1. REGULATION (EU) Nº 402/2013 of 30 April 2013 on the common safety method for risk evaluation and assessment. Use of accreditation for assessing the competence of a CSM Assessment Body April 2016

2. CONTENTS INTRODUCTION: R.402/2013 AND SPANISH SITUATION ACCREDITATION ACCREDITATION SCOPE NAB ASSESSMENT TEAM ASSESSMENTS Initial Assessment ISO/IEC 17020/2012 R 402/2013 TECHNICAL COMPETENCE Initial Assessment ISO/IEC 17020/2012 R 402/2013 TECHNICAL COMPETENCE Surveillance Assessment Re-Assessment BENEFITS OF ACCREDITATION 2 1 1 2 2 6 6 5 5 4 4 3 3 5.2 5.3 5.1

3. Who Who assess the application of the risk management process? An assessment body shall carry out an independent assessment of the suitability of both the application of the risk management process and its results. INTRODUCTION The Regulation (UE)402/2013 establishes a revised common safety method (CSM) for risk evaluation and assessment as referred to in the Directive 2004/49/EC (Railway Safety Directive) This regulation apply when any change (technical, operational or organisational) is made in the rail system in a Member State. When When the change is considered as significant, the risk management process shall be applied. The Regulation (UE)402/2013 establishes a revised common safety method (CSM) for risk evaluation and assessment as referred to in the Directive 2004/49/EC (Railway Safety Directive) This regulation apply when any change (technical, operational or organisational) is made in the rail system in a Member State. When When the change is considered as significant, the risk management process shall be applied. Accreditation/recognition of the assessment body The assessment body shall be either:  (a) accredited by the national accreditation body referred to in Article 13(1) using the criteria defined in Annex II; or  (b) recognised by the recognition body referred to in Article 13(1) using the criteria defined in Annex II; or  (c) the national safety authority under the requirement of Article 9(2). Accreditation/recognition of the assessment body The assessment body shall be either:  (a) accredited by the national accreditation body referred to in Article 13(1) using the criteria defined in Annex II; or  (b) recognised by the recognition body referred to in Article 13(1) using the criteria defined in Annex II; or  (c) the national safety authority under the requirement of Article 9(2). As you already know... 3

4. The situation that currently exists in Spain. AESF (the Spanish National Safety Agency) acts as Recognition Body as defined in clauses (b) (and (c) of Article 9(1) of Reg. 402/2013: (b) recognition by the national safety authority of the ability of an organisation or a part of it or an individual to conduct independent assessment through the assessment and supervision of the safety management system of a railway undertaking or an infrastructure manager; (c) when the national safety authority is acting as certification body in conformity with Article 10 of Regulation (EU) No 445/2011, recognition by the national safety authority of the ability of an organisation or a part of it or an individual to conduct independent assessment through assessment and surveillance of the system of maintenance of an entity in charge of maintenance ; AESF (the Spanish National Safety Agency) acts as Recognition Body as defined in clauses (b) (and (c) of Article 9(1) of Reg. 402/2013: (b) recognition by the national safety authority of the ability of an organisation or a part of it or an individual to conduct independent assessment through the assessment and supervision of the safety management system of a railway undertaking or an infrastructure manager; (c) when the national safety authority is acting as certification body in conformity with Article 10 of Regulation (EU) No 445/2011, recognition by the national safety authority of the ability of an organisation or a part of it or an individual to conduct independent assessment through assessment and surveillance of the system of maintenance of an entity in charge of maintenance ; The Member State should be able to use accreditation or recognition or any combination of these two options, as in Spain. RECOGNITIONRECOGNITION 4

5. The situation that currently exists in Spain. ENAC is the Spanish National Accreditation Body for the purposes of Regulation (EU) 402/2013. The Member State should be able to use accreditation or recognition or any combination of these two options, as in Spain. All of them have been registered in the European Railway Agency Database of Interoperability and Safety (ERADIS ) Assessment Bodies Accredited by ENAC under (EU) 402/2013  2 Type A  8 Type C Assessment Bodies Accredited by ENAC under (EU) 402/2013  2 Type A  8 Type C ACCREDITATIONACCREDITATION 5

