Updated: Added link to updated version of the BSI Standards report in the BSI Funding paragraph.
Standardisation
Standardisation helps innovation to be applied to the whole economy and makes sure that most companies are not too far behind the early adopters of new ideas.
Standardisation can help business by:
providing better access to markets
delivering measurable benefits when used within the infrastructure of a company itself
minimising business costs and risks
streamlining internal processes
improving communication
By promoting interoperability, standardisation provides a competitive edge in the market place; necessary for worldwide trading of products and services. In particular for SMEs (small and medium enterprises), demonstrable compliance with an accepted standard can replace the power of a big brand.
What is standardisation?
Standardisation includes the development of the standard as well as how it is used. End-users should have confidence in their purchase because the supplier has used an appropriate standard and has gone through independent assessment.
BIS’s role in standardisation
BIS is responsible for UK government policy on everything to do with standards-making, accreditation and conformity assessment. We will strengthen the standards, accreditation and conformity assessment infrastructure so that it meets the needs of UK industry and to make the processes more relevant and business friendly.
We sponsor, and work closely with, the British Standards Institution (BSI) as the UK National Standards Body (NSB) and the United Kingdom Accreditation Service (UKAS) as the National Accreditation Body (NAB).
Through the European Commission (EC) we help develop European standardisation policy, which can remove barriers to trade. This includes the recent EC regulation on accreditation and market surveillance, and the EC decision on a common framework for marketing products.
We are also the central contact point for Directive 98/34/EC that requires member states to notify the EC of proposed national technical regulations; and Mutual Recognition of Conformity Assessment; and Refusals of Mutual Recognition Decision 3052/95/EC.
We work closely with technical regulations colleagues and also a number of other government departments.
The MOD’s DStan (UK Defence Standardisation) works to develop, facilitate and communicate UK MOD standardisation policies, standards, procedures and guidance on standardisation both nationally and internationally.
Standardisation infrastructure
Conformity assessment helps companies demonstrate that they have met customers’ needs and includes activities like testing, inspection and certification. The organisations that test, inspect, etc, are known as Conformity Assessment Bodies (CABs).
BIS works to make sure conformity assessment in the UK is well managed, competent and market driven, and so contributes to the productivity and competitiveness of UK businesses.
CABs notified to the Commission under the European New Approach legislation are known as Notified Bodies (NBs). Where there is European Community legislation, the requirements for NBs makes sure that products and services assessed in one member state can be accepted in another.
However, where there are national regulatory requirements, conformity assessment requirements can differ from country to country and can create barriers to trade. Our work on the quality and conformity assessment infrastructure helps to reduce these barriers by providing ways that allow recognition of conformity assessment.
BIS has produced a guidance document for regulators, on the conformity assessment aspects of European Decision 768/2008/EC on a common framework for the marketing of products. It deals with the requirements for notification of CABs and conformity assessment procedures.
Accreditation
Accreditation is given when a conformity assessment body is recognised as competent to carry out specific tasks. It is generally accepted that for an accreditation body to be authoritative it must have the support of government.
A statement of the main principles relating to conformity assessment policy in the UK, including accreditation, has been developed and was first published in May 2005.
Standards
Standards are the the most important point of the infrastructure, providing the matrix in which the other elements operate with BSI, playing an important role in developing standards domestically and internationally.
For example:
If you are a toy maker the chances are you will wish to manufacture your toy so that it meets the relevant international and national standards - this will help you sell your product in the UK as well as overseas. To demonstrate to buyers that your product really does meet the standard you will need to employ an independent and impartial third party to assess your product against the standard. These third parties are known as conformity assessment bodies (CABs).
You wouldn’t want to use any old organisation, but a CAB who you know to be competent and whose assessment will be universally accepted. National Accreditation Bodies (NABs) - UKAS is the UK’s NAB - assess the CABs against international standards to make sure that they are competent to assess against specific standards.
NABs are reviewed to make sure that they are competent by taking evaluations by their peers and by being subject to government audit and appointment.
