Recently modified and new BELAC documents

06.01.2026 BELAC documentation update

As a result of the indexation of the rates, the following documents have been amended:

• BELAC 7-01 Rev 30-2026 - BELAC: General and practical information
• BELAC 7-06 Rev 21-2026 - General information on the tax aspects of assessor fees
• BELAC 6-209 Rev 17-2026 - Form: honorarium for the coordinator

27.11.2025 BELAC documentation update

BELAC 4-01 Rev 9-2025 - Guidelines on the presentation of the BELAC assessment reports and the request for payment of the hours

Revision due to new rules for submitting invoices.

BELAC 7-07 Rev 1-2025 - Information for experts

Revision due to new rules for submitting invoices.

23.10.2025 BELAC documentation update

BELAC 2-001 Rev 15-2025 - Rules governing the reference to BELAC accreditation and BELAC signatory status of international multilateral agreements/recognitions

The document has been completely revised, with the most significant changes/additions being :

• In the case of certification, activities that are not covered by accreditation cannot be included on a certificate together with activities that are covered by accreditation;
• The reference to accreditation must not appear on gadgets;
• There is no longer a mandatory text for the reference via wording;
• For the list of IAF scopes, reference to the IAF website.

Furthermore, the order of the various points in the document was adjusted without changing the content.

BELAC 2-002 Rev 8-2025 - Accreditation certificate and corresponding scope of accreditation: general guidelines for formulation and evaluation

The document was revised to clarify some concepts.

BELAC 2-106 Rev 3-2025 - Guidelines for participation in proficiency testing and/or interlaboratory comparisons other than proficiency testing  

The document was revised to clarify some concepts and to update references to normative documents.

BELAC 7-06 Rev 20-2025 - General information on the tax aspects of assessor fees

Update following changes of km rate.

BELAC 2-403 – Guidelines for the implementation of accreditation criteria in the framework of the self-checking guides for the food industry and its suppliers, including the use of a flexible scope

This document has been removed from the list of valid BELAC documents and is therefore no longer applicable.

02.07.2025 BELAC documentation update

BELAC 2-004 Rev 1-2025 - Rules for the notification to BELAC and the management by BELAC of significant changes regarding structure, organization and resources by the accredited bodies

Full revision. 

BELAC 2-105 Rev 5-2025 - Requirements for accredited laboratories applying for a flexible scope for analyses of residues of veterinary drugs, pharmacologically active substances authorised as food additives and prohibited or unauthorised pharmacologically active substances according to Implementing Regulation (EU) 2021/808

Editorial corrections and addition of points 3.3.1.2. b and 3.3.2.2 b.

BELAC 2-405 CyberFundamentals Rev 0-2025 - Specific provisions for the accreditation of conformity assessment bodies in the field of the CyberFundamentals Framework 

New document.

BELAC 7-06 Rev 19-2025 - BELAC: General and practical information

Update following changes of km rate.

23.04.2025 BELAC documentation update

BELAC 6-432 (17025) Rev 5-2025 – Module D: report of the technical assessor or expert EN ISO/IEC 17025:2017

Clause 7.7 were corrected in the English and French language versions. No substantive changes were made to the Dutch-language version of this document (other than increasing the version number). 

BELAC 6-431(15189) Rev 8-2025 - Module C: report of the lead assessor EN ISO 15189:2022
and
BELAC 6-432(15189) Rev 8-2025 - Module D: report of the technical assessor or expert EN ISO 15189:2022

Modules C and D were updated for the new version of EN ISO 15189:2022. Revision 7 remains temporarily available for assessments where a transition to the new version of the standard is still ongoing.

BELAC 6-431(15189-17025) Rev 5-2025 - Module C: report of the lead assessor EN ISO 15189:2022 in combination with EN ISO/IEC 17025:2017
and
BELAC 6-432(15189-17025) Rev 5-2025 - Module D: report of the technical assessor or expert EN ISO 15189:2022 in combination with EN ISO/IEC 17025:2017

Modules C and D were updated for the new version of EN ISO 15189:2022.

BELAC 4-01 Rev 8-2025 - Guidelines on the presentation of the BELAC assessment reports and the request for payment of the hours

The main changes are the addition of the concept of a remote closing meeting in case of a documentary assessment and the provision that a positive recommendation cannot be given if one or more non-conformities are maintained.

13.08.2024 BELAC documentation update

Recently, a number of documents of BELAC's management system were updated. Below you will find a brief overview of the changes made to these documents.

BELAC 2-405-ISMS Rev 4-2024 - Specific provisions for the accreditation of certification bodies in the field of information security management systems (EN ISO/IEC 27001) 

Limited editorial changes linked to the correct wording of the standards and a correct display of the table from IAF MD 13:2023.

BELAC 2-405-ASBESTOS REMOVAL Rev 1-2024 – Specific provision for the certification of the companies who carry out demolition or removal work during which great quantities of asbestos can be released 

The reason for the revision was the absence of a sentence in the Dutch-language version of this document. This sentence has been added to bring it into line with the French version. No substantial changes have been made to the content of the French version of this document (apart from the page layout and the increase in the version number).

A total overview of the applicable documents can be found via the list BELAC 6-001 (PDF, 841.5 KB).

02.07.2024 BELAC documentation update

Recently, a number of documents of BELAC's management system were updated. Below you will find a brief overview of the changes made to these documents.

BELAC 1-01 Rev 11-2024 – Management Manual

This document was completely revised with the main changes being the abolition of the National Accreditation Council, an adjustment of the BELAC secretariat's organisational chart, mandatory participation in the IAF CertSearch and mandatory reference to accreditation on reports and certificates.

