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GENERAL POLICY AND MEANS FOR THE IMPLEMENTATION

OF THE ISO/IEC 17011:2017 REQUIREMENTS ON THE


IDENTIFICATION AND MANAGEMENT OF RISKS RELATED TO
ITS OPERATION

The only valid versions of the documents of the BELAC management system are
those available from the BELAC website (www.belac.be).

English translation for information only.

French and Dutch version remain the authoritative documents.

Date of implementation: 16.12.2022

BELAC 1-02 Rev 8-2022 1/26


HISTORY OF THE DOCUMENT

Revision and Reason for revision Type of revision


date of approval
0
CC 16.09.2010
1 Extension of the concept of related bodies Point 4.1
CC 12.05.2011 having administrative link with BELAC to all Point 4.2
conformity assessment bodies placed under the
legal responsibility of the Belgian State.
Specific provisions with respect to the
accreditation of related bodies.
2 Accreditation of inspection activities of Point 4.2
CC 16.05.2013 FAPETRO (General Direction Energy)
3 Periodic update of the document
CC 27.10.2016 - Incompatible activities Point 4.1
- Accreditation by BELAC of conformity Points 4.2 and 4.3
assessment bodies operated by the FPS
Economy
4 Regular update of the document
CC 19.04.2018 Update with respect to the requirements of
ISO/IEC 17011:2017
5 Update of the content of the document in order Full revision
CC 07.11.2019 to comply with the ISO/IEC 17011:2017
requirements on the identification and
management of risks related to the operation of
BELAC
6 Regular update of the document Full revision
CC 29.06.2020
7 Regular update of the document – taking into Full revision
CC 02.12.2021 account EA 2/19
8 Analysis of the impact of taking up the position Full revision
CC of Director General of the Directorate General
01.12.2022 Quality and Safety by the Chairman of the
Accreditation Board

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TABLE OF CONTENTS

OBJECTIVES AND NORMATIVE REFERENCES ............................................................ 4


RECIPIENTS............................................................................................................................ 4
INTRODUCTION................................................................................................................... 5
RESULTS OF THE IDENTIFICATION OF RISKS IN TERMS OF IMPARTIALITY ..... 6
RESULTS OF THE IDENTIFICATION OF RISKS IN TERMS OF THE
IMPLEMENTATION OF THE ACCREDITATION PROCESS ..................................... 18
RESULTS OF THE IDENTIFICATION OF RISKS IN TERMS OF THE
IMPLEMENTATION OF THE ORGANISATIONAL PROCESSES ............................. 24

BELAC 1-02 Rev 8-2022 3/26


GENERAL POLICY AND MEANS FOR THE IMPLEMENTATION OF
THE ISO/IEC 17011:2017 REQUIREMENTS ON THE
IDENTIFICATION AND MANAGEMENT OF RISKS RELATED TO
ITS OPERATION

OBJECTIVES AND NORMATIVE REFERENCES

This document aims to define the general policy and means implemented by BELAC to
comply with ISO/IEC 17011:2017 requirements on the identification and management
of risks related to its operation. Document EA 2/19 was taken into account for this
purpose.

This document refers to and complies with the relevant sections of the legal
stipulations that determine the operation of BELAC.

RECIPIENTS

- Coordination Commission
- Accreditation Board
- Secretariat

BELAC 1-02 Rev 8-2022 4/26


INTRODUCTION

The standard ISO/IEC 17011:2017 requires each accreditation body to develop and
implement a risk-based approach for all the processes governing its operation.

The standard ISO/IEC 17011:2017 explicitly focuses on the risks that may impact
- the maintenance of the impartiality of the accreditation body at all levels of its
operation including its decision-making processes (ISO/IEC 17011:2017 clause
4.4);
- the reliability of the services performed by the accredited bodies, due to a lack
of control of the performance and the harmonization of the accreditation
processes (ISO/IEC 17011:2017 clauses 9.6 and 9.8);
- the efficiency of the accreditation body organizational processes and of the
implemented management system (ISO/IEC 17011:2017 clauses 9.6 and 9.8).

