Beruflich Dokumente
Kultur Dokumente
KAN REQUIREMENT ON
IMPLEMENTATION OF
ISO/IEC 17025 FOR CALIBRATION
LABORATORY
Issue Number : 2
January 2008
LIST OF AMANDMENT
Part
Part number
No. Date Brief description of changes revision
revised
number
1.
ii
1. Introduction
1.1. This document is an integral part of KAN laboratory accreditation system based on
the ISO/IEC 17025 : 2005
1.2. This document provides requirements on the specific interpretatio n to the technical
requirements of ISO/IEC 17025 : 2005, those shall be met by KAN accredited
calibration laboratory and used by KAN assessor to assess competence of
calibration laboratories
1.3. KAN has provided general interpretation of ISO/IEC 17025: 2005 i n the KAN Guide
on the Interpretation of ISO/IEC 17025: 2005)
1.4. KAN accreditted laboratories shall meet ISO/IEC 17025: 2005 requirements, and if
applicable KAN Guide on the Interpretation of ISO/IEC 17025: 2005 shall be used
as a reference to implement ISO/ IEC 17025: 2005 in the laboratory
1.5. Implementation of ISO/IEC 17025: 2005 in the calibration laboratories need specific
interpretation, especially for implementation of its technical requirements. This
document provides that specific interpretations to impr ove harmonization,
effectivness and efficiency of calibration laboratory’s management system
2. Scope of Accreditation
2.2. Calibration laboratory accreditation is not restricted only to high level of accuracy.
Accreditation may be granted to the lower accuracy level, provided with larger
BMC, as appropriate with the uncertainty of measurement achieved by the
laboratory in more or less routine calibrations.
3. Personnel
3.1. .Laboratories shall equipped with appropriately competence person nel to cover all
calibration included in its accreditation scopes and of sufficient number to cover
volume of calibration works. Personnel responsible for technical operation of the
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laboratory shall have adequate knowledge on the calibration principles (in cluding
evaluation of measurement uncertainty) and having skill to make critical evaluation
of calibration results)
3.4. When, more than one personnel are authorized to execute similar calibration work
of equivalence accuracy, laboratory shall provide objective evidence shows their
ability to achieve an equal accuracy level. If there is no objective evidence showing
an equal competency level of technical personnel, labor atory shall document the
accuracy level that may be achieved by individual laboratory personnel.
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5. Measurement Uncertainty
5.2. Calibration laboratory shall have documented procedure for the evaluation of
uncertainty covering important stages in the evaluation of measurement
uncertainty and the estimate of contribution summarizing in the uncertainty budget.
(guidance is given in the Annex C o f this document.
6.1. Best measurement Capability is simply defined as smallest uncertainty that the
laboratory can achieve in more or less routine calibration of nearly ideal devices
that can be calibrated aginst labora tory’s calibration system, which is stated as
expanded uncertainty at 95% in the scope of accreditation.
6.2. Best Measurement Capability should be routinely achieved by the laboratory when
calibrates unit under test having equivalent characteristic with those used as the
basis of their claimed BMC
6.3. In the framework of KAN calibration laboratory accreditation system, the claimed
BMC shall be supported by an appropriate uncertainty budget and experimental
evidence showing that the laboratory is capable to achiev e their BMCs
7.3. Note: procedures and records of the verification of standard’s accuracy may
be integrated with the internal quality control system of the lab oratory
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7.4. Laboratory shall have a list of all measurement standards, measuring equipments,
including any ancilliary equipment needed for all calibration in its scope, as well as
establishing the functions as a reference standards, working standards,
comparators, calibration media, ancilliary equipement (e.g measuring instruments
for environmental condition, etc)
7.5. Laboratory shall establih acceptance criteria of each measurement standards and
equipments and shall ensure that all of them meet that established acceptance
criteria. Record of verification againts acceptance criteria shall be documented.
7.8. All measurement standards and measuring equipment shall be labelled, coded or
otherwise identified to indicate their calibration status, i.e. the date of last
calibration and the next calibration date. Any lim itation of calibration or restriction
of use shall be clearly indicated on the equipment.
