Laboratory Management and

Biosafety
Laboratory Management
 Laboratory Management

A well- organized laboratory service is

efficient, and produces work of high standard
in a safe and pleasant working environment.
 Laboratory Management
The primary aspects of good management are:
 Setting up the main working room
 Arranging stocks of laboratory items

 Establishing routine procedures for

disinfection and disposal
 Establishing good communication with
clinicians and other parties involved
 Laboratory Management
The primary aspects of good management are:
 Maintenance of laboratory records
 Organizing staff training and responsibilities

 Establishing a reliable quality control system

 Laboratory Management
Organization and Management
Laboratory management is responsible for
design, implementation, maintenance and
improvement of quality management systems.
Should meet all needs.
 Laboratory Policies
Examples include;
 Laboratory hours and emergency work
 Range of tests to be performed

 Collection of specimens

 Subcontracting

 Turn around times, etc.

 Laboratory Safety

“DON'T LEARN SAFETY RULES SIMPLY

BY ACCIDENT”
ABRAHAM LINCOLN
 Laboratory Safety
Examples of laboratory hazards
Physical (poor architecture, burns, electric
shock, cuts)
Chemical (toxic, flammable, corrosive, explosive,
carcinogenic)
Biological (pathogen inhalation, absorption,
ingestion, lab animals)
 Radiation
Compressed gases
 Ergonomic
 Laboratory Safety

What causes accidents to occur??

 Laboratory Safety

What factors contribute to laboratory

accidents??
Laboratory design
Poor training
Human factors e.g. carelessness, fatigue, lack
of concentration
Large workload,etc.
 Laboratory Safety Measures
Safe use of equipment.
Safe use and storage of chemicals and reagents
Safe handling and disposal of specimens
Immunization
Use of safety signs.
Basic first aid training
Implementation of a laboratory safety program.
 Laboratory Safety Measures

Primary barriers (biological safety cabinets,

enclosed containers, use of personal protective
equipment (PPE))
Secondary barriers (Design, construction and
use of the laboratory, demarcation of work
areas)
 Laboratory Safety Measures
Secondary barriers
A. Adequate floor, bench and storage space
B. A well constructed non- slip floor, impermeable
to liquids, and resistant to chemicals.
C. Smooth walls, free from cracks, impermeable to
liquids and easily washable.
D. Easily accessible exit points.
E. Adequate ventilation.
F. Impervious bench surfaces, washable, and
resistant to disinfectants and chemicals.
 Laboratory Safety Measures
Secondary barriers
G. Well-demarcated sections.
H. Appropriate storage facilities (e.g. a well
ventilated, fire proof, locked store, for the
storage of flammables)
I. A good supply of utilities.
J. Provision of protective safety cabinets, fire
extinguishers at accessible points, and adequate
waste disposal area, etc.
 Laboratory Biological Safety
(Biosafety)
Containment (primary vs secondary
containment)
 To reduce or eliminate exposure of laboratory
workers, other persons, and the outside
environment to potentially hazardous agents
through e.g.,
 strict adherence to standard microbiological
practices and techniques.
 appropriate facility design and engineering
features.
 Use of safety equipment and safety practices.
 Laboratory Biosafety
Risk Groups
Classification of organisms according to risk
group is based upon the particular characteristics
of the organism, such as
pathogenicity
infectious dose
mode of transmission
host range
availability of effective preventive measures
availability of effective treatment.
 Laboratory Biosafety
Risk Group 1
No or low individual and community risk
A microorganism that is unlikely to cause human
or animal disease
Example: Bacillus subtilis
 Laboratory Biosafety
Risk Group 2
Moderate individual risk, low community risk.
A pathogen that can cause human or animal
disease but is unlikely to be a serious hazard to
laboratory workers, the community, live stock or
the environment.
Laboratory exposures may cause serious
infection, but effective treatment and
preventive measures are available and the
spread of infection is limited.
Example: ???
 Laboratory Biosafety
Risk Group 3
High individual risk, low community risk
A pathogen that usually causes serious human or
animal disease but does not ordinarily spread
from one infected individual to another.
Effective treatment and preventive measures
are available
Example: ???
 Laboratory Biosafety
Risk Group 4
High individual and community risk
A pathogen that usually causes serious human or
animal disease and that can be readily
transmitted from one individual to another,
directly or indirectly.
Effective treatment and preventive measures
are not usually available
Example: ???
 Risk Assessment
Risk assessment is a critical step in the
selection of an appropriate containment level
(level 1, 2, 3 or 4) facilities and operational
practices.
 Risk Assessment
In addition to the Risk Group classifications, the
following factors associated with the laboratory
operation should also be examined:
 potential for aerosol generation

