The International Standard

ISO/IEC 17043: 2023

Conformity assessment — General
requirements for the competence of
proficiency testing providers

Introduction

ISO/IEC 17043: 2023 has been issued in May 2023 by

ISO and IEC to specify the general requirements for the
Competence of proficiency testing providers

This second edition cancels and replaces the first edition

(ISO/IEC 17043:2010), which has been technically
revised

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Introduction

The main changes compared to the previous edition
are as follows:
 harmonization with ISO/IEC 17025:2017, including technical
requirements and structure;
 harmonization with ISO 13528:2022 in terms of terminology;
 incorporation of requirements from ISO/CASCO PROC 33;
 inclusion of the requirement that testing & calibration activities
and PT item production conform to the relevant requirements of
appropriate ISO conformity assessment standards;
 deletion of Annex C and revision of Annexes A and B.
 Alignment with the CASCO common structure for standards
and incorporation of CASCO common elements in clauses on
impartiality, confidentiality, complaints and management system
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Introduction

Transition Period
Transition period of 3 years has been approved by ILAC on 15
Nov 2022

ILAC Resolution GA 26.09

As the revised version of ISO/IEC 17043 is scheduled for
publication in 2022 or early 2023, the General Assembly endorses
the recommendation of the AIC that a transition period of 3 years
from the date of publication be adopted.

At the end of the transition period, accreditation of a proficiency

testing provider to ISO/IEC 17043:2010 will not be recognized
under the ILAC Arrangement.
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Introduction

Transition Period
 The AB is required to establish a transition plan to ensure
conforming with the requirements of the new edition of the
standard.
 The transition time will be completed before the due date of 3
years
 The accreditation of the PTP to the new revision will be based
on regular or extraordinary assessments
 All NCs resulting from the assessments based on the new
ISO/IEC 17043 will be closed before the end of the transition
period

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ISO/IEC 17043: 2023 Contents

1. Scope
2. Normative references
3. Terms and definitions
4. General requirements
4.1 Impartiality
4.2 Confidentiality
5. Structural requirements

6. Resources requirements
6.1 General
6.2 Personnel
6.3 Facilities and environmental conditions
6.4 External provided products and services
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ISO/IEC 17043: 2023 Contents

7. Process requirements
7.1 Establishing, contracting and communicating the PT scheme
objectives.
7.1.1 Review of requests, tenders and contracts
7.1.2 PT scheme communication
7.2 Design and planning of a PT scheme
7.2.1 General
7.2.2 Statistical design
7.2.3 Determination of assigned values
7.3 Production and distribution of PT items
7.3.1 Production of PT items.
7.3.2 Homogeneity and stability assessment of PT items
7.3.3 Handling and storage of PT items
7.3.4 Packaging, labelling and distribution of PT items
7.3.5 Instructions for participants
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ISO/IEC 17043: 2023 Contents

7. Process requirements ( continue)
7.4 Evaluation and reporting of PT scheme results
7.4.1 Data analysis
7.4.2 Evaluation of performance
7.4.3 PT reports
7.5 Control of the PT scheme process
7.5.1 Technical records
7.5.2 Control of data and information management
7.5.3 Surveillance of the processes
7.5.4 Nonconforming work
7.6 Handling of complaints
7.7 Handling of appeals

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ISO/IEC 17043: 2023 Contents
8. Management system requirements
8.1 General requirements
8.2 Management system documentation
8.3 Control of Management system documents
8.4 Control of records
8.5 Actions to address risks and opportunities
8.6 Improvements
8.7 Corrective actions
8.8 Internal audit
8.9 Management review

Annex A: (Informative) Types of PT schemes

Annex B: (Informative) Statistical methods for PT

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1. Scope

This document specifies general requirements for the
competence and impartiality of proficiency testing (PT)
providers and consistent operation of all proficiency testing
schemes.

This document can be used as a basis for specific technical

requirements for particular fields of application.

Users of proficiency testing schemes, regulatory authorities,

organizations and schemes using peer-assessment,
accreditation bodies and others can use these requirements in
confirming or recognizing the competence of proficiency
testing providers

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2.Normative references

ISO/IEC Guide 99, International vocabulary of metrology —

Basic and general concepts and associated terms (VIM)

ISO/IEC 17000, Conformity assessment — Vocabulary and

general principles

ISO/IEC 17025, General requirements for the competence of

testing and calibration laboratories

ISO 17034, General requirements for the competence of

reference material producers

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3. Terms and definitions

12 definitions
• Assigned Value
• Consensus value
• Customer
• Interlaboratory comparisons
• Outlier
• Participant
• Proficiency testing
• Proficiency testing item (PT item)
• Proficiency testing provider
• Proficiency testing round
• Proficiency testing scheme
• Standard deviation forMahmoud
proficiency
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4. General requirements
4.1 Impartiality

The PT activities are undertaken impartially

PT provider is structured & managed so as to safeguard impartiality

The PT provider does not allow commercial, financial or other

pressures to compromise impartiality.

The PT provider monitors its activities and its relationships to

identify threats to its impartiality. This monitoring includes the
relationships of its personnel.

The effect of identified threats is eliminated or minimized

Top management commitment to impartiality.

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4. General requirements
4.2 Confidentiality

legally enforceable agreement , for the management of all

information obtained or created during the performance of PT
activities.
Client informed in advance, of the information to be placed in the
public domain.

Client is notified of the confidential information released as

required by law or authorized contractual agreements.

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4. General requirements
4.2 Confidentiality

Information about the participant or customer obtained from other

sources (e.g. complainant, regulators) is also confidential. The
source is confidential to the PT provider unless agreed with the
source.