6. ACCREDITATION. To assess if the CAB performs the inspection activity according to standard ISO 17020/2012 and especially according to the Regulation 402/2013. In a nutshell, ABs evaluate if the CAB does things well but never defines what “doing the things well” means. To assess if the CAB performs the inspection activity according to standard ISO 17020/2012 and especially according to the Regulation 402/2013. In a nutshell, ABs evaluate if the CAB does things well but never defines what “doing the things well” means. Then: Who determines the State of the Art? In general; Scientific or Technical Organizations, Standards, technical Bibliography,…. etc. In our concrete case, the Regulation 402/2013 directly determines the State of the Art for the CSM for risk assessment. Then: Who determines the State of the Art? In general; Scientific or Technical Organizations, Standards, technical Bibliography,…. etc. In our concrete case, the Regulation 402/2013 directly determines the State of the Art for the CSM for risk assessment. What is the ACCREDITATION BODY role? ASSESSMENT OF COMPETENCE THE ULTIMATE GOAL 6

7. ACCREDITATION. Standard 17011 specifies general requirements for accreditation bodies assessing and accrediting conformity assessment bodies. It´s also appropriate as a requirements document for the peer evaluation process for mutual recognition arrangements between accreditation bodies. Standard 17011 specifies general requirements for accreditation bodies assessing and accrediting conformity assessment bodies. It´s also appropriate as a requirements document for the peer evaluation process for mutual recognition arrangements between accreditation bodies. What is the functioning of accreditation ? What kind of requirements are defined in ISO/IEC 17011 for Accreditation Bodies? ISO/IEC 17011 internationally accepted standard for accreditation bodies 7 Accreditation bodies operate under requirements of ISO/IEC 17011 Decision-making and granting accreditation Appeals Reassessment and surveillance Extending accreditation Suspending, withdrawing or reducing accreditation Records on CABs Proficiency testing and other comparisons for laboratories Decision-making and granting accreditation Appeals Reassessment and surveillance Extending accreditation Suspending, withdrawing or reducing accreditation Records on CABs Proficiency testing and other comparisons for laboratories Accreditation criteria and information Application for accreditation Resource review Subcontracting the assessment Preparation for assessment Document and record review On-site assessment Analysis of findings and assessment report Accreditation criteria and information Application for accreditation Resource review Subcontracting the assessment Preparation for assessment Document and record review On-site assessment Analysis of findings and assessment report Accreditation Process Personnel associated with the accreditation body Personnel involved in the accreditation process Monitoring Personnel records Personnel associated with the accreditation body Personnel involved in the accreditation process Monitoring Personnel records Human Resources Legal responsibility Structure Impartiality Confidentiality Liability and financing Accreditation Activity Legal responsibility Structure Impartiality Confidentiality Liability and financing Accreditation Activity Accreditation Body Management system Document control Records Nonconformities and corrective actions Preventive actions Internal audits Management reviews Complaints Management system Document control Records Nonconformities and corrective actions Preventive actions Internal audits Management reviews Complaints Management Obligations of the CAB Obligations of the accreditation body Reference to accreditation and use of symbols Obligations of the CAB Obligations of the accreditation body Reference to accreditation and use of symbols Responsibilities

8. Accreditation The ultimate goal To increase confidence in the information provided by the Inspection Bodies to carry out risk evaluation and assessment under Regulation 402/2013. 8

9. AUTHORITIES and ACCREDITATION.  Facilitate the implementation of better regulation: NAB constitute a body in the service of the National Safety Authority  Inform the NSA about the competence of assessment bodies, and the accreditation process carry out.  Provide competent resources The Nacional Safety Authority facilitates information about its monitoring. This information takes into account by NAB in the assessments carried out. THE ACCREDITATION IS A TOOL TO FEED BACK The accreditation doesn´t remove National Safety Authority's competences or control, on the contrary reinforcing them TEAM WORK 9