7.9. When neither labelling nor coding is practicable, or is not considered essential for
control purposes, other procedures shall be established to ensure conformance to
these requirements
NOTE: This requirement does not apply to adjustable devices that are intended to
be set by the user without needing external references.
8. Measurement Traceability
8.1. All quantitative measuring equipments and measure ment standards having
significant effect to calibration results shall be calibrated before used by the
laboratory.
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8.3. Calibration interval for each equipments and standards shall provide confidence
that specification limits defined by the laboratory is not breached between its
subsequent calibrations.
8.4. Calibration interval should not exce ed maximum recommended interval in the
Annex B of this document.
8.5. Laboratory may establish longer calibration interval if objective evidence provided
that extension of calibration interval will not affect its capability to achieve claimed
BMC
8.6. Extension of calibration interval shall only be done based on the evaluation of at
least 3 (three) subsequent calibration certificates, or based on IQC records having
more than 50 (fifty) QC periodic measurements.
8.7. Laboratory shall established shorter calibration int erval If evaluation on previous
calibration certificates and/or IQC records show that drift or instability of standards
and equipments between periodic calibration are not support its claimed BMC
8.9. Change of calibration interval will affect an estimate compensation for drift or
stability of standards and equipments those may affect BMC granted in its scope
of accreditation.
9.2. The system shall be satisfactory calibrated. If the measuring equipment cannot be
isolated from the data processing system, the system as a whole shal l be
calibrated either statically or dynamically. If the measuring equipment can be
isolated from the data processing system, the equipment can be calibrated in the
conventional manner and a separate verification of the data processing system
can be undertaken.
9.3. The data processing system shall allow for the detection of errors in data input
and the monitoring of the progress of the calibration.
9.4. data processing system shall maintain the original integrity of the measured data.
The limiting factor on the pr ecision of the numbers which the data processing
system can handle must be taken into account.
.
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9.5. The system shall be capable of being checked for error -free operation with
respect to data capture, data processing and freedom from sources of external
interference. This check shall be determined by manual check or by a set of
artefact data, etc
10.2. Laboratory’s internal quality control system shall be designed in such way that
short term and long term random variability and bias of the measurement system,
measurement standards, and all relevant resources will be monitored continuously
to assure validity of calibration results
10.3. Quality control data may be analyzed using a relevant control chart, or other
statistical analysis based on measurement data from calibration of reference
standards, calibration of working standards and supporting equipment,
intermediate check, calibration of customer items or other sources of data as
relevant with type and volume of laboratory acitivities
10.4. Degree of rigour of laboratory’s qual ity control system will depend on their
claimend BMC. Smaller claimed BMC will need more rigorous quality control,
while larger claimed BMC may need the only simple quality control system
10.5. To implement quality control programme, laboratory may refer to KAN Guide on
Measurement Assurance
10.9. Laboratory may arrange a bilateral calibration proficiency testing and/or other
interlaboratory comparison programmes with the other accredited calibration
