Policy and requirements for proficiency testing, interlaboratory comparison/
laboratorys performance assessment in test
Issue date 21 September, 2009
Bureau of Laboratory Quality Standard (BLQS), DMSc
N 07 15 003
Revision 04
page 1 of 13 pages
1. Purpose This policy and requirements of the BLQS aim to use the activities of proficiency testing, interlaboratory
comparison and laboratorys performance assessment in test, as a tool for accreditation in medical, public health testing
laboratories and forensic science laboratory.
2. Scope Scope of this policy and requirements are as follows :
2.1 Participation in proficiency testing and interlaboratory comparison of medical, public health testing
laboratories and forensic science laboratory which apply for accreditation and has already been accredited.
2.2 The consideration for PT result and interlaboratory comparison comply with the ISO/IEC Guide 43-2:1997.
3. Reference
3.1 ISO/IEC 17025:2005, section 5.9
3.2 ISO/IEC 17011:2004, section 7.15 item 7.15.1, 7.15.2 123 7.15.3
3.3 ISO/IEC G.43-1. Proficiency testing by interlaboratory comparisons - Part 1: Development and operation
of proficiency testing schemes. 2rd Edition, 1997.
3.4 ISO/IEC G.43-2, Proficiency testing by interlaboratory comparison - Part 2: Selection and use of
proficiency testing schemes by laboratory accreditation bodies. 1st Edition, 1997 (section 6.5, 7.1)
3.5 ILAC G.13:2000. Guidelines for the requirements for the competence of providers proficiency testing
schemes.
3.6 ILAC G.22:2004 Use of Proficiency Testing as a Tool for Accreditation in Testing.
3.7 ILAC : P9:2005 ILAC Policy for Participation in National and International Proficiency Testing
Activities.
3.8 APLAC PT 006:2008 Proficiency Testing Frequency Benchmarks.
4. Terminology
Proficiency Testing (PT) is determination of laboratory testing performance by means of interlaboraory
comparison.
Interlaboratory comparison is organization, performance and evaluation of test on the same or similar test items
by two or more laboratories in accordance with pre-determined condition.
Laboratorys performance assessment in test is one of the tools used to evaluate the laboratorys performance.
5. Policy and Requirements
5.1. In case that the PT providers are available. The laboratories shall participate in test parameters of test methods for
each disciplines that they apply for accreditation. However, the laboratory shall have mechanism to ensure that the PT test item
shall distribute among the various analysts that trained and qualified for the relevant tests. The criteria requirements for selection
the PT providers for participation are as follows:
Policy and requirements for proficiency testing, interlaboratory comparison/
laboratorys performance assessment in test
Issue date 21 September, 2009
Bureau of Laboratory Quality Standard (BLQS), DMSc
5.1.1
5.1.2
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Shall be the recognition PT providers in the international, national or group of related expert.
Source of PT Providers can search by access the website : www.dmsc.moph.go.th and website of PT
provider schemes in medical and public health testing laboratories mentioned in Appendix 1
5.1.3 Laboratory shall establish plan for participation in PT schemes coves the scope of their accreditation as
mentioned in Appendix 2,3. In case that the laboratory participate with the other PT providers which does
not in the list of PT Providers as mentioned in Appendix 1, the laboratory shall inform officially to the
BLQS and submit the evidence to demonstrate the competency of the PT providers that participated. The
BLQS shall make a dicision for the competency of those PT Providers.
5.2 In case that the PT providers are not available. The laboratories should carried out the interlaboratory comparisons
by two or more laboratories (where applicable). Laboratories should establish the procedure for interlaboratory comparsison (as
mentioned in Appendix 3) , should be adequate described the preparation of sample or test item, the providing of test item,
demonstrate the accurate value for the test item, the statistical techniques applied to review or evaluate the results. The criteria
requirements for selection the laboratory for carried out the interlaboratory comparison are as follows :
5.2.1 Laboratory which is the same level of competency by means of accredited laboratories comply with ISO/IEC
17025: 2005 or ISO 15189 : 2007 in the test item requested for carried out the interlaboratory comparison in
the same technique / the same matrix.
5.2.2 Source of interlaboratory comparison can search by access the website www.dmsc.moph.go.th
5.3 In case that the PT providers and interlaboratory comparison are not available. Laboratory shall carried out the
possible performance assessment in test for the certain testing in lieu of PT or interlaboratoy comparison. Laboratories shall
establish the procedure for their performance assessment in test (as mentioned in Appendix 3), should be adequate described the
preparation or providing of sample or test item, demonstrate the accurate value of the analyte, statistical technique that used for
evaluating such as ISO 5725 or the appropriate statistics, plan and frequency for assessment among the trained analyst, record
and report.
