Table of Contents

    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, 314.95 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, 190.29 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, 176.1 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, 221.87 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, 215.98 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, 198.88 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, 120.37 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.

    14.10.2020 Update BELAC-documentation

    Recently, a number of documents of the management system of BELAC have been adapted. Below you will find a brief overview of the changes made to these documents. In the section 'history' at the beginning of each document you can also find which adaptations have been made.

    BELAC 3-11 Rev 13-2020: ‘ The accreditation procedure: General provisions for implementation’

    For accredited bodies and assessors, the changes relating to the modules of the assessment report, the transfer of the modules E as well as the deadlines for dealing with the nonconformities and the assessment report are especially important.

    For example, modules 0, A, F and G were replaced by a new module A. The deadlines for dealing with nonconformities and the reporting procedure were also modified. Once the body has responded to the nonconformities within 4 weeks, the assessor has 2 weeks to evaluate the response. The assessor can make one more request for supplementary clarifications or additions. The body then has 1 week to submit a second answer, after which the assessor has 1 more week to review it. At the latest 8 weeks after the assessment, the technical assessor / expert sends his report to the lead assessor who sends the complete audit report to BELAC no later than 10 weeks after the assessment.

    Deadlines were added in the document, such as the deadline for accepting the quotation, the deadline for submitting documents prior to the assessment, the deadline for performing documentary assessment as well as the deadline for transmitting a warning.

    In several places, the text was clarified without this leading to new working methods or principles, such as with regard to the possible decisions that the Accreditation Board can take regarding the surveillance regime and the accreditation cycle, the possibility of partial audits, declaring an application admissible and the right to be heard in the event of the refusal of accreditation or a sanction.

    Given the importance of this document, we ask assessors and experts as well as the accredited bodies to read this document thoroughly.

    BELAC 4-01 Rev 7-2020: ‘Guidelines on the presentation of the BELAC assessment reports and the request for payment of the hours’

    This document is primarily addressed to assessors and experts and has been adapted as a result of the changes made to the modules and the deadlines for the different steps during the period following the assessment and up to the submission of the assessment report (see BELAC 3- 11 Rev 13-2020). We ask all assessors and experts to read this document with due care. Assessments that are currently ongoing may still be handled according to previous versions of the modules.

    Furthermore, there are new guidelines for the transfer of modules E to the companies and the details for submitting the payment request have been added.

    BELAC 6-429 Rev 1-2020: ‘Module A –Summary of the assessment report’

    The revised version of module A replaces and integrates the former module 0 (BELAC 428 Rev 7-2018), module A (BELAC 6-428 Rev 0-2011), module F (BELAC 6-434 Rev 0-2011) and module G (BELAC 6-435 Rev 0-2011). Assessments that are currently ongoing may still be handled according to the previous modules.

    BELAC 6-433 Rev 2-2020: ‘Module E – follow-up of non-conformities'

    Module E has been adapted to achieve the objective of a better registration of the various iterations when clarifications or additional information is requested and to register how the transfer of this module to the assessed body took place. Assessments that are currently ongoing may still be handled according the previous version of the module.

    BELAC 1-03 Rev 7-2020: ‘BELAC Activities: description and criteria for selection'’

    The revision of the document BELAC 1-03 aimed to include the provisions of ISO / IEC 17025: 2017 with regard to the activities that a laboratory can perform, namely:

    • calibration or testing activities (including, if applicable, preliminary sampling, issuing declarations of conformity and providing advice or interpretations);
    • activities limited to sampling, provided that this is associated with one (or more) subsequent test (s) or calibration (s).

    The BELAC policy on the accreditation of activities limited to sampling has been amended and the conditions for carrying out these activities by laboratories and inspection bodies have been included.

    BELAC 2-002 Rev 4-2020: ‘Accreditation certificate and corresponding scope of accreditation: general guidelines for the formulation and the evaluation’

    The document has been completely revised taking into account the provisions of EA-2/15: 2019. The main changes concern the implementation of the flexible accreditation scope and in particular the concept of "design / development process" of a new conformity assessment activity.

