QUALITY MANAGEMENT PROCEDURE AND DOCUMENTS:
Quality must be a prime consideration in the research and development of a Product to assure safety and efficacy. The defined quality criteria vary from country but are similar in general requirements viz.
- Customer focused Organization:
Organization depends on their customers and therefore should understand current and future customer needs, meet customer requirements. - Leadership:
For achieving the leadership create and maintain the organizational in which people can become fully involved for achieving the objectives. - Involvements of People:
Using people’s knowledge and experience and through training achieve involvement of people in operational decisions and process improvement. - Process Approach:
Focus on the use of resources in process activity, leading to effective use of people, equipments, methods and materials. - System Approach to Management:
Align the processes with the organization’s goals and targets, measure results against key objectives. - Continual Improvements:
Provide resources, facilities, opportunities and encouragement to people to contribute to the continual improvement of the processes. - Actual approach to decision making:
Take corrective and preventive action by analyzing the data and information to maximize productivity and to minimize waste and rework. - Mutually Beneficial Supplier Relationships:
Develop mutual trust, respect and commitment to customer satisfaction and continual improvement.
