Quality Manual Template

SUPPLEMENT TO THE LABORATORY QUALITY
MANAGEMENT SYSTEM TRAINING TOOLKIT, Module 16 -

Docume!" #d $eco$d"
QUALITY MANUAL
%e$"&o '(1)
Name of the laboratory
Address
Director name
Contact details
Written by Reviewed by Authorized by
Date: Date: Date:
Quality
Manual
1
P$e*#ce
This quality manual template provides guidance for public health and clinical
laboratories on writing policies and procedures that support a quality
management system. It is based on both ISO 11!" Standard for Medical
laboratories # Medical laboratories Particular requirements for quality and
competence - and $%SI &'()#*+ documents # Quality Management System: A
Model for Laboratory Services; Approved guideline t! edition # , and provides
information and e-amples to assist with writing a quality manual that addresses
all quality system essentials .QS/0 that are critical for quality management. The
template is organi1ed following the framewor2 developed by $%SI and the 31(
Quality System /ssentials4, as described in greater detail in the %aboratory
Quality Management System .%QMS0 Training Tool2it
1
. 5urthermore, additional
resources .e.g. glossary0 can also be found in the %QMS Training Tool2it and
6andboo2.
* quality manual is required for implementing a quality management system.
Such a system aims primarily at achieving customer satisfaction by meeting
customer requirements through application of the system, continuous
improvement of the system, and prevention of the occurrence of
nonconformities.
This quality manual template is based on internationally#accepted standards and
focuses on good quality principles and best practices.
"nformation noted in red in t!is template is provided as e#ample$ by no means
complete$ or as instruction% &!e individual laboratories are required to customi'e
t!e te#t of t!e template to t!e local situation% &!e (atermar) *template+ is to be
removed before ,nali'ation%
&!e resulting quality manual (ill need to be revie(ed annually and revised (!en
necessary$ and t!erefore needs a version number and !as to be veri,ed and
aut!ori'ed before using% &!e quality manual (ill be presented to all sta-$ and
accessible (!ile properly stored and protected from damaging%
&!is document (as developed (it! Microsoft .ord /010%
1
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Quality
Manual
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&+ A,,$e-&#!&o" #d #c$o.m"
:S% :iosafety %evel
$;$ $enters for ;isease $ontrol and 'revention, <S*
$%SI
$linical and %aboratory Standards Institute, =ayne,
'ennsylvania, <S*
/Q* /-ternal Quality *ssessment
ISO International Organi1ation for Standardi1ation
%IS %aboratory Information System
%QMS %aboratory Quality Management System
Q$ Quality $ontrol
QM Quality Manual
QMS Quality Management System
QS/ Quality System /ssential
SO'.s0 Standard Operating 'rocedure.s0
=6O =orld 6ealth Organi1ation
Quality
Manual
>
&&+ T#,le o* /o!e!"
'reface.........................................................................................................(
i. *bbreviations and acronyms.....................................................................>
ii. Table of $ontents.....................................................................................+
1. Introduction to the Quality Manual..........................................................)
1.1 Overview of the organi1ation................................................................................................... )
1.( Mission statement................................................................................................................... )
1.> ?ision statement..................................................................................................................... )
1.+ Ob@ectives............................................................................................................................... )
1. Scope...................................................................................................................................... )
(. Quality 'olicy...........................................................................................A
>. QS/7 Organi1ation....................................................................................!
>.1 Organi1ation policy.................................................................................................................. !
>.( $onBict of interest................................................................................................................... !
>.> Organi1ation chart................................................................................................................... !
>.+ Internal communication........................................................................................................... !
>. 'ersonnel responsibilities........................................................................................................ "
>.) Supporting documents.......................................................................................................... 1C
+. QS/7 5acilities and Safety......................................................................11
+.1 'olicy..................................................................................................................................... 11
+.( 5acilities................................................................................................................................ 11
+.> Security................................................................................................................................. 11
+.+ =or2ing environment............................................................................................................ 11
+. =aste disposal...................................................................................................................... 11
+.) Supporting documents.......................................................................................................... 1(
. QS/7 /quipment.....................................................................................1>
.1 'olicy..................................................................................................................................... 1>
.( Selection of equipment.......................................................................................................... 1>
.> Installation and *cceptance $riteria...................................................................................... 1>
.+ /quipment Inventory and master Dle..................................................................................... 1>
. ?alidation.............................................................................................................................. 1>
.) 'reventive maintenance and repair....................................................................................... 1+
.A ;ecommissioning.................................................................................................................. 1+
.! Supporting documents.......................................................................................................... 1+
). QS/7 'urchasing and Inventory..............................................................1)
).1 'olicy..................................................................................................................................... 1)
).( Eeagents and consumables management............................................................................. 1)
).> Selection and evaluation of providers.................................................................................... 1)
).+ 'rocurement.......................................................................................................................... 1A
).+.1 /quipment procurement................................................................................................. 1A
).+.( Eeagents, consumables and materials........................................................................... 1A
). Stoc2 management and inventory......................................................................................... 1A
).) Eeferral laboratories 8 subcontracting.................................................................................... 1A
).A Supporting documents.......................................................................................................... 1!