10. APPLICATION DECISION MAKING CORRECTIVE ACTIONS DOCUMENT REVIEW APPOINTMENT OF ASSESSMENT TEAM ASSESSMENT FINDINGS CLOSED ON SITE VISIT NECESSARY ACCREDITATION CERTIFICATE NO YES Accreditation Process/A general view 10 The Accreditation Process complies with the requirements of ISO/IEC 17011 (point 7) The content of accreditation certificate is described in points 7.9.4.and 7.9.5 of ISO/IEC 17011

11. ACCREDITATION SCOPE What is the Accreditation Scope? Accreditation is limited to a scope of accreditation in which the accredited activities are outlined clearly, precisely and unambiguously, so as to provide both the client of the organization and other parties concerned with specific information on the technical competence shown. AN ACCREDITATION SCOPE DESCRIBING THE DEMONSTRATED COMPETENCE Accreditation is limited to a scope of accreditation in which the accredited activities are outlined clearly, precisely and unambiguously, so as to provide both the client of the organization and other parties concerned with specific information on the technical competence shown. AN ACCREDITATION SCOPE DESCRIBING THE DEMONSTRATED COMPETENCE What is Inspected? Normative documents used for the inspection Type of inspection Legal framework, where applicable Legal framework, where applicable 11 DEFINED by ISO/IEC 17011: “specific conformity assessment services for which accreditation is sought or has been granted” Areas of competence

12. ACCREDITATION SCOPE UNDER R. 402/2013 areas of competence The assessment body may be accredited for one, several or all of the areas of competence listed in points 2 and 3 of ANEX II 402/2013. Structural areas Control-Command and Signalling Systems Energy Systems Infrastructure Systems Rolling Stock Systems Structural areas Control-Command and Signalling Systems Energy Systems Infrastructure Systems Rolling Stock Systems Functional areas Traffic operation and management Maintenance Functional areas Traffic operation and management Maintenance 12

13. ACCREDITATION SCOPE UNDER R.402/2013 What documents are included in the scope ? Directive 2004/49/EC on safety on the Community’s railways Directive 2008/57/EC on the interoperability of the rail system within the Community. REGULATION (EU) No 402/2013 of 30th April 2013 on the common safety method for risk evaluation and assessment. COMMISSION IMPLEMENTING REGULATION (EU) 2015/1136 of 13 July 2015 amending Implementing Regulation (EU) No 402/2013 on the common safety method for risk evaluation and assessment. Normative documents to give Conformity Normative documents to give Conformity Legal Framework 13

14. ACCREDITATION SCOPE UNDER R.402/2013 PRODUCTOS, PROCESOS, SERVICIOS E INSTALACIONES: SEGURIDAD DE APLICACIONES FERROVIARIAS PRODUCTS, PROCESSES,SERVICES AND INSTALLATIONS Safety of Railway Applications SUBSISTEMAS: Infraestructura, Energía, Material Rodante, Control Mando y Señalización, Explotación y Gestión del tráfico y Mantenimiento SUBSISTEMS: Infrastructure, Energy, Rolling Stock,Control-Command and Signalling Systems; Traffic operation and management and Maintenance DIRECTIVAS: Directiva 2004/49/CE sobre la seguridad de los ferrocarriles comunitarios y Directiva 2008/57/CE sobre la interoperabilidad del sistema ferroviario dentro de la Comunidad. DIRECTIVES: Directive 2004/49/EC on safety on the Community’s railways. Directive 2008/57/EC on the interoperability of the rail system within the Community. TIPO DE INSPECCIÓN Type of inspection DOCUMENTOS NORMATIVOS Normative Documents Evaluación y valoración del riesgo. Risk evaluation and assessment. REGLAMENTO DE EJECUCIÓN (UE) Nº 402/2013 DE LA COMISIÓN de 30 de abril de 2013 relativo a la adopción de un método común de seguridad para la evaluación y valoración del riesgo. REGULATION (EU) No 402/2013 of 30th April 2013 on the common safety method for risk evaluation and assessment. REGLAMENTO DE EJECUCIÓN (UE) 2015/1136 DE LA COMISIÓN de 13 de julio de 2015 por el que se modifica el Reglamento de Ejecución (UE) no 402/2013 relativo a la adopción de un método común de seguridad para la evaluación y valoración del riesgo (Texto pertinente a efectos del EEE) COMMISSION IMPLEMENTING REGULATION (EU) 2015/1136 of 13 July 2015 amending Implementing Regulation (EU) No 402/2013 on the common safety method for risk evaluation and assessment. Example of Accreditation Scope All our accreditation scopes have been registered in the European Railway Agency Database of Interoperability and Safety (ERADIS) 14

