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
- Documentation Requirements, including:
- Quality Manual with Scope of the QMS
- Required Procedures
- Required Forms & Records
- Control of Documents
- Control of Forms
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