1-iso 17025testing laboratory quality manual 207

7/26/2019 1-IsO 17025Testing Laboratory Quality Manual 207

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Luminus Devices, IncLuminus Testing Laboratory

Quality Management Systems ManualISO/IEC 17025

NVLAP, NIST HANDBOOKS 150,150-1

This document belongs to Luminus Devices, Inc. It cannot be reproduced without authorized authority


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Luminus Testing Laboratory Quality Manual

Area: Quality Systems Page 2 of 34

Document: QS!""#$%% Revision: "&

Oner Title: Laboratory Quality Manager

1.0 P!RPO"#

Luminus Devices, Inc. has set a re'uirement that the laboratory which (orms part o(its larger organization can o((er services and operate to a 'uality managementsystem that is compliant with )IST *+ #" and )IST *+ #"!#. These handboo-sincorporate the newest releases o( IS/I01 #2"3 Standards.

The Luminus Testing Laboratory Quality Manual is the procedure by which LuminusDevices operates a laboratory 'uality management system, which is competent, andcapable o( per(orming speci(ic tests as part o( the )ational 4oluntary Laboratory

5ccreditation rogram 6)4L57.

The Laboratory Quality Manual will be the basis by which accreditation bodiesrecognize the 'uality management system, competence o( testing and calibrationmethodologies by which to (orm the basis (or their accreditation.

2.0 "$OP#

This Quality Manual applies to our laboratory (acility at the (ollowing location8

Luminus Testing Laboratory%%&& Tec'nology Par( Drive)illerica* Mass* &%+2%

Res,onsible for9

2.1 Testing per(ormed using the I0S 5pproved Method (or Measuring LumenMaintenance o( L0D Light Sources, I0S LM!:".

The Laboratory Quality Manual encompasses re'uirements o( )IST *+ #", )IST*+ #"!# the IS /I01 #2"3 Standard.

1ompliance with regulatory, sa(ety re'uirements and guidelines o( regulatoryagencies is incorporated as appropriate with respect to installation o( e'uipment,handling o( test samples and conducting tests.

rinted copies o( this document are ;)1)T


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3.0 R#.#R#/$# DO$!M#/T"

=


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4.1.4 1on(lict o( Interest


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5) The 4ice resident o( 0ngineering, in con@unction with theLaboratory Manager and supported by the resident and 10 o(Luminus Devices, Inc de(ines the management structure o( theLuminus Testing Laboratory, it?s place in the parent organization, andthe relationship between 'uality management, technical operationsand support service.

6)The Laboratory Manager speci(ies the responsibility, authority andinterrelationships o( all personnel who manage, per(orm or veri(y wor-a((ecting the 'uality o( the tests and/or calibrations9

7) The Laboratory Manager, who is (amiliar with methods, procedures

and purpose o( each test and with the assessment o( the test results,provides supervision o( testing by persons who sta(( or utilize theLaboratory to conduct tests and measurements within the scope o(this standard9

8) The 4ice resident o( 0ngineering has overall responsibility (or thetechnical operations and the provision o( the resources needed toensure the re'uired 'uality o( laboratory operations9

9)The Laboratory Manager, acting as Laboratory Quality Manager,irrespective o( other duties and responsibilities, has the responsibilityand authority (or ensuring that the management system related to'uality is implemented and (ollowed at all times. The Laboratory

Manager has direct access to the highest level o( management atwhich decisions are made on laboratory policy or resources9

10) The Quality Manager o( Luminus Devices, Inc. is the deputy (orthe Laboratory Quality Manager. The 4ice resident o( 0ngineering o(Luminus Devices, Inc. is the deputy (or the Laboratory Manager.

11) The laboratory by the visibility o( the 'uality policy ensures thatits personnel are aware o( the relevance and importance o( theiractivities and how they contribute to the achievement o( the ob@ectiveso( the management system.

