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Application of the ISO/IEC 17020:2012 standard

for the accreditation of inspection bodies

ILAC-P15:05/2020
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About ILAC

ILAC is the global association for the accreditation of laboratories, inspection bodies, proficiency testing providers and
of reference material producers, consisting of accreditation bodies (AB) and stakeholder organizations from around the world
whole.

This is a representative organization that is involved in:

• the development of accreditation practices and procedures, • the promotion
accreditation as a tool for facilitating trade, • support for
provision of local and national services, • assistance with development
of accreditation systems, • the recognition of skills in
test materials (including medical) and calibration. laboratories, inspection bodies, proficiency testing providers and
producers of reference materials worldwide.

ILAC actively cooperates with other competent international organizations to pursue these objectives.

ILAC facilitates trade and supports regulators by establishing a global mutual recognition agreement.
The ILAC Arrangement - between the Organization Bodies. The data and test results provided by the laboratories and the
inspection bodies, collectively called conformity assessment bodies (CAB), accredited by the members of
The accreditation body of ILAC is accepted globally through this arrangement. Thus, the technical obstacles to
commerce, such as the new testing of products each time they enter a new economy, is reduced, which contributes to the
Achievement of the free trade objective 'accredited once, accepted everywhere'.

Furthermore, accreditation reduces risks for the company and its clients by ensuring that accredited OECs are competent to
carry out the work they undertake within the scope of their accreditation.

Furthermore, the results from accredited installations are widely used by regulators for the public good in providing
services that promote a non-polluted environment, healthy food, clean water, energy, health services and
social services.

Accreditation bodies that are members of ILAC and the CABs they accredit are required to comply with the standards.
appropriate international standards and applicable application documents of the ILAC for the coherent implementation of these standards.

Accreditation bodies that have signed the ILAC Arrangement are subject to peer evaluation through organizations of
regionally established and recognized cooperation using the rules and procedures of ILAC before becoming signatories of
the ILAC Arrangement.

The ILAC website provides a range of information on topics covering accreditation, conformity assessment, facilitation of
commerce, as well as the contact details of the members. More information illustrating the value of compliance assessment
accredited for regulators and the public sector through case studies and independent research are also available
onwww.publicsectorassurance.org.

For more information, please contact: The

ILAC Secretariat
P.O. Box 7507
Silverwater NSW 2128
Australia
Phone: +61 2 9736 8374
Email:[email protected]
SiteInternet:www.ilac.org

@ILAC_Official

https://www.youtube.com/user/IAFandILAC

© Copyright ILAC 2020

ILAC encourages the authorized reproduction of its publications, or parts thereof, by organizations wishing to use this
material in areas related to education, standardization, accreditation or other purposes relevant to the field of expertise or
of ILAC's activity. The document in which the reproduced material appears must contain a statement acknowledging the contribution.
from the ILAC to the document.
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LIST OF SUBJECTS

1. INTRODUCTION

2. AUTHOR'S NOTE .................................................. .................................................................. ...................................... 4

3. IMPLEMENTATION

4. TERMINOLOGY.................................................. .................................................................. .................................. 5

5. APPLICATIONS OF ISO/IEC 17020:2012

Terms and definitions............................................... .................................................................. ...................................... 5

General requirements – Impartiality and independence ............................................ ...................... 5

Structural requirements - Administrative requirements ............................................ ...................... 6

Structural requirements – Organization and management .................................................. ...................... 6

Resource needs - Personnel.................................................. .................................................................. ........... 7

Resource needs – Facilities and equipment........................................................ ...................................... 9

Resource needs - Outsourcing.................................................. .................................................................. ten

Process requirements - Inspection methods and procedures.................................................. ...................... ten

Process requirements - Inspection files............................................. ...................................................... 11

Process requirements - Inspection reports and inspection certificates.................................................. ....... 11

Management system requirements – Options.................................................. ............................................ 11

Management system requirements - Management system documentation (Option A) ............... 12

Management system requirements – Control of records (Option A).................................................. .............. 12

Management system requirements - Management review (Option A)............................................ ......... 12

