Acceptable Means of Compliance & Alternative Means of Compliance Margit Markus Moossen Legal department 31 January 2013

Overview Introduction of AMC; Introduction of AltMoC; AltMoC process: From the CA perspective; The Agency’s procedures; 2

Acceptable Means of Compliance Legal basis: Article 18(c) of Regulation 216/2008; Article 10 (1) of Regulation 748/2012; Article 8(1) of Regulation 2042/2003; ARA.GEN.120(a) of Annex VI to Regulation 1178/2011; ARO.GEN.120(a) of Annex II to Regulation 965/2012; Recital 7 of Regulation 805/2011; 15/08/2015change via "view" > "header and footer"3

Art 18(c) of Basic Regulation The Agency shall, where appropriate issue certification specifications and acceptable means of compliance […] for the application of this Regulation and its implementing rules. 15/08/2015change via "view" > "header and footer"4

AMC- ARO.GEN.120(a) The Agency shall develop acceptable means of compliance (AMC) that may be used to establish compliance with Regulation (EC) No 216/2008 and ist Implementing Rules. When the AMC are complied with, the related requirements of the Implementing Rules are met. 15/08/2015change via "view" > "header and footer"5

AMC ‚soft law‘- adopted by the ED; non-binding; not mandatory to use; not to introduce new requirements or alleviate the requirements; presumed compliance when following the AMC issued by the Agency; 15/08/2015change via "view" > "header and footer"6

Alternative Means of Compliance ARA.GEN.120(b): Alternative means of compliance may be used to establish compliance with the Impementing Rules. 15/08/2015change via "view" > "header and footer"7

ARA.GEN.105: “Alternative means of compliance” are those that propose an alternative to an existing AMC or those that propose new means to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules for which no associated AMC have been adopted by the Agency; 15/08/2015change via "view" > "header and footer"8

EASA Conference Authority & Organisation Requirements AltMOC: Principles AMC = Non-binding Alternative means may be used Compliance with rules demonstrated Process established to ensure: No negative effect on safety Transparency Harmonisation

ORA.GEN.115 Organisations may use AltMOC to establish compliance with rules Implementation is subject to prior approval by CA: 10  Full description of AltMOC  Revisions to manuals or procedures  Demonstration that rules are complied with

ARA.GEN CA needs to have a system in place to consistently evaluate the compliance of AltMOC with the rules  For AltMOC proposed by organisations  For AltMOC it proposes itself CA needs to have a system in place to consistently evaluate the compliance of AltMOC with the rules  For AltMOC proposed by organisations  For AltMOC it proposes itself

ARA.GEN Analysis of documentation provided & if needed inspection Notify applicant & change of certificate, if needed Notify the Agency of the content, including copies of relevant docs Inform other MS 12 CA evaluates AltMOC proposed: When AltMOC complies with the rule, CA:

ARA.GEN Makes them available to all organisations and persons under its oversight Notifies the Agency Full description of the AltMOC, including any revisions to procedures Demonstration that AltMOC complies with rules 13 CA proposes AltMOC itself

The Agency process - 1 Agency receives notification from CA 14 Standardisation  Risk based approach Rulemaking  Recurrent task  Simplified procedure

The Agency process Information included in database Quarterly review by S & R FP  Identification of significant AltMOC, requiring further assessment  Statistical report to S & R management

The Agency process Significant AltMOC reviewed by internal experts:  Compliance with rules  Regularity of procedure Input to S, for use in Standardisation Input to R, for possible RM task

Actions  Creation of a dedicated mailbox  Dedicated page on EASA website, with relevant information under development 17

We would like your input Any specific information you would like to see on the website? The RAG has already indicated they would like to have: A form for the notification A list of contacts in the different CA, where you could send your notifications and queries Do you have any further suggestions that would facilitate your work and our cooperation? 18

Questions? Suggestions? Contact