 quantity/concentration

 stability in the environment

 type of work proposed (e.g., in vitro , in vivo ,

aerosol challenge studies)
 use of recombinant organisms (e.g., gene coding
for virulence factors or toxins; oncogenicity;
capability to revert to wild type).
 Risk Assessment
Health and Medical Surveillance
The health and medical surveillance program is
determined and defined by a risk assessment.
This program may include:
 a medical examination;

 serum screening, testing and/or storage;

 immunizations/prophylaxis;

 any other tests as determined by the risk

assessment process.
 Laboratory Biosafety Levels
The four biosafety levels consist of a
combination of:
Laboratory practices and techniques
Safety equipment
Laboratory facilities
Conditions under which the agent can ordinarily
be handled safely
 Laboratory Biosafety
Biosafety Level 1
A basic level of containment.
Relies on standard microbiological practices
with no special primary or secondary barriers,
other than a sink for hand washing.
Appropriate for undergraduate and secondary
school teaching laboratories, and laboratories in
which work is done with defined and
characterized strains of viable microorganisms
not known to consistently cause disease in
healthy adult humans.
 Laboratory Biosafety
Biosafety Level 1
Examples of microbial agents handled???

NOTE: Many agents not ordinarily associated

with disease processes in humans are, however,
opportunistic pathogens and may cause infection
in the young, the aged, and immunodeficient or
immunosuppressed individuals. Vaccine strains
that have undergone multiple in vivo passages
should not be considered avirulent.
 Laboratory Biosafety
Biosafety Level 2
Appropriate for work done with any human-
derived blood, body fluids, tissues, or primary
human cell lines where the presence of an
infectious agent may be unknown.
Practices, equipment, and facility design and
construction are applicable to clinical, diagnostic,
teaching, and other laboratories in which work is
done with the broad spectrum of indigenous
moderate-risk agents that are present in the
community and associated with human disease of
varying severity.
 Laboratory Biosafety

Biosafety Level 2
With good microbiological techniques, these
agents can be used safely handled on the open
bench, provided the potential for producing
splashes or aerosols is low.
Personal protective equipment should be used as
appropriate, such as splash shields, face
protection, gowns, and gloves.
 Laboratory Biosafety
Biosafety Level 2
Procedures with aerosol or high splash potential
must be conducted in primary containment
equipment, or in devices such as a BSC.
Secondary barriers, such as hand washing sinks
and waste decontamination facilities, must be
available to reduce potential environmental
contamination.
Examples of microbial agents handled???
 Laboratory Biosafety
Biosafety Level 3
Practices, safety equipment, and facility design
and construction are applicable to clinical,
diagnostic, teaching, research, or production
facilities in which work is done with indigenous
or exotic agents with a potential for
respiratory transmission, and which may cause
serious and potentially lethal infection.
Primary hazards to personnel working with
these agents relate to autoinoculation,
ingestion, and exposure to infectious aerosols.
 Laboratory Biosafety
Biosafety Level 3
Use of primary and secondary barriers.
 All laboratory manipulations should be
performed in a BSC or other enclosed
equipment, such as a gas-tight aerosol
generation chamber.
 Secondary barriers include controlled access
to the laboratory and ventilation requirements
that minimize the release of infectious
aerosols from the laboratory.
Examples of microbial agents handled???
 Laboratory Biosafety
Biosafety Level 4
Practices, safety equipment, and facility design
and construction are applicable for work with
dangerous and exotic agents that pose a high
individual risk of life-threatening disease, which
may be transmitted via the aerosol route and for
which there is no available vaccine or therapy.
The primary hazards to personnel working with
BSL-4 agents are respiratory exposure to
infectious aerosols, mucous membrane or broken
skin exposure to infectious droplets, and
autoinoculation.
 Laboratory Biosafety
Biosafety Level 4
Use of Class III BSC or full-body, air-supplied
positive-pressure personnel suit.
The BSL-4 facility is generally a separate
building or completely isolated zone with
complex, specialized ventilation requirements
and waste management systems to prevent
release of viable agents to the environment.
 Laboratory Biosafety
Biosafety Level 4
Examples of microbial agents handled???