BELAC 1-03 Rev 11-2024 – BELAC Activities: description and criteria for selection

This document was revised as a result of the abolition of the National Accreditation Council and for an update of the reference to normative documents.

BELAC 3-05 Rev 15-2024 – Cooperation with BELAC assessors and experts: requirements and procedure for qualification, rights and duties

This document added the possibility for an expert to attend an assessment as a 'apprentice'. Furthermore, a risk-based approach can be used to determine the frequency of assessor monitoring.

BELAC 3-06 Rev 7-2024 – Guidelines for cooperation between BELAC and accredited bodies

In addition to a reworking of the structure of this document, the following additions were made:

• BELAC should proceed to a suspension when an accredited body offers conformity assessment activities at the level of an accreditation standard (obligation coming from IAF MD 7);
• BELAC should notify IAF when a withdrawal or suspension of a certification body's accreditation is based on the identification of fraudulent activities or deliberately providing false information or because a certification body is doing conformity assessment activities for an accreditation standard (obligation coming from IAF MD 7);
• Accredited ISO/IEC 17021-1 bodies should complete and keep up-to-date the IAF CertSearch database (obligation coming from IAF MD 28);
• BELAC (staff, assessors,...) shall not sign additional confidentiality or non-disclosure agreements.

BELAC 2-404 Rev 4-2024 – Guidance on the horizontal requirements for the accreditation of conformity assessment bodies for notification purposes

Resolution EA TMB 2022(10)02 was added in Annex C. This means:

• An on-site assessment (witness) should in principle be performed to grant the accreditation but a conditional granting is possible if no witness could take place;
• As long as no BELAC witness has taken place, no certificate under accreditation can be issued to a customer;
• If the witness cannot take place within 18 months, the accreditation of this activity is withdrawn. After such revocation, accreditation under condition is not possible for the relevant activity for 2 years.

BELAC 2-405-DOSI  Rev 1-2024 Specific provisions for the accreditation of laboratories recognized as dosimetric service by the Federal Agency for Nuclear Control (FANC)

The changes in this document relate to the formulation of the accreditation scope.

BELAC 2-405-EnMS Rev 3-2024 – Specific provisions for the accreditation of certification bodies of energy management systems (EN ISO 50001)

The changes relate to the references to ISO 50003:2014. These references were removed as the transition period ended on 30/11/2023.

BELAC 2-405-FSMS Rev 3-2024 – Specific provisions for the accreditation of certification bodies in the field of food safety management systems (EN ISO/IEC 17021-1:2015 + ISO 22003-1:2022)

This document has been revised due to the transition from ISO/TS 22003:2013 to ISO 22003-1:2022. References to the specific requirements of ISO/TS 22003:2013 were replaced by references to the specific requirements of ISO 22003-1:2022. Also, the document described separately the specific requirements of the new version of IAF MD 16 (IAF MD 16:2024). Finally, the specific requirements imposed on accreditation bodies by the FSSC 22000 scheme version 6.0 were also added to this document.

BELAC 2-405-FSMS Rev 2-2020 is still retained and applicable until the end of the transition period for ISO 22003-1:2022, i.e. 30/06/2025.

BELAC 2-405-ISMS Rev 3-2024 – Specific provisions for the accreditation of certification bodies in the field of information security management systems (ISO/IEC 27001)

This document has been revised to reflect the transition from EN ISO/IEC 27006:2020 (=ISO/IEC 27006:2015/AMD 1:2020) to ISO/IEC 27006-1:2024. References to the specific requirements of ISO/IEC 27006-1:2024 were added as well as a reference to IAF MD 29:2024 describing the transition requirements.

The existing references to the specific requirements of EN ISO/IEC 27006:2020 (=ISO/IEC 27006:2015/AMD 1:2020) are provisionally retained in this document until the end of the transition period, i.e. 31/03/2026.

BELAC 2-313 Rev 6-2024 – BELAC guidelines for the implementation of Regulation (EC) No. 1221/2009 (EMAS III) by accredited environmental verifiers

The reference to Commission Decision (EU) 2017/2285 of 6 December 2017 was replaced by the reference to Commission Decision (EU) 2023/2463 of 3 November 2023. (New version of the EMAS guidance document / User's Guide).

BELAC 6-431(17021-1) Rev 5-2024 – Module C: report of the lead assessor EN ISO/IEC 17021-1:2015

The reference to Commission Decision (EU) 2017/2285 of 6 December 2017 was replaced by the reference to Commission Decision (EU) 2023/2463 of 3 November 2023. (New version of the EMAS guidance document / User's Guide).

BELAC 6-432(17021-1) Rev 5-2024 – Module D: report of the technical assessor or expert EN ISO/IEC 17021-1:2015

The reference to Commission Decision (EU) 2017/2285 of 6 December 2017 was replaced by the reference to Commission Decision (EU) 2023/2463 of 3 November 2023. (New version of the EMAS guidance document / User's Guide).

A total overview of the applicable documents can be found via the list BELAC 6-001 (PDF, 841.5 KB).

06.06.2024 BELAC documentation update

Recently, a number of documents of BELAC's management system were updated. Below you will find a brief overview of the changes made to these documents.

Updated document:

• BELAC 2-405-RAILWAY Rev 2-2024 – Specific provisions for the accreditation of conformity assessment bodies seeking notification to perform notified bodies’ activities as described in the EU Railways legal framework
  
  This document was revised due to the update of a reference document (version 2.0 of the Technical document MNB- ERA Assessment Scheme 000MRA1044 ver 2.0).

