RECOMMENDATION FOR USE - NB

Supported by

NB-Rail Association

RECOMMENDATION FOR USE

Co-funded by the European Union

NB-RAIL COORDINATION GROUP Administrative Decision according to Interoperability Directive

(EU) 2016/797 art. 30.6

RFU-STR-704 Issue 03 Date 02/03/2021

Recommendation For Use Page 1 of 14

TITLE

REMOTE EVALUATION OR EXTENSION OF CLD VALIDITY DUE TO COVID-19 PANDEMIC

Temporary measures for the activities of Notified Bodies in the framework of the restrictions related to the COVID-19 pandemic:

Part 1: Remote performance of certain NoBo evaluation activities which in normal circumstances are intended to be performed ‘on-site’

Part 2: One-time-extension of the validity by 6 months of CLDs (Certification Level Documents, refer to RFU-STR-001) which have reached their foreseen period of validity

ORIGINATOR SUBJECT RELATED TO ORIGINATOR: CHAIRMAN + VICE-CHAIRMAN OF NB-RAIL COORDINATION GROUP

IOD 2008/57/EC AND (EU) 2016/797 MODULE DECISION 2010/713/EU, ALL TSIS, ERA ASSESSMENT SCHEME

AMENDMENT RECORD: ISSUE 02: ADDING OF PART 2: AMENDMENT OF CERTIFICATES WHICH HAVE REACHED THEIR END OF VALIDITY BASED ON /D06/, /D07/ AND /D08/ ISSUE 03: INCLUSION OF MODULE SG FOR INSPECTION ACTIVITIES IN PART 1. IMPROVED WORDING THROUGHOUT, CLEARER SEPARATION OFF PARTS 1 AND 2, ADDING OF FLOW-CHART AS NEW /D01/

DESCRIPTION AND BACKGROUND EXPLANATION Objective of this RFU: The objective of this RFU is to complement the high-level documents from DG GROW, ERA and EA with a detailed harmonized approach when NoBos use remote activities for evaluation under these prevailing circumstances. This approach shall apply to both accredited and recognised NoBos. Background (for both Parts of this RFU): On 06 April 2020 the European Commission’s directorate general for mobility and transport (DG MOVE) issued a communication note on the “Impact of COVID-19 on Vehicle Authorisation and NoBos work under Directive (EU) 2016/797” (see /D02/) On 03 April 2020 the European Union Agency for Railways (ERA) published a clarification note (see /D03/) “Temporary measures adopted by the European Union Agency for Railways for delivering authorisations in the framework of the restrictions related to the COVID-19 pandemic”. In this clarification note a line to take is defined when COVID-19

Supported by

NB-Rail Association




(EU) 2016/797 art. 30.6



emergency measures are temporarily preventing the NoBos from carrying out planned assessments, visits, inspections, audits or any other on-site activity necessary to issue or renew a certificate. On 27 March 2020, the European Commission’s directorate general GROW – Free movement of goods – issued a communication (see /D04/) on the impact of COVID-19 on the activities of notified bodies (NoBos). This communication provides for flexibility and specific guidance in reaction to the COVID crisis to NoBos when performing their tasks – particularly those activities requiring visits to manufacturers’ premises – and at the same time encourages NoBos to continue carrying out their tasks to the extent that is currently possible in respect of the different and varying confinement measures taken at Member States level. DG GROW’s communication also makes reference to an EA (European Accreditation) communication on Corona virus dated 23 MARCH 2020 (see /D05/ or https://european-accreditation.org/ea-communication-to-the-impact-of-the-covid-19-outbreak/). On 27 April 2020, the European Commission’s directorate general GROW – Free movement of goods – issued a communication (see /D06/) on the impact of COVID-19 on the activities of notified bodies (NoBos). This communication is considered to be not directly relevant for NoBos under IOD, but it has highlighted the need to consider a situation, where the measures against Corina virus may delay the performance of a project which is subject to certification with a defined validity. On 05 May 2020 the European Union Agency for Railways (ERA) published an update (V1.1) of the clarification note (see /D07/) “Temporary measures adopted by the European Union Agency for Railways for delivering authorisations in the framework of the restrictions related to the COVID-19 pandemic”. On 07 May 2020 the European Commission’s directorate general for mobility and transport (DG MOVE) issued a communication note on the “Validity of NB certificates” (see /D08/). This introduces the possibility to extend the validity of a certificate issued under LOC&PAS TSI 2011 and 2014 where a project is delayed due to the emergency measures adopted by the Member States to fight the COVID-19 outbreak. General Note: NB Rail considers that the content of this RFU may be applied mutatis mutandis also by DeBos.

https://european-accreditation.org/ea-communication-to-the-impact-of-the-covid-19-outbreak/

https://european-accreditation.org/ea-communication-to-the-impact-of-the-covid-19-outbreak/

Supported by

NB-Rail Association




(EU) 2016/797 art. 30.6



Part 1: Remote performance of certain NoBo evaluation activities which in normal circumstances are intended to be performed ‘on-site’ Description: As independent conformity assessment bodies, NoBos shall perform the EVALUATION activities INSPECTION, AUDIT and/or TESTING (where such testing is not already performed by an external test laboratory) as a prerequisite for CERTIFICATION. In many cases, and depending on the requirements of the module(s) chosen by the applicant, this requires a combination of ‘on-site’ and ‘remote’ evaluation activities. Due to the COVID-19 outbreak the balance between ‘on-site’ and ‘remote’ activities which is foreseen in normal circumstances may not be feasible (e.g. due to quarantine measures, travel restrictions). In order to support business-continuity for NoBos, for their clients and for the end-users of the certified products, this RFU provides an alternative approach which may be used in such a crisis situation: On-site activities may in these circumstances become partially or completely substituted or complemented by equivalent, alternative remote activities. Because of the high safety criticality and/or high commercial investment, which is often associated with railway products, it must be ensured that such alternative remote activities deliver an equivalent level of trust and confidence in the NoBo activities. Furthermore, NoBos have to satisfy also in these circumstances the relevant legal requirements and accreditation/recognition requirements which regulate their activities. Legal context: The following legal references directly or indirectly require the NoBo in normal circumstances to perform on-site EVALUATION activities:

• 2010/713/EU, Module SB (CB is similar): o 4.5+ 4.6 “carry out appropriate examinations and tests, or have them carried out, to check

whether, where the solutions in the relevant harmonised standards and/or technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding requirements of the relevant TSI(s);

o agree with the applicant on a location where the examinations and tests will be carried out.”

Note: Due to the nature of the products under evaluation, most of these INSPECTION activities require the NoBo staff to travel to such a location, which is usually the location of production, commissioning or testing.

• 2010/713/EU, Module SD (CD is similar): o 3.3 Initial Audit: “The audit shall include an assessment visit to the premises of the relevant

entities concerned.”

Supported by

NB-Rail Association




(EU) 2016/797 art. 30.6



o 7.2 Surveillance and Re-certification: “The applicant shall, for periodic audits purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:”

o 7.4 Additional Visits: “In addition, the notified body may pay unexpected visits to the applicant.”

• 2010/713/EU, Module SF (CA1, CA2 and CF are similar)

o 4.3 „The notified body shall agree with the applicant the locations where the tests will be carried out and shall agree that final testing of the subsystem and, whenever required in the relevant TSI(s), tests or validation under full operating conditions, are carried out by the applicant under direct supervision and attendance of the notified body. The notified body shall have entrance for testing and verification purposes to production workshops, locations of assembly and installations, and where appropriate, prefabrication and testing facilities in order to carry out its tasks as provided for in the relevant TSI(s).”

Note: Due to the nature of the products/ installations under evaluation, most of these INSPECTION activities require the NoBo staff to travel to such a location, which is usually the location of build/ installation, commissioning or testing.

• 2010/713/EU, Module SG

o 5.3 “The notified body shall agree with the applicant the locations where the tests will be carried out and shall agree that final subsystem tests and, whenever required in the TSI, tests under full operating conditions, are carried out by the applicant under direct supervision and attendance of the notified body.”

Note: Due to the nature of the installations under evaluation, many of these examinations require the NoBo staff to travel to such a location, which is usually the location of production, commissioning or testing.

• 2010/713/EU, Module SH1 (CH and CH1 are similar) o 3.3, 5.2 + 5.4 (similar requirements to SD as stated above)

Good practice for performing remote EVALUATION activities: The following documents define good practice for performing remote EVALUATION activities and have been used during the preparation of this RFU:

• IAF ID3: 2011, IAF Informative Document For Management of Extraordinary Events or Circumstances Affecting ABs, CABs and Certified Organizations

• IAF MD 4: 2018, IAF Mandatory Document for the use of Information and Communication Technology (ICT) for auditing/assessment purposes

• IAF ID 12: 2015, IAF Informative Document Principles on Remote Assessment • EA communication to EA members and accredited conformity assessment bodies regarding the

outbreak of COVID-19, 23.03.2020

Supported by

NB-Rail Association




(EU) 2016/797 art. 30.6



Part 2: One-time-extension of the validity by 6 months of CLDs which have reached their foreseen period of validity Description: In certain cases, which are defined in the relevant TSIs and/ or Module descriptions, a CLD ( must be issued with a foreseen period of validity. Refer to RFU-STR-060 for further details on the maximum permitted periods of validity. Due to the COVID-19 outbreak projects may unexpectedly become delayed, so that the originally foreseen validity period no longer suffices for the bearer of the CLD to complete the necessary declarations. In order to support business-continuity for the clients of NoBos and for the end-users of the certified products, this RFU provides an option to extend the originally foreseen validity of a CLD in such a crisis situation. This is possible, based on the provisions of Documents /D06/ and /D08/, which provide under certain circumstances the option to issue an amended NoBo CLD with an extended period of validity. The conditions require, that

• the original EC type or design examination certificate was issued under TSI LOC&PAS 2011 (and related NOI, PRM and SRT TSIs) and the project is delayed due to the emergency measures adopted by the Member States to fight the COVID-19 outbreak and that, due to this delay, the EC certificate of the vehicle type expires before the last vehicles of that project have been authorised. The client of the NoBo shall in this regard declare that, without the COVID-19 outbreak, the project would have been completed within the validity period of the certificate;

• the extension shall be no longer than 6 Months. • the extended CLD shall be based on the ‘examination’ (=evaluation and

certification review) done for the original CLD • NoBos shall

o act responsibly when analysing the situation and o act with full transparency in keeping records justifying the decisions

(=certification decision)

Because of the high safety criticality and/or high commercial investment, which is often associated with railway products, it must be ensured that such an option delivers an equivalent level of trust and confidence in the NoBo activities. Furthermore, NoBos have to satisfy also in these circumstances the relevant legal requirements and accreditation/recognition requirements which regulate their activities.

Supported by

NB-Rail Association




(EU) 2016/797 art. 30.6



Legal context: As summarised in RFU-STR-060, for certain Modules the CLDs shall have a maximum foreseen validity. NoBos are normally not permitted to provide their clients the option to extend this maximum foreseen validity.

RFU PROPOSAL PART 1 – REMOTE PERFORMANCE OF CERTAIN NOBO EVALUATION ACTIVITIES WHICH IN NORMAL CIRCUMSTANCES

ARE INTENDED TO BE PERFORMED ‘ON-SITE’ This RFU Proposal is composed of the following sections:

1. CONDITIONS FOR APPLYING PART 1 OF THIS RFU 2. PLANNING OF EVALUATION IN CASE OF REMOTE ACTIVITIES,

including detailed description of the “Risk and Opportunity Analysis for performing Remote Evaluation Activities”

3. RECORDING OF EVALUATION IN CASE OF REMOTE ACTIVITIES

1. CONDITIONS FOR APPLYING PART 1 OF THIS RFU C1) This part of the RFU applies only to the extraordinary events or circumstances related to the COVID-19 crisis which preclude NoBos from:

• performing their normal determination of a balance between on-site and remote EVALUATION activities, and

• fulfilling the minimum (direct or indirect) requirements for on-site activities as defined in 2010/713/EU.