    BELAC 2-101 Rev 4-2020: ‘Accreditatiescope toegekend aan een beproevingslaboratorium: leidraden voor de omschrijving en de beoordeling ervan

    This document is complementary to document BELAC 2-002 and therefore had to be brought in line with the revisions of BELAC 1-03 and BELAC 2-002.

    BELAC 2-003 Rev 2-2020: ‘Policy and guidance on traceability of measurements.’

    The text has been adjusted with regard to the acceptable routes for working out the traceability. A body that has the possibility to make use of the services of a National Metrological Institute or an accredited body, but that nevertheless decides to call on another organization (for example the manufacturer), must be able to demonstrate that the relevant requirements of EN ISO / IEC 17025 are met.

    In addition, a chapter was developed on obtaining traceability using reference materials and certified reference materials.

    BELAC 2-404 Rev 3-2020: ‘Guidance on the horizontal requirements for the accreditation of conformity assessment bodies for notification purposes’

    The revision is the result of the publication of the new version of the mandatory document EA-2/17. The most important change concerns the obligation for accredited bodies to use the same accreditation standard for conformity assessment activities as defined in European regulations. Accredited bodies with activities as notified body shall use the preferred standard by 01.04.2023 at the latest

    BELAC 2-405-MED Rev 1-2020: ‘ Specific provisions for the accreditation of medical laboratories authorized by the Minister of Health’

    This document was updated to take into account the replacement of the Royal Decree of 2 June 1993 by the Royal Decree of 17 January 2019 and the Royal Decree of 11 August 2017 and for the addition of Article 1 of the Nomenclature of Medical Interventions.

    BELAC 1-02 Rev 6-2020: ‘ 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 is revised annually. This revision integrates the comments of the members of the Coordination Committee made on the previous version and the recent experiences of BELAC (COVID-19 crisis). Furthermore, the sources of risks identified in the informative document EA-2/19 (List of risks for accreditation processes and operation of accreditation bodies) were also taken into account. The document is a BELAC policy document and contains no provisions applicable to accredited bodies.

    A complete overview of the applicable documents can be found in the BELAC 6-001 list (PDF, 618.56 KB).

    01.07.2020 Update BELAC documentation

    Several documents of the BELAC management system have recently been amended. Below is an overview of the changes made, which also appear in the "history" section at the beginning of each document:

    • BELAC 2-001 Rev 12-2020 (PDF, 231.29 KB): ‘Rules governing the reference to BELAC accreditation and BELAC signatory status of international multilateral agreements/recognitions’

      The changes made are the result of a revision of international documents EA 3/01, EA 2/13 and ILAC P8. As the impact of the changes is significant, the implementation date for this document has been set on 01.11.2020. Meanwhile, both revision 11 and revision 12 of the document are available on the BELAC website.

      The main changes are:

      • BELAC  accredited bodies are required to refer to their accreditation on the reports and certificates they issue when activities covered by the accreditation scope are performed in compliance with the accreditation requirements. In order for the activity to be considered as not covered by the accreditation, a written agreement of the customer of the accredited body will be required.
        This option is however not accepted in the following cases:
        • the reports or certificates contain results of activities in fields where accreditation is required by a specific regulation or linked to a contractual arrangement (e.g. a conformity assessment scheme);
        • the results are to be published or transmitted to third parties;
        • in case of certification of management systems, products or personnel.
      • In case an accreditation covers foreign sites, these sites are allowed to offer conformity assessment activities to the local market only on behalf and under the name of the accredited body. Certificates and reports issued with reference to accreditation shall mention the name and address of the accredited legal entity, without mention of the name of the local entity. The issued offers, contracts, certificates and reports shall not create confusion with respect to the identification of the entity that has been granted accreditation. 
      • An inspection label must clearly indicate that the instrument has been inspected.
      • Document 2-001 now states the text that can be used if one wishes to refer to accreditation by means of a wording instead of the logo.
      • In case a body is accredited for more than one accreditation program, a reference to the different accreditation programs the body is accredited for can be affixed together with the BELAC logo. The accredited body is allowed to use the combined symbol only for general communication on the different accredited activities but not on reports and certificates.
      • The document clarifies the responsibility of the accredited body with regard to the reference to accreditation by its clients. In case of incorrect use of the reference to accreditation by its clients, the accredited body shall take the necessary actions against the client and shall inform BELAC. The following applies:
        • The policies and procedures of the certification body shall include the necessary provisions in order to ensure that the certified bodies intending to make use of the BELAC symbol or another type of reference to accreditation reference comply with the related rules. The accredited certification bodies are responsible to inform the certified bodies with respect to the rules on the use of the BELAC symbol or reference to accreditation and to check whether these rules are correctly implemented.
        • The accredited laboratories, inspection bodies and validation/verification bodies shall inform their clients of the conditions for reference to accreditation.
           
