Legal aspects of UK and European Decontamination Standards

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1 Legal aspects of UK and European Decontamination Standards Rob Turpin BSI Healthcare Market Development Manager Scottish Health and Social Care Facilities Conference 4 th November

2 BSI Key Facts A global independent business services organization Founded in 1901; the world s first National Standards Body Founding member of ISO and CEN Established by Royal Charter - core activities are: Develop, Promote, Distribute Standards Provide Knowledge Solutions Register, Approve, Affix Quality Marks Testing and Certification Training 2

3 What is a BSI Standard? Voluntarily developed Developed by experts Specification Consensus-based Documented good practice Code of Practice Voluntarily applied Tested against * Guide 3

4 How BSI Standards are used in healthcare In support of regulation Fine tuning businesses Driving innovative solutions (changing behaviours) 4

5 The international and European standards bodies ISO 164 National Members CEN 33 National Members IEC 80 National Members, 80 Affiliates CENELEC 24 common members with CEN 5

6 BSI as the UK National Standards Body Total staff 330 Subscribing members 14,000 Committee members 11,000 Technical and Subcommittees 1,200 Current projects c.7,000 Current British Standards c.35,000 Standards published per annum c.2,500 Standards with international origin 95% Total ISO & European secretariats 198 6

7 A standardized process for standards New Idea Representative stakeholder group Drafting Publication Consensus Comment Review Public consultation 7 7

8 The relationship between regulations and standards Regulations Mandatory Created by legislator Consultation according to government body s policy Decided by government bodies Revised when legislator decides Gives requirements to protect public interest Standards Voluntary Developed by standards organizations Full open public consultation Based on consensus of all interested parties Considered for revision every 5 years Provide specifications, test methods, codes, etc. 8

9 How can standards be used to demonstrate regulations? Standards are market-based tools that can be used by Government to deliver better regulation: Co-regulation Can be used alongside accreditation, to verify conformity with a standard Benefits: Simplification of regulation Can incorporate technical development Reduce costs of Government policy delivery Legitimacy and market acceptance Business-friendly alternative to regulation 9

10 Harmonized Standards in Europe Legislation includes use of standards to show conformity Standardization request from EC Reviewed by Member States via Standards Committee Publication of reference in EU Official Journal Standards developed and proposed for listing in Official Journal Request accepted by European Standards Body Use of standard brings presumption of conformity with legal requirements 10

11 Deviations and implications Regulation should be sufficiently flexible to permit innovation and technological development Standards are often the most practical way of demonstrating conformity Other approaches can be used, e.g. in state of the art instances A voluntary standard remains a business tool, to be used when the market needs it Standards can be amended far more easily than regulations Corrections, amendments, revisions, new editions 5-year systematic review 11

12 Who is responsible for the legal repercussions? Manufacturers and private providers have a responsibility to meet the legal requirements They implement voluntary standards in order to demonstrate this They do not set the legal requirements Public Authorities have the right to take action through their powers and sanctions They set legal requirements They perform market surveillance BSI works with both to ensure that all voluntary standards are fit for purpose 12

13 The impact of UK leaving the EU BSI role remains to support UK businesses, terms of trade, growth and productivity in No changes anticipated to national activities, nor our international membership of ISO, IEC BSI maintains membership of European Standards Organisation CEN, CENELEC are private bodies that include non-eu members Work with UK Government and European Bodies regarding future role Ambition to continue to participate as a full member, in order to maximise benefit to UK economy and society 13

14 BSI collaboration with NHS Facilities Commonalities between NHS Facilities publications and BSI Standards: >400 references to BSI standards Almost 25% NHS experts involved with BSI Potential for BSI as an authoring partner? Building Information Modelling Multi-dimensional digital tool for the collaborative design of buildings Covers inception to demolition Creation, gathering and exchange of data to all parties 14

15 Conclusions Success stories for standards supporting flexible coregulation, or an alternative to regulation Standards are voluntary tools, used when businesses need them, or when the market requires them BSI continues to support development of strategies for creating and managing standards with a wide community of professional experts: As an independent catalyst for agreeing the standards landscape Advising Government and professions on the role of standards A UK platform to project knowledge as a basis for global standards 15

16 Thank you for listening Rob Turpin Healthcare Market Development Manager, BSI T: +44 (0) M: +44 (0) E: 16

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