Management system requirements – Internal audits (Option A)............................................ .................. 12

Management system requirements – Preventive actions (Option A) ............................................ ............ 13

Annex A Independence requirements of inspection bodies.................................................. ...................... 13

6. ANNEX 1 : POSSIBLE FORMAT FOR A BIAS ANALYSIS....... 14

7. ANNEX 2 RELATION BETWEEN IMPARTIALITY AND TYPE A INDEPENDENCE

REQUIREMENTS

8. REFERENCES .................................................. .................................................................. ...................................... 17

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1. INTRODUCTION

This document provides information for the application of the ISO/IEC 17020:2012 Standard Conformity Assessment -
Requirements related to the functioning of various types of bodies conducting inspections for accreditation
organismes d'inspection. Il est destiné à être utilisé par les organismes d'accréditation évaluant les organismes
inspection in view of their accreditation as well as by inspection bodies seeking to manage their operations
to meet the accreditation requirements.

To facilitate reference, each application note is identified by the relevant clause number of the ISO standard.
IEC 17020 and an appropriate suffix, for example 4.1.4 n1 would be the first application note on the requirements of the
clause 4.1.4 of the standard.

The term 'must' is used throughout this document to indicate provisions that reflect the
The requirements of ISO/IEC 17020, or in some cases the requirements related to the functioning of organizations
ISO/IEC 17011 accreditation is considered mandatory.

The term 'should' is used throughout this document to indicate provisions that, although not mandatory,
are provided by ILAC as a recognized means of meeting the requirements. The term 'may' is used to indicate
something that is allowed. The term 'may' is used to indicate a possibility or a capability. The
inspection bodies whose systems do not comply with the 'should' guidelines of this document ILAC do not
will be eligible for accreditation only if they can demonstrate to the accreditation body that their solutions meet
in accordance with the relevant clause of the ISO/IEC 17020 standard in an equivalent or better manner.

Individual inspection programs may specify additional requirements for accreditation.

The document does not attempt to identify what these requirements may be or how they should be implemented.

This version of the document includes advice on emerging technologies that are not covered in the
ISO/IEC 17020:2012 standard, and takes into account the fact that inspection can be an integrated activity in a
wider process including testing and certification.

When using ISO/IEC 17020 and this application document, accreditation bodies must neither add nor
subtract from the requirements of ISO/IEC 17020. However, note that accreditation bodies must always
meet the requirements of ISO/IEC 17011.

The examples included in the previous version of the document have been removed and added to the Committee's FAQ database.
inspection on the website ofthe ILAChttps://ilac.org/about-ilac/faqs/

2. AUTHOR'S NOTE

This publication was prepared by the ILAC Inspection Committee (IC) and approved for publication following a vote.
successfully voting members of ILAC in 2020.

3. IMPLEMENTATION

In order to comply with the provisions of clause 2.1.1 of the IAF/ILAC A2, the signatories of the ILAC MRA must implement
implement this document within 18 months from the date of publication.

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4. TERMINOLOGY

For the purposes of this document, the terms and definitions given in the ISO/IEC 17000 and ISO/IEC standards
17020 applies.

5. APPLICATIONS OF ISO/IEC 17020:2012

Terms and definitions

3.1 n1 The term "installation" can be defined as "a set of components assembled to achieve
jointly a goal that cannot be achieved by the components separately.

General requirements – Impartiality and independence

ISO/IEC 17020 places the highest importance on preventing any undue influence on activities.
Inspection. (4.1.2) demands that commercial, financial, and other pressures do not compromise impartiality.
and acknowledges that personal and organizational relationships (4.1.3) potentially compromise impartiality
and may require controls (4.1.4) to maintain impartiality.
Finally, it takes independence into account and classifies organizations into types of independence A, B and C to signal
the nature of the relationships between the inspection body and the inspected elements.
Annex 2 provides additional guidelines.

4.1.3 n1 "on a continuous basis" means that the control body identifies a risk each time that
events may occur that could affect the impartiality of the controlling body.

4.1.3 n2 The inspection body should describe all its relationships or those of its personnel that could be
to affect its impartiality, to the relevant extent, by using organizational charts or other
means.

