ISO 9001:2008 Requirements in Plain English
ISO 9001 outlines the requirements of the ISO 9000 Standard, but it isn’t easy reading.
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.
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:
- Control of Documents
Introduction to ISO 9001 PowerPoint Reviews each section of the standard
Section 5: Management ResponsibilityGives ISO requirements for Management’s role in the QMS
- Management Responsibility
- 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:
Section 7: Product Realization Gives ISO requirements for:
- The production of the product or service
- customer related processes and Customer Feedback
- 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.
- 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.