4.1.6 0>ecutive Management T05M 60MT7 ecutive Management Team shall ensure that appropriatecommunication processes are established within the laboratory andthe rest o( the larger organization that is Luminus Devices, Inc andthat communication ta-es place regarding the e((ectiveness o( the

!ncontrolle- 'en ,rinte- Luminus Devices $onfi-ential


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management system within the Management


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4.2.3 Management 1ommitment

0>ecutive Management Team 60MT7 provides evidence o(commitment to the development and implementation o( themanagement system and to continually improving its e((ectivenessthrough the QS!""""#, Management


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Area: Quality Systems Page + of 34



The Laboratory Quality Manager has responsibility to ensure that the

integrity o( the management system is maintained when changes tothe management system are planned and implemented. 5ll changesto the management system are generated in accordance with QS!"""""3, Document and Data 1ontrol.

4.3 DO$!M#/T $O/TROL

4.3.1 Beneral

The laboratory procedures are maintained in accordance with QS!"""""3, Document and Data 1ontrol to control all documents that(orm part o( its management system, internally generated or (rom

e>ternal sources, including regulations, standards, other normativedocuments, test and/or calibration methods, drawings, so(tware,speci(ications, instructions and manuals.

The control o( data related to testing is covered in section .&.2 o( thisdocument. The control o( records is covered in section &.#% o( thisdocument

4.3.2 Document 5pproval and Issue

4.3.2.1 Document 5pproval and


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3) Invalid or obsolete documents are promptly removed(rom all points o( issue or use, or otherwise assuredagainst unintended use9

4) bsolete documents retained (or either legal or-nowledge preservation purposes are suitably mar-ed.

4.3.2.3 Identi(ication o( Documents

5ll management system documents are uni'uely identi(ied asspeci(ied in QS!"""""3, Document and Data 1ontrol. Suchidenti(ication may include but not limited to a uni'ue document

number or document type, the date o( issue, revisionidenti(ication, page numbering, and the issuing authority 6ies7.

4.3.3 Document 1hanges

4.3.3.1


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Area: Quality Systems Page %& of 34



The operation o( the laboratory is suited to respond to re'uests sinceall testing and measurement is in response to re'uirements o( internalcustomers. 0>ternal Tenders and 1ontracts are not applicable. Thelaboratory uses =


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Area: Quality Systems Page %% of 34



4.4.3


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Area: Quality Systems Page %2 of 34



tests and/or calibrations, record o( IS/I01 #2"383"" accreditation

shall be re'uired..

4.6 P!R$;A"1/0 "#R91$#" A/D "!PPL1#"

4.6.1 Selection and urchasing o( Services and Supplies

The laboratory must (ollow corporate policies and procedure6s7 asoutlined in QS!""""":, urchasing (or the selection and purchasingo( services and supplies it uses that a((ect the 'uality o( the tests.rocedures e>ist (or the purchase, reception and storage o( laboratoryconsumable materials relevant (or tests and calibrations.

4.6.2 Incoming Inspection

QS!""""":, urchasing procedures ensure that purchased suppliesand consumable materials that a((ect the 'uality o( tests are not useduntil they have been inspected or otherwise veri(ied as complying withstandard speci(ications or re'uirements de(ined in the methods (or thetests and/or calibrations concerned. These services and suppliesused shall comply with speci(ied re'uirements.


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communicates any delays or ma@or deviations in the per(ormance o(

the tests as needed.4.7.2 1ustomer =eedbac-

The laboratory shall see- (eedbac-, both positive and negative (romits customers. The (eedbac- shall be used and analyzed to improvethe management system, testing and calibration activities andcustomer service. 0>amples o( such (eedbac- include a review o( testreports with customers or metrics such as test pro(iciency andmaintenance o( accreditation developed (or the Management


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e7 The responsibility (or authorizing the resumption o( wor- isde(ined.

4.9.2


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Area: Quality Systems Page % of 34



4.11.4 Monitoring o( 1orrective 5ction

The laboratory monitors the results to insure that the correctiveactions ta-en is e((ective be(ore closure in accordance with QS!"""""&, 1orrective and reventive 5ction System.


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4.13.1.2


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4.13.2.3 1orrections and reservation o( riginal Data

It is the laboratory policy that when mista-es occur inrecords, each mista-e is crossed out, not erased, notmade illegible and the correct value entered alongside.

