http://www.legislation.gov.uk/eur/2011/445Commission Regulation (EU) No 445/2011 of 10 May 2011 on a system of certification of entities in charge of maintenance for freight wagons and amending Regulation (EC) No 653/2007 (Text with EEA relevance) (repealed)Commission Regulation (EU) No 445/2011 (repealed)Commission Regulation (EU) No 445/2011 of 10 May 2011 on a system of certification of entities in charge of maintenance for freight wagons and amending Regulation (EC) No 653/2007 (Text with EEA relevance) (repealed)King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02011R0445-20200617texttext/xmlen2024-08-21Expert Participation2020-12-31 http://publications.europa.eu/resource/cellar/3c1bb3f2-d6be-11ea-adf7-01aa75ed71a1 3c1bb3f2-d6be-11ea-adf7-01aa75ed71a1 cellar http://publications.europa.eu/resource/celex/02011R0445-20200617 02011R0445-20200617 celex 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consolidation Commission Regulation (EU) No 445/2011 of 10 May 2011 on a system of certification of entities in charge of maintenance for freight wagons and amending Regulation (EC) No 653/2007 (Text with EEA relevance)Text with EEA relevance en en 001 2020-08-05T15:20:15.102+02:00 2020 08 05 2020-08-05T15:20:15.102+02:00 2020 08 05 eng 001 http://publications.europa.eu/resource/authority/language/ENG ENG language ENG ENG English English <VALUE>Commission Regulation (EU) No 445/2011 of 10 May 2011 on a system of certification of entities in charge of maintenance for freight wagons and amending Regulation (EC) No 653/2007 (Text with EEA relevance)Text with EEA relevance</VALUE> <LANG>en</LANG> Commission Regulation (EU) No 445/2011 of 10 May 2011 on a system of certification of entities in charge of maintenance for freight wagons and amending Regulation (EC) No 653/2007 Text with EEA relevanceRegulationCommission Implementing Regulation (EU) 2018/763 of 9 April 2018 establishing practical arrangements for issuing single safety certificates to railway undertakings pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council, and repealing Commission Regulation (EC) No 653/2007 (Text with EEA relevance. )Regulation Commission Regulation (EU) No 445/2011of 10 May 2011on a system of certification of entities in charge of maintenance for freight wagons and amending Regulation (EC) No 653/2007(Text with EEA relevance) (repealed)

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 Purpose Article 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scope Article 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Definitions Article 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Maintenance system Article 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Relationships between parties involved in the maintenance process Article 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Certification bodies Article 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System of certification for entities in charge of maintenance Article 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System of certification for outsourced maintenance functions Article 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Role of the supervision regime Article 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Provision of information to the Commission and the Agency Article 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Amendment to Regulation (EC) No 653/2007 Article 11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Transitional provisions Article 12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Entry into force Article 13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ANNEX I <Strong>Principles to be used for organisations applying for a certificate in respect of maintenance functions outsourced by an entity in charge of maintenance</Strong> 1. For certification of an entity or organisation taking on one or more maintenance functions of an entity in charge of maintenance (maintenance development, fleet maintenance management, maintenance delivery) or parts of them, the following requirements and assessment criteria contained in Annex III apply:

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2. For certification of a maintenance workshop taking on the maintenance delivery function, the following requirements and assessment criteria contained in Annex III apply:

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ANNEX II <Strong>Criteria for accreditation or recognition of certification bodies involved in the assessment and award of ECM certificates</Strong> 1. ORGANISATION

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2. INDEPENDENCE

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3. COMPETENCE

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4. IMPARTIALITY

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5. RESPONSIBILITY

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6. OPENNESS

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7. CONFIDENTIALITY

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8. RESPONSIVENESS TO COMPLAINTS

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9. LIABILITY AND FINANCING

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ANNEX III <Strong>Requirements and assessment criteria for organisations applying for an ECM certificate or for a certificate in respect of maintenance functions outsourced by an entity in charge of maintenance</Strong> I. <Strong>Management function requirements and assessment criteria</Strong> 1. Leadership — <Emphasis>commitment to the development and implementation of the maintenance system of the organisation and to the continuous improvement of its effectiveness</Emphasis>

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2. Risk assessment — <Emphasis>a structured approach to assess risks associated with the maintenance of freight wagons, including those directly arising from operational processes and the activities of other organisations or persons, and to identify the appropriate risk control measures</Emphasis> 2.1. The organisation must have procedures for:

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2.2.