    • BELAC 2-405 FSMS Rev2-2020 (PDF, 37.77 KB): ‘Specific Provisions for the Accreditation of Certification Bodies in the Field of Food Safety Management Systems’ 

      This document does not present any significant change, but the references have been updated.
       

    • BELAC 2-405 OHSMS Rev1-2020 (PDF, 123.94 KB): ‘Specific Provisions for the Accreditation of Certification Bodies in the Field of Occupational Health and Safety Management Systems’ (ISO 45001)

      This document has been updated following the new versions of the IAF MD 5, IAF MD 17 and IAF MD 22 documents.

    A full overview of the applicable documents can be found in the BELAC 6-001 list (PDF, 618.56 KB).

    16.12.2019 Update of the BELAC documentation

    Several documents from the management system of BELAC have been recently revised. You will find below a brief overview of the changes made; they also appear in the “History” section of each document.

    • BELAC 0-08 Rev 1-2019: ‘Cooperation agreement between the Federal State, the Flemish Region, the Walloon Region and the Brussels Capital Region with respect to the implementation of the of the EC Regulation nr 1221/2009 of the European Parliament and of the Council of 25 November 2009 on the voluntary participation by organisations in a Community eco-management and audit scheme, repealing Regulation (EC) 761/2001 and Commission Decisions 2001/680/EC and 2006/193/EC’

      The text was updated after publication of the agreement in the in the Official Gazette.
       
    • BELAC 1-01 Rev 10-2019: ‘Management manual’

      Complete revision of the document, inter alia for the introduction of the new version of ISO/IEC 17011.
       
    • BELAC 1-02 Rev 5-2019: ‘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’

      Extension of the scope of the document to meet the requirements of ISO/IEC 17011:2017 regarding the identification and management of risks related to the working of BELAC.
       
    • BELAC 2-312 Rev 10-2019: ‘Guidelines for the implementation of ISO/IEC 17021-1 by certification bodies for management systems’

      Update of the annex (summary table of the documents to be taken into account for the certification schemes under accreditation according to ISO/IEC 17021-1).
       
    • BELAC 2-313 Rev 5-2019: ‘BELAC guidelines for the implementation of Regulation (EC) No. 1221/2009 (EMAS III) by accredited environmental verifiers’

      Full revision of the document with regard to the publication of Regulation (EU) 2017/1505 and Regulation (EU) 2018/2026.
       
    • BELAC 2-403 Rev 13-2019: ‘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’

      Full revision.
       
    • BELAC 2-405 NGS Rev 2-2019: ‘Specific provisions for the accreditation of medical laboratory performing next generation sequencing for haematological and solid tumours’

      Document updated following the recommendation of the ComPerMed and Molecular Diagnostics.be (MD.be) workgroups.
       
    • BELAC 2-405 RAILWAY Rev 0-2019: ‘Specific provisions for the accreditation of conformity assessment bodies seeking notification to perform notified bodies’ activities as described in the EU Railsway legal framework’

      New document developed to include the mandatory requirements applicable in the field of interoperability in the rail sector, in addition to the ISO/IEC 17065 standard.
       