4.1.3 n3 Annex 1 provides an example of a possible format for the analysis of risks related to impartiality.

4.1.4 n1 The threats and inducements directed against inspectors or other staff members of
The inspection body can pose serious risks to impartiality. Threats and
Incentives can come from within or outside the regulatory body and can occur
at any time. The inspection body should record the perceived and explicit risks for
the impartiality of inspections. All personnel working on behalf of the inspection body
must be aware of the responsibility to act impartially, be involved accordingly
in the measures of impartiality of the inspection body and having appropriate access to provide
files when problems arise. Risk analysis for impartiality by the control body
should include details on the inspection body's responses to these risks.

4.1.5 n1 The inspection body must have a documented statement highlighting its commitment to
impartiality in the exercise of its inspection activities, the management of conflicts of interest and the guarantee
the objectivity of its inspection activities. Actions emanating from senior management must not
to contradict this statement.

4.1.5 n2 One way for top management to highlight its commitment to impartiality is to make
publish relevant statements and policies.

4.1.6 n1 An inspection body may have different types of independence (type A, B or C) for different
inspection activities listed within the scope of accreditation. However, it is not possible for
a control organization to propose different types of independence for the same control activity.

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4.1.6 n2 Compliance with the independence requirements of type A A.1b and A.1.c is binary (yes or no), this
which means that it is not possible to partially comply with the requirements
independence of type A. This also means that a risk analysis leading to
control measures aimed at minimizing the risks of bias in a situation where there is no
It's not possible to disregard these type A requirements. Therefore, only
The elimination of the non-compliant situation regarding these type A requirements is possible.

Exigences structurelles – Exigences administratives

5.1.3 n1 The inspection body should describe its activities by defining the general scope and
the scope of the inspection (for example categories/sub-categories of products, processes,
services or installations) and the inspection stage (see note related to article 1 of the standard) and,
if applicable, the regulations, standards or specifications containing the requirements regarding
to which the inspection will be carried out. ILAC G28 provides guidelines for the
formulation of the accreditation domains of inspection bodies.

5.1.4 n1 The level of provisions must be proportionate to the level and nature of the responsibilities.
pouvant découler des activités de l'organisme de contrôle.

An assessment of 'adequacy' may be based on evidence of an agreement between the parties.

in the contract and on the consideration of all legal requirements or system rules
relevant. The regulatory body should be able to show which factors have
was taken into account to determine what constitutes an 'adequate provision'. It is not
it is not the role of an accreditation body to approve the arrangement held by an organization
of inspection.

Structural requirements - Organization and management

5.2.2 n1 The size, structure, composition, and direction of a regulatory body, taken together,
must be adapted to the competent execution of activities in the field for which
the control body is accredited.

5.2.2 n2 "Maintain the ability to carry out inspection activities" implies that the organization
Inspection must take measures to keep him properly informed of developments.
techniques, regulatory and/or legislative applicable to its activities.

5.2.2 n3 The controlling bodies must maintain their capacity and competence to carry out
many control activities rarely carried out (normally at intervals
greater than one year). An inspection body can demonstrate its capacity and competence
for inspection activities carried out rarely through 'dummy inspections' and/or
inspection activities carried out on similar products.

5.2.3 n1 The control body must maintain an updated organization chart or documents.
clearly indicating the functions and hierarchical lines of the staff within
the inspection body. The position of the technical managers and the member of the
The direction referenced in clause 8.2.3 must be clearly indicated in the table or documents.

5.2.4 n1 It may be relevant to provide information about the personnel performing tasks of
work both for the regulatory body and for other units and services in order to take
considering the involvement and influence they can have on control activities.

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5.2.5 n1 To be considered 'available', the person must be either employed or

otherwise contracted.

5.2.5 n2 In order to ensure that inspection activities are carried out in accordance with the ISO/IEC 17020 standard,
the technical manager(s) and any assistant(s) must have the
technical expertise required to understand all important issues and technologies
involved in the execution of inspection activities.

5.2.6 n1 In an organization where the absence of a key person causes work to stop, the requirement for presence
deputies is not applicable.

