Recognized Experts. Competence Area

Transcription

1 1(4) Recognized Experts Competence Area This memo concerns the content of detailed instructions for the evaluation and approval of recognized experts in accordance with section 48, subsection 2 of the Vehicle Act (1090/2002, last amended by 1042/2014), which instructions the Finnish Transport Safety Agency is required to provide. A recognized expert carries out testing, measurements and inspections, and based on these provides reports concerning compliance in national type approval procedures. A recognized expert can also provide compliance reports for individual approval or EC small series type approval of vehicles. A recognized expert can also act as an individual approver or registration or alteration inspector. Recognized experts may not, however, provide individual approval or registration or alteration inspections for a vehicle for which they themselves have provided a compliance report. A recognized expert may not subcontract out the testing, measurements and inspections on which the compliance reports are to be based. The Finnish Transport Safety Agency approves recognized experts for specific areas of competence upon application. The competence area comprises a competence class (HA and HC classes) and the regulation under review (directive, decree, UNECE Regulation or national regulation). Competence Classes An HA-class recognized expert can provide reports related to national small series type approval, component type approval, and individual approval. Objects of Inspection Criteria An HC-class recognized expert can provide reports related to individual approval. An HA-class recognized expert can provide reports for national type approval on objects marked with the letters H, B, C or E in Annex 8 to the Decree of the Ministry of Transport and Communications on the Construction and Equipment of Motor Vehicles and Trailers (1248/2002, last amended by 1291/2014) and Annex 2 to the Decree on the Construction and Equipment of Two or Three-wheel Motor Vehicles and Quadricycles (1250/2002, last amended by 220/2014), and for EC small series type approval on objects marked with the letter C. An HC-class recognized expert can provide reports for national type approval on objects marked with the letters H, C or E in Annex 8 to the Decree of the Ministry of Transport and Communications on the Construction and Equipment of Motor Vehicles and Trailers (1248/2002, last amended by 1291/2014) and Annex 2 to the Decree on the Construction and Equipment of Two or Three-wheel Motor Vehicles and Quadricycles (1250/2002, last amended by 220/2014. The applicant must demonstrate the fulfilment of the requirements stated in section 17 of the Government Decree on the Approval of Vehicles (1244/2002, last amended by 1271/2014). More detailed specifications concerning the application of the demands of section 17, subsection 2 are provided by the Finnish Transport Safety Agency in the Annex to this memorandum.

2 2(4) Verification methods Approval Decision Obligations The standards which a recognized expert must fulfil are: HA experts: standard SFS-EN ISO/IEC 17025, applied in accordance to instructions from the Finnish Transport Safety Agency (section 1.1 of the Annex to this memorandum) HC experts: standard SFS-EN ISO/IEC 17025, applied in accordance to instructions from the Finnish Transport Safety Agency (section 1.2 of the Annex to this memorandum) Alternatively, the requirements for the HA and HC classes can be fulfilled by presenting an SFS-EN ISO/IEC accreditation certificate Onsite verification is performed by FINAS or another accreditation body that has signed an international recognition agreement concluded between accreditation bodies (MLA/MRA). Approval as a recognized expert requires an assessment and a written statement by FINAS or another accreditation body that has signed an international recognition agreement concluded between accreditation bodies (MLA/MRA). An approval decision is generally valid for four (4) years. An approval decision for a recognized expert assessed according to the Annex requires that no impediment to approval be found in the reassessment conducted to ensure the maintenance of the necessary capabilities within two (2) years of the initial assessment, and that all of the conditions for validity given in the decision continue to be fulfilled. The approval decision for an accredited recognized expert will remain valid according to the accreditation. The obligations of a recognized expert include: 1. Maintaining a record of the reports given. 2. Ensuring that their operations in the approved competence area fulfil the requirements of standard SFS-EN ISO/IEC either wherever applicable (sections 1.1 and/or 1.2 of the Annex) or in whole. 3. Ensuring that their operations continuously fulfil the stated requirements and conditions for approval. 4. Working in accordance with the operating system, procedures and explanations specified at the time of the competence assessment. 5. Informing the authorities, without delay and always within 20 days at most, or any changes in the organization or other working conditions, which may have significance with regard to working as a recognized expert or fulfilling the stated requirements. 6. Supplying the authorities with an annual report of operations within two months of its completion or, if such a report does not specify the work as a recognized expert, a separate report of related operations for each year of operation. 7. Maintaining up-to-date register of the persons competence and locations (municipalities) where reports will be given and delivers the register to Trafi after every update.