New documents following the new version of  ISO/IEC 17043:2023: 

• BELAC 6-113 Rev 0-2024 – Check-list for evaluation of compliance with the requirements of EN ISO/IEC 17043:2023
  New document to be used in preparation of transition assessment to the new version of ISO/IEC 17043:2023.
   
• BELAC 6-431(17043) Rev 5-2024 – Module C: report of the lead assessor EN ISO/IEC 17043:2023
• BELAC 6-432(17043) Rev 4-2024 – Module D: report of the technical assessor or expert EN ISO/IEC 17043:2023

A total overview of the applicable documents can be found via the list BELAC 6-001 (PDF, 841.5 KB).

22.02.2024 BELAC documentation update

Recently, a number of documents of BELAC's management system were updated. Below you will find a brief overview of the changes made to these documents.

BELAC 2-105 Rev 4-2024 - Requirements for accredited laboratories applying for a flexible scope for analyses of residues of veterinary drugs, pharmacologically active substances authorised as food additives and prohibited or unauthorised pharmacologically active substances according to Implementing Regulation (EU) 2021/808

Complete revision of the document.

BELAC 2-312 Rev 14-2024 – Guidelines for the implementation of ISO/IEC 17021-1 by certification bodies for management systems

The document has been revised following new versions of IAF MD1, 2, 4, 5, 11, 15 and 23. These are mainly non-significant or editorial changes. The references to the standards have also been updated.

BELAC 2-OHSMS Rev 2-2024 – Specific provisions for the accreditation of certification bodies in the field of occupational health and safety management systems (ISO 45001)

References to standards and IAF documents were updated in this document.

The section regarding the migration from OHSAS 18001:2007 to ISO 45001:2018 was removed as it is no longer relevant.

BELAC 2-405-MDQS Rev 4-2024 – Specific provisions for the accreditation of certification bodies in the field of medical devices quality management system (ISO 13485)

The document was revised following the new versions of IAF MD8 and IAF MD9. The changes are limited to introducing the possibility of organising remote certification assessments and accreditation assessments as well.

A total overview of the applicable documents can be found via the list BELAC 6-001 (PDF, 841.5 KB).

13.11.2023 BELAC documentation update

Recently, a number of documents of BELAC's management system were updated. Below you will find a brief overview of the changes made to these documents.

BELAC 2-405-PED-SPVD Rev 0-2023 - Specific provisions for the accreditation of bodies notified to the EU under Directive 2014/68/EU relating to the making available on the market of pressure equipment & Directive 2014/29/EU relating to the making available on the market of simple pressure vessels

This is a new document aimed at specifying the requirements for the accreditation of conformity assessment bodies for the purpose of their notification under Directive 2014/68/EU (PED) or Directive 2014/29/EU (SPVD). It includes the requirements defined by the notifying authority, which defines the applicable accreditation standards, if necessary by deviating from the preferred standards defined in document EA 2/17. As such, it complements document BELAC 2-404.

BELAC 2-405-ISMS Rev 2-2023 - Specific provisions for the accreditation of certification bodies in the field of information security management systems (ISO/IEC 27001)

This document has been updated following the new version of ISO MD13:2023 and ISO/IEC 27001:2022.

BELAC 2-405-MED Rev 5-2023 -  Specific provisions for the accreditation of medical laboratories authorized by the Minister of Health

This document was updated following the new version of EN ISO15189:2022. During the transition period (from EN ISO 15189:2012 to EN ISO 15189:2022), two versions of this document are available on the BELAC website. Revision 4 applies to laboratories working according to the version EN ISO 15189:2012. For laboratories working according to the new version EN ISO 15189:2022, Revision 5 is applicable.

BELAC 2-405-NGS Rev 4-2023 – Specific provisions for the accreditation of medical laboratory performing next generation sequencing for haematological and solid tumours

This document has been updated following the activities of the ComPerMed and Molecular Diagnostics.be working groups.

BELAC 6-102 Rev 4-2023 – Check-list: transition to EN ISO 15189:2022

Editorial adjustments.

In addition to the changes to the above documents, adjustments were also made to some modules of the assessment report.

BELAC 6-429 Rev 4-2023 - Module A: summary of the assessment report

Update of reference to standards and the possibility of issuing a recommendation in case of a pre-assessment was added.

BELAC 6-431(15189) Rev 7-2023: Module C
BELAC 6-432(15189) Rev 7-2023: Module D

The modules have been updated for the new version of EN ISO 15189:2022. Revision 6 remains temporarily available for assessments still being carried out according to standard EN ISO 15189:2012.

BELAC 6-431(17020) Rev 6-2023: Module C
BELAC 6-432(17020) Rev 6-2023: Module D
BELAC 6-431(17021-1) Rev 4-2023: Module C
BELAC 6-432(17021-1) Rev 4-2023: Module D
BELAC 6-431(17065) Rev 3-2023: Module C
BELAC 6-432(17065) Rev 3-2023: Module D
BELAC 6-431(17024) Rev 4-2023: Module C
BELAC 6-432(17024) Rev 4-2023: Module D

In these modules C and D, the reference to the document BELAC 2-405-PED-SPVD was added. The new modules are applicable from now on, but for ongoing assessments the previous version may still be used.

A total overview of the applicable documents can be found via the list BELAC 6-001.

28.09.2023 BELAC documentation update

Recently, a number of documents of BELAC's management system were updated. Below you will find a brief overview of the changes made to these documents.