Information obtained during performance of the PT activities are

kept confidential by all personnel including any committee
members, contractors, personnel of external bodies or persons
acting on the PT provider’s behalf

The identity of participants in a PT scheme is confidential and

known only to persons involved in the operation of PT scheme,
unless the participant or the Mahmoud
customerEltayeb
waives confidentiality

5. Structural requirements

The PTP is a legal entity, or a defined part of a legal entity, that is
legally responsible for its lab activities.
(governmental PTP is deemed to be a legal entity on the basis of its
governmental status)

Management that has overall responsibility for the PTP activities is

identified

The range of PT schemes for which it conforms with this standard is

defined and documented.
The PTP claims conformity with this standard for this range of PT
schemes only

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5. Structural requirements

The PT activities meet the requirements of this standard, customers,
participants , regulatory authorities and organizations providing
recognition.
The PT activities can be performed in PTP permanent facilities and
any other facility or site

The PTP has :

 Organization and management structure, its place in any parent
organization, and the relationships between management,
technical operations and support services
 Responsibility, authority and interrelationship of all personnel
 Procedures documented to the extent necessary to ensure the
consistent application and validity of PT activities.

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5. Structural requirements

The PTP has personnel with authorities and responsibilities to carry
out their duties including:
 Implementation, maintenance and improvement of MS
 Identification of deviations from the MS for performing activities
 Initiation of actions to prevent or minimize such deviations;
 Reporting to its management on the performance of MS and any
need for improvement;
 Ensuring the effectiveness of PT activities.

PTP management ensures :

 Communication takes place regarding effectiveness of MS and
importance of meeting requirements of participants, customers,
regulatory authorities and organizations providing recognition.
 The integrity of the MS is maintained when changes to the MS
are planned and implemented.
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6. Resource requirements
6.1 General

The PTP has access to the personnel, facilities, equipment, systems
and support services necessary to manage and perform its PT
activities.

Measurements or tests conducted under the responsibility of the PTP,

related to PT item characterization or for assessing homogeneity and
stability, are conducted in accordance with the relevant requirements
of ISO/IEC 17025 or for medical area ISO 15189.

Where the PT item is a “reference material”, it is produced under

conditions that meet the relevant requirements of ISO 17034 or for
medical area ISO 15194.
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6. Resource requirements
6.2 Personnel

Access to a sufficient number of competent personnel to perform PT
activities.

Personnel have the competence to perform the PT activities for

which they are responsible and to evaluate the significance of
deviations.

A process for managing competence of personnel.

All personnel (internal or external) act impartially

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6. Resource requirements
6.2 Personnel

Documented information demonstrating competence of personnel
including the requirements for education, qualification, training,
technical knowledge, skills and experience.

Authorization to personnel to perform specific activities within PT

schemes including but not limited to:
 plan PT schemes
 assess data/information to determine stability & homogeneity and
assigned values and associated uncertainties
 evaluate the performance of PT participants
 give opinions and interpretations and advice to participants
 review and authorize PT reports.

PT provider management communicates to all personnel their duties,
responsibilities and authorities.
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6. Resource requirements
6.3 Facilities and environmental conditions

Appropriate facilities for the operation of the PT scheme.

Environmental conditions do not compromise PT activities,

including operations undertaken at sites away from the PT provider's
permanent facilities or that are undertaken by external service
providers

Environmental conditions that can influence the validity of the PT

items and any measurements or tests carried out are documented.
Control, monitor, record and periodically review of these conditions
(Influences: microbial contamination, dust, electromagnetic
disturbances, radiation, humidity, electrical supply, temperature, ….)
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6. Resource requirements
6.3 Facilities and environmental conditions

Access control to, and use of, areas affecting the PT activities are
managed. The extent of access control based on particular
circumstances is determined.

Appropriate separation between neighbouring areas in which there

are incompatible PT activities.
Action is taken to prevent cross-contamination, interference or
adverse influences on PT activities

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6. Resource requirements
6.4 Externally provided products and services

External service providers are not used for the following activities:
 the design and planning of PT schemes;
 the evaluation of performance;
 the authorization of reports
This does not prevent the PT provider from using advice or
assistance from any advisors, experts or steering groups.

Procedures to ensure the experience & technical competence of the

providers of external products and services and the compliance with
relevant clauses of this document and other appropriate documents.

Participants and customers are informed in advance and in writing,

of products and services that are or can be provided externally, when
they affect the validity of theMahmoud
PT activities
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6. Resource requirements
6.4 Externally provided products and services

A procedure and records for:

 defining, reviewing and approving the requirements for
externally provided products and services;
 defining the criteria for evaluation, selection, monitoring of
performance and re-evaluation of the external providers;
 ensuring that externally provided products and services conform
to the established requirements, before used or directly provided
to the customer or participant
 taking any actions arising from evaluations, monitoring of
performance of the external providers.

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6. Resource requirements
6.4 Externally provided products and services

Communicate the requirements to external providers for:

 products and services to be provided;
 the acceptance criteria;
 competence, including any required qualification of personnel or
organization;
 activities that the PT provider or its customer, intends to perform
at the external provider's premises.

The PT provider is responsible to the participants or customers for
the externally provided products and services.
In cases where the customer or a regulatory authority specifies the
external provider to be used, the PT provider can take actions to
minimize undesired effect that directly affects the validity of PT
activities. Mahmoud Eltayeb

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 Case Study 1

Group Work
Each individual should be given the opportunity to participate

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7. Process requirements

The process requirements provide a flow of operations and focus on

how the PT provider operates.