15. NAB ASSESSMENT TEAM SELECTION: Assessment Teams are selected under the requirements as defined in the standard ISO/IEC 17011 (6.2, 7.5.2 and 7.5.3) Independence and impartiality Competence The Team must not have any professional, financial, family or friendship links or links of any other kind with the organisation to be assessed, which could compromise their impartiality. Efficiency Qualification Technical Knowledges Qualification Technical Knowledges The team: with the fewest members. requiring less travels with the most assessors who can speak various languages The team: with the fewest members. requiring less travels with the most assessors who can speak various languages 15 To select the assessment team ENAC takes into account geographical proximity to entity to assess. We have the necessary information in our databases to select the best option. To select the assessment team ENAC takes into account geographical proximity to entity to assess. We have the necessary information in our databases to select the best option.

16. NAB ASSESSMENT TEAM Where do we find our Technical Experts? FIND Technical Experts FIND Technical Experts Universities Technological Centres Professional Associations Social networking Twitter, LinkedIn …etc Social networking Twitter, LinkedIn …etc Technical Committees In the special case of Regulation 402/2013 we found our Technical Experts, in the Railway Area, in particular, people who had worked for infrastructure managers, railway operators…etc, but all of them complying with the requirements of independence,impartiality,competence, and efficiency as defined above 16

17. NAB ASSESSMENT TEAM Lead AssessorTechnical Expert COMPETENCE Qualified by ENAC as lead assessor in ISO/IEC 17020/2012 General Knowledge of – REGULATION 402/2013 – Explanatory note on the CSM Assessment Body referred to in Regulation 402/2013. – Railway Area (DISERABLE) Experience to do audits Qualified by ENAC as Technical expert in one or more scopes of accreditation described in this scheme Expertise – Risk assessment and management – REGULATION 402/2013 – Explanatory note on the CSM Assessment Body referred to in Regulation 402/2013. – Railway subsystems/areas of competence At least five years professional experience in risk assessment. 17

18. NAB ASSESSMENT TEAM Lead AssessorTechnical Expert Who assess each requirement? Compliance with ISO/IEC 17020 standard General requirements Structural requirements Resource requirements Process Requirements (complaints and appeals) Management system requirements Compliance with ISO/IEC 17020 standard/Technical competence. Resource requirements Process requirements Inspection methods and procedures Handling inspection items and samples Inspection records Inspection reports and inspection certificates Compliance with REGULATORY requirements ANEXX II Regulation 402/2013 ANEX III Regulation 402/2013 (content of safety assessment report ) 18 The assessment team operates under requirements established in ISO/IEC 17011

19. Assessment ACCREDITATION CYCLE Shall not be longer than 5 years SURVEILLANCE ACTIVITIES Initial assessment initial accredited reassess ISO/IEC 17011: The accreditation body shall establish an assessment programme for periodically carrying out assessment activities to cover the scope of accreditation at sufficiently close intervals to ensure that the accredited CAB continues to fulfil the requirements for accreditation at all locations from which it provides conformity assessment services. An accreditation cycle begins at the date of granting the accreditation and shall not be longer than 5 years. ISO/IEC 17011: The accreditation body shall establish an assessment programme for periodically carrying out assessment activities to cover the scope of accreditation at sufficiently close intervals to ensure that the accredited CAB continues to fulfil the requirements for accreditation at all locations from which it provides conformity assessment services. An accreditation cycle begins at the date of granting the accreditation and shall not be longer than 5 years. 19

20. To be accredited Conformity Assessment Bodies have to demonstrate compliance by fulfilling requirements set in the Standard and the Regulation 402/2013. Initial Assessment What is assessed? compliance with ISO/IEC 17020 standard compliance with requirements of R. 402/2013. ANEX II and ANEX III compliance with requirements of R. 402/2013. ANEX II and ANEX III Technical competence ASSESSMENT The assessment carries out in the same way with respect to all requirements. ISO/17020: 2012 and ANEX II of R. 402/2013. All requirements are important. The assessment carries out in the same way with respect to all requirements. ISO/17020: 2012 and ANEX II of R. 402/2013. All requirements are important. 20 ISO/IEC 17011: Initial assessment is described in points 7.5 to 7.9.