BELAC 2-002 Rev 7-2023 - Accreditation certificate and corresponding scope of accreditation: General guidelines for formulation and evaluation

In Rev 6 (dated December 2022), a section on listing and managing version numbers and issue dates was added. This stated that accredited bodies should have a list showing at any time which version(s) or issue dates of the documents mentioned in the accreditation scope apply. This list had to be submitted to BELAC prior to each planned audit. This information is important for BELAC for the organisation of the assessment.

In response to requests from several bodies, BELAC looked for an easier way to obtain information on changes to versions/issue dates. From now on, this information should be submitted to the secretariat via the additional columns in the 'working version scope' at the time of the application for the next assessment. The document BELAC 2-002 was revised again for this reason (Rev 7).  In this context, the templates for the scopes were also adapted and separated by accreditation standard (BELAC 6-213 (xxx) Rev 0-2023). The application form BELAC 6-201 Rev 18-2023 was also updated in this context.

The BELAC 2-002 Rev 7-2023 document also better describes what is meant by 'dormant activities'. Among other things, it was clarified that an activity need not be considered dormant if it can be demonstrated, based on solid risk-based substantiation, that resources and competences are maintained through other activities (e.g. other similar accredited activities that require the same resources and competences, participation in ring tests, conducting a simulation of the activity…).

BELAC 6-213 (xxx) Rev 0-2023 - template scope

A separate template scope was developed for each accreditation domain, also taking into account the requirements of ISO 17011 in terms of scope content as well as the information BELAC needs for a risk-based approach to organising assessments. All existing BELAC scopes will be gradually converted to these new templates. From a practical point of view, this will normally be done at the start of a new assessment phase (survey out).  All accredited bodies are asked to pay due attention to completing all requested information in these templates.

BELAC 6-201 Rev 18-2023- application form for accreditation

The list of information to be provided (part 2 of the form) was updated.

BELAC 6-102 Rev 3-2023 - Checklist: transition to EN ISO 15189:2022

Template to be used by accredited medical laboratories as part of the transition to EN ISO 15189:2022, to submit the transition plan no later than 1 month before the transition assessment.

BELAC 1-03 Rev 10-2023 - BELAC activities: description and criteria for selection

Update of reference to standards: transition from EN ISO 15189:2012 to EN ISO 15189:2022, transition EN ISO/IEC 17043:2010 to EN ISO/IEC 17043:2023 and transition ISO/TS 22003 :2013 from ISO 22003-1:2022.

BELAC 2-405 NAWI Rev 4-2023 - Specific provisions for the accreditation of inspection bodies authorized for the periodic verification of non-automatic weighing instruments

Editorial adjustments.

BELAC 2-405 LIQ Rev 1-2023 - Specific provisions for the accreditation of inspection bodies authorized for the periodic verification of measuring systems for liquids other than water

Editorial adjustments.

Total overview

A total overview of the applicable documents can be found via the list BELAC 6-001 (PDF, 841.5 KB).

20.03.2023: Update of the BELAC documentation

The templates for the assessment reports BELAC 6-431(xxxx) module C and BELAC 6-432(xxxx) module D have been adapted.
Editorial changes were made to all modules.

Substantive changes were implemented in the modules for ISO/IEC 17020 and in the combi-modules ISO/IEC 17025 + ISO 17034, ISO/IEC 17025 + ISO/IEC 17043 and ISO/IEC 17025 + ISO/IEC 17043 + ISO 17034.

The new modules are applicable from now on, but  the previous version can still be used until 20.05.2023 for ongoing assessments. 

 21.12.2022 Update of the BELAC documentation

Recently, some documents from the management system of BELAC have been adapted. Below you will find a short overview of the changes made to these documents.

General

BELAC 2-002 Rev 6-2022 - Accreditation certificate and corresponding scope of accreditation: general guidelines for the formulation and the evaluation

The main adjustments are:

• A section has been added about listing and managing version numbers and release dates.
  In the scope of accreditation, the activities are in principle described without mentioning version numbers or release dates of the applicable documents such as normative documents, schemes, methods, etc. except in the case of a legal obligation, a scheme requirement or specific sectoral requirements as included in documents of the BELAC 2-405 series.
  In specific cases, only the major version number of a document will be mentioned in the scope of accreditation, whereby the principles below also apply with regard to the management of the minor version number.
  When no version or only a major version is mentioned in the scope of accreditation, it is assumed that the accreditation applies to the most recent version of the method/scheme/normative document.
  In that case, the accredited body must have a list that indicates at any time which version(s) or issue dates of the documents stated in the accreditation scope are applicable.

  • This list must always be up-to-date and must be made available to BELAC and to any other interested party upon simple request. In any case, this list must be submitted to BELAC prior to any planned assessment. The application form BELAC 6-201 has also been updated in this context.
  • Information about which version(s) is and is not covered by the accreditation must be transparent and accurate at all times. On basis of this detailed list it must therefore undeniably be shown from which moment a specific version(s) is carried out under accreditation.

  When a normative document, scheme, method, etc. mentioned in the accreditation scope is revised, an accredited body is expected to switch to the most current version within a reasonable period of time and to keep the necessary records. In the list mentioned above, it should be clear from when the new version was applied at the accredited body.

  If a transition period has been determined (e.g. by a competent authority, scheme owner, standardization organisation, etc.), during this transition period, activities can exceptionally still be carried out according to the previously applicable version.

  In the event of significant changes in new versions of a normative document, scheme, method, etc. mentioned in the accreditation scope, the accredited body must inform BELAC in writing. BELAC will then determine whether an additional evaluation is required.