A. QS/7 'rocess Management....................................................................1"
A.1 'olicy..................................................................................................................................... 1"
A.( Sample management............................................................................................................ 1"
A.(.1 Specimen collection and transport................................................................................. 1"
A.(.( Specimen8sample receiving............................................................................................ (C
A.(.>. Specimen8sample handling, preparation and storage....................................................(C
A.> Method validation.................................................................................................................. (C
A.+ %ist of e-aminations.............................................................................................................. (C
A. Eestrictive list .if duty (+h8(+0.............................................................................................. (C
A.) Quality $ontrol...................................................................................................................... (C
A.A Eeporting............................................................................................................................... (1
A.! Sample retention and disposal.............................................................................................. (1
A." Supporting documents.......................................................................................................... (1
Quality
Manual
+
!. QS/7 *ssessments.................................................................................(>
!.1 'olicy..................................................................................................................................... (>
!.( Internal assessments............................................................................................................. (>
!.(.1 Internal *udits................................................................................................................ (>
!.(.( Eeview and follow up of corrective actions..................................................................... (>
!.(.> Quality indicators........................................................................................................... (>
!.(.+ StaF suggestions............................................................................................................ (>
!.(. Eeview of requests, methods and sampling requirements..............................................(+
!.> /-ternal assessments............................................................................................................ (+
!.>.1 /-ternal Quality *ssessment8 'roDciency testing...........................................................(+
!.>.( $ustomer feedbac2........................................................................................................ (+
!.>.> /-ternal audits............................................................................................................... (+
!.+ Supporting documents.......................................................................................................... (+
". QS/7 'ersonnel.......................................................................................(
".1 'olicy..................................................................................................................................... (
".( Eecruitment........................................................................................................................... (
".> 'ersonnel Dle 8 health Dle...................................................................................................... (
".+ Integration and clearance...................................................................................................... (
". Training................................................................................................................................. (
".) StaF competency.................................................................................................................. ()
".A 'ersonnel performance appraisal.......................................................................................... ()
".! $ontinuous education............................................................................................................ ()
"." Gon#permanent personnel..................................................................................................... ()
".1C Supporting documents........................................................................................................ ()
1C. QS/7 $ustomer 5ocus...........................................................................(A
1C.1 'olicy................................................................................................................................... (A
1C.( $ustomers satisfaction measurement.................................................................................. (A
1C.> $laims management........................................................................................................... (A
1C.+ Supporting documents........................................................................................................ (A
11. QS/7 Gonconforming /vent Management............................................(!
11.1 'olicy................................................................................................................................... (!
11.( $orrective *ctions............................................................................................................... (!
11.> Supporting documents........................................................................................................ (!
1(. QS/7 $ontinual Improvement...............................................................("
1(.1 'olicy................................................................................................................................... ("
1(.( Quality indicators................................................................................................................ ("
1(.> Management review............................................................................................................ ("
1(.+ 'reventive action................................................................................................................. >C
1(. Supporting documents........................................................................................................ >C
1>. QS/7 ;ocuments and Eecords..............................................................>1
1>.1 'olicy................................................................................................................................... >1
1>.( ;ocumentation management.............................................................................................. >1
1>.> ;ocuments and records control........................................................................................... >1
1>.+ *rchiving............................................................................................................................. >(
1>. Eeview of contracts............................................................................................................. >(
1>.) Supporting documents........................................................................................................ >(
1+. QS/7 Information Management............................................................>>
1+.1 'olicy................................................................................................................................... >>
1+.( Information system # Security.............................................................................................. >>
1+.> $onDdentiality..................................................................................................................... >>
1+.+ Supporting documents........................................................................................................ >>
1. *ppendices..........................................................................................>+

Quality
Manual
Insert Logo Laboratory Name Version X

Date of issue
1+ I!$oduc!&o !o !0e Qu#l&!. M#u#l
1.1 Overview of the organization
As part of t!e diagnostic services of 222 3if big structure4$ the 5ame of t!e
laboratory provides bioc!emistry$ immunology$ microbiology$ parasitology$
to#icology$ virology$ !aematology testing and other tests relevant to medicine
and6or disease surveillance to p!ysicians$ !ealt! care providers$ and
epidemiologists for the beneDt of the patient and population.
The laboratory has adopted a quality management system for the purpose of
the eFective and eHcient use of its resources. *ll employees are committed to
the culture of quality. *ll staF shares responsibility for identifying
nonconformities or opportunities for improvement, recording these instances
so that corrective or preventive actions can be ta2en to ensure the laboratory
meets the needs of its customers.
1.2 Mission statement
"nclude t!e organi'ation or laboratory7s mission statement !ere 3e%g%$ a brief
description of t!e laboratory7s fundamental purpose for e#isting4%
&!ese are usually de,ned by t!e laboratory director or senior administrative
management%
1.3 Vision statement
"nclude t!e organi'ation or laboratory7s vision statement !ere 3e%g%$ a
statement of (!at is possible$ t!e picture of t!e future laboratory in 8-year
time4%
management%
1.4 Objectives
&!e ob9ectives of t!e laboratory are to produce accurate$ reliable and timely
analyses: results$ ac!ieve and maintain an e-ective quality management
system and ensure compliance (it! relevant statutory and safety
requirements%
management (it! sta- participation%
The quality committee, through the quality manager, contributes to the
implementation of the quality management system to achieve the deDned
ob@ectives.
1.5 Scope
This quality manual describes the quality management system of the 5ame of
t!e laboratory+ Its scope is for7
Internal use # to communicate to staF the laboratoryIs quality policy and
quality ob@ectives, to ma2e the staF familiar with the processes used to
achieve compliance with quality requirements. This should facilitate the
implementation of the quality management system as well as ensure its
maintenance and required updates during altering circumstances. This
should also allow eFective communication and control of quality related
activities and a documented base for quality system audits.
Quality
Manual
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Date of issue
/-ternal use - to inform the 5ame of t!e laboratoryIs e-ternal partners
about its quality policy as well as its implemented quality management
system and measures of compliance with quality.
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Manual
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'+ Qu#l&!. Pol&c.
Senior management is dedicated to providing the resources necessary to
maintain the laboratory quality management system and to ensure the
laboratoryIs participation in the institutional quality plan.
The laboratory is committed to continual improvement, meeting internal
requirements and customer requirements, and providing a basis for the
establishment and review of the quality ob@ectives.
Quality practices are communicated within the organi1ation, understood and
adhered to by all employees.
The laboratory ensures a competent wor2force to deliver quality results in a
timely manner according to the c!osen internationally or nationally recogni'ed
standard.
;ate and Signatures
Quality
Manual
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)+ QSE1 O$2#&3#!&o
3.1 Organization policy
The laboratory director6manager and6or representative has the authority,
competence and responsibility for the services provided.
%aboratory management ensures the following7
there are no activities that could compromise laboratory performanceJ
there are appropriate procedures to ensure ethical respect of patient
samples and conDdentiality of patient informationJ
duties and responsibilities of laboratory personnel are deDnedJ
appropriate communication is established within the laboratoryJ
a quality manager and a biosafety o<cer are designated.
3.2 Confict of interest
The 5ame of t!e laboratory is not engaged in any activity that might inBuence its
technical @udgment. The laboratory is not committed to any commercial,
Dnancial or other pressure provided by any particular organi1ation that could
inBuence its technical @udgment or aFect its competencies and trust.