5.4 Frequency in participation of proficiency testing schemes/interlaboratory comparison/laboratorys performance
assessment in test
5.4.1 Frequency in participation of proficiency testing schemes should depend on the rounds of the PT providers or
as appropriate. However laboratory shall ensure the evidence of their performance that shall demonstrate on
onsite surveillance and re : assessment.
5.4.2 Frequency in the interlaboratory comparison and the laboratorys performance assessment in test should be
carried out at least once a year or as mentioned in the plan of laboratories.
5.5 Reporting of proficiency testing/interlaboratory/comparison/laboratorys performance assessment in test. Laboratories
shall submit the report of those activities to the BLQS. If the results of proficiency testing is unsatisfy, laboratories shall carried
out as follows:
5.5.1 Determine the root cause, remedial corrective action and report to the BLQS.
Policy and requirements for proficiency testing, interlaboratory comparison/
laboratorys performance assessment in test
Issue date 21 September, 2009
Bureau of Laboratory Quality Standard (BLQS), DMSc
N 07 15 003
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5.5.2 BLQS shall inform the assessor to examine the corrective action of those results. The acceptance criteria for
the result of proficiency testing evaluate by the statistic Z-score according to the ISO/IEC G43-1 : 1997
Z ≤2
2< Z <3
Satisfactory
Questionable
Z ≥3
Unsatisfactory
5.5.3 The acceptance criteria for interlaboratory comparison/laboratorys performance assessment in test should
depend on the statistical used in the internal quality control of laboratory testing or other statistics that followed ISO 5725 for
example T-test, F-test or other appropriate statistics.
5.5.4 BLQS shall make a decision for the unsatisfactory performance in PT scheme according to the ISO/IEC
G.43-2 section 6.5, specified that the laboratory accreditation body should advise participating laboratories of
the possible outcomes of unsatisfactory performance in a proficiency testing scheme. These may range from
continuing accreditation subject to successful attention to corrective actions within agreed time-frames,
temporary suspension of accreditation for the relevant test (subject to corrective action), through to
withdrawal of accreditation for the relevant test.
5.5.5 The decision of BLQS for temporary suspension will depend on history of performance of the laboratory over
time and from the most recent on-site assessments. As mentioned in the ISO/IEC G.43-2: 1997 Section 7.1
accredited laboratories should be required to maintain their own records of performance in proficiency testing
and any subsequent corrective or preventive actions.
6. Supplement note:
6.1 Appendix 1
Website of PT providers schemes in medical and public health laboratoies
6.2 Appendix 2
Scope of accreditation
6.3 Appendix 3
Actions for accredited laboratories and accreditation bodies
Policy and requirements for proficiency testing, interlaboratory comparison/
laboratorys performance assessment in test
Issue date 21 September, 2009
Bureau of Laboratory Quality Standard (BLQS), DMSc
Appendix 1
Website: PT providers schemes (Public health laboratory comply with ISO/IEC 17025: 2005)
- Food analysis performance assessment scheme (FAPAS)
www.fapas.com
- Food examination performance assessment scheme (FEPAS)
www.fepas.com
- National Association of Testing Authority, Australia (NATA)
www.nata.asn.au
- American Society of Brewing Chemists, USA
www.asbcnet.org
- Bureau Interprofessional d'Etudes Analytiques
www.bipea.org
- Canadian Food Inspection Agency
www.inspection.gc.ca
- Canadian Association for Environmental Analytical Laboratories (CAEAL)
www.caeal.ca
- Institute for Interlaboratory Studies (IIS) Netherlands
www.iisnl.com
- Institute for Animal Health, (UK)
www.iah.ac.uk
- American Optometric Association
www.aoa.org
- Health Protection Agency Food EQA Schemes, UK
www.hpa.org.uk
- Laboratory Government Chemist (LGC) Standards Proficiency Testing, UK
www.lgc.co.uk
- National Measurement Institute (NMI) Australia
www.measurement.gov.au
- Quality management (QM), UK
www.qmuk.co.uk
- European Directorate for Quality Medicines & Health Care
www.edqm.eu
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Policy and requirements for proficiency testing, interlaboratory comparison/
laboratorys performance assessment in test
Issue date 21 September, 2009
Bureau of Laboratory Quality Standard (BLQS), DMSc
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-
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IFM Quality service Pty, Ltd. (Australia)
www.ifmqs.com.au
American oil chemist society
www.aocs.org
American Society
www.asm.org
Bureau of Quality and Safety of Food Department of Medical Sciences, the Ministry of Public Health
http://www.dmsc.moph.go.th/webroot/BQSF/indexMain.htm
Institute of Nutrition, Mahidol University.
