IECEx
INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC) SYSTEM
FOR CERTIFICATION TO STANDARDS RELATING TO EQUIPMENT FOR
USE IN EXPLOSIVE ATMOSPHERES (IECEx SYSTEM)
For Consideration by Members of the IECEx Management Committee, ExMC
Report from the ExMC WG1 / WG5 Meeting held 25 May 2016 in Northbrook, USA
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Introduction
The attached is a report of the combined meeting of ExMC Working Groups WG1 (Revision of IECEx Scheme Rules) and WG5 (Manufacturer’s Quality System requirements) held on 25th May 2016 in Northbrook.
Members are asked to note this report and consider the following recommendations
• ExMC WG1 Recommendations #1, 2, 3, and 4
As mentioned in this report in preparation for the next ExMC meeting in Umhlanga, South Africa 8th and 9th September 2016.
Chris Agius
IECEx Executive Secretary
|Visiting address: |Contact Details: |
|IECEx Secretariat |Tel: +61 2 4628 4690 |
|Level 33 Australia Square |Fax: +61 2 4627 5285 |
|264 George Street |E-mail: info@ |
|Sydney NSW 2000 | |
|Australia | |
INTERNATIONAL ELECTROTECHNICAL COMMISSION SYSTEM FOR CERTIFICATION TO STANDARDS RELATING TO EQUIPMENT FOR USE IN EXPLOSIVE ATMOSPHERES (IECEx System)
MEETING REPORT and AGENDA
Combined Meeting of IECEx ExMC’s
Working Group WG1 – Revision of IECEx Scheme Rules and Procedures
and
Working Group WG5 – Quality System requirements of Ex Manufacturers
Held at UL LLC in Northbrook, IL, USA on
Wednesday 25th May 2016 (commencing 8:30 a.m.)
Working Group WG1 – Revision of IECEx Scheme Rules and Procedures
Attendance:
Marty Cole WG1 Convenor
Thorsten Arnhold IECEx Chairman
Alexander Zalogin IECEx Vice Chairman
Heinz Berger Certiconsult (CH)
Ron Sinclair SGS Baseefa (GB)
Julien Gauthier LCIE
David Adams QPS (CA)
Jasmin Omerovic UL International DEMKO A/S (DK)
Michael Slowinske UL LLC (US)
Thierry Houeix INERIS (FR)
Jim Munro Jim Munro (AU)
Guenter Gabriel Pepperl+Fuchs GmbH
Risto Sulonen VTT
Paul Meanwell SAFA
Matt Crow Joy Global
Ulrich Jacobs TUV SUD Product Service
Evans Massey Baldor Electric Company – ABB (US)
Yulia Tikhonenko Nanio CCVE
Anna Timofeeva NANIO CCVE
Steve Margis UL – Guest
Jerilyn Merrill UL - Guest
Chris Agius (CA) IECEx Executive Secretary
MEETING REPORT + AGENDA
|SUBJECT |
|OPENING OF THE WORKING GROUP 1 MEETING (Start 8:30) |
|Opening by the Convenor, self-introduction of the participants, and noting of apologies for absence. |
| |
|The Convener Mr Marty Cole opened the meeting welcoming members but noting that some members are not present as we do have a parallel |
|meeting of the IECEx CoPC Scheme underway in order to manage the number of meetings into the one week but noted with the attendance here|
|today there is plenty of expertise to draw on. |
| |
|He thanked UL for their hosting of these meetings and welcomed both Steve Margis and Jerilyn Merrill of UL as guests and invited them to|
|participate in the proceedings of the meeting. |
| |
|He then called for introductions. |
| WG1 Terms of Reference and Membership |
|Members to confirm WG1 Terms of Reference and Membership (as indicated on IECEx Website). |
| |
|The Convener referred to the Executive Secretary who displayed the IECEx website and WG1 membership with the meeting noting various |
|updates needed including:- |
|Guenter Gabriel |
|Ulrich Jacobs |
|NL to reconsider the nomination of Theo P. |
| |
|The meeting further reconfirmed the WGs Terms of Reference and no change is required. |
| |
| |
|APPROVAL OF THE AGENDA – Working Group 1 |
|Members are asked to consider any other items for raising that are not listed on the agenda and then approve the agenda as presented |
|here or as amended to include agreed additional items. |
| |
|The Convener called for any additional items to be added for the agenda with none raised at this time but the opportunity towards the of|
|the meeting time permitting. The Agenda was subsequently approved. |
|Outcome of WG1 Report and Recommendations to the ExMC 2015 Christchurch meeting |
|Members to note the ExMC’s acceptance (via Decision 2015/53) of all WG1 recommendations in the WG1/WG5 report submitted to ExMC |
|following the 2015 WG1 Toronto meeting as ExMC/1019/R. |
| |
|Documents for reference: |
|ExMC/1019/R – Report from WG1/WG5 2015 Meeting |
|ExMC/1083A/RM – Confirmed Minutes of 2015 ExMC Meeting |
|ExMC/1072/DL – 2015 ExMC Decision List |
| |
