This website presents questions and answers presented to the EA Horizontal Harmonization Committee (HHC) by the participating committee members. The answers represent the consensus view of the HHC – they are intended for informational purposes and aims for harmonisation between NABs.

When reading questions and answers take into consideration whether transition periods are ongoing. 

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ACCREDITATION MARK

Question 1.10 EA-3/01 use of accreditation mark on reports by certification bodies

5.2.1 of EA-3/01 states … When a CAB’s customer requires an activity, which is covered by the CAB’s scope of accreditation, it is an implicit expectation of the customer to get an accredited report/certificate…

And further, in the paragraph, it states:

In the case of certification of management systems, certification bodies (CBs) shall issue accredited certificates if they concern scopes for which they are accredited in accordance with the IAF Resolution 2016-17.

In the case of certification of products, CBs shall issue accredited certificates if they concern scopes for which they have been accredited in accordance with the IAF Resolution 2018-13.

The question we have regarding the use of the accreditation mark is regarding reports that certification bodies issue.

a) We consider the use of the mark obligatory for certificates, but not allowed on reports that are part/the output of the evaluation activities/phase by the CAB. For product certification the output of the evaluation phase can be recorded in combined or separate test reports and/or inspection reports and in some cases also in audit reports is supporting management system requirements are applicable. Should the reports bear the product certification mark? The ‘end-product’ of a CB is a certificate, not a report, therefor the certificate is the only product/deliverable t that is allowed and is expected to have an accreditation mark. Is this opinion shared by the other EA members?

b) Even if the CB does not issue/grant a certificate, simply because the product or system does not fulfill all requirements (no positive decision possible) and therefore a certificate can not be issued, a report by the CB is not allowed to have an accreditation mark if the CB is accredited for the specific scheme/standard.

Is this opinion shared by the other EA members?

  • a) EA-3/01 states:

§3 refers to accredited reports/certificates containing conformity assessment results covered by the CAB’s accreditation scope and bearing the accreditation symbol or an equivalent reference to accreditation

§5.2.1 The NAB shall set out such conditions to ensure that the accreditation symbol is not used in such circumstances as may be considered to mislead clients or to bring accreditation and/or EA MLA recognition into disrepute. In particular, it shall not mislead as to what is accredited (scope) or who holds accreditation.

§8.1 An accredited CAB which holds accreditation for only part of its activities may use the accreditation symbol or make claims of accreditation status provided there is no confusion as to which activity of the CAB is accredited.

The other accepted uses for the accreditation symbol are on Publicity Materials and Websites (§8.2.2), Letterheads for commercial documents (§8.2.3) and Other uses (§8.2.4), which require approval by the NAB.

It is to be understood that where EA-3/01 refers to “accredited reports/certificates” it refers to the document or media used to communicate the accredited conformity assessment activity results.

So, in conclusion any report on intermediate outputs of a certification process (such as audit reports) are not accredited reports/certificates, neither a commercial or publicity material, and may induce confusion whether the CAB is accredited for other activities, activities which may also be covered by a different accreditation standard.

Therefore, it shall not be allowed.

  • b) Where a negative decision is made by the CB, there will be no certificate issued. In such a case, the conformity assessment result is the certification decision, and it shall bear the accreditation symbol or an equivalent reference to accreditation.

ISO/IEC 17011 INTERPRETATION

Question 4.26: Information publicly available (ISO/IEC 17011:2017, clause 8.2.2)

Referring to ISO/IEC 17011:2017, clause 8.2.2 – is it responsibility of NAB to publish (where applicable) on the website (or in other way to make publicly available without request) information on suspension or withdrawal of accreditation in whole or in part, including dates and scopes?

(1) How the condition “where applicable” should be understood?

  • publication should be implemented whenever there is suspension and withdrawal of accreditation?
  • publication should be realized in every case of suspension and withdrawal of accreditation due to lack of fulfilment of accreditation requirements by CAB (not including cases of suspension and withdrawal on request of CAB, not related to the lack of fulfilment of requirements)?
  • publication should be carried out when accreditation is withdrawn or suspended in its full scope?
  • publication should be carried out when accreditation is withdrawn (reduced) or suspended in part of the scope? Is it reasonable for reducing of the scope of accreditation to be treated in the same way as withdrawal?