Item
Item

request PT
Report

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7. Process requirements
7.1 Establishing, contracting and communicating the PT
scheme objectives
7.1.1 Review of requests, tenders and contracts

Procedure for the review of requests, tenders and contracts:
 The objectives of the PT scheme are sufficiently defined and in
agreement with the customers' needs
 The requirements are adequately defined, documented &
understood
 The PTP has the capability and resources to meet the
requirements
 the PT scheme is technically appropriate taking into account the
needs of the given application or field of application.
This review is particularly important when a customer requests a PT
scheme to be created for a specific purpose or for a different level or
frequency of participation from that normally offered.
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7. Process requirements
7.1 Establishing, contracting and communicating the PT
scheme objectives
7.1.1 Review of requests, tenders and contracts

The review covers all aspects of the request, including any externally
provided products and services.

Records of reviews, including any significant changes, are retained.

Including pertinent discussions with a customer relating to their
requirements, or the results of the PT activities.

The customer is informed of any deviation from the contract

The request /contract review is repeated if the request /contract is

amended after the PT scheme is underway
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7. Process requirements
7.1 Establishing, contracting and communicating the PT
scheme objectives
7.1.2 PT scheme communication

Detailed information available about the PT scheme to participants
and customers:
Objectives and details of the PT scheme – criteria for participation -
criteria for determining the assigned value and the evaluation of
performance- confidentiality arrangements - critical timelines - any
fees for participation- details of how to apply

Participants and customers are advised in a timely manner by the PT

provider of any changes in PT scheme design or operation

Records of relevant communications are maintained and retained by

the PT provider, as appropriate.
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7. Process requirements
7.2 Design and planning of a PT scheme
7.2.1 General

Identification , design and planning of the activities which directly
affect the validity of the PT scheme and ensuring that activities are
carried out in accordance with prescribed procedures.
When designing and planning the PT scheme, the relevant standards and
requirements specific to the objectives of the PT scheme can be considered, e.g.
ISO/IEC 17025, ISO 15189, ISO/IEC 17020. Safety and ethical issues can also be
considered.

The risk is identified and managed to ensure the validity of the PT

scheme when a PT provider intends to introduce significant changes
to activities.
New approaches for PT item production, assessment of homogeneity and stability,
determination of the assigned value, statistical analysis
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7. Process requirements
7.2 Design and planning of a PT scheme
7.2.1 General

A documented plan is developed before commencement of the PT
scheme that addresses the objectives, purpose and basic design of the
PT scheme. The plan includes the following:
a) Personnel involved in the design and operation of PT scheme;
b) activities to be undertaken by external providers and their contact details;
c) criteria to be met for participation in the PT scheme;
d) the number and type of expected participants in the PT scheme;
e) activities to be performed & results to be reported by participants;
f) a description of the range of values or characteristics, or both, to be expected for
the PT items;
g) potential major sources of errors involved in area of PT offered;
h) requirements for production, quality control, storage & distribution of PT items;

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7. Process requirements
7.2 Design and planning of a PT scheme
7.2.1 General
i) arrangements to prevent collusion between participants or falsification of results and
procedures to be employed if collusion or falsification of results is suspected;
j) a description of the information which will be supplied to participants and the time
schedule for the various phases of the PT scheme;
k) for continuous PT schemes, the frequency or dates upon which PT items will be
distributed to participants, the deadlines for the return of results by participants , the
dates to carry out measurements or tests by participants;
l) any information on methods or procedures which participants must use to store,
handle, prepare, ship or dispose of PT item and perform the measurements or tests;
m) procedures for the measurement or test methods to be used for the homogeneity
and stability testing of PT items
n) preparation of any standardized reporting formats for use by participants;

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7. Process requirements
7.2 Design and planning of a PT scheme
7.2.1 General
o) a detailed description of the statistical analysis to be used;
p) the origin, metrological traceability and uncertainty of any assigned values
Note: Assigned values can have uncertainty contributions from sources in addition to
the uncertainty of measurement results used for characterization, such as
inhomogeneity & instability, and interlaboratory differences if more than one
laboratory is used for characterization
q) the treatment of results from different measurement or test methods, where
permitted by the PT scheme;
r) criteria for the evaluation of the performance of participants;
s) a description of the data, interim reports or information to be returned to
participants;
t) a description of the extent to which participant results, and conclusions that are
based on the outcome of the PT scheme, will be made public or shared;
u) actions to be taken in the case of lost, delayed or damaged PT items

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7. Process requirements
7.2 Design and planning of a PT scheme
7.2.2 Statistical design

Statistical designs is developed to meet the objectives of the scheme,
based on the nature of the data (quantitative or qualitative), statistical
assumptions, the nature of errors, and the expected number of results

NOTE Statistical design covers the process of planning, collection, analysis and
reporting of the PT scheme data. Statistical designs are often based on stated
objectives for the PT scheme, such as determination of assigned values with specified
measurement uncertainty

The statistical design and data analysis methods to be used to

identify the assigned value and evaluate participant results, are
documented. The reasons for their selection and assumptions upon
which they are based are described.
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7. Process requirements
7.2 Design and planning of a PT scheme
7.2.2 Statistical design

In designing a statistical analysis, PTP gives careful consideration
to the following:
a) the accuracy as well as the measurement uncertainty required or
expected for each measurand or characteristic in PT scheme
b) the minimum number of participants in the PT scheme needed for
the statistical design. In cases of insufficient number of participants
to produce statistically meaningful analysis of results, details of
alternative approaches used to assess participant performance
c) the relevance of significant figures to the reported result,
including the number of decimal places
d) the number of PT items to be measured and the number of repeat
tests or measurement for each PT item
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7. Process requirements
7.2 Design and planning of a PT scheme
7.2.2 Statistical design
e) the procedures used to establish the standard deviation for
proficiency assessment or other evaluation criteria
f) the procedures to be used to treat participant results from different
measurement or test methods which are not technically equivalent,
where permitted by the PT scheme
g) whether the measurement uncertainty of participant results shall
be reported and how it will be used to evaluate the participant's
performance
h) procedures to be used to identify or handle outliers
g) where relevant, the procedures for the evaluation of values
excluded from statistical analysis; and
j) where appropriate, the objectives to be met for the design and the
frequency of PT rounds. Mahmoud Eltayeb