|The Convener noted the action items and recommendations put to the 2015 ExMC Christchurch meeting with the Secretary informing the |
|meeting of the status of all 6 recommendations put to the last ExMC meeting as follows: |
| |
|Rec 1 = Completed updated editions of IECEx 01 published |
|Rec 2 = Supp to HBR Item 7 – updated and before this meeting |
|Rec 3 = CoC Conditions field = Item 12 before this meeting |
|Rec 4 = IECEx 02 ed 5.2 published Completed |
|Rec 5 = Published ExTAG Decisions Sheet on TS 60079-40 Complete |
|Rec 6 = IECEx 02 published as ed 5.2 completed |
|Rec 7 = Completed with the presentations made during the ExTAG Session |
|Reports on progress on Actions Items from past ExMC Meetings |
|Members to note the following report on progress on Action Items from the Dubai 2014, The Hague 2015 and Christchurch 2015 IECEx |
|Meetings: |
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|Update on action items assigned to ExMC WG1 by the ExMC |
|Members to receive a report on progress of reworking the proposal to the 2015 ExMC WG1 meeting by the Task Group formed at the 2014 |
|Dubai WG1 meeting regarding ‘manufacturer’s details’ on ExTRs as detailed in Item 5.1 of the report on the 2015 ExMC WG1 meeting. |
|Following this report, members are requested to consider the following two proposals from the Task Group |
| |
|Use of the terms “Manufacturer” vs “Manufacturing Location” vs “Production Site” |
|Members to consider an updated proposal (Version 4) from the Task Group |
| |
|Document for consideration: |
|“Use of the term Manufacturer V4.doc” |
| |
|“Applicant” vs Certificate Holder” vs “Issued to” |
|Members to consider a new proposal from the Task Group |
| |
|Document for consideration: |
|“Applicant vs Manufacturer V1.doc” |
| |
|The Convener called on the meeting to discuss and with both items 5.1.1 and 5.1.2 at the same time noting that we had formed a Task |
|Group led by Mike Slowinske and invited Mike to present the documents and work of his Task Group to date. |
| |
|Mike Slowinske gave a detailed background and informed the meeting of the work within the Task Group and the Secretariat in attempting |
|to clarify “Manufacturing Locations” compared to “Production Sites” and then the term “Manufacturer” |
| |
|The Convener thanked Mr Slowinske for his and his Task Group’s work and called on the meeting to consider the updated drafts with the |
|meeting noting the changes now proposed along with the Diagram (Fig 2) as requested from the last WG1 meeting. |
| |
|The meeting then focused discussion on use of the term “Storage” and listing of manufacturing sites and not production sites on |
|Certificates. |
| |
|The meeting then resolved for P+F and Joy representatives as manufacturers to provide Mr Slowinske with input for an updated version to |
|address how QARs may be used to satisfy both the requirements of certification and the needs of manufactuers. |
| |
|The meeting also considered that there may need some references to ISO/IEC 80079-34 |
| |
|The meeting further considered the need for an ExTAG Decision Sheet and agreed that the Task Group should also prepare a draft for |
|consideration, first by WG1 and then by ExTAG. As a result the meeting agreed to the following action |
| |
|ACTION #1: Mr Slowinske’s Task Group to update the draft documents and prepare a draft ExTAG Decision sheet based on the discussions at |
|this meeting and input from P+F and Joy as representing manufacturer’s interests. Updated drafts will be sent for a brief review by WG1|
|Members prior to progressing to ExMC and ExTAG as required. |
| |
|{Secretariat Note: Document ExMC/1152/CD has been issued for ExMC consideration} |
| |
| |
|The meeting then discussed the issue of Certificate Holder versus Applicant noting that while the term applicant is appropriate that |
|perhaps the Certificate should replace the term “Applicant” with “Issued To”. |
| |
|The meeting further noted that with the release of the new Non-Electrical Standards that the term “Electrical Equipment” should be |
|replaced with “Equipment” with the Secretary informing that this is already underway within the IEC Central Office as the Secretariat |
|has already performed a review of the CoC System to determine what changes were necessary to introduce the new Non Electrical Standards |
|and found this to be the only one, in order not to make too many changes. |
| |
