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.