ISO/IEC 17025:2017 ISO/IEC 17025:2017 TIPS & TRICKS in implementing FOR A BETTER LAB COMPETENCY JIMMY PUSAKA RESEARCH CENTER FOR METROLOGY, of the INDONESIAN INSTITUTE OF SCIENCES
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ISO/IEC 17025:2017ISO/IEC 17025:2017TIPS & TRICKS in implementing
FOR A BETTER LAB COMPETENCY
JIMMY PUSAKARESEARCH CENTER FOR METROLOGY, of theINDONESIAN INSTITUTE OF SCIENCES
The coverThe cover211
Jimmy Pusaka
Comparison between Comparison between the main clausesthe main clauses
212
2017 VERSION 2005 VERSION1. Scope 1. Scope2. Normative references 2. Normative references3. Terms and definitions 3. Terms and definitions3. Terms and definitions 3. Terms and definitions
4. General requirements 4. Management requirements5. Structural requirements 5. Technical requirements6. Resource requirements7. Process requirements8. Management system requirements
What would you like What would you like to do?to do?
213
New laboratoriesAccredited
laboratories
Apply the new version Migrate to the new version
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(Alternative 1) ISO/IEC 17025:2017 as the reference:
Listing (sub)clauses in the new version and sorting items in the
old version those can be reused in the new version.
Migration to Migration to ISO/IEC 17025:2017ISO/IEC 17025:2017
(Alternative 2) ISO/IEC 17025:2005 as the reference:
Listing (sub)clauses in the old version and sorting items in the
new version those can match into each (sub)clause within the
old version
215
ISO/IEC 17025:2017 as the
reference (alternative 1):
ISO/IEC 17025:2005 as the
reference (alternative 2):
Migration to Migration to ISO/IEC 17025:2017ISO/IEC 17025:2017
4. General req4.1 Impartiality4.2 Confidentiality
4. Management req 4.1 Organization4.2 Management sys.4.2 Confidentiality
5. Structural req6. Resource req6.1 General6.2 Personnel6.3 Facilities & env6.4 Equipment6.5 Metro traceability6.6 Ext prov prod & serv
5.7
5.9
4.2 Management sys.4.3 Doc control4.4 Rev of req, ten, con4.5 Subcontracting5 Technical req5.1 General5.2 Personnel5.3 Accom & env con5.4 Test & cal method
4.2
.2
8.4.1
Jimmy Pusaka
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ISO/IEC 17025:2017 as the reference:
Examining which (sub)clauses of the old version match to the
reference
Sequence of the Sequence of the subclausessubclauses(alternative 1)(alternative 1)
217
ISO/IEC 17025:2017 as the reference:
Examining which (sub)clauses of the old version match to the
reference
Wordings may have Wordings may have slightly different meaning slightly different meaning (alternative 1)(alternative 1)
218
ISO/IEC 17025:2017 as the reference:
Examining which (sub)clauses of the old version match to the
reference
Comparison may not Comparison may not always be 1 to 1 always be 1 to 1 (alternative 1)(alternative 1)
jump to cross ref
219
ISO/IEC 17025:2005 as the reference:
Examining which (sub)clauses of the new version contain the
same information as the reference
The same findings when The same findings when refering to version 2005 refering to version 2005 (alernative 2)(alernative 2)
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Notes become subclauses Notes become subclauses and vice versaand vice versa
Jimmy Pusaka
PreparationPreparation2111
1. Take ISO/IEC 17025:2017 as the reference
Good
structure
pros
structure
Keep
nothing
left out
Remake
documents
pros
cons
Restructuring 1/2Restructuring 1/22112
2.A Make the cross reference
4.1 4.14.2 4.1 4.7
7.1 4.4 4.7 5.4 5.107.2 5.47.3 5.7
8.1 ---
2017 2005 2017 2005 2017 2005 2017 2005
see details
4.2 4.1 4.7
5.1 4.15.2 4.15.3 4.25.4 4.15.5 4.1 4.25.6 4.1 4.25.7 4.1 4.2
6.1 5.16.2 4.1 5.26.3 5.36.4 5.56.5 5.66.6 4.6
7.3 5.77.4 5.87.5 4.137.6 5.47.7 5.97.8 5.107.9 4.87.10 4.97.11 5.4 5.5
8.2 4.28.3 4.38.4 4.138.5 4.128.6 4.7 4.108.7 4.118.8 4.148.9 4.15
Restructuring 2/2Restructuring 2/22113
2.B Make the cross reference in detail
4.1.1 4.1.4 4.1.5.d4.1.2 4.1.5.b4.1.3 4.1.5.b
5.1 4.1.15.2 4.1.5.h5.3 4.2.1
2017 2005 2017 2005
see details
4.1.3 4.1.5.b4.1.4 ---4.1.5 ---4.2.1 4.1.5.c4.2.2 ---4.2.3 4.7.14.2.4 4.1.5.c
5.3 4.2.15.4 4.1.2 4.1.35.5 4.1.5.e 4.1.5.f 4.2.15.6 4.1.5.a 4.2.2.e 4.2.35.7 4.1.6 4.2.4 4.2.7
