NAME OF LABORATORY

QUALITY MANUAL

Quality Manual: Table of contents

Number Section 1.0. 1.1. 1.2. 2.0. 2.1. 2.2. 3.0. 3.1. 3.2. .0. .1. .2. .3. . . .(. .$. .%. .+. .-. .10. .11. .12. .13. .1 . .1(. (.0. (.1. (.2. (.3. (. . (.(. (.$. (.%. (.+. (.-. (.10. General Index and revision status Purpose Background of the laboratory Activities History Definitions and conventions Definitions and terminology Abbreviations Management requirements !rgani"ation #anagement system Document control &evie' of contracts )ubcontracting Purc*asing )ervice to t*e customer ,omplaints ,ontrol of non.conforming 'or/ Improvement ,orrective actions Preventive actions ,ontrol of 0uality records Internal audits #anagement revie' Technical requirements 1eneral Personnel Accomodation 2est met*ods and validation 30uipment #easurement traceability )ampling 2est items 4uality control &eports 5 calibration certificates Page 3 3 3 3 3 3 3 3

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REVISION HISTORY Rev 0 1 2 3 ( Initial release Description of Change uthor . Effective Date 0 50$50(

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QM 1.0
QM 1.1

GENERAL
INDEX AND REVISION STATUS

Version 1 03/0 /!00"

Version 1 03/06/ 00!

2*e numbering of t*is 0uality manual corresponds directly to t*e numbering of I)! 1%02(. 2*is 0uality manual is only valid if all pages are at t*e same issue level as s*o'n in D 0316 index 0uality manual. 7pdates to t*is manual 'ill be made by re.issuing t*e relevant section of t*is manual and adapting t*e issue level in t*e index.
QM 1. "UR"OSE Version 1 03/06/ 00!

2*is 0uality manual documents our management system and demonstrates t*e laboratory8s ability to execute t*e indicated tests and5or calibrations and to meet regulatory re0uirements. 2*is manual establis*es compliance 'it* I)! 1%02(. QM !.0
QM .1

LA#$RAT$R% #A&'GR$(N)
A#TIVITIES

Version 1 03/0 /!00"

Version 1 03/06/ 00!

Describe the background, activities, personnel and tests of your laboratory. Our laboratory s tests ! calibrations include" ## list out the tests ! calibrations provided by your laboratory ## ## Distinguish bet$een the tests $hich are part of the management system and those tests $hich are not. ##
QM . $ISTORY Version 1 03/06/ 00!

Describe the history of your laboratory. QM 3.0 )E*+N+T+$N, AN) &$NVENT+$N,

QM 3.1 DEFINITIONS AND TERMINOLO%Y

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Version 1 03/06/ 00!

2*e 0uality manager is responsible for setting up and maintaining a list of definitions and conventions 9D 0001:.

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Definitions from I)!5I3,6 guide 26 edition 1-+$6 ;1eneral terms and t*eir definitions concerning standardi"ation and related activities; are relevant. 2*e list is added to t*e manual.
QM 3. ABBREVIATIONS Version 1 03/06/ 00!

2*e 0uality manager is responsible for setting up and maintaining a list of abbreviations used in t*e 0uality manual. 2*e list is added to t*e manual 9D 0002:. QM -.0
QM &.1

MANAGEMENT REQ(+REMENT,
OR%ANISATION

Version 1 03/0 /!00"

Version 1 03/06/ 00!

.1.1 <egal identity .1.1.1 2*e laboratory is aut*ori"ed under )tate statute =>? 9@!23A enter )tate statute title6 number6 and5or article number:. %ndicate the legal identity of the laboratory. %f the laboratory hasn t its o$n legal identity because it is part of a larger company, indicate the legal identity of this larger company. .1.2 !rgani"ation .1.2.1 2*e laboratory is part of t*e )tate 9@!23A enter )tate and department of t*e )tate t*at t*e laboratory is a part of:. Aut*ority6 interrelation6 and responsibilities of all laboratory personnel are on file in t*e form of Bob descriptions 9D (020 : and organi"ational c*arts 9D (0201:. 2*e responsibilities of 4uality #anager and 2ec*nical #anager are assigned to designated staff as s*o'n in t*e organi"ational c*art.

.1.3

&esponsibility

&OT'" The follo$ing is an e(ample of laboratory personnel responsibilities. %ndicate the responsibilities of key personnel of the large organisation that influence testing activities )*M, Tech M, +upport M, too. . -ut general function descriptions in this manual . -ut detailed function descriptions and organisation chart $ith names and replacements in separate documents ) Only for people influencing quality ,)D ./0/1 and D ./0/2,. .1.3.1 Director 2*e Director is responsible for t*e overall compliance of t*e laboratory to t*is 4uality #anual and is t*e direct supervisor of t*e )tate #etrologist.

