ISO 9001 Requirements in Plain English

ISO 9001 outlines the requirements of the ISO 9000 Standard, but it isn't easy reading.

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ISO 9001 Requirements
In Plain English

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 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 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
  • Control of Forms and Records
  • Document Control Considerations
  • Document Control Procedure
  • Document Control Software

Introduction to ISO 9001 PowerPoint Reviews each section of the standard

Section 5: Management Responsibility Gives 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 requirements for resources including:

• Personnel & Training
• Resource Management

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
• Verification of Purchased Product

Section 8: Measurement, Analysis and Improvement

• Gives 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
• Find Root Cause of Problems
• 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.