Standardization seminar, 10 November 2011, step 2, slide 1 Notice : Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the information contained in this presentation CIMATEC Srl, Viale San Bartolomeo, 103 – LA SPEZIA – ITALY Email: [email protected]The Standards Development Process Dr Peter Hatto Chairman ISO/TC 229 and BSI/NTI/1 Nanotechnologies standardization committees
Transcript
Standardization seminar, 10 November 2011, step 2, slide 1
Notice : Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the information contained in this presentation
CIMATEC Srl, Viale San Bartolomeo, 103 – LA SPEZIA – ITALY Email: [email protected]
The Standards Development Process
Dr Peter HattoChairman ISO/TC 229 and BSI/NTI/1
Nanotechnologies standardization committees
Standardization seminar, 10 November 2011, step 2, slide 2
Overview
– The ISO/IEC directives and CEN Internal Rules– Workshop agreements:
• purpose, • process, • Business Plan
– Formal standards:• The New Work Item Proposal and approval• Overview of development process• The role of experts and commitment required• Essential elements of a standard• Conditional and discretionary elements • Normative versus informative elements of the text
– Development and review checklist
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ISO/IEC Directives - regulate standards development in ISO, IEC, CEN and CENELEC
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CEN and ISO Workshop Agreements
• Relevant to emerging and areas not sufficiently stable for more formal standardization
• Represents consensus amongst stakeholders participating in a Workshop on the specific subject;
• There are costs involved in paying for the secretariat and organisation of the Workshop, which might require a charge to be made for participating in it.
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Workshop Business Plan contents
1. Status of BP – draft, draft for approval, approved;2. Background to Workshop;3. Workshop proposer and Workshop participants;4. Workshop scope and objectives;5. Workshop programme;6. Workshop structure;7. Resource requirements;8. Related activities, liaisons, etc;9. Contact points – e.g. Workshop chairperson,
Workshop secretariatiat, CCMC contact, etc10. Annex(es) where necessary
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The New Work Item Proposal and approval processesProposal (to be completed by the proposer)
Title of proposal (in the case of an amendment, revision or a new part of an existing document, show the reference number and current title)
English title
French title (if available)
Scope of proposed project
Concerns known patented items (see ISO/IEC Directives Part 1 for important guidance)
Yes No If "Yes", provide full information as annex
Envisaged publication type (indicate one of the following, if possible) International Standard Technical Specification Publicly Available Specification Technical Report
Purpose and justification (attach a separate page as annex, if necessary)
Target date for availability (date by which publication is considered to be necessary)
Proposed development track 1 (24 months) 2 (36 months - default) 3 (48 months) Relevant documents to be considered
Relationship of project to activities of other international bodies
Liaison organizations
Need for coordination with: IEC CEN Other (please specify)
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d) Purpose and justification: Give details based on a critical study of the following elements wherever practicable. Wherever possible reference should be made to information contained in the related TC Business Plan .1) The specific aims and reason for the standardization activity, with particular emphasis on the aspects of standardization to be covered, the problems it is expected to solve or the difficulties it is intended to overcome.2) The main interests that might benefit from or be affected by the activity, such as industry, consumers, trade, governments, distributors.3) Feasibility of the activity: Are there factors that could hinder the successful establishment or global application of the standard?4) Timeliness of the standard to be produced: Is the technology reasonably stabilized? If not, how much time is likely to be available before advances in technology may render the proposed standard outdated? Is the proposed standard required as a basis for the future development of the technology in question?5) Urgency of the activity, considering the needs of other fields or organizations. Indicate target date and, when a series of standards is proposed, suggest priorities.6) The benefits to be gained by the implementation of the proposed standard; alternatively, the loss or disadvantage(s) if no standard is established within a reasonable time. Data such as product volume or value of trade should be included and quantified.7) If the standardization activity is, or is likely to be, the subject of regulations or to require the harmonization of existing regula-tions, this should be indicated.If a series of new work items is proposed having a common purpose and justification, a common proposal may be drafted including all elements to be clarified and enumerating the titles and scopes of each individual item.
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Preparatory work (at a minimum an outline should be included with the proposal)
A draft is attached An outline is attached. It is possible to supply a draft by
The proposer or the proposer's organization is prepared to undertake the preparatory work required Yes No
Proposed Project Leader (name and address)
Name and signature of the Proposer (include contact information)
Comments of the TC or SC Secretariat Supplementary information relating to the proposal
This proposal relates to a new ISO document;
This proposal relates to the amendment/revision of an existing ISO document;
This proposal relates to the adoption as an active project of an item currently registered as a Preliminary Work Item;
This proposal relates to the re-establishment of a cancelled project as an active project.
