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What is Quality ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Why Quality system is required?   ,[object Object],[object Object],[object Object],[object Object]
What is ISO ,[object Object],[object Object],[object Object],[object Object],[object Object]
ISO An Introduction: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ISO An Introduction: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ISO 9000 Family standards ,[object Object],[object Object],[object Object],[object Object],[object Object]
Other standards ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Evolution of 9001 ,[object Object],[object Object],Direction Quality management 2000 Prevention Quality Assurance 1994 Detection Quality control 1987 Focus Requirement Standard
Quality management . ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ISO 9000:  THIRD PARTY REGISTRATION ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ADVANTAGES OF ISO 9000 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ISO 9001:2000 Survey . ( 2005  -776 608 )
Definition: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Definition: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Definition: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Definition: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
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8 Principles of the ISO Standard Based on eight quality management principles. Leadership Process approach Involvement of people System approach to Management Continual improvement Factual approach to decision making Mutual beneficial supplier relationship  Customer focus
Set realistic and challenging goals provides resources and give people the tools, opportunities and encouragements to contribute the continual improvement of the processes.  Continual improvement: Continual improvement of the organization’s overall performance should be permanent objective of the organization. 6 Create personnel ownership of the organizations target and goals by using the people’s knowledge and experience and through training achieve involvement in operational decisions and process improvement.  Involvement of people: People at all levels are essence of an organization and their full involvement enables and their abilities to be used for the organization’s benefit.  3 Understand current and future customer needs and expectations.  Measure customer satisfaction and act it. Customer focus: Organizations depend on the customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations 1 APPLICATION QUALITY MANAGEMENT PRINCIPLE #
Process Approach  –  Continual Improvements of All Processes 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 Understanding &  Meeting the Requirements PLAN
ISO 9001:2000 – Process Model CUSTOMER’S CUSTOMER ISO 9001:2000 Quality  Management System 5.Management Responsibility 7. Product Realization 6. Resource Management 8 . Measurement Analysis and  Improvements Requirements Satisfaction Continual Improvement of the Quality Management System Consumption Product
 
 
Structure of the Standard 4 Quality Management System Requirements Provision of Resources Human Resources Infrastructure Work Environment 6 Resource Management General Requirements Documentation Requirements Planning Customer Related Processes Design & Development Purchasing Production & Service Provision Management Commitment Customer Focus Quality Policy Planning Responsibility, Authority & Communication Management Reviews 5 Management Responsibility 8 Measurement Analysis & Improvements  7  Product Realization General Monitoring & Measurements Control of NCP’s Analysis of Data Improvements
4.0 Quality Management System   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
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4.0 Quality Management System ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Documentation requirements ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
4.0 Quality Management System ,[object Object],[object Object],[object Object],[object Object]
5.0 Management Responsibility ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
5.0 Management Responsibility ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
5.6 Management Review ,[object Object],[object Object],[object Object]
6.0 Resource Management ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
6.0 Resource Management ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
7.0  Product Realization ,[object Object],[object Object],[object Object],[object Object],[object Object]
7.2 Customer related processes.  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
7.3 Design and development:  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
7.4 Purchasing: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
7.5. Production and service provision: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
7.6 Control of monitoring and measuring devices ,[object Object],[object Object],[object Object]
8.0 Measurement Analysis, and Improvement ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
8.0 Measurement Analysis, and Improvement ,[object Object],[object Object],[object Object],[object Object],[object Object]
Internal Audits ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
8.0 Measurement Analysis, and Improvement ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Criteria for Measurements System Performance ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Self Assessment ,[object Object],[object Object],[object Object]
Criteria for Measurements Products Processes ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
8.3 Control of non-conforming product ,[object Object],[object Object],[object Object],[object Object],[object Object]
8.4 Analysis of data ,[object Object],[object Object],[object Object],[object Object],[object Object]
8.5 Improvement ,[object Object],[object Object]
8.5.2 Corrective action ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
8.5.3 Preventive action ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
cGMP Vs ISO standards ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
More information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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  • 14. ISO 9001:2000 Survey . ( 2005 -776 608 )
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  • 20. 8 Principles of the ISO Standard Based on eight quality management principles. Leadership Process approach Involvement of people System approach to Management Continual improvement Factual approach to decision making Mutual beneficial supplier relationship Customer focus
  • 21. Set realistic and challenging goals provides resources and give people the tools, opportunities and encouragements to contribute the continual improvement of the processes. Continual improvement: Continual improvement of the organization’s overall performance should be permanent objective of the organization. 6 Create personnel ownership of the organizations target and goals by using the people’s knowledge and experience and through training achieve involvement in operational decisions and process improvement. Involvement of people: People at all levels are essence of an organization and their full involvement enables and their abilities to be used for the organization’s benefit. 3 Understand current and future customer needs and expectations. Measure customer satisfaction and act it. Customer focus: Organizations depend on the customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations 1 APPLICATION QUALITY MANAGEMENT PRINCIPLE #
  • 22. Process Approach – Continual Improvements of All Processes 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 Understanding & Meeting the Requirements PLAN
  • 23. ISO 9001:2000 – Process Model CUSTOMER’S CUSTOMER ISO 9001:2000 Quality Management System 5.Management Responsibility 7. Product Realization 6. Resource Management 8 . Measurement Analysis and Improvements Requirements Satisfaction Continual Improvement of the Quality Management System Consumption Product
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  • 26. Structure of the Standard 4 Quality Management System Requirements Provision of Resources Human Resources Infrastructure Work Environment 6 Resource Management General Requirements Documentation Requirements Planning Customer Related Processes Design & Development Purchasing Production & Service Provision Management Commitment Customer Focus Quality Policy Planning Responsibility, Authority & Communication Management Reviews 5 Management Responsibility 8 Measurement Analysis & Improvements 7 Product Realization General Monitoring & Measurements Control of NCP’s Analysis of Data Improvements
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