5ll such alterations to records shall be signed orinitialed by the person ma-ing the correction. In thecase o( records stored electronically, e'uivalentmeasures shall be ta-en to avoid loss or change o(original data. 6Sec. .37

4.14 1/T#R/AL A!D1T"

&.#&.# =re'uency, 1ontent and


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Area: Quality Systems Page %+ of 34



4.14.4 4eri(ication o( Internal 1orrective 5ction

=ollow!up audit activities shall veri(y and record the implementationand e((ectiveness o( the corrective action ta-en prior to the correctiveaction being closed.

4.15 MA/A0#M#/T R#91#

4.15.1 ecutive Management Team conducts a review o( the

laboratoryAs management system and testing activities to ensure theircontinuing suitability and e((ectiveness, and to introduce necessarychanges or improvements as de(ined in QS!""""#, Management


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5.0 T#$;/1$AL R#Q!1R#M#/T"

5.1 0#/#RAL

5.1.1 1orrectness and


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Area: Quality Systems Page 2& of 34



5.2.2 Identi(ication

Laboratory management in con@unction with *uman


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Area: Quality Systems Page 2% of 34



1 Identi(y and


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5.3 T#"T1/0 .A$1L1T1#" A$$OMODAT1O/ A/D #/91RO/M#/TAL$O/D1T1O/"

5.3.1 Maintenance o( 0nvironment

Laboratory (acilities have little or no in(luence in testing as the testsystems have independent temperature controls and measurementsto (acilitate correct per(ormance o( the tests. The laboratoryenvironmental conditions are maintained so as to not adversely a((ectthe li(etime o( the test and measurement e'uipment as well as toallow (or a sa(e and com(ortable wor- environment.

5.3.2 Monitor and 1ontrol o( 0nvironment

The laboratory shall monitor and control environmental conditions asre'uired by the relevant speci(ications, methods and procedures orwhere they in(luence the 'uality o( the results. Due attention is paid tominimize dust in photometry spheres, electromagnetic disturbances,;4 radiation, electrical supply stability, humidity, temperature, andsound and vibration levels, as appropriate to the technical activitiesconcerned. Tests and calibrations are stopped when theenvironmental conditions @eopardize the results o( the tests and/orcalibrations. LTL!""#$3:, Lab Test Methods outlines the recording o(environmental conditions.

5.3.3 Separation o( Incompatible 5ctivities

There are e((ective separations between neighboring areas in whichthere are incompatible activities.

5.3.4 1ontrol o( Laboratory 5ccess

5ccess to the laboratory and use o( instrumentation a((ecting the'uality o( the tests are controlled.

5.3.5 *ouse-eeping

Measures are ta-en to ensure good house-eeping in the laboratory.



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5.4 T#"T A/D $AL1)RAT1O/ M#T;OD" A/D M#T;OD 9AL1DAT1O/

5.4.1 Beneral

The laboratory uses appropriate methods and procedures (or testswithin its scope. These include handling, transport, storage andpreparation o( items to be tested, and, where appropriate, anestimation o( the measurement uncertainty as well as statisticaltechni'ues (or analysis o( test data. The laboratory maintainsinstructions on the sa(e and appropriate use and operation o( allrelevant e'uipment, and on the handling and preparation o( items (ortesting. 5ll instructions, standards, manuals and re(erence data

relevant to the wor- o( the laboratory are -ept up to date and areavailable to personnel. Deviation (rom test and calibration methodsshall occur only i( the deviation has been documented, technically

@usti(ied, authorized, and accepted by the customer.

5.4.2 Selection o( Methods

The laboratory uses the I0S LM!:" test method that is incorporatedinto the Luminus Test Laboratory test methods. Chen necessary, thestandard is supplemented with additional details to ensure consistentapplication.

5.4.3 Laboratory!developed Methods

Test methods developed by the laboratory are assigned to 'uali(iedpersonnel e'uipped with ade'uate resources.

5.4.4 )on!standard Methods

Chen it is necessary to use methods not covered by standardmethods, these are sub@ect to agreement with the customer andincludes a clear speci(ication o( the re'uirements and the purpose o(the test. The method developed is validated be(ore use.


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5.4.5 4alidation o( Methods

5.4.5.1 4alidation is con(irmed by e>amination o( the data producedand that the re'uirements were (ul(illed.