C2) The measures which EA has defined for conformity assessment bodies (which includes NoBos) in its ‘communication to EA members and accredited conformity assessment bodies regarding the outbreak of COVID-19, 23.03.2020’ (/D05/) shall be applicable to accredited as well as recognised NoBos. C3) It is noted that this EA communication requires for NoBos in a regulated scheme – NoBo certification under (EU) 2016/797 is such a regulated scheme - that the respective scheme owners or relevant competent authorities inform on how they expect the related conformity assessment activities to be managed under these circumstances. This information has been provided by ERA (as relevant scheme owner) in close co-ordination with the European Commission (see /D03/ and /D02/).

Supported by

NB-Rail Association




(EU) 2016/797 art. 30.6



2. PLANNING OF EVALUATION IN CASE OF REMOTE ACTIVITIES The Planning of an EVALUATION (e.g the project specific assessment plan or audit programme) shall include the following topics (in addition to the usual ones): Planning Topic 1) Identification of those activities which are to be performed remotely in substitution of any activities which shall in normal circumstances be performed as on-site activities. For the following EVALUATION activities specific approaches apply in relation to the module applied and the type of normally foreseen on-site activity: Note: The purpose of this part 1 of the RFU is to propose alternative approaches where in normal circumstances it would be required to perform an on-site activity.

1) INSPECTION for Modules CA1/CA2/CB/CF/CH/CH1/SB/SF/SH1/SG The NoBo shall consider that in this case it is not required by legislation that the NoBo performs the inspection at a specific location, but for practical reasons and under normal circumstances it is typical to perform a balanced approach between remote and on-site activities.

2) Initial AUDIT for Modules CD/CH/CH1/SD/SH1 The NoBo shall consider that in this case the NoBo is required by legislation to perform the AUDIT at least partially at an on-site location.

3) Surveillance or Recertification AUDIT for Modules CD/CH/CH1/SD/SH1 The NoBo shall consider that in this case it is required by legislation to perform the AUDIT at least partially at an on-site location. The NoBo may in this case apply IAF ID-3, which provides the possibility to postpone the on-site activities for up to 6 months. The conditions defined in IAF ID-3 apply. These conditions require a specific Risk Analysis to be performed by the NoBo for each case of postponement.

4) TESTING to complement any Module The NoBo shall consider that in this case it is not required by legislation to perform the TESTING of a subsystem or ICs at a specific location, but for practical reasons and under normal circumstances it is typical to perform testing either by a NoBo or by an accredited testing body. Note: If on-site tests are required (e.g. when fixed installations can not be tested in a laboratory), then this is usually done by an accredited testing body, by the NoBo or – where permitted by the TSI - by the applicant (refer e.g. to chapter 6.2.2.1 of TSI INF or ENE). All applicable requirements have to be respected also in a situation when RFU-STR-022 is used.

Supported by

NB-Rail Association




(EU) 2016/797 art. 30.6



Planning Topic 2) Identification which information/communication technology is intended to be used during remote activities. The use of web-cams, cameras, etc. may be encouraged when a physical evaluation is desired or necessary. Planning Topic 3) A Risk and Opportunity Analysis for performing Remote Evaluation Activities which relates to

- potential risks & chosen mitigations (see checklist below) - potential opportunities (e.g. permitting the performance of an AUDIT despite travel

prohibition)

The minimum set of topics for this Risk and Opportunity Analysis (ROA) is provided in the section here below numbered from ROA-Topic 1 to ROA-Topic 6. The summary result of the ROA shall be taken as key input for the decision of whether remote evaluation may be performed or not. If one of the topics mentioned here provides anegative value, the respective on-site, reduced on-site or remote evaluation cannot be performed. In such a case it will be required to wait for an improvement of the situation. ROA-Topic 1) Health and Safety Conditions (if appropriate) NoBo staff as well staff of the client/evaluated party shall be protected against hazards related to health and safety due to the COVID-19. European as well as most national legislation require in this regard at least to perform:

a) A close coordination and cooperation between the NoBo and the client/evaluated party

b) Performance of health and safety-risk identification, assessment (determination of risk as combination of severity and frequency of harmful occurrences) and mitigation. This is usually expected to result in following measures:

1) Substitution of an activity with an alternative that provides lesser residual risk (e.g. perform a remote audit instead of an on-site audit)

2) Technical measures to suppress the severity and frequency of harmful occurrences (e.g. travel alone in car instead of public transport where social distancing cannot maintained)

3) Organisational measures (e.g. maintain a social distancing of 2m from other persons)

4) Personal Protective Equipment (e.g. FFP2 level face mask where infectious persons may be present)

c) Consideration for a specific medical condition of any used staff (e.g. pregnancy, existing health risks with individual persons)

Supported by

NB-Rail Association




(EU) 2016/797 art. 30.6



Further (local) conditions may apply und must be identified between NoBo and the client/ evaluated party. >Where no agreement on particular Health and Safety precautions can be found with a client/ evaluated party, the NoBo shall not perform any on-site activities and propose an alternative method. (>No Result for normal or limited on-site, Yes Result for remote activity<) >Where agreement on the particular Health and Safety precautions can be found with a client/ evaluated party and the risk can be further mitigated by reducing the on-site time in favour of remote activity time, the NoBo may perform reduced on-site activities in combination with extended remote activities. (>Yes Result for limited on-site or remote, No Result for normal on-site activity<) >Where agreement on the particular Health and Safety precautions can be found with a client/ evaluated party and the risk is tolerable, the NoBo may perform on-site activities as usual. (>Yes Result for normal or limited on-site or remote activity<) ROA-Topic 2) Travel Restrictions NoBo staff as well the staff of the client/ evaluated party or a specific nation/ region/ location may be subject to travel restrictions. >Where due to travel restrictions no on-site activities are possible, the NoBo may perform alternative remote activities. (>No Result for normal or limited on-site, Yes Result for remote activity<) >Where due to travel restrictions only partial on-site activities are possible (e.g. travel in and out on the same day), the NoBo may perform reduced on-site activities. (>Yes Result for limited on-site or remote, No Result for normal on-site activity<) >Where no relevant travel restrictions apply, the NoBo may perform on-site activities. (>Yes Result for normal or limited on-site or remote activity<) ROA-Topic 3) Data Security and Confidentiality The data security and confidentiality of electronic or electronically-transmitted information must be maintained as well as when employing information/communication technology during a remote evaluation. The use of the specific information/communication technology (e.g. video conferencing) shall be agreed between the NoBo and the client/ evaluated party: the agreement shall be documented. In case no agreement can be reached, the NoBo shall not use this technology and propose another information/communication technology.

Supported by

NB-Rail Association




(EU) 2016/797 art. 30.6



>Where an agreement on the use of information/communication technology has been found, the NoBo may perform remote activities. (>Yes Result for normal or limited on-site or remote activity<) >Where no agreement on the use of information/communication technology on-site activities is possible, the NoBo shall not perform remote activities. (>Yes Result for normal on-site and a No Result for reduced on-site or remote activity<) ROA-Topic 4) Validity and Objectivity of the information gathered The way in which remote evaluation is intended to be used shall cause no impacts on the validity and objectivity of the information gathered (e.g. sampling shall not become reduced in scope and remain unpredictable, evidence chosen remotely shall become directly visible to the NoBo staff). When Modules Decision requires “tests or validation under direct supervision and attendance of the NoBo” (e.g. point 4.3 of SF module and point 5.3 of SG module), then particular care shall be taken to ensure the absence of loss of quality of the information gathered during these activities. >Where a negative effect on Validity and Objectivity of the information gathered cannot be avoided, the NoBo shall not perform remote activities. (>No Result for limited on-site or remote, Yes Result for normal on-site activity<) >Where no negative effect on Validity and Objectivity of the information gathered is expected, the NoBo may perform remote activities. (>Yes Result for normal or reduced on-site or remote activity<) ROA-Topic 5) Effects of Complexity and Novelty on the effectiveness A remote activity often requires more time to cover the same topic as social interaction is limited, misunderstandings may happen, technical problems may reduce efficiency. This is further negatively impacted by a complex or novel scope (e.g. initial assessment). A positive impact may result, where a similar scope is already known to the evaluation team or where a complex activity can be broken down into suitable sub-elements. Another mitigation may be the ability to obtain precise information on participants, site layout and related activities in advance of the evaluation. Providing more evaluation time for a remote activity may be a further mitigation. >Where a negative effect on the effectiveness due to high Complexity and Novelty cannot be avoided, the NoBo shall not perform remote activities. (>No Result for limited on-site or remote, Yes Result for normal on-site activity<) >Where no negative effect on the effectiveness due to high Complexity and Novelty is expected, the NoBo may perform remote activities. (>Yes Result for normal or reduced on-site or remote activity<)

Supported by

NB-Rail Association




(EU) 2016/797 art. 30.6



ROA-Topic 6) Ability and/or Aptitude of client/ evaluated party Remote assessments may be less favourable where a client/ evaluated entity has a history of nonconformities or shows aversion against the remote evaluation. >Where a negative effect on the effectiveness due to Ability or Aptitude of client/ evaluated party cannot be avoided, the NoBo shall not perform remote activities. (>No Result for limited on-site or remote, Yes Result for normal on-site activity<) >Where no negative effect on the effectiveness due to Ability or Aptitude of client/ evaluated party is expected, the NoBo may perform remote activities. (>Yes Result for normal or reduced on-site or remote activity<) Note: The Results of the Risk and Opportunity Analysis may be presented in table format:

ROA-Topics Option 1 Results permit normal balance of on-site and remote evaluation (Y/N)

Option 2 Results permit reduced on-site evaluation and increased remote evaluation (Y/N)

Option 3 Results permit on-site evaluation to be fully substituted by remote evaluation (Y/N)

Comments

1 Health and Safety Conditions

(Y or N) (Y or N) (Y or N) (text)

2 Travel Restrictions


3 Data Security and Confidentiality


4 Validity and Objectivity of the information gathered


5 Effects of Complexity and Novelty on the effectiveness


6 Ability and/or Aptitude of client/ evaluated party


OVERALL RESULT: Only in case of all (Y) in a column, an option may be used. Where no option may be used, the evaluation may not be performed.

(all Y above indicate that this option can be used) (at last one N indicates that this option cannot be used)



Supported by

NB-Rail Association




(EU) 2016/797 art. 30.6



Planning Topic 4) Preparation and practical checking of the information/communication technology Involved staff shall have the required competency (=knowledge and ability) in using the technology agreed for the remote evaluation. Practical checking of the technology to be used shall usually be performed one week before the actual remote EVALUATION. Planning Topic 5) Policy of conduct related to execution of any remote activity This shall define the approach for topics as e.g.

