AQ Viro M1 UDs - Fr.en

SOP / Quality Assurance
Virology
THROUGH
DR. FOUNOU ZANGUE RASPAIL CARREL

Ph.D. MEDICAL MICROBIOLOGY
1
Summary
• Goals
• General
• Definitions
• Quality system in a virology laboratory
• Stakes and quality requirement
• Performing an SOP
Goals:
• Master the general implementation arrangements to guarantee the quality of the laboratory
design, the performance of examinations, until the results are released in a virology laboratory.
• Master the processes and quality standards in a clinical virology laboratory.
• Master the fields of application of quality in the virology laboratory.
• Master the realization of a standard operating procedure (SOP / POS).

GENERAL
• Set of processes and arrangements implemented to ensure the quality of a medical analysis result.
• It applies to the clinical laboratory as a research laboratory according to a very precise standard ISO 15
189.
• All the provisions are contained in the GBEA (Guide to Good Execution of Analyzes).
• GBEA manual describing all the provisions applying to the internal and external activities of the
laboratory in order to guarantee a good result.
DEFINITIONS
• Virological analysis laboratory

• Enabling space or environment ➔ carrying out virology examinations
• Pre-analytical phase
• Contributing analysis step ➔ reception + labeling + sampling
• Analytical phase
• Analysis steps + analytical validation
• Post analytical phase
• Biological interpretation + biological validation + rendering of results + waste
management.
• Quality
• All the characteristics of a product or a service which give it the ability to satisfy needs.
• Quality assurance
• All the procedures from the pre-analytical phase to the post-analysis contributing to reduce the
risk of false results.
• Quality Control
• Process of evaluating a test with the aim of guaranteeing its reliability in a virology
laboratory.
• Internal quality control

• Process of evaluation of a test within the laboratory with the aim of guaranteeing its
reliability.
• External quality control

• Process of evaluation of a test by other laboratories or by a quality control agency with the
aim of ensuring its specificity and reliability in a laboratory.
• Quality audit
• Technical skills assessment exam, administrative and financial management aimed at ensuring
the proper execution of examinations, the proper management of consumables in a laboratory.
• Standards
• Set of rules governing compliance and the requirements of good technique

• Rules ➔ contained in the GBEA
• ISO 15 189 standard medical analysis laboratory
• ISO ➔ international Organization for standardization

Quality system in a laboratory
1. Quality policy
• Goals
• Ensure the quality of the results both in substance and in form, respecting
international standards.
• Material resources
• Define the type of equipment, consumables, reagents depending on the examinations to be carried
out.
• Human ressources
• Define the level of study and professional experience of the staff according to the
tasks.
• Organizational chart
• Creation of an organization chart according to positions and role.
• Awareness and education

• Raise awareness and build on the good foundation and respect for the norm by
highlighting the consequences of violating it.
• The formation continues

• Participation in continuous training or retraining of personnel in the field.
2. Quality unit
• Establishment of the management and quality assurance system
• Manual and Computerized
• Redundable
• Manage orders and reagents (supply, stocks, etc.)
• Ensures the traceability of examinations
• Ensures execution by competent personnel.

• Validation of procedures
• Responsible for the realization
• Responsible for follow-up
• Responsible for execution
• Responsible for modifications

• Identification of system flaws
• Violation of procedures, respect or not of maintenance etc….
• Take corrective action on procedures already in place

• Reconceptualization of the SOP of a method has a direct or indirect consequence
• Recalibration of a PLC etc ...
3. Documentation System
• Manual in register form
• Computerized or automated
4. Quality assurance manual

• GBEA as a barometer
• SOP
• Stakes and quality requirement
• Optimization and rationalization of resources
• Reduction of sources of non-quality

• System improvement
• Recognition of the laboratory at international level (accreditation)
• Patient satisfaction by ensuring the image of the laboratory
• Respond to emerging needs

Realization of an SOP
• On your mind
• Title
• SOP information
• Approval and validation
• History of the SOP
• Contextualization
1. Scope
2. Goal
3. Generalities
4. Responsibilities
5. Practical Notes
6. Premises and equipment
7. Operating mode
8. Annex
THANK YOU FOR YOUR KIND ATTENTION

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SOP / Quality Assurance

DR. FOUNOU ZANGUE RASPAIL CARREL

• Master the processes and quality standards in a clinical virology laboratory.

• Master the fields of application of quality in the virology laboratory.

• Master the realization of a standard operating procedure (SOP / POS).

• Virological analysis laboratory

• Internal quality control

• External quality control

• Set of rules governing compliance and the requirements of good technique

• ISO ➔ international Organization for standardization

• Creation of an organization chart according to positions and role.

• Awareness and education

• The formation continues

• Establishment of the management and quality assurance system

• Manual and Computerized

• Manage orders and reagents (supply, stocks, etc.)

• Ensures the traceability of examinations

• Ensures execution by competent personnel.

• Responsible for the realization

• Responsible for follow-up

• Responsible for execution

• Responsible for modifications

• Take corrective action on procedures already in place

4. Quality assurance manual

• Reduction of sources of non-quality

• Recognition of the laboratory at international level (accreditation)

• Patient satisfaction by ensuring the image of the laboratory

• Respond to emerging needs

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