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7. Process requirements
7.2 Design and planning of a PT scheme
7.2.2 Statistical design
Statistical methods for proficiency testing ( Annex B)
ISO 13528 describes preferred specific methods for each of the
situations discussed below, but also states that other methods may be
used as long as they are statistically valid and are fully described to
participants.
The methods covers the fundamental steps common to nearly all PT
schemes

Preliminary determination of test item homogeneity & stability

Determination of the assigned values

Calculation of performed statistics

Evaluation of performance
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7. Process requirements
7.2 Design and planning of a PT scheme
7.2.3 Determination of assigned values

Procedure for determining the assigned values for the measurands or

characteristics in a particular PT scheme taking into account the
metrological traceability and measurement uncertainty required to
demonstrate that PT is fit for its purpose.

PT schemes in the area of calibration shall have assigned values with

metrological traceability, including measurement uncertainty.

For PT schemes in areas other than calibration, the relevance, needs

and feasibility for metrological traceability and associated
measurement uncertainty of the assigned value is determined by
taking into account the purpose of the PT scheme.
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7. Process requirements
7.2 Design and planning of a PT scheme
7.2.3 Determination of assigned values

When a consensus value is used as the assigned value, the estimate

of the uncertainty of the assigned value is described as in the plan for
the PT scheme.

Policy regarding the disclosure of assigned values. The policy

ensures that participants cannot gain advantage from early
disclosure.

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7. Process requirements
7.2 Design and planning of a PT scheme
7.2.3 Determination of assigned values

Determination of assigned value and its uncertainty (Annex B)

Formulation

Certified reference values

Results from one laboratory

Consensus values from expert laboratories

Consensus value from participant results (a chosen subset, or all
participants).
ISO 13528 describes a specific robust method for determination of the
consensus mean and standard deviation, without the need for outlier
removal

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7. Process requirements
7.3 Production and distribution of PT items
7.3.1 Production of PT items

Procedures to ensure that PT items are prepared in accordance with

the plan described and are fit for the PT scheme's purpose.

Procedures to ensure appropriate acquisition, collection, preparation,

handling, storage and disposal of all PT items.

In PT schemes that require participants to prepare or manipulate PT

item and submit it to PTP, the PTP issue instructions for preparation,
packaging, storage and shipping of the PT item.

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7. Process requirements
7.3 Production and distribution of PT items
7.3.2 Homogeneity and stability assessment of PT items

Criteria for suitable homogeneity and stability based on the effect

that inhomogeneity and instability will have on the evaluation of the
participants' performance.

Procedures for the assessment of homogeneity and stability are

documented and conducted in accordance with appropriate statistical
designs.

The assessment of homogeneity and stability is performed for every

PT round after the PT items have been packaged in their final form.
Different approaches are described in Annex B of this document, in ISO 13528 and
in ISO Guide 35.
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7. Process requirements
7.3 Production and distribution of PT items
7.3.2 Homogeneity and stability assessment of PT items

Where experimental evidence is needed to assess homogeneity or

stability of the PT item (or both), the PT provider uses appropriate
methods to assess the homogeneity and stability of the PT item.

PT items are demonstrated to be sufficiently stable to ensure that

they will not undergo any significant change throughout the conduct
of the PT round. When this is not possible, the stability is quantified
and considered as an additional component of uncertainty associated
with the assigned value of the PT item and/or taken into account in
the evaluation criteria..

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7. Process requirements
7.3 Production and distribution of PT items
7.3.2 Homogeneity and stability assessment of PT items

When PT items from previous PT rounds are retained for another PT

round, property values or characteristics to be determined in the PT
scheme are confirmed by the PT provider prior to distribution.

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7. Process requirements
7.3 Production and distribution of PT items
7.3.3 Handling and storage of PT items

From the time of production to their distribution to participants, the

PT provider ensures that PT items are appropriately identified and
stored to prevent contamination, damage or deterioration.

Appropriate procedures for dispatch to, and receipt from, storage.

The condition of stored PT items is assessed at specified intervals or

prior to distribution in order to detect possible deterioration.

Where potentially hazardous PT items are used, facilities are

available to ensure their safe handling, decontamination and disposal.
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7. Process requirements
7.3 Production and distribution of PT items
7.3.4 Packaging, labelling and distribution of PT items

Control of packaging and labeling processes to the extent necessary

to ensure conformity with relevant national, regional, or international
safety and transport requirements

Relevant environmental conditions for the transport of PT items are

documented . Where relevant, the environmental conditions of PT
item are monitored during transport

In PT schemes where participants are required to transport PT items

to other participants, documented instructions for this transport is
supplied
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7. Process requirements
7.3 Production and distribution of PT items
7.3.4 Packaging, labelling and distribution of PT items

labels are securely attached to the packaging of individual PT items

and are designed to remain legible and intact throughout the PT
round.

A procedure to enable the confirmation of delivery of the PT items is

followed.

