Nabl 181 PDF

NABL 181
NABL
NATIONAL ACCREDITATION
BOARD FOR TESTING AND
CALIBRATION LABORATORIES
SPECIFIC CRITERIA
for PT PROVIDER
ACCREDITATION
ISSUE NO : 01 AMENDMENT NO : 00
ISSUE DATE: 01.06.2011 AMENDMENT DATE: --
AMENDMENT SHEET
Sl Page Clause Date of Amendment made Reasons Signature Signature

No. No. Amendment QO Director
10
National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 181 Specific criteria for Proficiency Testing Provider
Issue No: 01 Issue Date: 01.06.2011 Last Amend No: 00 Amend Date: -- Page No: i
ABBREVIATIONS
AOAC : Association of Official Analytical Chemists
APHA : American Public Health Association
APLAC : Asia Pacific Laboratory Accreditation Cooperation
ASTM : American Society for Testing and Materials
BIS : Bureau of Indian Standards
CRM : Certified Reference Material
e.g. : For Example
ISO : International Organization for Standardization
IEC : International Electro-technical Committee
ILAC : International Laboratory Accreditation Cooperation
IUPAC : International Union of Pure and Applied Chemists
NABL : National Accreditation Board for Testing and Calibration Laboratories

NGO : Non-governmental Organisation
PT : Proficiency Testing
QC : Quality Control
w.r.t. : with respect to

Issue No: 01 Issue Date: 01.06.2011 Last Amend No: 00 Amend Date: -- Page No: ii
CONTENTS
Sl Title Page
Amendment Sheet i
Abbreviations ii
Contents iii
1. Scope 1
2. References 2
3. Introduction 3
4. Technical Requirements 5
5. Management Requirements 13
Annexure-A (Specified Requirements for Personnel) 17
Annexure-B (Guidance for Prevention of Collusion and Falsification 21
while Conducting PT Programs by PT Provider)
Annexure-C (Example of Flow Chart to be followed by Proficiency 23
Testing Provider)
6. Technical Committee Members 24

Issue No: 01 Issue Date: 01.06.2011 Last Amend No: 00 Amend Date: -- Page No: iii
1. SCOPE
1.1 This document provides amplification / explanation / additions to the requirements stipulated
in ISO/IEC 17043:2010 for the benefit of accreditation of PT provider, NABL assessors,
other interested parties and stakeholders.
1.2 The requirements for accreditation are laid down in the International Standard ISO/IEC
17043: 2010 (Conformity assessment – General requirement for proficiency testing). These
requirements apply to all types of proficiency testing schemes but in certain instances
additional guidance is necessary to take account of the type of
testing/measurement/inspection involved.
1.3 This document has been produced by a Technical Committee constituted by NABL for the
purpose detailed in 1.1.
1.4 PT Providers providing services for tests/calibration/inspection on different PT Item(s)

(matrices/groups) should also consult relevant NABL specific criteria in respective
disciplines like NABL – 102, 103, 107, etc and other relevant applicable document like
ISO/IEC 17025, ISO 15189, ISO/IEC 17020, ISO/IEC 13528, ISO Guides 34 and 35, IUPAC
Harmonized Protocol for the Proficiency Testing of Analytical Chemistry Laboratories.

Doc. No: NABL 181 Specific Criteria for Proficiency Testing Provider
Issue No: 01 Issue Date: 01.06.2011 Amend No: 00 Amend Date: - Page No. 1/24
2. REFERENCES
o ISO/ IEC 17043: 2010, Conformity assessment – General requirement for proficiency
testing
o ISO/IEC 13528: 2005, Statistical methods for use in proficiency testing by inter
laboratory comparisons
o ISO/IEC 17025: 2005, General requirements for the competence of testing and
calibration laboratories
o ISO/IEC 17020:1998, General criteria for the operation of various types of bodies
performing inspection
o ISO 15189:2007, Medical laboratories - Particular requirements for quality and
competence
o IUPAC Harmonized Protocol for the Proficiency Testing of Analytical Chemistry
Laboratories, 1996
o ISO/IEC Guide 99: 2007, International Vocabulary of Metrology-Basic and General
concepts and associated terms (VIM)
o ISO/IEC 17000:2004, Conformity Assessment- Vocabulary and General Principles.

