Developing a Quality
Management System
Viki Massey
Quality Coordinator
A Joint Venture of London Health Sciences Centre and St. Joseph’s Health Care London
Today’s Presentation
LLSG profile
 Implementation Plan
 Outline Quality System Essentials
 Review: Where are we?
 Outline the next steps
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London Laboratory Services Group
Joint venture between LHSC and SJHC
 Pathology and Laboratory Medicine
Program
 9 disciplines
 55 laboratories
 4 campuses
 500 employees
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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 (OLA)
 Consistent with international trends and
laboratory science
 We are committed to providing the
highest level of care to the patient
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How to Implement a Quality
Management System?
LLSG Implementation Plan
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Quality Coordinator
Discipline Task Teams
Quality Team
Develop Policies
GAP analysis
Map Processes
Write procedures
Quality Manual
Communicate/Educate/Train
Audit
Accreditation
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
QSE: Documents and Records
 Document
-
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create
identify
change
approve
file
distribute
archive
Management System
Hierarchy of Documents
Policy
Process
Procedures
Forms
What to do
How it happens
How to do it
Records
Policy Development
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Quality Policies
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QSE’s
Map OLA requirements
Policy statement
Responsibility
Supporting statements
Supporting processes
- included in procedures
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Operational Policies
POLICY STATEMENT:
PURPOSE:
This policy provides the direction for the processes and procedures to….
RESPONSIBILITY
(use those that apply)
Program Leader/Discipline Leader/Section Head is responsible for
Lab Manager is responsible for
Technical Specialist/Coordinator is responsible for
Staff members are responsible for
Other:
The following sections are derived from the OLA requirements. They determine the supporting statements for the policy.
There should be one section and related statement for the major categories defined in the requirements. Make a broad
statement about the Laboratory's intentions for the sections below.
SECTION
SUPPORTING STATEMENTS
References:
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NCCLS document HS1-A Vol.22, No.13- A Quality System Model for
Health Care; Approved Guideline
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QMP-LS- Ontario Laboratory Accreditation Requirements
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Others:
Supporting
Documents
List the processes that support this policy:
Process Mapping
Address the path of workflow
 Describe how things happen here
 Flow Charts or Tables
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What Happens
(List the steps)
1)
2)
3)
Who’s
responsible
Procedure (or
another Process)
Results
Procedure Development
Identified from process mapping
 Templates developed based on NCCLS
guidelines
 Used for analytical and non analytical
procedures
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PURPOSE
POLICY
EQUIPMENT
MATERIALS
SPECIMEN
SPECIAL SAFETY
QUALITY CONTROL
PROCEDURE
LIMITATIONS
INTERPRETATION
CALCULATIONS
REFERENCE RANGE
RESULTS REPORTING
REFERENCES
RELATED DOCUMENTS
APPENDICES
This procedure gives instructions……
Procedures
 Accessible
 Up
to date
 User friendly- accurate, easy to
follow
QSE: Process Control
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Laboratory processes and procedures
Validation
Establishing Reference Intervals
Quality Control
Internal and External QA
Method Comparability
Accreditation
QSE: Occurrence Management
Quality Control: Corrective Action
 External and Internal Quality Assurance
 Turn Around Time (TAT) delay
 Discrepant Results
 Corrected Results
 Specimen Rejection Criteria
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QSE: Information Management
Results Reporting
 Release of Results
 Computer Procedures
 Change Approval
 Computer QA
 Computer Security
 Computer Validation
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QSE: Purchasing and Inventory
Inventory Control System
 External Services
 Purchasing Documents
 Material Resources
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QSE: Safety
Safety Officer, Safety Committee
 Safety Manual
 Audit and Inspections
 Reporting Incidents, Accidents, Illness
 Training
 Personnel Responsibilities
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QSE: Facilities
Location and design
 Environmental Conditions
 Access
 Communication Systems
 Storage
 Computer Environment
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QSE: Equipment
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Equipment selection, calibration,
verification, validation
Inventory
Equipment operation maintenance and
records
Defective Equipment
QSE: Personnel
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Job Description and
Qualifications
 Training
 Competence
 Continuing Education
 Personnel Records
 Performance Appraisal
QSE: Organization
License
 Mission Statement
 Accreditation
 Organizational Structure
 Resource Allocation
 Referral Laboratories
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QSE: Assessment
 Quality
Indicators
 Internal Audits
 Management Review
QSE: Process Improvement
 Quality
Improvement Activities
 Occurrence management
 Problem Solving
QSE: Service and Satisfaction
 Customer
Satisfaction (Complaints)
 Internal and external
Where are We?
Quality Team
Quality policies developed
 Processes identified/mapped
 Procedures written
 Document Management System
 Quality Manual
 Web site for referral labs
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Where are We?
Discipline Task Teams
GAP analysis
 Processes mapped
 Procedures written
 Revisit requirements and close GAP
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What’s Next?
Quality Team to continue to address
QSE
 Discipline Task Teams to complete
sections of OLA requirements
 Educate and train staff
 Perform self assessment
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Celebrate Success!
Resource Material
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ISO documents:
9001:2000
15189
NCCLS documents:
GP26-A
GP22-A
HS1- A
QMP-LS- OLA Consensus Requirements