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7. Process requirements
7.3 Production and distribution of PT items
7.3.5 Instructions for participants

PTP gives participants sufficient prior notice before sending PT

items, providing the date on which the PT items are likely to arrive
or to be dispatched

PTP gives detailed documented instructions to all participants

including :
a) the necessity to treat PT items as the routine tested samples
b) details of factors which could influence the testing or calibration
of the PT items, e.g. conditions of storage, test methods, and timing
of testing or measurement;
c) instructions for preparing or conditioning PT item before tests or
calibrations; Mahmoud Eltayeb

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7. Process requirements
7.3 Production and distribution of PT items
7.3.5 Instructions for participants

d) handling PT items, including any safety requirements;

e) Specific environmental conditions to conduct tests/calibrations
f) the manner of recording and reporting test or measurement results
and associated uncertainties if required. This includes also units of
measurement, the number of significant figures or decimal place
g) specific instructions on providing details concerning the
measurement or test method used by the participant, where a single
specific measurement or test method is not required;
h) instructions on return or forwarding PT items, when applicable;
i) last date for the PT provider to receive results from participants;
j) the contact details of the PT provider for enquiries.
Mahmoud Eltayeb

Case Study 2

Group Work
Each individual should be given the opportunity to participate

Mahmoud Eltayeb

26
7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.1 Data analysis

Results received from participants are recorded and analysed by

appropriate methods. Procedures to check the validity of data entry,
data transfer, statistical analysis, and reporting.

Data analysis generates summary statistics, performance statistics,

and associated information consistent with the statistical design of
PT scheme

The influence of outliers on summary statistics is minimized by the

use of an appropriate statistical approach

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7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.1 Data analysis

Procedures for treatment of results from different measurement or

test methods, where the PT scheme allows participants to use
different measurement or test methods.

Documented criteria and procedures for dealing with measurement or

test results that are inappropriate for statistical evaluation, e.g.
because of calculation errors, transpositions and other gross errors.

Documented criteria and procedures to identify and manage

situations where distributed PT items and the collected data are
subsequently found to be unsuitable for performance evaluation, e.g.
because of inhomogeneity, instability,
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damage or contamination.

27
7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.2 Evaluation of performance

Valid methods of evaluation which meet the purpose of the PT

scheme. The methods are documented and include a description of
the basis for the evaluation.

where appropriate , PTP provides expert commentary on the

performance of participants with regard to the following:
a) overall performance against prior expectations, taking
measurement uncertainties into account;
b) variation within and between participants, and comparisons with
any previous PT rounds, similar PT schemes, or published precision
data;
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7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.2 Evaluation of performance

c) variation between methods or procedures

d) possible sources of error (with reference to outliers) and
suggestions for improving performance;
e) advice and educational feedback to participants as part of the
continual improvement procedures of participants;
f) situations where unusual factors make evaluation of results and
commentary on performance impossible;
g) any other suggestions, recommendations or general comments;
h) conclusions.

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7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.2 Evaluation of performance

Calculation of performance Statistic ( Annex B)

Proficiency test results often need to be transformed into a performance

statistic, in order to aid interpretation and to allow to measure the
deviation of participants values from the assigned value in a manner
that allows comparison with performance criteria

The most widely used proficiency test performance statistics are percent
difference, z scores, En number and Zeta score

Mahmoud Eltayeb

7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.2 Evaluation of performance

Calculation of performance Statistic ( Annex B)

 Percent difference

Percent difference D % = [(x – X) / X] * 100

where x = participants test value, X = assigned value

 Z Score
z-score: (x – X) / s
where s = PT standard deviation

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7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.2 Evaluation of performance

Calculation of performance Statistic ( Annex B)

 z′ score
The z′ score is similar to the z score, but with allowance for
the uncertainty of the assigned value,
It is calculated when u ref > 0.3 S

z′= (x – X) / √ (S² + u² ref)

u ref = assigned value standard uncertainty

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7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.2 Evaluation of performance

Calculation of performance Statistic ( Annex B)

 The Zeta score ζ

ζ : (x – X) / √ (u² lab + u² ref)

Where : u lab = participant lab test data Standard

uncertainty
u ref = assigned value standard uncertainty

x = participants test value, X = assigned value

Mahmoud Eltayeb

30
7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.2 Evaluation of performance

Calculation of performance Statistic ( Annex B)

 The En Score

En: (x – X) / √ (U² lab + U² ref)

Where U lab = participant lab test data expanded

uncertainty
U ref = assigned value expanded uncertainty

x = participants test value, X = assigned value

Mahmoud Eltayeb

7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.2 Evaluation of performance

Calculation of performance Statistic ( Annex B)

Criteria for performance evaluation is established:

 Z score, z′ score and Zeta score
|z| ≤ 2 indicates acceptable performance
2 < |z| < 3 indicates questionable performance
|z| ≥ 3 indicates unacceptable performance

 En Score
| En | < 1 indicates acceptable performance
| En | ≥ 1 indicates unacceptable performance
Mahmoud Eltayeb

31
7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.3 PT report

PT reports are clear and accurate, objective and comprehensive and

include data covering the results of all participants, together with an
indication of the performance of individual participants.

NOTE Where all original data cannot be reported to participants, a summary of the
results, e.g. in tabulated or graphical form, can be supplied.

Mahmoud Eltayeb

7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.3 PT report

Reports include the following, unless it is not applicable or the PTP

has valid reasons for not doing so:
a) the name and contact details of the PT provider;
b) identification of person(s) authorizing the report;
c) an indication of which activities are provided by external
providers when they affect the PT items or the services provided;
d) the date of issue and status (e.g. preliminary, interim, or final) of
the report;
e) unique identification that all its components are recognized as a
portion of a complete report and a clear identification of the end;
f) a statement of the extent to which results are confidential;
Mahmoud Eltayeb

32
7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.3 PT report
g) a unique identification of the report and the PT scheme;
h) a clear description of the PT items used, including necessary
details of the PT item's production and homogeneity and stability
assessment;
i) the results of participants, including the reported measurement
uncertainties;
j) procedures used to statistically analyse the data;
k) statistical data and summaries, including assigned values, range
of acceptable results and graphical displays;
l) details of the metrological traceability, and uncertainty of any
assigned value;
m) procedures used to establish any assigned value and its
uncertainty; Mahmoud Eltayeb