3. INTRODUCTION
3.1 The Scope of accreditation of a PT Provider is the formal statement of the range of PT
services in various tests/measurements/ Inspection. This scope is recorded in detail on
annexures of PT provider’s accreditation certificate. A PT provider’s scope should be
defined as precisely as possible so that all parties concerned know accurately and
unambiguously the range of tests/measurements covered by that particular PT provider’s
accreditation. The format below typically defines the PT provider’s accreditation for different
field(s).
3.2 This criteria amplifies/adds to the requirements specified in ISO/IEC 17043:2010
3.3 Examples are cited below for guidance:
3.3.1 Examples for Chemical/Biological Testing

PT Scheme Proficiency Test Parameter(s) Range of Periodicity Remarks
Item (as defined in Measurement (Minimum)
3.8) (if applicable)
Heavy Metals in Water Cadmium 10µg/L to 3 times a year
Food Lead 100mg/L
Arsenic
Mercury
Pesticide Honey Endosulfan 10µg -50 mg/L One time in a

Residue in Food Malathion year
Food Chemistry Cereals Protein 5% to 50% 3 times in a
Program Milk Powder Ash 1% to 10 % year
Moisture 0.5% to 10%
Fat 0.5% to 15%
Food Water, Meat, Milk Coliforms - Twice a year
Microbiology Powder E –coli
Yeast and
Mould
Textile Chemistry Fabrics, Garments Colour Grade 1 to 5 Twice a year Qualitative
Program Fastness Scheme
Fibre Upto 100% Method as
Composition, per
pH 1 to 14 participant
lab
3.3.2 Examples for Mechanical Testing

PT Scheme Sample/Matrix/ Parameter(s) Range of Frequency Method
Artifact Measurement
Metallic Materials Ferrous and Non Hardness-HRC 10HRC to 90HRC Once a year ASTM E
–Physical Testing Ferrous Materials Charpy Impact V 10J to 40J 18
2
Program Notch 200N/mm to
2
Tensile Testing 600N/mm
Metallic Material- Ferrous and Non Grain Size Once a year
Metallographic Ferrous Materials
Program
Textile in Fabrics Tensile Strength 100N to 5000N Twice in a ASTM D
Mechanical Garments GSM year 5034 and
Dimensional 25 to 500 5035 or IS
Stability -50% to +20% 1969
3.3.3 Examples for Medical Testing

PT Scheme Sample/Matrix/ Parameter(s) Range of Periodicity Remarks
Artifact Measurement
Human Body Urine Sodium Six times a
Fluids Scheme-1 Urea year
Glucose
Creatinine
Human Body Whole Blood Haemoglobin Eight times
Fluids Scheme-2 Glucose a year
Complete Blood Whole blood Heamoglobin Six times a
Count RBC year
WBC
Platelets
MCV
3.3.4 Examples for Measurement / Calibration

PT Scheme PT Item Parameter(s) Range of Periodicity Remarks
Measurement
Dimensional Portable Gauging Micrometers Upto 50mm Once in a
Metrology and Hand Tools Dial Indicators Upto 12.5mm year
Program 1
Dimensional ID- Artifacts and Plug Gauges Upto 500mm
Metrology Parts Ring Gauges Upto 100mm
Program 1
Electrical Current DC Current 1mA to 3A
Measurement Voltage DC Voltage 10mV to 1000V
Program (Measure/Source)
Mass Weights/Balance Mass 1mg to 1 kg Once in two
years
Temperature Thermometers/ Temperature 1ºC to 600ºC
Thermocouples
3.3.5 Examples for sampling

PT Scheme PT Item Parameter(s) Range of Periodicity Remarks
Measurement
Sampling in Case study based Sampling - Once a year To assess
Ambient Air on Sampling Procedure performanc
Monitoring Guidelines for e of labs
Ambient for pre-
Atmosphere as per analytical
IS:5182 part-14 phase and
post
analytical
phase

4. TECHNICAL REQUIREMENTS
4.1 General
The development and operation of proficiency testing schemes shall be undertaken by

proficiency testing providers having competence to conduct inter laboratory comparisons
and access to expertise with the particular type of proficiency test items.
4.2 Personnel
This section details about the availability of staff working within the PT provider. The
qualifications of key staff should be as per requirements listed in Annexure A. Care should
be taken by PT Provider to avoid any conflict of interest arising due to its other activities
(refer Annexure B)
PT provider shall authorise and ensure supervision for all activities enlisted as per ISO/IEC
17043 Clause 4.2.4 (a) to (k). Job responsibilities should be clearly defined in the procedure
document of PT Provider. Records related to authorization, qualification, experience should
be maintained and updated time to time and be retrievable.
4.3 Equipment, Accommodation and Environment Conditions
The PT provider shall ensure that there is availability of enough accommodation. In addition,
appropriate environmental conditions like temperature, humidity, vibrations, biological
sterility are maintained to ensure integrity and stability of PT item. These conditions will need
to be maintained and monitored during various phases of operations of PT scheme which
could include sample preparation, sample reception, handling, manufacturing (where
applicable), storage, packaging, dispatch and retrieval of materials.
It is the responsibility of the PT Provider to ensure that the similar conditions are also
maintained at subcontractor’s site. PT Providers shall have adequate records to establish
the same. Periodic visits shall be conducted for maintenance and ensuring the above
conditions is met.
PT Provider shall follow national/local regulatory norms for appropriate and safe
decontamination of toxic and hazardous material. Care shall be taken that Biomedical waste
is disposed as per requirements of regulators. In case toxic or hazardous materials have to
be stored, they should be stored taking care of safety requirements.
4.4 Design of PT Scheme
Designing of PT scheme involves: Planning of scheme, preparation of PT items, Conducting

