Table of Contents
2017
05.10.2017: BELAC has become a signatory of the EA multilateral agreement (MLA) for Proficiency Testing Providers
National accreditation bodies are involved in networks at a regional level which, in turn, cooperate on a worldwide basis. These networks make it possible to harmonize accreditation practices and lead to mutual recognition of accreditation services.
National accreditation bodies are admitted to the MLA only after stringent evaluation of their operations by a peer evaluation team to determine continued compliance with ISO/IEC 17011, the internationally recognized standard for accreditation bodies.
Market confidence in the EA MLA and the conformity assessment results provided by organizations accredited by EA MLA signatories support the free movement of goods and services in Europe and the rest of the world by acting as a “passport for trade” through elimination of the need for products and services to be retested, recalibrated, re-inspected or recertified in each country which they are imported and sold.
BELAC had already joined:
- the MLAs of EA (testing including medical testing, calibration, inspection, certification of persons, products and management system and GHG validation and verification)
- the MRA (multirecognition agreement) of ILAC and the MLA (multilateral agreement) of IAF.
- the agreement of the FALB (Forum of Accreditation and Licensing Bodies) for EMAS verification.
Recently, EA has also launched a MLA for PTP (proficiency testing providers). In this context, BELAC was peer evaluated in May 2017. At the last meeting of EA-MAC, a positive decision was made and BELAC is from now on also a signatory of the EA MLA for Proficiency Testing Providers.
17.02.2017: BELAC policy and approach with regard to the transition of accreditation to certification of management systems according to the 2016 version of standard ISO 13485
1. Introduction
On 1 March 2016, a new version of the standard ISO 13485 was published by the International Organization for Standardization.
The changes in the new version of the standard impact the way in which the certification of the management system is prepared and operated. BELAC therefore holds the view that the organization and the operation of the certification process applied by certification bodies should be assessed before a certification covered by accreditation can be performed.
The current document describes BELAC’s principles and practical approach for the transition of accreditation with regard to the certification of management systems according to the new version of standard ISO 13485.
IAF resolution 2015/13 foresees a transition period of three years following the date of publication of the new version of the standard. This means that a certification that makes reference to the current version of the standard (EN ISO 13485:2003) loses its validity three years (01/03/2019) after the date of publication of the new version of the standard.
Furthermore, ISO recommends in its “Transition Planning Guidance for ISO 13485:2016” that 2 years after the date of publication (i.e. from 01/03/2018) all new certificates and all certificates for accredited re-certification be issued according to the new version of standard ISO 13485.
2. General principles for the transition of the accreditation
2.1. The current accreditations issued by BELAC for the certification of management systems (QMS certifications with ISO 13485 included in their scope) are only valid for the previous version of the standard (ISO 13485:2003).
2.2. When the next modification to the scope of the accreditation takes place, BELAC will systematically and specifically mention the version of the management system standard (MSS) that is covered by the accreditation.
2.3. In the case of certification according to the 2016 version of the MSS, the certification body (CB) may only make reference to accreditation after BELAC has explicitly included the new MSS in the scope of the accreditation.
2.4. The enquiries and audits undertaken to assess the transition of the accreditation to the new version of the MSS will normally take place in the course of the regular monitoring programme of BELAC.
A CB may however, if it wishes to do so, apply for an early audit for the purpose of the transition of the accreditation to the new version of the standard. In both cases the transition will be treated as a request for extension of the scope of the accreditation and a specific decision can be taken from the moment that the conditions for a positive advice are met.
2.5. In order to assess if the CB is qualified to issue a certification covered by accreditation, according to the 2016 version of the ISO 13485 standard, BELAC sets up the following transitional arrangement:
2.5.1. The introduction of a formal request by the CB for the accreditation of certification according to the 2016 version of the ISO 13485.
2.5.2. A documentary examination, in preparation of an office audit, of the gap analysis, transition plan and relevant documentation to be supplied by the CB.
2.5.3. An office audit for the assessment of the implementation (including an internal audit) of the CB’s transition plan.
2.5.4. A decision by BELAC and a review of the technical annex of the accreditation certificate.
2.6. From 01/02/2017 onwards, BELAC can perform transition audits at the request of the CB (combined or not with a regular audit).