  In the event of limited changes in new versions of a normative document, scheme, method, etc. mentioned in the accreditation scope, the accredited body will inform BELAC when requesting the next assessment. The registrations (gap and impact analysis of the change(s), implementation plan, etc.) and measures regarding the switch to the new version will be discussed during this assessment.

  An accreditation for an outdated or expired version can only be issued if the accredited body can provide a thorough argumentation for this. In that case, the version(s) or release dates are specifically mentioned in the accreditation scope

• The conditions for maintaining dormant activities have been supplemented. It is important that the accredited body keeps the human and material resources available, required for the performance of the relevant activities and for following the standards, regulations and other relevant documents relating to these activities, so that the activities can be restarted at any time when a customer or a request comes in. Information on the dormant activities as well as the dormant activities procedure and the risk analysis must be provided to the Secretariat prior to each audit.

BELAC 1-03 R9-2022 – BELAC Activities: description and criteria for selection

This document has been completely revised with the following main changes:

• Clarifications regarding opinions and interpretations at calibration and testing laboratories.
• Sampling at test laboratories and inspection bodies: conditions and indication in the scope.
• Clarification of what is meant by systematic and temporary outsourcing in laboratories. A temporary outsourcing of an activity due to force majeure (where the activity cannot be carried out by the calibration or test laboratory itself in that period of time) will in principle not last longer than 3 months. If the laboratory has not been able to solve the causes of force majeure after 3 months, the BELAC secretariat will be informed about this. In addition, the laboratory will provide a risk analysis and action plan, as well as an estimate of the time span deemed necessary to eliminate the causes of force majeure. The Accreditation Board will decide on the further procedure. If the temporary outsourcing is expected to last longer than 6 months, a suspension should be considered.
• When a test laboratory or inspection body carries out critical calibrations itself in the context of its activities, the evaluation thereof will be carried out by BELAC on basis of the relevant EN ISO/IEC 17025:2017 requirements regarding calibration.
• Assessment of supporting calibration and/or testing activities at proficiency testing organizers or reference material producers is done according the relevant requirements of ISO/IEC 17025:2017 (and/or ISO 15189:2012 if relevant).

BELAC 1-04 Rev 2-2022 - Procedures and provisions for the accreditation of multi-site conformity assessment bodies

A complete revision of the text has been carried out to bring this document into line with international documents. The emphasis here is on the risk-based approach for developing an audit programme. The amendments do not bring any significant changes to the current policy and working methods of BELAC.

BELAC 3-06 Rev 6-2022 - Guidelines for cooperation between BELAC and accredited bodies

Editorial adjustments.

BELAC 6-201 Rev 16-2022 – Application form

From 01.02.2023, the list stating the version or date of issue of the methods/regulations/schemes/normative documents used by the body as stated in the accreditation scope must also be sent when submitting the application form.

BELAC 7-06 Rev 5-2022 – General information on the tax aspects of assessor fees

Adjustment of the rate for the km allowance.

TEST

BELAC 2-405-DNA-JUST Rev 1-2022 – Specific provisions for the accreditation of DNA laboratories recognized by the Minister of Justice

The adjustment takes into account the publication of new legal reference documents. Furthermore, there are clarifications on the additional requirements regarding personnel, evaluation of requests, tenders, contracts, selection of methods and reporting of results.

NEW! BELAC 2-405-DOSI Rev 0-2022 – Specific provisions for the accreditation of laboratories recognized as dosimetric service by the Federal Agency for Nuclear Control (FANC)

This is a new document for laboratories recognized by FANC for performing external dosimetry and radiotoxicological analyses for the individual dosimetric monitoring of occupationally exposed persons.

The document lists the reference documents and provides additional requirements regarding equipment, externally supplied products and services and guaranteeing the quality of the results.

BELAC 2-108 Rev 1-2022 – Expression of the uncertainty in quantitative testing

This document has been completely revised taking into account the publication of ILAC G17/2021 and the withdrawal of EA 4/16 and the list of useful information resources has been updated. Basic principles for measurement uncertainty evaluation have not changed.

MED

BELAC 2-405-MED Rev 3-2022 – Specific provisions for the accreditation of medical laboratories authorized by the Minister of Health

This document has been completely revised following the publication of version 2 of the Practice Guideline for pathological anatomy laboratories (in the context of the Recognition

Decree). Furthermore, legal requirements regarding quality policy/management statement have been added.

PTP

BELAC 2-109 Rev 1-2022 – The accreditation scope granted to a proficiency testing provider: guidelines for its description and evaluation

This document has been completely revised following the revision of ILAC G18:12/2021 and the withdrawal of EA 2/18. The amendments do not constitute significant changes to the policy or principles, but are rather clarifications, in particular with regard to the flexible scope.

Overview

A complete overview of the applicable documents can be found in the list BELAC 6-001 (PDF, 841.5 KB).

27.10.2022: Update BELAC documentation

These documents have been updated following the transition from EN ISO 14065:2013 to EN ISO/IEC 17029:2019+EN ISO 14065:2021:

• BELAC 2-405-GHG ETS Rev 4-2022: Bijzondere bepalingen voor de accreditatie van verificatie-instellingen in het « GHG EU ETS » domein (Greenhouse Gas –European Union Emission Trading Scheme)
• BELAC 6-431(17029-14065-AVR) R0-2022 : Module C (verslag van de hoofdauditor EN ISO/IEC 17029:2019 + EN ISO 14065:2021 + AVR)
• BELAC 6-432(17029-14065-AVR) R0-2022 : Module D (verslag van de technisch auditor/expert EN ISO/IEC 17029:2019 + EN ISO 14065:2021 + AVR)

06.09.2022 - Update BELAC-documentation

Recently, some documents from the management system of BELAC have been adapted. Below you will find a short overview of the changes made to these documents. A history of the changes is included at the front of each document.