Other:
Voting information The ballot associated with this proposal comprises a vote on:
Adoption of the proposal as a new project
Adoption of the associated draft as a committee draft (CD)
Adoption of the associated draft for submission for the enquiry vote (DIS or equivalent)
Other:
Annex(es) are included with this proposal (give details)
Date of circulation
Closing date for voting
Signature of the TC or SC Secretary
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Approval of NWIPs
• 3 month ballot• Approved for development in ISO if:
– >50% of the P members voting approve its development, AND
– 5 or more ‘P’ members agreed to participate in its development
– No formal requirement for a NWIP ballot for TRs.
• Approval for development in CEN if– >72% of weighted votes of those members voting approve
its development (for TS and EN, for TR a simple majority of members voting is required), AND
– 5 or more members agree to participate in its development
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Standards development in CEN and ISO
– P and L members may participate in the development of standards,though only P members have the right (indeed the obligation) to vote on TC matters in ISO – in CEN all 31 members may vote.
– To be a P member of a TC a NSB (MB) must have a national ‘mirror committee’ representing national stakeholders, which develops a national position on items under ballot, appoints national experts for project development, and prepares New Work Item Proposals.
• In the UK the BSI ‘mirror committee’ for the CEN, ISO and IEC nanotechnologies standardization committees, CEN/TC 352, ISO/TC 229 and IEC/TC 113, is NTI/1.
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Development of international standards – similar process for CEN standards
New Work Item Proposal from member body3 month ballot - approved if at least 5 Pmembers agree to participate
Working draft
Final draft
Development by nominated experts
3 month review and ballot by committee
First Committee Draft
Final Committee DraftPublish as TS or TR
5 month review and ballot by all ISO members
Draft International Standard
Final Draft International Standard2 month ballot of all ISO members
Published as International Standard
Consensus amongst experts
Consensus amongstall ISO members
Also ISO Workshop Agreement
Publish as PAS
‘Enquiry’ stage
‘Approval’ stage
‘Proposal’ stage
‘Project’ stage
Consensus amongst TC members
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The role of experts and commitment requiredExperts:• nominated by the members of the Standards
Organisation that wish to participate in the project;• nominated for their expertise and act as individuals
not as representatives of their nominating body or their employer;
• work with the Project Leader to develop the draft (submitted with the NWIP or subsequently) into a consensus Final Working Draft within about 12 months.
• need to participate actively, both by taking part in meetings, if possible, and by timely response to drafts for comment.
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Essential elements of a standard
• Title – must reflect the ‘scope’– usually three element
• An introductory element indicating the general field to which the document belongs (typically title of TC);
• a main element indicating the principal subject treated within that general field;
• a complementary element indicating the particular aspect of the principal subject or giving details that distinguish the document from other documents, or other parts of the same document.
– e.g. EN ISO 15614-7:2007 - Specification and qualification of welding procedures for metallic materials - Welding procedure test - Part 7: Overlay welding (ISO 15614-7:2007), and
– ISO 13555-2:2003 - Diesel engines -- Procedure for checking the dynamic timing of diesel fuel injection equipment -- Part 2: Test method
• Foreword – formal element not prepared by the project group and not voted on during ballots
• Scope – must reflect the title– defines without ambiguity the subject of the document and the aspects covered,
indicating the limits of applicability of the document or particular parts of it. It does not contain requirements.
• All other elements are conditional upon the type of document andinformation to be provided in the standard
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Conditional and discretionary elements• Introduction – discretionary element – provides background information – puts the
document in context. Must not contain requirements or recommendations;• Normative references – conditional;• Terms and definitions - conditional;• Symbols - conditional;• For test methods (conditional)
– a) principle; – b) reagents and/or materials– c) apparatus – d) preparation and preservation of test samples and test pieces;– e) procedure; – f) expression of results, including method of calculation, precision of the test method,
and the measurement uncertainty; – g) test report.
• Normative annex(es) – conditional;• Informative annex(es) – conditional – must not contain requirements;• Bibliography• Notes, examples, footnotes – conditional – all informative hence must not contain
requirements.
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Normative versus informative elements of the text
• Normative elements contain requirements:– must be met in order to comply with the standard –
usually indicated by the use of the word ‘shall’ or by being written in the imperative.
– must be verifiable• Informative elements are for information only
and must not contain requirements - must not use the word ‘shall’.
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Development and review checklist (courtesy ISO/TC 229)
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