This quality manual template provides guidance for laboratories on developing policies and procedures to support a quality management system based on international standards. It addresses all 12 quality system essentials and includes examples and additional resources. Laboratories should customize the template text to their local situation and review and revise the quality manual annually. The manual requires authorization before use and will be accessible to staff.
This quality manual template provides guidance for laboratories on developing policies and procedures to support a quality management system based on international standards. It addresses all 12 quality system essentials and includes examples and additional resources. Laboratories should customize the template text to their local situation and review and revise the quality manual annually. The manual requires authorization before use and will be accessible to staff.
This quality manual template provides guidance for laboratories on developing policies and procedures to support a quality management system based on international standards. It addresses all 12 quality system essentials and includes examples and additional resources. Laboratories should customize the template text to their local situation and review and revise the quality manual annually. The manual requires authorization before use and will be accessible to staff.
This quality manual template provides guidance for laboratories on developing policies and procedures to support a quality management system based on international standards. It addresses all 12 quality system essentials and includes examples and additional resources. Laboratories should customize the template text to their local situation and review and revise the quality manual annually. The manual requires authorization before use and will be accessible to staff.
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 http788www.who.int8ihr8training8laboratory9quality8en8 Quality Manual ( &+ 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% &!ese are usually de,ned by t!e laboratory director or senior administrative 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% &!ese are usually de,ned by t!e laboratory director or senior administrative 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 ) Insert Logo Laboratory Name Version X 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. Quality Manual A Insert Logo Laboratory Name Version X Date of issue '+ 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 ! Insert Logo Laboratory Name Version X Date of issue )+ 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#$!me! Head name Tec0&c" 6 Name(s) L#,o$#!o$. D&$ec!o$7M##2e$1 Name Qu#l&!. m##2e$1 Name Quality team: Names M&c$o,&olo2. de4#$!me! Head name Tec0&c" 6 Name(s) B&oc0em&"!$ . de4#$!me! Head name Tec0&c" 6 Name(s) P#$#"&!olo2. de4#$!me! Head name Tec0&c" 6 Name(s) " Insert Logo Laboratory Name Version X Date of issue .ee)ly meetings are held for all personnel in the laboratory. ;uring the meetings7 activities of t!e (ee) are reviewed and activities to be performed are deDned all information on general organi1ation, actions and pro@ects is communicated. Minutes .notes0 are ta2en of meeting discussions, followed by a written report. Add any ot!er type of meeting regularly !eld in t!e laboratory% 3.5 Personnel responsibilities List t!e positions and t!eir responsibilities% &!e e#act titles of t!e positions 3e%g% director versus manager; manager versus o<cer4 may vary bet(een organisations% &!e title in use s!ould be selected as appropriate to t!e environment by t!e management% Laboratory director/manager (to be adated) designs$ 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) Quality Manual 1C Insert Logo Laboratory Name Version X Date of issue 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 11 Insert Logo Laboratory Name Version X Date of issue Organi1ation review 5orms8%ogs Meeting minutes $onBict of interest and ethics form Quality Manual 1( Insert Logo Laboratory Name Version X Date of issue 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 1> Insert Logo Laboratory Name Version X Date of issue 4.6 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 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 Quality Manual 1+ Insert Logo Laboratory Name Version X 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. Quality Manual 1 Insert Logo Laboratory Name Version X Date of issue 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. 5.8 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 Selection and acquisition of equipment .see chapter ) 'urchasing and Inventory0 /quipment installation Ap ? /quipment repair Ap ;ecommissioning Quality Manual 1) Insert Logo Laboratory Name Version X 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 $hec2list for decontamination Ap 8 Service certiDcation Ap 8 Quality Manual 1A Insert Logo Laboratory Name Version X Date of issue 6+ QSE1 Pu$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! Insert Logo Laboratory Name Version X 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 1" Insert Logo Laboratory Name Version X Date of issue The laboratory ensures and can demonstrate that its subcontractor is competent to perform the activities in question. Quality Manual (C Insert Logo Laboratory Name Version X Date of issue 6.7 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; $ode Selection and acquisition of equipment, reagents, consumables and service providers .see chapter /quipment0 Eeceipt of supplies Stoc2 and inventory management 'rocedures Selection 'urchasing Eeceipt Stoc2 management Inventory management 5orms8%ogs %ist of providers %ist of referral laboratories Stoc2 log Inventory log Quality Manual (1 Insert Logo Laboratory Name Version X Date of issue <+ QSE1 P$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 (( Insert Logo Laboratory Name Version X 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 (> Insert Logo Laboratory Name Version X 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. 