ISO 9001:2008 Requirements in Plain English

ISO 9001 outlines the requirements of the ISO 9000 Standard, unfortunately its hard to interpret and not very fun to read.

This page summarizes the ISO 9001:2008 Requirements with links to additional pages with supporting information.

Your Quality Management System must address each of these ISO requirements.

ISO 9001 Requirements Summary

NOTE: ISO 9001 references relationship to ISO 9004

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

• The importance of a process approach
• Meet regulatory requirements of your products & services
• Processes must be 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, outlined in ISO 9000:2005

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

• Quality Management System
• Documentation Requirements, including:
  • Quality Manual with
    • Scope of the QMS
    • Required Procedures
  • Required Forms & Records
• Control of Documents
  • Document Control Considerations
  • Document Control Software

Introduction to ISO 9001 PowerPoint Reviews each section of the standard

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

• Management Responsibility
  • Management Commitment
  • Management Representative
• Quality Policy & Objectives
• Customer Focus & Customer Satisfaction
• Corrective and Preventive Actions
• Effective Management Review (FREE Forms & Checklists)

Section 6: Resource Management Gives ISO requirements for resources including:

• Personnel & Training
• Resource Management

Section 7: Product Realization Gives ISO 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
• Verification of Purchased Product

Section 8: Measurement, Analysis and Improvement

• Gives ISO requirements on monitoring processes and improving those processes
• Customer Satisfaction
• Internal Audits
  • NOTE: You should follow ISO 19011
• Control of Non-Conforming Product
• Corrective and Preventive Action (CAPA)
• Statistical Techniques like Root Cause Analysis should be used.

Continual Improvement

• This is a critical piece of ISO 9001.
• Measure/monitor your QMS
• Follow the Guidance of ISO 9004:2009
• Realize the economic benefits with the tools is ISO 10014

These tools will help you understand ISO 9001 and teach it to others.

ISO Step-by-Step: Review the Steps to ISO 9001 Certification to learn how to become ISO 9001 certified.

“Introduction to ISO 9001” PowerPoint: Train your team:
This PPT Reviews each section of the standard with speaker notes.

“Understanding the Standard“: This 2+ hour online training discusses the entire standard and how to implement it. It has audio and quizzes.