5.2.7 n1 The categories of positions involved in inspection activities are inspectors and other positions.
having an effect on the management, execution, recording, or reporting of inspections.

5.2.7 n2 The job description or any other document must detail the tasks, responsibilities
and the authorities for each category of position mentioned in article 5.2.7n1.

Resource needs – Personnel

6.1.1 n1 If applicable, inspection bodies must define and document the competence requirements.
for each inspection activity, as described in 5.1.3n1. Certain aspects of the requirements of
competence can already be defined by regulators and system owners or specified
by the clients. When this is the case, the inspection body must incorporate/reference these requirements.
in its global definitions of competencies.
The inspection body remains responsible for the appropriateness of the skills definitions and
of their compliance with the requirements of the ISO/IEC 17020 standard.

6.1.1 n2 For the "staff involved in inspection activities", see 5.2.7n1.

6.1.1 n3 Competence requirements must include knowledge of the organization's management system
inspection and the ability to implement applicable administrative and technical procedures
to the activities carried out.

6.1.1 n4 When professional judgment is necessary to determine compliance, this must be taken into
consideration when defining skill requirements.

6.1.2 n1 All the requirements of the ISO/IEC 17020 standard apply equally to individuals.
employees and under contract.

6.1.5 n1 The formal authorization procedure for inspectors must specify that the relevant details are
documented, for example the activity of authorized inspection, the commencement of the authorization, the identity of the
person who executed the authorization and,
if applicable, the end date of the authorization.

The "supervised work period" mentioned in point b must include participation in

inspections at the locations where these inspections are carried out.

6.1.7 n1 The identification of training needs for each person must take place at regular intervals.
The interval must be chosen to ensure compliance with clause 6.1.6, point c.
The results of the training exam, for example, complementary training projects or a statement.
according to which no additional training is required, must be documented.

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One of the main objectives of the monitoring requirement is to provide the inspection body with a tool
ensuring the consistency and reliability of inspection results, including any judgment
professional in relation to general criteria. Monitoring may lead to the identification of needs for
individual training or needs for revision of the management system of the inspection body.

6.1.8 n2 For "other personnel involved in inspection activities", see 5.2.7n1.

6.1.9 n1 To be considered sufficient, the evidence that the inspector continues to carry out
competence must be justified by a combination of information such as:

-
satisfactory completion of exams and assessments,
-
positive result of the monitoring (see note related to clause 6.1.8),
-
positive result of separate evaluations to confirm the outcome of the inspections (this may be
possible and appropriate in the case, for example, of inspecting construction documents,

-
positive result of mentoring and training,
-
absence of calls or legitimate complaints, and
-
satisfactory results of a testimony by a competent body, for example a body of
certification of individuals.

6.1.9 n2 An effective on-site observation program for inspectors can help meet the requirements.
clauses 5.2.2 and 6.1.3. The program must be designed with consideration for:

-
the risks and the complexity of inspections,
-
the results of previous surveillance activities, and
-
the relevant technical, procedural, or legislative developments for inspections.

The frequency of on-site observations depends on the issues listed above, but must be
at least once during the accreditation reassessment cycle, see however the application note
6.1.9n1. If the levels of risk or complexity, or the results of previous observations,
they indicate, or if technical, procedural or legislative changes have occurred, then a frequency
higher should be considered. Depending on the areas, types, and fields of inspection covered
With the inspector's permissions, several observations by the inspector may be necessary.
to adequately cover all the required skills. Furthermore, observations
On-site assessments may be necessary if there is no evidence of ongoing performance.
and satisfactory.

6.1.9 n3 This requirement applies even when the control body consists of only one person.
technically competent.

6.1.10 n1The authorization files must specify the basis on which the authorization was granted (for example,
the on-site observation of inspections.

6.1.12 n1The policies and procedures should assist the staff of the inspection body in identifying and addressing
the threats or commercial, financial or other incentives that could affect his impartiality,
whether they come from inside or outside the inspection body.
These procedures should specify how any conflict of interest identified by the staff of
The inspection body is reported and registered. However, it should be noted that even if expectations
in terms of inspector integrity can be communicated through policies and

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procedures, the existence of such documents cannot indicate the presence of integrity and impartiality
required by this clause.