3 3(4) Oversight Applications 8. Allowing the authorities or another party acting officially on their behalf to conduct inspections in accordance with the Vehicle Act and other related regulations. These inspections will be conducted at the recognized expert s own expense. 9. Performing comparison measurements with respect to measurement results within the expert's competence area, unless the measurement results' comparability among other recognized experts in a corresponding competence area is not otherwise sufficiently ensured through systematic operational assessments. 10. Guaranteeing confidentiality without, however, preventing access by the authorities or another party acting officially on their behalf to data concerning demonstration of impartiality, competence of personnel, systems, equipment, tools and the reports given. 11. Operating in accordance with the approval decision. Should any significant deficiencies or negligence be observed in the recognized expert s operations, or should monitoring or reassessment procedures demonstrate any non-compliance with requirements, then corrective action must be taken within one month of being presented with a demand. 12. Forwarding the statements written by the accreditation body on the onsite assessments to the Finnish Transport Safety Agency. 13. Informing the authorities without delay of cessation of operations as a recognized expert. The accreditation body performs assessments of the operating system of the recognized expert in accordance with the criteria specified by the Finnish Transport Safety Agency. Such criteria are listed in the Annex to this memorandum. The accreditation body carries out assessments of the operating system at the intervals required by the approval decision. The operations of an accredited recognized expert are assessed by the accreditation body that assesses its operating system in accordance with the accreditation principles. The Finnish Transport Safety Agency carries out practical oversight by requesting to see the documentation on which the recognized experts reports are based. The aim is to focus oversight actions on certain predetermined areas. The Finnish Transport Safety Agency can also carry out further oversight actions if it has any doubts concerning the recognized expert s operations or reports. Applications for recognition as a recognized expert can be made in writing to the Finnish Transport Safety Agency, including the following information: 1. The applicant's information: name, extract from Trade Register, form of incorporation, role in larger organization (if applicable), address(es) of place(s) of business, contact person(s), address and telephone number. 2. Competence area applied for: basic regulation and latest valid regulation (directive, decree, UNECE Regulation, national regulation).

4 4(4) Additional Information 3. Vehicle classes on which the applicant intends to provide reports. 4. Details of the persons responsible for the operations. 5. Up-to-date list of the persons who will provide reports as recognized experts. 6. Up-to-date list of the locations (municipalities) where reports will be given. 7. Proof of a documented management system in accordance with SFS- EN ISO/IEC The management system is assessed by FINAS or another accreditation body that has signed an international recognition agreement concluded between accreditation bodies (MLA/MRA) or, in exceptional cases, the Finnish Transport Safety Agency only. The minimum requirements of the management system are listed in the Annex to this memorandum. The management system documentation, procedural instructions and explanations, and the report on the onsite assessment must be sent to the Finnish Transport Safety Agency. 8. Application sending methods: By Technicalservices@trafi.fi By secure o Use your web browser to go to o Requires registration. By post: Finnish Transport Safety Agency, Organisational Licences, PO Box 320, FI Helsinki Finnish Transport Safety Agency PO Box 320 FI Helsinki Technicalservices@trafi.fi Tel.: Fax:

5 ANNEX 1(4) Annex: Requirements for Recognized Experts This Annex addresses the Finnish Transport Agency's requirements, other than those pertaining to the accreditation, for the assessment of recognized experts. Section 1.1: Requirements for HA-class recognized experts Section 1.2: Requirements for HC-class recognized experts 1.1 Requirements for HA-class recognized experts Verification is performed by FINAS or another accreditation body that has signed an international recognition agreement between accreditation bodies (MLA/MRA). The assessment of recognized experts operations is subject to the standard SFS-EN ISO/IEC 17025, with the exceptions listed in the table below. Assessment of the fulfilment of requirements listed in SFS-EN ISO/IEC Section of SFS- EN ISO/IEC concerning the matter Requirements of SFS-EN ISO/IEC with the exception of sections related to subcontracting of testing, measurements and inspections 4 5

6 1.2 Requirements for HC-class recognized experts TRAFI/5938/ /2014 ANNEX 2(4) Verification is performed by FINAS or another accreditation body that has signed an international recognition agreement between accreditation bodies (MLA/MRA) or, in exceptional cases only, the Finnish Transport Safety Agency. Recognized experts must document their operations at least in relation to the items listed in the table below. The assessment of recognized experts operations is subject to the standard SFS-EN ISO/IEC

7 ANNEX 3(4) Description of the content of sections included within SFS-EN ISO/IEC The content of the sections includes, but is not limited to, the following: Specification of the organization s facilities and processes, as well as of the persons responsible for these and their authorizations. Specification of any possible conflicts of interest and related party arrangements, and of the procedures in place for ensuring that no internal or external commercial, financial or other pressures are applied to the management or personnel. Specification of the organization s procedures for operational management. Documented management system comprising the following items, among others: quality policy, objectives, management reviews and internal audits. Continuous improvement Section of SFS- EN ISO/IEC concerning the matter , 4.14, Instructions for the recognition and management of documents and records. Procedures related to reviews of bid requests, bids and agreements. The requirements, including the procedures applied, must have been specified, documented and understood to a sufficient extent, ensuring that the laboratory has the ability and resources to fulfil these requirements. Procedure for acquiring the equipment that is significant for the operations in question (e.g. measurement and calibration equipment). Confidentiality in relation to other customers. 4.3, Handling, recording and tracking of complaints. 4.8 Recorded procedure for handling anomalies observed during testing/calibration, for correcting these and for monitoring the effects of corrective measures. Specification of the competence, training requirements, job orientation, independence and legal compliance of personnel. 4.9, 4.11, Report on impartiality (Administrative Procedure Act, 434/2003): A recognized expert shall not take part in manufacturing or developing (including design) of the company s products, or be in a subcontracting or any other dependent relationship with the company. Specification of the facilities and conditions in which the work is conducted. 5.3

8 ANNEX 4(4) Specification of the testing and calibration methods used and of the evaluation of measurement uncertainty. Specification of the equipment used and its calibration, storage and transportation. Sampling plan and sampling procedures (for recording essential sampling data and functions related to testing or calibration). Quality control procedures related to tracking test and calibration accuracy. Content and structure of the test report , 5.6,