homogeneity and stability studies, statistical design and finally assigning the values.
4.4.1 Planning of Scheme
PT Provider cannot subcontract the planning of scheme and during this stage care should
be taken for selecting of test item, method, design such that the processes which directly
affect the quality of PT scheme are identified. Objectives of the scheme should be clearly
identified at this stage. During planning PT Provider shall also ensure that they have
appropriate technical expertise to help them during planning, statistical calculations,
technical issues, evaluating the performance and providing technical commentary as
feedback etc.
In addition to this PT provider shall also ensure that the requirements of the standard
ISO/IEC 17043:2010 Clause 4.4.1.3 (a) to (u) are fulfilled and records with documentary
evidence are available for the purpose of evaluation. PT Provider shall take utmost care to
prevent collusion or falsification of results (refer Annexure B) for activities which could lead
to conflict of interest. Appropriate care shall also be taken for quality control, storage,
distribution of items, their homogeneity and stability studies with procedure to be adapted
and statistical design to be used. Documented procedure shall be available for actions
required if the PT items are damaged or lost with implementation records to be satisfactory.
Subcontractors and the activity rendered by them shall also be identified and records of
assessment of subcontractors activity should be retrievable. The assessment shall ensure
compliance to the relevant requirements of ISO/IEC 17043 and other related standards like
ISO/IEC 17025, ISO Guide 34, ISO 15189, ISO/IEC 17020 etc. The subcontractor
providing critical activities shall be informed that they may be subjected to an
assessment by the accreditation body.
Note 1: A laboratory/production unit which is part of the same legal entity as the PT provider is also
termed as subcontractor.
Note 2: The participants should be suitably informed that the records of PT schemes shall be
accessible to national accreditation body.

4.4.2 Preparation of PT Items
PT provider shall take care that PT items are prepared as per plan and their handling and
storage are appropriate.
Appropriate care should be taken to ensure that there are no interferences faced during
analysis of PT items and they do not deteriorate over a period of time.
Where PT provider uses case study e.g in sampling proficiency testing, the case study
should be well documented and evaluation criteria be documented and should preferably be
objective.
The proficiency test items shall be prepared in accordance with documented plan for the
selected measurand(s) or characteristics(s) of interest. Due consideration shall be given to
the preparation of sufficient number of proficiency test items in order to allow replacement of
proficiency test items due to genuine loss or damage during distribution to ensure that
participants are not deprived of participation. The quality of PT items shall be controlled as
stipulated in quality control requirements of documented plan.
4.4.3 Homogeneity and Stability
One of the most critical parameter in the design of scheme is to ensure homogeneity of
sample where possible. In case of inhomogeneous samples, scheme design shall be such
that uncertainty of the assigned value is considered while evaluating the performance of the
participants.
Care should be taken by PT provider to select items which are stable during the period of
storage and transport e.g. materials sensitive to temperature and/or humidity, PT items for
microbiological testing.
In order to ensure that every participant receives comparable proficiency test items and also
to ensure that these proficiency test items remain stable throughout proficiency testing, the
PT provider shall conduct homogeneity and stability studies on these items as appropriate.
The assessment of homogeneity and stability shall be conducted as per documented
procedure which shall be in accordance with appropriate statistical design.
It is recommended to use one the following methods to conduct homogeneity and stability
studies as appropriate.
i) Method given in Annex "B" of ISO/IEC13528: 2005 "Statistical methods for use in
proficiency testing by interlaboratory comparisons".
When a method of sample preparation is used such that homogeneity criteria as

given in Annex "B" above is not met, then replicate samples shall be tested by the
participants or the standard deviation for proficiency testing shall include an
allowance for heterogeneity of the sample as described in Annex "B" of ISO/IEC
13528:2005
ii) Para 3.11, Appendix 1 and Appendix 2 of the International Harmonized Protocol for
the Proficiency Testing of Analytical Chemistry Laboratories (IUPAC Technical
Report 2006) published by International Union of Pure and Applied Chemistry.
iii) Any other statistically valid method could be used for homogeneity and stability
studies.
4.4.4 Statistical Design
PT provider shall take care to select the design of the scheme as per objective. During the
statistical design following items have to be considered:
• accuracy
• minimum number of participants for statistical inference
• number of PT test item to be measured or tested.
• procedure to assign the test value,
• procedure to handle outliers
• where appropriate, the statistical procedure for the evaluation of censored
(removed) values;
• homogeneity and stability of test item
The PT provider shall use the guidelines for statistical design and interpretation of
proficiency tests as given in section 4 of ISO/IEC 13528:2005 to the extent they are
applicable to the proficiency test schemes provided by the PT provider.
4.4.5 Assigned Value
PT provider shall ensure that the implementation of documented procedure for determining
assigned values.