As a consequence, each accreditation body is required :


a) to identify the sources, the impact and the level of severeness of all potential
risks ;
b) to document and implement appropriate mechanisms in order to eliminate or
control the identified risks; these mechanisms shall be approved by the
committee/structure responsible to supervise the operation of the accreditation
body (i.e. for BELAC, the Co-ordination Commission where all parties with
interest in the accreditation are represented) ;
c) to review at regular intervals whether the results of the risks analysis and the
mechanisms set up for their control are still relevant, considering the evolution
of the activities and of the operational structure.

The present document covers the points a and b , considering the obligation for the
accreditation body
- to ensure the impartiality of its operation (see point 4 of the present document);
- to guarantee the competence of the accredited bodies for all concerned
activities through the implementation of appropriate assessment plans and
programs (see point 5 of the present document);
- to set into force an efficient management system aiming to continuous
improvement (see point 6 of the present document).

The tables under points 4, 5 and 6 present the details of the analysis. Based on the
working experience, a level is assigned for each identified risk (major - high –
medium – low – not significant) as well as the existence of a potential residual risk.

The present document is reconsidered or updated each time an evolution of BELAC


or specific circumstances make it necessary and at least as part of each management

BELAC 1-02 Rev 8-2022 5/26


review. Where possible, data aiming to provide objective evidence with respect to the
declared level of risk have been added.

RESULTS OF THE IDENTIFICATION OF RISKS IN TERMS OF


IMPARTIALITY

Government accreditation bodies - including BELAC - present specific risks since they
are generally placed under the final responsibility of the State and inserted into a wider
administrative structure with its own management requirements and which may also
include conformity assessment bodies such as laboratories, inspection or certification
bodies and even notified bodies.

Considering the environment in which BELAC is operating and the potential impact on
impartiality, the following elements are to be taken into account in the identification of
potential risks :
- the provision of services by the larger administrative structure which are
incompatible with the accreditation activities (consultancy, conformity
assessment activities such as those can be offered by bodies accredited by
BELAC);
- the existence of conformity assessment bodies within the larger administrative
structure to which BELAC also belongs and whose activities can create conflicts
of interest;
- the possibility for BELAC to grant accreditation to related conformity
assessment bodies that are part of the larger administrative structure;
- the role of the administration (Federal public Service Economy) in the
management of BELAC;
- the external influences on the decision-making mechanisms;
- the nature of the accredited activities;
- pressures of financial type;
- the methods of recruitment and assignment of the BELAC permanent
secretariat staff;
- the methods of recruitment and appointment of accreditation assessors and
experts;
- the handling of appeals;
- the recourse to sub-contracting or to externalised services;
- discrimination in the handling of applications for accreditation.

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Source of risk Description and impact of the Level of Measures aiming to eliminate or Residual Situation as of
identified risk risk minimize the risk risk 01.08.2022
Performance of This may cover consultancy activities Medium Apart from general training sessions Low
consultancy for the benefit of dealing with accreditation and the
activities accredited/applicant bodies, applicable BELAC requirements and
performed by BELAC or its external procedures, the BELAC staff and the
assessors. external assessors commit
themselves to refrain from any form
of advice or service that might
compromise the objectivity of the
decision-making process.
(References : BELAC 1-01,
BELAC 3-05, BELAC 3-08,
BELAC 3-11)
Conducting a pre-assessment is not Medium BELAC has documented the Low A feedback has been
considered to be a consultancy obligation for the persons involved in sent to different
activity insofar as the BELAC the accreditation process to refrain assessors following
assessors identify possible from any type of consultancy. This is request of the
shortcomings within the an attention point during the on-site Accreditation Board
organization, but refrain from any monitoring of assessors (form
form of advice. The concept of pre- BELAC 6-207), the review of
assessment (preliminary visit) is in assessment reports and the decision-
fact integrated in the standard making processes. In case the
ISO/IEC 17011 (clause 7.5.1) deontological rules are not complied
with, the co-operation with the
concerned person is stopped.
(References BELAC 3-05, BELAC 3-09,
BELAC 3-1, BELAC 6-207)

