F Technical Document - ERA
Technical documentMNB Assessment scheme-000MRA1O44 ver 1.1EUROPEANUNIONAGENCYFOR RAILWAYSMaking the raflway systemwork better for society.FTechnical documentREQUIREMENTS FOR CONFORMITY ASSESSMENT BODIES SEEKINGNOTIFICA TIONDrafted byValidated byApproved byAnna GIGANTINONameLuca TRINCAJosef DOPPELBAUERAndreas SCHIRMERPositionDateProject officerInteroperability UnitExecutive 0 Rue Marc LefrancqIBP 20392IFR-59307 Valenciennes CedexTel. 33 (0)327096500 I era.europa.euAny printed copy is uncontrolled.I1/ 54
EUROPEAN UNION AGENCY FOR RAILWAYSTechnical documentMNB - Assessment scheme000MRA1044 ver 1.1ForewordThe European Union Agency for Railways has drafted this document within the framework of theManagement Board adoption of the provisions for audits for monitoring notified conformity assessmentbodies as Agency Regulation 2016/796 Art 34.4.The 27th of June 2017, the Management Board of the Agency adopted its Decision No. 156 “Provisions onauditing notified conformity assessment bodies in the framework of Article 34 § 3 of Regulation (EU)2016/796”, to which this document refers.In the context of this document:››››“shall” indicates a requirement;“should” indicates a recommendation;“may” indicates a permission;“can” indicates a possibility or a capability.This document has been drafted using a template according to the Agency policy. This document can bephotocopied with black/white machines without any loss of information. The Agency designed this documentfor A4 format paper, two sides.120 Rue Marc Lefrancq BP 20392 FR-59307 Valenciennes CedexTel. 33 (0)327 09 65 00 era.europa.euAny printed copy is uncontrolled.2 / 54
EUROPEAN UNION AGENCY FOR RAILWAYS1.Technical documentMNB - Assessment scheme000MRA1044 ver 1.1ContentsREQUIREMENTS FOR CON FORMITY ASSESSMENT B ODIES SEEKING NOTIFICATION . 1PART 1: INTRODUCTION . 61.ABBREVIATIONS AND ACRONYMS . 72.REFERENCE DOCUMENTS . 83.REFERENCE LEGISLATION . 8PART 2.A: FRAMEWORK .101.OBJECTIVES OF THE ASSESSMENT SCHEME .102.APPLICATION OF THIS ASSESSMENT SCHEME .103.SCHEME OWNER .104.BASELINE STANDARD FOR THE ASSESSMENT SCHEME .105.LEGAL REQUIREMENTS .105.1.COMPARISON BETWEEN LEGAL REQUIREMENTS AND THIS SCHEME . 116.CYCLE FOR THIS ASSESSMENT SCHEME .117.COOPERATION BETWEEN NOTIFYING AUTHORITIES AND OTHER ENTITIES .118.NOTIFYING AUTHORITIES ASSESSMENT TEAM .128.1.PRINCIPLES . 128.2.COMPOSITION . 128.2.1.AT Lead Assessor (LA) . 138.2.2.AT Assessor (AS). 138.2.3.AT Technical expert (TE) . 138.3.INDEPENDENCE AND IMPARTIALITY. 138.4.COMPETENCE . 138.5.PRINCIPLES OF EFFICIENCY . 149.INFORMATION TO PROVIDE .14PART 2.B: REQUIREMENTS .15INTRODUCTION .151.SCOPE.152.NORMATIVE REFERENCES .163.TERMS AND DEFINITIONS .164.GENERAL REQUIREMENTS .174.1.4.2.4.3.4.4.4.5.4.6.5.LEGAL AND CONTRACTUAL MATTERS . 17MANAGEMENT OF IMPARTIALITY . 17LIABILITY AND FINANCING . 18NON-DISCRIMINATORY CONDITIONS. 18CONFIDENTIALITY . 18PUBLICLY AVAILABLE INFORMATION . 18STRUCTURAL REQUIREMENTS .18120 Rue Marc Lefrancq BP 20392 FR-59307 Valenciennes CedexTel. 33 (0)327 09 65 00 era.europa.euAny printed copy is uncontrolled.3 / 54
