ANSI REFRESHER COURSE 2019 CHANGES TO THE ISO DIRECTIVES

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2019 ISO DIRECTIVES, PART 1 UPDATES COURSE GENERAL What Has Changed? In keeping with decisions of the ISO/TMB to foster greater project management discipline in ISO committees, and with the introduction of a new ISO project management methodology and clarified committee leader roles, the title of “Committee Secretary” has been changed to “Committee Manager” throughout the Directives, Part 1. Impact on US Persons Serving as ISO Committee Leaders: Committee managers should review the latest ISO/TMB document on committee leader roles and responsibilities and understand the expectations of committee managers going forward. ISO is developing training for committee managers in this role and with the new expectations. When the ISO training is available, ANSI will adapt it and offer such training to ISO committee managers in the USA. Impact on US/TAGs: None. © 2019 3

2019 ISO DIRECTIVES, PART 1 UPDATES COURSE FOREWORD What Has Changed? In section e) on General principles for voting and decisions, the following new text has been added: When a document is out for ballot (NP, CD or any later stage) formal discussion during meetings or distribution of National Body positions via formal committee distribution channels are prohibited. Impact on US Persons Serving as ISO Committee Leaders: Committee chairs, committee managers, WG convenors and project leaders shall ensure that no formal discussions takes place on the agenda of a meeting of a document that is currently out for ballot at the time of that meeting. This will help to prevent inappropriate discussions and lobbying seeking to influence the outcome of the voting. Committee leaders will also ensure that official committee sites and communications channels are not used by National Bodies or experts to share national positions and comments in order to seek support for them. It is more appropriate for National Bodies, delegates and experts to seek support and network on voting positions by other means. Impact on US/TAGs: US/TAGs and US delegates and experts shall find other electronic means to share positions and comments and to seek support. Please note that the sharing of national positions and comments on open social media platforms is not appropriate. © 2019 4

2019 SO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 1. 8 2019 SO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 1.8.1 – APPOINTMENT OF COMMITTEE CHAIRS What Has Changed? New text has been added to this clause that reads: Where two NSBs agree to share the leadership of an ISO committee, they may jointly identify a chair and jointly agree the way in which they will support that chair. In such cases, the NSB holding the committee secretariat is encouraged to nominate a chair from the other NSB. For the purposes of transparency, the NSBs involved shall inform the committee members of any cooperative relationships. Impact on US Persons Serving as ISO Committee Leaders: In cases where two NSBs voluntarily agree to share the leadership of the committee, they will mutually agree on which country will hold the committee chair positions and which country will hold the committee manager position. As all procedures for appointment of committee chairs will still be followed in such cases, the committee manager will nominate the committee chair, presumably from the other national body partner, to the TMB for approval. The committee manager shall ensure that all P and O members of the committee are fully aware of any such agreements and arrangements. Impact on US/TAGs: To support cases, where appropriate, where ANSI and another NSB wish to share leadership, and to support the proposed delineation of responsibilities between ANSI and the partner NSB. © 2019 5

2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 1. 8 2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 1.8.3 – TWINNED CHAIRS What Has Changed? The first paragraph of this clause has been revised as follows, in keeping with new ISO/TMB decisions in 2018 to improve twinning in ISO: Committees are encouraged to establish chair level twinning arrangements where one ISO member body acts as the lead partner and the other ISO member body as the twinned partner (with a limit of one twinned-chair per committee). Twinned- chairs shall be a P-member (i.e. any P-member whether through a twinning arrangement or not) in the committee concerned. The same rules apply for the appointment and term of chairs and twinned-chairs. The delineation of responsibilities shall be decided by mutual agreement and recorded in a twinning agreement between the two member bodies nominating the chair and the twinned-chair, with the committee members and the office of the CEO being informed accordingly. Impact on US Persons Serving as ISO Committee Leaders: To implement this clause as stated above, including the documentation of the arrangements in a mutual twinning agreement and informing all committee members and ISO Central Secretariat of any such arrangements. Impact on US/TAGs: None. © 2019 6