Agents with a close or identical antigenic

relationship to BSL-4 agents also should be
handled at this level.
When sufficient data are obtained, work with
these agents may continue at this level or at a
lower level.
 Relation of Risk Groups to
Biosafety Levels, Practices,
and Equipment
Risk Group Biosafety Laboratory Laboratory Safety
Level Type Practices Equipment

1. Basic – Basic GMT None; open

Biosafety teaching, bench work
level 1 research
2. Basic – Primary GMT plus Open bench
Biosafety health protective plus BSC
level 2 services, clothing, for
diagnostic biohazard aerosols
services, sign
 Relation of Risk Groups to
Biosafety Levels, Practices,
and Equipment
Risk Biosafety Laboratory Laboratory Safety
Group Level Type Practices Equipment

3. Containment Special As Level 2 BSC and/or

– Biosafety diagnostic plus special other primary
level 3 services, clothing, devices for
research controlled all activities
access,
directional
airflow
 Relation of Risk Groups to
Biosafety Levels, Practices,
and Equipment
Risk Biosafety Laboratory Laboratory Safety
Group Level Type Practices Equipment

4. Maximum Dangerous As level 3 Class III BSC,

containment pathogen plus airlock or protective
– Biosafety unit entry, pressure suits
level 4 shower exit, in conjunction
special with Class II
waste BSCs, double-
disposal ended
autoclave,
 Laboratory Biosafety
In a clinical laboratory, all specimen submitted
for analysis should be handled as potentially
infectious.
The initial processing of clinical specimens and
serological identification of isolates can be done
safely at BSL-2 (with some exceptions).
Every laboratory should establish standard
procedures in the laboratory that realistically
address the issue of the infective hazard of
clinical specimens.
 Animal Facility Containment
Levels
Animal facility – Biosafety Level 1
Suitable for maintenance of most stock animals
after quarantine (except nonhuman primates,
regarding which national authorities should be
consulted), and for animals that are deliberately
inoculated with agents in Risk Group 1.
An appropriate medical surveillance programme
for the staff must be instituted.
A safety or operations manual must be prepared
and adopted
 Animal Facility Containment
Levels
Animal facility – Biosafety Level 2
Suitable for work with animals that are
deliberately inoculated with micro- organisms in
Risk Group 2.
 Animal Facility Containment
Levels
Animal facility – Biosafety Level 3
Suitable for work with animals that are
deliberately inoculated with agents in Risk
Group 3, or when otherwise indicated by a risk
assessment.
All systems, practices and procedures need to
be reviewed and recertified annually.
 Animal Facility Containment
Levels
Animal facility – Biosafety Level 4
Work in this facility will normally be linked with
that in the maximum containment laboratory –
Biosafety Level 4, and national and local rules and
regulations must be harmonized to apply to both.
 Animal Facility Containment
Levels

