ISO 9001 Requirements

This is a summary of the ISO 9001:2008 Standard Requirements - i.e. the items spelled out in the ISO 9001 document. Your Quality Management System must address each of these requirements.

Read Steps to ISO 9001 Certification to learn how to become ISO 9001 certified.

Detailed clause by clause review: ISO 9001 Requirements Explained (by L. Whittington)
Detailed list of 2008 changes: Changes to ISO 9001:2008 (by L. Whiittington)

ISO 9001 Presentation to review the complete standard with your organization.

Section 1: Scope Talks about the standard and how it applies to organizations and:

the importance of a process approach
you need to include regulatory requirements of your products & services
you need to have processes in place for continual improvement.
Learn: What is ISO 9001?

Section 2: Normative Reference

References ISO 9000:2005 which should be used along with the standard. It outlines the
Quality Management Systems-Fundamentals and Vocabulary

Section 3: Terms and Definitions

Gives definitions used in the standard

Section 4: General Requirements Gives requirements for the overall Quality Management System

Documentation Requirements, including:

Section 5: Management Responsibility Gives requirements for Management's role in the QMS

Section 6: Resource Management Gives requirements for resources including:

Section 7: Product Realization Gives requirements for:

the production of the product or service
Planning
customer related processes and Customer Feedback
Design
Purchasing
Process control
Identification and Traceability
Customer Property

Section 8: Measurement, Analysis and Improvement

Gives requirements on monitoring processes and improving those processes
Customer Satisfaction
Internal Audits
Control of Non-Conforming Product
Corrective and Preventive Action