NABL 181-Specific Criteria For PT Provider Accreditation

NABL 181
NABL
NATIONAL ACCREDITATION
BOARD FOR TESTING AND
CALIBRATION LABORATORIES
SPECIFIC CRITERIA
for PT PROVIDER
ACCREDITATION
ISSUE NO : 01
ISSUE DATE: 01.06.2011
AMENDMENT NO : 00
AMENDMENT DATE: --
AMENDMENT SHEET
Sl
Page
No.
Clause
Date of
No. Amendment
Amendment made
Reasons
Signature
QO
Signature
Director
10
National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 181
Issue No: 01
Specific criteria for Proficiency Testing Provider

Issue Date: 01.06.2011
Last Amend No: 00
Amend Date: --
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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
NGO
Non-governmental Organisation
PT
Proficiency Testing
QC
Quality Control
w.r.t.
with respect to

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CONTENTS
Sl
Title
Page
Amendment Sheet
Abbreviations
ii
Contents
iii
1.
Scope
2.
References
3.
Introduction
4.
Technical Requirements
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

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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.

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Specific Criteria for Proficiency Testing Provider

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2.
REFERENCES
o
ISO/ IEC 17043: 2010, Conformity assessment General requirement for proficiency
testing
ISO/IEC 13528: 2005, Statistical methods for use in proficiency testing by inter
laboratory comparisons
ISO/IEC 17025: 2005, General requirements for the competence of testing and
calibration laboratories
ISO/IEC 17020:1998, General criteria for the operation of various types of bodies
performing inspection
ISO 15189:2007, Medical laboratories - Particular requirements for quality and

competence
IUPAC Harmonized Protocol for the Proficiency Testing of Analytical Chemistry

Laboratories, 1996
ISO/IEC Guide 99: 2007, International Vocabulary of Metrology-Basic and General

concepts and associated terms (VIM)
ISO/IEC 17000:2004, Conformity Assessment- Vocabulary and General Principles.

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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 providers accreditation certificate. A PT providers 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 providers
accreditation. The format below typically defines the PT providers 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
Item (as defined in
3.8)
Water
Parameter(s)
Pesticide
Residue in Food
Food Chemistry
Program
Honey
Food
Microbiology
Water, Meat, Milk

Powder
Textile Chemistry
Program
Fabrics, Garments
Endosulfan
Malathion
Protein
Ash
Moisture
Fat
Coliforms
E coli
Yeast and
Mould
Colour
Fastness
Fibre
Composition,
pH
Heavy Metals in
Food
3.3.2
Cereals
Milk Powder
Cadmium
Lead
Arsenic
Mercury
Range of
Measurement
(if applicable)
10g/L to
100mg/L
Periodicity
(Minimum)
10g -50 mg/L
One time in a
year
3 times in a
year
Remarks
3 times a year
5% to 50%
1% to 10 %
0.5% to 10%
0.5% to 15%
-
Twice a year
Grade 1 to 5
Twice a year
Upto 100%
1 to 14
Qualitative
Scheme
Method as
per
participant
lab
Examples for Mechanical Testing

PT Scheme
Metallic Materials
Physical Testing
Program
Metallic MaterialMetallographic
Program
Sample/Matrix/
Artifact
Ferrous and Non
Ferrous Materials
Ferrous and Non

Ferrous Materials
Parameter(s)
Hardness-HRC
Charpy Impact V
Notch
Tensile Testing
Grain Size
Range of
Frequency
Measurement
10HRC to 90HRC Once a year
10J to 40J
2
200N/mm to
2
600N/mm
Once a year
Method
ASTM E
18

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Textile in
Mechanical
3.3.3
Fabrics
Garments
Human Body
Fluids Scheme-1
Human Body
Fluids Scheme-2
Complete Blood
Count
3.3.5
100N to 5000N
Parameter(s)
Range of
Measurement
Twice in a
year
ASTM D
5034 and
5035 or IS
1969
Periodicity
Remarks
25 to 500
-50% to +20%
Examples for Medical Testing

PT Scheme
3.3.4
Tensile Strength
GSM
Dimensional
Stability
Sample/Matrix/
Artifact
Urine
Whole Blood
Whole blood
Sodium
Urea
Glucose
Creatinine
Haemoglobin
Glucose
Heamoglobin
RBC
WBC
Platelets
MCV
Six times a
year
Eight times
a year
Six times a
year
Examples for Measurement / Calibration