http://www.inmu.mahidol.ac.th
National Food Institute
http://nfi.foodfromthailand.com
Bureau of Laboratory Accreditation, Department of Science Service
http://www.dss.go.th/dssweb/bla/index.html
Bureau of Cosmetics and Hazardous Substances Control
http://www.dmsc.moph.go.th/webroot/cosmetics/
Centers of Disease Control and Prevention, CDC
www.cdc.gov/
World Health Organization, WHO
www.who.int
Institute of Animal Health, UK
www.iah.ac.uk
Bureau of Quality Control of Livestock Product
www.dld.go.th/qcontrol/bqclp.html
Enersol Consulting Engineers, Australia
www.enersol.com.au
Nelson Laboratory, Inc.
www.nelsonlabs.com
APLAC PT 003 JProficiency Testing DirectoryK
http://www.aplac.org
European Information System on Proficiency Testing Schemes, EPTIS
http://www.eptis.bam.de
Bureau of Laboratory Quality Standards Department of Medical Sciences, Ministry of Public Health
Policy and requirements for proficiency testing, interlaboratory comparison/
laboratorys performance assessment in test
Issue date 21 September, 2009
Bureau of Laboratory Quality Standard (BLQS), DMSc
N 07 15 003
Revision 04
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www.dmsc.moph.go.th
Website PT Provider schemes (Medical laboratory comply with ISO 15189)European Information System on Proficiency
- Testing Schemes, EPTIS
http://www.eptis.bam.de)
- Bureau of Laboratory Quality Standards Department of Medical Sciences, Ministry of Public Health
www.dmsc.moph.go.th
- UK National External Quality Assessment Schemes (UKN EQAS, clinical laboratory disciplines)
http://www.ukneqas.org.uk
- WEQAS Clinical Chemistry (University Hospital of Wales Medical Biological Department Health Park, UK)
- CAP Clinical Chemistry (>100 Programs ) (College Of American Pathologists, USA)
- Australian Institute of Medical Scientists (Immunohaematology)
http://www.aims.org.au
- The Royal College of Pathologist of Australia
- Bio-Red External Quality Assurances Services
www.bio-rad.com
- Diagnostic Chemicals Ltd. West Royalty Industrial Park for Veterinary Laboratory
www.delchem.com
- Toxicology Unit PaLMS Northern Sydney Area Health Service
www.toxicologyunit.com
Policy and requirements for proficiency testing, interlaboratory comparison/
laboratorys performance assessment in test
Issue date 21 September, 2009
Bureau of Laboratory Quality Standard (BLQS), DMSc
Appendix 2
1. Biological :General
Sub-disciplines Include:
• Quantitative Bacteriology
• Quantitative Mycology
• Quantitative Virology
• Qualitative Bacteriology
• Qualitative Mycology
• Qualitative Virology
• Molecular sub-typing
• Serology
• ELISA
• PCR
• Microscopy
• Quantitative Microbiology
• Qualitative Microbiology
2. Chemical:General
Sub-disciplines:
Chromatography
• TLC
• GC, GC-MS, GC :MS/MS
• HPLC, HPLC MS/MS
• UPLC, UPLC MS/MS
• IC
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Policy and requirements for proficiency testing, interlaboratory comparison/
laboratorys performance assessment in test
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Bureau of Laboratory Quality Standard (BLQS), DMSc
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Spectroscopy
• AAS
• GFAAS
• Fluorescence
• ICP, ICP-OES
• IR/FTIR
• UV/VIS
Titration
- Potentiometry
Gravimetric
- Gravimetry
3. Mechanical
Sub-disciplines include :
• Tensile
• Dimension
• Bursting pressure and volume
• Water leakage
• Oven conditioning
• Filtration (Minimum HVL for X-ray)
• Beam-limiting devices (Type of dental radiation for dental radiography using intra-oral image receptors,
a beam-limiting devices or cone)
• Distance of focus from the light source
• Diameter of a beam-limiting
• Leakage radiation
Policy and requirements for proficiency testing, interlaboratory comparison/
laboratorys performance assessment in test
Issue date 21 September, 2009
Bureau of Laboratory Quality Standard (BLQS), DMSc
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Materials/Matrices/Product Types
Foods :
- Milk and milk products
- Egg and egg products
- Meat and meat products (Fresh, Frozen,
Chilled, Heat Treated, Processed)
- Aquatic animal and aquatic animal products
(Fresh, Frozen, Heat Treated, Processed)
- Poultry and poultry products (Fresh, Frozen,
Heat Treated, Processed)
- Vegetable and vegetable products
- Cereals and grain products
- Legume and legume products
- Algae and their products
- Fruit and fruit products
Drugs
-
Cosmetics
- Hair cosmetic products
-
Flour and flour products
Oil, Fat and Butter
Supplementary foods for infant & young children
Condiments , Sauce and Spices
Noodle and noodle products
Semi processed food ,OPQPRSRTOUVRWX
Instant foods
Snack Food and Desserts
Ready to eat foods
Water, Ice, Bottled drinking water and Supply
water, Potable water
Beverages
etc.