    • BELAC 3-08 Rev 7-2019: ‘Internal rule of order: Coordination Commission’

      Full revision with changes related to the number of issued votes, measures to be taken in case of absence and the use of consultation by correspondence.
       
    • BELAC 3-12 Rev 13-2019: ‘The accreditation procedure: specific provisions’

      Adjustments made following the publication of the new version of the IAF MD17 document.

    An overview of the applicable documents can be found in the BELAC 6-001 (PDF, 618.56 KB) list.

    25.07.2019 Update of the BELAC documentation

    Several documents from the management system of BELAC have been recently revised. Below you will find a brief overview of the changes made; they also appear in the “History” section of each document.

    • BELAC 2-001 Rev 11-2019: ‘Rules Governing the Reference to BELAC Accreditation and BELAC Signatory Status of International Multilateral Agreements/Recognitions’

      A clarification with respect to the mandatory reference to accreditation by certification bodies in case part of the activities listed in the certificate are not covered by the accreditation has been added.

      The provisions documented under point 3.3 are not applicable to the environmental verifiers that are no longer mentioned in the title of the paragraph. A separate point (point 4.4) dedicated to the environmental verifiers has been added.
       
    • BELAC 2-312 Rev 9-2019: ‘Guidelines for the implementation of ISO/IEC 17021-1 by certification bodies for management systems’

      This document has been updated with respect to the information on the applicable mandatory IAF documents. For each document, a short presentation of the content and of the objectives have been added. Moreover, the annex presents a comprehensive table of the documents to be taken into account for each certification scheme being eligible for accreditation under ISO/IEC 170212-1 .
       
    • BELAC 2-405 NGS Rev 1-2019: ‘Specific provisions for the accreditation of medical laboratory performing next generation sequencing for haematological and solid tumours’ 

      This document has been updated following the recommendation of the workgroups of ComPerMed and  Molecular Diagnostics.be (MD.be).
       
    • BELAC 2-405 EnMS Rev 1-2019: ‘Specific provisions for the accreditation of certification bodies of energy management systems (EN ISO 50001)’

      This document has been updated following the publication of ISO 50001:2018.

    Amendments to modules:

    • BELAC 6-431(15189) Rev 4-2019: ‘Module C: Report of the Lead Assessor (ISO 15189:2012)’ and BELAC 6-432(15189) Rev 4-2019:  ‘Module D: Report of the Technical Assessor / Expert (ISO 15189:2012)’
      The new versions includes a correction of the numbering of the clauses of the standard.

    The document BELAC 6-001 (PDF, 618.56 KB) presents the list of the valid documents.

    05.04.2019 Update of the BELAC documentation

    Several documents from the management system of BELAC have been recently revised. Below you will find a brief overview of the changes made; they also appear in the “History” section of each document.

    In addition, new documents have been issued:

    Amendments to forms or modules:

    • BELAC 2-001 Rev 10-2019: ‘Rules Governing the Reference to BELAC Accreditation and BELAC Signatory Status of International Multilateral Agreements/Recognitions’

      The reference to accreditation was already mandatory for management system certification bodies. This obligation has now been extended to products and persons certification bodies.

      During the transition period, the following rules are in force:

      After getting initial accreditation for a particular standard or scheme, a certification body for management systems, product or persons shall, within one year after the accreditation decision, re-issue the certification documents previously issued without reference to accreditation. For this purpose, the certification body has to perform a comprehensive evaluation aiming to confirm that all accreditation requirements are met, followed with a new certification decision. The date of this decision will be the issue date of the re-issued certification documents without modification of the expiry date of the certificate.

      The document also states that the reference to mutual recognition agreements of IAF and ILAC is no longer limited to certificates and reports. The reference to the EA-MLA agreement remains, however, limited to reports and certificates.