• all participants should aim for a quiet environment whenever possible to avoid interference and background noise,

• all parties should make their best effort to confirm what was heard, stated and read throughout the evaluation,

• approach on exchange and management of nonconformities, • who instructs remotely an on-site operator with a camera, • what happens, when the remote connection fails during the evaluation, • how topics which cannot be (completely) determined due to circumstances caused

by a remote activity may be moved to a separate evaluation activity, • all remote evaluation should be started with a kick-off presentation and be

concluded with a closing presentation (summary review of the events, nonconformities and postponed activities)

Planning Topic 6) Obtaining confirmation from the client/evaluated entity on the intended format for remote evaluation The NoBo and the client shall document their respective acceptance on the approach for any remote EVALUATION which substitutes originally intended on-site activity. Planning Topic 7) Adjusted Time Planning The NoBo shall accommodate suitable breaks for the client/ evaluated party and to consider, if appropriate, different time zones. 3. RECORDING OF EVALUATION IN CASE OF REMOTE ACTIVITIES In addition to the usual topics, the report of an EVALUATION shall include the following: Recording Topic 1) Description of the COVID-19 extraordinary situation in which the remote evaluation took place. Recording Topic 2) Identification of those activities which have been performed remotely as a substitution of an originally intended on-site activity. Recording Topic 3) Relevant occurrences which relate to/ have affected the remote activities in this project (e.g. premature termination in case of connectivity problems).

Supported by

NB-Rail Association




(EU) 2016/797 art. 30.6



RFU PROPOSAL PART 2 - ONE-TIME-EXTENSION OF THE VALIDITY BY 6 MONTHS OF CLDS WHICH HAVE REACHED THEIR FORESEEN

PERIOD OF VALIDITY Where a NoBo has been asked by an applicant to use the option to extend the originally foreseen period of validity of a certificate, the Certification Decision check must include in addition to the usual topics also the following requirements: Requirements for the CERTIFICATION DECISION check Result Are the original and the amended certificates an EC type or design examination certificate issued under TSI LOC&PAS 2011 (and related NOI, PRM and SRT TSIs)?

(Y or N)

Has the applicant declared a need to extend the originally foreseen period of validity due to an unexpected time delay in the project which was caused by Covid-19?

(Y or N)

Is the extension of validity, as requested by the applicant, no longer than 6 Months beyond the original period of validity of the CLD?

(Y or N)

To act responsively as NoBo: Can you confirm that there is no indication (obtained by NoBo internal staff, from the client or from the public domain), which calls in question, that the product actually meets the original conformity assessment requirements?

(Y or N)

Is the evaluation reporting and the certification review prepared for the original certificate still available and can be used as evidence for this certification?

(Y or N)

Positive answers (Y) to all above items are needed before providing an extension of the validity. An extension of the validity of a CLD can only be performed by the same NoBo, that had issued that CLD. An extension of the validity of a CLD can only be performed for one time. Note: Part 1 of this RFU may be used, if a one-time extension of validity for 6 months is not sufficient. In order to act with full transparency, the NoBo shall keep the results of the certification decision as records for justifying the certification decision.

Supported by

NB-Rail Association




(EU) 2016/797 art. 30.6



THIS RFU WAS AGREED ON

PLE 61, 25/02/2021

THIS RFU ENTERS INTO FORCE ON 02/03/2021 (DATE OF PUBLICATION) FROM THIS DATE ON, THIS RFU CAN BE APPLIED.

RFU APPLICATION IS MANDATORY STARTING FROM 02/03/2021 (DATE OF PUBLICATION) RFUS SHALL BE APPLIED BY ALL NOBOS. PLEASE REFER TO RFU-STR-702, CHAPTER 3 OF THE SECTION “DESCRIPTION AND BACKGROUND EXPLANATION”, FOR THE LEGAL BASIS SUPPORTING THIS OBLIGATION.

ERA COMMENTS VIA AD-HOC CO-ORDINATION: THIS RFU COMPLEMENTS THE ASSOCIATED ERA AND DG MOVE DOCUMENTATION ON COVID-19. (SEE /D02/, /D03/, /D07/ AND /D08/)

Reference documents and attachments: /D01/ Flow chart on graphical presentation of processes contained in this RFU

/D02/ DG MOVE Note ‘Impact of COVID-19 on Vehicle Authorisation and NoBos work under Directive (EU) 2016/797’; Ares (2020)1942274 of 06 April 2020

/D03/ Clarification note of European Union Agency for Railway, Temporary measures during COVID-19 pandemic; ERA1209/088 V1.0 of 03 April 2020

/D04/ DG GROW Note on COVID-19 outbreak of 27 March 2020

/D05/ EA communication to EA members and accredited conformity assessment bodies regarding the outbreak of COVID-19 of 23 March 2020

/D06/ DG GROW Note on Validity of NB certificates-27 April 2020

/D07/ Clarification note of European Union Agency for Railway, Temporary measures during COVID-19 pandemic; ERA1209/088 V1.1 of 05 May 2020

/D08/ DG MOVE Note on Validity of NB certificates of 07 May 2020

Start here

Planning Topic 1

Risk & Opportunitiesreport

Yes

No

Normal balance on-site and remote

possible?

Perform normalremote and on-

site activities

Prepare reportsfor Certification

New certificate, validity according to

RFU-STR-060

Perform enlargedremote and

reduced on-siteactivities

Yes

No

Enlarged remote activities

and reduced on-site

possible ?

Perform onlyremote activities

These decisions arebased on the result of

the Risk andOpportunity analysis

Yes

No

NoFull Remotepossible ?

Inform applicantabout decision

CAB cannot carry outrequired activities -

certification notpossible

Letter to applicant

Original certificatevalidity can be

extended by max. 6months

Certificate withextended validity

period (max 6months)

Yes - Part 2

No

Postponementrequested ?

Only once!

Yes

No

Confidence in QMS being effective inproducing confomant

products without further audit ?

ExtendedCertification

Collect informationon QMS

effectiveness andproduct conformity

Postponement Risk Analysis

Planning Topics 2 and 3 Risk and

OpportunityAnalysis

Planning Topics4,5,6 and 7

Planning Topics4,5,6 and 7

Certification

Part 1and

Part 2

Part 1

From: FITCH Keir (MOVE) <[email protected]> Sent: Monday, 06 April 2020 10:57 To: Undisclosed recipients Topic: Ares(2020)1942274 - Impact of COVID-19 on Vehicle Authorisation and NoBos work under Di-rective (EU) 2016/797 Attachments: ERA1209-088 Clarification about exceptional measures during COVID-19.pdf EA communication Coronavirus 23March2020.pdf

Ares(2020)1942274 - Impact of COVID-19 on Vehicle Authorisation and NoBos work under Directive (EU) 2016/797

Sent by FITCH Keir (MOVE) <[email protected]>. All responses have to be sent to this

email address.

Envoyé par FITCH Keir (MOVE) <[email protected]>. Toutes les réponses doivent être

effectuées à cette adresse électronique.

Dear Colleagues, The current COVID-19 outbreak affects the activities of many of us, including activities related to vehicle authorisations and certification activities of notified bodies (NoBos). In this context, some of you have been asking us whether we should provide for flexibility and specific guid-ance on these issues. You will find below the note that our colleagues from DG GROW sent on 27 March 2020 to your Notifying Authorities regarding possible arrangements allowing NoBos to continue carrying out their activities in the context of the current COVID-19 outbreak, in particular insofar as this re-quires performing visits to manufacturers premises. You will also find attached the EA commu-nication referred to in the note of DG GROW. In addition to that note, the European Union Agency for Railways (ERA) issued on 3 April 2020 the attached “Clarification note on Temporary measures adopted by the European Union Agen-cy for Railways for delivering authorisations in the framework of the restrictions related to the COVID-19 pandemic”. This note covers ERA’s line to take in reaction to: - COVID-19 emergency measures temporarily preventing the NoBos from carrying out

planned assessments, visits, inspections, audits or any other on-site activity necessary to is-sue or renew a certificate;

- COVID-19 emergency measures delaying the process of notification of a NoBo for Directive (EU) 2016/797;

- COVID-19 emergency measures temporarily preventing an applicant to gather all the neces-sary information from a supplier that is needed to build and submit the file accompanying the application for authorisation (e.g. files accompanying the certificates for ICs), or to an-swer issues raised by the assessors for an on-going application.

For your complete information, NB-Rail is currently preparing a document aiming to provide further structured guidance to the internal NoBo risk-assessment that results from COVID-19

https://webgate.ec.testa.eu/Ares/documentInfo/documentInfoDetailsExt.do?documentId=080166e5cde0fd77

mailto:[email protected]


emergency measures temporarily preventing the NoBos from carrying out planned assess-ments, visits, inspections, audits or any other on-site activity necessary to issue or renew a cer-tificate. It should become available on the NB-Rail website (http://nb-rail.eu/co/co_docs_rfu_en.html) in parallel to this communication. I would like to take this opportunity to remind that pursuant to Article 30(6) of Directive (EU) 2016/797, NoBos “shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group [NB-Rail]”. Furthermore, as indicated in the ERA note, the same principles may be applied, mutatis mutan-dis, to the evaluations to be performed by Designated Bodies (DeBos) and the evidence that DeBos should produce (e.g. certificate of verification for national rules). Best regards, Keir Fitch Head of Unit

European Commission Unit C4 (Rail Safety and Interoperability) DG MOVE C Rue De Mot 28, 04/116 B-1049 Brussels/Belgium Tel : +32(0) 2 295 93 16 [email protected] http://ec.europa.eu/transport/index_en.htm

http://nb-rail.eu/co/co_docs_rfu_en.html

http://nb-rail.eu/co/co_docs_rfu_en.html


http://ec.europa.eu/transport/index_en.htm

Clarification noteTemporary measures during COVID-19 pandemic

ERA1209/088 V1.0

Making the railway system work better for society.

120 Rue Marc Lefrancq | BP 20392 | FR-59307 Valenciennes Cedex 1 / 6 Tel. +33 (0)327 09 65 00 | era.europa.eu

Clarification note

Temporary measures adopted by the European Union Agency for Railways for delivering authorisations in the framework of the restrictions related to the COVID-19 pandemic

Drafted by Validated by Approved by

Name DEL RIO Eduardo BREYNE Thierry DOPPELBAUER Josef

Position Project officer Head of PAD unit Executive Director

Date 03/04/2020 03/04/2020 03/04/2020

Signature

Document History

Version Date Comments

1.0 03/04/2020 Initial version

The purpose of this document is to provide applicants and other external stakeholders of the vehicle authorisation business with information in regards to the specific topic referenced in the title. The clarifications contained in this document may be integrated in the next revision of the guidelines for the practical arrangements for the vehicle authorisation process, without prejudice of the formal process foreseen for updating the guideline.

The present document is a non-legally binding guidance of the European Union Agency for Railways. It is without prejudice to the decision-making processes foreseen by the applicable EU legislation. Furthermore, a binding

interpretation of EU law is the sole competence of the Court of Justice of the European Union.

EUROPEAN UNION AGENCY FOR RAILWAYS Clarification note Temporary measures during COVID-19 pandemic

ERA1209/088 V1.0

120 Rue Marc Lefrancq | BP 20392 | FR-59307 Valenciennes Cedex Page 2 / 9 Tel. +33 (0)327 09 65 00 | era.europa.eu

1. Description of the issue

The emergency measures adopted in different countries to fight the COVID-19 outbreak, which often include severe travel restrictions, shutdowns of manufacturing facilities and teleworking of the concerned staff, are creating difficulties for some actors involved in the vehicle authorisation process to fulfil their legal duties and obligations. In particular:

Notified Bodies (NoBos) cannot perform the evaluations, audits, visits and inspections as planned, affecting the issuing and renewal of certificates

Applicants cannot obtain from suppliers the documentation that they need to build the file accompanying the application for authorisation (in particular, files accompanying the EC declarations of conformity and/or suitability for use for Interoperability Constituents (IC) )

This documentation needs to be included in the file accompanying the application for authorisation pursuant to Regulation (EU) 2018/545 in order to consider that an application is complete and to issue an authorisation.

2. Line to take

In view of the exceptional situation created by the COVID-19 outbreak, the Agency has decided, pending the possible adoption of EU temporary measures related to the acts governed by Regulation (EU) 2018/545, to adopt the following temporary measures when assessing applications for vehicle and/or vehicle type authorisation:

› When COVID-19 emergency measures are temporarily preventing the NoBos from carrying out planned assessments, visits, inspections, audits or any other on-site activity necessary to issue or renew a certificate.

