3. DEFINITIONS
• QUALITY
• Quality is "meeting or exceeding customer expectations."
• the customer's definition of quality is the only one that matters.
• QUALITY ASSURANCE
• the maintenance of a desired level of quality in a service or product,
especially by means of attention to every stage of the process of delivery or
production
4. • GOOD MANUFACTURING PRACTICE (GMP)
• That part of QA which ensures that products are consistently produced
and controlled to the quality standards appropriate to their intended use.
• QUALITY CONTROL
• That part of GMP which is concerned with sampling, specifications and
testing.
6. BASIC REQUIREMENTS
QUALITY MANUAL
• Document Control
• Ethics
• Sample Handling
• Sample Acceptance
• Departures from SOP
• Quality Control
• Reporting Results
7. THE M'S OF QUALITY
• Man
• Material
• Machinery
• Manuals/Methodology ( SOP)
8. FACTORS INFLUENCING QUALITY
PRE ANALYTICAL ANALYTICAL POST ANALYTICAL
Right specimen laboratory professionals Recording
right collection Reagent Interpretation
Right labelling Equipment Report to user
Right quantity Selection of test
Right transport Biosafety
right storage