      • Management systems certification bodies shall re-issue with reference to accreditation the certification documents previously issued, on the occasion of the re-certification decision and this at the latest by November 06, 2019.
      • Certification bodies for persons shall re-issue with reference to accreditation the certification documents previously issued, on the occasion of the re-certification decision and this at the latest by October30, 2020 .
      • Products certification bodies shall re-issue with reference to accreditation the certification documents previously issued, at the latest by October 31, 2021.
    • BELAC 3-05 Rev 12-2019: ‘Cooperation with BELAC Assessors and Experts: Requirements and Procedure for Qualification Rights and Duties’

      The competence criteria applicable to assessors/experts for the accreditation of validation and verification bodies and for the accreditation of certification bodies for management systems have been adapted.

    • BELAC 3-11 Rev 12-2019: ‘The Accreditation Procedure: Provisions for Implementation'

      Given the importance of the amendments, we recommend that accredited bodies and assessors/experts read this document carefully!
       

      • Amendments with the aim of facilitating the audit and the timely processing of non-conformities were included. They included provisions regarding the transfer of documents prior to assessment, as well as rules if a second answer is needed to deal with the non-conformities.
      • The decision date will be stated on new issued certificates.
      • The concept of “cancellation” has been moved to Chapter 5, and this chapter has been extended to all types of adjustments to the scope.
      • It is now described what a “significant amendments of the scope” means. Significant amendments require a decision from the Accreditation Board; minor changes can be validated by the secretariat.
      • It is further detailed which information is published on the BELAC website in case of suspension, cancellation or withdrawal of the accreditation.
    • BELAC 2-110 Rev 0-2019: ‘The Accreditation Scope of a Calibration Laboratory: Guidelines for Formulation and Evaluation’
    • BELAC 2-405 OHSMS Rev 0-2019 : ‘Specific Provisions for the Accreditation of Certification Bodies in the Field of Occupational Health and Safety Management Systems (ISO 45001)’
    • BELAC 2-405 MED Rev 0-2019: 'Specific Requirements for the Accreditation of Medical Laboratories of Clinical Biology and Pathological Anatomy approved by the Minister of Public Health'
    • BELAC 2-405 Asbestos Removal Rev 0-2019 'Guidelines for the Certification of Companies Carrying out Demolition or Removal Work in Which Large Quantities of Asbestos Can Be Released'
    • BELAC 6-431 (17034) Rev 0-2019: 'Module C: Report of the Lead Assessor (EN ISO 17034:2016)'
    • BELAC 6-432 (17034) Rev 0-2019: 'Module D: Report of the Technical Assessor / Expert (EN ISO 17034: 2016)'
    • BELAC 6-112 Rev 1-2019 : ‘Cross Reference 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 adjustment only related to an incorrect standard reference in a title that was corrected.

    • BELAC 6-432 (17025) Rev 2-2019 : ‘Module D: Report of the Technical Assessor / Expert (EN ISO/IEC 17025:2017)’

      The clauses of Chapter 8 of the EN ISO/IEC 17025:2017 standard were missing and have now been added.

    • BELAC 6-431(15189) Rev 2-2019: ‘Module C: Report of the Lead Assessor (ISO 15189:2012)’

      The list of additional requirements (Part C) has been further detailed.

    • BELAC 6-432(15189) Rev 2-2019: ‘Module D: Report of the Technical Assessor / Expert (ISO 15189:2012)’

      The list of additional requirements (Part C) has been further detailed.

    30.10.2018 Update BELAC documentation

    In the document BELAC 6-428 Rev 7-2018 : ‘Module 0: table of content of the assessment report’  the references to accreditation standards were updated.

    07.09.2018 Update BELAC documentation

    A new sectoral document has been developed:
    BELAC 2-405-NGS Rev 0-2018 : ‘Specific provisions for the accreditation of medical laboratory performing next generation sequencing for haematological and solid tumours’

    22.05.2018: Update BELAC documentation

    A new version of the standard ISO/IEC 17011 that documents the requirements for the operation of an accreditation body has been issued in November 2017. Several amendments to the existing BELAC documents have been found necessary in order to ensure compliance with the new requirements of the standard. A majority of the amendments are related to the internal operation of BELAC and these do not necessarily impact the operation of the accredited bodies of the performance of assessments by BELAC assessors / experts.