For invertebrates the animal facility biosafety

level will also be determined by the risk groups of
the agents under investigation or when otherwise
indicated by a risk assessment.
 Animal facility containment
levels: summary of practices
and safety equipment
Risk Containment Level Animal facility containment
Group levels: summary of practices
and safety equipment

1. ABSL-1 Limited access, protective

clothing and gloves.
2. ABSL-2 ABSL-1 practices plus: hazard
warning signs. Class I or II
BSCs for activities that
produce aerosols.
Decontamination of waste and
 levels: summary of practices
and safety equipment
Risk Group Containment Animal facility containment
Level levels: summary of practices
and safety equipment

3. ABSL-3 ABSL-2 practices plus:

controlled access. BSCs and
special protective clothing for all
activities.
4. ABSL-4 ABSL-3 plus: strictly limited
access. Clothing change before
entering. Class III BSCs or
positive pressure suits. Shower
on exit. Decontamination of all
Laboratory Biosecurity
 Laboratory Biosecurity
Biosecurity is implemented to prevent
 theft,

 misuse or
 intentional release of pathogens.
 Laboratory Biosecurity
“Laboratory biosafety” describes the
containment principles, technologies and
practices that are implemented to prevent
unintentional exposure to pathogens and toxins,
or their accidental release.
 “Laboratory biosecurity” refers to
institutional and personal security measures
designed to prevent the loss, theft, misuse,
diversion or intentional release of pathogens
and toxins.
 Laboratory Biosecurity
Effective biosafety practices are the very
foundation of laboratory biosecurity activities.
Through risk assessments, performed as an
integral part of an institution’s biosafety
programme, information is gathered regarding
the type of organisms available, their physical
location, the personnel who require access to
them, and the identification of those
responsible for them.
 Laboratory Biosecurity
A specific laboratory biosecurity programme
must be prepared and implemented for each
facility according to the requirements of the
facility, the type of laboratory work conducted,
and the local conditions.
National standards should be developed that
recognize and address the ongoing responsibility
of countries and institutions to protect
specimens, pathogens and toxins from misuse.
 Laboratory Biosecurity

Laboratory biosecurity measures should include;

a comprehensive programme of accountability for
pathogens and toxins
an updated inventory with storage location,
identification of personnel with access,
description of use
documentation of internal and external transfers
within and between facilities
any inactivation and/or disposal of the materials.
 Laboratory Biosecurity

Laboratory biosecurity measures should include;

Laboratory biosecurity training
An institutional laboratory biosecurity protocol
for identifying, reporting, investigating and
remediating breaches in laboratory biosecurity,
including discrepancies in inventory results.
 Laboratory Biosecurity
Physical Protection
Perimeter security, facility security, laboratory
security and agent specific security, and outline
procedures for securing the area, e.g., card
access, key pads, locks etc. unauthorized entry
and/or unauthorized removal of infectious
materials from their facility. Information
security for data and electronic technology
should also be addressed.
 Laboratory Biosecurity