21. Procedures Initial Assessment necessary An Initial assessment will be carried out, when the Conformity Assessment Body has the necessary technical and human resources to perform the inspections.  Equipment  Personnel  Procedures….. necessary An Initial assessment will be carried out, when the Conformity Assessment Body has the necessary technical and human resources to perform the inspections.  Equipment  Personnel  Procedures….. Equipment Personnel It isn´t possible to assess technical competence if the CAB hasn´t necessary resources to prove it. 21

22. Initial Assessment ISO/IEC 17020:2012 Impartiality and Independence Confidentiality Management System Complains and appeals Administrative requirements Organization Impartiality of inspection activities (not allow pressures to compromise impartiality) To identify risk to its impartiality and minimizes or eliminates it. Independence: TYPE A/TYPE B/TYPE C. Confidentiality. Impartiality of inspection activities (not allow pressures to compromise impartiality) To identify risk to its impartiality and minimizes or eliminates it. Independence: TYPE A/TYPE B/TYPE C. Confidentiality. Legal entity Adequate provision to cover liabilities Documentation of the contractual conditions to provide the inspections. Enough Resources/Competent Staff Technical Manager/Deputy Documentation concerning the job descriptions (position category) Legal entity Adequate provision to cover liabilities Documentation of the contractual conditions to provide the inspections. Enough Resources/Competent Staff Technical Manager/Deputy Documentation concerning the job descriptions (position category) Management system documentation Control of documents Control of records Management review Internal Audits Corrective Actions Preventive actions Management system documentation Control of documents Control of records Management review Internal Audits Corrective Actions Preventive actions 22

23. Initial Assessment Technical Competence Activities to assess ResourcesResources ProcessProcess Activities carried out Equivalent activities Simulated inspections Conditioned Accreditation Activities carried out Equivalent activities Simulated inspections Conditioned Accreditation Personnel Facilities and equipment Subcontracting Personnel Facilities and equipment Subcontracting Inspections Methods and Procedures ANEX II in Regulation 402/2013 Handling inspection items and samples Inspection records Inspection reports and inspection certificates ANEX III in Regulation 402/2013 Inspections Methods and Procedures ANEX II in Regulation 402/2013 Handling inspection items and samples Inspection records Inspection reports and inspection certificates ANEX III in Regulation 402/2013 23

24. How to assess… the competence of CAB which never did in the past independent assessments The CAB can demonstrates competence throw: EQUIVALENT ACTIVITIES  Provide sufficient information on the competence.  Are representative  Enable it to assess the competence  Provide sufficient information on the competence.  Are representative  Enable it to assess the competence SIMULATED INSPECTIONS The inspection Body obtains the information needed to make a simulated inspection: An agreement with the customer Consultancy activities Engineering activities …etc. The inspection Body obtains the information needed to make a simulated inspection: An agreement with the customer Consultancy activities Engineering activities …etc. CONDITIONED ACCREDITATION In regulatory activities where the CAB cannot act if it isn´t accredited and therefore it cannot demonstrate experience in the activity for which it requests the accreditation, and if it is not possible to do a simulation or it may be very expensive. In this case it could be possible to accredit the entity without making witnessing assessment, under the condition that the inspection body cannot give accredited certificates until the witnessing assessment is already made. The inspection Body shall inform ENAC about all the activities available to perform their assessment by ENAC. In regulatory activities where the CAB cannot act if it isn´t accredited and therefore it cannot demonstrate experience in the activity for which it requests the accreditation, and if it is not possible to do a simulation or it may be very expensive. In this case it could be possible to accredit the entity without making witnessing assessment, under the condition that the inspection body cannot give accredited certificates until the witnessing assessment is already made. The inspection Body shall inform ENAC about all the activities available to perform their assessment by ENAC. During the initial assessment all requirements are covered. Only when we have conditioned accreditation there are some activities that will be assess when the CAB has activities available to assess. 24