3.3 Organization chart
"f embedded in a big structure 3e%g%$ !ospital4$ t!e laboratory collaborates (it!
ot!er departments suc! as t!e !uman resources department$ training and
education department$ ,nance department$ procurement department$ as (ell as
support services%
The laboratory internal organi1ation consists of a team of 22 professionals shown
in the organi1ational chart below7
3.4 Internal communication
The management ensures appropriate communication ta2es place to 2eep staF
members informed.
Quality
Manual
Sec$e!#$.1
Name
Immuolo2.
de4#$!me!
Head name
Tec0&c&#5"
6
Name(s)
L#,o$#!o$. D&$ec!o$7M##2e$1 Name
Qu#l&!. m##2e$1
Name
Quality team: Names
M&c$o,&olo2.
de4#$!me!
Head name
Tec0&c&#5"
6
Name(s)
B&oc0em&"!$
.
de4#$!me!
Head name
Tec0&c&#5"
6
Name(s)
P#$#"&!olo2.
de4#$!me!
Head name
Tec0&c&#5"
6
Name(s)
"
Date of issue
.ee)ly meetings are held for all personnel in the laboratory. ;uring the
meetings7
activities of t!e (ee) are reviewed and activities to be performed are
deDned
all information on general organi1ation, actions and pro@ects is
communicated.
Minutes .notes0 are ta2en of meeting discussions, followed by a written report.
Add any ot!er type of meeting regularly !eld in t!e laboratory%
3.5 Personnel responsibilities
List t!e positions and t!eir responsibilities% &!e e#act titles of t!e positions 3e%g%
director versus manager; manager versus o<cer4 may vary bet(een
organisations% &!e title in use s!ould be selected as appropriate to t!e
environment by t!e management%
Laboratory director/manager (to be adated)
designs$ approves$ implements and maintains t!e quality management
system;
ensures t!at t!e necessary !uman and material resources$ as (ell as t!e
necessary information$ are available to enable e-ective operation and
control of t!e processes of t!e quality management system;
delegates tas)s to quali,ed personnel;
selects suppliers;
manages contracts;
ensures adequate training;
ensures internal and e#ternal communication%
Quality manager (to be adated)
assesses t!e facilities$ procedures$ practices$ and training of personnel
involved in t!e laboratory7s activities$ in regard to t!e quality management
system;
revie(s t!e quality plan annually and recommends any revisions needed
to t!e laboratory7s director6manager;
see)s advice from di-erent departments and specialists and may require
assistance from independent e#perts;
establis!es an internal audit program and informs t!e laboratory
director6manager of audit outcomes;
ensures t!at t!e quality management system is managed and maintained;
establis!es and monitors all processes and procedures for t!e quality
management system;
resolves nonconformities;
ensures t!at action is ta)en in order to obtain continuous improvement of
processes6activities;
ensures all sta- !as up-to-date QMS training%
Quality committee (to be adated)
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Manual
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if e#isting$ t!e quality committee assists t!e quality manager%
!uer"isor/authori#ed ersonnel (to be adated)
plans and co-ordinates t!e (or) sc!edule;
ensures stoc) management6material management;
ensures activities6processes included in t!e scope of t!e quality
management system are identi,ed and performed in compliance (it! t!is
manual;
applies t!e necessary tec!niques and criteria in order to verify t!at
establis!ed processes6activities and t!eir implemented controls are
e-ective;
evaluates and identi,es ne( products%
$echnologist/Head $echnician (to be adated)
manages$ protects$ and preserves stoc);
manages and maintains equipment;
provides tec!nical advice on laboratory quality procedures to personnel;
reports to t!e supervisor any signi,cant problems of (!ic! !e6s!e
becomes a(are in daily practice%
$echnician (to be adated)
performs t!e tests;
controls and maintains equipment;
reports to t!e tec!nologist6!ead tec!nician any signi,cant problems of
(!ic! !e6s!e becomes a(are in daily practice;
c!ec)s performance of internal quality controls to validate t!e tests%
%ther ositions& such as biosafety o'cer& document manager or
information manager can be described as needed(
3.6 Supporting documents
&!e laboratory s!ould develop its o(n complete list of supporting documents%
&!e table belo( suggests processes$ procedures and forms6logs% Some but not all
documents are provided as e#amples in appendices and referred to as Ap 222%
'rocesses I; $ode
$ommunication
$onBict of interest
Eeview of the general organi1ation
'rocedures
Meetings management Ap 1
Internal communication
/thics and conBict of interest
Quality
Manual
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Date of issue
Organi1ation review
5orms8%ogs
Meeting minutes
$onBict of interest and ethics form
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Manual
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8+ QSE1 9#c&l&!&e" #d S#*e!.
4.1 Policy
The laboratory is provided with suHcient space and reliable infrastructure to
perform its wor2, to ensure the quality, safety and eHcacy of the services
provided, and to meet national safety regulations%
The laboratory design provides an eHcient and safe environment for the
laboratory staF, other health care personnel, patients, and the community.
'ersonnel are trained in the basics of safety and bioris2 management issues.
4.2 Facilities
The laboratory has several rooms, each designated for speciDc usesJ for e-ample,
oHces, storage facilities, washrooms, patient collection area, and laboratory
wor2ing areas.
"nclude a labelled =oor plan of t!e laboratory%
4.3 Security
The laboratory reception is clearly mar2ed with the appropriate signage. Access
to all facilities ot!er t!an reception is restricted to aut!ori'ed personnel% Access
is regulated by an access card 3magnetic badge or code4%
Access to t!e >SL? 3>iosafety Level ?4 requires:
a general training on biosafety concerning >SL? level (or)
a tutorial by t!e person in c!arge of t!e >SL?
a speci,c clearance
a medical e#amination report communicating necessary vaccination%
*ccess to the laboratory outside the opening hours is limited to laboratory
management, technical staF and to personnel on duty call.
A /-!our security service is in e-ect%
&!e facilities and 'ones at ris) are lin)ed to an alarm system at t!e central post
of security%
4.4 Working environment
*ll manipulation presenting a ris2 of contamination .for the operator,
environment and8or sample0 is isolated from other activities.
=or2ing areas are 2ept clean, dust free and are well maintained.
