qwerthytewrqedq

1. ISO/IEC 17025 .
Technical
Requirements
By:
Aminuddin Sulaeman
ISO
/
IEC
17025
:
2005
Translated from Indonesian to English - www.onlinedoctranslator.com

2. TECHNICAL REQUIREMENTS
5.1 General
5.2 Personnel
5.3 Accommodation and environmental
conditions
5.4 Mtest method, method calibration and
validation method
5.5 Equipment
5.6 Traceability of measurement
5.7 Samplesg
5.8 Handling of tested and calibrated items
5.9 Quality assurance of test and calibration
results
5.10 Reporting resultsl
ISO
/
IEC
17025
:
2005

3. 5.1 GENERAL
5.1.1 Influencing factorsi test results/ results
calibration
5.1.2 All this must be taken into account when
developing procedures, selection
equipment and personnel training
ISO
/
IEC
17025
:
2005

4. 5.2 PERSONNEL
5.2.1 Personnel performing certain tasks must qualified
based on education, training, experience and skills
5.2.2 Policies and procedures for identifying training
required and provide training
5.2.3 Ensure that the work of contracted personnel
issupervision and according to the laboratory
Management System
5.2.4 Maintenance of technical job descriptions,
managerial darikey personnel
5.2.5 Authorization for sampling, testing/calibrating.signing
certificate, interpretation/opinion, certain equipment
operation
Maintenance Records of qualifications, training and
personnel skills
ISO
/
IEC
17025
:
2005

5. ISO
/
IEC
17025
:
2005
5.3 ACCOMMODATION AND ENVIRONMENTAL
CONDITIONS
5.3.1 Technical accommodation requirements
and influencing environmental conditions
results testing / calibration must be
documented and controlled
5.3.2 Monitoring, control and record
environmental conditions
5.3.3 There is separation which Effective
between testing for potential cross-
contamination
5.3.4 Control aaccess to room testing /
calibration
5.3.5 Good household arrangement

6. ISO
/
IEC
17025
:
2005 5.4 METHOD TESTING/ CALIBRATION AND
METHOD VALIDATION
5.4.1 GENERAL
Using the right method for pengtestan/ calibration,
including sampling, transportation, storage,
uncertainty estimation etc
Availability of instructions work, standards,
manuals and workplace data
5.4.2 METHOD SELECTION
Use of methods/procedures has published
Use of laboratory methods which developed
yourself must have validated
Information to customer time regarding use
method which no in accordance

7. ISO
/
IEC
17025
:
2005
5.4.3 METHOD DEVELOPED LABORATORY
Method development plan pengtestan/
calibration
Activity assignment tb. on analyst who
competent
Update development result plan
5.4.4 NON-STANDARD METHODS
Use of non-standard methods should
subject to the agreement with customr
the method must have divvalidation
before use

8. ISO
/
IEC
17025
:
2005
5.4.5 METHOD VALIDATION
5.4.5.1 Validation is confirmation through the
evidence inspection and has been in
accordance with texam testing
5.4.5.2 Validation method non-standard,
method developed laboratory
Maintenance of validation records
5.4.5.3 Range measuring and accuracy can be
obtained from results validation of
methods that suit your needs customer

9. ISO
/
IEC
17025
:
2005 5.4.6 ESTIMATION OF MEASUREMENT
UNCERTAINTY
5.4.6.1 Procedure for uncertainty estimation
measurement and calibration
5.4.6.2 Procedure for uncertainty estimation
measurements in testing, wherever
possible using statistical
methodsappropriate k.
5.4.6.3 Considerations for all components of
estimation uncertainty
5.4.7 CONTROL DATA
5.4.7.1 Check calculations and transfers️data
.4.7.2 Suitable control when data is acquired and
processed via computer or with equipment
which automatic

10. 5.5 EQUIPMENT
5.5.1 Availability of equipment needed
5.5.2 Equipment and software must match
to achieve the required accuracy.
Establishment of a calibration program
5.5.3 Operation️by an officer authorized to use
up to identification date instructions
5.5.4 unique of each item equipment
5.5.5 Equipment maintenance records
5.5.6 Procedures for handling, transporting,
storage, use and maintenance planned
ISO
/
IEC
17025
:
2005

11. ISO
/
IEC
17025
:
2005
5.5.7 Removal from service is imposed
overloading / error handling. Usage like
equipment only after inspection or calibration
after repair
5.5.8 Status indication️calibration on equipment
5.5.9 When an equipment goes out of control
laboratory, check calibration
validity before reuse
5.5.10 Intermediate inspection according to established
procedures
5.5.11 Procedures to ensure the application of
corrections
which factor is needed equipment
5.5.12 Safeguards against adjustment which intentional

