Introduction to quality systems Flashcards
What is a standard?
a level of quality or attainment
Why are standards important?
Consistency in testing
High quality results
Cost effectiveness
Patient safety
Quality Standards used in Canada:
ISO (International Organization for Standardization) 9000 series– 15189; 2007
CLSI – Clinical and Laboratory Standards Institute
AABB – American Association of Blood Banks
CAP – College of American Pathologists
Most common hospital accreditation body in Canada:
Now includes: IQMH – Institute of Quality Management in Healthcare. Rebranded as Accreditation Canada Diagnostics
Quality Control
Operational process control techniques
Quality Assurance
Planned and systematic activates
Quality Management System
Systematic process-oriented approach to quality
Quality Cost Management
Measurement system economic aspect
Total Quality Management
Management approach centered on sustained high-quality
What is a Quality Management System?
A Quality Management System (QMS) can be described as a “set of essential building blocks needed for a laboratory’s work operations to fulfill stated quality objectives”
Quality documents
Policies, processes, procedures
Quality Manual
Describes what the QMS is and contains all polices that define the work and responsibilities
Path of workflow
Pre-examination/examination/post-examination
Policy
Statements of the organization’s intentions and/or commitments
Answers the question “What do we do?”
The compilation of the stated policies is the purpose of the Quality Manual
Process
List of activities required to accomplish the intent of the policy
Sequence of the events in order to obtain a successful outcome
Identifies who is responsible for each piece