25. How to assess…personnel Enough personnel Procedures/docu ment Qualifications Experience Knowledge Qualifications Experience Knowledge employhave contracts The inspection body shall employ, or have contracts with, a sufficient number of persons with the required competencies, including, where needed, the ability to make professional judgements, to perform the type, range and volume of its inspection activities. ⁻appropriate qualifications, ⁻ training, ⁻experience ⁻knowledge of the requirements of the inspections to be carried out. ⁻relevant knowledge: the technology the operation of processes and the delivery of services; ⁻appropriate qualifications, ⁻ training, ⁻experience ⁻knowledge of the requirements of the inspections to be carried out. ⁻relevant knowledge: the technology the operation of processes and the delivery of services; _To document the competence requirements for all personnel involved in inspection activities, including requirements for education, training, technical knowledge, skills and experience. _ To do procedures for selecting, training, formally authorizing, and monitoring inspectors and other personnel involved in inspection activities. _To document the competence requirements for all personnel involved in inspection activities, including requirements for education, training, technical knowledge, skills and experience. _ To do procedures for selecting, training, formally authorizing, and monitoring inspectors and other personnel involved in inspection activities. 25

26. How to assess…personnel Training Others requirements Monitoring _ depends upon the ability qualifications and experience of each inspector, and also the results of monitoring. _shall document in a procedure and shall address the following stages: a) an induction period; b)a mentored working period with experienced inspectors; c) continuing training to keep pace with developing technology and inspection methods. _ depends upon the ability qualifications and experience of each inspector, and also the results of monitoring. _shall document in a procedure and shall address the following stages: a) an induction period; b)a mentored working period with experienced inspectors; c) continuing training to keep pace with developing technology and inspection methods. _will be done by personnel familiar with the inspection methods and procedures. _each inspector “in situ” unless there was sufficient supporting evidence that the inspector is continuing to perform competently. _records of monitoring shall be maintain. _will be done by personnel familiar with the inspection methods and procedures. _each inspector “in situ” unless there was sufficient supporting evidence that the inspector is continuing to perform competently. _records of monitoring shall be maintain. impartiality confidentiality remuneration impartiality confidentiality remuneration 26

27. How to assess…personnel When the CAB has offices over several countries whereas only your site is seeking for the accreditation but they intend to use experts from other sites Only the main site is accredited. The remaining sites only provides personnel. Only the main site is accredited. The remaining sites only provides personnel. If the CAB uses experts from the others sites, it shall establish an agreement to use them, and then this personnel will operate under its procedures and management system. 27

28. How to assess…personnel When the CAB is accredited in a country but has local sites with key activities in others countries…. This is known as Cross_ frontier an then is applies the EA-s document called “EA-2/13 EA Cross Border Accreditation Policy and Procedure for Cross Border Cooperation between EA Members” This is known as Cross_ frontier an then is applies the EA-s document called “EA-2/13 EA Cross Border Accreditation Policy and Procedure for Cross Border Cooperation between EA Members” When the CAB is accredited and has local sites with key activities locations in others countries. It means that the sites are included in its scope and shall be evaluated. The local site shall be under control of Headquarters. When the CAB is accredited and has local sites with key activities locations in others countries. It means that the sites are included in its scope and shall be evaluated. The local site shall be under control of Headquarters. This document states the policy and procedures agreed by EA members concerning accreditation of conformity assessment bodies with sites or key activities in other countries than that where the accredited conformity assessment body is established. 28 LOCAL SITE WITH KEY ACTIVITIES Asks for assessment

29. LOCAL SITE WITH KEY ACTIVITIES Headquarters Accredits Asks for assessment Assesses Foreign AB Local AB Inspection certificate Accreditation Certificate HEADQUARTERS Legal entity (UK) LOCAL SITE (SPAIN) Controls ENAC ASSESSES ON BEHALF OF UKAS LOCAL SITE WITH KEY ACTIVITIES ISSUING THE CERTIFICATES WITH THE NAME AND THE ADDRESS OF THE LEGAL ENTITY (HEADQUARTERS) UNDER UKAS´S ACCREDITATION. LOCAL SITE WITH KEY ACTIVITIES IS INCLUDED WHITIN THE SCOPE BY UKAS, TOGETHER WITH THE HEADQUARTERS How to assess…personnel An example of the implementation of activities of CROSSFRONTIER 29

