dr peter hatto chairman iso/tc 229 and bsi/nti/1 ... · standardization seminar, 10 november 2011,...

Standardization seminar, 10 November 2011, step 1, slide 1

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Preparing for StandardizationDr Peter Hatto

Chairman ISO/TC 229 and BSI/NTI/1 Nanotechnologies standardization committees


Overview

• Background to standards and standardization• Recognising opportunities for standardization:• Research results appropriate for standardization• Standards for knowledge dissemination versus journal

publications• Standards versus patents – which option to choose?• What is needed before starting? – verification and

validation• Which type of standard deliverable?• Under which SO should a standard be developed? • Standardization project characterization template


StandardsStandards are of two types:

Metrological – standards of mass, length, time, etcWritten

Written Standards (also referred to as documentary standards) provide agreed ways of:

Naming, describing and specifying thingsMeasuring and testing things Managing and reporting things e.g. quality and environmental management:

• ISO 9001 and ISO 14000Good practice, as in e.g. ISO 26000 (Social Responsibility)

Standards can be:NORMATIVE, defining what MUST be done in ,e.g., a specific test method, in order to comply withthe standard;INFORMATIVE, providing information only,Most standards have both normative and informative elements

Standards are VOLUNTARY unless agreed to in a contract or referred to in Regulation, and are based on CONSENSUS (no sustained opposition), not necessarily unanimity


StandardsPlay a critical role in:

• ensuring the safety, quality, reliability and interoperability of products, processes and services;

• efficient production; • cost reduction through competition;• supporting regulation.

Provide a valuable tool for promoting innovation and commercialization by:• dissemination of good practice, • validation of new measurement tools and methods, • verification of new processes and procedures,• allowing comparison of measurement/characterization data by providing

repeatable measurement protocols.

Standards development couples ‘needs’ of stakeholders to available solutions – it is the role of Pre-Normative Research (PNR) to develop ‘solutions’ and of Co-Normative Research (CNR) to validate them.


Standards – “not essential to life but absolutely essential to modern living”.Standards are:– Ubiquitous – covering such things as shoe sizes, nuts and bolts, petrol

grades, warning signs, pipes and fittings, fire extinguishers, gas cylinders, shipping containers, electrical sockets and plugs, steel specifications, ....

– Virtually invisible to “the man in the street” – there some 18,000+ International Standards, many with multiple parts;

– Are absolutely critical to our modern way of life – covering things such as:– internet protocols, – aircraft fuels– credit cards, – business continuity management– quality and environmental management, – carbon trading, – sustainable development– life cycle costing– feed and food chain traceability– …………………………………..


How standards benefit us all – filling our cars with petrol or diesel fuel

SAFETY OF EQUIPMENTEN 13617-1:2004 +A1:2009Petrol filling stations - Part 1: Safety requirements for construction and performance of metering pumps, dispensers and remote pumping units

COMPATABILITY OF SYSTEMS

ISO 9158:1988Road vehicles -- Nozzle spouts for unleaded gasolineISO 9159:1988Road vehicles -- Nozzle spouts for leaded gasoline and diesel fuel

PERFORMANCE OF FUELS

EN 228:2008 Automotive fuels — Unleaded petrol — Requirements and test methods

EN 590:2009 Automotive fuels - Diesel -Requirements and test methods


How standard benefit us all – paying for our fuel, etc

CREDIT CARD SPECIFICATIONSISO/IEC 7810:2003Identification cards -- Physical characteristicsISO/IEC 7810:2003/Amd 1:2009Criteria for cards containing integrated circuitsISO/IEC 7811-1:2002 Identification cards -- Recording technique -- Part 1: EmbossingISO/IEC 7816-1:1998Identification cards -- Integrated circuit(s) cards with contacts -- Part 1: Physical characteristics

SECURITY OF SERVICEISO 9564-1:2002Banking -- Personal Identification Number (PIN) management and security -- Part 1: Basic principles and requirements for online PIN handling in ATM and POS systemsISO 9564-2:2005Banking -- Personal Identification Number management and security -- Part 2: Approved algorithms for PIN encipherment

Credit cards in perspective:

In 2007 one credit card company had:

20,000 member banks;

1.59 billion cards in circulation accepted in 170 countries

59 billion transactions per year at peaks of 6,800 per sec

Annual transaction volumes of $4.8 trillion

all requiring consistent and reliable message exchange based on standards


Principal Formal Standards Organisations• National:

– AENOR, AFNOR, BSI, DIN, ……..• Publications: National standards (EN’s, adopted IS documents, and national

publications• European:

– CEN: European Committee for Standardization• 31 national members• Publications: ENs, TS, TR and CWA

– Also CENELEC (European Committee for Electrotechnical Standardization) and ETSI (European Telecommunications Standards Institute)

• International:– ISO: International Organization for Standardization

• Around 160 national members• Publications: IS, TS, TR, PAS, IWA

– Also IEC (International Electrotechnical Commission) and ITU (International Telecommunications Union)

• Many ‘informal’ SDOs:– ASTM International, IEEE, SAE, SEMI, TAPPI,…….