BELAC 1-02 Rev 8-2022 7/26


Performance by This may cover conformity Not BELAC refrains from performing any Not No example until now
BELAC of assessment activities and in significant type of conformity assessment significant
conformity particular the organization of activity and in particular from
assessment interlaboratory comparisons organizing or contributing to the
activities, such as organization of interlaboratory
those offered by comparisons in sectors where
BELAC accredited publicly or privately organized
bodies programs of interlaboratory
comparisons are available. BELAC
may however integrate a specific
exercise (measurement audit) in an
assessment program.
(References: BELAC 1-03,
BELAC 2-106)
Pressures due to Considering that BELAC is placed The functional separation between
the existence of under the responsibility of the Not the activities and responsibilities of Not
CAB’s with Belgian State and has no specific legal significant the FPS Economy and the other significant
administrative link identity, all entities of the Belgian administrative entities is effective
to BELAC. administration have formally to be based on the relevant legislation.
considered as related bodies
especially if they perform conformity
assessment activities.
BELAC cooperates with conformity Not The federal and regional competent Not No case of
assessment bodies operated by significant authorities are represented in the significant pressure by
administrations at the federal and BELAC management committees and an authority
regional level. This cooperation may BELAC benefits from their particular registered until now
in particular involve the provision of expertise; however, their
assessors/experts and/or the representatives do not have any
drafting of interpretative documents special status and are not able to
in order to facilitate the block a decision.
implementation of accreditation (References: BELAC 0-05, BELAC 3-08,
standards in specific sectors. BELAC 3-09
The risk for a conflict of interest with
conformity assessment bodies
operated by federal or regional

BELAC 1-02 Rev 8-2022 8/26


administrations is minimum to non-
existent.

The following conformity assessment Not BELAC belongs to the Directorate Not
bodies currently operate within the significant General Quality and Safety and the significant
FPS Economy: different Directorates General within
- the Directorate General the FPS Economy are managed in a
Economic Inspections and the completely independent manner.
Directorate General Energy
perform inspection activities; The National Standards service
- the Directorate General Quality carries out only occasionally
and Safety (to whom BELAC calibration services for third parties.
belongs) includes: These services generate only a
- the National Standards service limited fraction of the operational
that performs calibration budget.
activities.
- several testing and inspection No tests or inspections are carried
services within the framework out on request of third parties. The
of legal metrology and activities concerned fall directly
under the responsibility of the
product safety.
regulatory authority within the
framework of market surveillance.

The conformity assessment activities


performed by the services of the
Directorate General Quality and
Safety do not compete with those
performed by accredited bodies and
cannot cast any doubt on the
impartiality of BELAC.
Accreditation of BELAC grants accreditation to Not The functional separation between Not No case of
administratively conformity assessment bodies significant the activities and responsibilities of significant pressure by
related conformity depending on federal administrations the FPS Economy and the other an authority
assessment bodies. other than the FPS Economy or administrative entities is effective registered until now
depending on regional based on the relevant legislation. In
administrations. case of accreditation, provisions

BELAC 1-02 Rev 8-2022 9/26


complementary to those defined by
the general accreditation procedure
are not necessary.
Within FPS Economy, the following Low BELAC takes the view that the Not Recourse to foreign
activities are accredited by BELAC: general provisions for accreditation significant assessors may be
- the calibration activities of the ensure an impartial and independent difficult to respect in
National Standards service and decision-making even in case of case of inspection
inspection activities within the accreditation of bodies belonging to according to Belgian
framework of market surveillance the FPS Economy. legislation
(Directorate General Quality and However, in order to reinforce the
Safety; safeguard mechanisms that are Strictly respected (see
- the inspection activities of already in place, the following file BELAC 425, B-
FAPETRO (Directorate General specific provisions have been 490 and minutes of
Energy). implemented : the Accreditation
This relation may endanger the - recourse to foreign assessors for Board
impartiality of the decision-making the evaluation of the technical
process. aspects is preferred;
- the members of the Accreditation
Board who represent the FPS
Economy are not allowed to
attend the discussions and
deliberations and have no voting
right in the case of accreditations
of the FPS Economy.
Since both the chairman and the
vice-chairman of the
Accreditation Board belong to the
FPS Economy, discussions about
these files are led by a member of
the Accreditation Board who
does not belong to the FPS
Economy.
Role of the In accordance with the legal Low The administration is represented in Not
administration of stipulations, the FPS Economy has the BELAC decision-making bodies significant
the Federal public the final responsibility for the (Coordination Commission and
Service Economy in operation of the Belgian Accreditation Board) by only a limited