30. The subcontracting requirements have been defined by ISO/IEC 1720:2012 How to assess…subcontracting shall itself normally perform the inspections that it contracts The inspection body shall itself normally perform the inspections that it contracts to undertake. an unforeseen or abnormal overload; key inspection staff members being incapacitated; key facilities or items of equipment being temporarily unfit for use; an unforeseen or abnormal overload; key inspection staff members being incapacitated; key facilities or items of equipment being temporarily unfit for use; When could the inspection body subcontract? shall inform the client of its intention to subcontract any part of the inspection. the responsibility for any determination of conformity of the inspected item with the requirements shall remain with the inspection body. shall record and retain details of its investigation of the competence of its subcontractors shall inform the client of its intention to subcontract any part of the inspection. the responsibility for any determination of conformity of the inspected item with the requirements shall remain with the inspection body. shall record and retain details of its investigation of the competence of its subcontractors responsibilities 30

31. Don´t constitute subcontracting How to assess…subcontracting Where the inspection body engages individuals or employees of other organizations to provide additional resources or expertise, these individuals are not considered to be subcontractors provided they are formally contracted to operate under the inspection body's management system. The CAB subcontracting a part of inspection The CAB obtains resources that operate under its management system. The difference 31

32. Inspections Methods and Procedures How to assess…Process requirements Review of the technical documentation The assessment process begins with a study conducted by the assessment team of the technical documentation for the purpose of ensuring that this documentation is adequate for the correct performance of the activity for which accreditation is requested, and contains all requirements defined in Regulation 402/2013 to carry out the inspection. The evaluation of compliance with the requirements is undertaken by observing the activities of the applicant under normal operating conditions and by reviewing records, reports and interviewing staff. The evaluation of compliance with the requirements is undertaken by observing the activities of the applicant under normal operating conditions and by reviewing records, reports and interviewing staff. An assessment of the implementation of the revised procedures 32

33. How to assess…Process Inspection records, reports and certificates RECORDS REPORTS & CERTIFICATES REPORTS & CERTIFICATES To demonstrate the effective fulfilment of the inspection procedures and to enable an evaluation of the inspection. To cover the work carried out by the inspection body including the requirements in ANEX III of R. 402/2013 To cover the work carried out by the inspection body including the requirements in ANEX III of R. 402/2013 The content of the report shall be supported by the records. 33

34. Surveillance Assessments What are the main purposes of these assessments? To check that the accredited organization has complied with the requirements established for the granting of accreditation over the period. To assess how deficiencies detected in previous assessments have been resolved.. To assess how deficiencies detected in previous assessments have been resolved.. To assess any change in the organization, procedures and resources of the accredited organization for performance of the activities in the scope of its accreditation. To verify that it has fulfilled the responsibilities resulting from its accreditation. To check the activity of the organization for the scope accredited. To conduct a technical assessment of part of the accredited scope. The accredited scope must be fully assessed each accreditation cycle To conduct a technical assessment of part of the accredited scope. The accredited scope must be fully assessed each accreditation cycle NOTE: The interval between surveillance assessments will be established on the basis of the results of previous visits Compliance with the requirements (Regulation 402/2013 and the Standard 17020/2012) shall be shown by the Inspection body to maintain the Accreditation. 34 ISO/IEC 17011: (7.11) Surveillance on-site assessments are less comprehensive than re-assessments.

