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Quality Management Systems

Quality Management Systems are All About Client Service and Satisfaction

Customer Requirements

Input Output

Customer Satisfaction

Answer to Question 1!

The Quality Hierarchy

We do the bluebut we want the gold
World Class Quality TQM Baldridge Quality Award Operating Excellence


QUALITY SYSTEM coordinated QUALITY ASSURANCE planned/systematic QUALITY CONTROL operational techniques


Regulatory compliance

Answer to Question 2!

Quality Management System

QSE 1 : Organization QSE 2 : Document & Record QSE 3 : Purchasing & Inventory QSE 4 : Occurrence Mgm QSE 5 : Equipment QSE 6 : Personnel QSE 7 : Process Control QSE 8 : Assessment QSE 9 : Process Improvement QSE 10 : Information Mgm QSE 11 : Service & Satisfaction QSE 12 : Facility & Safety

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

Quality Management Systems

Document across the Path of Workflow Pre-analytical Analytical Post-analytical

Collection Manual
Specimen Transport

Method Validation
Sources of Error

Results Reporting

Answer to Question 4!

How QMS Relates to OLA

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!

Relating our Quality Management System Essentials to OLAS Requirements

I. Organizational Structure, Personnel Policies and Training, and Laboratory Management Human Resources Quality Management System - Organization, Process Improvement, Documents and Records, Occurrence Management, Purchasing & Inventory Physical Facilities Facilities and Safety Equipment, Reagents and Supplies Equipment, Purchasing & Inventory Pre-analytical Process Information Management, Process Control



Relating the QSEs to OLA

VI. Analytical Process Process Control VII. Quality Assurance Process Control, Assessment VIII Post-analytical Process (Reporting) Information Management, Service and Satisfaction IX. Laboratory Information System Information Mgm X. Safety Facilities and Safety

And more about the OLA requirements

It is essential for us to design, not fully implement a QMS for the first round Essential to meet requirements for safety and care of patients and employees Essential for us to meet requirements for the protection of patient and employee rights Essential for us to meet requirements for appropriate, accurate, timely and reliable laboratory results Essential for us to do this for legal requirement

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

We need to operationalize these now in every lab