Quality Management Flashcards
Describes whether a product or a service meets the minimum specifications set by the customer in a timely manner
Quality
Composed of quality management, quality assurance and quality control
Quality system
Planned and systematic control that will give assurance to the client or customer that the quality of the data being generated in the lab are of good quality
Quality assurance
Programs that will ensure that the quality control activities are being practiced in every aspect of the system
Internal (quality to the management) and External (quality to the clients) Quality Assurance
Provides all guidelines and procedures involved in managing quality systems
Quality Manual
Inspection made on different areas of the laboratory to determine whether the area complies with the arranged quality management plans
Quality Audit
Internal (conducted by a member of the area)
External (conducted by individual that is not directly related to the organization being audited)
Process of certifying by an independent third party individual that a lab is competent
Accreditation
Examples of Accrediation Body
European Accreditation Cooperation
Asian Pacific Laboratory Accreditation Cooperation
International Laboratory Accreditation Cooperation
Quality System Standard: Most generl and globally recognized standard employed by testing and calibration laboratories that provices technical competece of the lab
ISO/ EIC 17025: 2005
Commonly used by manufacturing organizations or suppliers of products
ISO 9000 QMS
Standard protocol required for all the analytical lab which is concerned in the overall process in the laboratory from planning, execution, monitoring …., a subsection of GMP
Good Lanoratory Practices (GLP)
Protocol that requires all organizations manufacturing products for human consumption to be safe, pure and effective
Good Manufacturing Practice (GMP)
Quality system standard employed specifically on pathology Lab
Clinical Pathology Accreditation