* complete and thorough description of safety rules is available and all personnel
are trained in safety and bioris2 management issues when wor2ing with
chemicals and samples. @urt!er details can be found in t!e safety manual%
4.5 Waste disposal
=aste .chemical, biological and other0 is segregated and disposed according to
national regulations on waste disposal. 'eople in charge of the waste disposal are
trained to handle bioha1ardous waste.
Quality
Manual
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Date of issue
'rocesses I; $ode
5acility maintenance
Security
Safe wor2ing environment
=aste disposal
'rocedures
Safety manual .all speciDc safety procedures including biosafety0
5acility maintenance
Safe manipulation Ap /
Security
=aste disposal
5orms8%ogs
Incident report form
?isitors log
6ouse2eeping log
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Manual
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Date of issue
:+ QSE1 E;u&4me!
5.1 Policy
The management of the laboratory ensures that equipment is properly selected,
installed, validated, maintained and disposed of according to established
procedures and manufacturerKs instructions to meet the needs of the laboratory
to perform quality diagnostic testing.
5.2 Selection of equipment
This section is developed in chapter ) 'urchasing and Inventory.
5.3 Installation and acceptance Criteria
Gew instruments and equipment are installed, calibrated and documented by the
vendor who assures satisfactory performance.
The vendor or laboratory ensures space, ventilation, humidity and electricity
meet speciDcations for satisfactory performance.
The vendor or laboratory provides documentation that each instrument meets all
the required criteria for its use in the laboratory.
5.4 Equipment Inventory and master fle
*ll equipment is uniquely identiDed 3serial number or unique number developed
by t!e laboratory4%
*n inventory and master Dle is maintained for each piece of equipment.
The inventory represents the list of all equipment, and persons in c!arge of the
diFerent pieces of equipment. <pdating of this inventory is ensured by the
persons in charge of the equipment and the department of service and repair.
The same for the attribution of the inventory number of each piece of equipment.
The following information is in the master Dle7
name of the equipment
brand .manufacturer0
inventory number
serial number
model and year
location
cost
date of purchase
date of Drst use
type of maintenance .contract with an e-ternal company, in house, etc.0
regular preventive maintenance to be performed, and frequency to
perform these activities
calibration activities
record of preventive maintenance activities
record of repairs
parts of the equipment that have been changed or repaired.
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Manual
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5.5 Validation
The laboratory validates each new piece of equipment.
The validation process depends on the type of equipment and its use in the
laboratory. Eeproducibility and accuracy tests are performed, documented,
reviewed and approved before the instrument is used in the testing environment.
*ll equipment used for speciDc testing is the responsibility of sta- in c!arge of
t!at discipline.
The responsible staF conducts or delegates the required calibrations of the
equipment and maintains records of all interventions on the equipment.
<se and maintenance of each equipment is based on the manufacturerKs
instructions.
* standard operating procedure .SO'0 on the use, maintenance and safety ris2s
of the equipment is accessible at the bench.
The operating manual of each piece of the equipment is available in the language
spo2en and understood by the laboratory staF.
5.6 Preventive maintenance and repair
'reventive maintenance is recorded in the instrument daily logboo2.
Maintenance contracts and warranty service are documented and maintained by
the department of service%
;efective or malfunctioning equipment is identiDed (it! label alerting t!at it is
not in use%
/quipment requiring service due to a malfunction is decontaminated following
manufacturers requirements.
Serviced or repaired equipment is calibrated to ensure it meets the
manufacturerIs performance criteria.
5.7 Decommissioning
Obsolete equipment is decontaminated and removed from the laboratory.
'rocesses I; $ode
Selection and acquisition of equipment .see chapter ) 'urchasing and
Inventory0
/quipment installation Ap ?
/quipment repair Ap
;ecommissioning
Quality
Manual
1)
Date of issue
/quipment identiDcation
'rocedures
/quipment selection .see chapter ) 'urchasing and Inventory0
/quipment validation
/quipment identiDcation
;econtamination of laboratory equipment Ap 8
/quipment decommission Ap A
/quipment SO's .calibration, operation and maintenance of each piece
of equipment0
5orms8%ogs
%aboratory equipment disposal form Ap A
$hec2list for decontamination Ap 8
Service certiDcation Ap 8
Quality
Manual
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6+ QSE1 Pu$c0#"&2 #d I-e!o$.
6.1 Policy
The 5ame of t!e laboratory ensures an uninterrupted supply of consumables
and8or services are available to perform all quality laboratory functions.
The laboratory maintains a list of vendors that meet the requirements for the
product or service to be purchased. The laboratory strives to purchase high
quality reagents at a reasonable cost and without bias.
The laboratory has a documented procedure for ordering, receiving,
documenting, evaluating and storing all consumables supplies.
The laboratory has an inventory management system.
The laboratory selects its referral laboratories and is responsible for all tests
performed by these laboratories.
6.2 Reagents and consumables management
The laboratory ensures that the procedures for the purchase, receipt and storage
of all reagents guarantee that the quality of testing is not compromised.
*ll new lots of reagents are crosschec2ed and documented with previous lots to
ensure reproducibility. /nvironmental conditions for the storage of all reagents
and consumables are monitored and documented.
The laboratory maintains a record of all laboratory supplies, including reagents
and consumables. This information includes7
identity of the reagent or consumableJ
manufacturers nameJ
contact information for the supplier or the manufacturerJ
date of receiving and date of entering into serviceJ
condition when received .e.g. acceptable or damaged0J
manufacturersI instructionsJ
records that conDrmed the reagentKs or consumables initial acceptance for
useJ
performance records that conDrm the reagents or consumables ongoing
acceptance for use.
All reagents t!at are prepared (it!in t!e laboratory$ suc! as media$ must contain
all t!e above information as (ell as t!e name of t!e person (!o prepared it and
t!e date of preparation%
6.3 Selection and evaluation of providers
The laboratory evaluates the providers for the reagents, consumables and
equipment. The evaluation should be conducted against deDned criteria which
may include7
value for money
post#delivery support
availability
in#country distribution
registration of the provider.
Quality
Manual
1!
Date of issue
*ll the evaluations are recorded and a list of retained providers is established.
6.4 Procurement
6+8+1 E;u&4me! 4$ocu$eme!