The following new text has been added to this clause: 2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 1.9.1 – NSB COOPERATION ON SECRETARIATS What Has Changed? The following new text has been added to this clause: Two NSBs may cooperate on the work of an ISO committee secretariat, to support one another on strategic thinking and to share the resource burden of the work. However, only one of these parties will be considered the official committee secretariat and such arrangements shall not be considered “cosecretariats”. For the purposes of transparency, the NSBs involved shall inform the committee members of any cooperative relationships. Impact on US Persons Serving as ISO Committee Leaders: Committee managers in the USA who choose to work with support from another NSB may do so, defining the delineation of the work. Alternatively, we may choose to support another NSB that holds the committee manager role. In all cases, all members of the committee shall be fully informed of the arrangements. Impact on US/TAGs: To support cases, where appropriate, where ANSI and another NSB wish to share responsibilities for the committee manager role, and to support the proposed delineation of responsibilities between ANSI and the partner NSB. © 2019 7

2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 1. 9 2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 1.9.2 – TWINNED CHAIRS What Has Changed? The following text has been added to this clause, in keeping with new ISO/TMB decisions in 2018 to improve twinning in ISO: Member bodies are encouraged to establish twinning arrangements between a secretariat and a twinned secretariat with a limit of one twinned secretariat per committee. The lead partner will hold the secretariat and the twinned partner the twinned secretariat. Twinned secretariats shall be from member bodies holding P-membership in the committee concerned (either directly or via a twinning arrangement). The same rules apply for the allocation of secretariats and twinned secretariats, as well as secretaries and twinned secretaries. The delineation of responsibilities shall be decided by mutual agreement between the member bodies concerned, and recorded in the twinning agreement, with the committee members and the office of the CEO being informed accordingly. Impact on US Persons Serving as ISO Committee Leaders: To implement this clause as stated above, including the documentation of the arrangements in a mutual twinning agreement and informing all committee members and ISO Central Secretariat of any such arrangements. Impact on US/TAGs: None. © 2019 8

2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 1. 12 2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 1.12.1 – WORKING GROUPS What Has Changed? The following text has been added to this clause, in keeping with new ISO/TMB decisions in 2018 to improve twinning in ISO: The convenor may be supported by a secretariat, as needed. The nomination of the working group secretary shall be confirmed by his/her National Body. Committees are encouraged to establish arrangements between a convenor and a twinned convenor, with a limit of one twinned convenor per working group. The lead partner (convenor) and twinned partner (co-convenor) will be decided by mutual agreement. Convenors and twinned convenors shall be from the P-members in the committee concerned. The same rules apply for the appointment of convenors and twinned convenors. Note that twinned convenors are only possible through twinning arrangements. Co-convenors are only possible in Joint Working Groups (JWG) — see 1.12.6. Impact on US Persons Serving as ISO Committee Leaders: WG convenors shall implement this clause as stated above. Impact on US/TAGs: To support, where appropriate, the nomination of working group secretaries from the USA. © 2019 9

2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 1. 12 2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 1.12.2 – WORKING GROUPS What Has Changed? The following text has been added to this clause: Experts not registered to a working group in the ISO Global Directory or the IEC EMS respectively, shall not participate in its work. Convenors may invite a specific guest to participate in a single meeting. Impact on US Persons Serving as ISO Committee Leaders: WG convenors and secretaries shall ensure that only those persons officially registered in ISO Global Directory participate in the working groups. Convenors may invite guests to working group meeting who may be able to present relevant information that cannot be gained through an official WG expert to support the working group’s efforts. However, these invitations shall be for a single meeting only and cannot be blanket invitations for such guests to attend any and all working group meetings. Convenor shall issue separate invitations for each meeting at which they would like a specific guest to be present. However, such guests are there only to provide information and shall not actively participate in working group decisions on the content of the draft documents. Impact on US/TAGs: To inform ANSI when it is perceived that working group convenors are allowing unofficial participants or where guests are exceeding the expectations of their engagement. © 2019 10

2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 1. 12 2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 1.12.6 – JOINT WORKING GROUPS What Has Changed? Text has been added to this clause to clarify that the committee having lead for a JWG shall do the following: conduct the call for experts in all committees that are part of the JWG; be responsible for addressing comments (usually referred back to the JWG) and ensure that the comments and votes at all stages of the project are compiled and handled appropriately (see 2.5, 2.6 and 2.7) — all comments are made available to the leadership of the committees; prepare drafts for the committee, enquiry and approval stages according to procedures given in 2.5, 2.6 and 2.7; send all relevant documents (minutes, Working drafts, drafts for the committee, enquiry and approval stages) to the secretariat of the other committee(s) for circulation in their respective committee and/or action; Impact on US Persons Serving as ISO Committee Leaders: US convenors of JWG shall implement the activities indicated above, among their other roles as JWG convenors. Impact on US/TAGs: To inform ANSI in cases where experts from other committees involved in JWGs do not believe that the lead committee is conducting the activity in a way that is fair to all committees involved. © 2019 11