|RECOMMENDATION #1: that ExMC consider replacing “Applicant” with “Issued To” on the Certificates associated with the IECEx 02 Equipment|
|Scheme. |
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|Reports on progress on Actions Items from past ExMC WG1 Meetings |
|Members to note the following report on progress on Action Items from the past ExMC WG1 meetings. |
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|Outstanding Action Items from IECEx WG1 Toronto 2015 Minutes |
|Members to note progress on the Actions assigned during the Toronto 2015 WG1 meeting and receive reports on progress of any that remain |
|outstanding. |
| |
|The Convener referred the meeting to an issue previously discussed concerning Indemnification with Mr Slowinske informing the meeting of|
|concerns from an ExCB perspective when issuing a local national approval or mark based on testing and assessment done by another ExCB |
|located in a different country and noted the provisions within the IECEE CB Scheme. |
| |
|The meeting considered the various points raised noting the different legal jurisdictions that exist in different countries and agreed |
|for Mr Slowinske to prepare an initial draft based on the IECEE CB Scheme and circulate for WG1 further consideration. Should there be |
|support then the matter could go directly to the ExMC for more open discussion |
| |
| |
|ACTION #2: Mr Slowinske to form a small Task Group to consider an initial draft on Indemnification based on the IECEE provisions for |
|initial consideration by WG1 then by ExMC. Members of WG1 interested in early input may contact Mr Slowinske directly. |
| |
|IEC Conformity Assessment Systems Harmonised Basic Rules |
|Members to receive a report from the IECEx Secretary regarding the status of IEC Harmonised Basic Rules and the IEC CAB response to the|
|changes proposed by IECEx members and the IECEx Supplement. |
| |
|Members to note Section 5.4 of ExMC/1083/RM and ExMC 2015 Decisions 2015/12 and 2015/13 in ExMC/1072/DL and then consider the contents |
|of ExMC/988A/CD. |
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| |
|The Chairman reminded the meeting of the background behind the move towards a single document as the “IEC Harmonised Basic Rules” to be |
|common across all 4 Conformity Assessment Systems and any future CA System that may come along. The meeting further noted the provision|
|for a “Supplement” Document that each of the CA Systems may develop and submit for CAB approval to address items specific to the |
|individual Systems. |
| |
|The meeting also noted that ExMC/988A/CD as an initial draft IECEx Supplement to the HBR taking into account ExMC/988/CD which was |
|considered in Christchurch and in light of work being done within other CA Systems, including IECQ and IECEE undertook to prepare an |
|updated version of the Supplement for submission to ExMC as ExMC/988A/CD. |
| |
|During the course of reviewing the draft Supplement ExMC WG1 agreed to the following for inclusion in a revised version for submitting |
|to ExMC:- |
| |
|The Supplement should include ALL Clause numbers of the HBR to be clear to the reader of the Supplement what applies and what does not. |
|Composition of the Executive needs to be included |
|Include clarification in the scope regarding use of TC 31 publications |
|Include WG Conveners as members of ExMC without vote |
|Include reference to “or other aspects of explosion protection” in Clause 11 |
| |
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|RECOMMENDATION #2: that ExMC accept document ExMC/988B/CD as the IECEx Supplement to IEC Harmonised Basic Rules (HBR), for passing onto|
|IEC Conformity Assessment Board (CAB) for final approval. |
| |
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|{Secretariat Note: Document ExMC/988B/CD has been issued for ExMC approval} |
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|IECEx Basic Rules, IECEx 01 |
|Members to consider a draft revision of IECEx 01, Rules of Procedure, Edition 7.0. |
|Document for consideration: |
|Draft of IECEx 01 Ed 7.1 |
| |
|The Convener noted that while work is underway to introduce IEC Harmonised Basic Rules, IECEx still needs to work according to the |
|current IECEx Basic Rules. With this in mind he and the Secretary pointed out an inconsistency between the text within the Introduction|
|of IECEx 01 Basic Rules and that of the updated IECEx 02 Rules of procedures, Clause 11.2.2 in that IECEx 02 enables an application from|