On 27 march 2020, the European Commission’s directorate general GROW – Free movement of goods – issued a communication on the impact of COVID-19 on the activities of Notified Bodies. This communication provides for flexibility and specific guidance in reaction to the COVID crisis to NoBos when performing their tasks – particularly those activities requiring visits to manufacturers’ premises – and at the same time encourages NoBos to continue carrying out their tasks to the extent that is currently possible in respect of the different and varying confinement measures taken at Member States level.

DG GROW’s communication also makes reference to an EA communication on Corona virus dated 23 MARCH 2020 (https://european-accreditation.org/ea-communication-to-the-impact-of-the-covid-19-outbreak/).

Furthermore, the Mandatory Document IAF MD 4:2018, issued by the International Accreditation Forum (IAF), gives further details on the use of information and communication technologies (ICT) for auditing/assessment purposes. The Informative Document IAF ID 3:2011, issued by IAF as well, provides information on the different steps the NoBos could follow regarding the management of extraordinary events or circumstances1.

Recommendations are also published in the website of IAF, European Accreditation (EA) and International Laboratory Accreditation Cooperation (ILAC):

https://iaffaq.com/

https://european-accreditation.org/information-center/newsroom/news/

https://ilac.org/latest_ilac_news/

1 Informative Document IAF ID 3:2011 specifically covers activities related to surveillance audits, but similar principles can be followed for other NoBo

activities.


ERA1209/088 V1.0


In addition to this, NoBos shall apply as general guidance the recommendations for use (RFUs) and other administrative decisions and documents issued or updated by NB-Rail, including in relation to COVID-19 issues.

As concerns the renewal (surveillance or re-certification) of a certificate for the quality management system:

› It can be decided to postpone the audit for a limited period of time (not normally exceeding 6 months beyond the expiry date of the certificate), providing that the certified quality management system (QMS) is considered to be effective enough to ensure that the subsystems and/or Interoperability Constituents (ICs) manufactured during this period are conforming to the approved type and therefore meet the essential requirements.

› This is under the condition that NoBos produce evidence supporting its confidence about the effectiveness of the QMS for the manufacturing process to ensure that the manufactured subsystems/ICs will conform to the approved type during the extension and explaining the alternative assessment methods and the results of the assessments2. This can take the form of a new version of the certificate with extended time validity (including the file accompanying the certificate), a letter, a report, etc.

For the issuing of new certificates:

› It can be decided to perform the evaluation by means of alternative methods2, where possible, if mutually agreed by the parties involved (e.g. manufacturer, applicant, NoBo). This is a decision to be taken by NoBos.

› NoBos should identify and document the impact of the use of alternative methods on the evaluation activities, in particular the validity, representativeness and objectivity of the evaluations performed remotely.

› The outcomes of the evaluation activities shall indicate the extent to which the alternative methods have been used and their effectiveness in achieving the assessment objectives

› NoBos should produce evidence supporting its confidence that the object of assessment (be it a QMS, subsystem or an IC) meets the applicable requirements. This can take the form of a regular certificate (with the relevant supporting documentation), when there are no doubts about the fulfilment of the applicable requirements despite the alternative methods used, or another similar document, etc.

NoBos should act responsibly and assess and balance the risk when providing services in a more flexible manner. In particular, the NoBo should record deviations and not provide such services if the deviations jeopardize the technical validity of that specific activity.

The use of remote assessment should not put at risk the health and safety of products in the EU and the role that NoBos play in conformity assessment. NoBos are requested to inform the relevant authorities of any issues relating to possible non-conformity of products, including where this may be relevant due to the need to postpone specific on-site visits in the context of the conformity assessment activities.

The applicant should include the evidence produced by NoBos in the file accompanying the application (or as a response to an issue created by an assessor), explaining and documenting the deviations as compared to the normal regime, including any risk management undertaken to balance the limitation of the current situation.

2 Evidences could be off site reviews of documentation (such as design documents, drawings, calculation notes, technical specifications, test reports,

corrective action records, results of internal audits, test/inspection reports, minutes of relevant meetings, register of non-conformities etc.), remote interviews, access to the IT tools supporting the implementation of the QMS, etc


ERA1209/088 V1.0


The same principles may be applied, mutatis mutandis, to the evaluations to be performed by Designated Bodies (DeBos) and the evidence that DeBos should produce (e.g. certificate of verification for national rules).

› When COVID-19 emergency measures are delaying the process of notification of a NoBo for Directive (EU) 2016/797.

NoBos established in Member States not having transposed Directive (EU) 2016/797 (or the relevant provisions of the Directive, namely Articles 27 to 45 (with the exceptions of Articles 38, 40(1), 40(3), 40(4) and 43) will in principle not be able to carry out activities after 15 June 2020 as their notification under Directive 2008/57/EC will have expired and the MS in question cannot pursue a re-notification under the 4RP due to lack of transposition.

However, NoBos having already obtained the accreditation necessary under Directive (EU) 2016/797, including compliance with the ERA Assessment Scheme for NoBos3, can establish evidence equivalent to the content of an EC certificate (including the accompanying technical documentation). This is subject to all applicable requirements of Directive (EU) 2016/797 and of the ERA Assessment Scheme for NoBos having been fulfilled, and that the evidence is included in the file accompanying the application for authorisation.

› When COVID-19 emergency measures are temporarily preventing an applicant to gather all the necessary information from a supplier that is needed to build and submit the file accompanying the application for authorisation (e.g. files accompanying the certificates for ICs), or to answer issues raised by the assessors for an on-going application.

In this case, the applicant should produce evidence describing:

– the reasons for not providing all the required documents (including supporting evidence which should be related to COVID-19), and

– the details of the missing documents with regards to the mandatory content of the file accompanying the application for authorisation pursuant to Annex I of Regulation (EU) 2018/545 (see also the clarification note ERA1209/001).

For the cases described above, the Agency, when acting as an authorising entity, will analyse the alternative evidence provided. When this alternative evidence, together with the rest of required documentation, provides reasonable assurance that the applicant and the actors supporting the applicant have fulfilled their obligations and responsibilities despite the deviations imposed by the current exceptional circumstances, the Agency may include a time limit in the authorisation, pursuant to article 46(6)(a) of Regulation (EU) 2018/545.

The time limit will be decided on a case by case basis, taking into account the information provided by the applicant, and will normally not be longer than 6 months from the date of issuing of the authorisation.

It will be the responsibility of the applicant to provide as soon as possible the missing evidences and request the withdrawal of the time limit to the Agency, through the OSS (the applications in OSS will be kept open for this purpose). If the applicant cannot provide the missing documentation before the expiry of the time limited authorisation, a new timeframe may be agreed. In such case, the applicant should inform the Agency through the OSS.

This clarification note will be subject to any EU measure adopted by the Commission and will be revised or repealed accordingly.

3 Technical Document 000MRA1044 ver. 1.1


ERA1209/088 V1.0


3. Legal background

a) Regulation (EU) 2018/545

› Article 30(1). Application content and completeness

“For the application to be considered complete by the authorising entity and when relevant by the concerned NSAs for the area of use it shall contain the information set out in Annex I.”

› Article 31(1). The submission of the application through the one-stop shop

“The application for a vehicle type authorisation and/or a vehicle authorisation for placing on the market shall be formally submitted by the applicant through the single entry point of the one-stop shop referred to in Article 12 of Regulation (EU) 2016/796 and shall contain the information set out in Annex I.”

› Article 46(6). Decision for the authorisation or refusal of the application

“The authorisation decision shall not contain any time limited conditions for use of the vehicle and other restrictions, unless the following conditions are fulfilled:

(a) it is required because the conformity to the TSIs and/or national rules cannot be completely proven before the issuing of the authorisation; and/or

(b) the TSIs and/or national rules require that the applicant produces a plausible estimate of compliance.

The authorisation may then include a condition that real use demonstrates performance in line with the estimate within a specified period of time.”

b) International Accreditation Forum (IAF) Informative document for management of extraordinary events or circumstances affecting Accreditation Bodies (AB), Conformity Assessment Bodies (CAB) and certified organisations (IAF ID 3: 2011 issue 1)

› 2. Definition. 2.1 Extraordinary event or circumstance

“A circumstance beyond the control of the organization, commonly referred to as “Force Majeure” or “act of God”. Examples are war, strike, riot, political instability, geopolitical tension, terrorism, crime, pandemic, flooding, earthquake, malicious computer hacking, other natural or man-made disasters.”

› 3. Extraordinary event or circumstance affecting a certified organization

“An extraordinary event affecting a certified organization or CAB may temporarily prevent the CAB from carrying out planned audits on-site. When such a situation occurs, ABs and CABs, operating under recognised standards or regulatory documents need to establish (in consultation with certified organizations) a reasonable planned course of action.

The CAB should assess the risks of continuing certification and establish a documented policy and process, outlining the steps it will take in the event a certified organization is affected by an extraordinary event.

The established policy and process of the CAB should define methods for evaluating the current and expected future situation of the certified organization, and define alternate potential short-term methods of assessing the organization to verify continuing effectiveness of its management systems.

To enable the CAB to assess risk for continuing certification and understand the certified organization’s current and expected future situation, the CAB should gather necessary information


ERA1209/088 V1.0


from the certified organization before deciding on an appropriate course of action. The information collected by the CAB should include the following as appropriate:

When will the organization be able to function normally?

When will the organization be able to ship products or perform the service defined within the current scope of certification?

Will the organization need to use alternative manufacturing and/or distribution sites? If so, are these currently covered under the current certification or will they need to be evaluated?

Does existing inventory still meet customer specifications or will the certified organization contact its customers regarding possible concessions?

If the certified organization is certified to a management system standard that requires a disaster recovery plan or emergency response plan, has the certified organization implemented the plan and was it effective?

Will some of the processes and/or services performed or products shipped be subcontracted to other organizations? If so, how will the other organizations’ activities be controlled by the certified organization?

To what extent has operation of the management system been affected?

Has the Certified organization conducted an impact assessment?

Identification of alternative sampling sites, as appropriate.

If the risk of continuing certification is low, and based on the collected information the CAB may need to consider alternative short-term methods of assessment to verify continuing system effectiveness for the organization. This may include requesting relevant documentation (for example, management review meeting minutes, corrective action records, results of internal audits, test/inspection reports, etc.) to be reviewed off site by the CAB to determine continuing suitability of the certification (on a short-term basis only). At a minimum, the process should address the following items:

Proactive communication between the affected certified organization and the CAB.

Steps the CAB will take to assess the affected organization and how the plan to move forward will be communicated.

Specifying the maximum time an alternative short-term assessment method could be used before suspension or withdrawal of certification

Criteria for renewing normal oversight, including the method and timing of any reinstatement activities and assessments.

Possible amendments to organization’s oversight plans on a case-by-case basis and in accordance with CAB procedures.

Ensuring that any deviation from accreditation requirements and CAB procedures is justified and documented, and agreement reached with the AB on plans to address temporary deviations from requirements.

Re-establishment of surveillance/recertification activities according to CAB oversight plans when access to the affected location is re-established.

If contact with the organization cannot be made, the CAB should follow normal processes and procedures for suspension and withdrawal of certification.

When developing alternate short-term methods of assessment the CAB should take into consideration the following limitations:


ERA1209/088 V1.0


a) First Surveillance Audit

Normally, the first surveillance audit after initial certification is to be within 12 months of the last day of the initial stage 2 audit (ISO/IEC 17021:2011, 9.3.2.2).