2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSES 1. 13. 2 & 1. 13 2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSES 1.13.2 & 1.13.6 – ADVISORY GROUPS What Has Changed? In order to provide greater integrity and responsiveness to participating (P) members, text has been revised to read as follows: 1.13.2 A proposal to establish such a group shall include recommendations regarding its constitution and terms of reference, including criteria for membership, bearing in mind the requirement for sufficient representation of affected interests while at the same time limiting its size as far as possible in order to ensure its efficient operation. Members of advisory groups shall be committee officers, individuals nominated by National Bodies and/or, as relevant, by A-liaison organizations. The parent committee shall approve the final constitution and the terms of reference prior to the establishment of and nominations to the advisory group. For chair’s advisory groups, consideration shall be given to the provision of equitable participation. 1.13.6 Such a group shall be disbanded once its specified tasks have been completed and agreed by the parent committee. Impact on US Persons Serving as ISO Committee Leaders: Committee chairs and managers shall implement the provisions above in relation to any advisory groups formed by their committees. Impact on US/TAGs: To inform ANSI of any cases where the formation and composition of committee advisory groups may not be consistent with the text in 1.13.2 and 1.13.6. © 2019 12

2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 1. 17 2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 1.17.2 – APPROVAL OF LIAISON REQUESTS What Has Changed? The TMB has revised the process for approval of liaison requests as follows: In all cases, such requests shall be made to ISO/CS for assessment that the organization qualifies before the committee ballots the request. ISO will contact the NSB of the country where the potential liaison is located. The NSB will indicate its agreement or disagreement with the ISO assessment on whether the organization qualifies. The NSB may also raise any other concerns it may have as to why the liaison request should not be granted. If the ISO and NSB assessment on qualification disagree or if the NSB raises other objections to granting the liaison, the case will be presented to the ISO/TMB for decision on whether the liaison request should proceed to the committee for balloting. Impact on US Persons Serving as ISO Committee Leaders: Committee chairs and managers shall ensure that the ISO and NSB assessment on qualification occurs first before the committee ballots the liaison request. Impact on US/TAGs: None. © 2019 13

Impact on US Persons Serving as ISO Committee Leaders: 2019 ISO DIRECTIVES, PART 1 UPDATES COURSE CLAUSE 2.1.6 – SKIPPING THE FDIS STAGE What Has Changed? The text has been revised to indicate that the final draft International Standard (FDIS) shall be skipped if no technical changes incorporated as a result of comments resolution on the DIS stage. It is no longer optional to skip the FDIS stage if there are no technical changes. Impact on US Persons Serving as ISO Committee Leaders: Committee leaders shall ensure that their committees do not insist on an FDIS if there are no technical changes introduced after the DIS stage. Impact on US/TAGs: None. © 2019 14

Impact on US Persons Serving as ISO Committee Leaders: 2019 ISO DIRECTIVES, PART 1 UPDATES COURSE ANNEX B, CLAUSE B.4.2.2 – MODE 4, COLLABORATIVE RELATION What Has Changed? The text of this clause has been revised to clarify some points regarding the role of liaison representatives of other committees as follows: One organization takes the lead in the activities, but the work sessions and meetings receive liaison representatives from the other. Such liaison representatives should have the right to intervene in the debate but have no right to vote. The full flow of information is oriented through this liaison. Impact on US Persons Serving as ISO Committee Leaders: Committee leaders shall implement their liaison relationships and representatives as detailed above. Impact on US/TAGs: None. © 2019 15

Impact on US Persons Serving as ISO Committee Leaders: 2019 ISO DIRECTIVES, PART 1 UPDATES COURSE ANNEX L – MANAGEMENT SYSTEMS STANDARDS What Has Changed? The IEC/SMB has agreed that Annex SL of the previous ISO Directives, Part 1 shall also apply in IEC in relation to the development of IEC management system standards. Therefore, the previous Annex SL has been revised to be generic to both ISO and IEC and has been renamed as Annex L. Impact on US Persons Serving as ISO Committee Leaders: To continue to implement Annex L as they have been doing to date with Annex SL. Impact on US/TAGs: None. © 2019 16