This infrastructure provides confidence, trust and assurance to consumers and purchasers that the toy meets the standard that the manufacturer claims it does.
Non-accredited certification
BIS is aware that some certification bodies and certification body representative associations are concerned at the increase in the number of UK organisations offering non-accredited certification.
For more information, have a look at Conformity Assessment Accreditation Policy on Accreditation and Conformity Assessment, and specifically to section 3.4 on the application of the accreditation principles:
“In applying these principles, the Department for Business Innovation & Skills:
recommends Conformity Assessment Bodies to be accredited by the National Accreditation Body
recommends UK businesses, government and local authorities requiring third party conformity assessment services to source such services, where they exist, from conformity assessment bodies accredited by a National Accreditation Body”
BIS has further advised certification representative organisations in the UK that:
You can only get ‘accreditation’ (in the UK) from United Kingdom Accreditation Service through the regulation. Any organisation that is suggesting it is accredited in the sense of the regulation when they are not, is likely to be guilty of an offence under the Business Protection from Misleading Marketing Regulations 2008 (Statutory Instrument 2008/1276).
Certification bodies or representative organisations should refer these cases to trading standards or the Office of Fair Trading in the first instance.
European regulation on standardisation
A seminar was arranged by BIS for 7 November to give an overview of the recent European Regulation on Standardisation (Regulation (EU) No 1025/2012 on European Standardisation). The seminar included presentations from the European Commission and the British Standards Institution (BSI) as well as BIS.
The regulation and the presentations
European Regulation
The regulation on European standardisation
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BSI presentation - The UK national standards body response to the new European standardization regulation
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ICT standardisation in Europe - a participant view
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European standards regulation - UK government response
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A short question and answer session followed the presentation. The answers given are set out below.
How can consistency of mandated standards be maintained across related sectors?
The annual work programme arising from the Regulation will afford more time to scan the horizon and help identify what needs to be done to maintain a balance of mandated standards across related sectors. Ultimately however whether standards are chosen as an option, as well as what standards are mandated, depends on what the legislators choose to opt for.
How does conformity assessment fit with the Regulation?
Standards makers will ensure that standards are clear and, where appropriate, written in a format suitable for conformity assessment. Some standards however are not intended to be used in conjunction with conformity assessment and will be clearly identified as such.
Will it be possible for non-members to be an observer at meetings of the Multi-Stakeholder Platform (MSP)?
MSP has a large and diverse membership. To extend attendance wider would serve only to make the MSP unwieldy and reduce its effectiveness. Other stakeholders are encouraged to make their views known through the existing members.
Will the Commission use the European Standards Organisations rather than develop its own “pseudo” standards?
This question may confuse “pseudo” standards with technical regulations.
The Commission hopes to persuade legislators of the desirability of using standards, as opposed to regulation, as a way of achieving policy goals. DG Enterprise will continue to push this view in its ambassadorial role with other DGs
Is the Commission bound to accept standards developed through the mandating process?
Yes: unless the standard thus developed does not meet the mandate requirements.
How can UK SME interests be better represented, for example, in ETSI?
There exists extensive UK SME representation at ETSI and CEN/CENELEC. Establishing some new body to represent UK SME interests at the European standardisation level is unlikely, in itself, to improve communication. SMEs should engage with existing representatives such as the national standards body, the ETSI UK members meetings, the Federation of Small Businesses or their specialist trade association.
BSI has been leading work in CEN/CENELEC to develop a toolbox that will facilitate SME involvement in standardisation.
How will the continuity of expertise and knowledge resident in individuals be maintained?
BSI works with BSI committees in maintaining continuity and recruiting new experts to committees and will increase its activities in this respect over the coming year. BSI will throw the net wider to create opportunities to become engaged in the knowledge side of standards drafting even if they are not immediately engaged in the standardisation process.
How from a regulation perspective to drive standardization?
UK government and UK companies are well represented in standards development; indeed the UK is one of the largest participants in that arena in Europe. This means that the UK already has a lot of inherent synergy between these two areas. These links need to be maintained as well as regular contact and interaction.