In case of calibration programs assigned values shall have meteorological traceability
directly from NMI.
During the use of consensus value reason for selection of this method should be
documented along with uncertainty of assigned value.
PT Provider shall ascertain the validity of assigned value at the commencement and/or end
of each cycle. PT Provider shall also examine the values obtained from the participants in
order to ensure all participants are evaluated fairly.
Assigned value of the measurand(s) or characteristics(s) of interest along with its associated
uncertainty of measurement should be determined using one of the methods given in
section B.2.1, of Annex B of ISO/IEC 17043:2010 and guidelines given in ISO 13528:2005
as appropriate. The assigned value should also be compared with the robust average
derived from results of round and/or where possible with a reference value obtained by a
competent laboratory (refer section 5.7 of ISO/IEC 13528:2005). In case of discrepancy, PT
Provider shall analyze and investigate the reason.
If the assigned value is determined based on consensus values from expert laboratories or
consensus value from participants, the assigned value should be calculated using robust
statistical methods or outliers shall be removed prior to calculation. The PT provider should
have criteria for acceptability of an assigned value in terms of its uncertainty.
4.5 Choice of Method
PT Provider shall ensure compliance to 4.5.2 of ISO/IEC 17043 where different methods
are used by participants.
For sampling programs, PT item (case study) shall be based on laid down
national/international standard or guidelines on sampling or procedures given by regulatory
bodies.
4.6 Operation of Proficiency Testing Schemes
A typical example of process flow of operation of PT scheme is provided in Annexure C.

4.6.1 Instructions to Participants
The PT Provider shall comply with all the requirements of section 4.6.1 of ISO/IEC
17043:2010.
These instructions could include but may not be limited to the following:
1. Test/measurement/sampling/inspection method to be adopted: If the participants are
permitted to use a method of their choice, the same should be explicitly mentioned.
2. Format for recording/reporting of the PT results including unit of measurement and

number of significant figures (number of decimals) to be reported.
3. Last date for the provider to receive the proficiency testing results. The results
received after this date may not be included in the analysis and will not be
incorporated in the Proficiency test report.
4.6.2 Proficiency Test Items Handling and Storage
The proficiency test items shall not be stored along with other items which can affect or
contaminate them. They should be stored in a appropriately segregated area with controlled
access throughout the conduct of the PT Scheme.
4.6.3 Packaging, Labeling and Distribution of Proficiency Test Items
Extreme care shall be taken by the PT provider while packing, labeling and transporting the
proficiency test items to the participants. The packing materials used such as duralumin
boxes, wooden boxes, card board, polystyrene, polyethylene bags, shall be such that the
integrity of the proficiency test items is not affected during storage and transport.
Labels containing the unique identity of the individual proficiency test items shall be
firmly/securely attached to the packaging. Further, it shall be ensured that the labels are
legible and intact till the completion of the PT Scheme.
If the proficiency test item is to be returned to PT Provider or forwarded to another

participant, then detailed instructions for packing and transporting the same shall be
provided.
Confirmation of the receipt of the proficiency test item is to be obtained promptly from the
participants on receipt of the proficiency test items.

4.7 Data Analysis and Evaluation of Proficiency Testing Scheme Results
4.7.1 Data Analysis and Records
Requirements stipulated in ISO/IEC 17043:2010 shall apply.
4.7.2 Evaluation of Performance
The participants shall be evaluated against criteria for evaluation of performance given in
plan document.
a. For statistical analysis of test results of participants who have adopted different
test/ calibration methods, only technically equivalent methods shall be pooled
together. And for those which are not technically equivalent, analysis shall be
done separately.
b. The criteria for performance evaluation for quantitative results of participants shall be
based on calculation of performance statistics as given in Annex B.3 and B.4 of ISO/IEC
17043:2010. The statistics used for performance evaluation shall be one or more of
those given in sub section B.3.1.3 of Annex B.3 of ISO/IEC 17043: 2010. While judging
the participants performance the aspects given in section B.3.1.4 of Annex B.3 of
ISO/IEC 17043:2010 should also be taken into consideration. If any other method is
used the PT provider shall maintain records of statistical validity of such methods.
c. While calculating performance statistics guidelines should be taken from section 7 of ISO
13528:2005.
d. If z-score or a variant of it is used as a criteria for performance, the determination of
standard deviation for proficiency assessment shall be done using one of the methods
as appropriate and as given in section 6 of ISO 13528:2005.
e. If performance evaluation criteria consider the participants reported estimate of

measurement uncertainty, the PT provider shall ensure that uncertainty estimates are
determined in a consistent manner by all participants. PT Provider shall ensure that the
uncertainty reported by the laboratory is in accordance with the laboratory capabilities.