7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.3 PT report
n) assigned values, their uncertainties and summary statistics for
measurement or test methods used by each group of participants (if
different measurement or test methods are used by different groups);
o) procedures used to establish the standard deviation for
proficiency assessment, or other criteria for evaluation;
p) comments on the performance of participants;
q) information about design and implementation of the PT scheme;
r) advice on the interpretation of the statistical analysis;
s) comments or recommendations based on the outcomes of the PT
round.
NOTE For continuous PT schemes, it can be sufficient to have simpler reports,
such that many of the elements in this subclause (7.4.3.2) can be excluded from
routine reports but included in the PT scheme procedures or in periodic summary
reports that are available to participants.
Mahmoud Eltayeb

33
7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.3 PT report

Reports are available to participants within planned timescales. In

sequential PT schemes, e.g. where the turn-around time may be very
long, and in schemes involving perishable materials, preliminary or
anticipated results may be provided before final results are disclosed.

PTP has a policy for the use of reports by participants and customers

When it is necessary to issue a new or amended report for a PT

scheme, this includes the following:
a) a unique identification;
b) a reference to the original report that it replaces or amends;
c) a statement concerning the reason for the amendment or re-issue.
Mahmoud Eltayeb

7. Process requirements
7.4 Evaluation and reporting of PT scheme results
7.4.3 PT report

When issuing an amended report to a subset of participants, an
analysis of the potential impact on the other participants for that PT
scheme and/ or PT round is made to ensure there is no influence on
the general performance of the other participants.

If the PT provider issues a statement of participation or performance

in addition to the PT report, the statement shall not be misleading.

Mahmoud Eltayeb

34
7. Process requirements
7.5 Control of the PT scheme process
7.5.1 Technical records

Technical records for each PT activity contain the results, reports and
sufficient information to facilitate, if possible identification of factors
affecting the PT performance evaluation and enable the repetition of
the PT activity under conditions as close as possible to the original.

The technical records include the date and the identity of personnel
responsible for each PT activity and for checking data and results.

Data used to verify the PT items, instructions to participants, the

original responses of participants and any other information included
in reports is recorded at the time they are made and is identifiable
with the specific task. Mahmoud Eltayeb

7. Process requirements
7.5 Control of the PT scheme process
7.5.1 Technical records

Amendments to technical records can be tracked to previous versions

or to original information submitted by participants. Both the original
and amended data and files are retained, including the date of
alteration, an indication of the altered aspects and the personnel
responsible for the alterations.

Mahmoud Eltayeb

35
7. Process requirements
7.5 Control of the PT scheme process
7.5.2 Control of data and information management

Access to the data and information needed to perform PT activities.

The PT provider information management system(s) is used for the

collection, processing, recording, reporting, storage or retrieval of
data. It is validated for functionality before introduction.
Any changes, including lPt provider software configuration or
modifications to commercial off-the-shelf software is authorized,
documented and validated before implementation.

“laboratory information management system(s)” includes the management of data

and information in computerized and non-computerized systems.
Commercial off-the-shelf software used within its designed application range is
considered to be sufficiently validated.
Mahmoud Eltayeb

7. Process requirements
7.5 Control of the PT scheme process
7.5.2 Control of data and information management

The PT provider information management system:
 be protected from unauthorized access
 be safeguarded against tampering and loss
 be operated in an environment that complies with supplier or PT
provider specifications or, in the case of non-computerized
systems, provides conditions which safeguard the accuracy of
manual recording and transcription
 be maintained in a manner that ensures the integrity of the data
and information;
 include recording system failures and the appropriate immediate
and corrective actions.

Mahmoud Eltayeb

36
7. Process requirements
7.5 Control of the PT scheme process
7.5.2 Control of data and information management

When a PT provider information management system is managed
and maintained off-site or through an external provider, the PT
provider ensures that the provider or operator of the system complies
with all applicable requirements of this standard.

Instructions, manuals and reference data relevant to the pt provider

information management system are made readily available to
personnel.

Calculations and data transfers are checked in an appropriate and

systematic manner.

Mahmoud Eltayeb

7. Process requirements
7.5 Control of the PT scheme process
7.5.3 Surveillance of the processes

A procedure to ensure the validity of the PT scheme. Surveillance
activities are planned and reviewed with resulting data recorded for
the continuous improvement process.

Depending on the PT scheme, surveillance activities can include:

 evaluation of externally provided products and services;
 use of reference materials or other control items;
 the transmission of results from participants;
 control of statistical conditions to confirm the validity of
performance evaluation;
 checking of reports;
 for continuous schemes, comparisons against previous PT
rounds. Mahmoud Eltayeb

37
7. Process requirements
7.5 Control of the PT scheme process
7.5.4 Nonconforming work

A procedure is implemented when any aspect of the PT

provider activities do not conform to its own procedures or the greed
requirements of participants or customers. The procedure ensures:
 defining the responsibilities & authorities for the management of
nonconforming work
 actions (including halting of ongoing PT schemes and/or PT
rounds and withholding of reports, as necessary) are based upon
the risk levels established by the PT provider
 an evaluation is made of the significance of the nonconforming
work, including an impact analysis on previous PT activities
 a decision is taken on acceptability of the nonconforming work
Mahmoud Eltayeb

7. Process requirements
7.5 Control of the PT scheme process
7.5.4 Nonconforming work

 PT scheme participants and customers, as appropriate, are

informed and the nonconforming PT items or PT reports already
sent to participants are recalled or disregarded;
 defining the responsibility for authorizing resumption of work

Records of nonconforming work and actions are retained.

Corrective action is implement when the evaluation indicates that the

nonconforming work could recur, or that there is doubt about the
compliance of the PT provider with its own management system.