The accreditation standard ISO/IEC 17029:2019 has been added in the following documents

• BELAC 2-002 Rev 5-2022: Accreditation certificate and corresponding scope of accreditation: general guidelines for the formulation and the evaluation
• BELAC 6-201 Rev 15-2022: Application form
• BELAC 7-01 Rev 25-2022: BELAC: BELAC: General and practical information

In the document below, an update has been made of the domains for which BELAC is a signatory of the international mutual recognition agreements.

• BELAC 2-001 Rev 14-2022: Rules governing the reference to BELAC accreditation and BELAC signatory status of international multilateral agreements/recognitions

A complete overview of the applicable documents can be found in the list BELAC 6-001.

08.07.2022 -  Update BELAC-documentation

The modules for the preparation of audit reports were changed:

• BELAC 6-429 Rev 3-2022  Module A: summary of the assessment report
• BELAC 6-430 Rev 1-2022  Module B: history of the file
• BELAC 6-431(xxx) Rev x-2022  Module C:  report of the lead assessor xxx
• BELAC 6-432(xxx) Rev x-2022  Module D: report of the technical assessor or expert xxx
• BELAC 6-433 Rev 3-2022  Module E: follow-up of non-conformities

These can be found on Series BELAC 6-4xx: Modules assesment reports.

The changes mainly concern the layout and harmonisation across the different modules.

The “refresh for auditors and experts” webinar organised in April and September 2022 explains the new modules in more detail.

As far as module E is concerned, the document “2022 traitement des non-conformités” is available (in Dutch and French only) for clarification on Additional information from BELAC.

Important dates:

• Until 31/08/2022, the auditor may choose which version of the modules to use for the report.
• From 01/09/2022 onwards, the use of the new versions of the modules is mandatory.

Overview

A complete overview of the applicable documents can be found in the list BELAC 6-001 (PDF, 841.5 KB).

22.06.2022 - Update BELAC-documentation

Recently, some documents from the management system of BELAC have been adapted. Below you will find a short overview of the changes made to these documents. A history of the changes is included at the front of each document.

General

BELAC 2-003 Rev 4-2022: Policy and provisions on traceability of measurement results

An adaptation of the provisions for the realization of traceability for calibrations entrusted to a third party was made.

BELAC 2-106 Rev 2-2022: Proficiency testing: guidelines on the level of participation and evaluation of performances in proficiency testing activities in the context of accreditation assessments

This document has been completely revised a.o. following the publication of EA 4/18 G:2021.

BELAC 2-107 Rev 3-2022 Expression of measurement uncertainty in calibration

The document reproduces the revised version of EA‑4/02 rev3 in its entirety to replace EA‑4/02 rev2.

BELAC 3-05 Rev 14-2022: Cooperation with BELAC assessors and experts: requirements and procedure for qualification rights and duties

This document has been completely revised. For the auditors and experts, the most important change is the obligation to annually submit the list of consultancy activities to BELAC.

TEST

BELAC 2-405-WADA Rev 0-2022: Specific provisions for the EN ISO/IEC 17025 accreditation of WADA anti-doping laboratories

New document.

CAL

BELAC 2-110 Rev 3-2022: The accreditation scope of a calibration laboratory: guidelines for formulation and evaluation

The adjustment is limited to correction of types and layout in the examples of the measurement uncertainty.

MS

BELAC 2-312 Rev 13-2022: Mandatory guidance for the application of the ISO/IEC 17021-1 standard by certification bodies of management systems

The update was implemented following the new version of IAF MD4.

BELAC 2-405-MDQS  Rev 3-2022: Specific provisions for the accreditation of certification bodies in the field of medical devices quality management systems (ISO 13485)

This document has been completely revised following the new versions of IAF MD9.

BELAC 2-405-Railway  Rev 1-2022: Specific provisions for the accreditation of conformity assessment bodies seeking notification to perform notified bodies’ activities as described in the EU railway legal framework

An update of the reference documents was made in this document.  

BELAC 2-405-Weldments Rev 0-2022: Guidelines for the use of EN ISO/IEC 17065 and EN ISO/IEC 17021-1 for certification according to EN 3834

This is a new document. It describes the guidelines for certification in the field of fusion welding and takes into account the requirements of EA 6/02.

PROD

BELAC 2-405-Weldments Rev 0-2022: Guidelines for the use of EN ISO/IEC 17065 and EN ISO/IEC 17021-1 for certification according to EN 3834

This is a new document. It describes the guidelines for certification in the field of fusion welding and takes into account the requirements of EA 6/02.

Overview

A complete overview of the applicable documents can be found in the list BELAC 6-001.

 

28.02.2022 – Update BELAC-documentation

BELAC 2-405 ORG.PROD rev3-2022

The regulations on organic production were revised and amended by the European Commission with the publication of Regulation EU 2018/848.

The specific BELAC requirements related to organic production have been adapted based on the revision of EA 3/12. Revision 3 of the document BELAC 2-405 Organic Production has been published.

Overview

A complete overview of the applicable documents can be found in the list BELAC 6-001.

22.12.2021 Update BELAC-documentation

Recently, some documents from the management system of BELAC have been adapted. Below you will find a short overview of the changes made to these documents. A history of the changes is included at the front of each document.