BELAC 1-02 Rev 8-2022 10/26


the management of Accreditation Body. The legal number of representatives; they do
BELAC stipulations guarantee the autonomy not have any special status and are
of BELAC decisions and the role of not able to block a decision.
the administration of the FPS (References : BELAC 0-05,
Economy in the BELAC daily BELAC 1-01)
management is limited to the See points 7 and 8 for further details
provision of human and material
resources.
Possible influence Role of the groups of interest : Low Representation of the groups of Low
on the decision- By groups of interest are meant in interest :
making particular the regulatory authorities The representation of the groups of
mechanisms. which call upon accredited interest in the National Council, the
organisations for agreements and Coordination Commission and the
(With regard to the notifications and the accredited Accreditation Board is fixed by Royal
role of the FPS bodies themselves. Decree. The candidates are required
Economy : see to comply with documented criteria
under points 5 and of competence and to commit
6) themselves with rules on impartiality
and confidentiality.
(References : BELAC 0-05)
Decisions on the operation rules of Low Records available in
BELAC: the minutes of the
The decisions are generally made by Coordination
consensus or, if necessary, by vote Commission for each
with simple majority. Specific specific case
measures are in place to avoid that a
group of interest can force a decision
unilaterally. (References : BELAC 3-08)
Decision on the accreditation files : Low Records available in
The methods of examination of the the minutes of the
files and the rules for decision making Accreditation Board
are identical for all the files and are for each specific case
the subject of detailed records. The
members of the Accreditation Board
who took part in an assessment as
assessor or expert are excluded from

BELAC 1-02 Rev 8-2022 11/26


the deliberations and have no voting
rights.
Members of the Bureau who have a
direct personal interest or are
associated with a file cannot attend
the discussions and the deliberations
and have no voting rights.

(References : BELAC 3-09)


Sanctions Medium BELAC is conscious of the damage Low No example of
There are numerous activities in the that a refusal, a withdrawal or a pressure having
regulated sectors for which suspension of accreditation can resulted in not
accreditation is a mandatory cause to any CAB. These sanctions deciding for a
prerequisite. The refusal, the are thus taken after detailed sanction
withdrawal or the suspension of an examination and the body has the
accreditation can thus have possibility of putting forward its
particularly detrimental arguments. Sanctions always imply a
consequences for the accredited decision by the Accreditation Board.
body. Giving consideration to such In the case of the regulated sectors, a
situations could endanger the dialog takes place with the regulatory
impartiality of the accreditation authority but this one does not have
decisions any prerogative at the time of
decision making.
The current provisions make it
possible for BELAC to take the
decision to impose sanctions as soon
as facts are identified which call in
question the compliance with the
accreditation requirements.
(References : BELAC 3-11)
Nature of BELAC may accept any application Low Even if such applications do not Not
accredited for accreditation, even when constitute an extension of the scope significant
activities covering very specific activities with of application of BELAC in a strict
possibly only one candidate to the sense, they are the subject of a
accreditation and for which the documented review of feasibility and,
if necessary, the opinion of the

BELAC 1-02 Rev 8-2022 12/26


BELAC competence may not be easy Accreditation Board and/or of the
to guarantee. Coordination Commission are
required.
BELAC accredits bodies with a Not So as to ensure competence and Not This provision is
reference status at Belgian level significant guarantee independence during the significant actually implemented
(primarily in the laboratories sector), assessment, it is normally called upon
which imposes specific provisions to foreign assessors and experts coming
ensure competence and from organizations with an
independence during the equivalent level of competence.
assessment.
Financial pressure In accordance with the provisions of Medium The financial provisions governing Low
the law on accreditation, the BELAC are such as to ensure the
financing of BELAC rests on: continuity of the activities without
- The contribution of the FPS generating profit.
Economy via various articles of The legal provisions on the operation
its ordinary budget of BELAC allow for, if felt necessary
Are covered: to meet the financial needs, a revision
- the provision of office buildings of the accreditation costs in order to
and equipment, including IT reinforce the resources of the
services (via the general budget Accreditation Fund.
of the Directorate of Quality and
Safety);
- the provision of personnel to
ensure the daily management of
BELAC .
A potential limitation of the budget
allowed to BELAC may endanger the
efficiency and the continuity of
activities but without direct impact
on the impartiality of its operation.
- The contributions of the Low The assessment costs are fixed by Not The results of the
accredited bodies. Royal Decree. They are calculated on significant Fund is a systematic
The balance between the income and a case-by-case basis, according to the item of each
outcome of the Accreditation Fund complexity of the assessment audit management review.
does not depend on the number of to be performed. Equilibrium of the
accredited bodies , which contributes Fund is reached.

