1. QUALITY MANAGEMENT SYSTEM
ISO 9001:2000
QUALITY MANAGEMENT SYSTEM
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2. Objectives Introduce the Concept of ISO 9001:2000 Standard
Highlight the Important Areas and Changes of the New Standard
Briefly introduce the system requirements of the Standard
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3. Introduced considerable conceptual changes
What is ISO 9001: 2000
2nd revision of Quality Management System Requirement Standard from International Organization for Standards
Replacement of the previous ISO 9001 / 9002 and 9003: 1994 version of the Standards
Introduced considerable conceptual changes
Applicable to all types of Organizations with possible permissible omissions of certain requirements
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4. Continual Improvements cycle
New ISO 9001:2000
QMS
Management
Responsibility
General Requirements
Resource
Management
Measurement,
Analysis &
Improvements
Product
Realization
Continual Improvements cycle
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5. CUSTOMER’S CUSTOMER ISO 9001:2000 – Process Model 5.Management
Continual Improvement of
the Quality Management System
ISO 9001:2000 Quality
Management System
5.Management
Responsibility
8. Measurement
Analysis and
Improvements
CUSTOMER
CUSTOMER’S
6. Resource
Management
Satisfaction
7. Product
Realization
Requirements
Product
Consumption
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6. 8 Principles of the New Standard
Customer focus
Leadership
Mutual beneficial supplier relationship
Involvement of people
Based on eight quality management principles.
Factual approach to decision making
Process approach
System approach to Management
Continual improvement
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7. Process Approach Process Definition:
Set of interrelated or interacting activities which transforms Inputs into Outputs
Identify the Processes
Identify the Inputs & Outputs
Identify the Interactions to other Processes
Establish Measuring Criteria
Ensure Continual Improvements
Do it for all “Value Adding Processes”
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8. Process Approach – Continual Improvements of All Processes
Understanding &
Meeting the Requirements
PLAN
PDCA Cycle
Processes in terms
Of Added Value DO
Continual Improvements
of Processes Based on
Objective Measurements
ACTION
Measure Results of Process
Performance and Effectiveness
- Objective Measurements
CHECK
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9. E.g. - Purchasing Process
Procedure
Inputs
Required item / quantity / date
Applicable specs
Supplier source
Suppliers capability to meet our requirements
Outputs
Receipt of Materials on right conditions
Right Quality, Right Quantity
Right Time.
Interactions to
Storage
Inspection and Testing
Manufacturing
Finance
Performance Measurements
Delivery status – On-time, On spec, NCP etc
Supplier evaluation
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10. System Requirements / Structure of the Standard
4 Quality Management System Requirements
5 Management Responsibility
6 Resource Management
7 Product Realization
8 Measurement Analysis & Improvements
Management Commitment
Customer Focus
Quality Policy
Planning
Responsibility, Authority & Communication
Management Reviews
General Requirements
Documentation Requirements
Provision of Resources
Human Resources
Infrastructure
Work Environment
Planning
Customer Related Processes
Design & Development
Purchasing
Production & Service Provision
General
Monitoring & Measurements
Control of NCP’s
Analysis of Data
Improvements
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11. Criteria for Measurements
Satisfaction Surveys for customers and other interested parties
Feedback on products
Customer & market requirements
Financial Measurements
Prevention cost
Non conforming / failure cost
Lifecycle cost
System Performance
Self Assessment
Internal Audits
Effectiveness & Efficiency of Processes
Opportunities for Improvements
Use of Data / Information
Effective & Efficient Use of Resources
Adequacy, Accuracy and Performance of Measurements
Relationships with customers/ suppliers/ other interested parties
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12. Criteria for Measurements
Process Capability / Process validation
Reaction time
Cycle time / throughput (Capacity)
Utilization of new technology
Waste reduction
Cost reduction
Processes
Products
Inspection and testing of incoming, in process and final products
Product verification
Product validation
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13. Challenges in Implementing the Standard
Management Support
Encouragement
ISO 9001
Other employee Support
Communication
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Thank you for your time.
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