12. ISO
/
IEC
17025
:
2005 5.6 Traceability Measurement
5.6.1 GENERAL
Calibrate equipment before use
A program for calibration
5.6.2 SPECIAL REQUIREMENTS
5.6.2.1 Calibration
5.6.2.1.1 traceable to calibration International
System Units (SI Units)
5.6.2.1.2 Where there is no possibility of using
SI units, the establishment of measurement
traceability through
Use of certified materials and specific
methods Inter-laboratory comparison

13. ISO
/
IEC
17025
:
2005
5.6.3 REFERENCE STANDARDS AND
MATERIALS
5.6.3.1 Standard Reference
Program for calibration Reference standardt
only diguse for calibration, Calibration
before adjustment after, if any
5.6.3.2 Material Reference
Ingredient Reference wherever possible
traceable to SI units,
5.6.3.3 Check between
Pexamination Among according to
procedures and schedules set
5.6.3.4 Transport and Storage
Safe handling procedures of reference
materials and reference standard, to prevent
deterioration

14. ISO
/
IEC
17025
:
2005
5.7 SAMPLING
5.7.1 Sampling Plans/procedures for sampling
where
needed. It is based on exact
statistical techniques, if possible
5.7.2 If customr want procedural deviation
required details must be included in all
documents related to testing/calibration
5.7.3 Procedures for recording relevant data on
sampling is done

15. ISO
/
IEC
17025
:
2005
5.8 HANDLING ITEMS TESTED/
CALIBRATION
5.8.1 Procedures for transportation, receiving
handling, protection, storage, retention and
disposal items received for
testing/calibrating
5.8.2 A system/procedure for identification items
intest/calibration
If there is Recording abnormality
5.8.3 if any and consultation with Customer
upon required instructions/action carry
onan
5.8.4 Procedures to avoid quality degradation
during handling, storage and preparation

16. ISO
/
IEC
17025
:
2005
5.9 QUALITY ASSURANCE OF TESTING AND
CALIBRATION RESULTS
Use of quality control procedures to monitor the
validity of the test/calibration
Monitoring may include, but is not limited to :
a) Use of certified materials
b) Participation in inter-laboratory comparisons /
proficiency testing
c) Replicating the test
d) Re-testing / recalibration of items maintained
e) correlation of results for different
characteristics

17. ISO
/
IEC
17025
:
2005
5.10 REPORTING RESULTS
5.10.1 GENERAL
Result reporting should clear and objective in
the form of a Test / Calibration Report
In the case of internal Customers or special
agreements with customerresults can be
reported in a simplified form; however
complete information (listed in 5.10.2 -
5.10.4) must be maintained by the laboratory

18. ISO
/
IEC
17025
:
2005
5.10.2 CALIBRATION TEST AND CERTIFICATE
Test Report / Certificate Calibration loading
a) Title (Test Report / Certificate Calibration)
b) Laboratory name & address
c) unique identification (such as a serial number)
d) Name & address Customers
e) Identification of Test Method
f) Item condition & identification Test / Calibration
g) Acceptance date & test/calibration date
h) Reference sampling plan, if any
i) Test / calibration results
j) Authorization person report name &
designation
k) k) A statement stating that the results relate
only to the item being tested/calibrated

19. ISO
/
IEC
17025
:
2005
5.10.3 TEST REPORT
5.10.3.1 Apart (5.10.2) Report on Test
must load
a) Deviations from Test Procedures &
environmental conditions, if applicable
b) Statement of compliance/non-compliance, if
relevant
c) Estimation uncertainty statement
d) Opinions / interpretations, if any
e) e) Additional information required by customer
5.10.3.2 Where sampling of details applies from
the date, methods, environmental conditions,
etc be included

20. ISO
/
IEC
17025
:
2005
5.10.4 CERTIFICATE CALIBRATION
5.10.4.1 In addition to the details given in
5.10.2 The calibration certificate must include
a) Environmental conditions, if any
b) Measurement uncertainty
c) Evidence of traceability measurements
5.10.4.2 Declaration of compliance includes
which parameter specifications are met/
not fulfilled
5.10.4.3 Any adjustments/repairs made must be
reported
5.10.4.4 No recommendation on calibration
interval

21. ISO
/
IEC
17025
:
2005
5.10.5 OPINIONS AND INTERPRETATION
Document who menbasei give
opinion/interpretation
Empty marking equals in reports
5.10.6 TESTING / CALIBRATION OF RESULTS
FROM
Subcontractor Cancel identification of
results from subcontractors
5.10.7 ELECTRONIC TRANSMISSION
RESULT
Controls required to protect
confidentiality when transmitting results
by electronic media such as fax,

22. ISO
/
IEC
17025
:
2005
5.10.8 REPORT/CERTIFICATE FORMAT
format appropriate good for result report
testnor calibration report/certificate to
avoid kwrong understanding
5.10.9 CHANGES TO REPORT RESULTS
TEST / CALIBRATION CERTIFICATE
Aamendment to result report
test/calibration with more reports, must
be accompanied previous report as
reference.
Amendment for fulfil international standard