How to drive M2M, Cloud Computing standardization from regulatory perspective? It seems the drivers are mainly from industry and private sectors.
These are areas in which a lot of fora and consortia standards are used and can therefore be difficult for the regulatory side to access. The MSP provides direct links with major bodies in the fora and consortia space. ETSI and the other ESOs are working with the Commission on initiatives that address M2M and cloud directly, as well as on actual standards work on these areas. This should allow direct interaction between standards work and regulatory issues to be worked through.
What role does the panel see for the UK standardisation: assessment and certification to sell UK complex standards, certification and assessment practices overseas?
The role of the National Standards Bodies is crucial both now and going forward as it is at national level that the viewpoints of industry, especially SMEs but government and other parties as well, are best heard. Standards should nevertheless be produced at the most appropriate level. The UK supports the development of international standards where possible, but also European standards in the case where the standard will support EU regulation. National standards will continue to be a useful tool for specific local issues and for acting as a trial for new specifications that are subsequently rolled out internationally.
In the European Standardization Regulation, much is aimed at the needs of SMEs, Consumers and Societal Stakeholders, but little regard is paid to the needs of industry, not just manufacturers but architects, designers, structural and civil engineers, those who use a wide range of standards every day, Why is this group ignored?
The Commission and the Standards Bodies see ’industry’ as the backbone of the standardisation system. European and National Standardisation has traditionally been organised to meet the needs of industry - this is why the new European Standardisation Regulation acknowledges that it is important to capture the views of other stakeholders including SMEs, Consumers and Social and Environmental interests and ensure that they are also taken into account when developing standards. It is considered that as industry provides most of the participants in the standards making processes that necessary changes and developments from an industry perspective can readily be achieved by these participants.
EU Regulation 765/08 on accreditation and market surveillance
On 9 July 2008 the EU Parliament and the Council of the European Union adopted the EU Regulation 765/08 on Accreditation and Market Surveillance.
From 1 January 2010, the EU Regulation, for the first time, established a legal framework for providing accreditation services across Europe. The regulation lays down rules on the organisation and operation of accreditation of conformity assessment bodies in both the voluntary and regulated sectors.
Article 4(1) of Regulation 765/08 required that BIS appoint a single National Accreditation Body (NAB) for the United Kingdom. The Accreditation Regulations 2009 (Statutory Instrument 2009 No. 3155), laid in Parliament on 3 December 2009, appointed the United Kingdom Accreditation Service (UKAS) as the UK’s NAB.
The statutory instrument and explanatory memorandum are available from the legislation.gov.uk website.
In support of this statutory instrument, BIS signed, on 8 December 2009, a revised memorandum of understanding with UKAS.
Implementation of EU Regulation 765/08 on accreditation and Market Surveillance in the United Kingdom
On 9 July 2008 the EU Parliament and the Council of the European Union adopted the EU Regulation 765/08 on Accreditation and Market Surveillance.
From 1 January 2010, the EU Regulation established a legal framework for providing accreditation services across Europe. The regulation lays down rules on the organisation and operation of accreditation of conformity assessment bodies in both the voluntary and regulated sectors.
Drafts of both the statutory instrument and MoU were tabled at the UKAS Policy Advisory Committee on 1 October 2009 as well as being circulated to the BIS conformity assessment consultation group (ConCAss). While the main interest in these documents is contained within these 2 groups, they were open for comment to the public in general, and a copy is available below. BIS’s response to the comments received was made on 25 November 2009.
Concass September 2009 - Statutory Instrument and MoU
Response to comments and questions arising out of the BIS informal consultation
Open day presentations - 3 December 2008
DIUS open day presentation
DIUS open day presentation: text-only version
Agilent open day presentation
Agilent open day presentation: text-only version
Bureau Veritas open day presentation
Bureau Veritas open day presentation: text-only version
European Commission open day presentation
European Commission open day presentation: text-only version (
UKAS open day presentation
UKAS open day presentation: text-only version
Responses to stakeholder questions – February 2009
Read the responses to stakeholder questions here
British Standards Institution (BSI)
Our work in this area covers:
the government’s general policy on matters relating to standards-making (but not on the individual standards)
the government’s relations with the British Standards Institution (BSI) and its funding of BSI’s standards development work, including support for delegations representing the UK at overseas standards meetings and for consumer representation in standards-making activities
Consumer representation is vital in influencing the standards to reflect the needs and expectations of the general public for things like safety and security, labelling, accessibility, fairness and redress.