BELAC 1-02 Rev 8-2022 13/26


to protect the objectivity of the The contributions of the accredited
accreditation decisions. bodies are managed through the
The existence of bodies being Accreditation Fund, which
accredited guarantees their exclusive
for a wide range of conformity assignment for the profit of the
assessment activities may represent a operation of BELAC.
risk as they are contributing for a The collected amounts automatically
relatively high amount to the BELAC cover the remuneration of the
financial resources. members of the assessment teams
and the surpluses are used for
recruiting contractual personnel to
reinforce the BELAC secretariat and
to perform various other actions
(financing of the international
obligations and of the promotion
actions).
The Coordination Commission and
the National Council are responsible
for the supervision of the
management of the Fund as part of
the management review.
No individual contribution represents
such an amount as to significantly
impact the BELAC financial budget.

BELAC 1-02 Rev 8-2022 14/26


- The remuneration of the Low The provisions for remuneration are Not
personnel involved in the fixed by the legal stipulations and do significant
accreditation process not include any possibility for
The existence of financial incentives supplements:
related to the type and volume of The members of the BELAC
activities has to be considered permanent staff are civil servants and
are remunerated according to the
relevant legal provisions
The assessors and experts are
remunerated based on an hourly rate
: the duration of each assessment is
fixed and validated by the BELAC
permanent staff.
The function of member of the
Accreditation Board or of the
Coordination Commission is not
remunerated
Recruitment and The BELAC secretariat internal staff Not The following provisions make it Not
assignment of the is composed of : significant possible to guarantee the significant
BELAC secretariat - civil servants depending on the independence, the impartiality and
internal staff FPS Economy and made available the objectivity but also the
to BELAC by the Directorate competence of the internal staff of
general Quality and Safety the BELAC secretariat (statutory and
- staff engaged on basis of the contractual):
Accreditation Fund; they are - The personnel is held to respect
subject to the same obligations as the ethical obligations of the civil
the civil servants. servants;
The independence, impartiality and - The general procedure of
objectivity but also the competence recruiting applicable to the civil
of the BELAC secretariat internal servants is complied with in all
staff need to be ensured. the cases (definition of a function
profile and minimum level of
competence, selection exams
with classification and
appointment according to the
order of classification). The

BELAC 1-02 Rev 8-2022 15/26


specificities of the function
profiles are fixed by BELAC
according to the needs and
BELAC takes an active part in the
selection exams. The same
criteria are used in the event of
transfer to BELAC of a civil
servant already appointed in
another service of the
administration.
- The direction of BELAC is
ensured by a civil servant who has
the administrative rank of
department manager and is
appointed by the administration.
The function profile is defined at
the administrative level and
supplemented by specific
requirements documented in the
management system of BELAC;
these elements are taken into
account for any appointment.
- The direction is responsible for
the allocation of the tasks and
responsibilities between the
various BELAC staff members;
annual performance objectives
are laid down for each
collaborator.
Recruitment and The existence of conflicts of interest Medium The BELAC secretariat has the full Low
appointment of in case of recruitment and responsibility for the selection,
assessors and appointment of assessors and training (initial and continued), and
experts experts needs to be considered. the formal qualification of the
assessors and experts.

BELAC 1-02 Rev 8-2022 16/26


The BELAC secretariat is sole
responsible for the assignment of
assessment teams.

Several measures are in place to


ensure the impartiality:
- documentation of the general
ethical obligations for assessors
and experts ;
- the possibility of challenge of any
assignment by the body to be
evaluated;
- assessors and experts are
required to fill in a written
commitment
- each assessor or expert is
reminded of the obligation to
declare any conflict of interest;
- regular change of the members of
an assessment team in order to
avoid undesirable familiarity
relation.