laboratories having similar scope of accreditation and submit the results of those
program to KAN secretariat as an evidence for their participation in proficiency
testing programmes
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10.10. In case of bilateral interlaboratory comparison, laboratory should chose the other
laboratory that has been participated in national/regional/international
interlaboratory comparison programmes and having smaller BMC than their own
claimed BMC
10.11. Laboratory shall follow-up any outliers results in proficiency testing in accordance
with KAN Policy on Proficiency Testing Activity
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ANNEX A
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2.2 Balances
1.2.1 Electronic Balance
1.2.2 Mechanical Balance
1.2.3 Equal Arm Balance
1.2.4 Batching Plant
4. Pressure
4.1 Dead Weight Tester (DWT – Pressure Balance)
4.2 Pressure Test Gauge (used for calibration fo r
pressure gauge)
4.3 Pressure Gauge
4.4 Electromechanical manometer (indicated pressure
transducer, pressure transmitter, digital
manometer)
4.5. Vacuum gauge (gauge or absolute indication)
4.6 Barometer
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9.2 Micrometer
9.2.1 Outside micrometer
9.2.2 Inside micrometer
9.2.3 Micrometer head
9.2.4 3-point inside micrometer
9.2.5 Depth micrometer
9.2.6 indicating micrometer
9.2.7 Mikrometer roda gigi
9.3 Calliper
9.3.1 Vernier caliper
9.3.2 Height gauge
9.3.3 Depth caliper
9.5 Gauges
9.5.1 Feeler gauge
9.5.2 Pin gauge
9.5.3 Straight edge
9.5.4 Plug gauge
9.5.5 Ring gauge
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10.2. Voltage
10.2.1 AC/DC Voltage source
10.2.2 AC/DC Voltmeter
10.2.3 AC/DC voltage recorder
10.2.4 AC/DC voltage devider)
10.2.5 AC/DC voltage transducer
10.3. Resistance
10.3.1 Resistor
10.3.2 Decade resistor
10.3.3 Hammond resistor
10.3.4 Current shunt
10.3.5 Ohmmeter
10.3.6 Resistance bridge
10.4. Capacitance
10.4.1 Capasitor
10.4.2 Decade capacitor
10.4.3 Capacitance bridge
10.4.4 Capacitance meter
10.5. Inductance
10.5.1 lnductor
10.5.2 Decade capacitor
10.5.3 Inductance bridge
10.5.4 Inductance meter
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11.2. Frequency
11.2.1 Frequency standard
11.2.1.1 Rubidium frequency standard
11.2.1.2 X'tal frequency standard
11.2.2 Counter
11.2.2.1 Frequency counter
11.2.2.2 Frequency meter
11.2.2.3 Microwave frequency counter
11.2.2.4 Universal time counter
11.2.3 Frequency converter
11.2.4 Down converter
11.2.5 RPM converter
11.2.5.1 Optical
11.2.5.2 Electromagnetic
11.2.5.3 Mechanical
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11.5 AF / RF Analyzer
11.5.1 Analyzer
11.5.1.1 Distortion analyzer / distortion
meter
11.5.1.2 Modulation analyzer / modulation
meter
11.5.1.3 Spectrum analyzer
11.5.1,4 Impedance analyzer
11.5.1.5 Audio analyzer
11.5.1.6 Network analyzer
11.5.2 Osiloskop
11.5.2.1 Oscilloscope
11.5.2.2 Digitizing oscilloscope
11.5.2.3 Storage oscilloscope
11.5.2.4 Plug-in-type oscilloscope
11.5.3 Measuring receiver / signal analyzer
11.5.4 Other measuring equipment
12. Accoustics and 12.1 Accoustics
Vibration
12. 1.1 Sound level meter
12. 1.2 Microphone
12.2 Vibration
12.2.1 Accelerometer
12.2.2 Displacement
12.2.3 Vibratiometer / Vibrometer
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Appendix B
Recommended Calibration Interval
The following table sets out nominal maximum periods between successive
calibrations for a number of reference standards and measuring instruments. It
must be stressed that these periods are generally considered to be the maximum
appropriate in each case providing that the other criteria as specified below are met:
That the equipment is of good quality and proven adequate stability, and
That the laboratory has both the equipment capability and staff expertise to
perform adequate intermediate checks, and
Where the above criteria cannot be met appropriately, shorter intervals shall
be specified.