However, providing that sufficient evidence has been collected as above, to provide confidence that the certified management system is effective consideration may be given to postpone the first surveillance for a period not normally exceeding 6 months (18 months from date of initial certification).

Otherwise the certificate has to be suspended or the scope reduced.

b) Subsequent Surveillance Audits

There may be specific circumstances by which a CAB can justify adjusting the timing of a subsequent surveillance audit. If an organization has to shut down completely for a limited period of time (less than 6 months), it would be reasonable for a CAB to postpone an audit that had been scheduled to occur during the shutdown until the organization resumes operations. The organization should inform the CAB when operations resume so that the CAB can conduct the audit promptly.

c) Recertification Audits

Normally the recertification audit must be completed and the recertification decision made prior to expiration to avoid loss of certification (ISO/IEC 17021:2011, 9.1.1.2). However, providing that sufficient evidence has been collected as above, to provide confidence that the certified management system is effective consideration may be given to extend the certification for a period not normally exceeding 6 month beyond the original expiry date.

The re-certification should be carried out within this permissible extended period. Otherwise, a new initial audit should be performed. The expiration of the renewed certification should be based on the original recertification cycle.

d) Information to the AB

All deviations from the established certification program should be justified, documented and made available to ABs upon request.“

c) International Accreditation Forum (IAF) Mandatory document for the use of information and communication technology (ICT) for auditing/assessment purposes (IAF MD 4: 2018 issue 2)

› 0. Introduction

“0.1 As information and communication technology (ICT) becomes more sophisticated, it is important to be able to use ICT to optimize audit/assessment effectiveness and efficiency, and to support and maintain the integrity of the audit/assessment process.

0.2 ICT is the use of technology for gathering, storing, retrieving, processing, analysing and transmitting information. It includes software and hardware such as smartphones, handheld devices, laptop computers, desktop computers, drones, video cameras, wearable technology, artificial intelligence, and others. The use of ICT may be appropriate for auditing/assessment both locally and remotely.

0.3 Examples of the use of ICT during audits/assessments may include but are not limited to:

• Meetings; by means of teleconference facilities, including audio, video and data sharing

• Audit/assessment of documents and records by means of remote access, either synchronously (in real time) or asynchronously (when applicable)

• Recording of information and evidence by means of still video, video or audio recordings


ERA1209/088 V1.0


• Providing visual/audio access to remote or potentially hazardous locations

0.4 The objectives for the effective application of ICT for audit/assessment purposes are: i. To provide a methodology for the use of ICT that is sufficiently flexible and non-prescriptive

in nature to optimize the conventional audit/assessment process

ii. To ensure that adequate controls are in place to avoid abuses that could compromise the integrity of the audit/assessment process

iii. To support the principles of safety and sustainability

Measures shall also be taken to ensure that security and confidentiality is maintained throughout audit/assessment activities.

0.5 Other schemes, normative documents and conformity assessment standards may impose limitations on the use of ICT for audit/assessment and may take precedence over this document. ”

› 4. Requirements. 4.1 Security and Confidentiality

“4.1.1 The security and confidentiality of electronic or electronically-transmitted information is particularly important when using ICT for audit/assessment purposes.

4.1.2 The use of ICT for audit/assessment purposes shall be mutually agreed upon by the body being audited/assessed and the body performing the audit/assessment in accordance with information security and data protection measures and regulations before ICT is used for audit/assessment purposes.

4.1.3 In the case of non-fulfilment of these measures or non-agreement of information security and data protection measures, the body performing the audit/assessment activities shall use other methods to conduct the audit/assessment.

4.1.4 When no agreement is reached for the use of ICT for audit/assessment, other methods shall be used to fulfil audit/assessment objectives.”

› 4. Requirements. 4.2 Process Requirements

4.2.1 The body shall identify and document the risks and opportunities that may impact audit/assessment effectiveness for each use of ICT under the same conditions, including the selection of the technologies, and how they are managed.

4.2.2 When ICT is proposed for the audit/assessment activities, the application review shall include a check that the client and the audit/assessment body have the necessary infrastructure to support the use of the ICT proposed.

4.2.3 Considering the risks and opportunities identified in 4.2.1, the audit/assessment plan shall identify how ICT will be utilized and the extent to which ICT will be used for audit/assessment purposes to optimize audit/assessment effectiveness and efficiency while maintaining the integrity of the audit/assessment process.

4.2.4 When using ICT, auditors/assessors and other involved persons (e.g. drone pilots, technical experts) shall have the competency and ability to understand and utilize the information and communication technologies employed to achieve the desired results of audit(s)/assessment(s). The auditor/assessor shall also be aware of the risks and opportunities of the information and communication technologies used and the impacts that they may have on the validity and objectivity of the information gathered.

4.2.5 If ICT is used for audit/assessment purposes, it contributes to the total audit/assessment time as additional planning may be necessary which may impact audit/assessment duration


ERA1209/088 V1.0


4.2.6 Audit/assessment reports and related records shall indicate the extent to which ICT has been used in carrying out audit/assessment and the effectiveness of ICT in achieving the audit/assessment objectives.

4.2.7 If virtual sites are included within the scope, the certification/accreditation documentation shall note that virtual sites are included and the activities performed at the virtual sites shall be identified.

d) European Accreditation (EA) communication to EA members and accredited conformity assessment bodies regarding the outbreak of COVID-19, 23.03.2020

“[…]

Under these circumstances although not all the applicable standards foresee the use of remote assessment techniques, including document reviews, and recognizing that these assessment techniques may not always enable exactly the same objective to be achieved as on-site assessments, EA suggests the use of these techniques whenever needed to substitute or complement on-site assessments.

Nevertheless EA recognises that, in certain circumstances, accredited CABs and NABs will have to take difficult decisions that could include stopping the provision of certain services or temporarily deviating, in order to be able to provide the services, from certain requirements included in the standards or in the accreditation rules.

When facing these situations, both EA members and accredited CABs are required to act responsibly, to analyse the risk of providing services with deviations from the requirements and not to provide them if such deviations jeopardize the technical validity of that specific activity. EA also expects EA NABs and accredited CABs to act with full transparency, informing affected clients of any change in the procedures and keeping records justifying the decisions taken.

[…]”

From: [email protected] Sent: Friday, 27 March 2020 11:07 To: Undisclosed recipients Topic: Impact of COVID-19 on NBs work Attachments: EA communication Coronavirus 23March2020.pdf Dear Notifying Authorities, dear Chairs of Notified Bodies Groups, dear colleagues, In the context of the current COVID-19 outbreak, we understand that the activities of notified bodies may be affected, in particular insofar as this requires performing visits to manufacturers premises. Due to the exceptional circumstances we are facing, some of you have been asking us whether we should provide for flexibility and specific guidance on this issue. We believe that notified bodies should continue to carry out their tasks to the extent that this is current-ly possible in view of the confinement measures taken at Member States level. Notified bodies are en-couraged to perform remote assessment techniques, including document reviews, as far as possible to substitute or complement on-site assessments. However, remote or virtual assessments will not always provide a substitute to on-site visits which are required by notified bodies under specific modules. When faced with such situations, Notified Bodies are required to act responsibly, to analyse the risk of provid-ing services with deviations from the requirements and not to provide them if such deviations jeopard-ize the technical validity of that specific activity. Notified Bodies should also act with full transparency, informing affected clients of any change in the procedures and keeping records justifying the decisions taken. These arrangements should however not put at risk the health and safety of products in the EU and the role that Notified Bodies play in conformity assessment. Notified Bodies are requested to inform the relevant authorities of any relevant issues relating to possible non-conformity of products, including where this may be relevant due to the need to postpone specific on-site visits in the context of the con-formity assessment activities. For information, please find attached the communication that EA has distributed to its members on this same issue. Kind regards,

European Commission DG for Internal Market, Industry, Entrepreneurship and SMEs Goods in the Single Market and Enforcement Unit B1 Free movement of goods

Follow us on Facebook: EU Growth Twitter: @EU_Growth Our Websites: ec.europa.eu/growth

http://www.facebook.com/EU.growth

http://twitter.com/EU_growth

http://ec.europa.eu/growth/index_en.htm

23 March 2020

EA communication to EA members and accredited conformity assessment bodies regarding the outbreak of COVID-19

Due to the outbreak of the coronavirus disease 2019 (COVID-19) and the subsequent travel restrictions established by national governments in the vast majority of countries both conformity assessment and accreditation activities have been seriously affected in different ways. In particular, conformity assessment bodies (CABs) and national accreditation bodies (NABs) are being forced to cancel or postpone most of their “in situ” activities such as on-site assessments, audits, witnessing visits and inspections and they will have to face the situation of only being able to provide their services with a workforce that that is now mostly working remotely. This will affect the service provided and also lead to a possible temporary lack of access to certain supplies or services normally subcontracted by the CABs.



When facing these situations, both EA members and accredited CABs are required to act responsibly, to analyse the risk of providing services with deviations from the requirements and not to provide them if such deviations jeopardize the technical validity of that specific activity. EA also expects EA NABs and accredited CABs to act with full transparency, informing affected clients of any change in the procedures and keeping records justifying the decisions taken.

Accreditation is an international activity so we recommend both NABs and accredited CABs to visit the ILAC and IAF websites where they can find useful information regarding aspects of global impact. This information also contains valuable information regarding required transition periods like the transition of laboratories to ISO/IEC 17025:2017.

For activities performed in the regulatory field or under a specific scheme CABs must seek information from scheme owners or relevant competent authorities on how they expect related conformity assessment activities should be handled under these circumstances.

As the situation is constantly changing and different countries are establishing different measures to adapt to it, accredited CABs should contact their NAB for further details or questions.

EA will closely follow the development of the coronavirus crisis in order to take any further action when needed and will publish more specific advice and relevant information.

Further information from IAF: https://iaffaq.com/

Further information from ILAC: https://ilac.org/latest_ilac_news/potential-impact-of-coronavirus-outbreak-on-accreditation-activities/

https://iaffaq.com/

https://ilac.org/latest_ilac_news/potential-impact-of-coronavirus-outbreak-on-accreditation-activities/

https://ilac.org/latest_ilac_news/potential-impact-of-coronavirus-outbreak-on-accreditation-activities/

From: [email protected] Sent: Monday, April 27, 2020 11:53 AM To: Undisclosed recipients Subject: Validity of NB certificates Dear Notifying Authorities, dear Chairs of Notified Bodies Groups, dear Chairs of Administrative Cooper-ation groups, dear colleagues,

In the context of the current COVID-19 outbreak, we understand that the activities of notified bodies may be affected. Due to the exceptional circumstances we are facing, we already provided for certain flexibility and specific guidance on this issue, in particular where the difficulty to currently perform visits to manufacturers’ premises affected the conformity assessment activities. We understand that the current exceptional circumstances may also delay the renewal of existing certif-icates issued by Notified Bodies and due to expire in the coming days. It may be that Notified Bodies are not in a position to carry out all the necessary tests and activities to deliver the new certificates. To the extent that Notified Bodies cannot carry out their tasks in view of the confinement measures taken at Member States level, Notified Bodies could exceptionally extend the validity of such certificates about to expire for a maximum period of 6 months. Certain pieces of Union harmonization legislation set a specif-ic duration for such certificates, such as 5 or 10 years. In those cases the Notified Body can envisage to issue a new temporary certificate of maximum 6 months for the same product or model, based on the examination done for the current certificate. As mentioned in our previous email, Notified Bodies are encouraged to continue to carry out their tasks as far as possible. Notified Bodies are required to act responsibly when analysing the situations where certificates may have to be extended beyond their foreseen period of validity. Notified Bodies should also act with full transparency, informing affected clients of any change in the procedures and keeping records justifying the decisions taken. We would like to recall that these flexibility arrangements should however not put at risk the health and safety of persons or other aspects of public interest protection in the EU by affecting the conformity of the products concerned to the relevant EU harmonisation legislation, and in particular the role that No-tified Bodies play in conformity assessment to that legislation. Notified Bodies are requested to inform the relevant authorities of any relevant issues relating to possible non-conformity of products, including where such certificates may need to be exceptionally extended for a limited time period as described above. Kind regards,

European Commission DG for Internal Market, Industry, Entrepreneurship and SMEs Goods in the Single Market and Enforcement Unit B1 Free movement of goods

Follow us on

Facebook: EU Growth Twitter: @EU_Growth Our Websites: ec.europa.eu/growth

http://www.facebook.com/EU.growth

http://twitter.com/EU_growth

http://ec.europa.eu/growth/index_en.htm

Clarification noteTemporary measures during COVID-19 pandemic

ERA1209/088 V1.1

Making the railway system work better for society.

