1 Luca Moro, ECMP 2014, 11 – 14 September 2014, Athens, Greece CEN Standard on Medical Physics Services: CEN standardization procedure Luca Moro AIFM representative on the EFOMP Working Group CEN Standard on: Medical Physics Services

2 CEN (European Committee for Standardization) is: a private international non-profit organization based in Brussel that brings together the National Standardization Bodies of 33 European countries (Members) and 17 Affiliates plus other international Partners; one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level. WHO

3 The CEN System consists of three main levels or functions: Technical Board (BT) and Administrative Board (BA): policy setting, general co-ordination, overall management and arbitration. Technical Committees (TC) and CEN-CENELEC Management Centre: programming and planning of the execution of future standards and other deliverables, and management of consensus building processes. Working Groups (WG): drafting of documents leading to the timely production of high quality standards and other deliverables. WHO

4 CEN brings together knowledge and expertise from its members, from all interested parties - including manufacturers, users, consumers and regulators - and from other stakeholders, in order to develop European Standards and technical specifications for products, materials and services through a transparent, open and consensus based process. WHAT members Interested parties stakeholder

5 Proposals for new work: may originate from a European trade, professional, technical or scientific organization, are introduced by a CEN member. HOW

6 The appropriate CEN Technical Committee makes a decision on the adoption of the proposal. An adopted standardization project is allocated to one of the Working Groups for the drafting of the standard. HOW

7 Once the draft of a European Standard is prepared, it is released for public comment, a process known in CEN as the ‘CEN Enquiry’. HOW STAKEHOLDERS DRAFT These views are collated by the National Standards Bodies and analyzed by the CEN Technical Committee. During the public commenting stage, everyone who has an interest (e.g. manufacturers, public authorities, consumers, etc.) may comment on the draft.

8 Taking into consideration the comments resulting from the CEN Enquiry, a final version is drafted, which is then submitted to the CEN national Members for a weighted formal vote. HOW

9 After ratification by CEN, each of the National Standards Bodies adopts the European Standard as an identical national standard and withdraws any national standards which conflict with the new European Standard. Hence one European Standard becomes the national standard in the 33 member countries of CEN. HOW

10 HOW PROPOSALACCEPTANCEDRAFTINGCEN ENQUIRY ADOPTION BY WEIGHTED VOTE PUBLICATION OF THE EUROPEAN STANDARD (EN) 3 YEARS