Learning Objective
 To  understand    the  requirements  of  QMS  in 
   Quality  Control  Laboratory  and  be  able  to 
   implement same in a GMP environment and meet 
   the quality objectives of the company.
    OUTLINE
    Definition of QMS
    Quality Management System
    Responsibility
    Resources
    Organization
    Personnel
    Accommodation
    Documentation
    Occurrence Management
    Self Audit
    Monitoring laboratory QMS
    Effective implementation of QMS in the laboratory
             Quality Management System
  Is the organizational 
    structure,responsibilities,procedures ,processes, and 
    resources for implementing quality management.
  Organizational structure
  Responsibilities
  Processes and Procedures
  -  Laboratory process flow
  Resources
                      Responsibility
  
    The  management  should  ensure  that  all 
  parts of the quality management system are 
  adequately    resourced    with   competent 
  personnel, suitable premises ,equipment and 
  facilities.
  Resources
     Ensure necessary resources are available for running & maintenance of the laboratory
     Adequate number of  trained personnel
     Trained deputies for specialized scientific personnel
     Appropriate infrastructure
     Size
     Facilities-water ,waste disposal etc. 
     Equipment- analytical, safety etc.