EUROPEAN UNION AGENCY FOR RAILWAYS5.1.5.2.6.ORGANIZATIONAL STRUCTURE AND TOP MANAGEMENT . 18MECHANISM FOR SAFEGUARDING IMPARTIALITY. 19RESOURCE REQUIREMENTS .196.1.6.2.7.Technical documentMNB - Assessment scheme000MRA1044 ver 1.1CERTIFICATION BODY PERSONNEL . 19RESOURCES FOR EVALUATION . 20PROCESS REQUIREMENTS .217.1.GENERAL . 217.2.APPLICATION . 227.3.APPLICATION REVIEW . 227.4.EVALUATION . 22TESTING . 24INSPECTIONS . 26QUALITY MANAGEMENT SYSTEM APPROVAL . 307.5.REVIEW . 347.6.CERTIFICATION DECISION . 347.7.CERTIFICATION DOCUMENTATION . 357.8.DIRECTORY OF CERTIFIED PRODUCTS . 357.9.SURVEILLANCE . 357.10. CHANGES AFFECTING CERTIFICATION . 357.11. TERMINATION, REDUCTION, SUSPENSION OR WITHDRAWAL OF CERTIFICATION . 357.12. RECORDS . 357.13. COMPLAINTS AND APPEALS . 358.MANAGEMENT SYSTEM REQUIREMENTS .358.1.8.2.8.3.8.4.8.5.8.6.8.7.8.8.OPTIONS . 35GENERAL MANAGEMENT SYSTEM DOCUMENTATION (OPTION A) . 35CONTROL OF DOCUMENTS (OPTION A). 35CONTROL OF RECORDS (OPTION A) . 35MANAGEMENT REVIEW (OPTION A) . 35INTERNAL AUDITS (OPTION A) . 35CORRECTIVE ACTIONS (OPTION A) . 36PREVENTIVE ACTIONS (OPTION A) . 36ANNEX A (INFORMATIVE) PRINCIPLES FOR PRODUCT CERTIFICATION BODIES AND THEIR CERTIFICATION ACTIVITIES.37ANNEX B (INFORMATIVE) APPLICATION OF THIS INTERNATIONAL STANDARD FOR PROCESSES AND SERVICES .37ANNEX C (NORMATIVE) COMPETENCE DESCRIPTIONS.38DECISION MAKER . 38TECHNICAL REVIEWER. 39TECHNICAL MANAGER (PER SCOPE OF ASSESSMENT) . 40INSPECTOR (PER SCOPE OF ASSESSMENT) . 42QMS LEAD AUDITOR . 43QMS AUDITOR . 44ANNEX D (NORMATIVE) LIST OF TECHNICAL TOPICS PER SCOPE OF ASSESSMENT .46D0 - GENERAL . 46D1 – INFRASTRUCTURE (INF, PRM, SRT) . 46D2 - ENERGY . 47D3 – COMMAND, CONTROL AND SIGNALLING . 48D4 - ROLLING STOCK (LOC&PAS, NOI, WAG, SRT, PRM). . 48ANNEX E (INFORMATIVE) DOCUMENTS FLOW CHART .50120 Rue Marc Lefrancq BP 20392 FR-59307 Valenciennes CedexTel. 33 (0)327 09 65 00 era.europa.euAny printed copy is uncontrolled.4 / 54
EUROPEAN UNION AGENCY FOR RAILWAYSTechnical documentMNB - Assessment scheme000MRA1044 ver 1.1ANNEX F (INFORMATIVE) AUDIT TOPICS – CORRELATIONS WITH ISO 9001 .52BIBLIOGRAPHY .54FIGURE 1 - REMOVED 50FIGURE 2 - REMOVED 50FIGURE 3 : DOCUMENTS FLOW CHART 50TABLE 1 : TABLE OF ABBREVIATIONS AND ACRONYMS 7TABLE 2 : TABLE OF REFERENCE DOCUMENTS 8TABLE 3 : TABLE OF REFERENCE LEGISLATION 8TABLE 4 : REQUIREMENTS COMPARISON: DIRECTIVES AND ASSESSMENT SCHEME 11TABLE 5 : CRITERIA OF COMPETENCE FOR ASSESSMENT TEAM 14TABLE 6 : CORRESPONDENCE TABLE BETWEEN ITEMS LISTED IN 5.1.3, IDENTIFIED PERSON OR GROUP OF PERSON AND COMPETENCEDESCRIPTION. 19TABLE 7 : COMPETENCE COMPOSITION DESCRIPTION 19TABLE 8 : EXAMPLE OF CHECK LIST MATRIX 27TABLE 9 : APPLICABLE SPECIFIC KNOWLEDGE PER SCOPE OF ASSESSMENT 46120 Rue Marc Lefrancq BP 20392 FR-59307 Valenciennes CedexTel. 33 (0)327 09 65 00 era.europa.euAny printed copy is uncontrolled.5 / 54
EUROPEAN UNION AGENCY FOR RAILWAYSTechnical documentMNB - Assessment scheme000MRA1044 ver 1.1PART 1: INTRODUCTIONMember States shall appoint notifying authorities responsible for setting up and carrying out the necessaryprocedures for the assessment, notification and monitoring of bodies responsible for the conformityassessment of railway products. These bodies are called conformity assessment bodies (CABs). In thiscontext:›››Assessment is the process demonstrating that the CAB fulfills the requirements identified inthe Interoperability Directive (EU) 2016/797.Notification is the act of the notifying authority informing the European Commission and theother Member States that a CAB meets all requirements identified by the interoperabilityDirective (EU) 2016/797.Monitoring is the process demonstrating that the notified conformity assessment bodycontinues fulfilling the requirements identified in the Interoperability Directive (EU)2016/797.Member State’s notifying authority may decide to delegate the assessment and monitoring to:›a national accreditation body (NAB), within