2.7. In any case, the transition of the accreditation must be completed before 01/09/2018.
3. Specific guidance for the assessment of the transition
3.1. General
In principle, the assessment in relation to the transition of the accreditation takes place on the basis of an office audit, preceded by an examination of the documentation submitted by the CB (documentary examination).
The documentary examination comprises at least an in-depth analysis and assessment:
- of the transition plan,
- of the training programme,
- of the procedure for the determination of the duration of the audit,
- and of all relevant operational documents (templates, checklists, model reports …) for the preparation, carrying out and reporting of the certification audits.
During the office audit, the efficiency and sustainability of the implementation of the transitory measures are evaluated.
3.2. Documentary examination
The documents to be submitted by the CB at least 2 weeks prior to the office audit, for the assessment of the transition to the new version of the standard, are:
3.2.1. An overview of the certification activities of the organization (register of certificates, mentioning the name and address of the certificate holder, the expiry date of the certificate); The recently requested data can be used for this purpose.
3.2.2. A qualification matrix of all the personnel (internal and external) that intervenes (or can/will intervene) in the certification process ;
3.2.3. A gap analysis and transition plan of the certification body, including a list of the measures to be taken and the appropriate timing ;
3.2.4. A detailed time schedule for the training of (internal and external) auditors ;
3.2.5. A summary of the principles of the transition of the certification for new customers and of re-certification for existing customers ;
3.2.6. The procedure and calculation rules for determining the duration of the audit ;
3.2.7. The principal changes in the certification process, including in particular the modified procedures and model documents ;
3.2.8. The report on the internal audit of the transition
If BELAC deems it necessary, it may also request other documents for the purpose of the evaluation.
3.3. During the transition period, the CB will ensure that with regard to the client’s certificate as well as the associated audit file and audit report, a clear and unambiguous distinction can be made between the files handled in accordance with the old and those handled in accordance with the new version of the standard.
3.4. Training of the personnel of the CB : The CB will document the planning and execution of the certification trainings in accordance with the new version of the standard. When assessing the transition of the accreditation, the BELAC auditors will check the suitability of the planning and its timely execution.
3.5. The specifications for the in-office evaluation of the transition, will be drawn up as follows:
| Preparation: | 4 h |
| Audit at the company seat: | 4 h |
| Report: | 4 h |
10.02.2017 Collecting data of organizations accredited for certification of MS according to ISO 17021(-1) (QMS, EMS and EMAS)
In accordance with the provisions of document IAF MD 15 (incorporated in Belac 2-312 Chapter 9), Belac shall annually collect and exploit a certain number of data concerning accredited management system certification bodies.
In order to avoid the repeated transfer of identical or similar data, it was decided that for MS (QMS, EMS and EMAS) applications, all necessary data will be collected once a year, instead of the current collection of data at every audit request (in accordance with part 3 of Belac 6-201, second indent).
For this purpose, at the beginning of each year, an appropriate working version of the technical annex to the accreditation certificate will be sent to every accredited certification body concerned. In addition to the ‘recurrent data’ that BELAC requests in preparation of the audit, a number of extra data are required according to IAF MD 15 (transfers, overdue audits and auditor hours).
The data, to be completed line by line in the scope, should apply to the previous year. In practice, this means:
In the case of a flexible scope, the data must be provided for each activity included in the internal list of activities.
- the number of certificates and auditors on the 31st December of the previous year.
- For the other data (transfers, overdue audits, number of auditor days and outsourcing) the data must be provided on a yearly basis (for the period 01/01-31/12)
The number of valid certificates (not the number of files) shall be reported according to the following rules:
- If a client holds a valid certificate with covers one site, this has to be counted as one certificate (single-site certificate).
- If a client has more than one site, for which one certificate (which covers all sites) is issued, it is still counted as one certificate (multiple site certificate). If however, the multiple sites are certified individually, then each granted certificate has to be counted.
- If a client holds several single-site certificates (with each site holding its own individual certificate) or several multiple-site certificates (with one certificate covering multiple sites), then the total number of certificates shall be reported.