Mahmoud Eltayeb

38
7. Process requirements
7.6 Handling of complaints

A documented procedure for handling complaints that includes at

least:
 a description of the process for receiving, substantiating and
investigating the complaint and deciding on actions to be taken
 b) tracking and recording the complaint, including the actions
undertaken to resolve it;
 c) ensuring that any appropriate action is taken.

A description of the handling process for complaints is publicly

available

Upon receipt of a complaint, the PT provider confirms whether the

complaint relates to PT activities in order to resolve the complaint
Mahmoud Eltayeb

7. Process requirements
7.6 Handling of complaints

The PT provider is responsible for gathering all necessary

information to determine whether the complaint is substantiated.

Whenever possible the PT provider acknowledges receipt of the

complaint and provide the complainant with the outcome and, if
applicable, progress reports.

Investigation and resolution of complaints shall not result in any

discriminatory actions.

Mahmoud Eltayeb

39
7. Process requirements
7.6 Handling of complaints

The resolution of complaints is made by, or reviewed and approved

by, persons not involved in the subject of the complaint in question.
Where resources do not permit, any alternative approach does not
compromise impartiality.

Whenever possible, the PT provider gives formal notice of the end of

handling of the complaint to the complainant.

The PT provider is responsible for all decisions at all levels of the

handling process for complaints.

Mahmoud Eltayeb

7. Process requirements
7.7 Handling of appeals

A documented procedure for handling appeals that includes at least:
 a description of the process for receiving, substantiating and
investigating the appeal and deciding on actions to be taken
 b) tracking and recording the appeals , including the actions
undertaken to resolve it;
 c) ensuring that any appropriate action is taken.

A description of the handling process for appeals is publicly

available

The PT provider acknowledges receipt of the appeal and provide the

appellant with the outcome and, if applicable, progress reports.

Mahmoud Eltayeb

40
7. Process requirements
7.7 Handling of appeals

The PT provider receiving the appeal is responsible for gathering all

necessary information to determine whether the appeal is valid.

The PT provider is responsible for all decisions during the process

for handling appeals.

The decision on the appeal is made by, or reviewed and approved by,
persons not involved in the decision that is the subject of the appeal
in question.

Investigation and decision on appeals do not result in any

discriminatory actions.
Mahmoud Eltayeb

Case Study 3

Group Work
Each individual should be given the opportunity to participate

Mahmoud Eltayeb

41
8. Management system requirements
8.1 General requirements
8.1.1 The management system is documented, implemented and
maintained to support and demonstrate the consistent fulfilment of the
requirements of this document and its scope of PT activities..
8.1.2 The management system of the PT provider includes the at least
the following:
• policies;
• responsibilities;
• management system documentation (see 8.2);
• control of management system documents (see 8.3);
• control of records (see 8.4);
• actions to address risks and opportunities (see 8.5);
• improvement (see 8.6);
• corrective actions (see 8.7);
• internal audits (see 8.8);
Mahmoud Eltayeb
• management reviews (see 8.9).
.

8. Management system requirements

8.1 General requirements
8.1.3 A PT provider may meet 8.1.2 by establishing, implementing and
maintaining a quality management system (e.g. in accordance with the
requirements of ISO 9001). This quality management system supports
and demonstrate the consistent fulfilment of the requirements of this
document.

8.1.4 The PT provider management provides evidence of commitment

to the development and implementation of the management system and
to continually improving its effectiveness

Mahmoud Eltayeb

42
8. Management system requirements
8.2 Management system documentation

8.2.1 The policies and objectives addresses the competence,

impartiality and consistent operation of the PT provider.

8.2.2 All documentation, processes, systems and records related to the

fulfilment of the requirements of this document are included in, or
referenced from, the management system.

8.2.3 All personnel involved in PT activities have access to the parts of

the management system documentation and related information that are
applicable to their responsibilities.

Mahmoud Eltayeb

8. Management system requirements

Types of documents
policy Quality Man. procedures

Instructions Regulations Standards

Test Methods Cal Methods Drawings

Specifications Text books Notices

memorandum Plans Software

43
8. Management system requirements
8.3 Control of management system documents
8.3.1 All documents (internal and external) that relate to the fulfillment
of this document are controlled

8.3.2 The lab ensures that:

 documents are approved by authorized personnel for adequacy
prior to issue
 documents are periodically reviewed, and updated as necessary;
 changes and the current revision status of documents are
identified;
 relevant versions of applicable documents are available at points
of use and, where necessary, their distribution is controlled;
 documents are uniquely identified;
 the unintended use of obsolete documents is prevented, and
suitable identification is applied to them if they are retained for
Mahmoud Eltayeb
any purpose

8. Management system requirements

8.4 Control of records

8.4.1 The PT provider establishes and retains legible records to

demonstrate fulfilment of the requirements in this document.

8.4.2 The PT provider implements the controls needed for the

identification, storage, protection, back-up, archive, retrieval, retention
time and disposal of its records.

8.4.3 The PT provider retains records for a period consistent with its
contractual obligations. Access to these records is consistent with the
confidentiality commitments and records are readily available.

Mahmoud Eltayeb

44
8. Management system requirements
8.5 Actions to address risks and opportunities

8.5.1 The risks and opportunities associated with the PT activities are
considered in order to:
 give assurance that the MS achieves its intended results;
 enhance opportunities to achieve the PT provider purpose &
objectives
 prevent, or reduce, undesired impacts and potential failures in the
lab activities;
 achieve improvement

Mahmoud Eltayeb

8. Management system requirements

8.5 Actions to address risks and opportunities

8.5.2 The PT provider plans:

 actions to address these risks and opportunities;
 how to integrate & implement these actions into its MS;
 How to evaluate the effectiveness of these actions.