    The following documents include amendments that are of direct interest for the accredited bodies and the assessors/experts:

    Several documents related to the internal operation of BELAC have been revised, without direct impact for the accredited bodies or the assessors/experts:

    The document BELAC 6-001 presents the list of the valid documents.

    • BELAC 3-11 Rev 11-2018 : ‘The accreditation procedure: general provisions for implementation’. The document has been fully reconsidered. The main changes are related to the following aspects:

      Considering the number of amendments in the document, accredited bodies and assessors/experts are recommended to reconsider the whole document and not limit their review to the elements identified in the “history” of the document or in the brief summary presented above.

      • The concepts of “assessment programme” and “assessment plan” have been clarified as well as the frequency of assessments and the content of the different types of assessments. The assessment programme covers the period of an accreditation cycle starting after the initial or renewal assessment and includes the surveillance assessments and the next renewal. Without this being an obligation, the composition of the assessment team will normally be maintained during the whole cycle. However, in order to ensure continuity in the transmission of the information, a new team leader is appointed for the re-assessment but the technical assessors / experts are maintained and replaced for the next coming surveillance assessment.
      • The provisions for the acceptance of an application have been further documented.
      • A conformity assessment body is no longer allowed to refuse to make documents available before the assessment and to have this step replaced by an on-site assessment with increase of the quotation.
      • The withdrawal of accreditation will be declared in cases where serious or repeated failure to meet the conditions of accreditation has occurred or where there is evidence of fraudulent behaviour or where the conformity assessment body intentionally provides false information or conceals information.
      • Applications for extension of scope need to be finalized within maximum 6 months.
    • BELAC 1-03 Rev 5-2018 : ‘BELAC Activities: description and criteria for selection’
      As a consequence of the new requirements of ISO/IEC 17025:2017, systematic sub-contracting of a whole testing process is no longer allowed under accreditation. Deviations can be agreed by the Accreditation Board in case of systematic sub-contracting of a part or step of the testing process, provided specific conditions are complied with.
    • BELAC 1-05 Rev 1-2018 : ‘Procedures and provisions for cross frontier accreditation and cooperation with accreditation bodies members of EA, ILAC and IAF’
      When an assessment or part of an assessment has to be performed abroad, the provisions of the mutual recognition agreements require BELAC to rely on the accreditation body of the concerned country provided the accreditation body is signatory of the mutual recognitions agreements for the concerned accreditation field. In case an accredited body does not agree with this principle or on the sub-contracting conditions or does not accept the foreign accreditation body, BELAC keeps the right to refuse the accreditation for the concerned activity.
    • BELAC 2-001 Rev 8-2018 : ‘Rules governing the reference to BELAC accreditation and BELAC signatory status of international multilateral agreements/recognitions’
      The document now includes a formal obligation for the accredited body to immediately inform its customers in case of total or partial suspension, reduction, total or partial cancellation or withdrawal of the accreditation scope, including the consequences hereof.
    • BELAC 2-002 Rev 3-2018: ‘The schedule of accreditation: general guidelines for the formulation and the evaluation’

      The maximum term for maintaining under accreditation an activity in “dormant mode” has been revised. The activity will be considered as dormant one year after the activity has been performed for the last time. From that date on, the activity can be maintained for a maximum of 2 years under accreditation. This means that an activity may remain under accreditation for a total of 3 years after the date of last performance.

      Before each assessment, the accredited body shall inform BELAC about the existence of “dormant” activity with mention of the date of last performance.