Impact on US Persons Serving as ISO Committee Leaders: 2019 ISO DIRECTIVES, PART 1 UPDATES COURSE ANNEX M – SECTOR SPECIFIC MANAGEMENT SYSTEMS STANDARDS What Has Changed? The IEC/SMB has agreed that this Annex of the previous ISO Directives, Part 1 shall also apply in IEC in relation to the development of IEC sector specific management system standards. Therefore, the previous ISO annex has been revised to be generic to both ISO and IEC and has been renamed as Annex M. Impact on US Persons Serving as ISO Committee Leaders: To continue to implement Annex M as they have been doing to date with the previous Annex. Impact on US/TAGs: None. © 2019 17

2019 ISO DIRECTIVES, PART 1 UPDATES COURSE ANNEX SI, CLAUSE SI 2019 ISO DIRECTIVES, PART 1 UPDATES COURSE ANNEX SI, CLAUSE SI.9 – REVIEW OF ISO INTERNATIONAL WORKSHOP AGREEMENTS What Has Changed? Clause S1.9 has been revised as follows to reflect ISO/TMB decisions on the ongoing maintenance of IWAs that may relate to the work of an existing committee: If there is an existing ISO committee whose scope covers the topic, the published IWA shall automatically be allocated to this committee for maintenance. An IWA shall be reviewed three years after its publication. This review shall be organized by the member body which provided the workshop secretariat, or the committee which has been allocated the responsibility for the maintenance of the IWA. The review shall include the consultation of interested market players. The result of the review may be to confirm the IWA for a further three year period, to withdraw the IWA or to submit it for further processing as another ISO deliverable in accordance with Part 1 of the ISO/IEC Directives. Impact on US Persons Serving as ISO Committee Leaders: To implement the clause above for the ongoing maintenance of any IWAs that the ISO/TMB may assign to existing committees. Impact on US/TAGs: None. © 2019 18

Impact on US Persons Serving as ISO Committee Leaders: 2019 ISO DIRECTIVES, PART 1 UPDATES COURSE ANNEX SQ, CLAUSE SQ.3.1.4 – IT CAPABILITIES OF WORKING GROUP CONVENORS What Has Changed? Clause SQ.3.1.4 has been revised to indicate that convenors of working groups are required to have appropriate knowledge and capabilities in using MS Word based drafting tools and the ISO web-based applications, in order to support the working group’s work. Impact on US Persons Serving as ISO Committee Leaders: WG convenors in need of improving their IT capabilities should contact ANSI or ISO/CS for possible training and support. Impact on US/TAGs: None. © 2019 19

Impact on US Persons Serving as ISO Committee Leaders: 2019 ISO DIRECTIVES, PART 1 UPDATES COURSE ANNEX SR, CLAUSE SR.3 – REGULATORY AND LEGAL REFERENCES IN ISO STANDARDS What Has Changed? This clause has been extensively revised to reflect 2018 decisions of the ISO/TMB on what is and is not allowed in terms of references to regulation and legal aspects in ISO standards. Impact on US Persons Serving as ISO Committee Leaders: Committee leaders, especially WG convenors and project leaders, shall ensure that ISO standards are drafted in compliance with the details of this clause. Impact on US/TAGs: US/TAGs shall ensure that their positions and comments, as well as the input from US experts to WGs is in compliance with this clause. © 2019 20

2019 ISO DIRECTIVES, PART 1 UPDATES COURSE ANNEX ST - TWINNING What Has Changed? This Annex is new and has been added to the Directives to provide the details of 2018 ISO/TMB decisions regarding twinning in ISO committees in order to support capacity building is less capable countries. The details are extensive and cannot be summarized easily, so all parties are encouraged to review this Annex if they are considering new or maintaining existing twinning arrangements. Impact on US Persons Serving as ISO Committee Leaders: All committee leaders shall understand and comply with the provisions of this Annex for the establishment and maintenance of twinning arrangements. Impact on US/TAGs: None. © 2019 21

For questions on the content of this course, please contact Steve Cornish at scornish@ansi.org or 1-212-642-4969 For questions regarding compliance requirements for this course, please contact Sara Desautels at sdesautels@ansi.org or 1-212-642-4937

Once you complete this ISO Directives Refresher Course, please click here to complete the  registration form so your attendance can be recorded.  You must complete the registration form to comply with the ANSI Executive Standards Council (ExSC) requirement for training on new changes to the ISO Directives, processes and procedures that are introduced each year.  © 2019 23