Personnel Suitability/Reliability
Background checks and security clearances, photo
identification badges for employees and
temporary badges for escorted visitors
Procedures are needed for approving and granting
visitors access to controlled areas.
Biosecurity training needs to be provided to all
personnel who are given access.
 Laboratory Biosecurity
Pathogen Accountability
Inventory requirements for proper labelling,
tracking of internal possession, inactivation and
disposal of cultures after use, and transfers
within and outside the facility.
These inventory controls also assist in keeping
track of pathogen storage locations and under
whose responsibility the pathogens lie.
The record keeping should include pathogen
inventories, who has access to agents, who has
access to areas where agents are stored or used,
as well as transfer documents.
 Laboratory Biosecurity
Pathogen Accountability
Inventories must be updated regularly
A notification process for identifying, reporting,
and remediating security problems, i.e., inventory
discrepancy, equipment failure, breach of
security, release of agents, etc., should be in
place.
 Laboratory Biosecurity
Biosecurity Incident and Emergency Response
A protocol for reporting and investigating
security incidents e.g., missing infectious
substances, unauthorized entry, should be
established.
Biosecurity incident and emergency plans should
include response to intentional (bomb threats
etc.), unintentional (accidental release) and
natural events (power outages, severe weather).
Training needs to be provided to all relevant
personnel.
 Laboratory Biosecurity
Biosecurity Incident and Emergency Response
Expert advice from security and/or law
enforcement experts should be sought in the
development of threat assessments and security
protocols specific to each facility.
The threat assessment and security practices
should be regularly reviewed and updated to
reflect new threats that may be identified.
 Laboratory Biosecurity
Laboratory biosecurity measures should not
hinder the efficient sharing of reference
materials, clinical and epidemiological specimens
and related information necessary for clinical or
public health investigations.
Legitimate access to important research and
clinical materials must be preserved.
There should be regular risk and threat
assessments, and regular review and updating of
procedures.
 Quality Assurance

“QUALITY MEANS DOING IT

RIGHT WHEN NO ONE IS
LOOKING.”
HENRY FORD
 Quality Assurance

A quality assurance program is an indispensable

part of modern laboratory.
Quality assurance is more than a set of routine
procedures, it is also a state of mind.
 Quality Assurance

“…the total process whereby the

quality of laboratory reports can be
guaranteed. It is a set of activities
followed starting from specimen
collection up to issuing of test
results to ensure test results are as
accurate and precise as possible.”
 Quality Assurance

It has been summarized as the:

RIGHT RESULT,
at the right TIME,
on the right SPECIMEN,
from the right PATIENT,

with RESULT INTERPRETATION based on

correct reference data,
and at the right price
 Quality Assurance

What then is the purpose of quality

assurance (QA) in laboratory practice??
 Quality Assurance

What then is the purpose of quality

assurance (QA) in laboratory practice??

 to provide test results that are relevant,

reliable, timely, interpreted correctly.
 Quality Assurance

A quality assurance program has four separate

aspects
 internal quality control

 external quality assessment

 proficiency surveillance

 standardization.
 Quality Assurance

i) Internal Quality Control: is based on monitoring

the test procedures that are performed in the
laboratory.
It is intended to ensure that there is continual
evaluation of the reliability of the work of the
laboratory and that control is exercised over the
release of test results. However, it is primarily a
check of precision (i.e. reproducibility) but not
necessarily accuracy.
 Quality Assurance

i) Internal Quality Control:

It includes measurements on specially prepared

materials, and repeated measurements on routine
specimens, as well as statistical analysis of, day by
day, of data obtained from the tests which have
been routinely carried out.
 Quality Assurance

ii) External Quality Assessment: is the objective

evaluation by an outside agency of the performance
by a number of laboratories on material which is
supplied specially for this purpose.

The objective is to achieve comparability, but

again not necessarily accuracy unless the
specimens have been assayed by a reference
laboratory, using methods of known precision,
alongside a reference preparation of known value.
 Quality Assurance

iii) Proficiency Surveillance: This implies critical

supervision of all aspects of laboratory tests, where
as internal quality control and external quality
assessment relate only to the actual analysis.
Proficiency includes maintenance and control of
equipment and apparatus; collection, labeling,
delivery and storage of specimens before the
tests are performed; interpretation and reporting
of results.
 Quality Assurance

iv) Standardization:
A material standard or reference preparation is
used to calibrate analytical instruments and to
assign a quantitative value to calibrators.
A reference method is an exactly defined
technique which provides sufficiently accurate
and precise data for it to be used to assess the
validity of other methods.
 Quality Assurance
Implementing QA requires:
 Preparation and use of Standard Operating
Procedures (SOPs) with details of QC for all
laboratory tests and activities.
 System for monitoring whether test results are
delivered in time to influence clinical and public
health decision making.
 Policies that enable a laboratory to operate
reliably, effectively, and in harmony with the
other departments and service providers.
 Quality Assurance
QA is defined by three main activities:

1. Preventive activities: this helps to prevent

error before it occurs by;
 Method selection

 Good laboratory design and organization

 Competent personnel

 Use of SOPs

 Effective maintenance program for equipment

 Quality Assurance
QA has three activities:

2. Assessment activities: This is used to maintain

the process though;
 Testing a QC system

 Perform instrument function check

 Participation in external quality assessment

schemes
 Quality Assurance
QA has three activities:

3. Corrective actions: This includes all activities

performed to correct errors after they occur
through;
 Review of work

 Trouble shooting of instruments

 Timely communication with users, etc

 Quality Assurance
Effective quality assurance detects errors at an
early stage before they lead to incorrect test
results.
Laboratory personnel need to be aware of the
errors that can occur when;
 collecting specimens (pre-analytical stage)

 testing specimens (analytical stage)

 reporting and interpreting test results (post

analytical stage).
 Quality Assurance

What are the possible sources of

error in the pre-analytical stage?
 Quality Assurance

Analytical QA
This stage includes those activities employed
during performance of test.
It is mainly concerned with the control of errors
during the actual analysis of materials and also
verification of test results.
Analytical QA is mainly effected by the use of
SOPs.
 Quality Assurance
Analytical QA
SOPs are required for the following reasons:
 To provide users with written instructions on
how to perform tests consistently to an
acceptable standard in their laboratory.
 To prevent changes in the performance of
tests with new users.
 To improve and maintain the quality of lab
service to patients and identify problems
associated with poor work performance.
 Quality Assurance
Analytical QA
SOPs are required for the following reasons:
 To make clinical and epidemiological
interpretation of test results easier by
standardizing the procedure.
 To provide written standardized techniques for
use in the training of laboratory personnel.
 To facilitate the preparation of a list and
inventory of essential reagents, chemicals and
equipment.
 To promote safe laboratory practice.
 Quality Assurance
Post-analytical QA
This includes
calculation
Recording
Reporting
verification of test results
taking appropriate action whenever a result has
serious clinical implication
ensuring test results are interpreted correctly.
Quality Control
 Quality Control
The term quality control covers that part of
quality assurance, which primarily concerns the
control of errors in the performance of tests
and verification of test results.
QC must be practical, achievable, affordable,
and above all continuous.
Quality control involves the use of a variety of
methods or techniques to reduce variance in
analytical procedures
 Quality Control

Quality control involves the use of a variety of

methods or techniques to reduce variance in
analytical procedures
 Quality Control
The purpose of QC is to:
1. monitor the analytical process
2. monitor analytical errors
3. correct results of analysis
 Quality Control
Types of QC

Internal quality control - intra-laboratory QC.

This is a quality control program which is carried
out in the lab. It encompasses all measures taken
and technical performances within an individual
laboratory. It is mainly based on the use of control
samples like pooled serum prepared for such
purpose.
Purpose: To ensure tests are performed reliably
and reported correctly.
 Quality Control
Types of QC

External QC (inter laboratory QC) This has very

similar application with external quality
assessment scheme. It involves observation of
variance in results when the same material is
analyzed in different laboratories
 Quality Control
Use of Controls
1. Expected values are known by the analyst: this
helps to know whether analytical system is
reliable or not.
2. Expected value is unknown by the analyst: this
is important to obtain independent assessment
of all the procedures performed in the lab and
also to assess the quality of the analyst.
 Quality Control
Assessing Value of Tests