120 Rue Marc Lefrancq | BP 20392 | FR-59307 Valenciennes Cedex 1 / 6 Tel. +33 (0)327 09 65 00 | era.europa.eu

Clarification note

Temporary measures adopted by the European Union Agency for Railways for delivering authorisations in the framework of the restrictions related to the COVID-19 pandemic

Drafted by Validated by Approved by

Name DEL RIO Eduardo BREYNE Thierry DOPPELBAUER Josef

Position Project officer Head of PAD unit Executive Director

Date 05/05/2020 05/05/2020 05/05/2020

Signature

Document History

Version Date Comments

1.0 03/04/2020 Initial version

1.1 05/05/2020 Update to take into account DG GROW note on extension of EC certificates

The purpose of this document is to provide applicants and other external stakeholders of the vehicle authorisation business with information in regards to the specific topic referenced in the title. The clarifications contained in this document may be integrated in the next revision of the guidelines for the practical arrangements for the vehicle authorisation process, without prejudice of the formal process foreseen for updating the guideline.

The present document is a non-legally binding guidance of the European Union Agency for Railways. It is without prejudice to the decision-making processes foreseen by the applicable EU legislation. Furthermore, a binding

interpretation of EU law is the sole competence of the Court of Justice of the European Union.


ERA1209/088 V1.1


1. Description of the issue

The emergency measures adopted in different countries to fight the COVID-19 outbreak, which often include severe travel restrictions, shutdowns of manufacturing facilities and teleworking of the concerned staff, are creating difficulties for some actors involved in the vehicle authorisation process to fulfil their legal duties and obligations. In particular:

Notified Bodies (NoBos) cannot perform the evaluations, audits, visits and inspections as planned, affecting the issuing and renewal of certificates

Applicants cannot obtain from suppliers the documentation that they need to build the file accompanying the application for authorisation (in particular, files accompanying the EC declarations of conformity and/or suitability for use for Interoperability Constituents (IC) )

This documentation needs to be included in the file accompanying the application for authorisation pursuant to Regulation (EU) 2018/545 in order to consider that an application is complete and to issue an authorisation.

On the other hand, projects including the placing on the market of railway vehicles conforming to the LOC&PAS TSI 2011 (and related NOI, PRM and SRT TSIs) may have suffered delays in the manufacturing and/or authorisation process caused by emergency measures to fight the COVID-19 outbreak. Due to this delay, the EC type or design examination certificate of the vehicle type may expire before the last vehicles of that project are authorised in conformity to the type. This would require:

The issuing of a new certificate according to LOC&PAS TSI 2014 which will probably require modifications of the type to meet the new requirements, new conformity assessments, a new authorisation of the changed type etc., or

The application of Article 7 of Directive (EU) 2016/797 for requesting the non-application of the LOC&PAS TSI 2014

In both cases, the impacted projects would suffer further delays and economic impact as compared to a situation where the COVID-19 outbreak would not have occurred.

2. Line to take

2.1. Temporary measures when assessing applications for authorisation

In view of the exceptional situation created by the COVID-19 outbreak, the Agency has decided, pending the possible adoption of EU temporary measures related to the acts governed by Regulation (EU) 2018/545, to adopt the following temporary measures when assessing applications for vehicle and/or vehicle type authorisation:

› When COVID-19 emergency measures are temporarily preventing the NoBos from carrying out planned assessments, visits, inspections, audits or any other on-site activity necessary to issue or renew a certificate.

On 27 march 2020, the European Commission’s directorate general GROW – Free movement of goods – issued a communication on the impact of COVID-19 on the activities of Notified Bodies. This communication provides for flexibility and specific guidance in reaction to the COVID crisis to NoBos when performing their tasks – particularly those activities requiring visits to manufacturers’ premises – and at the same time encourages NoBos to continue carrying out their tasks to the extent that is currently possible in respect of the different and varying confinement measures taken at Member States level.

DG GROW’s communication also makes reference to an EA communication on Corona virus dated 23 MARCH 2020 (https://european-accreditation.org/ea-communication-to-the-impact-of-the-covid-19-outbreak/).


ERA1209/088 V1.1


Furthermore, the Mandatory Document IAF MD 4:2018, issued by the International Accreditation Forum (IAF), gives further details on the use of information and communication technologies (ICT) for auditing/assessment purposes. The Informative Document IAF ID 3:2011, issued by IAF as well, provides information on the different steps the NoBos could follow regarding the management of extraordinary events or circumstances1.

Recommendations are also published in the website of IAF, European Accreditation (EA) and International Laboratory Accreditation Cooperation (ILAC):

https://iaffaq.com/

https://european-accreditation.org/information-center/newsroom/news/

https://ilac.org/latest_ilac_news/

In addition to this, NoBos shall apply as general guidance the recommendations for use (RFUs) and other administrative decisions and documents issued or updated by NB-Rail, including in relation to COVID-19 issues.

As concerns the renewal (surveillance or re-certification) of a certificate for the quality management system:

› It can be decided to postpone the audit for a limited period of time (not normally exceeding 6 months beyond the expiry date of the certificate), providing that the certified quality management system (QMS) is considered to be effective enough to ensure that the subsystems and/or Interoperability Constituents (ICs) manufactured during this period are conforming to the approved type and therefore meet the essential requirements.

› This is under the condition that NoBos produce evidence supporting its confidence about the effectiveness of the QMS for the manufacturing process to ensure that the manufactured subsystems/ICs will conform to the approved type during the extension and explaining the alternative assessment methods and the results of the assessments2. This can take the form of a new version of the certificate with extended time validity (including the file accompanying the certificate), a letter, a report, etc.

For the issuing of new certificates:

› It can be decided to perform the evaluation by means of alternative methods2, where possible, if mutually agreed by the parties involved (e.g. manufacturer, applicant, NoBo). This is a decision to be taken by NoBos.

› NoBos should identify and document the impact of the use of alternative methods on the evaluation activities, in particular the validity, representativeness and objectivity of the evaluations performed remotely.

› The outcomes of the evaluation activities shall indicate the extent to which the alternative methods have been used and their effectiveness in achieving the assessment objectives

› NoBos should produce evidence supporting its confidence that the object of assessment (be it a QMS, subsystem or an IC) meets the applicable requirements. This can take the form of a regular certificate (with the relevant supporting documentation), when there are no doubts

1 Informative Document IAF ID 3:2011 specifically covers activities related to surveillance audits, but similar principles can be followed for other NoBo

activities. 2 Evidences could be off site reviews of documentation (such as design documents, drawings, calculation notes, technical specifications, test reports,

corrective action records, results of internal audits, test/inspection reports, minutes of relevant meetings, register of non-conformities etc.), remote interviews, access to the IT tools supporting the implementation of the QMS, etc


ERA1209/088 V1.1


about the fulfilment of the applicable requirements despite the alternative methods used, or another similar document, etc.

NoBos should act responsibly and assess and balance the risk when providing services in a more flexible manner. In particular, the NoBo should record deviations and not provide such services if the deviations jeopardize the technical validity of that specific activity.

The use of remote assessment should not put at risk the health and safety of products in the EU and the role that NoBos play in conformity assessment. NoBos are requested to inform the relevant authorities of any issues relating to possible non-conformity of products, including where this may be relevant due to the need to postpone specific on-site visits in the context of the conformity assessment activities.

The applicant should include the evidence produced by NoBos in the file accompanying the application (or as a response to an issue created by an assessor), explaining and documenting the deviations as compared to the normal regime, including any risk management undertaken to balance the limitation of the current situation. The same principles may be applied, mutatis mutandis, to the evaluations to be performed by Designated Bodies (DeBos) and the evidence that DeBos should produce (e.g. certificate of verification for national rules).

› When COVID-19 emergency measures are delaying the process of notification of a NoBo for Directive (EU) 2016/797.

NoBos established in Member States not having transposed Directive (EU) 2016/797 (or the relevant provisions of the Directive, namely Articles 27 to 45 (with the exceptions of Articles 38, 40(1), 40(3), 40(4) and 43) will in principle not be able to carry out activities after 15 June 2020 as their notification under Directive 2008/57/EC will have expired and the MS in question cannot pursue a re-notification under the 4RP due to lack of transposition.

However, NoBos having already obtained the accreditation necessary under Directive (EU) 2016/797, including compliance with the ERA Assessment Scheme for NoBos3, can establish evidence equivalent to the content of an EC certificate (including the accompanying technical documentation). This is subject to all applicable requirements of Directive (EU) 2016/797 and of the ERA Assessment Scheme for NoBos having been fulfilled, and that the evidence is included in the file accompanying the application for authorisation.

› When COVID-19 emergency measures are temporarily preventing an applicant to gather all the necessary information from a supplier that is needed to build and submit the file accompanying the application for authorisation (e.g. files accompanying the certificates for ICs), or to answer issues raised by the assessors for an on-going application.

In this case, the applicant should produce evidence describing:

– the reasons for not providing all the required documents (including supporting evidence which should be related to COVID-19), and

– the details of the missing documents with regards to the mandatory content of the file accompanying the application for authorisation pursuant to Annex I of Regulation (EU) 2018/545 (see also the clarification note ERA1209/001).

For the cases described above, the Agency, when acting as an authorising entity, will analyse the alternative evidence provided. When this alternative evidence, together with the rest of required documentation, provides reasonable assurance that the applicant and the actors supporting the applicant have fulfilled their

3 Technical Document 000MRA1044 ver. 1.1


ERA1209/088 V1.1


obligations and responsibilities despite the deviations imposed by the current exceptional circumstances, the Agency may include a time limit in the authorisation, pursuant to article 46(6)(a) of Regulation (EU) 2018/545.

The time limit will be decided on a case by case basis, taking into account the information provided by the applicant, and will normally not be longer than 6 months from the date of issuing of the authorisation.

It will be the responsibility of the applicant to provide as soon as possible the missing evidences and request the withdrawal of the time limit to the Agency, through the OSS (the applications in OSS will be kept open for this purpose). If the applicant cannot provide the missing documentation before the expiry of the time limited authorisation, a new timeframe may be agreed. In such case, the applicant should inform the Agency through the OSS.

This clarification note will be subject to any EU measure adopted by the Commission and will be revised or repealed accordingly.

2.2. Extension of the validity of EC type or design examination certificates

Following the note issued by DG GROW regarding the validity of EC certificates issued by notified bodies (NoBos), and after coordination with DG MOVE and NB-Rail regarding the application of the note by DG GROW to railway NoBos, the Agency, when assessing applications for placing on the market of vehicles in conformity to an authorised type, will consider deemed granted an extension by 6 months of the validity of the Phase B (as defined in section 7.1.3.1 of both LOC&PAS TSI 2011 and 2014) for EC type or design examination certificates.

