Table of Contents

    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, 134.81 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’ (DOC, 108.5 KB)  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
    26 July 2019