    • BELAC 2-312 Rev 8-2018: ‘Guidelines for the implementation of ISO/IEC 17021-1 by certification bodies for management systems’
      The list of mandatory IAF documents has been updated.
    • BELAC 2-405-MDQS Rev 1-2018: ‘Specific provisions for the accreditation of certification bodies in the field of medical device quality management system (ISO 13485)’
      This revision is due to the revision of IAF MD8, IAF MD9 et ISO 17011.
    • BELAC 3-04 Rev 5-2018 : ‘Handling of dysfunctions’

      The document has been fully revised in order to improve its structure and readability. This means that some parts of the text have been moved or grouped without significant amendment of the content.

      The following elements have however been added:

      • The fact that a complaint against an accredited body can only be lodged by BELAC if the complaint has been first addressed to the accredited body and that body has had the opportunity to provide an answer directly to the complainant party, has been extended to formal complaints. BELAC will only consider directly the complaint on presentation of a duly motivated justification for the non-involvement of the concerned accredited body.
      • An accredited body is required to assist in the investigation and resolution of complaints and disputes.
    • BELAC 3-06 Rev 5-2018: ‘Guidelines for cooperation between BELAC and accredited bodies”

      Two new principles have been included in the document:

      he text has also been revised with respect to:

      • The consequences for an accredited body when there is evidence of fraudulent behavior, or the conformity assessment body intentionally provides false information or conceals information;
      • The BELAC commitment not to take any discriminatory action as a consequence of lodging a complaint or an appeal.
      • The conditions the accredited bodies have to comply with;
      • The confidentiality of information obtained from third parties and related to accredited bodies.
    • BELAC 1-02 Rev 4-2018 : ‘General policies and provisions implemented in order to comply with the requirements of the Regulation EC 765/2008, the standard EN ISO/IEC 17011 as well as the requirements of EA/ILAC/IAF with respect to independence, objectivity and impartiality’
    • BELAC 3-03 Rev 6-2018: ‘Internal assessment’
    • BELAC 3-09 Rev 5-2018: ‘Internal rule of order: Accreditation Board’
    • BELAC 3-13 Rev 3-2018 : ‘Procedure for the control of BELAC records’

    06.12.2017 Update BELAC documentation

    Several documents pertaining to the BELAC documentation have recently been subject to revision or have been issued. A short survey is presented hereafter:

    Several modules of the assessment reports templates were also amended as the texts still included some incorrect reference to the classification +*. The following templates have therefore been reissued:

    Part 2 of the document BELAC 6-432 (17021-1) Rev 1-2017 ‘Module D: report of the lead assessor ISO/IEC 17021-1 ( reports on witness assessments) has been furthermore completed in order to reflect the requirements of IAF MD 17.

    Two new sectoral documents have been developed:

    The document BELAC 6-001 presents the list of the valid documents.

    • BELAC 2-001 Rev 8-2017: ‘Rules governing the reference to BELAC accreditation and BELAC signatory status of international multilateral agreements/recognitions’
      A clarification of the provisions resulting from the resolution of IAF 2016-17 regarding the mandatory reference to accreditation by management system certification bodies has been added.
    • BELAC 2-314 Rev 2-2017: ‘Legal Compliance as a part of Accredited ISO 14001:2015 certification’
      This revision is due to the introduction of the new revision of EA 7/04.
    • BELAC 3-05 Rev 11-2017: ‘Cooperation with BELAC assessors and experts: requirements and procedure for qualification rights and duties’
      The changes are limited and mainly relate to the possibility that in certain situations technical assessors may also be asked to assess the management system.
    • BELAC 3-11 Rev 10-2017 : ‘The accreditation procedure: general provisions for implementation’
      The changes are limited and mainly relate to the possibility that in certain situations technical assessors may also be asked to assess the management system.
    • BELAC 3-12 Rev 12-2017 : ‘The accreditation procedure: specific provisions’
      The changes in this document mainly consist of including the requirements of IAF MD 17.
    • BELAC 6-431(17020) Rev 3-2017 ‘Module C: report of the lead assessor ISO/IEC 17020’
    • BELAC 6-431 (17021-1) Rev 1-2017 ‘Module C: report of the lead assessor ISO/IEC 17021-1’
    • BELAC 6-432 (17020) Rev 3-2017 ‘Module D: report of the technical assessor ISO/IEC 17020’
    • BELAC 2-405-ISMS Rev 0-2017 : ‘Specific provisions for the accreditation of certification bodies in the field of information security management systems (ISO/IEC 27001)’.
    • BELAC 2-405-EnMS Rev 0-2017 : ‘Specific provisions for the accreditation of certification bodies of energy management systems (EN ISO 50001:2011)’.