Resource Requirements - Facilities and Equipment

6.2.3 n1 If controlled environmental conditions are required, for example, for proper execution of
Control, the monitoring body must observe them and record the results. If the conditions were situated
outside the acceptable limits for the inspection to be carried out, the inspection body must
record the measures taken. See also clause 8.7.4.

6.2.3 n2 Continuous adequacy can be established through visual inspection, functional checks and/or recalibration.
This requirement is particularly relevant for equipment that has left direct control of
the control body.

6.2.4 n1 Inspection bodies must document and retain the justification for decisions on significance.
on the influence of equipment on inspection results, as these decisions form a basis
essential for subsequent decisions regarding calibration and traceability.

6.2.4 n2 In order to allow tracking when items are replaced, the unique identification of an item
Equipment may be appropriate even when there is only one item available.

6.2.4 n3 When controlled environmental conditions are necessary, the equipment used for monitoring
These conditions must be considered as equipment that significantly influences the outcome.
inspections.

6.2.6 n1 The justification for the non-calibration of the equipment that has a significant influence on the result of
The inspection (see clause 6.2.4) must be recorded.

6.2.6 n2 Guidelines on how to determine calibration intervals can be found in ILAC G24.

6.2.6 n3 When appropriate (usually for the equipment covered by clause 6.2.6), the
the definition must include the required accuracy and measurement range.

6.2.7 n1 According to ILAC P10, it is possible to perform internal calibration of the equipment used for
measures. Accreditation bodies must have a policy ensuring that these services
Internal calibrations are carried out in accordance with the relevant criteria for metrological traceability.
the ISO/IEC 17025 standard.

6.2.7 n2 Preferred channels for control bodies requesting external services for calibration
their equipment is defined in ILAC P10

6.2.9 n1 When the equipment is subjected to in-service checks between regular recalibrations, the nature of
These controls, the frequency and acceptance criteria must be defined.

6.2.10 The information provided in 6.2.7, 6.2.7 and 6.2.9 for the calibration programs
Equipment is also valid for reference material calibration programs.

6.2.11 n1When the control body engages suppliers to carry out activities that do not include
the execution of part of the control, but which are relevant to the outcome of the control activities,
for example the recording of orders, archiving, the provision of ancillary services during a
control, the drafting of inspection reports or

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calibration services, these activities are covered by the term 'services' used in this document
clause.

6.2.11 n2 The verification procedure must ensure that incoming goods and services are not used until
their compliance with the specifications has not been verified.

Resource needs - Outsourcing

6.3.1 n1 By definition (ISO/IEC 17011, clause 3.1), accreditation is limited to the evaluation tasks of the
compliance for which the inspection body has demonstrated its competence to carry out itself
the same. Thus, accreditation cannot be granted for the activities mentioned in the fourth point of the
note 1, if the control body does not have the required skills and/or resources.
However, the task of evaluating and interpreting the results of these activities for the purpose of determination
compliance may be included in the scope of accreditation, provided that
appropriate skills have been demonstrated for this purpose.

6.3.3 n1 In footnote 2 of the definition of the term "inspection" in Article 3.1, it is stated that in certain cases,
The inspection can be solely an examination, without further determination of conformity. In
In these cases, clause 6.3.3 does not apply as there is no determination of conformity.

6.3.4 n1 Accreditation is the preferred means to demonstrate the subcontractor's competence, but in some
justified situations (based on a qualified assessment/professional judgment), the results
non-accredited organizations could be accepted.

6.3.4 n2 If the evaluation of the subcontractor's competence is based in whole or in part on its accreditation,
the regulatory body must ensure that the scope of accreditation of the subcontractor
covers the activities to subcontract.

Process requirements - Inspection methods and procedures

7.1.1 n1 If the inspection includes measurements, ILAC G27 provides guidance on how to determine
what requirements may be relevant.

7.1.1 n2 For the development of specific inspection methods and procedures, the guidelines of
ISO/IEC 17007 can be used.

