Professional Documents
Culture Documents
Quality Management Systems are All About Client Service and Satisfaction
Customer Requirements
Input Output
PRODUCT
Customer Satisfaction
Answer to Question 1!
Efficiency
QUALITY MANAGEMENT
QUALITY SYSTEM coordinated QUALITY ASSURANCE planned/systematic QUALITY CONTROL operational techniques
Effectiveness
Regulatory compliance
Answer to Question 2!
Quality manual
(Policy, Process, Procedures) On the 12 QSEs Policy: What we want to do Process: How to do it Procedure : What to do Emphasize education & staff awareness
Method Validation
Sources of Error
Results Reporting
Responsiveness
Answer to Question 4!
OLA Requirement
OLA has 11 sections with multiple questions in each section (See OLA Requirements Handout):
I. II. III. IV. V. VI. VII. VIII IX. X. XI. Organizational Structure, Personnel Policies and Training, and Laboratory Management Quality Management System Physical Facilities Equipment, Reagents and Supplies Pre-analytical Process Analytical Process Quality Assurance Post-analytical Process (Reporting) Laboratory Information System Safety Point-of-Care Testing Answer to Question 5!
II.
III. IV. V.
1. Assessment 2. Documents and Records 3. Equipment 4. Facilities and Safety 5. Human Resources 6. Information Management 7. Occurrence Management 8. Organization 9. Process Control 10. Process Improvement 11. Purchasing and Inventory Pre-analytical Analytical 12. Service and Satisfaction
Post-analytical