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2.3.

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2.4.

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3. Monitoring — <Emphasis>a structured approach to ensure that risk control measures are in place, working correctly and achieving the organisation’s objectives</Emphasis> 3.1. The organisation must have a procedure to regularly collect, monitor and analyse relevant safety data, including:

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3.2.

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3.3. For a periodic review of all processes, the organisation must have an internal auditing system which is independent, impartial and acts in a transparent way. This system must have procedures in place to:

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4. Continuous improvement — <Emphasis>a structured approach to analyse the information gathered through regular monitoring, auditing, or other relevant sources and to use the results to learn and to adopt preventive or corrective measures in order to maintain or improve the level of safety</Emphasis>

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5. Structure and responsibility — <Emphasis>a structured approach to define the responsibilities of individuals and teams for secure delivery of the organisation’s safety objectives</Emphasis> 5.1.

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5.2.

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5.3.

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5.4.

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5.5.

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6. Competence management — <Emphasis>a structured approach to ensure that employees have the competences required in order to achieve the organisation’s objectives safely, effectively and efficiently in all circumstances</Emphasis> 6.1. The organisation must set up a competence management system providing for:

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6.2. Within the organisation’s competence management system, there must be procedures to manage the competence of staff, including at least:

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7. Information — <Emphasis>a structured approach to ensure that important information is available to those making judgments and decisions at all levels of the organisation</Emphasis> 7.1.

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7.2. To ensure an adequate exchange of information, the organisation must have procedures:

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7.3. The organisation must have procedures to ensure that key operational information is:

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7.4. The requirements set out in points 7.1, 7.2 and 7.3 apply in particular to the following operational information:

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8. Documentation — <Emphasis>a structured approach to ensure the traceability of all relevant information</Emphasis> 8.1.

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8.2. The organisation must have adequate procedures in place to:

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9. Contracting activities — <Emphasis>a structured approach to ensure that subcontracted activities are managed appropriately in order for the organisation’s objectives to be achieved</Emphasis> 9.1.

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9.2. When making use of contractors and/or suppliers for safety related products and services, the organisation must have procedures in place to verify at the time of selection that:

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9.3.

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9.4.

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9.5.

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9.6. At least the basic principles for the following processes must be clearly defined, known and allocated in the contract between the contracting parties:

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II. <Strong>Requirements and assessment criteria for the maintenance development function</Strong> 1.

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2.

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3.

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4.

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5.

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6.

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7.

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III. <Strong>Requirements and assessment criteria for the fleet maintenance management function</Strong> 1.

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2.

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3.

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4.

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5.

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6.

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7.

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8.

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9.

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10.

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IV. <Strong>Requirements and assessment criteria for the maintenance delivery function</Strong> 1.

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2.

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3.

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4.

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5.

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6.

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7.

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8.

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9.

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10.

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ANNEX IV

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ANNEX V

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ANNEX VI

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Repealed (16.6.2020) by Commission Implementing Regulation (EU) 2019/779 of 16 May 2019 laying down detailed provisions on a system of certification of entities in charge of maintenance of vehicles pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council and repealing Commission Regulation (EU) No 445/2011 (Text with EEA relevance), Art. 16 (with transitional provisions in Art. 15)Regulation, in so far as still in force, revoked (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 7; 2020 c. 1, Sch. 5 para. 1(1)