Legal aspects of UK and European Decontamination … · BSI Healthcare Market Development Manager...

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Legal aspects of UK and European Decontamination Standards

Rob Turpin

BSI Healthcare Market Development Manager

Scottish Health and Social Care Facilities Conference

4th November 2016


• 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

BSI – Key Facts


Voluntarily developed

Developed by experts

Consensus-based

Documented good practice

Voluntarily applied

Tested against *

Specification

Code of Practice

Guide

What is a BSI Standard?


In support of regulation

Driving innovative solutions (changing behaviours)

Fine tuning businesses

How BSI Standards are used in healthcare


ISO

164 National Members

IEC 80 National Members,

80 Affiliates

CEN 33 National Members

CENELEC 24 common members

with CEN

The international and European standards bodies

http://www.iso.org/

http://www.iec.ch/

http://www.cen.eu/


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

BSI as the UK National Standards Body


7

New Idea Representative stakeholder group

Drafting

Publication Consensus Comment Review

Public consultation

A standardized process for standards


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

Regulations

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.

Standards

The relationship between regulations and standards


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


Legislation includes use of standards to

show conformity

Standardization request from EC

Reviewed by Member States via Standards Committee

Request accepted by European

Standards Body

Standards developed and proposed for

listing in Official Journal

Publication of reference in EU Official Journal

Use of standard brings presumption of

conformity with legal requirements

Harmonized Standards in Europe


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


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


The impact of UK leaving the EU

• BSI role remains to support UK businesses, in terms of trade, growth and productivity

• 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


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


Conclusions

•Success stories for standards supporting flexible co-regulation, 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


Rob Turpin

Healthcare Market Development Manager, BSI

T: +44 (0)20 8996 7140

M: +44 (0)7795 813043

E: [email protected]

Thank you for listening

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Legal aspects of UK and European Decontamination … · BSI Healthcare Market Development Manager...

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