Tablets
Liquid
Capsule
etc.
- Face cosmetic products
- Body cosmetic products
- etc.
: (Cold-wave, Straightening, Hair Dye, Bleaching, Hair
dressing, Anti-dandruff, Shampoo & Conditioner)
: (Antiacne-anti-melasma cream, Antimelasma cream,
Sunscreen cream, Creams & Lotions, Lipstick, Eyepencil, Eyebrow, Eyeshadow, Toothpaste, Dental floss,
Mouthwash, Anti bacterial spray)
: (Talcum, Body lotion, Soap, etc.)
Policy and requirements for proficiency testing, interlaboratory comparison/
laboratorys performance assessment in test
Issue date 21 September, 2009
Bureau of Laboratory Quality Standard (BLQS), DMSc
Household products :
- Pesticide products
- Larvicide sand granules products
- Repellent products
- Rodenticides, Tick, Flea products
- Cleaning and amend of pipe clogged products
- Disinfectant products
- Bleaching clothes
- Correction fluid products
- ect.
Toxicology :
- Biological samples, Clear water sac, Water bladder, Organs.
- etc.
Narcotics :
- Urine
- Biological sample, Suspected sample
- Dry plants
- etc.
Medical materials and medical devices :
- Condoms
- Examination Gloves
- Syringes
- X-ray equipments (Diagnostic)
- etc.
Veterinary:
- Muscle
- Dog Chew
- Egg and egg products
- Animal fat
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Policy and requirements for proficiency testing, interlaboratory comparison/
laboratorys performance assessment in test
Issue date 21 September, 2009
Bureau of Laboratory Quality Standard (BLQS), DMSc
- Internal organ, Visceral organ
- Carcass
- Animal serum
- Milk and milk products
- Milk
- Honey and royal jelly
- Animal tissue and processed products
- Meat and meat products
- Urine
- Mammal brain
- Animal hide
Forensic science
- Blood
- Urine
- Aqueous humor
- Serum
- Other liquid media
- Non biological physical evidence
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Policy and requirements for proficiency testing, interlaboratory comparison/
laboratorys performance assessment in test
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Bureau of Laboratory Quality Standard (BLQS), DMSc
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Appendix 3
Actions for accredited laboratories
1. Appropriate participation in proficiency testing, both in proficiency testing and interlaboratory
comparisons, covering the scope of the laboratorys accreditation, in a useful and cost-effective manner.
The laboratory should satisfy itself of the competence of the providers of PT schemes in which they
voluntarily participate.
2. The laboratory policy for participation in proficiency tests as a form of external quality control should be
adequately described in the Quality Manual or in other operational documents of the laboratory. This
particularly concerns planning, performance/operation, evaluation, corrective action, records and its
storage.
3. The laboratory should be prepared to justify non-participation in readily available proficiency testing
schemes, where one or more appropriate schemes exist
Actions for accreditation bodies and assessors
1. Promotion of the benefits of participation in proficiency testing, and how performance is used to help
assess the competence of laboratories.
2. Supporting of organization or arrangement of proficiency tests, wherever possible and useful in the most
cost-effective manner.
3. The accreditation body should judge the appropriateness of proficiency tests in which the laboratory
participates, which will be taken into account in the accreditation. Where the accreditation body
recommends participation in any particular PT scheme, for its accredited laboratories, in should satisfy
itself of the competence of the organization providing the proficiency test.
4. Ensuring that assessors have the following competences:
- Have demonstrable competence in interpretation of the assigned value and acceptability criteria
in all types of proficiency testing in order to afford a critical evaluation of quantitative and
qualitative results of laboratories;
Policy and requirements for proficiency testing, interlaboratory comparison/
laboratorys performance assessment in test
Issue date 21 September, 2009
Bureau of Laboratory Quality Standard (BLQS), DMSc
N 07 15 003
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page 13 of 13 pages
- Have relevant knowledge about standards and Guidelines on the organization, performance and
evaluation of interlaboratory comparisons, as e.g. ISO/IEC Guide 43: 1997 [1],
ISO
5725 B1.1-6 [3];
5. Check that laboratories have a written procedure in the Quality Manual (QM) or in laboratory
instructions covering participation in proficiency testing, including how the performance in proficiency
testing is used to demonstrate the laboratorys competence and procedures followed in the event of
unsatisfactory performance.