|a candidate ExTL to come via/be endorsed by any IECEx Member Body whereas the Introductory text in IECEx 01 has not been updated. |
| |
|The meeting then considered the proposed changes in the Draft amendment to IECEx 01 and agreed with the following adjustment |
| |
| |
|Certification bodies and testing laboratories wishing to be accepted into the IECEx System must reside in a participating country. Their|
|application for acceptance is made through their National Member Body of the IECEx System for the country in which the Certification |
|Body intends to operate or any Member Body in the case of testing laboratories. |
| |
|The meeting also agreed to update the reference to ISO/IEC Guide 65 to ISO/IEC 17065 |
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|RECOMMENDATION #3: that ExMC approves the editorial correction to the Introduction of the IECEx 01 Basic Rules to align with the |
|provisions of IECEx 02 Clause 11.2.2. |
| |
| |
|{Secretariat Note: Document ExMC/1151/CD has been issued for ExMC consideration} |
|IECEx RoP, IECEx 02 |
|Members to note the publication of IECEx 02, Rules of Procedure, Edition 5.2 as agreed by ExMC Decision 2015/33 |
| |
|The meeting noted publication of Edition 5.2 of the IECEx 02 Rules of procedures during October 2015, following on from the Decisions of|
|the ExMC Christchurch meeting. Not action required at this stage. |
|IECEx Rules, IECEx 02 – proposed revision |
|Members to discuss the RU proposal regarding IECEx 02 and the relationship between ExCBs and ExTLs noting (from ExMC/1083/RM, Item 8.2 |
|as extracted as follows and also Decision 2015/35) that “… In reply to the RU proposal (a repeat of a proposal to the 2014 ExMC |
|Meeting), the IECEx Secretary advised the meeting of the outcomes of discussions in the 2015 Executive meeting in Toronto on this matter|
|which recommends that the current wording of IECEx 02 relating to ExCBs and ExTL relations remain but suggested that this matter should |
|be monitored by the Executive and included as part of ExMC WG1 considerations as part of their maintenance of IECEx 02.” |
| |
|Documents for reference: |
|ExMC(Christchurch/RU)04 - RU Proposal concerning ExCB + ExTL Relations |
|Letter from RU of 29th February 2016 |
| |
|RU experts present at the ExMC WG1 meeting presented the proposals and concerns from RU regarding the relationship between ExCBs and |
|ExTLs with the meeting agreeing that we need to ensure that ExTLs are robust in both their facilities and capabilities. |
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|While considering various aspects of the RU proposal the meeting agreed to forma small Task Group to enable more time to carefully |
|consider the RU proposal and options as discussed. |
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|The meeting then appionted the following Task Group |
| |
|Jim Munro (convenor) AU |
|Anna Timofeeva RU |
|Ron Sinclair GB |
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|With the Task Group to provide a final proposal for consideration at the ExMC Umhlanga meeting |
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|ACTION #3: Mr Munro to form a small Task Group to consider proposed changes to IECEx 02 in light of the RU proposals for presenting at |
|the 2016 ExMC meeting. |
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|{Secretariat Note: Document ExMC/1160/CD has been issued for ExMC consideration} |
|IECEx OD 009 Draft Revision |
|Members to consider the draft revision of IECEx OD 009, Operational Document - Procedures for the Issuing of IECEx Certificates of |
|Conformity, IECEx Test Reports and IECEx Quality Assessment Reports |
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|Documents for consideration: |
|Draft of Edition 4.0 of IECEx OD 009 |
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|The Secretary informed the meeting of work within the Secretariat to prepare suggested changes/updates to OD 009 as part of the |
|documents on-going maintenance, noting that it is perhaps one of the most used ODs within the IECEx 02 Scheme. |
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|The meeting noted the draft revised edition of OD 009 prepared by the Secretariat and while agreeing with the document also identified |
|other areas to be reviewed such as:- |
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|Clarification required to clearly identify what is expected at the Certification Decision stage, as raised by Jim Munro. |