f. The criteria for performance of qualitative and semi qualitative results (eg results
reported as per rating/grades such as 1 = Poor, 2= Unsatisfactory, etc) shall be based
on section B.3.2 of Annex B of ISO/IEC 17043:2010
4.8 Reports
The proficiency test reports shall incorporate results reported by all the participants
and their performance in the PT Scheme. However, the identity of the participants
shall be codified.
In case performance evaluation is reported in terms of En value/Zeta score, PT

reports shall also incorporate uncertainty reported by participant.
In addition, PT report shall incorporate all the requirements as per clause 4.8.2 of
ISO/IEC 17043:2010.
4.9 Communication with Participants
Requirements stipulated in ISO/IEC 17043:2010 shall apply. The records of

communication with the participants shall be maintained for at least for one full
accreditation cycle, with controlled access to authorized personnel.
4.10 Confidentiality
The PT provider to ensure that the participants are identified in reports by code only.
The PT results/data of individual participants and the communications with them will be
stored securely with controlled access to limited authorized personnel.
The performance of any individual participant shall not be revealed to others (except
regulatory authorities) without explicit permission from the concerned participant In case of
regulatory authorities the concerned participants shall be notified in writing.

5. MANAGEMENT REQUIREMENTS
5.1 Organization
PT Provider shall establish legal identity mentioning the date of incorporation. The legal
identity could be in either of these forms:
• Private Organisation/Sector (Proprietorship, Partnership, Private Limited, Public Limited)

• Government Organisation,
• Autonomous bodies
• Public Sector
• NGO/Trust/Society
• Any other like university.
If the PT provider is part of an organization which has laboratory/ inspection body, the roles
of key personnel such as Quality Manager/Technical Manager/PT Coordinator, etc shall be
clearly defined identifying any potential conflict of interest. In addition the organization chart
shall clearly define the position and relationship of PT provider with other activities.
(Refer Annexure B).
5.2 Management System
5.3 Document Control
5.4 Review of Requests, Tenders and Contracts
All requirements of section 5.4 of ISO/IEC 17043 shall apply. The review shall be conducted
in detail when the customer request a PT scheme for a specific purpose. However, it can be
simplified for regularly conducted PT schemes described in the catalogue or announced by
other means.
Note 1: Customer is an organization or individual for whom the PT scheme is designed and operated.
Participants are those laboratories which receive PT items and submit results for review by PT

Provider. For eg. A regulators wants a PT scheme to assess the performance of several laboratories.
The regulator is a customer and laboratories are participants. A participant is also a customer.
5.5 Subcontracting Services
If a PT provider subcontract services pertaining to determination of assigned value,

conducting homogeneity and stability studies etc. to a laboratory , it shall ensure that such
services are subcontracted to competent laboratories conforming to relevant
requirements of ISO/IEC 17043:2010.
Note 1: ISO/IEC 17025,ISO 15189, ISO Guide 34 Accredited laboratories with appropriate scope of
accreditation could be used as an evidence to establish competence.
The following records generated by subcontractor shall be readily available with PT

Provider:
a. Raw test data generated while performing testing/calibration for the purpose of
assigning value or homogeneity or stability testing.
b. Method adopted for assigning values and ensuring homogeneity & stability of PT
items.
Note 2: Subcontracted critical activities may be subjected to assessment at the subcontractor

locations.
5.6 Purchasing services and Supplies
5.7 Service to the Customers
The PT Provider shall obtain positive and negative feedback both from participants
and other customers.
5.8 Complaints & Appeals
Records of all complaints and appeals shall be maintained along with the corrective actions
taken to the satisfaction of the complainant.