5.4.5.2 Laboratory management validates that non!standardlaboratory!designed or developed methods, standard methodsused outside their intended scope, ampli(ications andmodi(ications o( standard methods, are (it (or the intended use.

5.4.5.3 The range and accuracy o( the values obtainable (romvalidated methods 6e.g. the uncertainty o( the results,detection limit, selectivity o( the method, linearity, limit o(

repeatability and/or reproducibility, robustness against e>ternalin(luences and/or cross!sensitivity against inter(erence (romthe matri> o( the sample/test ob@ect7, as assessed (or theintended use, are relevant to the customer.

5.4.6 0stimation o( ;ncertainty o( Measurement


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c7 1omputers and e'uipment are maintained to ensureproper (unctioning and are provided with theenvironmental and operating conditions necessary tomaintain the integrity o( test data.

5.5 #Q!1PM#/T

5.5.1 0'uipment 5vailability

The laboratory shall be (urnished with instruments and relatede'uipment re'uired (or the correct per(ormance o( the tests including,preparation o( test and/or calibration items, processing and analysis o(test data. In those cases where the laboratory needs to usee'uipment outside its permanent control, it ensures that there'uirements o( this manual are met.

5.5.2 5ccuracy


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5.5.6 Maintaining and *andling o( 0'uipment

Instruction LTL!""#$3:, Lab Test Methods describes the sa(ehandling, transport, storage, use and planned maintenance o(measuring e'uipment and aging rac-s to ensure proper (unctioningand to prevent contamination, deterioration and sa(ety.

5.5.7 1ontainment o( 0'uipment

0'uipment that has been sub@ected to overloading or mishandling,gives suspect results, or has been shown to be de(ective or outsidespeci(ied limits, is ta-en out o( service. It is isolated by physical

removal (rom the laboratory, bo>ed and identi(ied, until it has beenrepaired and shown by calibration or test to per(orm correctly orotherwise de!commisioned. Cor- instructions de(ine the responsibility(or identi(ication and communication o( non!compliant e'uipmentre'uiring maintenance, calibration or repair. The laboratory e>aminesthe e((ect o( the de(ect or departure (rom speci(ied limits on previoustests and/or calibrations and institutes the procedure LTL!""#$3,1ontrol o( )oncon(orming Test.

5.5.8 1alibration o( 0'uipment

5ll e'uipment under the control o( the laboratory and re'uiringcalibration is labeled, to indicate the status o( calibration, the datewhen last calibrated and the date or e>piration criteria whenrecalibration is due.


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5.5.11 1orrection =actors

Chere calibrations give rise to a set o( correction (actors, thelaboratory shall have procedures to ensure that copies 6e.g. incomputer so(tware7 are correctly updated. 1urrently no correction(actors are used.

5.5.12 revention o( 5d@ustment

Chere possible, test and calibration e'uipment, including bothhardware and so(tware, are sa(eguarded (rom ad@ustments whichcould invalidate the test results as speci(ied in QS!"""""2, control o(Measuring and Monitoring 0'uipment.

5.6 M#A"!R#M#/T TRA$#A)1L1T6

5.6.1 Beneral

5ll e'uipment used (or tests, including e'uipment (or subsidiarymeasurements 6e.g. (or environmental conditions7 having a signi(icante((ect on the accuracy or validity o( the result o( the test or calibrationare to be calibrated be(ore being put into service.


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5.6.3


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;pon receipt o( the test item, abnormalities or departures (rom normalor speci(ied conditions, as described in the test method, are recorded.


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is the responsibility o( the Test and Measurement Laboratory Manager

to ensure the electronic version o( the report is tamper!proo( bygenerating a Eread!onlyF (ormatted copy (or distribution.

5.10.2 Test clusions (romthe test method, and in(ormation on speci(ic testconditions, such as environmental conditions.

2) Chere relevant, a statement o( compliance/non!compliance with re'uirements and/or speci(ications.

3) Chen re'uested, a statement on the estimateduncertainty o( measurement will be given.

4) Chen re'uested, opinions and interpretations 6see.#".7 will be given.