| |
|The meeting agreed to allow a further 30 days for other remarks or comments from members and then submit to ExMC for approval, noting |
|there may be other changes required arising out of Mike Slowinske’s the Task Group regarding manufacturer, Manufacturer Locations and |
|Production Sites. |
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|RECOMMENDATION #4: that ExMC approves the Revised Edition of IECEx OD 009 as presented by WG1, noting other changes may be required |
|depending on the ExMC decision concerning proposed changes to Manufacturer, Manufacturing Location and Production Sites. |
| |
| |
|{Secretariat Note: Document ExMC/1154/DV has been issued for ExMC approval} |
|Additional modifications for IECEx Certificate and Supporting document fields |
|Electrical Apparatus field of Certificates |
|In noting (in the preceding Agenda Item) need for a change to the format of IECEx Equipment Certificates of Conformity members to |
|discuss a proposal that the “Electrical Apparatus” field be renamed as “Equipment” so as to enable certificates to be issued for |
|non-electrical equipment in the future. |
| |
|The meeting noted the need to replace “Electrical Apparatus” and agreed that this is a regarded as an editorial change. |
| |
|ExTR Free Reference field of ExTRs |
|Members to discuss a proposal to remove the automatic population of the ‘ExTR Free Reference’ field with the same number as the IECEx |
|ExTR automatically generated number. |
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|The meeting discussed this proposed changed and agreed on the need to retain the ExTR field as a free text field and therefore |
|determined that no changes were necessary. |
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|“Overrun” of the Certificate History field |
|Members to discuss options for avoiding the problem of overrun of the Certificate History field on Equipment Certificates interfering |
|with other fields as the number of Issues exceeds approximately 10 issues – as an example, refer to IECEx DEK 14..0025X Issue 15 |
|The meeting noted advice from the Secretary that they are working with IT in Geneva to address some issues relating to the On-Line |
|Certificate System including the over run of Certificate history. During discussions the meeting raised that we should have consistency|
|in how editions of Standards are shown and assigned the Secretary to action this. |
| |
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|ACTION #4: IECEx Secretariat to review the manner in which editions of Standards are shown on IECEx Certificates in order to achieve |
|consistency. |
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|Proposal for clarifying requirements for “Additional Testing Locations” |
|Members to discuss a proposal from the IECEx Secretariat for clarifying the requirements of the acceptance, operation, management |
|responsibility of the increasingly popular facility of “additional testing location”. In general terms it is proposed that such testing|
|facilities are treated as part of the operations of the Additional Testing Location’s ExTL however the details of this relationship need|
|to be agreed and documented. |
| |
|The Secretary informed the meeting of the growing number of situations where ExTLs approved by ExMC to operate in the IECEx 02 Equipment|
|Scheme are seeking to conduct testing at additional locations but doing so under the procedures and controls of the ExTL that was |
|assessed and approved by ExMC. |
| |
|The Secretary also mentioned that such applications have treated to date as Scope extensions for the ExTL already operating in the |
|Scheme and that a special site assessment is undertaken. He further commented that the membership and community could benefit from some|
|clarity and additional text in the Rules or an OD to also provide transparency of the requirements and expectations of such |
|arrangements. |
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|The meeting considered these points and in agreeing on the value for some clarity agreed with the Secretary’s recommendation that a |
|small Task Group be formed under the Convenorship of Simon Barrowcliff of Elements in UK, as follows |
| |
|Simon Barrowcliff – UK |
|Jim Munro – AU |
|Jasmin Omerovic – DK |
|Ulrich Jacobs - DE |