On its own initiative, BELAC may call


for expertise by the regulatory
authorities but keeps the final
responsibility for the selection of
assessors and experts.
(References : BELAC 3-05,
BELAC 3-11)
Handling of appeals The handling of appeals must ensure Low A Board of Appeal independent of Low Lodged appealshave
independence from the decision- the decision-making process is been handled.
making process which motivates the responsible for the handling of according to the
lodging of the appeal appeals. procedure.
The provisions for the operation of The criteria for the
the Board of Appeals (composition, selection of the

BELAC 1-02 Rev 8-2022 17/26


competence and impartiality criteria members ensure their
for the members, timing …) have been competence and
defined as to ensure a full separation impartiality.
with the decision-making process
which motivates the lodging of the
appeal and an impartial handling of
the files. (References : BELAC 0-05,
BELAC 3-04)
Subcontracting The existence of conflicts of interest, Not BELAC does not subcontract any Not The documented
of confusion in the assignment of the significant accreditation activity except in case significant provisions applicable
responsibilities or of lack of of partnership with another in case of sub-
competence of the subcontractor accreditation body for assessments contracting to foreign
needs to be considered. to be performed outside Belgium in accreditation bodies
compliance with the cross-frontier are strictly respected.
policy.
By recoursing only to accreditation
bodies signatories of the EA-MLA,
BELAC ensures the independence,
impartiality and competence of the
subcontractor. (References :
BELAC 1-01)
Acceptance of No discriminatory condition can be Not The conditions to accept an Not
accreditation used to refuse an accreditation significant application for accreditation do not significant
applications application. include discriminatory clauses.
(References : BELAC 1-01)

RESULTS OF THE IDENTIFICATION OF RISKS IN TERMS OF THE IMPLEMENTATION OF THE


ACCREDITATION PROCESS

BELAC commits itself to take into account the risks at all levels of the performance of the accreditation process.

The following processes may negatively impact the level of performance and the reliability of the accreditation decisions and are
given specific attention : the review of the applications for accreditation, the composition of the assessment teams, the duration of

BELAC 1-02 Rev 8-2022 18/26


the assessments, the coverage of the accredited scope within an accreditation cycle (assessment program) and the extension of the
accreditation scope.

Source of risk Description and impact of the risk Level of Measures aiming to eliminate or Residual Situation as of
risk minimize the risk risk 01.08.2022
Competence of the BELAC has to ensure the Medium BELAC has documented competence Low The efficiency of the
personnel involved competence of the personnel criteria, a description of tasks and implemented tools is
in the accreditation involved at all stages of the responsibilities as well as training checked during the
process accreditation process, which methods and monitoring of the internal audits : no
includes: performance level for all the major problem
- The permanent staff in charge of functions involved in the detected until now.
the handling of the accreditation accreditation process. Various tools
files; for monitoring the implementation of
- The assessors and experts (mainly these provisions are in place.
external personnel) (References : BELAC 1-01, BELAC 3-
- The members of the Board who 05, BELAC 3-09, BELAC 5-07)
make decisions.
Despite the recruitments, BELAC As of 01.08.2022,
continues to struggle with the Medium BELAC has 32
understaffing of some critical employees and a
functions number of
recruitments are still
on the agenda
The risks linked to the following Medium The competence issue is part of the Low .
situations need to be taken into feasibility review performed by
account: BELAC prior to any significant
- the obligation for BELAC to extension of the BELAC activities
demonstrate competence at all scope. BELAC may decide not to
stages of the accreditation propose a specific accreditation
process in case of extension of program if competence cannot be
the BELAC activities scope ; ensured. Whenever possible,
- the constraint following a legal preliminary contacts are made with
obligation to offer an the regulators who consider to have

BELAC 1-02 Rev 8-2022 19/26


accreditation service in a specific recourse to accreditation for their
regulated sector ; regulatory tasks
(References : BELAC 1-03,
BELAC 3-07)
- the limited availability of Belgian Medium Whenever necessary, BELAC calls on Medium In 2021-2022-2023,
assessors and experts in specific foreign assessors/experts, which training on ISO IEC
sectors considering that the level implies specific supervision (including 17065 and ISO IEC
of technical competence and providing information on national 17021-1 is provided
impartiality required by BELAC is reglementary requirements) as well with a view to training
high; as management of the use of new assessors
languages ; this may result in an
increase of the accreditation costs. .
(References : BELAC 3-05)
- the obligation for BELAC to High Despite the involvement of the Medium As of 01.08.2022,
comply with the rules applicable BELAC management, recruiting BELAC has 32
to all public services for the cannot always be carried out in time employees and a
recruitment of permanent staff. to ensure an optimal operation of number of
BELAC . recruitments are still
on the agenda

