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Summary of ISO 9001:2008 Standards :
This is a summary of the
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.
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:
o Quality Manual with Scope of the QMS
o Required Procedures
o Required Forms & Records
o Control of Documents
o 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 |