- If one certificate is issued for more than one management system, this shall be counted with as many certificates as management systems are covered by the certification (the respective management systems shall also be indicated in the scope)
A valid certificate refers to a certification that is currently under the validity of a certification contract with an active or suspended status. Withdrawn certificates, as well as applications, are not to be counted for this purpose.
For the audits organized by BELAC, the most recent (yearly) data submitted shall be used as the basis. If, at the end of the year, there are no valid certificates for certain lines in the scope, this will be monitored closely by BELAC in the context of dormant activities.
2015
8.10.2015 Accreditation of conformity assessment bodies for non-automatic weighing instruments and automatic weighing instruments in the context of the European directives 2014/31/EU (NAWID) and 2014/32/EU (MID)
As of April 20, 2016 the provisions of the new European directives 2014/31/EU (Non-automatic Weighing Instruments Directive, abbreviated NAWID) and 2014/32/EU (Measuring Instruments Directive, abbreviated MID) shall apply.
Conformity assessment bodies that wish to be notified as a body to carry out conformity assessment of measuring instruments, must be able to submit an accreditation certificate showing that they meet the relevant criteria of these European directives.
BELAC therefore intends to extend its scope to accreditation of activities carried out as a notified body for the conformity assessment procedure "Module F: Conformity to type based on product verification", defined in:
- the European directive 2014/31/EU for non-automatic weighing instruments,
- and the European directive 2014/32/EU with respect to the automatic weighing instruments defined in annex VIII – “Automatic weighing instruments (MI-006)” – of the directive.
The candidate notified bodies may submit an application for accreditation as ‘inspection body’ according to NBN EN ISO/IEC 17020 or as ‘certification body for products’ according to NBN EN ISO/IEC 17065.
Candidate notified bodies can contact BELAC for more information (belac@economie.fgov.be , contact person : mr. Dirk Bils +32 2 277 98 43
2014
01.04.2014: Modification of the Royal Decree creating BELAC
The Royal Decree of 7 February 2014 regarding the modification of the Royal Decree of 31 January 2006 creating BELAC was published on 4 March 2014. The legal provisions contained therein take effect on 1 January 2014.
The document BELAC 0-05 Rev 1 – 2014 is a consolidated version of the Royal Decrees of 2006 and 2014. It is the basic rule regarding BELAC’s activities.
The modification of the legal provisions concerns mainly the following points:
- The modification of the judicial references (substitution of the Law regarding Accreditation by the Code of Economic Law);
- The observance of the stipulations of the EU Regulation 765/2008;
- The introduction of some minor modifications concerning changes in the operation practice;
- The implementation of new fees for accreditation services.
The changes related to the points 1-3 above are mostly formal and influence BELAC’s functioning, the accreditation procedure and the relationship between BELAC and the accredited bodies only in a limited way.
The implementation of the new fees, on the other hand, brings important changes:
- From now on, the application fee shall only be required for initial assessment (previously this was required for initial assessment and renewal assessment);
- Starting the year after the year in which an accreditation has been granted, a yearly fee shall be invoiced per certificate;
- The hourly rate has been raised.
Starting 1 January 2014 the following fees apply:
- The hourly rate for accreditation services: 122,17 euro
- Initial application for accreditation: 775,76 euro
- Yearly fee per accreditation certificate: 310,31 euro
Several practical arrangements will be necessary to insure a smooth introduction of the new fees:
- Invoices regarding the collection of the yearly fee 2014 will be sent out starting April 2014;
- In case of a renewal assessment in 2014, the former application fee won’t have to be paid. If a payment has already been made, this will be corrected;
- In case of an initial application for accreditation introduced in 2014, the new fees will apply. If a payment has already been made, this well be corrected;
- All assessments carried out during 2014 will be invoiced using the new hourly rates. We do not intend to modify quotations that have been approved already, but the final invoice will contain a special mention;
- Invoices that have already been sent and that cover assessment services performed in 2014 will be supplemented by an additional invoice that takes into account the 2014 price increase.
We would like to remind that the new price policy aims at reducing the financial differences between the accredited bodies by taking into account the size and diversity of their activities. It also aims at raising the financial income of BELAC, so the accreditation services might be further developed to better serve the needs of the accredited bodies and those of their customers. Please be ensured that this is an absolute priority for BELAC!