If any appeal is unresolved for over three months it shall be brought to the notice of
NABL. The appeal handling process shall be made known to participants.
5.9 Control of Non Conforming Work
5.10 Improvement
5.11 Corrective Actions
5.12 Preventive Actions
5.13 Control of Records
All records which provide evidence carrying out various PT activities shall be maintained for
a minimum period of one accreditation cycle.
5.14 Internal Audits
The Internal audit program shall be completed every 12 months. Every internal audit shall
essentially cover various stages in a life cycle of a Proficiency testing program like
planning, proficiency test item preparation, homogeneity and stability studies, storage and
distribution, evaluation and reporting for the operation of a PT scheme as well as generic
management system elements.
Note: accredited PT providers who are not engaged in organizing PT programs regularly, shall also
comply with the requirements detailed above
In case any of the activities, as permitted vide clause 5.5 of ISO 17043, are subcontracted,
then these shall be covered under the scope of Internal audit. The audit of the
subcontracted activities shall include physical visit to the subcontractor premises, preferably
when the activities are being actually undertaken. It should also include witnessing of the

subcontracted activities like testing, etc, on a sample basis by an internal auditor competent
in the relevant activity being audited.
The Internal Audit report shall clearly report with objective evidence of the audit findings,
both the compliance aspects and the non compliance aspects, to cover the areas audited
and the applicable requirements of ISO 17043.
In case of any nonconformity observed the PT provider shall conduct detailed root cause
analysis and identify and take actions to correct the nonconformity observed and institute
appropriate systemic corrective actions to prevent recurrences. These shall be appropriately
recorded and demonstratable.
5.15 Management Reviews
The frequency of management reviews shall be determined by the laboratory, taking

account of the results from internal audits and previous reviews and reports from an
accreditation body. A management review should include consideration of related subjects
at regular management meetings. Where PT provider is part of larger organization, it shall
be preferable to hold a separate review meeting to cover proficiency testing activities.
The inputs to the management review shall be described and recorded in detail. The
performance of subcontractor(s) shall be input to the management review.
*******

ANNEXURE A
Specified Requirements for Personnel
General: This criteria defines the requirements of accredited /applicant organization to select
and appoint PT Coordinator, Authorized signatory, Statistician, Quality Manager and Technical
manager. A person can perform more than one of these functions as far as he satisfies
minimum requirements of qualification and experience subject to that work load is adequately
justified in relevance to scope and with deputies in each field.
PT Coordinator
Personnel with overall responsibility for coordinating all of the activities involved in operations
of Proficiency Test Scheme.
a) Shall be technically competent in the field of activity and should have

awareness/knowledge to evaluate the results of homogeneity and stability studies.
b) Demonstrate awareness/knowledge in statistical applications related to inter-

laboratory performance evaluations
c) Be able to demonstrate the capability to evaluate results of variety of

matrices/groups.
d) Have knowledge of ISO/IEC 17043 along with ISO/IEC 17025 or ISO/15189 or

ISO/IEC 17020 as applicable and adequate knowledge of other specific criteria.
The Authorised Signatory: (Person ISO/IEC 17043, chapter 4.2.4 point j)
Is the competent person whose signature confers validity on the reports issued by PT provider
under NABL accreditation.
For a person to be approved as authorised signatory personal evaluation shall be done during
assessment. The following criteria shall be fulfilled by the Authorised signatory:
a) Shall be a postgraduate in a relevant field of science or graduate in engineering with

at least three years of relevant working experience (eg: quality control, laboratory,
R&D, inspection etc. )

b) Shall have sound current knowledge of technical requirements of the relevant
national or international method(s) used, as well as the objectives of the
test/measurement/inspection.
c) Accepts responsibility for the contents (i.e. results of evaluations) of the report
which he/she is signing or authorizing;
d) Be able to assess and interpret the data;
e) Be confident when authorizing the reports, that all the necessary checks had been
completed as required by the Management System to ensure the quality of the
results of PT.
f) Be conversant with the management system implemented within the organization.
Statistician
Is the competent person with a specific knowledge of statistical methods and their application
in Proficiency Testing. The nominated person shall fulfil the following requirements.
a) Basic education or extended education in statistical methods as e.g.: according to

ISO 5725, ISO 13528 or other statistical methods necessary for the specific PT
program.
b) Be familiar with specific methods used in the evaluation of PT results as z-score, En

ratio or other methods used in the specific PT program.
c) Be familiar with use of software for the evaluation of PT results.
Quality Manager
a) Is the personnel responsible for maintaining quality management system. The nominated
person should fulfill the following requirements.
b) Be familiar with and fully understand the requirements of the relevant standard (ISO/IEC
17043:2010), and principles applicable to the organisation’s field of
accreditation/compliance.