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|ACTION #5: Mr Barrowcliff to form a small Task Group to consider an initial draft on requirements for ExTLs seeking to conduct testing |
|at additional locations. |
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|Clarification of the use of Attachments to IECEx Certificates |
|Members to note the existing provision for the use of Attachments / Annexes to IECEx Equipment Certificates for additional information |
|about the certified equipment (that may include “non Hazloc” information such as ATEX and IECEE CB Scheme documents) |
| |
|The Secretary informed of inquires received concerning how non Ex aspects could be covered within the IECEx Scheme and identified on the|
|Certificate or associated with the IECEx Certificate of Conformity. |
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|The meeting considered this issue and noted the recent approach to have 2 types of Annexes: |
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|Type A = An Annex that contains information that is integral with and part of the IECEx CoC |
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|Type B = An Annex that contains information that is not part of the Ex attributes of the product |
| |
|As such the meeting felt that at this point the provision of the 2 types of Annexes would address this issue and therefore no action was|
|required at this stage. |
|Unit Verification being applied to Components |
|Members to note a view that Unit Verification Certification covers specific items as identified by serial number or other unique means |
|and hence an IECEx Unit Verification Certificate can cover a completed item, completed assembly, component(s) or component assembly and |
|that it may be appropriate to include any special information such as limitations of use, if a component or component assembly within |
|the description field. The assigning of U to the certificate number in this instance could be treated as an option to be agreed between|
|the ExCB and their client manufacturer to suit the specifics needs of the manufacturer |
| |
|The Secretary informed the meeting of questions received asking if a Component could be assigned an IECEx Unit Verification Certificate |
|with the Secretary suggesting that this is possible but sought the views of the ExMC WG1 experts. |
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|In discussion all present agreed with the Secretary that is possible. No action was required. |
|Clarification of Applicant and Manufacturer identities |
|Members to discuss (with a view to perhaps provider clearer definitions in IECEx 02, Items 3.16 and 3.17) the acceptable use of ‘company|
|names’, ‘trading names’ and ‘…trading as …’ to clearly identify the liable parties for IECEx Certificates fields’ content. It is also |
|recommended that members consider a need for a requirement to identify the relevant ‘legal entity’ (noting that the use of this term in |
|Clause 11.1.1 of IECEx 02 with respect to ExCBs) |
| |
|The Secretary informed the meeting of questions posed to the Secretariat whether or not the IECEx Rules should include a requirement to |
|clearly identify the legal entity that is lodging an application. The meeting considered this and quickly concluded that in their view |
|this a matter for the ExCB to satisfy itself whom they are dealing with noting that it is the ExCB and the manufacturer/applicant that |
|are entering into contract for the certification service. |
| |
|Therefore, no action required at this time. |
| Proposal for an IECEx Manufacturer Declaration template |
|Members to consider a proposal for the development of an IECEx template (based on ISO/IEC 17050-1 requirements) for use by manufacturers|
|to declare conformance of a specific batch of equipment based on an existing IECEx Certificate of Conformity. |
| |
|The Secretary informed the meeting of suggestions received that a Template for a suppliers declaration in accordance with ISO/IEC 17050 |
|should be prepared and introduced into the IECEx 02 Equipment Scheme. |
| |
|The meeting discussed this and concluded that this is a matter outside the IECEx scheme and that we should not allow the use of IECEx as|
|a reference in such a Suppliers Declaration document. |
| |
|Therefore no action required at this point. |
|State of the Art Requirements |
|In accordance with Item 16.5 in the 2015 ExMC WG1 meeting report, members are invited to raise matters regarding opportunities for “… |