The laboratory ensures that when purchasing, leasing or acquiring new
equipment, it conforms to the established requirements .for e-ample testing
capacities0. See chapter /quipment.
6+8+' Re#2e!", co"um#,le" #d m#!e$&#l"
'urchasing orders
The orders for purchase of supplies .reagents, consumables and materials0 are
requested using a speciDc form and submitted to the provision6purc!asing
department.
Eeceipt of orders
The laboratory conDrms receipt of the supplies with the assistance of the
,nancial department6 provision department%
The date of receipt is recorded.
The person in the laboratory ta2ing receipt of the supplies crosschec2s the
information indicated on the pac2age and accompanying documents with the
data of the order.
6.5 Stock management and inventory
The laboratory has a stoc2 management system to ensure consumables are
stored under correct environmental conditions and are used prior to their
e-piration dates.
* regular inventory is performed.
6.6 Referral laboratories / subcontracting
The laboratory is responsible for all tests performed by another laboratory on
patient samples that are referred. The laboratory should select referral
laboratories according to pre#deDned criteria such as competency to perform t!e
requested tests%
It will be the quality committee7s responsibility to designate the laboratories
and8or companies with whom they will subcontract tests or calibration. These will
be listed and 2ept in a folder with all documents referring to the subcontractors.
Subcontracting of samples may occur under any of the following circumstances7
test not performed routinely by the laboratory
instrument brea2down or reagents not available
wor2load restrictions
client requested turnaround time cannot be met.
=here a laboratory subcontracts any part of the calibration of equipment, this
wor2 is contracted with a company complying with the requirements of this
quality manual.
Quality
Manual
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Date of issue
The laboratory ensures and can demonstrate that its subcontractor is competent
to perform the activities in question.
Quality
Manual
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Date of issue
'rocesses I; $ode
Selection and acquisition of equipment, reagents, consumables and
service providers .see chapter /quipment0
Eeceipt of supplies
Stoc2 and inventory management
'rocedures
Selection
'urchasing
Eeceipt
Stoc2 management
Inventory management
5orms8%ogs
%ist of providers
%ist of referral laboratories
Stoc2 log
Inventory log
Quality
Manual
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Date of issue
<+ QSE1 P$oce"" M##2eme!
7.1 Policy
The laboratory has processes for each phase of the sample processing7 pre#
e-amination, e-amination and post#e-amination phases, to ensure accurate and
reliable testing.
The laboratory has quality control measures to monitor the e-amination phase of
testing 3qualitative$ quantitative and semi-quantitative4.
P$oce""e" *ollo=&2 !0e 4#!0 o* =o$>?o=1
7.2 Sample management
<+'+1 S4ec&me collec!&o #d !$#"4o$!
The laboratory provides written instructions for specimen collection and
transport.
Quality
Manual
((
Date of issue
The laboratory provides specimen containers%
Specimen transport follows national or international transport guidelines or
regulations.
<+'+' S4ec&me7"#m4le $ece&-&2
The laboratory establishes written specimen8sample acceptance and re@ection
criteria for each test oFered and provides this information to its customers, as
applicable. *ll specimens8samples are inspected according to these
acceptance8re@ection criteria.
The laboratory re@ects specimens8samples that are not suitable for processing.
The requestor is notiDed of the reason for re@ection. If the specimen8sample is
critical and cannot be re@ected, the e-amination is performed and a notation is
made on the report.
In the case of critical specimens8samples, such as one of limited volume, the
laboratory management consults with the requestor to prioriti1e testing.
* unique registration number is assigned to each specimen8sample to be
analysed.
*ll patientIs data is recorded 3specify (!ere t!is is to be recorded4.
<+'+)+ S4ec&me7"#m4le 0#dl&2, 4$e4#$#!&o #d "!o$#2e
If the specimen needs to be shared for diFerent tests throughout the laboratory
and8or storage purposes, each aliquot .sample0 is labelled individually with the
unique registration number.
Samples are stored under proper temperature and safety conditions.
7.3 Method validation
The laboratory is in charge of diagnostics in immunology$ bacteriology$ virology$
etc%
The methods developed in the laboratory have been through a documented
validation process.
The methods used in the laboratory, that have been published in scientiDc
reviews or transmitted by national or international reference centers, have been
veriDed and documented under the laboratoryKs conditions and adapted when
needed.
The methods and techniques used in the laboratory are described in the standard
operating procedures .SO's0 and associated documents .recording ,les$ benc!
,les$ control ,lesB0.
7.4 List of examinations
List e#aminations performed in t!e laboratory and references to t!e
corresponding SCPs%
7.5 Restrictive list (if duty 24h/24)
List e#aminations performed outside opening !ours in t!e laboratory and
references to t!e corresponding SCPs%
Quality
Manual
(>
Date of issue
7.6 Quality Control
The laboratory has a Quality $ontrol .Q$0 program with written policies and
procedures.
%aboratory technical staF is trained to review and ta2e appropriate action
regarding quality control data.
Internal quality controls are required to ensure the results are valid.
The laboratory quality control program is a monitoring system that7
Drst, provides immediate information for ma2ing the decision about the
acceptability of patient resultsJ
second$ provides a met!od for evaluating data over time to help in ma2ing
decisions about the overall performance of the test procedure. &!ese
controls are run on bot! qualitative 3result is positive or negative4 and
quantitative 3result is a number or value4 tests% &!e resulting data is
recorded in suc! a (ay t!at trends are detectable and$ (!ere practicable$
statistical tec!niques are applied to t!e revie(ing of t!e results%
/quipment calibration and servicing are monitored.
The e-aminationsI results are documented by the technicians on t!e
corresponding records and recorded in a computer to create a permanent
traceable record.
If Q$ results are not validated, patientsI e-amination results cannot be reported.
=hen problems occur the laboratory investigates, corrects and repeats sample
testing .see chapter 11 Gonconforming /vent Management0.
7.7 Reporting
/-amination results are reviewed by an aut!ori'ed personnel and agreed upon
before transmission. If discrepancies occur the aut!ori'ed personnel initiates
corrective actions.
The aut!ori'ed personnel contacts the clinician, ward or public health service for
further clinical details, if needed, or to transmit critical results.
5inal reports are signed by the aut!ori'ed personnel and released to the
requestor.
