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.

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

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

  • Management Responsibility
  • Quality Policy & Objectives
  • Customer Focus & Customer Satisfaction
  • Management Review

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

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

Continual Improvement

  • This is a critical piece of ISO 9001.
  • Measure/monitor your QMS
  • Find Root Cause of Problems