c) Have defined responsibility and authority for ensuring that the management system are
implemented and followed at all times. Have direct access to the highest level of
management at which decisions are made on the accredited organisation policies and
resources.
d) Be responsible to inform NABL of changes within the organization which may affect the
accreditation status of the organization (this includes changes in key personnel, location,
etc).
Technical Manager
The personnel having overall responsibility for the technical operations and the provision of the
resources needed to ensure the required quality of proficiency testing schemes. This shall
include access to the necessary technical expertise and experience in the relevant field of
testing, calibration or inspection, as well as statistics. [PT Coordinator can also be the TM, but
the responsibility for monitoring technical operations has to be defined separately, apart from
coordinating all activities while designing and conducting PT schemes].
The nominated person should fulfill the following requirements:
a) Shall be a postgraduate in a relevant field of science or graduate in engineering with

at least 3 years of working experience in Testing/Calibration/ Inspection/ Operating
PT schemes.
b) Shall have sound knowledge of technical requirements of the relevant national /

international method used, as well as the objectives of the test/measurement.
c) Have knowledge or access to person having knowledge of the product/article and

technology involved in design/manufacture/use.
d) Be familiar with the testing/measurements of different parameters for which PT

programs are organized.
e) Have defined responsibility and authority for ensuring that (i) competent and
trained technical staff are engaged for activities related to organizing PT programs,
(ii) calibrated equipments and accessories of suitable capacity and accuracy
are used and (iii) the accommodation and environment in which various activities
including sample preparation are done, is adequate.
f) Responsible for monitoring the conduct of homogeneity and stability testing of PT
items, their proper storage and distribution among participant laboratories.
g) Awareness of statistical methods used for evaluation of participants performance.
Advisory/ Steering Group:
This group shall have the expertise to carry out the functions as described vide clause 4.4.1.5
of ISO/IEC 17043. Technical experts including statisticians may be used on an ad-hoc basis
either in-house or external (refer to Para related to Conflict of interest). The terms of reference
and membership criteria of the advisory/steering group shall be documented. As they are also
key personnel involved in the design and conducting of the PT program, they should have
appropriate competence for the assigned task. Records of the competence of
advisory/steering group shall be maintained.

ANNEXURE B
Guidance for Prevention of Collusion and Falsification while Conducting PT Programs

by PT Provider
Collusion may take place either amongst the participants or between the PT provider and
participants. Few suggested means that will provide guidance to the PT provider and assessor
to prevent collusion and falsification are as follows:
i. PT provider should provide adequate justification for the method adopted for assigning
value to PT items.
ii. The size/amount of PT item sent to participants should not be too large. Care
should be taken to enable participant laboratories to preserve (where applicable) the PT
items for demonstration during their assessments/corrective actions.
iii. The design of the PT scheme should ensure that the time gap between receipt of the
sample, date of testing and date of reporting should be minimum. Adequate
justification should be provided in case of longer time gap.
iv. The participant laboratories may be asked to send the tested specimens of PT items
(where applicable) to examine the same by the PT Provider and/or by NABL
assessor during assessments.
v. All raw data including data from the computer controlled equipments should be obtained
by the PT provider.
vi. When a PT schemes requires testing on a particular date and time, PT provider should
obtain the results from the participants within the specified time by fax/e-mail
initially, followed by courier also.
vii. PT provider shall identify, analyze and document risks to impartiality, integrity and
objectivity and also collusion and falsification. The threats to the above could arise from
following but not limited to:
a. PT provider being part of a testing/calibration laboratory (common management;

same personnel; coercion openly or secretively, etc).

b. PT provider may be related to another body which is a laboratory (eg. under same
ownership).
c. Subcontractor could also be a participant.
d. Advisory/Steering committee members may be from participant laboratories.
e. Participation from competitor laboratories in PT program.
f. Collusion among participants such as discussion among participants,

testing/calibration of PT item in another laboratory (better equipped, specialized).
g. Request from participants for duplicate PT items with false justification.
viii. PT provider shall document and implement a procedure for identifying risks and
mitigation measures, where applicable.
ix. When a relationship poses unacceptable threat to impartiality, PT services shall not be
provided to the related participant.
x. It should be ensured that PT items are prepared, handled and distributed by authorized
person / agencies. The access to the records of codification and distribution of PT items
shall be controlled.
xi. If there is provision for witnessing on line testing, this should be resorted to. In this
case the different participant laboratories may be asked to carry out testing on different
days at different times to enable the PT Provider to monitor testing activities. Similarly in
case studies as for sampling, PT provider may videograph the conduct of case study if
practically possible or get witnessed the case study from independent experts in its
advisory group.
xii. The case studies in sampling should be well documented, approved by independent
experts and objective evaluation should be possible.