Formal standards• Developed in Project Groups working in Working Groups (WGs) within

Technical Committees (TCs, or SubCommittees - SC) responsible for a particular area of standardization

• ~400 TCs in CEN• ~250 TCs in ISO

• Horizontal committees develop standards that provide underpinning support to all, or a number of different, sectors, e.g.

• ISO TC 176: Quality management and quality assurance • ISO TC 46: Information and documentation • ISO TC 229: Nanotechnologies• Not usual in CEN

• Vertical committees develop standards relevant to specific sectors, e.g.• ISO TC 61: Plastics• ISO TC 34: Food products• CEN TC 184: Advanced Technical Ceramics

• ISO and CEN can cooperate on projects under the terms of the ‘Vienna Agreement’. This provides for joint working between the two organizations.Projects are led by either the ISO of CEN committee involved. Outputs are voted separately by both organisations. The process is designed to provide harmonized ISO and CEN standards and to make efficient use of resources.


Typical TC working group structure

Technical Committee ‘P’ (participating), ‘O’ (observer) and

‘L’ (liaison) members + Chairman and Secretary

Working Group National experts

+ Convenor Working Group National experts

+ Convenor

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+ Convenor


Typical TC structure for TCs with sub-committees

Sub-Committee ‘P’, ‘O’ and ‘L’ members

+ Chair and Secretary







+ Convenor

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+ Convenor



+ Convenor

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+ Convenor



+ Convenor

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+ Convenor

Technical Committee‘P’ (participating), ‘O’ (observer) and

‘L’ (liaison) members + Chairman and Secretary


+ Convenor Working GroupNational experts

+ Convenor

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+ Convenor


Recognising opportunities for standardization

• Standard‘document, established by consensus and approved by a recognized body, that provides, for common and repeated use,rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given contextNOTE Standards should be based on the consolidated resultsof science, technology and experience, and aimed at the promotion of optimum community benefits’[ISO/IEC Guide 2:2004, definition 3.2]

• promote a uniform approach to doing something through a transparent, open access process.

• developed for the general good of stakeholders and should not support the commercial or other interests of a single organization.


Research project outputs suitable for standardization

– Repeatable techniques for:• analysing, characterizing, identifying, manipulating,

measuring, etc– Repeatable procedures for:

• handling, preparing, testing, etc– Guidance on:

• dispersing, disposal, handling, specifying, etc– Significant modification of an existing standard to

make it applicable:• at a different length scale, to different materials, under

different conditions, etc


Standards versus patents – which option?

Standards• Represent agreement (consensus) between experts about the

best way of doing something. • The adoption of standards should support efficiency and

overall cost reduction through competition whilst ensuring product quality, interoperability, safety and reliability.

• They do not require an inventive step, rather they document ‘good practice’.

• There is no charge for applying a standard, though there might be costs associated with compliance.

• The cost of developing a standard is relatively low for the individual participants, being mainly the cost of taking part inmeetings, though there might also be fees for membership of the relevant SDO or ‘national committee’, which need to be factored in, and cost associated with validating the standard.


Patents• Designed to protect the intellectual property of an inventor

and to limit the scope of competitors to gain access to the market for products or services based on that invention.

• The cost of obtaining, maintaining and possibly defending a patent can be considerable and a clear commercial benefit should be identified, either from direct exploitation, licencingor selling to another organisation, before embarking on acquiring patent protection.

• Patents require an inventive step - something that is not obvious to ‘those skilled in the art’, i.e. something that another expert would not do as a matter of course as a consequence of their training.

• Questions to consider: – inventive step?– commercial potential sufficient to offset cost of protection? – potential life time of invention?


What is needed before starting?

• Research results need to be:– reproducible and repeatable, i.e. give the same

results, within statistical error, when repeated by a single user and by multiple users;

– Relevant to other stakeholders;– Generic, i.e. not dependent on use of a particular

piece of equipment available from only one source;

• Commitment of those involved!


Which type of standards deliverable?• Depends on maturity of the subject matter, relevance of the subject to an

existing standards body and committee, and geographical relevance.• Research outputs more likely to be relevant for publication as a PAS

(national or ISO only), TS or TR or as a Workshop Agreement (CEN or ISO).

• CWA and IWA routes directly involve stakeholders, but have cost and organisational implications and are not usually appropriate where the subject matter is covered by an existing TC;

• TR are informative only and shall not contain requirements• TS are expected ultimately to become full standards in CEN or ISO, hence

the approval criteria are similar to those for EN and IS. In particular, ‘weighted’ voting applies in CEN, where all members have a vote. This can be more onerous than getting a 2/3 majority in ISO, where only the ‘P’members of the particular TC vote on a TS.