(2) Are there any other restrictions (circumstances) concerning publication of information on suspension and withdrawal of accreditation resulting from the condition “where applicable” leading to non-publication ?

(3) What type of information shall be published by NAB regarding withdrawn and suspended accreditations ?

  • should it be full information as in clauses 7.8.1 and 7.8.3 of ISO/IEC 17011:2017, taking into account the NOTE to clause 8.8.2 ?
  • how long should information be publicly available?
  • should information on the date and scope of suspension continue to be publicly available even after reinstatement or withdrawal?

HHC TFG Withdrawals/Suspensions Communication – understanding of clause 8.2.2 of ISO/IEC 17011:2017

ISO/IEC 17011 8.2.2 “As a minimum the accreditation body shall make publicly available without request, information on conformity assessment bodies as described in 7.8.1 and, where applicable, information on suspension or withdrawal of accreditation, including dates and scopes.

NOTE In exceptional cases, access to certain information can be limited upon the request of the conformity assessment body (e.g. for security reasons).”

General

The aim of 8.2.2 clause is to make publicly available the information on the scopes of CABs which are accredited. This information shall be accurate and up to date in order not to mislead the users of accredited services. The NAB implementing related actions or tools should have regard to prevent unauthorized reference to accreditation and to enable users of accredited services to verify information on the current accreditation status of the CAB.

Publicly available information

With regard to withdrawal of accreditation as well as to full or partial suspensions, the NAB shall provide publicly available information as described below, together with the unique accreditation identification of the CAB.

For a total suspension, the tool used to publicly inform the suspension is to be decided by the NAB – some may choose to keep the detailed scope visible as long as it is clearly marked as suspended, while others may prefer to just declare that the CAB is under (total) suspension. Whatever the tool chosen, it must be clearly publicised the date that the total suspension started.

For a partial suspension, the NAB can also choose the mechanism that it uses: some continue to provide the full scope, but clearly marking or identifying the conformity assessment activities under suspension, while others prefer to present only the scope that is ‘active’ under accreditation, omitting the suspended scope. Independently of the mechanism used, it must be clear which is the date that each accredited conformity assessment activity was suspended, either by:

 explicitly stating the date for each suspended scope presented, or

 implicitly stating it, by showing the accreditation decision date corresponding to the ‘active’ scope being presented.

Although the NAB needs to be able to confirm the validity of a given accredited scope in the past, it is recommended not to publish past suspensions no longer in force, since it can be misused and misinterpreted by the market and readers.

Regarding withdrawals (ISO/IEC 17011:2017 clause 3.19 considers them to be for the full scope, not partial), the NAB shall maintain that information publicly available for a period of time compatible with the view of the interested parties and legal requirements. The period for maintaining the information publicly available shall be determined by the NAB although a minimum period of 1 year is recommended (taking into account easy access to information for users of previously accredited services that might still be available on the market). The period shall commence from the date of withdrawal.

It is noted that ISO/IEC 17011:2017 does not require that the scope reduced to be made publicly available, nevertheless the NAB shall ensure that the information on the accredited scope is up to date.

Exceptions and additions

The NAB shall take into account any additional requirement in schemes or regulations regarding publication of information on suspension or withdrawals (e.g. for EU ETS see EA-INF/09).

According to the NOTE to clause 8.2.2 of ISO/IEC 17011:2017, the NAB may exceptionally apply limited access in the publication of information upon request of the CAB (e.g. security reasons). In addition, some schemes may have justifiable reasons for requesting that scopes of accreditation do not present certain data relating to the scheme. Such action shall be justified and measures need to be taken to ensure that it does not mislead the users of accredited CABs where such exceptions have been applied.

NOTIFICATION

Question 6.22: EA-2/20

Document EA-2/20 is about “Consultancy, and the Independence of Conformity Assessment Bodies”.

The document refers specifically to CABs. The requirements of the legislative framework it refers to, the requirements of 768/2008 are incorporated in the different regulations/directives. These requirements make a differentiation to a conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment

and:
They shall not engage…

<< ref. R17.4: A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those products, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.>>

Is the EA-2/20 meant to be applicable also to “its top level management and the personnel responsible for carrying out the conformity assessment”

regarding what is considered consultancy?