6.1 – 6.6.3 7.1.1 – 7.11.6 8.1.1 – 8.9.3
AdditionAddition2114
3. What’s new in 2017 version?
4.1.4 The laboratory shall identify risks to its impartiality
4.1.5 The lab shall eliminate or minimize risks to impartiality
.1.4 The laboratory shall identify risks to its impartiality .1.4 The laboratory shall identify risks to its impartiality 4.2.2 Notification to customers arrangement if conf. info released
6.6.2.a Deciding requirmt. for extern. provided prod. & services
6.6.2.d Actions to follow up examining results of external providers
laboratory shall identify risks to its impartiality 6.6.3 Communication between lab and external providers
+ 10 more
Revising your Revising your documents 1/2documents 1/2
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4.1.1 (2005) - 5.14.1.2 (2005) - 5.4…..…..4.1.6 (2005) - 5.7.a
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5 ve
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NC
EQuality Document
4.1.6 (2005) - 5.7.a6.2.4
------------------------4.1.4 (2017)4.1.5 (2017)------------------------4.2.1 (2005) - 5.3
5.5.c4.2.2 (2005) dsthard
copy
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CR
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RTest/ Calibration Laboratory
on the basis of ISO/IEC 17025
Jimmy Pusaka
Revising your Revising your documents 2/2documents 2/2
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4.1.1 (2017) - 4.1.44.1.5.d
4.1.2 (2017) - 4.1.5.b4.1.3 (2017) - 4.1.5.b4.1.4 (2017) - addition
TAB
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Quality Document
4.1.4 (2017) - addition4.1.5 (2017) - addition4.2.1 (2017) - 4.1.5.c4.2.2 (2017) – additiondst
softc
opy
/ re
arra
nged
h/c
TAB
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RTest/ Calibration Laboratory
on the basis of ISO/IEC 17025
The new version of ISO/IEC 17025 has very little or no effect on the lower levels of quality documents, i.e.:
Do we have to change the Do we have to change the rest of our rest of our quality documents?quality documents?
2117
on the lower levels of quality documents, i.e.:Work InstructionsRecords and Forms
Note: document numbers or reference numbers may changeNote: document numbers or reference numbers may change
Do we have to change Do we have to change our room conditions?our room conditions?
2118
NoNo
Room conditions such as temperature, humidity, content of carbon dioxide, etc refers to other standards.
Do we have to change Do we have to change our master equipment?our master equipment?
2119
Again, master equipment follows other documentary standards for their traceability to the SI. So the answer to most cases is
No(6.4.5) but there is an emphasis concerning the importance of achieving accuracy and/or uncertainty(6.4.5) but there is an emphasis concerning the importance
of achieving accuracy and/or uncertainty
Do we have to change Do we have to change our human resources?our human resources?
2120
Requirements for human resources are mainly the same
.
(6.2.1) But there is an emphasis that internal personnel(also) be competent and work in accordance with the laboratory's management system.
(6.2.1) But there is an emphasis that internal personnel
(also) be competent and work in accordance with the
laboratory's management system.
Jimmy Pusaka
Thank youThank you
2121
Please address your questions, comments, or suggestions to:Please address your questions, comments, or suggestions to:[email protected][email protected]@[email protected]@[email protected]
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