the European Co-operation for accreditation (EA)– accreditation path, or› a relevant national authority complying with the legal requirements identified in theInteroperability Directive (EU) 2016/797 – recognition (i.e. non accreditation) path.The Member State’s notifying authority remains always responsible for the delegated tasks.The CAB concerned may perform the activities of a notified body only where no objections are raised by theCommission or by the other Member States pending on the path followed, within:››two weeks if accreditation , ortwo months if recognition.NOTE 1: The 'Blue Guide' on the implementation of EU product rules 2016 provides an exhaustive descriptionabout the above topics. See http://ec.europa.eu/DocsRoom/documents/18027.About this technical documentThis technical document is composed by:›PART 1 INTRODUCTIONwhich introduces the topic of assessments and accreditation/recognition for NoBos,including references.›PART 2.A FRAMEWORKwhich provides an overarching framework for the application of the requirements describedin PART 2.B.›PART 2.B REQUIREMENTSwhich provides requirements to apply when assessing bodies seeking notification under theIODs.NOTE 1: In this document the terms conformity assessment bodies (CAB) and “certification body” (in referenceto the ISO/IEC 17065) are considered synonyms.120 Rue Marc Lefrancq BP 20392 FR-59307 Valenciennes CedexTel. 33 (0)327 09 65 00 era.europa.euAny printed copy is uncontrolled.6 / 54
EUROPEAN UNION AGENCY FOR RAILWAYS1.Technical documentMNB - Assessment scheme000MRA1044 ver 1.1Abbreviations and acron
› a national accreditation body (NAB), within the European Co-operation for accreditation (EA) – accreditation path, or › a relevant national authority complying with the legal requirements identified in the Interoperability Directive (EU) 2016/797 – recognition (i.e. non accreditation) path.
Qual era l'organizzazione sociale e politica dei Sumeri? I Sumeri vivevano in città-stato, ovvero ogni città formava un piccolo Stato indipendente. Chi era a capo di ogni città? A capo di ogni città vi era un re, il quale era affiancato da un consiglio degli anziani. Inizialmente il re era anche sacerdote.Era il sacerdot
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Write the answer on the other side of the card. Quiz yourself until you know all of the answers. Visual Check 1. Name List the periods of the Mesozoic era from oldest to youngest. Mesozoic Era Eons Eras Periods Phanerozoic Mesozoic Cretaceous Jurassic Triassic Precambrian 251 mya 65.5 mya Mesozoic The Mesozoic Era Geologic Time The Mesozoic Era .
Jan 29, 2021 · major era will look like. But let’s start by looking at the megatrends that will shape that era. 1970 2014 The beginning of the Digitalization Era 1979 The beginning of the Globalization Era 1970s The end of the Industrialization Era 1980 1990 2000 2010 2020 2030 8 Finding
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1900's. The reform era developed in reaction to the political. It took hold during the 1930's, thrived during the 1950's and 1960's, began to erode during the late 1970's. The reform era now seems to be giving way to an era emphasizing community problem solving. 6 6 The reform era now seems to be gi
890 CHAPTER 38 The Eisenhower Era, 1952–1960. his own throat by parading his essential meanness and irresponsibility. A few months later, the Senate formally condemned him for “conduct unbecoming, CHAPTER 38 The Eisenhower Era, 1952–1960. 38 The Eisenhower Era, 1952–1960.
