Commission Implementing Regulation (EU) No 402/2013Show full title

1. Introductory Text

2. Article 1. Subject matter

3. Article 2. Scope

4. Article 3. Definitions

5. Article 3A. Designated standards

6. Article 4. Significant changes

7. Article 5. Risk management process

8. Article 6. Independent assessment

9. Article 7. Accreditation/recognition of the assessment body

10. Article 8. Acceptance of accreditation/recognition

11. Article 9. Types of recognition of the assessment body

12. Article 10. Validity of recognition

13. Article 11. Surveillance by recognition body

14. Article 12. Relaxed criteria where a significant change is not to be mutually recognised

15. Article 13. Provision of information to the Agency

16. Article 14. Support from the Agency to accreditation or recognition of the assessment body

17. Article 15. Safety assessment reports

18. Article 16. Declaration by the proposer

19. Article 17. Risk control management and audits

20. Article 18. Feedback and technical progress

21. Article 19. Repeal

22. Article 20. Entry into force and application

23. Signature

24. 1. ANNEX I

       1. 1. GENERAL PRINCIPLES APPLICABLE TO THE RISK MANAGEMENT PROCESS

          1. 1.1. General principles and obligations

             1. 1.1.1. The risk management process shall start from a definition of...

             2. 1.1.2. The risk management process shall include appropriate quality assurance activities...

             3. 1.1.3. The proposer in charge of the risk management process shall...

             4. 1.1.4. The actors who already have in place methods or tools...

             5. 1.1.5. Without prejudice to civil liability in accordance with the legal...

             6. 1.1.6. The first step of the risk management process shall be...

             7. 1.1.7. Evaluation of the correct application of the risk management process...

          2. 1.2. Interfaces management

             1. 1.2.1. For each interface relevant to the system under assessment and...

             2. 1.2.2. If, in order to fulfil a safety requirement, an actor...

             3. 1.2.3. For the system under assessment, any actor who discovers that...

             4. 1.2.4. The actor implementing the safety measure shall then inform all...

             5. 1.2.5. When agreement cannot be reached between two or more actors...

             6. 1.2.6. When a requirement in a national rule cannot be fulfilled...

             7. 1.2.7. Independently from the definition of the system under assessment, the...

       2. 2. DESCRIPTION OF THE RISK ASSESSMENT PROCESS

          1. 2.1. General description

             1. 2.1.1. The risk assessment process is the overall iterative process that...

             2. 2.1.2. The system definition shall address at least the following issues:...

             3. 2.1.3. A hazard identification shall be carried out on the defined...

             4. 2.1.4. The risk acceptability of the system under assessment shall be...

             5. 2.1.5. The proposer shall demonstrate in the risk evaluation that the...

             6. 2.1.6. The application of these risk acceptance principles shall identify possible...

             7. 2.1.7. The iterative risk assessment process is considered to be completed...

          2. 2.2. Hazard identification

             1. 2.2.1. The proposer shall systematically identify, using wide-ranging expertise from a...

             2. 2.2.2. To focus the risk assessment efforts upon the most important...

             3. 2.2.3. As a criterion, risks resulting from hazards may be classified...

             4. 2.2.4. During the hazard identification, safety measures may be identified. They...

             5. 2.2.5. The hazard identification only needs to be carried out at...

             6. 2.2.6. Whenever a code of practice or a reference system is...

          3. 2.3. Use of codes of practice and risk evaluation

             1. 2.3.1. The proposer, with the support of other involved actors, shall...

             2. 2.3.2. The codes of practice shall satisfy at least the following...

             3. 2.3.3. Where compliance with NTSNs is required ... and the relevant...

             4. 2.3.4. National rules ... may be considered as codes of practice...

             5. 2.3.5. If one or more hazards are controlled by codes of...

             6. 2.3.6. Where an alternative approach is not fully compliant with a...

             7. 2.3.7. If the risk for a particular hazard cannot be made...

             8. 2.3.8. When all hazards are controlled by codes of practice, the...

          4. 2.4. Use of reference system and risk evaluation

             1. 2.4.1. The proposer, with the support of other involved actors, shall...

             2. 2.4.2. A reference system shall satisfy at least the following requirements:...

             3. 2.4.3. If a reference system fulfils the requirements listed in point...

             4. 2.4.4. If the system under assessment deviates from the reference system,...

             5. 2.4.5. If at least the same safety level as the reference...

          5. 2.5. Explicit risk estimation and evaluation

             1. 2.5.1. If the hazards are not covered by one of the...

             2. 2.5.2. The acceptability of the estimated risks shall be evaluated using...

             3. 2.5.3. If the risk associated with one hazard or a combination...

             4. 2.5.4. The proposer shall not be obliged to perform additional explicit...

             5. 2.5.5. Where hazards arise as a result of failures of functions...

             6. 2.5.6. Without prejudice to points 2.5.1 and 2.5.4, the ... design...

             7. 2.5.7. The risk associated with the failures of functions of technical...

             8. 2.5.8. The following specific definitions shall apply in reference to the...

             9. 2.5.9. Where the failure of a function of the technical system...

             10. 2.5.10. ...

             11. 2.5.11. Where a technical system is developed on the basis of...

             12. 2.5.12. The explicit risk estimation and evaluation shall satisfy at least...

       3. 3. DEMONSTRATION OF COMPLIANCE WITH SAFETY REQUIREMENTS

          1. 3.1. Prior to the safety acceptance of the change, fulfilment of...

          2. 3.2. This demonstration shall be carried out by each of the...

          3. 3.3. The approach chosen for demonstrating compliance with the safety requirements...

          4. 3.4. Any inadequacy of safety measures expected to fulfil the safety...

       4. 4. HAZARD MANAGEMENT

          1. 4.1. Hazard management process

             1. 4.1.1. Hazard record(s) shall be created or updated (where they already...

             2. 4.1.2. The hazard record shall include all hazards, together with all...

          2. 4.2. Exchange of information

       5. 5. EVIDENCE FROM THE APPLICATION OF THE RISK MANAGEMENT PROCESS

          1. 5.1. The risk management process used to assess the safety levels...

          2. 5.2. The documentation produced by the proposer under point 5.1 shall...

          3. 5.3. The assessment body shall establish its conclusion in a safety...

       6. Appendix

          1. Risk management process and independent assessment

    2. ANNEX II

       CRITERIA FOR ACCREDITATION OR RECOGNITION OF THE ASSESSMENT BODY

       1. 1. The assessment body shall fulfil all requirements of the ISO/IEC...

       2. 2. The assessment body shall be accredited or recognised for the...

       3. 3. The assessment body shall be accredited or recognised for assessing...

       4. 4. The assessment body may be accredited or recognised for one,...

    3. ANNEX III

       SAFETY ASSESSMENT REPORT OF THE ASSESSMENT BODY

       1. The safety assessment report of the assessment body shall contain...

       2. identification of the assessment body; the independent assessment plan; the...