ANNEXURE C
Example of Flow Chart to be followed by Proficiency Testing Provider
Proficiency Testing Provider
Send initial detailed proposal and invite nominations
Scrutinize and accept nominations of laboratories
Arrange distribution of samples after establishing

homogeneity and stability along with instructions
Receive reports from Laboratory
Send interim report to participating Laboratory
Request,
Corrections if
required
Send draft report

to participating
Yes
laboratory for
comments
Receive comments and take necessary actions

No
Send final report to participating laboratories in time
Where performance satisfactory
End
Request laboratory for
corrective actions in
case of unsatisfactory
performance
If required provider assistance to participating laboratory

for result evaluation
End

TECHNICAL COMMITTEE MEMBERS
Sh. Anil Relia Chairman

Director, NABL
Sh. S.K. Kimothi Member

Ex-Director
ERTL (N)
Ms. Rajalakshmi Subrahmanyam Member

Ex-Director,
BIS (SRO)
Sh. S. Subramanian Member

Ex-Joint Director
Textile Committee, Mumbai
Ms. Shobha Hegde Member

Ex-Director
BIS (WRO)
Dr. Sukesh Chandran Nair Member

Prof. & Head, Dept. of Transfusion Medicine & Immunohaematology
CMC, Vellore
Dr. Rina Sharma Member

Scientist E II
NPL, New Delhi
Dr. Aparna Dhawan Convener

NABL
Ms. Anita Rani Co-Convener

NABL

3rd Floor, NISCAIR
14, Satsang Vihar Marg
New Mehrauli Road
New Delhi – 110 067
Tel.: +91-11 -46499999
Fax: 91-11 26529716
Website: www.nabl-india.org

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NABL 181

Sl Page Clause Date of Amendment made Reasons Signature Signature

National Accreditation Board for Testing and Calibration Laboratories

AOAC : Association of Official Analytical Chemists

APHA : American Public Health Association

APLAC : Asia Pacific Laboratory Accreditation Cooperation

ASTM : American Society for Testing and Materials

BIS : Bureau of Indian Standards

CRM : Certified Reference Material

e.g. : For Example

ISO : International Organization for Standardization

IEC : International Electro-technical Committee

ILAC : International Laboratory Accreditation Cooperation

IUPAC : International Union of Pure and Applied Chemists

NABL : National Accreditation Board for Testing and Calibration Laboratories

w.r.t. : with respect to

National Accreditation Board for Testing and Calibration Laboratories

Annexure-A (Specified Requirements for Personnel) 17

Annexure-B (Guidance for Prevention of Collusion and Falsification 21

while Conducting PT Programs by PT Provider)

Annexure-C (Example of Flow Chart to be followed by Proficiency 23

6. Technical Committee Members 24

National Accreditation Board for Testing and Calibration Laboratories

1.4 PT Providers providing services for tests/calibration/inspection on different PT Item(s)

National Accreditation Board for Testing and Calibration Laboratories

National Accreditation Board for Testing and Calibration Laboratories

3.2 This criteria amplifies/adds to the requirements specified in ISO/IEC 17043:2010

3.3 Examples are cited below for guidance:

3.3.1 Examples for Chemical/Biological Testing

Pesticide Honey Endosulfan 10µg -50 mg/L One time in a

3.3.2 Examples for Mechanical Testing

3.3.3 Examples for Medical Testing

3.3.4 Examples for Measurement / Calibration

3.3.5 Examples for sampling

National Accreditation Board for Testing and Calibration Laboratories

The development and operation of proficiency testing schemes shall be undertaken by

4.3 Equipment, Accommodation and Environment Conditions

Designing of PT scheme involves: Planning of scheme, preparation of PT items, Conducting

4.4.1 Planning of Scheme

National Accreditation Board for Testing and Calibration Laboratories

4.4.3 Homogeneity and Stability

When a method of sample preparation is used such that homogeneity criteria as

4.4.4 Statistical Design

4.4.5 Assigned Value

National Accreditation Board for Testing and Calibration Laboratories

4.5 Choice of Method

4.6 Operation of Proficiency Testing Schemes

A typical example of process flow of operation of PT scheme is provided in Annexure C.

National Accreditation Board for Testing and Calibration Laboratories

2. Format for recording/reporting of the PT results including unit of measurement and

4.6.2 Proficiency Test Items Handling and Storage

4.6.3 Packaging, Labeling and Distribution of Proficiency Test Items

If the proficiency test item is to be returned to PT Provider or forwarded to another

National Accreditation Board for Testing and Calibration Laboratories

4.7.1 Data Analysis and Records

Requirements stipulated in ISO/IEC 17043:2010 shall apply.

4.7.2 Evaluation of Performance

e. If performance evaluation criteria consider the participants reported estimate of

National Accreditation Board for Testing and Calibration Laboratories

In case performance evaluation is reported in terms of En value/Zeta score, PT

4.9 Communication with Participants

Requirements stipulated in ISO/IEC 17043:2010 shall apply. The records of

National Accreditation Board for Testing and Calibration Laboratories