Transcript A Quality Management System

A Quality Management
System
Viki Massey
Quality Coordinator
A Joint Venture of London Health Sciences Centre and St. Joseph’s Health Care London
Objectives

Quality Management System
- What
- Why
- Goals/Benefits
- Structure
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Ontario Laboratory Accreditation (OLA)
Implementation Plan
Accreditation Process
What is a Quality
Management System
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ISO 9000 defines a QMS as:
“ Management system to direct and
control an organization with regard to
quality”
Why Quality Management
System?
QMP-LS: Quality Management Program –
Laboratory Services; Ontario Laboratory
Accreditation
 Consistent with international trends and
laboratory science
 Providing the highest level of care to the
patient

LPTP to OLA
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1974 -Laboratory Proficiency Testing
Program (LPTP)
 1992-1994- Laboratory Review
Quality
Improvement Model
 2000- Quality Management ProgramLaboratory Services (QMP-LS)
 Ontario Laboratory Accreditation (OLA)
Ontario Laboratory
Accreditation
 Mandatory
for all Ontario laboratories
 Peer accreditation
 Based on a process approach
 Review of policies and processes
 Standards of practice
Building Blocks of OLA
 ISO
9000; ISO 17025; ISO 15189
 NCCLS- A Quality System Model for
Health Care
 Ontario Law
 Generally accepted standards of
laboratory practice
The Benefits of a QMS
 Encourages
active and effective
leadership
 Involves and empowers staff
 Staff will clearly understand their
responsibilities
 Ensures consistency
 Focuses on root cause of problems
Goal of a Quality Management
System
For the laboratory :
 to operate efficiently and effectively, meeting
regulatory requirements
 to be managed with the interests of the patient
 to ensure that everyone understands who is
responsible for doing what, when, why,where and
how
 to continually strive for improvement
Stated Simply:

Say what you do (document)
 Do what you say
 Standardize, standardize, standardize
 Measure and monitor those things that are
important to your customer
 Focus on the process
 Assess
Structure for a Quality system
Quality System Essentials
Organization
Personnel
Path of Workflow
Pre-Analytic Analytic Post-Analytic Info Mgmt
Equipment
Purchasing/Inventory
Process Control
Documents/Records
Occurrence Mgmt
Internal Assessment
Process Improvement
Service and Satisfaction
Facilities and Safety
Information Management
Quality system essentials apply
to all operations in the path of
workflow
LLSG Implementation Plan
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Quality Coordinator
Discipline Task Teams
Quality Team
Policies drafted
GAP analysis
Mapping Processes
Quality Manual
Communication/Education/Training
Audit
Accreditation
Accreditation Process
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Institution
– Meet Essential Requirements (614)
– Meet Good Practice Recommendations (66)
– Submit Quality Manual
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QMPLS
– Review Quality Manual
– Appoint Accreditation Team
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Accreditation Team
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Interview
Observe
Check list of requirements
Assess compliance
Recommend accreditation
Summary

Need an organized plan to implement QMS
 Use OLA requirements to develop QMS
 Develop Quality Manual addressing QSE
 Operationalize Quality Manual
 Prepare for accreditation assessment visit
Additional Information
 Can
be found at these Web Sites:
- www.qmpls.org
- www.lhsc.on.ca/lab/qmanage/qmsys.htm