This will apply only for vehicle types conforming to LOC&PAS TSI 2011 when the applicant can prove that the emergency measures following the COVID-19 outbreak caused a delay that prevented the placing on the market of the last vehicles of the project within the validity period of the EC type or design examination certificate.

For certificates of conformity and/or suitability for use of Interoperability Constituents (ICs), please see ERA Technical Opinion ERA/OPI/2016-03 “Revised opinion of the European Union Agency for Railways for European Commission regarding question of NB-Rail QC-STR-009 concerning the certification according to withdrawn TSIs”: it is possible that ICs are certified against a withdrawn TSI where this is necessary to match the TSI to which the subsystem is conforming with.

3. Legal background

3.1. Regulation (EU) 2018/545

› Article 30(1). Application content and completeness

“For the application to be considered complete by the authorising entity and when relevant by the concerned NSAs for the area of use it shall contain the information set out in Annex I.”

› Article 31(1). The submission of the application through the one-stop shop

“The application for a vehicle type authorisation and/or a vehicle authorisation for placing on the market shall be formally submitted by the applicant through the single entry point of the one-stop shop referred to in Article 12 of Regulation (EU) 2016/796 and shall contain the information set out in Annex I.”

› Article 46(6). Decision for the authorisation or refusal of the application

“The authorisation decision shall not contain any time limited conditions for use of the vehicle and other restrictions, unless the following conditions are fulfilled:

(a) it is required because the conformity to the TSIs and/or national rules cannot be completely proven before the issuing of the authorisation; and/or


ERA1209/088 V1.1


(b) the TSIs and/or national rules require that the applicant produces a plausible estimate of compliance.

The authorisation may then include a condition that real use demonstrates performance in line with the estimate within a specified period of time.”

3.2. International Accreditation Forum (IAF) Informative document for management of extraordinary events or circumstances affecting Accreditation Bodies (AB), Conformity Assessment Bodies (CAB) and certified organisations (IAF ID 3: 2011 issue 1)

› 2. Definition. 2.1 Extraordinary event or circumstance

“A circumstance beyond the control of the organization, commonly referred to as “Force Majeure” or “act of God”. Examples are war, strike, riot, political instability, geopolitical tension, terrorism, crime, pandemic, flooding, earthquake, malicious computer hacking, other natural or man-made disasters.”

› 3. Extraordinary event or circumstance affecting a certified organization

“An extraordinary event affecting a certified organization or CAB may temporarily prevent the CAB from carrying out planned audits on-site. When such a situation occurs, ABs and CABs, operating under recognised standards or regulatory documents need to establish (in consultation with certified organizations) a reasonable planned course of action.

The CAB should assess the risks of continuing certification and establish a documented policy and process, outlining the steps it will take in the event a certified organization is affected by an extraordinary event.

The established policy and process of the CAB should define methods for evaluating the current and expected future situation of the certified organization, and define alternate potential short-term methods of assessing the organization to verify continuing effectiveness of its management systems.

To enable the CAB to assess risk for continuing certification and understand the certified organization’s current and expected future situation, the CAB should gather necessary information from the certified organization before deciding on an appropriate course of action. The information collected by the CAB should include the following as appropriate:

When will the organization be able to function normally?

When will the organization be able to ship products or perform the service defined within the current scope of certification?

Will the organization need to use alternative manufacturing and/or distribution sites? If so, are these currently covered under the current certification or will they need to be evaluated?

Does existing inventory still meet customer specifications or will the certified organization contact its customers regarding possible concessions?

If the certified organization is certified to a management system standard that requires a disaster recovery plan or emergency response plan, has the certified organization implemented the plan and was it effective?

Will some of the processes and/or services performed or products shipped be subcontracted to other organizations? If so, how will the other organizations’ activities be controlled by the certified organization?

To what extent has operation of the management system been affected?

Has the Certified organization conducted an impact assessment?

Identification of alternative sampling sites, as appropriate.


ERA1209/088 V1.1


If the risk of continuing certification is low, and based on the collected information the CAB may need to consider alternative short-term methods of assessment to verify continuing system effectiveness for the organization. This may include requesting relevant documentation (for example, management review meeting minutes, corrective action records, results of internal audits, test/inspection reports, etc.) to be reviewed off site by the CAB to determine continuing suitability of the certification (on a short-term basis only). At a minimum, the process should address the following items:

Proactive communication between the affected certified organization and the CAB.

Steps the CAB will take to assess the affected organization and how the plan to move forward will be communicated.

Specifying the maximum time an alternative short-term assessment method could be used before suspension or withdrawal of certification

Criteria for renewing normal oversight, including the method and timing of any reinstatement activities and assessments.

Possible amendments to organization’s oversight plans on a case-by-case basis and in accordance with CAB procedures.

Ensuring that any deviation from accreditation requirements and CAB procedures is justified and documented, and agreement reached with the AB on plans to address temporary deviations from requirements.

Re-establishment of surveillance/recertification activities according to CAB oversight plans when access to the affected location is re-established.

If contact with the organization cannot be made, the CAB should follow normal processes and procedures for suspension and withdrawal of certification.

When developing alternate short-term methods of assessment the CAB should take into consideration the following limitations:

a) First Surveillance Audit

Normally, the first surveillance audit after initial certification is to be within 12 months of the last day of the initial stage 2 audit (ISO/IEC 17021:2011, 9.3.2.2).

However, providing that sufficient evidence has been collected as above, to provide confidence that the certified management system is effective consideration may be given to postpone the first surveillance for a period not normally exceeding 6 months (18 months from date of initial certification).

Otherwise the certificate has to be suspended or the scope reduced.

b) Subsequent Surveillance Audits

There may be specific circumstances by which a CAB can justify adjusting the timing of a subsequent surveillance audit. If an organization has to shut down completely for a limited period of time (less than 6 months), it would be reasonable for a CAB to postpone an audit that had been scheduled to occur during the shutdown until the organization resumes operations. The organization should inform the CAB when operations resume so that the CAB can conduct the audit promptly.

c) Recertification Audits

Normally the recertification audit must be completed and the recertification decision made prior to expiration to avoid loss of certification (ISO/IEC 17021:2011, 9.1.1.2). However, providing that sufficient evidence has been collected as above, to provide confidence that the


ERA1209/088 V1.1


certified management system is effective consideration may be given to extend the certification for a period not normally exceeding 6 month beyond the original expiry date.

The re-certification should be carried out within this permissible extended period. Otherwise, a new initial audit should be performed. The expiration of the renewed certification should be based on the original recertification cycle.

d) Information to the AB

All deviations from the established certification program should be justified, documented and made available to ABs upon request.“

3.3. International Accreditation Forum (IAF) Mandatory document for the use of information and communication technology (ICT) for auditing/assessment purposes (IAF MD 4: 2018 issue 2)

› 0. Introduction

“0.1 As information and communication technology (ICT) becomes more sophisticated, it is important to be able to use ICT to optimize audit/assessment effectiveness and efficiency, and to support and maintain the integrity of the audit/assessment process.

0.2 ICT is the use of technology for gathering, storing, retrieving, processing, analysing and transmitting information. It includes software and hardware such as smartphones, handheld devices, laptop computers, desktop computers, drones, video cameras, wearable technology, artificial intelligence, and others. The use of ICT may be appropriate for auditing/assessment both locally and remotely.

0.3 Examples of the use of ICT during audits/assessments may include but are not limited to:

• Meetings; by means of teleconference facilities, including audio, video and data sharing

• Audit/assessment of documents and records by means of remote access, either synchronously (in real time) or asynchronously (when applicable)

• Recording of information and evidence by means of still video, video or audio recordings

• Providing visual/audio access to remote or potentially hazardous locations

0.4 The objectives for the effective application of ICT for audit/assessment purposes are: i. To provide a methodology for the use of ICT that is sufficiently flexible and non-prescriptive

in nature to optimize the conventional audit/assessment process

ii. To ensure that adequate controls are in place to avoid abuses that could compromise the integrity of the audit/assessment process

iii. To support the principles of safety and sustainability

Measures shall also be taken to ensure that security and confidentiality is maintained throughout audit/assessment activities.

0.5 Other schemes, normative documents and conformity assessment standards may impose limitations on the use of ICT for audit/assessment and may take precedence over this document. ”

› 4. Requirements. 4.1 Security and Confidentiality

“4.1.1 The security and confidentiality of electronic or electronically-transmitted information is particularly important when using ICT for audit/assessment purposes.

4.1.2 The use of ICT for audit/assessment purposes shall be mutually agreed upon by the body being audited/assessed and the body performing the audit/assessment in accordance with information security and data protection measures and regulations before ICT is used for audit/assessment purposes.


ERA1209/088 V1.1


4.1.3 In the case of non-fulfilment of these measures or non-agreement of information security and data protection measures, the body performing the audit/assessment activities shall use other methods to conduct the audit/assessment.

4.1.4 When no agreement is reached for the use of ICT for audit/assessment, other methods shall be used to fulfil audit/assessment objectives.”

› 4. Requirements. 4.2 Process Requirements

4.2.1 The body shall identify and document the risks and opportunities that may impact audit/assessment effectiveness for each use of ICT under the same conditions, including the selection of the technologies, and how they are managed.

4.2.2 When ICT is proposed for the audit/assessment activities, the application review shall include a check that the client and the audit/assessment body have the necessary infrastructure to support the use of the ICT proposed.

4.2.3 Considering the risks and opportunities identified in 4.2.1, the audit/assessment plan shall identify how ICT will be utilized and the extent to which ICT will be used for audit/assessment purposes to optimize audit/assessment effectiveness and efficiency while maintaining the integrity of the audit/assessment process.

4.2.4 When using ICT, auditors/assessors and other involved persons (e.g. drone pilots, technical experts) shall have the competency and ability to understand and utilize the information and communication technologies employed to achieve the desired results of audit(s)/assessment(s). The auditor/assessor shall also be aware of the risks and opportunities of the information and communication technologies used and the impacts that they may have on the validity and objectivity of the information gathered.

4.2.5 If ICT is used for audit/assessment purposes, it contributes to the total audit/assessment time as additional planning may be necessary which may impact audit/assessment duration

4.2.6 Audit/assessment reports and related records shall indicate the extent to which ICT has been used in carrying out audit/assessment and the effectiveness of ICT in achieving the audit/assessment objectives.

4.2.7 If virtual sites are included within the scope, the certification/accreditation documentation shall note that virtual sites are included and the activities performed at the virtual sites shall be identified.

3.4. European Accreditation (EA) communication to EA members and accredited conformity assessment bodies regarding the outbreak of COVID-19, 23.03.2020

“[…]



When facing these situations, both EA members and accredited CABs are required to act responsibly, to analyse the risk of providing services with deviations from the requirements and not to provide them if such deviations jeopardize the technical validity of that specific activity. EA also expects EA NABs and


ERA1209/088 V1.1


accredited CABs to act with full transparency, informing affected clients of any change in the procedures and keeping records justifying the decisions taken.

[…]”

3.5. DG GROW communication to Notifying Authorities and Notified Bodies regarding the “Impact of COVID-19 on NBs work”, 27/03/2020

“[…]

In the context of the current COVID-19 outbreak, we understand that the activities of notified bodies may be affected, in particular insofar as this requires performing visits to manufacturers premises. Due to the exceptional circumstances we are facing, some of you have been asking us whether we should provide for flexibility and specific guidance on this issue.