7.1.1 n3 Many inspection methods use the human eye to carry out visual inspections.
More and more new technologies (for example drones, cameras, special glasses,
computing, artificial intelligence, etc.) are introduced to be used during inspections. It
may involve a (partial) replacement of an existing inspection method (such as the human eye) or
of a new inspection method.

7.1.3 n2 The aspects that require special attention when introducing new technologies are:

-
Validation of the new or modified inspection method using new technology.
In the case of a partial replacement of an existing inspection method, it is necessary to verify
if the result of the inspection is just as (or more) reliable as that of the existing method;

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-
The applicable legal and security requirements (such as permits), the legal limitations and
the legal conditions;
-
The limits and conditions applicable to the inspection method when a new technology
is used;
-
If the use of new technologies is to be mentioned in the inspection report;

-
If the use of new technologies must be mentioned concerning the scope of the inspection and/
or of accreditation.

7.1.5 n1 If applicable, the contract or work order control system must also ensure
what;

-
the terms of the contract are agreed
-
the staff's competence is adequate
-
All legal requirements are identified.
-
the security requirements are identified
-
the extent of the required subcontracting arrangements is identified

For requests for ongoing or repeated work, the examination may be limited to considerations of
time and human resources. An acceptable file in such cases would be a
acceptance of the contract signed by a duly authorized person.

7.1.5 n2 In situations where verbal work orders are acceptable, the inspection body must
keep a record of all requests and instructions received verbally. If applicable, the dates
Relevant information and the identity of the client's representative must be recorded.

7.1.5 n3 The contract or work order control system must ensure that there is an understanding
clear and demonstrable between the inspection body and its client the scope of the inspection work to
to undertake by the inspection body.

The information mentioned in this clause is not information provided by a subcontractor.

contractor, but information received from other parties, such as a regulatory authority or the
client of the control body. The information may include general data about the activity
of inspection, but not the results of the inspection activity.

Process Requirements - Inspection Files

7.3.1 n1 The records must indicate which specific piece of equipment has an influence
Significant on the result of the inspection, was used for each inspection activity.

Process requirements - Inspection reports and inspection certificates

7.4.2 n1 ILAC P8 provides requirements for the use of accreditation symbols and for claims.
of the accreditation status.

Management system requirements – Options

8.1.3 n1 The expression 'this International Standard' refers to ISO/IEC 17020.

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8.1.3 n2 Option B does not require the management of the inspection body to be certified to ISO 9001.
However, when determining the extent of the required assessment, the accreditation body
must take into account whether the inspection body has been certified according to the ISO 9001 standard by a
certification certificate. organization accredited by an accreditation body that is a signatory to the MLA of
the IAF, or a regional MLA, for the certification of management systems.

Exigences du système de gestion – Documentation du système de gestion (Option A)

8.2.1 n1 The policies and objectives must focus on competence, impartiality, and operation.
coherent with the inspection body.

8.2.4 n1 To facilitate reference, it is recommended that the inspection body indicate where the requirements of
ISO/IEC 17020 is addressed, for example, through a cross-reference table.

Management system requirements – Control of records (Option A)

8.4.1 n1 This requirement means that all records necessary to demonstrate compliance with
Requirements of the standard must be established and maintained.

8.4.1 n2 In cases where seals or electronic authorizations are used for approvals, access
Electronic supports or the seal must be secured and controlled.

Management system requirements – Management review (Option A)

8.5.2 n1 An examination of the process for identifying risks related to impartiality and its conclusions (clauses
4.1.3/4.1.4) devrait faire partie de la revue annuelle de direction.

8.5.2 n2 The management review must take into account information on the adequacy of human resources
and current materials, projected workloads, and the need for staff training
new and existing.

8.5.2 n3 The management review must include an examination of the effectiveness of the established systems to ensure a
adequate competence of the staff.

Management system requirements - Internal audits (Option A)

8.6.4 n1 The inspection body must ensure that all the requirements of the ISO/IEC 17020 standard are met.
covered by the internal audit program within the accreditation cycle. The requirements to be covered
must be taken into account for all areas of inspection and for all premises where
activités d'inspection sont gérées ou réalisées.

