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 AMENDMENT NO : 00 ISSUE DATE: 01.06.2011 AMENDMENT DATE: --

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

AMENDMENT SHEET

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Amendment made Reasons Signature QO

Signature Director

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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: ii

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

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: iii

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

while Conducting PT Programs by PT Provider)

21

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

Testing Provider)

23

6. Technical Committee Members 24

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 Amend No: 00 Amend Date: - Page No. 1/24

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.


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

Item (as defined in 3.8)

Parameter(s) Range of Measurement (if applicable)

Periodicity (Minimum)

Remarks

Heavy Metals in Food

Water Cadmium Lead Arsenic Mercury

10µg/L to 100mg/L

3 times a year

Pesticide Residue in Food

Honey Endosulfan Malathion

10µg -50 mg/L One time in a year

Food Chemistry Program

Cereals Milk Powder

Protein Ash Moisture Fat

5% to 50% 1% to 10 % 0.5% to 10% 0.5% to 15%

3 times in a year

Food Microbiology

Water, Meat, Milk Powder

Coliforms E –coli Yeast and Mould

- Twice a year

Textile Chemistry Program

Fabrics, Garments Colour Fastness Fibre Composition, pH

Grade 1 to 5 Upto 100% 1 to 14

Twice a year Qualitative Scheme Method as per participant lab

3.3.2 Examples for Mechanical Testing PT Scheme Sample/Matrix/

Artifact Parameter(s) Range of

Measurement Frequency Method

Metallic Materials –Physical Testing Program

Ferrous and Non Ferrous Materials

Hardness-HRC Charpy Impact V Notch Tensile Testing

10HRC to 90HRC 10J to 40J 200N/mm2 to 600N/mm2

Once a year ASTM E 18

Metallic Material- Metallographic Program

Ferrous and Non Ferrous Materials

Grain Size

Once a year


Textile in Mechanical

Fabrics Garments

Tensile Strength GSM Dimensional Stability

100N to 5000N 25 to 500 -50% to +20%

Twice in a year

ASTM D 5034 and 5035 or IS 1969

3.3.3 Examples for Medical Testing PT Scheme Sample/Matrix/

Artifact Parameter(s) Range of

Measurement Periodicity Remarks

Human Body Fluids Scheme-1

Urine Sodium Urea Glucose Creatinine

Six times a year

Human Body Fluids Scheme-2

Whole Blood Haemoglobin Glucose

Eight times a year

Complete Blood Count

Whole blood Heamoglobin RBC WBC Platelets MCV

Six times a year

3.3.4 Examples for Measurement / Calibration PT Scheme PT Item Parameter(s) Range of


Dimensional Metrology Program 1

Portable Gauging and Hand Tools

Micrometers Dial Indicators

Upto 50mm Upto 12.5mm

Once in a year

Dimensional Metrology Program 1

ID- Artifacts and Parts

Plug Gauges Ring Gauges

Upto 500mm Upto 100mm

Electrical Measurement Program

Current Voltage (Measure/Source)

DC Current DC Voltage

1mA to 3A 10mV to 1000V

Mass Weights/Balance Mass 1mg to 1 kg

Once in two years

Temperature Thermometers/ Thermocouples

Temperature 1ºC to 600ºC

3.3.5 Examples for sampling PT Scheme PT Item Parameter(s) Range of


Sampling in Ambient Air Monitoring

Case study based on Sampling Guidelines for Ambient Atmosphere as per IS:5182 part-14

Sampling Procedure

- Once a year To assess performance of labs for pre-analytical 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 Requirements stipulated in ISO/IEC 17043:2010 shall apply.

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

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

5.10 Improvement


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

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

5.13 Control of Records Requirements stipulated in ISO/IEC 17043:2010 shall apply.

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

Request, Corrections if

required

Yes

Receive comments and take necessary actions

Send draft report to participating laboratory for

comments

Send interim report to participating Laboratory

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

National Accreditation Board for Testing and Calibration Laboratories 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

http://www.nabl-india.org/�

Documents

NABL 181-Specific Criteria for PT Provider Accreditation