We believe that notified bodies should continue to carry out their tasks to the extent that this is currently possible in view of the confinement measures taken at Member States level. Notified bodies are encouraged to perform remote assessment techniques, including document reviews, as far as possible to substitute or complement on-site assessments. However, remote or virtual assessments will not always provide a substitute to on-site visits which are required by notified bodies under specific modules. When faced with such situations, Notified Bodies are required to act responsibly, to analyse the risk of providing services with deviations from the requirements and not to provide them if such deviations jeopardize the technical validity of that specific activity. Notified Bodies should also act with full transparency, informing affected clients of any change in the procedures and keeping records justifying the decisions taken.

These arrangements should however not put at risk the health and safety of products in the EU and the role that Notified Bodies play in conformity assessment. Notified Bodies are requested to inform the relevant authorities of any relevant issues relating to possible non-conformity of products, including where this may be relevant due to the need to postpone specific on-site visits in the context of the conformity assessment activities.

For information, please find attached the communication that EA has distributed to its members on this same issue.

[…]”

3.6. DG MOVE communication to Notifying Authorities, RISC members and 4thRP Experts Group. Ares(2020)1942274 - Impact of COVID-19 on Vehicle Authorisation and NoBos work under Directive (EU) 2016/797, 06/04/2020

“[…]

The current COVID-19 outbreak affects the activities of many of us, including activities related to vehicle authorisations and certification activities of notified bodies (NoBos). In this context, some of you have been asking us whether we should provide for flexibility and specific guidance on these issues.

You will find below the note that our colleagues from DG GROW sent on 27 March 2020 to your Notifying Authorities regarding possible arrangements allowing NoBos to continue carrying out their activities in the context of the current COVID-19 outbreak, in particular insofar as this requires performing visits to manufacturers premises. You will also find attached the EA communication referred to in the note of DG GROW.

In addition to that note, the European Union Agency for Railways (ERA) issued on 3 April 2020 the attached “Clarification note on Temporary measures adopted by the European Union Agency for Railways for delivering authorisations in the framework of the restrictions related to the COVID-19 pandemic”. This note covers ERA’s line to take in reaction to:


ERA1209/088 V1.1


• COVID-19 emergency measures temporarily preventing the NoBos from carrying out planned assessments, visits, inspections, audits or any other on-site activity necessary to issue or renew a certificate;

• COVID-19 emergency measures delaying the process of notification of a NoBo for Directive (EU) 2016/797;

• COVID-19 emergency measures temporarily preventing an applicant to gather all the necessary information from a supplier that is needed to build and submit the file accompanying the application for authorisation (e.g. files accompanying the certificates for ICs), or to answer issues raised by the assessors for an on-going application.

For your complete information, NB-Rail is currently preparing a document aiming to provide further structured guidance to the internal NoBo risk-assessment that results from COVID-19 emergency measures temporarily preventing the NoBos from carrying out planned assessments, visits, inspections, audits or any other on-site activity necessary to issue or renew a certificate. It should become available on the NB-Rail website (http://nb-rail.eu/co/co_docs_rfu_en.html) in parallel to this communication.

I would like to take this opportunity to remind that pursuant to Article 30(6) of Directive (EU) 2016/797, NoBos “shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group [NB-Rail]”.

Furthermore, as indicated in the ERA note, the same principles may be applied, mutatis mutandis, to the evaluations to be performed by Designated Bodies (DeBos) and the evidence that DeBos should produce (e.g. certificate of verification for national rules).

[…]”

3.7. DG GROW communication to Notifying Authorities, Notified Bodies and Cooperation groups regarding the “Validity of NB certificates”, 27/04/2020

“[…]

In the context of the current COVID-19 outbreak, we understand that the activities of notified bodies may be affected. Due to the exceptional circumstances we are facing, we already provided for certain flexibility and specific guidance on this issue, in particular where the difficulty to currently perform visits to manufacturers’ premises affected the conformity assessment activities.

We understand that the current exceptional circumstances may also delay the renewal of existing certificates issued by Notified Bodies and due to expire in the coming days. It may be that Notified Bodies are not in a position to carry out all the necessary tests and activities to deliver the new certificates. To the extent that Notified Bodies cannot carry out their tasks in view of the confinement measures taken at Member States level, Notified Bodies could exceptionally extend the validity of such certificates about to expire for a maximum period of 6 months. Certain pieces of Union harmonization legislation set a specific duration for such certificates, such as 5 or 10 years. In those cases the Notified Body can envisage to issue a new temporary certificate of maximum 6 months for the same product or model, based on the examination done for the current certificate.

As mentioned in our previous email, Notified Bodies are encouraged to continue to carry out their tasks as far as possible. Notified Bodies are required to act responsibly when analysing the situations where certificates may have to be extended beyond their foreseen period of validity. Notified Bodies should also act with full transparency, informing affected clients of any change in the procedures and keeping records justifying the decisions taken.

We would like to recall that these flexibility arrangements should however not put at risk the health and safety of persons or other aspects of public interest protection in the EU by affecting the conformity of the products concerned to the relevant EU harmonisation legislation, and in particular the role that Notified Bodies play in conformity assessment to that legislation. Notified Bodies are requested to inform


ERA1209/088 V1.1


the relevant authorities of any relevant issues relating to possible non-conformity of products, including where such certificates may need to be exceptionally extended for a limited time period as described above.

[…]”

3.8. ERA/OPI/2016-03 “Revised opinion of the European Union Agency for Railways for European Commission regarding question of NB-Rail QC-STR-009 concerning the certification according to withdrawn TSIs DG GROW communication to Notifying Authorities, Notified Bodies and Cooperation groups regarding the “Validity of NB certificates”, 26/06/2017

› 3.4. Case of Interoperability Constituents

“For Interoperability Constituents, the term “relevant TSI” used in Article 11(2) and Article 13(1) of Directive 2008/57 (resp. in Article 10(1) of Directive 2016/797) is to be understood as “applicable TSI” or “TSI in force”.

This view is supported by: • Article 11(5) of Directive 2008/57 (resp. Article 9(6) of Directive 2016/797) which states that

transition periods may be defined for Interoperability Constituents ((Cs);

• Article 1(1) of Decision No 768/2008/EC 5(New Approach Decision), which states that “Products placed on the Community market shall comply with all applicable legislation.”

The term “relevant TSI” can thus not be understood as “any TSI as requested by the applicant”.

Whereas there is no specific transition phase defined in TSIs for the Interoperability Constituents, the transition between successive versions of a TSI is covered by the period of validity of the type or design examination or suitability for use certificate (e.g. five years specified in point 7.1.3.2 of the TSI LOC&PAS 2014, seven years specified in article 8 of the TSI INF); during this period of validity, lCs manufactured in conformity to the type can be placed on the market, even if a revised TSI enters in force. Before the end of the period of validity of the type or design examination or suitability for use certificate, the IC type shall be re-assessed according to the latest revision of the relevant TSI.

There may be other circumstances requiring a subsystem manufacturer to source ICs conforming to superseded TSIs, in order to allow their integration in a subsystem conforming to those superseded TSls. This can be the case:

a) for ICs intended to be integrated in subsystems for which a derogation having an impact on the IC has been granted,

b) for ICs for which there is no backward compatibility with previous versions of a TSI, if one of the following conditions is met:

i) when the TSI in force explicitly allows the use of a previous version of a TSI; or

ii) in the case of spare parts for subsystems that are already placed in service when the corresponding TSI enters into force, as specified in Article 11(4) of Directive 2008/57 (resp. in Article 9(5) of Directive 2016/797).

In both cases a) and b), these constituents could be certified by the notified body in accordance with an earlier version of a TSI, namely the most recent version of the TSI that ensures compatibility of the IC with

The TSI requirements that apply (or applied) to the subsystem at the time of its authorisation 6.

It is the responsibility of the applicant for the subsystem including such constituents to ensure the appropriateness of the version of the TSI selected for those constituents and their consistency at subsystem level. It is the responsibility of the notified body assessing the Subsystem that integrates these


ERA1209/088 V1.1


Interoperability Constituents to verify their integration at Subsystem level in accordance with the applicable TSIs.

Case b) should remain exceptional as, when revising TSIs, the Agency should ensure the backward compatibility of technical requirements, so that Cs conforming to the latest version of a TSI remain compatible with subsystems conforming to a previous version of the same TSI. There may however be exceptional cases where backward compatibility is not possible or wished 7.

An example of situation (b)(i) is the case for the IC “universal toilet module” defined in the TSl PRM, for which it is stated in article 3: “Universal toilet modules which have been assessed against the requirements of Commission Decision 2008/1 64/EC shall not be re-assessed when they are intended for rolling stock of an existing design as defined in Commission Regulation (EU) No 1302/2014.” It is also the case for the Cs defined in the TSI CCS, that includes in the table 6.2 of its Annex the way to handle lCs certified for previous versions of the TSI, when assessing a subsystem.”

› 4. The opinion

“[…]

The Agency is of the opinion that Interoperability constituents shall be certified according to the latest applicable version of a TSl, being understood that the TSI implementation strategy (e.g. transition period) defined for subsystems also applies to the ICs. There are two exceptions for which the constituent could be certified according to an earlier version of a TSI in addition to the cases defined in the implementation strategy of the TSI in force: (i) a derogation granted to the subsystem and (ii) ICs for which there is no backward compatibility, under the conditions detailed above in point 3.4.”

From: FEELEY Barbara (MOVE) <[email protected]> On Behalf Of FITCH Keir (MOVE) Sent: Thursday, May 7, 2020 5:00 PM To: Undisclosed recipients Subject: Validity of NB certificates Dear Colleagues, You may have received the below note from our Colleagues of DG GROW regarding the validity of EC certificates issued by notified bodies (NoBos). As you know, we have already provided for flexibility in context of the COVID-19 outbreak in previous notes, complemented by a clarification note of the Europe-an Union Agency for Railways (ERA) and a recommendation for use (RFU) of NB-Rail. You will find in the attached email the note we sent to you on 6 April, as complemented on 8 April. Based on a joint analysis between DG MOVE, ERA and NB-Rail, we came to the conclusion that, in the case of the railway sector, the documents mentioned above provide the necessary flexibility in the con-text of the COVID-19 outbreak, except for one specific situation for which an extension of the validity of the EC certificate would be appropriate. It could namely happen that a project for placing in service rail-way vehicles conforming to the LOC&PAS TSI 2011 (and related NOI, PRM and SRT TSIs) is delayed due to the emergency measures adopted by the Member States to fight the COVID-19 outbreak and that, due to this delay, the EC certificate of the vehicle type expires before the last vehicles of that project have been authorised. In this case, we consider that an extension of the validity of this specific EC type or design examination certificate by up to 6 months, as proposed in the below note of DG GROW, would be justi-fied in order to allow for the authorisation of the last vehicles of the project. This would correspond to an extension by up to 6 months of the Phase B for this specific vehicle type (as defined in section 7.1.3.1 of both LOC&PAS TSI 2011 and 2014). You will thus find attached an updated version of the ERA clarifica-tion note taking account of this situation. NB-rail is also preparing an update of its “RFU-STR-704 Remote Evaluation due to Covid-19 pandemic”, which will be available on NB-Rail’s website (http://nb-rail.eu/co/co_docs_rfu_en.html) as soon as possible. Best regards, Keir Fitch Head of Unit European Commission DG MOVE C4-Rail Safety and Interoperability Unit


https://urldefense.com/v3/__http:/nb-rail.eu/co/co_docs_rfu_en.html__;!!DOxrgLBm!T8E_znTSI73Hs6FmoQa_AXLv425YUSmBIx79dSRph1yWnSyWABENygN4yfgT88_nmr7bkTi_Jgk$

https://urldefense.com/v3/__http:/nb-rail.eu/co/co_docs_rfu_en.html__;!!DOxrgLBm!T8E_znTSI73Hs6FmoQa_AXLv425YUSmBIx79dSRph1yWnSyWABENygN4yfgT88_nmr7bkTi_Jgk$