The control body must justify the choice of audit frequency for different types of requirements.
inspection areas and premises within the framework of the audits planning conducted.
The justification may be based on considerations such as:

-
criticality
-
maturity
-
previous performances,

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-
organizational changes,
-
the changes of
- procedures and the effectiveness of the experience transfer system between different sites
operational and between different areas of operation.

8.6.4 n2 The internal audit is an essential tool that the inspection body must apply at a frequency
short enough to consistently meet the requirements of
the ISO/IEC 17020 standard. When an inspection body detects issues that affect
the compliance with ISO/IEC 17020 standard. In accordance with the requirements of IEC 17020 (by
example increase in complaints and calls; unsatisfactory results during audits
external; staff qualification issues, etc.), it should consider increasing the
frequency and depth of its internal audits, and/or extend their coverage to include
d'autres lieux et domaines d’inspection.

8.6.5 n1 The qualified personnel under external contract can perform internal audits.

Management system requirements – Preventive actions (Option A)

8.8.1 n1 Preventive actions are taken as part of a proactive process of identifying non-
potential compliance and opportunities for improvement rather than as a reaction to
the identification of non-conformities, issues, or complaints.

Annex A Independence requirements for inspection bodies

The annexes A.1 and A.2 of ISO/IEC 17020 refer to the term 'inspected items' in this regard.
which concerns type A and type B inspection bodies (4.1.6 n1 clarifies the cases where a
the inspection body can have different types of independence). In Annex A.1 b, it is
indicated that "in particular, they must not participate in the design, manufacturing,
supply, installation, purchase, ownership, use or maintenance of the elements
inspected." In Appendix A.2 c, it is indicated that "in particular, they must not participate in
design, manufacturing, supply, installation, use or maintenance
inspected elements." The reference to "they" in the above sentences refers to
the relevant control body and its personnel. The elements in this case are those that
are specified in the certificate/the annex of the accreditation body regarding the
accredited scope of the control body (for example pressure vessels).

Also considered a conflicting activity is the provision of advice on

design, manufacturing, supply, installation, purchase, use or maintenance of
inspected elements.

A 'regulatory requirement' means that the exception has been included in the relevant legislation and/
or when a regulator provides publicly accessible guidance indicating that this exception
is authorized when it is carried out within the framework of regulated inspection activities.

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6. Appendix 1: Possible format for an analysis of risks related to impartiality (informative)

Clause 4.1.3 requires the inspection body to continuously identify risks to impartiality and the clause
4.1.4 requires the inspection body to demonstrate how it eliminates or minimizes these risks. In practice, the combination of
these two clauses indicate that 'an analysis of risks related to impartiality' is required. Although this term 'risk analysis'
"risks of impartiality" is not mentioned in the ISO/IEC 17020 standard, in this application note, it is used as
a widely used term by which the requirements of articles 4.1.3 and 4.1.4 can be addressed by the organization
of inspection.

The actions by which the monitoring body demonstrates how it eliminates or minimizes risks in practice.
Identified impartiality measures are often referred to as 'control measures'. Furthermore, this term is not mentioned in the
ISO/IEC 17020 standards.

A possible format for an impartiality risk analysis is presented in the table below.

Situation Risk of bias Control measure and its At what place in the system of
tracking management of control measures
Are they integrated?
(procedure, instruction,
form, declaration)?
1. Activities of the control body
-
-
-
-

2. Relations of the control body

-
-
-
-

3. Staff Relations
-
-
-
-

Table 1. Possible format for an analysis of risks related to impartiality

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7. Appendix 2: Relationship between impartiality and type A independence requirements

(Informative)

-
Impartiality (defined as the presence of objectivity) is the main requirement;
-
The impartiality of an inspector is present when the inspector demonstrates objectivity in all cases.
his judgment;

