LABORATORY SERVICES
FACILITY NAME(S)
Page 1 of 40
QUALITY SYSTEM
TABLE OF CONTENTS
1.0 INTRODUCTION 2
1.1 Scope 2
1.2 Distribution 2
1.3 Revisions 2
2.0 GLOSSARY 3
3.0 GENERAL INFORMATION 3
3.1 Vision 3
3.2 Mission 3
3.3 Organizational Values 3
3.4 Organization Identity 3
4.0 QUALITY SYSTEM 4
4.1 Quality Policy 4
4.2 Quality Objectives 4
4.3 Quality System Essentials 4
4.4 Quality Plan 4
5.0 QUALITY SYSTEM ESSENTIALS 5
5.1 QSE: Organization Policy 5-7
5.2 QSE: Resources Policy 8-10
5.3 QSE: Equipment Policy 11-14
5.4 QSE: Supplier and Customer Issues Policy 15-17
5.5 QSE: Process Control Policy 18-22
5.6 Overall Blood Bank/Transfusion Service Path of Workflow 22
5.7 QSE: Documents and Records Policy 23-26
5.8 QSE: Deviations, Non conformance and
Complications Policy 27-31
5.9 QSE: Assessments Policy 32-34
5.10 QSE: Process Improvement through Corrective
and Preventive Action Policy 35-38
5.11 QSE: Facilities and Safety Policy 39-40
1.0 INTRODUCTION:
1.1 SCOPE:
The quality system of the laboratory testing areas listed below is based on the
following guidelines and standards:
1.2 DISTRIBUTION:
1.3 REVISIONS:
2.0 GLOSSARY:
The terms and descriptions used within this quality manual are generally
defined in;
o CSA Z902-04 Blood and blood components standard
o CANP4D ISO/IEC 17025:1999 General Requirements for the
Competence of Calibration and Testing Laboratories
o ISO 15189:2003 Medical Laboratories-Particular Requirements for
Quality and Competence
3.1 VISION:
Insert facility vision statement here.
3.2 MISSION:
Insert facility vision statement here.
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Blood bank/Transfusion Service
Organization Chart
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Specialist
− Identifying and informing the Quality
Specialist of any problems, issues, etc.
related to policies, processes or
procedures that may affect the safety and
quality of blood, blood components,
services
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regulating bodies
• The Blood transfusion committee is
responsible for:
− Evaluation of adverse reaction and
transfusion error data
− Evaluation of provincial and federal reports
of adverse events
− Recommendations for corrective measures
and practice changes
• The Quality Specialist is responsible for:
− Ensuring appropriate audits are conducted
on a routine basis
− Trending data and developing reports
related to deviations, non conformances,
errors and accidents
− Ensuring non conforming blood, blood
components, critical supplies and services
are quarantined according to defined
processes
− Ensuring all appropriate notifications are
made in response to adverse reactions
according to defined processes
− Developing, reviewing and maintaining all
policies, processes, procedures, forms and
documents related to preparation and
maintenance of the deviations, non
conformance and complications essential
− Assessment of all deviation reports,
determination and implementation of
corrective actions and approval of
corrective action reports
− Forwarding all reports for final review and
approval to the blood bank/transfusion
service manager/supervisor
• The blood bank/blood transfusion
service staff is responsible for:
− Documenting and implementing corrective
action(s) as defined by policies, processes
and standard operating procedures and/or
by the Quality Specialist/Laboratory
Manager/Supervisor.
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appropriate
− Developing and initiating appropriate
improvement processes and procedures as
determined through quality indicators
− Developing, initiating and reporting
process audits as defined by processes
and procedures
− Performs investigations of incidents,
errors, accidents, non conformances,
customer complaints and other issues as
appropriate and develops reports
according to defined processes and
procedures
− Ensures corrective action(s) are reviewed
for acceptability and forwards to blood
bank/transfusion service
manager/supervisor for approval
− Conducts reassessment of corrective
action(s) taken to ensure expectations are
met
• The blood bank/blood transfusion
service staff are responsible for:
− Participating in identifying and
implementing preventive and corrective
actions when asked to do so.
− Performing corrective action(s) as
requested by the Quality
Specialist/Laboratory Manager/Supervisor
− Reporting and documenting errors,
accidents, non conformances, complaints
and other issues to the Quality Specialist
according to defined policies, processes
and standard operating procedures
Supporting Documents:
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Number
Supporting Documents:
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