BELAC 1-02 Rev 8-2022 20/26


Review of the The composition of the teams and Medium BELAC has defined guidelines for Low Records are available
applications for the duration of assessments shall determining the skills to be included Examples are
accreditation, make it possible to conduct each in an assessment team, the average documented and a
composition of evaluation with the level necessary to assessment durations and the specific mention is
teams and duration demonstrate the organization’s assessment techniques to be used. included in the
of assessments compliance with the accreditation The objectives of the various types of decision letters
requirements and its competence for assessment are taken into account as
the performance of the accredited well as the factors of influence
activities specific to each file: nature,
The specific risks related to the complexity and volume of activities -
organization and the work location of the activity site (s) - results
environment of the body are of previous assessments.
essential elements that shall be Each determination of team
identified and taken into account. composition and duration of the
A proportionate approach is however assessment is subject to a reasoned
necessary. decision, recorded and subject to
control.
If it appears after the assessment that
the team composition and / or the
assessment duration did not allow
the objectives of the assessment to
be achieved, the Accreditation Board
decides on the need to organize
additional assessment or to
strengthen the following assessment.
(References : BELAC 5-02)
Assessment The program of assessments to be Medium to An accreditation program is prepared Low The assessment
program performed during an accreditation high after each initial or renewal programs are well
cycle is expected to cover a depending assessment ; the program may need defined.
representative sampling of the on the to be updated in function of the
accredited activities. type of evolution of the file. The accredited
Linked to the assessment plannings (see case activities are defined according to the
point 5 below). fields and sub-fields in order to
facilitate and harmonize the sampling
of activities to be assessed during
each assessment. The specific

BELAC 1-02 Rev 8-2022 21/26


requirements of regulations,
EA/ILAC/IAF and of the conformity
assessment schemes are taken into
account. (References : BELAC 5-02,
BELAC 6-017, BELAC 2-405 xxx)
Extension of Applications for extension of the Medium BELAC considers the following Low All decisions for
accreditation accreditation have to be handled in processes for the extension of the significant requests
such a way as to satisfy the accreditation scope : for extension of
expectations of the accredited bodies - an administrative extension accreditation are
and the market (especially with process when the applied taken by the Board.
respect to delivery time) without extension falls within the general In case of urgency, a
jeopardizing the reliability of the competence of the accredited decision-making
accreditations. body; process is organized
- an extension with assessment by written
(documentary or with on-site correspondence. (see
assessment) and a simplified or minutes of the Board)
full decision-making process
depending on the impact of the
request for extension on the
competence of the body.
Specific provisions in case of urgent See cases related to
requests due to extraordinary recent crisis
circumstances; these requests are situations: (FIPRONIL,
given high priority. COVID-19)
(References : BELAC 3-11)
Respect of Performing the surveillance and Medium to The assessments planning is fixed per Low to The assessment
assessment plans renewal assessments according to high accreditation cycle with each initial or medium planning for complex
the planning fixed in the depending renewal accreditation decision. The depending cases (multi-
accreditation decision is an essential on the planning may need to be updated at on the standards, multi-sites,
element to ensure that compliance type of each moment of the cycle depending type of multi-activities) is not
with the accreditation requirements case. on the situation. All data related to case always sufficiently
is maintained. the assessments plannings are respected.
Linked to the assessment programs(see traceable The three factors that
point 3 above). play a role in this are
the availability of the
assessors, capacity at

BELAC 1-02 Rev 8-2022 22/26


the BELAC secretariat
and the rigid attitude
of the accredited
bodies.
Implementation of Extraordinary events outside of the Rare but BELAC considers any event that Low During the COVID-19
the accreditation control of BELAC or of the accredited high risk prevents the organization of crisis, BELAC has
process in case of bodies may result in BELAC no longer when such assessments and in particular political carried out the
extraordinary being able to implement the situations events, natural or climate disasters organization of
events accreditation process according to are and sanitary crises affecting one or assessments in
the documented provisions. A lack of encounter more accredited bodies and / or alternative ways (e.g.
control of the accredited bodies may ed. BELAC services as an exceptional remote, more
endanger the reliability of the event extensive use of
accreditations. In the case of an exceptional event, document/file
BELAC takes the necessary measures review). A further
to control the situation (e.g. COVID- digitization of file
19 crisis). A general policy has been management was
developed in this regard implemented.
The use of IT tools to perform remote Medium A policy for conducting remote Low BELAC restricted the
assessments can be hindered by assessments has been introduced use of IT tools and
unstable connections or can be within BELAC. Guidelines are tried to split up the
disrupted by the inadequacy of the currently being developed at assessments. More
tools. It must also be possible to European and international level. documents were also
guarantee the security of the data requested in advance.
exchange.