1- Risks eliminated by complying with type A independence requirements

Compliance with Type A independence requirements eliminates risks of bias related to involvement in
activities that could conflict with independence of judgment and integrity regarding the
inspection activities;
Type A independence requirements aim to enhance confidence in impartiality and to exclude only
certain risks related to impartiality. Therefore, adherence to these type A independence requirements
does not eliminate all risks of bias;
The remaining risks regarding impartiality must be identified (4.1.3) and minimized or eliminated.
(4.1.4);

2- Analysis of risks of impartiality and control measures

-
In practice, the identification of potential risks to impartiality is often called 'risk analysis.'
"of impartiality"; the minimization or elimination of the risks of impartiality according to 4.1.4 is often referred to in
the practice "control measures" ;
An analysis of impartiality risks is required for the three types of independence (Type A, Type B)
and type C);
The compliance with the independence requirements of type A A.1b and A.1.c is binary (yes or no), which means that the
Partial respect of these type A independence requirements is not possible.
This also means that a risk analysis leading to control measures aimed at minimizing
the risks of bias in a situation where there is no respect for these type A requirements is not
possible. Therefore, only the elimination of the situation that does not comply with these type A requirements
is possible;
The type A independence requirements A.1d could be met by control measures.
resulting from the risk analysis;
The assessment of the compliance of a control body with the independence requirements type A A.1b and A.1c
may be complex in certain specific situations (depending on the inspected elements and the
market characteristics), but the result must be yes or no;

3- Inspected items

The term ' inspected elements' is mentioned in the type A independence requirements of Annex A.1b/c.
from the ISO/IEC 17020 standard and is specified in this document ILAC-P15 under A n1.
The reasoning behind the clarification of the ILAC-P15 is that a potential influence on the market or a
Any potential market influence must be avoided, thus also avoiding commercial/financial pressures.
on the inspection body and/or its personnel (for example, the inspectors);
-
Regulatory bodies can operate in markets with different characteristics in terms
by name of suppliers/producers:
• Markets where there is a limited number of suppliers/producers. For example, elevators,
cars, pressure equipment;
• Markets where there are a very large number of suppliers/producers. For example, in
the agri-food sector.
This type of difference in the market situation has no influence on the interpretation of ILAC-P15.
In clause n1, inspection bodies and their inspectors must not be involved in the inspected elements such as

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mentioned on the scope of the accreditation, thus generally and not limited to only specific/unique elements
individuals who are subject to inspection by the inspection body.

4-Type A/Type C

-
It can be difficult to comply with the independence requirements of type A A.1b and A.1c in certain sectors.
economic activity where potential external inspectors in these sectors are, in most cases,
engaged on the inspected items; In such cases, type C is an alternative to type A.

-
It should be noted that the requirements for impartiality and competence for type A and type C are the same;
only the requirements for independence are different.

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8. REFERENCES

6.1 ISO/IEC 17000:2004 Conformity assessment – Vocabulary and general principles.

6.2 ISO/IEC 17011:2017 Conformity assessment - General requirements for accreditation bodies
accrediting conformity assessment bodies.

6.3 ISO/IEC 17020:2012 Conformity assessment - Requirements for the operation of various types
of organizations carrying out inspections.

6.4 ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories

6.5 ISO 15189:2012 Medical laboratories - Requirements for quality and competence

6.6 Quality management systems ISO 9001:2015 – Requirements

6.7 IAF/ILAC A2:01/2018 IAF/ILAC Multilateral Mutual Recognition Arrangements

Provisions: Requirements and evaluation procedures of a single accreditation body

6.8 ISO/IEC 17007:2009 Conformity assessment - Guide for the drafting of normative documents that can be
used for conformity assessment

6.9 ILAC P8:03/2019 ILAC Mutual Recognition Arrangement (Arrangement): Additional Requirements
for the use of accreditation symbols and for claims of accreditation status by the
accredited conformity assessment bodies

6.10 ILAC P10:01/2013 ILAC Policy on the Traceability of Measurement Results

6.11 ILAC G24:2007 Guidelines for determining calibration intervals for measurements
instruments

6.12 ILAC G27:06/2017 Guidelines on measurements taken in the context of a

inspection process

6.13 ILAC G28:07/2018 guideline for the formulation of accreditation scopes

inspection bodies

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