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5) 5dditional in(ormation which may be re'uired bythe customer

5.10.4 1alibration 1erti(icate

Ce are not a calibration laboratory.

5.10.5 pinions and Interpretations

Chen opinions or interpretations are re'uested by the customer, thelaboratory documents the basis upon which the opinions andinterpretations have been made and are clearly mar-ed as such in the

test report.

5.10.6 Testing results obtained (rom subcontractors

Subcontractors are not used.

5.10.7 0lectronic transmission o( results

In the case o( transmission o( test results by telephone, tele>,(acsimile or other electronic or electromagnetic means, there'uirements o( this document are to be met 6see also .&.27. D=(ormat should be used wherever possible to prevent edits by thereceiver.

5.10.8 =ormat o( report certi(icates

=


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A//#= A

Referencing /9LAP accre-itation

It is the policy o( the Luminus Testing Laboratory o( Luminus DevicesIncorporated 6herea(ter re(erred to as Ethe LaboratoryF7 to control the use o( the term )4L5and the )4L5 logo as described e>plicitly in 5nne> 5 o( the )IST *andboo- #" 6latestedition7. The Laboratory Manager, acting in the capacity o( Quality Manager (or theLaboratory Management System, is responsible (or control and authorized usage o( the term)4L5 and the )4L5 logo.

1

+oth the term and symbol will not be used in a manner that brings )4L5 intodisrepute or misrepresents the Laboratory?s scope o( accreditation or accreditedstatus.

2 Chen the term )4L5 is used to re(erence the Laboratory?s accredited status,it shall be accompanied by the )4L5 Lab code.

3 Chen the )4L5 logo is used to re(erence the Laboratory?s accredited status,it shall be accompanied by the )4L5 Lab 1ode in an approved caption.

4Chen used, the (orm o( the )4L5 logo will not be combined with any other logo,symbol or graphic.

5 The name o( the Laboratory Manager, an 5pproved Signatory, will appear onany test report that bears the )4L5 symbol or re(erences )4L5 accreditation. I( acomputer!generated report does not bear the handwritten signature o( an 5pprovedSignatory, it will bear the printed name o( an 5pproved Signatory with the results and

cannot be generated and distributed without the review and consent o( that 5pprovedSignatory.

6 5 test report that contains both data covered by our accreditation and data notcovered by our accreditation clearly identi(ied the data not covered by theaccreditation by displaying the (ollowing statement at the beginning o( the report9EThis report covers data not covered by the )4L5 accreditation.F

7 0ach test report bearing the term or symbol will include a statement that therecipient o( that report must not use the report to claim certi(ication, approval orendorsement by )4L5, )IST or any agency o( the =ederal Bovernment.

8 Chile the Laboratory does not currently, should procedures change andcontracts or proposals are used, the term and/or symbol will be accompanied by adescription o( the Laboratory?s scope o( accreditation and current accreditationstatus. TheLaboratory recognizes and will use the correct term when re(erencing our )4L5accreditation or con(ormance to IS #2"3 re'uirements9 accredited.



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A//#= )

1m,lementation of traceability ,olicy

+.# olicy verview

It is the policy o( Laboratory that the results o( all calibrations and the results o( allcalibrations re'uired to support accredited tests shall be traceable to national andinternational standards o( measurement

1alibration certi(icates received by )4L5!accredited testing and calibration laboratorieswith new or recalibrated e'uipment shall meet the re'uirements o( IS/I01 #2"3. Thecerti(icates include the uncertainty o( measurement and/or a statement o( compliance withan identi(ied metrological speci(ication or clauses thereo(.

+.3 Beneral

1) The laboratory uses appropriate L0D standards with traceability directly to )IST.Documentation is (iled appropriately and maintained.

2) =or calibration o( its test e'uipment, the laboratory currently uses only IS/I01 #2"3accredited calibration service providers.

+% Demonstration o( traceability

.+%.# The laboratory submits L0D standards to )IST per LT!""#2:2 0>ternal1alibration (or


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Table #. Documentation Matri>

Document Title Documents s'are- A,,licable section/umber beteen Luminus Test 'erein

Lab an- LuminusDevics* 1nc3

=