7.8 Sample retention and disposal
Eetention of the samples is done according to the laboratoryIs policy and
respects national regulations%
5or disposal of samples, refer to chapter + 5acilities and Safety.
'rocesses I; $ode
Quality
Manual
(+
Date of issue
Sample collection, transport, receipt, processing and storage
Method validation
Quality control
Eeporting
'rocedures
&eneral sampling conditions Ap D
Sample labelling Ap E
Sample re@ection or acceptance Ap F
Sample transport Ap 10
Sample storage and disposal
*nalytical SO's .procedure for each e-amination8test performed0
Eesults validation Ap 11
$ritical results reporting Ap 1/
Eesults reporting
5orms8%ogs
Quality control logs
Test result form
%ist of e-aminations
Test request form Ap E
Quality
Manual
(
Date of issue
@+ QSE1 A""e""me!"
8.1 Policy
The laboratory performs ongoing quality assessments such as7
periodic review of e-amination requests, suitable methods and sampling
requirementsJ
monitoring and evaluation of customer feedbac2, staF suggestions and
impact of potential failures on e-amination results and customer
e-pectationsJ
monitoring of determined quality indicators, corrective actions underta2en,
and follow#upJ
participation in proDciency testing program and review of the
corresponding reportsJ
participation in internal and e-ternal audits.
The laboratory strives to continuously improve the quality of laboratory
performance, the eFectiveness of the quality management system and the
reliability of test data.
The laboratory does its best to identify and resolve any nonconformity that may
aFect laboratory performance and patient outcome.
8.2 Internal assessments
@+'+1 I!e$#l Aud&!"
;uring internal audits, information is gathered about7
processes and operating procedures
staF competence and training
equipment
environment
handling of samples
quality control and validation of results
recording and reporting practices.
The Dndings are compared with the laboratoryIs internal policies and to t!e
c!osen national or international standard. *ny brea2down in the system or
departure from procedures should be identiDed.
*ny gap or nonconformity in performance shows if the policies and procedures
that the laboratory has set require revision or are not being followed.
@+'+' Re-&e= #d *ollo= u4 o* co$$ec!&-e #c!&o"
*ll corrective actions underta2en in the laboratory will be reviewed and their
follow up evaluated.
This is described in the chapter 11 Gonconforming /vent Management.
@+'+) Qu#l&!. &d&c#!o$"
Quality indicators have been determined for 222 period of time to monitor the
quality ob@ectives of the laboratory.
This monitoring is detailed in chapter 1( $ontinual Improvement.
Quality
Manual
()
Date of issue
@+'+8 S!#A "u22e"!&o"
*ll staF is encouraged to oFer suggestions for improvement of any aspect of the
laboratory. These suggestions are recorded, evaluated and implemented if useful.
5eedbac2 on the suggestions implemented is provided to the staF.
@+'+: Re-&e= o* $e;ue"!", me!0od" #d "#m4l&2 $e;u&$eme!"
Eequests are systematically reviewed to evaluate the appropriateness of the
methods used for the test required.
The required sample volume and general sampling requirements are also
reviewed every 222 period of time to ensure that samples are collected properly
and in the correct volume needed for the best performance of the test.
8.3 External assessments
@+)+1 EB!e$#l Qu#l&!. A""e""me!7 P$oCc&ec. !e"!&2
'roDciency testing serves as a tool for quality improvement in the laboratory. One
of the ma@or beneDts is identifying performance issues and correcting them.
%ist of the /-ternal Quality *ssessment ./Q*0 programmes in which the
laboratory participates in7
List !ere t!e GQA programmes in (!ic! t!e laboratory participates in$ (it! t!e
corresponding tests
@+)+' /u"!ome$ *eed,#c>
$ustomer feedbac2 is collected and reviewed on a regular basis. This is described
in the chapter 1C $ustomer 5ocus.
@+)+) EB!e$#l #ud&!"
The laboratory participates in an e-ternal audit in order to be assessed according
to a c!osen national or international standard%
*ssessment reports are shared with all staF. $orrective actions are underta2en
accordingly.
'rocesses I; $ode
Internal and e-ternal audits
Quality indicators
/Q* programmes selection
See chapters 1C $ustomer 5ocus, 11 Gonconforming /vent Management,
and 1( $ontinual Improvement
'rocedures
Internal audit Ap 1?
'reparing for e-ternal audit
Quality
Manual
(A
Date of issue
5ollow up staF suggestion
/Q* review
5orms8%ogs
*udit chec2list
StaF suggestion form
%ist of /Q* programmes
Quality
Manual
(!
Date of issue
D+ QSE1 Pe$"oel
9.1 Policy
The laboratory recogni1es that its most important resource is its personnel.
The laboratory management deDnes staF educational requirements and
competency qualiDcations necessary for conducting laboratory procedures.
The laboratory management strives to ensure recruitment is unbiased.
The laboratory (or)s (it! t!e Human Iesources department to ensure education
qualiDcations and references of @ob applicants are chec2ed and to ensure legal
contracts8agreements are signed by all parties prior to employment or (it!in a
set period%
The laboratory has a documented procedure for personnel management.
*ll personnel .temporary, permanent, students, etc.0 sign a conDdentiality
agreement.
*ll laboratory personnel respect the laboratory rules concerning health, safety
and security.
The laboratory provides training to its staF according to its needs.
9.2 Recruitment
The laboratory director6manager submits a completed sta- recruitment form to
the !uman resources department 3if big structure4 that describes the appropriate
education, training, e-perience, and s2ills needed for the available position. &!e
dates of t!e position are clearly stated% "ntervie(s are arranged by t!e Human
Iesources department.
9.3 Personnel fle / health fle
*n individual administrative Dle is established for each staF member .temporary,
permanent, trainee, etc.0 that contains documents concerning the staF
qualiDcations .diplomas, $?, training certiDcate, etc.0. $ertain documents may be
managed and stored by t!e Human Iesources department 3if big structure4%
&!e orientation record$ competency assessments$ training records$ continuing
education$ 9ob descriptionsB are stored in t!e laboratory in a controlled access
area and updated regularly by t!e quality manager%
Gac! ne( sta- member or trainee requires a medical c!ec)-up (it!in ?0 days of
arrival% &!e capacity certi,cate for t!e given activities is stored in t!e sta-:s
individual ,le along (it! t!e list of applicable vaccinations%
9.4 Integration and clearance
StaF orientation of all new employees is to be completed within ?0 days of hire.