Ability of diagnostic tests to indicate presence or

absence of disease.
 Sensitivity

 Specificity

 Efficiency

 Predictive values
Quality Standards and
Certification
 Quality Standards
HISTORICAL BACKGROUND
In the past laboratory quality was not
questioned –it was assumed.
Until the mid-1970’s regulatory agencies
assumed that reports of ‘test’ data were
accurate and were generated according to
expected quality standards.
Similarly, the invisible ‘hazards’ of working in a
laboratory were largely ignored .
 Quality Standards
HISTORICAL BACKGROUND
US FDA and US EPA audit of laboratory data
supporting two new drug applications indicated :
1. Poorly designed experiments.
2. Poor execution.
3. Inaccurate reporting of test results

Laboratory personnel were unaware of the

importance of protocol adherence, accurate
observations and record keeping.
 Quality Standards

HISTORICAL BACKGROUND
The first laboratory quality regulations were
passed in the early 1980’s.
 Quality Standards
Egs of International Quality Standards
Principles of Good Laboratory Practice
ISO 9001 - Management Standards
ISO 17025: 2005 - Competency of Testing and
Calibration Lab
ISO 15189 - Medical Lab
ISO 43 - Proficiency Testing Lab
 Quality Standards
ISO/IEC 17025:2005
This specifies the general requirements for the
competence to carry out tests and/or
calibrations, including sampling.
It covers testing and calibration performed
using standard methods, non-standard methods,
and laboratory-developed methods.
Contains management requirements and technical
requirements
 Quality Standards
ISO/IEC 17025:2005 Requirements
Quality Management Plan and associated written
procedures and policies
Implementation of a full laboratory quality
system
Internal audits
Correction of non-conformities and improvement
in laboratory efficiency with respect to quality
systems
Continuing review of quality systems to ensure
their continued suitability and effectiveness
 Quality Standards
ISO/IEC 15189: Medical Laboratories,
Particular requirements for quality and
compliance
Sample collection, transportation and
identification
Sample processing
Test validation and interpretation
Disease and patient management and advice
Staff experience and training
Quality Assurance and Quality Control systems
 Quality Standards
Laboratory safety necessitates:

Recognition of hazards
Effective control of hazards
Safety-focused attitude
Good personal behavior
Good housekeeping
Continual practice of good laboratory technique
 Quality Standards
Egs of standards to guide and/or regulate
laboratory safe working practices:
ISO 15190: Medical laboratories - Requirements
for safety
 ISO 15189: Medical laboratories – Particular
requirements for quality and compliance
 Clinical and Laboratory Standards Institute
(CLSI): Clinical Laboratory Safety (GP17
guideline)
CLSI: Protection of Laboratory Workers from
Occupationally Acquired Infections (M29)
 Quality Standards

Employer and employee share responsibility

Employer has ultimate responsibility
Safety management starts with a safety policy
Quality is guided by a quality management
system
 Quality Standards
Employer’s Responsibilities
Establish work methods and safety policies
Provide supervision and guidance to staff
Provide safety information, training, PPE, and
medical surveillance
Provide and maintain equipment and facilities
that are adequate to the task
 Quality Standards
Employee’s Responsibilities
Know and comply with the established work
safety practices
Positive attitude towards supervisors,
coworkers, facilities and safety training
Give prompt notification of unsafe conditions or
practices
Engage in the conduct of safe work practices
and use of PPE
 Quality Standards
Quality Management System
Documented and communicated procedures and
policies
Internal and external QA/QC systems
Quality policy statement
Quality manual describing the quality
management system
Program for monitoring equipment, reagents, and
analytical systems
 Quality Standards
Quality Management System
Document Control
External Services and Supplies
Advisory Services
Identification and Control of Nonconformities
Corrective Action
Preventive Action
Continual Improvement
Quality and technical records
Internal audits
 Quality Standards

Laboratory Quality Technical Requirements

Personnel
Accommodation & Environmental Conditions
Laboratory Equipment
Pre-examination, examination and post-
examination procedures
Reporting of results
 Quality Standards

What is the role of national

regulatory authorities in quality
management (SAZ, MCAZ, BAZ,
etc)??