There is no requirement for formal methods for risk management or

a documented risk management process. The lab can decide whether
or not to develop a more extensive risk management methodology
than is required by this document, e.g. through the application of
other guidance or standards.

Mahmoud Eltayeb

45
8. Management system requirements
8.5 Actions to address risks and opportunities

8.5.3 Actions taken to address risks and opportunities are proportional

to the potential impact on the validity of PT scheme.

Examples of addressing risks include developing strategies for

preventing collusion between participants and performing a feasibility
study to evaluate the best transport conditions for the PT items of a PT
scheme.

Opportunities can lead to expanding the scope of the PT activities,

increasing the number of participants in a PT scheme, making a PT
scheme more cost effective for the PT provider as well as the
participants and customers, and reducing the time required to produce
the PT items.
Mahmoud Eltayeb

8. Management system requirements

8.5 Actions to address risks and opportunities

Mahmoud Eltayeb

46
8. Management system requirements
8.6 Improvement
8.6.1 The PT provider identifies and select opportunities for
improvement and implement any necessary actions.

Opportunities for improvement can be identified through the review

of operational procedures, the use of the policies, overall objectives,
audit results, corrective actions, management review, suggestions
from personnel, risk assessment, analysis of data, PT results.

8.6.2 The PT provider seeks feedback, both positive and negative, from
its participants and customers. The feedback is analysed and used to
improve the management system, PT activities and customer service.

Examples of the types of feedback include customer satisfaction

surveys, communication records & review of reports with customer.
Mahmoud Eltayeb

8. Management system requirements

8.7 Corrective actions
8.7.1 When a nonconformity occurs, the PT provider:
 react to the nonconformity and, as applicable:
o take action to control and correct it;
o address the consequences;
 evaluate the need for action to eliminate the cause(s) of the NC,
in order that it does not recur or occur elsewhere, by:
o reviewing and analysing the NC;
o determining the causes of the NC;
o determining if similar NCs exist, or can potentially occur;
 implement any action needed;
 review the effectiveness of any CA taken;
 update risks and opportunities determined during planning, if
necessary;
 make changes to the management system, if necessary.
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47
8. Management system requirements
8.7 Corrective actions

8.7.2 Corrective actions are appropriate to the effects of the NC

encountered.

8.7.3 The PT provider retains records as evidence of:

 the nature of the NCs, cause(s) and any subsequent actions taken;
 the effectiveness of any corrective action.

Mahmoud Eltayeb

8. Management system requirements

8.7 Corrective actions

Re examine Define the

RCA problem

Monitor Take
immediate
CAs correction

Identify &
Identify
implement
RCA
CAs
Mahmoud Eltayeb

48
8. Management system requirements
8.8 Internal audit

8.8.1 The PT provider conducts internal audits at planned intervals to

provide information on whether the management system:
 conforms to:
o the PT provider’s own requirements for its MS, including the
PT activities;
o the requirements of this document;
 is effectively implemented and maintained.

Mahmoud Eltayeb

8. Management system requirements

8.8 Internal audit (Option A)
8.8.2 The PT provider:
 Plan, establish, implement and maintain an audit programme
including the frequency, methods, responsibilities, planning
requirements and reporting, which take into consideration the
importance of the PT activities concerned, changes affecting the
PT provider, and the results of previous audits;
 define the audit criteria and scope for each audit;
 ensure that the results of the audits are reported to relevant
management;
 implement appropriate correction and CAs without undue delay;
 retain records as evidence of the implementation of the audit
programme and the audit results.

ISO 19011 provides guidance for internal audits.

Mahmoud Eltayeb

49
8. Management system requirements
8.8 Internal audit

Corrective actions Planning &

& follow up preparing the
audit

Prepare & distribute Perform the audit

audit report

Internal audit process implementation

Mahmoud Eltayeb

8. Management system requirements

8.9 Management review

8.9.1 The PT management reviews its MS at planned intervals, in order

to ensure its continuing suitability, adequacy and effectiveness,
including the stated policies and objectives related to the fulfilment
of this standard.

8.9.2 The inputs to management review are recorded and include

information related to :
 changes in internal and external issues relevant to the PT
provider;
 fulfillment of objectives;
 suitability of policies andMahmoud Eltayeb
procedures;

50
8. Management system requirements
8.9 Management review (Option A)
8.9.2 The inputs to management review are recorded and include
information related to (continue):
 status of actions from previous management reviews;
 outcome of recent internal audits;
 corrective actions;
 assessments by external bodies;
 changes in the volume and type of the work in PT activities;
 Customer, participant and personnel feedback;
 Complaints and appeals;
 effectiveness of any implemented improvements;
 adequacy of resources;
 results of risk identification;
 outcomes of the surveillance of the processes;
 other relevant factors, such as training.
Mahmoud Eltayeb

8. Management system requirements

8.9 Management review (Option A)

8.9.3 The outputs from the management review record all decisions and
actions related to at least:
 the effectiveness of the MS and its processes;
 improvement of the PT activities related to the fulfillment of the
requirements of this document;
 provision of required resources;
 any need for change.

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51
 Annexes

Mahmoud Eltayeb

Annex A (informative)
Types of PT schemes

A.1 General

A.2 Types of PT schemes

A.3 External quality assessment programmes

A.4 Alternative interlaboratory comparisons

Mahmoud Eltayeb

52
Annex B (informative)
Statistical methods for PT

B.1 General

B.2 Assessment of PT item homogeneity and stability

B.3 Determination of the assigned value and its uncertainty

B.4 Calculation of performance statistics

B.5 Evaluation of performance

Mahmoud Eltayeb

Case Study 4

Group Work
Each individual should be given the opportunity to participate

Mahmoud Eltayeb

53
Thank You

Mahmoud Eltayeb

54