    15.09.2017: Update BELAC-documentation

    The following document has been revised:

    Documents can be downloaded through the section ‘management system’. An overview of the applying documents can be retrieved by means of the list BELAC 6-001

    • BELAC 1-01 Rev 9-2017: “BELAC Quality Manual “

    12.07.2017: Update BELAC documentation

    Several documents of the BELAC documentation have recently been revised. A short survey is presented hereafter:

    The document BELAC 6-001 presents the list of the valid documents.

    • The document BELAC 2-404 Rev 1-2016: ‘Guidance on the horizontal requirements for the accreditation of conformity assessment bodies for notification purposes’ was revised for the integration of the document EA-2/17(november 2016).
    • A new sectoral document has been developed: BELAC 2-405-CPR Rev 0-2017: ‘Specific provisions for the accreditation of notified bodies for Regulation (EU) No 305/2011 for the marketing of construction products’

    21.06.2017: Update BELAC documentation

    The document BELAC 3-11 Rev9-2017 “The accreditation procedure: General provisions for implementation” has been revised. Besides some editorial amendments, significant changes have been included in relation to:

    The new version is applicable from 01.07.2017.

    • Maximum time limit in case of conditional accreditation
    • Clarification with respect to the categorization and follow-up of non-conformities
    • Deletion of the concept of “remark” +*
    • Transmission of the electronic version of module E to the secretariat
    • Definition of the concept of accreditation cycle and assessment program on the cycle
    • Publication in case of withdrawal or suspension of an accreditation

    15.05.2017: Update BELAC documentation

    Several documents pertaining to the BELAC documentation have recently been subject to revision or have been issued. A short survey is presented hereafter:

    Several documents related to the internal operation of BELAC have been revised, without direct impact for the accredited bodies or the assessors/experts:

    The document BELAC 6-001 presents the list of the valid documents.

    • BELAC 1-04 Rev 2-2017 : ‘Procedures and provisions for the accreditation of multi-site conformity assessment bodies’
      The definition of key activities in the case of assessment of Laboratories, Proficiency Testing Providers and Producers of Reference Materials have been added.
    • BELAC 2-001 Rev7-2017: ‘Rules governing the reference to BELAC accreditation and BELAC signatory status of international multilateral agreements/recognitions’
      The requirements for the reference to accreditation by Proficiency Testing Providers and by Producers of Reference Materials have been added. The other changes are related to the reference to accreditation in case of subcontracting and the addition of the possibility of referring to the IAF mutual recognition agreements. The document also confirms that accredited bodies shall have a procedure documenting their policy regarding the reference to accreditation.
    • BELAC 2-109 Rev 2-2017: ‘Schedule of accreditation of a proficiency testing provider: guidelines for formulation and evaluation’
      This is a new document that complements BELAC 2-002.
    • BELAC 3-05 Rev 10-2017: ‘Cooperation with BELAC assessors and experts: requirements and procedure for qualification rights and duties’
      The document has been complemented with:

      • competence criteria applicable to assessors / experts for the accreditation of Proficiency testing Providers and Reference Materials Producers;
      • new provisions with respect to the code of professional conduct of assessors and experts.
    • BELAC 3-12 Rev 11-2017 : ‘The accreditation procedure: specific provisions’ Provisions for Proficiency Testing Providers and Reference Materials Producers have been added.
    • BELAC 3-01 Rev 6-2017: ‘Procedure for the management of the documents of BELAC’· BELAC 3-03 Rev 5-2017: ‘Internal audit’
    Last update
    1 June 2021

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