Safety orientation occurs before an employee is assigned to duties.
*ll newly hired employees are trained comprehensively on all policies and
procedures in the department that apply to their @ob description and assignments
.see ".) StaF competency, below0.
Quality
Manual
("
Date of issue
9.5 Training
The laboratory provides training for all personnel, which includes the quality
management system, assigned wor2 processes and procedures, the laboratory
information system, health and safety, ethics and conDdentiality.
The eFectiveness of the training program is periodically reviewed.
9.6 Staf competency
StaF competencies cover technical and practical s2ills and general 2nowledge.
$ompetency of each new employee is assessed and veriDed before permitting to
perform testing and report results.
All employees are assessed for competency on an annual basis%
9.7 Personnel performance appraisal
/ach staF is given the opportunity for an annual interview with the laboratory
director6manager.
9.8 Continuous education
* continuing education program is available for the professional development of
staF. /-pectations for staF participation are communicated for those education
sessions that are deemed mandatory.
9.9 Non-permanent personnel
Gon#permanent personnel suc! as students$ post doctorates and trainees follow
the general laboratory orientation procedures for integration in the laboratory.
'rocesses I; $ode
Orientation, training and competency
Eecruitment
$ontinuing education
'erformance appraisals
'ersonnel record maintenance
'rocedures
Orientation
Internal training Ap 18
$ompetency assessment Ap 1A
'ersonnel handboo2 .group of procedures0
Eecruitment
5orms8%ogs
Quality
Manual
>C
Date of issue
Orientation chec2list Ap 1
$ompetency assessment chec2list Ap 1A
$ompetency assessment logboo2 Ap 1A
'erformance appraisal form
Training logs
Quality
Manual
>1
Date of issue
1(+ QSE1 /u"!ome$ 9ocu"
10.1 Policy
The 5ame of t!e laboratory management is dedicated to providing quality and
timely service to all customers, both internal and e-ternal. The laboratory
management commits to providing adequate resources to meet customersI
requirements and to provide an on#going program for continual improvement.
10.2 Customers satisfaction measurement
$ustomer surveys are implemented. The ob@ective is to assess the satisfaction of
the main customers7 patients, clinicians and public health institutes.
The analysis of survey results leads to implementation of corrective actions
where needed.
10.3 Claims management
$omplaints are managed in order to lead to corrective or preventive actions .also
refer to chapter 11 Gonconforming /vent Management, and chapter 1( $ontinual
Improvement0.
The ob@ective is to ensure continuous improvement of the quality system by
ta2ing into account the customersK concerns. The claim management will
facilitate trac2ing and investigating potential non#satisfaction of customers.
'rocesses I; $ode
$ustomer satisfaction
See chapters 11 Gonconforming /vent Management, and 1( $ontinual
Improvement
'rocedures
$ustomer survey Ap 1D
$ustomer complaint Ap 1E
5orms8%ogs
$ustomer survey form8questionnaire
$ustomer complaint logboo2
Incident report
Quality
Manual
>(
Date of issue
11+ QSE1 Noco*o$m&2 E-e! M##2eme!
11.1 Policy
The 5ame of t!e laboratory is committed to the identiDcation, documentation,
correction, and prevention of nonconforming events in all aspects of the quality
management system including pre#e-amination, e-amination and post#
e-amination processes. 'rocedures are in place that7
designate the individuals responsible and actions necessary for handling
nonconformitiesJ
ensures that each nonconforming event is documented, recorded, and
reviewed at identiDed intervals, a root cause analysis performed, and that
corrective action is ta2en and documentedJ
deDne when testing procedures and data reporting will be withheld due to
nonconformities and when, and under what conditions, e-amination can
resumeJ
deDnes the steps ta2en when e-amination data resulting from a
nonconforming event has already been released.
11.2 Corrective Actions
*ll nonconforming events .from occurrence reports, claims, audit reports,
patient8customer complaints, failed proDciency testing, etc.0 are recorded,
trac2ed, trends identiDed, and root cause analysis performed. The appropriate
corrective actions are ta2en.
The results of an occurrence assessment are communicated to management and
become part of periodic management review.
The ob@ective is to ensure continuous improvement of the quality system.
'rocesses I; $ode
;ocumentation, review of nonconforming events and corrective actions
Gonconforming event resolution
See chapters A 'rocess Management, and 1C $ustomer 5ocus
'rocedures
6andling nonconformities
Gonconforming event management Ap 1F
$orrective actions
5orms8%ogs
Incident report
$orrective actions
Quality
Manual
>>
Date of issue
1'+ QSE1 /o!&u#l Im4$o-eme!
12.1 Policy
The laboratory continuously improves the eFectiveness of its quality
management system and its processes, as stated in its quality policy and quality
ob@ectives.
* management review is performed annually to evaluate the laboratoryIs quality
management system, evaluation activities, corrective actions and preventive
actions.
The laboratory develops an action plan according to improvement needs every
222 period of time and monitors the eFectiveness of the actions underta2en.
12.2 Quality indicators
The laboratory establishes quality indicators to monitor and evaluate
performance of its processes every 222 period of time.
List !ere t!e quality indicators%
@or e#ample:
t!e traceability of t!e sample from t!e reception to t!e storage after
testing;
t!e turnaround time from reception of t!e sample to t!e !and-out of t!e
report;
t!e reliability of t!e competence of t!e tec!nical sta- 3average of test
competency assessments for determined tests4%
These indicators are regularly monitored as for their concordance with the
deDned ob@ectives and the activities established in the laboratory. These
indicators are presented during the annual management review.
12.3 Management review
The annual management review ensures that the organi1ation and the activities
of the laboratory remain appropriate and eHcient. Therefore, it allows the
evaluation and continuous improvement of the eHciency of the quality system of
the laboratory.
The elements reviewed are related to the quality system management.
/lements of entry of the management review7
quality ob@ectives of the past year
quality indicators
occurrences and nonconforming events recorded
customer complaints reports
customer satisfaction survey reports
internal audit reports
proDciency testing reports
corrective8preventive actions and follow up
changes in wor2 load or type of wor2
all pertinent factors7 resources, future activities, etc.