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.1.3.2. #anagement 9Program #anager6 *o'ever named : 2*e management of t*e laboratoryA A. implements and enforces t*e applicable good laboratory practices described in reference documentsC B. provides resources6 adBusts 'or/loads6 and provides training opportunities for laboratory staff to facilitate completion of assigned tas/s in a safe 'or/ environment consistent 'it* test re0uirements and personnel capabilitiesC and #. assigns deputies for bot* t*e tec*nical and 0uality managers in t*e case of an absence. .1.3.2. 2ec*nical #anager 2*e tec*nical manager A D. is a metrologist '*o *as completed t*e re0uired level of @I)2 !D# training as specified in accreditation re0uirements for t*e level at '*ic* t*e laboratory maintains accreditationC E. is responsible for t*e overall administrative and tec*nical operations of t*e laboratoryC F. specifies and5or approves all met*odologies usedC %. implements good laboratory practices by providing instruction and training as needed6 develops 'or/ plans and procedures6 and re0uires t*at t*ese be follo'ed in all day.to.day operationsC $. assigns only competent personnel to complete testsC I. attests6 by signature6 to t*e validity of all laboratory tests and reports 9a list of Approved )ignatories is maintained in t*e laboratory 9D 0310: and '. ensures continued accreditation of t*e laboratory. .1.3. 4uality #anager 2*e 0uality manager A (. is a metrologist '*o *as completed t*e re0uired level of @I)2 !D# training as specified in accreditation re0uirements for t*e level at '*ic* t*e laboratory maintains accreditationC L. coordinates internal audits of t*e laboratory in accordance 'it* )ection .1 of t*is 0uality manualC M. maintains6 analy"es6 and updates statistical data and5or control c*artsC N. participates in available and relevant proficiency tests6 round. robins6 and5or interlaboratory collaborative studiesC O. '*ere necessary6 identifies6 develops6 and implements improvement of t*e laboratory measurement capability to meet t*e re0uirements of @I)26 department programs6 and laboratory customersC ". maintains t*e 0uality manualC and Q. *as direct access to management and to t*e tec*nical

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manager. &OT'" Many laboratories are limited in staff. These laboratories are often operated by one person or a part#time person. %n these cases, the responsibilities of both technical and quality manager fall on that person. +pecial care and precaution must be taken and documented to ensure that the management system and measurements are not adversely affected by limited laboratory staff. .1. . Einancial or political considerations don8t influence testing. .1.(. 2op management ensures t*at appropriate communication processes are establis*ed 'it*in t*e laboratory for implementation of t*e management system6 and t*at communication ta/es place regarding t*e effectiveness of t*e management system.
QM &. MANA%EMENT SYSTEM Version 1 03/06/ 00!

.2.1. 2*e management system documentation consists of different levelsA . documented statements of t*e 0uality policy issued by t*e laboratory director 9D 0201: and t*e 0uality obBectives 9D 0202: . t*is 0uality manual . documented procedures re0uired by all applicable standardsA t*ey detail t*e implementation of re0uirements and operation guidelines. . InstructionsA t*ey detail specific 0uality or inspection information and specific instructions for performance or individual tas/s. . documents needed by t*e organi"ation to ensure t*e effective planning6 operation and management of its processes6 and . records re0uired by all applicable standards per t*e records procedure. D*en t*e term documented procedure appears 'it*in t*is 0uality manual6 t*e procedure is establis*ed6 documented6 implemented and maintained. !ur laboratory maintains its documents on various media suc* as paper6 electronic6 magnetic6 optical6 etc. .2.2. !ur laboratory *as establis*ed and maintains t*is 0uality manual t*atA . defines t*e structure of t*e management system. . ma/es reference to t*e 0uality policy6 t*e supporting procedures 9also tec*nical: and t*e instructions. . defines t*e roles and responsibilities of tec*nical and 0uality staff 2*e management system documentation is communicated to all relevant personnel. 2*ese documents are understood and implemented. 2*ey are available at t*e location needed. .2.3. A list of t*e procedures6 t*e instructions and t*e 0uality records '*ic* are included in t*e management system6 is maintained 9D 03016 D 03026 D 03036 D 030 6 D 030( and D 030$:. .2. . 2op management is committed to t*e development and implementation of t*e

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management system as 'ell as statutory and regulatory re0uirements. 2op management communicates to t*e organi"ation t*e importance of meeting customer re0uirements as 'ell as statutory and regulatory re0uirements. 2op management ensures t*at t*e integrity of t*e management system is maintained '*en c*anges to t*e management system are planned and implemented.
QM &.3 DO#UMENT #ONTROL Version 1 03/06/ 00!

.3.1. Documents re0uired by t*e management system are managed per t*e documentation management procedure 9P 03: . &ecords are a special type of document and are managed per t*e records procedure 9P 13:. .3.2. 2*e documentation management procedure is establis*ed to define t*e means needed toA . approve documents for ade0uacy prior to issue . revie' and update as necessary and re.approve documents . ensure t*at c*anges and t*e current revision status of documents are identified . ensure t*at relevant versions of applicable documents are available at points of use . ensure t*at documents remain legible and readily identifiable . ensure t*at documents of external origin are identified and t*eir distribution managed using t*e documentation master list6 and . prevent t*e unintended use of obsolete documents and to apply suitable identification to t*em if t*ey are retained for any purpose.

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