Find out more about consumer representation and BSI’s Consumer and Public Interest Network on the BSI website.
BSI itself is an independent body, established by Royal Charter in the 1920s, although its origins go back to 1901. Its HQ is at Chiswick. More information can be found on BSI’s own website
BSI and the Department for Business, Innovation & Skills recognise that, whilst the process of developing standards facilitated by BSI in the UK is a voluntary activity, there is a public interest in standardisation.
A revised memorandum of understanding (MoU) between BSI and the department was signed on 20 June 2002. The main changes from the previous MoU included:
incorporation of main points from the joint statement of the public interest
recognition that BSI has significant commercial businesses outside its NSB functions, and focuses on the relationship between the NSB and non-NSB sides - this has meant defining a ‘ring-fence’ both in terms of the use of public funds and in the precedence of the NSB as a whole
an indication of a willingness in principle to provide government support if the NSB runs into major difficulties
strengthening of the international and European context, including a specific reference to standardisation policy developed by the Council of the EU
clear encouragement to BSI to develop their standardisation business beyond traditional ‘full’ standards in response to new technology, globalisation, etc, coupling this with a specific obligation to avoid ‘new products’ spreading at the expense of full standards in circumstances where the new features of full standards are still required
The Memorandum of Understanding (MoU), provides a framework for BSI and the government to meet the challenges to the UK’s standards-making infrastructure.
Memorandum of Understanding between BSI and BIS
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Funding
The government’s funding of BSI standards work is provided in 2 main ways:
as direct financial support to BSI (which is linked to specific deliverables)
as help to those involved in the standards preparation work
The annual report on BIS funding to BSI is available on the BSI website.
See some of the project outputs resulting from the funding:
ISO 50001 energy management systems: case studies
BS 10500 specification for anti-bribery management system: case studies
BS 8905 framework for sustainable use of materials: case studies
BS 8909 specification for a sustainability management system for film: case studies
structuring knowledge: standards development briefing
Schemes
the Assisted International Travel Scheme provides a contribution towards the travel costs of the leaders of committee delegations to overseas standards meetings
the Consultancy Drafting Scheme allows the BSI technical committees to use an outside expert to help prepare the first draft of a standard that is needed quickly
the consumer travel expenses fund contributes to the travel costs of consumer representatives in national and overseas committees
As a condition on approval of funding of BSI and standards-making activities in 2000-2001, the Secretary of State for Trade and Industry requested that a study be carried out of the economic benefits of standardisation, in particular of the government’s financial support for standardisation.
Professor Peter Swann of Manchester Business School, conducted this study, beginning with a review of the literature in this particular field. The report of his study is available below in English, French and German, along with an update from May 2010 exploring developments and progress.
The Economics of Standardization - in English
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The Economics of Standardization - in French
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The Economics of Standardization - in German
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The Economics of Standardization: an update
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United Kingdom Accreditation Service (UKAS)
Under a MoU, UKAS is recognised as the sole UK organisation for the accreditation of certification, testing and inspection bodies to the EN 45000 and ISO 17000 series of standards. These bodies - the Conformity Assessment Bodies - in turn certify, test and inspect companies’ systems and products.
UKAS is licensed by BIS to use and confer the national accreditation symbols (formerly national accreditation marks) which symbolise government recognition of the accreditation process.
Information on UKAS and accredited organisations is available from the UKAS website. UKAS-accredited certification bodies and companies registered by UKAS-accredited certification bodies are listed in the United Kingdom Register of Quality Assessed Companies published by the Stationery Office.
