, 2011. On the Web since May 25, 1997.

Disclaimer and Limitation of Liability
The publisher and authors have used their best efforts in designing and
developing this electronic publication. We make no representation or warranties
with respect to accuracy or completeness of the contents of this publication and
specifically disclaim any implied warranties or merchantability or fitness for any
particular purpose and shall in no event be liable for any loss of profit or any
other commercial damage, including but not limited to special, incidental,
consequential, or other damages.

Legal Restrictions on the Use of this Page
Thank you for visiting this page. You are, of course, welcome to view our
material as often as you wish, free of charge. And as long as you keep intact
all copyright notices, you are also welcome to print or make one copy of this
page for your own personal, noncommercial, home use. But, you are not
legally authorized to print or produce additional copies or to copy and paste
any of our material onto another web site or to republish it in any way.