7.9 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 Quality Manual (+ Insert Logo Laboratory Name Version X 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 $ritical results reporting Ap 1/ Eesults reporting 5orms8%ogs Quality control logs Test result form %ist of e-aminations Test request form Ap E Quality Manual ( Insert Logo Laboratory Name Version X Date of issue @+ QSE1 A""e""me!" 8.1 Policy The laboratory performs ongoing quality assessments such as7 periodic review of e-amination requests, suitable methods and sampling requirementsJ monitoring and evaluation of customer feedbac2, staF suggestions and impact of potential failures on e-amination results and customer e-pectationsJ monitoring of determined quality indicators, corrective actions underta2en, and follow#upJ participation in proDciency testing program and review of the corresponding reportsJ participation in internal and e-ternal audits. The laboratory strives to continuously improve the quality of laboratory performance, the eFectiveness of the quality management system and the reliability of test data. The laboratory does its best to identify and resolve any nonconformity that may aFect laboratory performance and patient outcome. 8.2 Internal assessments @+'+1 I!e$#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 () Insert Logo Laboratory Name Version X 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. $orrective actions are underta2en accordingly. 8.4 Supporting documents &!e laboratory s!ould develop its o(n complete list of supporting documents% &!e table belo( suggests processes$ procedures and forms6logs% Some but not all documents are provided as e#amples in appendices and referred to as Ap 222% 'rocesses I; $ode Internal and e-ternal audits Quality indicators /Q* programmes selection See chapters 1C $ustomer 5ocus, 11 Gonconforming /vent Management, and 1( $ontinual Improvement 'rocedures Internal audit Ap 1? 'reparing for e-ternal audit Quality Manual (A Insert Logo Laboratory Name Version X Date of issue 5ollow up staF suggestion /Q* review 5orms8%ogs *udit chec2list StaF suggestion form %ist of /Q* programmes Quality Manual (! Insert Logo Laboratory Name Version X Date of issue D+ QSE1 Pe$"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 (" Insert Logo Laboratory Name Version X 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. 9.10 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 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 Insert Logo Laboratory Name Version X Date of issue Orientation chec2list Ap 1 $ompetency assessment chec2list Ap 1A $ompetency assessment logboo2 Ap 1A 'erformance appraisal form Training logs Quality Manual >1 Insert Logo Laboratory Name Version X Date of issue 1(+ QSE1 /u"!ome$ 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( $ontinual Improvement0. The ob@ective is to ensure continuous improvement of the quality system by ta2ing into account the customersK concerns. The claim management will facilitate trac2ing and investigating potential non#satisfaction of customers. 10.4 Supporting documents &!e laboratory s!ould develop its o(n complete list of supporting documents% &!e table belo( suggests processes$ procedures and forms6logs% Some but not all documents are provided as e#amples in appendices and referred to as Ap 222% 'rocesses I; $ode $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 $ustomer complaint logboo2 Incident report Quality Manual >( Insert Logo Laboratory Name Version X Date of issue 11+ QSE1 Noco*o$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. 11.3 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 ;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 $orrective actions Quality Manual >> Insert Logo Laboratory Name Version X Date of issue 1'+ QSE1 /o!&u#l Im4$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 >+ Insert Logo Laboratory Name Version X 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. 12.5 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 $ontinual review Quality indicators Management review See chapters ! *ssessments, and 11 Gonconforming /vent Management 'rocedures Quality indicators .including management and use0 Management review /valuation activities .see chapter ! *ssessments0 5orms8%ogs Eeview logs 'reventive actions Quality Manual > Insert Logo Laboratory Name Version X Date of issue 1)+ QSE1 Docume!" #d Reco$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 >) Insert Logo Laboratory Name Version X 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 ).) 13.6 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 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 / $ontract review 5orms8%ogs ;ocument control logboo2 Ap / Quality Manual >A Insert Logo Laboratory Name Version X Date of issue 18+ QSE1 I*o$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. 14.4 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 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 >! Insert Logo Laboratory Name Version X Date of issue 5orms8%ogs %IS down#time log :ac2 up log Quality Manual >" Insert Logo Laboratory Name Version X 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