UKAS accreditation provides an assurance of the competence, impartiality and integrity of conformity assessment bodies. UKAS-accredited certification, testing and calibration and inspection reduces the need for suppliers to be assessed by each of their customers.
UKAS’ involvement in international groups provides mutual recognition that reduces the need for multiple assessments of suppliers and helps to reduce barriers to trade. BIS therefore recommends the use of UKAS accredited conformity assessment services whenever this is an option.
UKAS also assesses potential Notified Bodies on behalf of BIS and other government departments according to the principles established by BIS.
Recent EC legislation
EC Regulation on accreditation and market surveillance [EC 765 of 2008]
EC Decision on a common framework for the marketing of products [EC 768 of 2008]
have received approval, following a review of the new approach. These are complementary and both aim to improve the free movement of goods within the internal market.
The regulation puts accreditation into a legal framework in the EEA, enhancing confidence in conformity assessment by strengthening the role of accreditation. It will also reinforce market surveillance structures to protect citizens from unsafe products (including those from outside the EU) and helps compliant businesses by removing those products from the market.
The decision, which will not have direct effect in member states, will set a formal framework for future European legislative proposals that fall within its scope. The scope is very broad for both proposals and includes all products subject to community harmonisation legislation (with notable exceptions such as food and medicines).
The decision contains additional measures that will be integrated into the legal framework as specific legislative proposals are brought forward. This will clarify commonly used procedures and terms (which are often used differently) so that all stakeholders can be clear on relative responsibilities. In addition there are new rules to enhance confidence in CE marking.
EU notification requirements: goods and electronic services
Directive 98/34/EC
EU Notification requirements for goods and electronic services is known as the Technical Standards and Regulations Directive 98/34/EC (as amended by Directive 98/48/EC).
The directive applies to ‘information society services’ (ie services supplied at a distance by electronic means and at the individual request of a recipient of services), and to all industrially manufactured products and agricultural products.
The directive aims to prevent new technical barriers to trade being created and has a procedure for providing information on technical standards and regulation. It applies to all member states, the European Economic Area (Norway, Iceland and Liechtenstein), EFTA (Switzerland) and Turkey.
Technical regulations
Regulations that need notification have to be notified to the commission in draft, and generally observe a 3-month ‘standstill’ period before the regulation is made or brought into force. This is so that the commission and member states can raise concerns about potential barriers to trade. If a notified regulation is considered as a barrier to trade, a detailed opinion may be submitted and this will extend the standstill period for a another 3 months.
BIS acts as the central unit for the UK, administering the notification procedure on behalf of government departments and receiving other member states’ notifications for onward transmission to the relevant department. Government departments involve industry as appropriate in their comments.
Directive 98/34 - a guide
Directive 98/34 sets up a legal mechanism, which requests member states to notify the commission and the other members of their technical regulations, at a draft stage, where amendments can still be introduced and a standstill period of 3 months observed before the draft technical regulation (except for urgencies, fiscal and financial measures) is adopted.
Form A for all government departments and agencies for notifying proposed technical regulations under Directive 98/34/EC
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Tool to see if a measure requires notification to the Commission and if a standstill period applies - The Technical Standards Directive (98/34/EC)
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Directive 98/34/EC: Procedure for the provision of information in the field of technical regulations and rules on information society services
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Guidance for officials. Avoiding new barriers to trade: Directive 98/34/EC (as amended by Directive 98/48/EC)
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Case study: non-notification of technical regulations under directive 98/34/ec – video recordings act 1984
In late 2009 there was a great deal of negative press coverage when it was discovered that the provisions of the Video Recordings Act 1984 were unenforceable as a result of the UK’s failure to notify the measure under Directive 98/34/EC. It was made clear that, because of the unenforceability of the regulations, legislation that would protect under 18s from unsuitable videos - potentially containing violent or sexually-explicit material - was never enacted.
Although non-notification of technical regulations falling within the scope of Directive 98/34/EC is not a major issue in the UK, the consequences of any failure to notify can be serious and steps h