EA-2/20 G:2020 is applicable to CABs. Consultancy and impartiality requirements are applicable to the CAB and its personnel, whether they are top management or not.

Question 6.24: EA-2/17 and fulfillment of EA-3/01

Does an accredited NoBo fulfill EA-3/01 by affixing its NoBo number on the issued reports/certificates (under the accredited scope), alleging that its accreditation scope can be found on NANDO, instead of using its accreditation symbol for the (notification) activities under accreditation?

No. EA-3/01 is clear: the use of the accreditation symbol or a claim of accreditation status is mandatory – the NoBo number is neither of these.

Question 6.25: EA-2/17 and fulfillment of EA-3/01

Can an accredited NoBo be dismissed from affixing its accreditation symbol in the accredited certificates/reports that it issues when:

  • a) agreed and documented between the accredited NoBo and the NAB;
  • b) the accredited NoBo includes in the report/certificate a written statement to being accredited, with the accreditation code
  • c)  there are other non-accredited NoBos in the same notified area that don’t use accreditation symbols
  • d)  the notifying authority issued a regulation specifying the format to be used for the reports that prohibits affixing the accreditation symbol
  • a) No. A NAB and a CAB cannot have a ‘private’ arrangement to not fulfill EA-3/01. EA-3/01 is mandatory and takes precedence.
  • b) Yes. This is what is required by EA-3/01.
  • c) No. If others are not fulfilling it is not a justification to also not fulfil.
  • d) Yes. EA-3/01 §5.2.1 states an exception to the mandatory character of using the accreditation symbol or a claim to accreditation when “prevented by legal or regulatory requirements”, which is the case (regulation issued by the NA).

Question 6.26: EA-2/17 and fulfillment of EA-3/01

When using the conditional accreditation option indicated in Annex C of EA-2/17, the NAB:

  • a) may allow the NoBo to issue accredited certificates before witnessing, if the witnessing chosen by the NAB has not yet been possible
  • b) may allow the NoBo to issue unaccredited certificates until a satisfactory witnessing is completed

Or simply the NAB cannot allow the NoBo to issue any accredited certificate until a satisfactory witnessing is concluded.

  • a) No. EA-2/17 is clear that “The NAB shall have the necessary arrangements in place to ensure that no accredited certificates are issued until appropriate witnessing has been satisfactorily performed”, so only after an appropriate (successful) witnessing can the NoBo issue accredited certificates.
  • b) No. EA-3/01 §5.2.1 prevents the possibility of issuing unaccredited certificates by stating that “this last possibility cannot be applied when the reports/certificates containing results covered by the accreditation scope are in an area where accreditation is mandatory by law”

SUBCONTRACTING

Question 9.3: Notified Body (NB) assessment activities and subcontracted laboratory

What kind of assessment activities the Notified Body need to do in case of the subcontracted laboratory has ISO/IEC 17025 accreditation for the given scope? And what kind of assessment activities the Notified Body need to do in case of the subcontracted laboratory has ISO/IEC 17025 accreditation but NOT only for the given scope or if the subcontracted laboratory does not maintain ISO/IEC accreditation at all?

In order to obtain accreditation for notification purposes, NB shall have appropriate testing capability that may be assured by:

  • (a) having an own laboratory within the same legal entity accredited for the scope corresponding to NB activities;
  • (b) having a legally binding contract concluded with a subcontractor’s laboratory accredited for the appropriate scope;
  • (c) having an own non-accredited laboratory or outsource testing to non-accredited laboratories (internal and external resources). In such cases, the NB shall have evidence to demonstrate that the laboratories meet the applicable requirements of the EN ISO/IEC 17025 standard;

For cases b) and c), it is not only the requirements of ISO/IEC 17025 which need to be fulfilled by the subcontractor (whether accredited or not), but also the requirements of the application legislation, namely that :

  • the laboratory is competent for the pre-analytical phase if the subcontracting includes sampling (Art R 17 point 7 of Decision 768);
  • all the specific requirements related to impartiality (Art R17 3, 4, 5 and 8) are fulfilled, notably with respect to being a third-party body independent of the organisation or the product the subcontractor assesses;
  • the lab has subscribed a liability insurance (Art R17 9);
  • the lab is aware of the activities of the notified body coordination group (Art R17 11).