BELAC 1-02 Rev 8-2022 23/26


RESULTS OF THE IDENTIFICATION OF RISKS IN TERMS OF THE IMPLEMENTATION OF THE
ORGANISATIONAL PROCESSES

Complementary to the issues related to the obligation for BELAC to operate with the necessary level of impartiality and to control the
accreditation process, the BELAC operational processes and their implementation through a documented management system may
generate sources of risks and impact the general level of performance and the expectations with respect to accreditation.

In this respect, specific attention has to be paid to the following issues :

Source of risk Description and impact of the Level of Measures aiming to eliminate or Residual Situation as of
identified risk risk minimize the risk risk 01.08.2022
Structure Risk of confusion in the definition of Not The legislation governing the Not
tasks and responsibilities with significant operation of BELAC together with significant
respect to the management of the documented provisions of the
BELAC and of the accreditation management system specify the
processes. tasks and responsibilities of the
involved functions. These provisions
are strictly implemented.
(References : BELAC 0-05,
BELAC 1-01)
Resources Insufficient resources in competent Medium IT tools are made available to BELAC Medium The development of a
personnel for all functions involved in by the FPS Economy. Improvements new IT tool has been
the accreditation process : see table are however necessary to ensure an started.
5 point 1 optimal management of the
Lack in appropriate material accreditation files and an effective
resources (premises, equipment, IT communication between BELAC, its
tools) assessors and its accredited bodies.
Financial resources : see table 1 point
8

BELAC 1-02 Rev 8-2022 24/26


Processes Potential risks are related to Low The policies, procedures and Not The document BELAC
shortcomings in terms of process instructions intended to support the significant 6-001 (see dates of
documentation and/or functioning of BELAC are revision of the
harmonization in their documented and regularly reviewed; documents)
implementation; control mechanisms to facilitate their demonstrates that the
Inadequate procedures for implementation and check their management system
processing particularly complex adequacy in relation to the is living, with proper
accreditation files. requirements applicable to an attention paid to the
accreditation body are in place. integration of the
Derogations made necessary by the international
processing of complex files must be requirements as well
documented and validated. as for the
(References: all management system development of
documents) BELAC specific
documents.
Information and Risk of shortcomings in terms of : Low The policies, procedures and Not
archiving - protection of data with instructions intended to support the significant
confidential character; information and communication
- communication with concerned actions of BELAC are documented
parties; and regularly reviewed; control
- publication of relevant mechanisms to facilitate their
information on the operation of implementation and check their
BELAC, accreditation adequacy in relation to the
requirements and data on requirements applicable to an
accredited bodies. accreditation body are in place.
Respect for confidentiality
obligations is taken into account.
BELAC only uses internal support
services provided by the FPS
Economy (IT management,
maintenance of premises).
(References: all management system
documents)

BELAC 1-02 Rev 8-2022 25/26


A systematic recourse to digital Low A SLA with the responsible IT Not
archiving may result in an increased department of the FPS Economy is in significant
risk with respect to the maintenance place.
of data.
Management Risks of shortcomings in terms of Low The management system is Not All decisions of the
system conception, documentation and constantly evolving to respond to significant Coordination
implementation of the management situations encountered in daily Commission are
system. practice. Its development and the traceable (see minutes
monitoring of its implementation are of the meetings)
placed under the supervision of the See also under point 3
Coordination Commission where all
the parties concerned are
represented. The conclusions and
proposals for action to improve the
efficiency of the system and the level
of services provided by BELAC are
presented during the management
review.
Risk of confusion between the ISO Not The management system of E6 does Not
9001 management system in force in significant not include the BELAC activities. The significant
E6 (Directorate general of Quality BELAC management system is fully
and Safety) on which BELAC separated with respect to the
administratively depends and the definition of the principles and
BELAC Management system in policies, the development of the
compliance with the requirements documents and their approval, as well
ISO/IEC 17011:2017 as the supervision mechanisms.

BELAC 1-02 Rev 8-2022 26/26

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