35. SURVEILLANCE AND AUTHORITY (NSA) What does the NSA provide to the surveillance assessment? The NSA facilitates information about its monitoring. This information takes into account by NAB in the surveillance assessments carried out. NAB SURVEILLANCE NAB SURVEILLANCE OUTCOME MONITORING MARKET ACTIVITIES NSA INFORMATION INFORMATION AFTER SURVEILLANCE 35

36. RE-ASSESSMENT What is the re-assessment? At the end of each accreditation cycle ENAC re-assesses that the system implemented complies with the requirements for accreditation in force and the competence of the accredited organization for its scope, taking into account for this the activities assessed during the surveillance assessments, and conducting an assessment equivalent to the initial one. The re-assessment is a renewal of The Agreement between Inspection Body and ENAC. If the Inspection Body refused to be assessed, it will be understood that the organization is not interested in maintaining its accreditation. 36 ISO/IEC 17011: (7.11.1) Reassessment is similar to an initial assessment, except that experience gained during previous assessments shall be taken into account.

37. Surveillance and RE-ASSESSMENT OUTCOME During the surveillance and reassessment, the inspection body shall demonstrate compliance with the requirements which gave rise to its accreditation. If not, it could lose the accreditation. 37 ISO/IEC 17011: (7.11.6) The accreditation body shall confirm the continuation of accreditation, or decide on the renewal of accreditation, based on the results of surveillance and reassessments described above.

38. BENEFITS OF ACCREDITATION What kind of benefits do we obtain with the accreditation?  increases confidence in the information provided by the Conformity Assessment Body.  provides an infrastructure of competent CABs to be used both by authorities and the market.  increases confidence in the information provided by the Conformity Assessment Body.  provides an infrastructure of competent CABs to be used both by authorities and the market.  Technically competent.  Impartial and independent from CABs.  Taking into account all the stakeholders.  No competition with CABs.  Under supervision of International Accreditation Organizations.  Technically competent.  Impartial and independent from CABs.  Taking into account all the stakeholders.  No competition with CABs.  Under supervision of International Accreditation Organizations. ACCREDITATION BODIES ACCREDITATION BODIES 38

39. BENEFITS OF ACCREDITATION Benefits for the National Safety Authorities Put to their disposition an infrastructure of CABs that have demonstrated their competence against the same requirements and through the same evaluation process performed by trustful bodies (NABs) to be used when the authorities decide to outsource evaluation and control activities avoiding the cost to perform their own assessments. Decisions relating to Health and safety are based in technically sound information provided by competent bodies diminishing risks and enhancing the trust in public services FORNSAFORNSA 39

40. BENEFITS OF ACCREDITATION Benefits for the Market International recognition Recognition by National and European authorities Sound criteria for choosing a CAB, enhancing a competition between CABs based not only in price but in competence International recognition Recognition by National and European authorities Sound criteria for choosing a CAB, enhancing a competition between CABs based not only in price but in competence Minimize risks not only of providing non-conforming products but, also, to demonstrate the due diligence when taking decisions based in conformity assessment results Defence against bad practice. NAB investigate any feedback of bad practice from the market Minimize risks not only of providing non-conforming products but, also, to demonstrate the due diligence when taking decisions based in conformity assessment results Defence against bad practice. NAB investigate any feedback of bad practice from the market FOR THE MARKET FOR 40

41. BENEFITS OF ACCREDITATION Benefits to both parties Facilitate the implementation of better regulation. Technics as self-regulation that may avoid the need to regulate or, earned recognition that allow to the authorities to concentrate resources in the most risky situations are fostered in markets with mature accreditation systems. MARKETMARKET NSANSA 41

42. ACCREDITATION VERSUS RECOGNITION ACCREDITATION RECOGNITION ASSESSMENT AND SURVEILLANCE, under requirements as defined in standard ISO/IEC 17011 The requirements and rules for the evaluation and surveillance of assessment bodies in the case of recognition should be equivalent to those used for accreditation, in order to achieve a similar level of quality and trust as expected through accreditation. Transparent and harmonised process in Europe. The process is carried out at national level, but is coordinated at European level (EA). Transparent and harmonised process in Europe. The process is carried out at national level, but is coordinated at European level (EA). ‘Recognition’ means an attestation by a national body other than the national accreditation body to check if the assessment body meets the requirements set out in Annex II of Regulation 402/2013 to carry out the independent assessment activity. “Accreditation” means an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity; Each country operates with its own procedures. Issues it would be considering 42

43. Thank you for your attention. You can contact Mrs Susana Huerta for more information (shuerta@enac.es)