General

BELAC 1-02 Rev 7-2021: Elements of the general policy and mechanisms introduced by BELAC in response to the requirements of the ISO/IEC 17011:2017 standard with regard to the identification and control of the risks related to its operation

This document has been periodically updated.

BELAC 1-05 Rev 2-2021: Cross border accreditation and cooperation with accreditation bodies members of EA

The structure of this document has been completely revised following the new version of EA 2/13 (EA Cross Border Accreditation Policy and Procedure for Cross Border Cooperation between EA Members). The main changes in the document include clarification on the different types of cross border cooperation and the practical modalities for cooperation between BELAC and foreign ABs.

CAL

BELAC 2-107 Rev 2-2021: Expression of the uncertainty of measurement in calibration

The revised version of the document EA-4/02 (Evaluation of the Uncertainty of Measurement in Calibration) has been integrated in the BELAC document. The changes are not significant but are limited to minor clarifications and improvements, correction of minor errors, references to ISO/IEC 17025:2017 and addition of a reference to decision rules.

BELAC 2-110 Rev 2-2021: The accreditation scope of a calibration laboratory: guidelines for formulation and evaluation

The revision of this document is limited to section 4.1.2.2 where a reference to a clause of ISO/IEC 17025 was corrected. The correct reference is §7.1.2 instead of §5.4.2.

MS

BELAC 2-312 Rev 12-2021: Guidelines for the implementation of ISO/IEC 17021‑1 by certification bodies for management systems (only available in Dutch and in French)

Following the withdrawal of IAF MD 10 (Assessment of Certification Body Management of Competence) and the publication of ISO 50003:2021 (energy management systems), this document has been revised. An annex illustrating the application of the various IAF MD documents has also been added.

BELAC 2-405-EnMS Rev 2-2021: Specific provisions for the accreditation of certification bodies of energy management systems (EN ISO 50001) (only available in Dutch and in French)

This document has been revised in response to the new versions of the ISO 50003:2021 and ISO 50004:2020 standards. ISO 50003:2021 provides new elements regarding audit evidence, competence and the calculation of audit duration.

The reference to EN ISO 50001:2011 has been removed as the transition period is now over.

BELAC 6-112 Rev 2-2021: Cross reference table for the evaluation of compliance with ISO/IEC 17021-1, IAF MD 22 and ISO/IEC TS 17021-10 for the accreditation for ISO 45001

The cross-reference table has been updated to reflect the new version of IAF MD 22 (Application of ISO/IEC 17021-1 for the certification of occupational health and safety management systems (OH&SMS)).

EMAS

BELAC 3-14 Rev 3-2021: Provisions for the supervision of environmental verifiers  operating in Belgium under accreditation granted in another member state

An additional explanation regarding the supervision program of foreign accredited environmental verifiers operating in Belgium was added.

GHG

BELAC 2-405-GHG ETS Rev 3-2021: Specific provisions for the accreditation of verification bodies in the « GHG EU ETS » field (Greenhouse Gas – European Union Emission Trading Scheme)

Following an update of the legal framework, this document has been revised.

New elements include:

• Phase IV (2021-2030)
• New requirements on verifiers (Annex II)
• Rules on virtual site visits
• Limitation on the number of years an EU ETS lead auditor can be active for a given installation
• New concept on reliability of verification

Overview

A complete overview of the applicable documents can be found in the list BELAC 6-001 (PDF, 841.5 KB).

05.07.2021 Update BELAC-documentation

Recently, some documents from the management system of BELAC have been adapted. Below you will find a short overview of the changes made to these documents. A history of the changes is included at the front of each document.

General

BELAC 2-003 Rev 3-2021: Policy and provisions on traceability of measurement results

The adaptation is limited and only relates to adding the explicit statement that critical calibrations must be performed by a laboratory accredited for the relevant calibration or NMI that is a signatory of the CIPM Mutual Recognition Arrangement for the relevant calibration.

RM

NEW! BELAC 2-111 Rev 0-2021: The accreditation scope of a producer of reference materials: guidelines for formulation and evaluation

This is a new document that complements the document BELAC 2-002 «Accreditation certificate and corresponding scope of accreditation: general guide-lines for formulation and evaluation» and provides specific guidelines for an accreditation scope assigned to a producer of reference materials.

Overview

A complete overview of the applicable documents can be found in the list BELAC 6-001 (PDF, 841.5 KB).

30.04.2021 Update BELAC-documentation

Recently, some documents from the management system of BELAC have been adapted. Below you will find a short overview of the changes made to these documents. A history of the changes is included at the front of each document.

BELAC 2-405 MED Rev 2-2021: Specific provisions for the accreditation of medical laboratories  authorized by the Minister of Health (only available in French and in Dutch)

The reason for the revision is the entry into force of the law of 22 April 2019 on the quality of healthcare practice. The requirement regarding the 15h continuing education for MLTs was deleted in the BELAC document. A clarification was also added regarding the application for derogation for those who do not have an MLT diploma.

BELAC 2-405 NGS Rev 3-2021: Specific provisions for the accreditation of medical laboratory performing next generation sequencing for haematological and solid tumours (only available in French and in Dutch)

This document has been updated following the activities of the ComPerMed and Molecular Diagnostics.be working groups.

29.03.2021 Update BELAC-documentation

Recently, some documents from the management system of BELAC have been adapted. Below you will find a short overview of the changes made to these documents. A history of the changes is included at the front of each document.