PT Scheme
PT Item
Parameter(s)
Dimensional
Metrology
Program 1
Dimensional
Metrology
Program 1
Electrical
Measurement
Program
Mass
Portable Gauging
and Hand Tools
Micrometers
Dial Indicators
Range of
Measurement
Upto 50mm
Upto 12.5mm
ID- Artifacts and

Parts
Plug Gauges
Ring Gauges
Upto 500mm
Upto 100mm
Current
Voltage
(Measure/Source)
Weights/Balance
DC Current
DC Voltage
1mA to 3A
10mV to 1000V
Mass
1mg to 1 kg
Temperature
Thermometers/
Thermocouples
Temperature
1C to 600C
Range of
Measurement
-
Periodicity
Remarks
Once in a
year
Once in two
years
Examples for sampling

PT Scheme
PT Item
Parameter(s)
Sampling in
Ambient Air
Monitoring
Case study based

on Sampling
Guidelines for
Ambient
Atmosphere as per
IS:5182 part-14
Sampling
Procedure
Periodicity
Remarks
Once a year
To assess
performanc
e of labs
for preanalytical
phase and
post
analytical
phase

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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 subcontractors 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.
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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.

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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.
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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.
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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.

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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.
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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.

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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.

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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

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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.

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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
essentially cover various stages in a life cycle of a Proficiency
testing
internal audit shall

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
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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.
*******

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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 interlaboratory 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. )

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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
organisations
field
accreditation/compliance.

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of
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.

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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
advisory/steering group shall be maintained.

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of
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).

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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.

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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
laboratory for
comments
Yes
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

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TECHNICAL COMMITTEE MEMBERS
Sh. Anil Relia

Director, NABL
Chairman
Sh. S.K. Kimothi

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

Ex-Director,
BIS (SRO)
Member
Sh. S. Subramanian
Ex-Joint Director
Textile Committee, Mumbai
Member
Ms. Shobha Hegde

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

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

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

NABL
Convener
Ms. Anita Rani

NABL
Co-Convener

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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

NABL 181-Specific Criteria For PT Provider Accreditation

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NABL 181

National Accreditation Board for Testing and Calibration Laboratories

Specific criteria for Proficiency Testing Provider

Association of Official Analytical Chemists

American Public Health Association

Asia Pacific Laboratory Accreditation Cooperation

American Society for Testing and Materials

Bureau of Indian Standards

Certified Reference Material

International Organization for Standardization

International Electro-technical Committee

International Laboratory Accreditation Cooperation

International Union of Pure and Applied Chemists

National Accreditation Board for Testing and Calibration Laboratories

National Accreditation Board for Testing and Calibration Laboratories

Specific criteria for Proficiency Testing Provider

Annexure-A (Specified Requirements for Personnel)

Annexure-B (Guidance for Prevention of Collusion and Falsification

while Conducting PT Programs by PT Provider)

Technical Committee Members

National Accreditation Board for Testing and Calibration Laboratories

Specific criteria for Proficiency Testing Provider

Page No: iii

This document provides amplification / explanation / additions to the requirements stipulated

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

National Accreditation Board for Testing and Calibration Laboratories

Specific Criteria for Proficiency Testing Provider

Page No. 1/24

ISO 15189:2007, Medical laboratories - Particular requirements for quality and

IUPAC Harmonized Protocol for the Proficiency Testing of Analytical Chemistry

ISO/IEC Guide 99: 2007, International Vocabulary of Metrology-Basic and General

ISO/IEC 17000:2004, Conformity Assessment- Vocabulary and General Principles.

National Accreditation Board for Testing and Calibration Laboratories

Specific Criteria for Proficiency Testing Provider

Page No. 2/24

The Scope of accreditation of a PT Provider is the formal statement of the range of PT

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

Examples are cited below for guidance:

Examples for Chemical/Biological Testing

Water, Meat, Milk

10g -50 mg/L

Examples for Mechanical Testing

Ferrous and Non

National Accreditation Board for Testing and Calibration Laboratories

Specific Criteria for Proficiency Testing Provider

Page No. 3/24

Examples for Medical Testing

Examples for Measurement / Calibration

ID- Artifacts and

Examples for sampling

Case study based

National Accreditation Board for Testing and Calibration Laboratories

Specific Criteria for Proficiency Testing Provider

Page No. 4/24

Equipment, Accommodation and Environment Conditions

Specific Criteria for Proficiency Testing Provider

Page No. 5/24

National Accreditation Board for Testing and Calibration Laboratories

Specific Criteria for Proficiency Testing Provider