Quality
Manual
>+
Date of issue
/lements of output of the management review7
actions for improvement
deDnition of the quality ob@ectives for the ne-t year
establishment of new quality indicators in concordance with the new
quality ob@ectives
improvement of the quality management system.
12.4 Preventive action
The laboratory reviews the data and implements preventive actions allowing the
laboratory to anticipate eventual nonconforming events in its activities. * follow
up of the actions implemented for improvement is ensured in the same way as
described in chapter 11 Gonconforming /vent Management.
'rocesses I; $ode
$ontinual review
Quality indicators
Management review
See chapters ! *ssessments, and 11 Gonconforming /vent Management
'rocedures
Quality indicators .including management and use0
Management review
/valuation activities .see chapter ! *ssessments0
5orms8%ogs
Eeview logs
'reventive actions
Quality
Manual
>
Date of issue
1)+ QSE1 Docume!" #d Reco$d"
13.1 Policy
The laboratory ensures that documents and records are managed from creation
and receipt to archival and destruction, according to national la(s$ local
regulations and international standards.
13.2 Documentation management
The four levels of documentation are represented in the pyramid below.
The quality manager reviews and approves all requests for amendments to
e-isting documents and the development of new procedures, processes, and
policies.
StaF is not permitted to ma2e temporary amendments to documentation without
the prior consent of the quality manager.
=hen new or modiDed policies, processes and procedures are instituted, staF
requires retraining.
The quality manual is reviewed periodically 3establis! time frame4. *ll laboratory
procedures are reviewed on an annual basis. The responsibility for t!e annual
review lies with the document manager or quality manager.
The document manager or quality manager is responsible for the distribution of
new documents, retrieval of old documents and maintenance of records of
amendments.
13.3 Documents and records control
*ll documents are uniquely identiDed. ;ate of issue, revision version, total
number of pages and authori1ing signatories are included in the document.
;ocuments are signed as a paper copy or authori1ed electronically.
Quality
Manual
>)
Date of issue
* document control log is maintained identifying the current valid versions and
their distribution.
* secure master Dle is maintained of all documents to prevent unauthori1ed
access, loss or damage.
13.4 Archiving
The document manager or quality manager is responsible for the proper
archiving of documents and records.
The laboratory respects the national regulations or legislations concerning the
retention time of all records.
* copy of an obsolete document is 2ept to provide a means for review if the
situation arises.
13.5 Review of contracts
Eefer to section ).)
'rocesses I; $ode
IdentiDcation and control of documents and records
$reation, edit, review and approval of documents
./-ample7 Internal documents management0 Ap /0
*rchive and retention of documents
$ontract review
'rocedures
SO' management Ap /1
;ocument management Ap //
Short term archiving Ap /?
%ong term archiving
;ocument control Ap /
$ontract review
5orms8%ogs
;ocument control logboo2 Ap /
Quality
Manual
>A
Date of issue
18+ QSE1 I*o$m#!&o M##2eme!
14.1 Policy
The 5ame of t!e laboratory has access to the data and information needed to
provide a service that meets the needs and requirements of internal and e-ternal
customers. The laboratory information system .%IS0 3(!et!er computeri'ed or
paper-based4 provides for the collection, processing, recording, storage, and
retrieval of data, and has documented procedures in place to ensure the
conDdentiality of patient information and the security of the data during each
step of the process.
14.2 Information system - Security
"f computeri'ed$ t!e information management system used in t!e laboratory is
managed by t!e informatics department% &!is department is in c!arge of
installing on eac! computer a bac)up and antivirus system and !as procedures
in place to meet national and international requirements for data protection and
to restrict unaut!ori'ed access%
"f paper-based$ appropriate measures s!ould be put in place to ensure t!at all
documents are protected from ris) of damage by (ater$ ,re or animals suc! as
rats and mice% Procedures s!ould be put in place to meet national and
international requirements for data protection and to restrict unaut!ori'ed
access%
14.3 Confdentiality
The personnel .temporary, permanent, student, etc.0, whatever the duration of
their contract, will sign a conDdentiality agreement.
The laboratory has a secure process for archiving and8or data disposalJ refer to
chapter 1> ;ocuments and Eecords.
'rocesses I; $ode
Information security and conDdentiality
Selection of an information management system .see chapter )
'urchasing and Inventory0
%IS down#time
'rocedures
Transmission of results
Informatics system maintenance
:ac2 up
%IS down#time
Eetrieval of data .manual or computeri1ed0
Quality
Manual
>!
Date of issue
5orms8%ogs
%IS down#time log
:ac2 up log
Quality
Manual
>"
Date of issue
1:+ A44ed&ce"
*ppendi- 17 SO'7 Meetings management
*ppendi- (7 SO'7 Safe manipulation
*ppendi- >7 'rocess7 /quipment installation
*ppendi- +7 'rocess7 /quipment repair
*ppendi- 7 SO'7 ;econtamination of laboratory equipmentJ 5orms7 $hec2list for
decontamination, $ertiDcation for service
*ppendi- )7 SO'7 /quipment decommissionJ 5orm7 %aboratory equipment
disposal
*ppendi- A7 SO'7 &eneral sampling conditions
*ppendi- !7 SO'7 Sample labellingJ 5orm7 Test request
*ppendi- "7 SO'7 Sample re@ection or acceptance
*ppendi- 1C7 SO'7 Sample transport
*ppendi- 117 SO'7 Eesults validation
*ppendi- 1(7 SO'7 $ritical results reporting
*ppendi- 1>7 SO'7 Internal audit
*ppendi- 1+7 5orm7 Orientation chec2list
*ppendi- 17 SO'7 Internal training
*ppendi- 1)7 SO'7 $ompetency assessmentJ 5orms7 $ompetency assessment
chec2list, $ompetency assessment logboo2
*ppendi- 1A7 SO'7 $ustomer survey
*ppendi- 1!7 SO'7 $ustomer complaint
*ppendi- 1"7 SO'7 Gonconforming event management
*ppendi- (C7 'rocess7 Internal documents management
*ppendi- (17 SO'7 SO' management
*ppendi- ((7 SO'7 ;ocument management
*ppendi- (>7 SO'7 Short term archiving
*ppendi- (+7 SO'7 ;ocument controlJ 5orm7 ;ocument control logboo2
Quality
Manual
+C

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