General

BELAC 2-001 R13-2021 (PDF, 796.77 KB) - Rules governing the reference to BELAC accreditation and BELAC signatory status of international multilateral agreements/recognitions

• In order to comply with the international requirements laid down in ILAC P8:03/2019, the document has been adapted. Consequently, a reference to the accreditation may no longer appear on the documents (reports, certificates but also, for example, quotations etc.) that only concern activities outside the accreditation scope. As a result, the use of pre-printed stationery with the BELAC symbol is not allowed in such cases, even if a disclaimer is added stating that none of the activities are accredited.
• In order to clarify that the obligation to refer to accreditation only applies to the release of results of a conformity assessment, a note has been added.
• In addition to some editorial changes, specific provisions were also included for validation and verification.

NEW! BELAC 2-004 R0-2021 (PDF, 734.67 KB) – Rules for the notification to BELAC and the management by BELAC of significant changes by the accredited bodies

A new BELAC document has been created for the purpose of:

• specifying the general principles regarding the obligation for accredited bodies to notify BELAC of any significant organisational, administrative, legal or technical change that may affect the maintenance of the accredited body status;
• specifying the most important situations (without the list being exhaustive) to which the notification obligation applies;
• determining the actions to be taken by the accredited body;
• clarifying how BELAC manages the notifications of changes and their consequences for the accredited body.

NEW! BELAC 3-15 R0-2021 (PDF, 133.73 KB) – Management of extraordinary circumstances or events that have an impact on the operation of BELAC, the accredited bodies and the relationship with their customers

A new BELAC document has been created in order to define the policy concerning the actions to be taken when extraordinary events of circumstances occur that may have an impact on the operation of BELAC, the accredited bodies and the relationship with their customers.

This document describes the policy and the measures to be taken if:

• The internal functioning of BELAC may be affected by an extraordinary circumstance or event;
• the extraordinary circumstance or event has a direct impact on the capacity of the Accreditation body or Conformity Assessment Body (CAB) to perform their work;
• the access of BELAC to the accredited conformity assessment bodies or the access of accredited conformity assessment bodies to their customers is prevented, so that the planned activities, such as accreditation audits and conformity assessment activities cannot take place at that time;
• the access of BELAC to specific accredited conformity assessment bodies or to their customers is prevented;
• or the general access to a geographic area (including critical locations) is not possible.

CAL

BELAC 2-110 R1-2021 (PDF, 488.85 KB) – The accreditation scope of a calibration laboratory: guidelines for formulation and evaluation

In order to comply with the international requirements in ILAC P14:09/2020, the document has been modified:

• adding requirements regarding the indication of measurement uncertainty on calibration certificates;
• adding the possibility of a flexible scope for calibration activities in the area of Reference Measurements (ISO 15195);
• possibility to mention outdated versions of standardised calibration methods in the accreditation scope;
• adding a reference to the “SI Brochure: The International System of Units (SI)” of the BIPM.

RM

BELAC 3-05 (PDF, 483.43 KB) R13-2021 - Cooperation with BELAC assessors and experts: requirements and procedure for qualification, rights and duties

The document has been adapted to better describe the requirements regarding the competence, training and professional experience of the technical auditors and experts for laboratories, PTP’s and RMP’s.

MS

BELAC 2-312 R11-2021 (PDF, 646.68 KB) - Guidelines for the implementation of ISO/IEC 17021-1 by certification bodies for management systems

In order to comply with international requirements, the document has been modified:

• Withdrawal of IAF MD3;
• Introduction of version 2020 of IAF MD8 and IAF MD13;
• Cancellation of IAF MD11:2019 and reintroduction of IAF MD11:2013;
• Update of annex 1 (application of BELAC 3-12 for ISO 45001 and VCA).

BELAC 2-405 ISMS R1-2021 (PDF, 667.61 KB) – Specific provisions for the accreditation of certification bodies in the field of information security management systems (ISO/IEC 27001)

The document has been modified in order to comply with the international requirements of IAF MD13:2020. The references to standards have been updated.

BELAC 3-12 R15-2021 (PDF, 304.19 KB) - The accreditation procedure: specific provisions

The document has been adapted with specific additions for ISO 45001 and VCA/VCU, which include the requirements of IAF MD 17.

INSP

BELAC 2-201 R8-2021 – Guidelines for the implementation of EN ISO/IEC 17020:2012 by inspection bodies

In order to comply with the international requirements imposed in ILAC P15:05/2020, the document was modified: various terms are now explained in more detail.

BELAC 2-405 NAWI R3-2021 (PDF, 448 KB) – Specific provisions for the accreditation of inspection bodies authorized for the periodic verification of non-automatic weighing instruments

• Adaptation of the hyperlink to instruction note E63100 4-C-01;
• Addition of the content of note E6/METRO/2020/001207 (note on the discontinuation of the calibration of weights < 50kg by Unit Metrology & calibration of weights/masses < 50kg used for the calibration of weighing instruments);
• Addition of the reference to the additional requirement from article 33 in the RD of 12 April 2016 on non-automatic weighing instruments.

11.03.2021 Update BELAC-documentation

BELAC 6-429 Rev 2-2021: ‘Module A –Summary of the assessment report’

Since October 2020, BELAC has been working with a revised version of module A - Summary of the assessment report.

This replaces and integrates the former

• module 0 (BELAC 6-428),
• module A (BELAC 6-429),
• module F (BELAC 6-434),
• module G (BELAC 6-435).

Editorial changes were made in the new version (revision 2).

For further explanation, we refer to the webinar for lead assessors on 18/03/2021 or 23/03/2021.

Please always check whether you are using the latest version of the BELAC modules when writing up your assessment report.