2 Thermocouple
Rare metal, reference for 100 hours use or three years
use below 1000 0 C
Rare metal,reference for u se 10 hours use or three years
above 1000 0C
Rare metal, working 100 hours use or three years
standard
Base metal, working Calibration interval to suit particular
standard application
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Electrical
1 Electronic standard cells 1 year
2 Digital meters 1 year, compare every sixth month
3 Analog meters 2 years, compare every sixth months
4 Resistors 3 years, compare anually
5 Capacitor 3 years, compare anually
6 Standard cell, Weston 2 years, compare at least sixt monthly
7 AC-DC Transfer standards 2 years, compare immediately after
calibration
8 Bridges 3 years (full calibration), check against
laboratory standard anually
9 Potentiometer 3 years, compare anually
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Radiometry
1 Spectral irradiance lamps 100 hours burning time or three years,
whichever is earlier
2 UV irradiance meters 6 months (heavy usage)
1 year (light usage)
3 Laser/optical power meter 1 year
4 Fibre optic power meter 1 year
5 Laser wavelength (fiber 1 year
optic)
Spectrophotometry
1 Wavelength standard filters 1 year
2 Transmittance standard 1 year
filters
3 Reflectance standards 1 year
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Untuk memudahkan verifikasi instruksi kerja, sebaiknya instruksi kerja tersebut disajikan
dengan format yang terdiri atas:
1) mathematical model
2) uncertainty equation,
3) description of uncertainty sources, and
4) uncertainty budget table.
Model Matematis
Model matematis menyatakan hubungan matematis antara measurand (besaran ya ng
diukur) dengan besaran-besaran yang mempengaruhi. Jika suatu besaran dianggap
mempengaruhi hasil pengukuran, maka variabel yang melambangkan besaran tersebut
harus ada dalam model matematis. Sebaliknya, jika suatu besaran dianggap tidak
berpengaruh, maka tidak perlu ada variabel yang mewakilinya dalam model matematis.
Model matematis dapat dimodifikasi dengan penye derhanaan atau pendekatan yang
logis untuk mempermudah evaluasinya.
Persamaan Ketidakpastian
Persamaan ketidakpastian pada dasarnya adalah e laborasi dari rumus ketidakpastian
baku gabungan (ISO GUM):
uc2 = ∑ (ci2·ui2) = c12·u12 + c22·u22 + c32·u32 + … [1]
Untuk setiap variabel x i dalam model matematis, akan ada komponen ketidakpastian
baku ui dan koefisien sensitivitas c i. Perlu diperhatikan bahwa nilai (atau rumus) koefisien
sensitivitas sangat bergantung pada bentuk persamaan dalam model matematis, karena
itulah penentuan model matematis harus tepat dan jelas.
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Model matematis
Model dasar yang meliputi besaran -besaran yang utama atau dominan diturunkan
sebagai berikut:
L = Ls + d [2]
dengan: L = panjang balok tes
Ls = panjang balok acuan
d = penunjukan komparator
Untuk memperhitungkan pengaruh besaran-besaran lain yang berpengaruh, model
tersebut dielaborasi menjadi sebagai berikut:
L(1 + ·) = Ls(1 + s·s) + d + L drift [3]
dengan: = koefisien muai panjang balok tes
= suhu balok tes
s = koefisien muai panjang balok acuan
s = suhu balok acuan
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Persamaan ketidakpastian
Setelah menurunkan koefisien sensitivitas untuk tiap -tiap komponen ketidakpastian,
maka persamaan ketidakpastian u ntuk kalibrasi gauge block dengan metode
perbandingan dapat diturunkan dari Persamaan [ 4] sebagai berikut:
u2(L) = u2(Ls) + (·s + ·s)2·u2(Ls) + Ls2·s2·u2() + Ls2·s2·u2() + Ls2·2·u2(s) +
Ls2·2·u2(s) + u2(d) + u 2(Ldrift) [5]
Karena dan masing-masing mempunyai nilai taksiran nol, maka Persamaan [ 5]
dapat dipersingkat menjadi
u2(L) = u2(Ls) + Ls2·s2·u2() + Ls2·s2·u2() + u2(d) + u 2(Ldrift) [6]
Persamaan [6] merupakan persamaan ketidakpastian kalibrasi gauge block metode
perbandingan.
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The values of constants used in the uncertainty equation may be eva luated as follows:
Uncertainty sources Unit Distribution Symbol Expanded Cov.erage Degrees of Standard. Sensitivity ci.ui (ci.ui)2 (ci.ui)4/vi
uncertainty Factor freedom Uncertainty Coefficiients
(U) (k) (vi) (ui) (ci)
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