transmille training - 17025 quality system.ppt

8/18/2019 Transmille Training - 17025 Quality System.ppt

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Transmille TrainingTransmille Training17025 Quality System


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Overview: Quality SystemsOverview: Quality Systems

For an organisation to be accredited it must be seen and be proven by independent assessment to be working to a system.

Te international standard !or tis system is

ISO 17025.

"S# 17025 covers all te individual topics$ section bysections !or te complete operation o! a laboratory. Testandard is split into two parts

1: covering Management Requirements

2: covering Technical Requirements


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Key Elements ForKey Elements For

Accredited Laboratories Accredited Laboratories Quality manual to "S#17025 %nvironmentally &ontrolled 'aboratory(ead o! 'aboratory responsible !or te operation

o! te laboratory wit a good understanding o!measurement procedures$ te operation o! tee)uipment and te )uality system.

Quality *anager must be assigned

Traceable +e!erence standards wit calibrationistory.*easurement procedures wit uncertainty

budgets.


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Quality Manual to ISO!"#$Quality Manual to ISO!"#$*ust address all aspects o! *anagement +e)uirements

re)uired by 17025 standard.

Organisation (4.1) Quality system (4.2)

Document control (4.3) Reie! o" re#uests$ ten%ers an% contracts (4.4) Su&'contracting o" tests an% cali&rations (4.5) urcasing serices an% su**lies (4.+) Serice to te client (4.7) ,om*laints (4.-) ,ontrol o" non'con"orming testing an%or cali&ration !or/ (4.) ,orrectie ction (4.10) reentie action (4.11) ,ontrol o" recor%s (4.12) Internal au%its (4.13) anagement reie! (4.14)


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Quality Manual to ISO!"#$:% Management &e'uirementsQuality Manual to ISO!"#$:% Management &e'uirements

Organisation ' 4.1Organisation ' 4.1 :: Topics to be covered Topics to be covered

,ame o! laboratory or organisation wicis legally responsible

-ctivities con!orming to relevant standardsand guidelines

ermanent or mobile facilities

#rganisation membersip


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Quality System ' 4.2Quality System ' 4.2 :: Topics to be covered Topics to be covered

Scope o! )uality system

-ctivities con!orming to relevant standards

and guidelines+e!erence to )uality policy statement

Supporting systems suc as procedure and

so!twareTitle responsible !or "S#17025

con!ormance


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Document ,ontrolDocument ,ontrol ' 4.3' 4.3 :: Topics to be covered Topics to be covered

-pproval and review o! documentation

-ctivities con!orming to relevant standards

and guidelines'ocation o! documentation

+eview / update / obsolescence policies

-ccess control backup o!documentation

RECOMMENDATION : USE MASTER DOCUMENT

LIST


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Quality Manual to ISO!"#$ (Quality Manual to ISO!"#$ (

E)am*le +ontrolled ,ocuments ListE)am*le +ontrolled ,ocuments ListIR6 DO,S

6a&oratory roce%ure anual

6a&oratory Quality anual

**aratus Inentor

**roe% Su& ,ontractor

**roe% Su**lier

,ali&ration Re#uest 8orm

9S ,om*laints 8orm

ro,al So"t!are anual

ro,al'rac/ So"t!are anualS/ills atri:

raining 6og

**roe% Signatory 6ist

Sce%ule O" ccre%itation

ccre%itation ,erti"icate

;R6 DO,S

9S 4

ISO17025

9S 3003R ---7

9S 6a& 1

9S 6a& 3

9S 6a& 5


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Reie! o" ,ontractsReie! o" ,ontracts ' 4.4' 4.4 :: Topics to be covered Topics to be covered

rocedure !or te review o! re)uests$ tenders and contracts e!ining and documenting metods to be used &apability and resources to meet te re)uirements.

Te appropriate test and/or calibration metod is selectedand capable o! meeting te clients re)uirements

*aintaining records o! reviews and any signi!icantcanges .

+eviews on sub3contracted by te 'aboratory

"n!orming clients o! any deviation !rom teir contracts. rocedure i! contract needs amending a!ter work as

commenced


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Su&'contracting !or/Su&'contracting !or/ ' 4.5' 4.5:: Topics to be covered Topics to be covered

'aboratory policy on sub contracting work

"n!orming customer o! sub contracted work +esponsibility !or sub contracted work

+egister o! approved sub contractors


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urcasingurcasing ' 4.+' 4.+:: Topics to be covered Topics to be covered

'aboratory policy on purcasing

&ecking o! supplies critical to calibration work &ecking / reviewing o! purcasing documents

-pproved suppliers list


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Serice to te ,lientSerice to te ,lient ' 4.7' 4.7:: Topics to be covered Topics to be covered

olicy o! te laboratory to cooperate witcustomers and to veri!y te work per!ormed and

ensure con!identiality


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,om*laints,om*laints ' 4.-


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on ,on"orming =or/on ,on"orming =or/ ' 4.


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,orrectie ction,orrectie ction ' 4.10


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reentatie ctionreentatie ction ' 4.11


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,ontrol o" recor%s,ontrol o" recor%s ' 4.12


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Internal u%itsInternal u%its ' 4.13


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anagement Reie!anagement Reie! ' 4.14


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Quality Manual to ISO!"#$Quality Manual to ISO!"#$

*ust address all aspects o! Tecnical+e)uirements re)uired by 17025 standard.

-eneral .$/0

1ersonnel .$/#0 Accommodation and environmental .$/20 conditions Test and calibration met3ods and met3od validation .$/40 E'ui*ment .$/$0 Measurement traceability .$/50

Sam*ling .$/!0 6andling o7 test calibration items .$/80 Assuring t3e 'uality o7 test and calibration results .$/90 &e*orting t3e results .$/"0


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Quality Manual to ISO!"#$:% Tec3nical &e'uirementsQuality Manual to ISO!"#$:% Tec3nical &e'uirements

>>eneraleneral ? 5.1 ? 5.1


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ersonnel ? 5.2ersonnel ? 5.2


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ccommo%ation ? 5.3ccommo%ation ? 5.3


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eto%s B Cali%ation ? 5.4eto%s B Cali%ation ? 5.4


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ncertanties ? 5.4.+ncertanties ? 5.4.+


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,ontrol o" Data ? 5.4.7,ontrol o" Data ? 5.4.7


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#ui*ment ? 5.5#ui*ment ? 5.5


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easurement racea&ility ? 5.+easurement racea&ility ? 5.+


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@an%ling #ui*ment ? 5.-@an%ling #ui*ment ? 5.-


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ssuring Quality ? 5.ssuring Quality ? 5.


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Re*orting Results ? 5.Re*orting Results ? 5.<< Topics to be covered Topics to be covered

Te laboratories policy on reporting results is to issue te clientwit an unambiguous and legible certi!icate tat meets te

re)uirements o! :-S and "S# 17025 and provides all o! te datare)uested by te client.

(ow and wen certi!icate and labels are printed$ cecked andsigned$ and ow can sign.

!ote: The details on a test report are different from a calibrationcertificate details which follow:"

Q lit M l t ISO!"#$ T 3 i l & i t


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Re*orting Results ? 5.Re*orting Results ? 5.


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SummarySummary

Tis course as covered all topics in te"S#17025 )uality system and sown tere)uirements to be meet in operating alaboratory.

To !urter develop an understanding te standarditsel! sould be studied along wit te template)uality manual wic can be customised to

produce your own manual.

lease !eedback to us any comments on tistraining session


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AS" or oter ,ational Standards "nstitutions

:-S

"nternet ,' web site

transmille training - 17025 quality system.ppt

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