• National standardization routes should not be overlooked – they can be quicker and could provide the basis for subsequent proposal to CEN or ISO.

• The more formal products (TS, EN and IS) can take significant time before publication – typically two – three years, though all are strictly timetabled.


Under which organisation should a standard be developed – CEN or ISO?• Geographical relevance of subject matter;• Relevance of subject matter to the focus of existing

TCs, e.g.– ISO/TC 147 ‘Water quality’ deals with validated

measurement methods for chemical, biological and radiological contaminants, whereas CEN/TC 164 ‘Water supply’ deals with specifying materials that come into contact with potable water;

• Cost and time implications of participating in ISO project meetings;

• Availability of financial support – for EU ‘mandated’work, funding might be available to CEN TCs but would not be available to ISO TCs


Development of standards• Whilst details vary, all standards development has essentially four

stages:– Proposal stage

– Proposals for new standards submitted to the relevant committee by one or more members of the standardization body (NSB’s in the case of CEN and ISO).

– Approved for development if supported by sufficient members;– Project stage

– The draft, submitted by the proposer, is developed into a consensus document (FWD) by a group of experts, nominated by members wishing to participate in the work. Experts act as individuals, not as representatives of either their MB or their employer;

– Enquiry stage– Consensus document is reviewed by the relevant membership - either the TC

(for PAS, TS and TR in ISO) or the full membership (for DIS in ISO and for TS, TR and EN in CEN). Document modified to take account of comments submitted;

– Approval stage– Modified document (FDIS in ISO, prEN in CEN) balloted by the full

membership.The goal at each stage is to reach consensus amongst the parties involved


Consensus - 1‘general agreement, characterized by the absence of sustained opposition to substantial issues by any important part of the concerned interests and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting argumentsNOTE Consensus need not imply unanimity.’[ISO/IEC Guide 2:2004, definition 1.7]

• In formal standardization following the procedures laid down in the ISO/IEC Directives, all published standards achieve consensus at two levels:– the experts nominated to develop the FWD– the wider stakeholder community represented by the mirror

committees of the MBs that take part in the various ballots.


Consensus - 2

• For practical purposes:– In ISO, consensus means >2/3 of the responsible TC ‘P’ members

voting are supportive and <25% of total votes are negative;– In CEN, consensus means >71% of weighted votes are supportive.

• True consensus can only be achieved if experts and members ‘vote’ from a position of knowledge and national mirror committees make it their responsibility ‘to take into account the views of all parties concerned’. Voting approval (or disapproval) without having or referring to national experts undermines the principle of consensus.

• Possible additional question for the ballot forms:– ‘Have you read this document and do you have the expertise to review

it?’– ‘Have you any comments to submit ?’ (for ballots prior to Approval)


Standardization project characterization template - 1

Name and acronym of FP project:Specific research result identified as relevant to standardization: Template completed by:

Characteristic Criterion Response/StatusWhy is the result relevant to standardization and what purpose could it serve?Who are the possible contributors in the consortium?Are they prepared to participate in developing a standard in this area?What are their expected benefits?Do they see any obstacles and, if so, what are they?Are there IPR issues involved?What are the estimated costs of taking the result to a finished standard?Have appropriate searches been undertaken to establish whether relevant National, European or International standards in the area already exist or are under development? If so, provide a list of standards and relevant technical committeesHow will the new standard complement existing documents?Workshop Agreement (WA)Publicly Available SpecificationTechnical ReportTechnical SpecificationFull standard

Specific research result

Type of standard deliverable planned – please specify


Standardization project characterization template - 2

NationalEuropean (CEN/CENELEC/ETSI)International (ISO/IEC/ITU)Other - please specifyHas a relevant Technical Committee (TC) for the project been identified? Is so please specifyIf a WA is planned has the TC route been fully evaluated?For a WA has a National Standards Body (NSB) been identified to help plan and host the workshop? If so please specifyWho will lead the development of the standard or WA?

New Work Item Proposal (NWI P)

Has a New Work Item Proposal or Workshop business plan been prepared?Has this been submitted to an appropriate NSB? If so please specify.

NWIP stage Has the NSB submitted the NWIP to the relevant TC If so please specify th TCStandardization

projectHas the standardization project been approved for development? If so what is the expected publication date?

Pre-approval Is the document under ballot? If so please specify ballot stage and closing date of ballot.Has the document been approved?What was the result?Are there comments to be resolved?Are there additional ballot stages before publication? If so specify what they are and when they are likely to be completed.

Publication Has the document been published? If so please state when. If not please indicate publication date.

Development route

Approval

dr peter hatto chairman iso/tc 229 and bsi/nti/1 ... · standardization seminar, 10 november 2011,...

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