|raising the value and EU acceptance of IECEx through an alignment between IECEx and ATEX on the issue of promoting ‘State of the Art’.” |
| |
|The Secretary informed the meeting of a proposal from Mr Schwarz regarding “State of the Art” as covered by ATEX and whether or not this|
|should be introduced to IECEx. The meeting considered this noting that this would effectively mean that Certificates would have a set |
|life which would be dictated to by the edition of the Standard. |
| |
|In discussion the meeting noted the difficulty in constantly brining Ex equipment up to date with current editions of Standards but did |
|note the positive side that this may assist in gaining recognition within Europe. |
| |
|In conclusion the meeting agreed that at this point in time, keep this on the WG1 agenda for future consideration but not to progress at|
|this point. |
|Consideration of any additional work for WG1 for the immediate future. |
|The opportunity to discuss items that relate to the IECEx Equipment Certification Scheme Rules ahead of the next ExMC meeting in |
|Umhlanga, South Africa in September 2016. |
| |
|The Convener called on members to raise any additional items for WG1 to consider with the Secretary advising the meeting of the need for|
|some additional guidance to ExCBs when faced with the situation of Suspending or Cancelling an IECEx Certificate. |
| |
|The meeting supported the Secretary’s proposal and formed the following Task Group to explore this:- |
| |
|Andy Smith – Convener UK |
|Chris Agius - Secretariat |
|Heinz Berger - CH |
|Jasmin Omerovic - DK |
|Paul Meanwell - ZA |
|Evans Massey - US |
|Julien Gauthier - FR |
| |
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|ACTION #6: Mr Smith to form a small Task Group to consider an initial draft set of guidelines for ExCBs when faced with Suspending or |
|Cancelling an IECEx Certificate |
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|{Secretariat Note: The Task Group plan to meet on Sunday 4 September 2016 ahead of the ExTAG and ExMC meetings.} |
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|Other Business |
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|Nil |
|Next Working Group 1 Meeting |
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|The meeting agreed to hold the next meeting with the 2017 series of operational meetings noting the kind invitation from SIRA/CSA to |
|meet in the UK. Date to be confirmed. |
|Close of Working Group 1 Meeting |
| |
|Mr Cole as Convener closed the meeting thanking all present for their active contributions and the progress made. |
| |
Working Group WG5 – Quality System requirements of Ex Manufacturers
Attendance:
Marty Cole WG1 Convenor
Thorsten Arnhold IECEx Chairman
Alexander Zalogin IECEx Vice Chairman
Heinz Berger Certiconsult (CH)
Ron Sinclair SGS Baseefa (GB)
Julien Gauthier LCIE
David Adams QPS (CA)
Jasmin Omerovic UL International DEMKO A/S (DK)
Michael Slowinske UL LLC (US)
Thierry Houeix INERIS (FR)
Jim Munro Jim Munro (AU)
Guenter Gabriel Pepperl+Fuchs GmbH
Risto Sulonen VTT
Paul Meanwell SAFA
Matt Crow Joy Global
Ulrich Jacobs TUV SUD Product Service
Evans Massey Baldor Electric Company – ABB (US)
Yulia Tikhonenko Nanio CCVE
Anna Timofeeva NANIO CCVE
Steve Margis UL – Guest
Jerilyn Merrill UL - Guest
Chris Agius (CA) IECEx Executive Secretary
DRAFT AGENDA
|SUBJECT |
|OPENING OF THE WORKING GROUP 5 MEETING (to commence at the conclusion of ExMC WG1 meeting) |
|Opening by the Convenor, self-introduction of the participants, and noting of apologies for absence. |
| |
|Mr Marty Cole acted as Meeting Chair in the absence of the Convener and opened the meeting welcoming members, noting that this is a joint |
|meeting with WG1. |
|WG5 Terms of Reference and Membership |
|Members to confirm WG5 Terms of Reference and Membership (as indicated on IECEx Website). |
| |
|The meeting noted that issue of terms of Reference and membership were dealt with during the WG1 session this morning. No further action at|
|this stage. |
|APPROVAL OF THE AGENDA – Working Group 5 |
|Members are asked to consider any other items not listed on the agenda. |
|Report / Discussion on Action Items from Dubai 2014 Meeting |
|Members to report on progress on Action Items from the Toronto 2015 ExMC WG5 Meeting as summarised in Annex B: |
| |
|Document for reference : 2015 WG5 Meeting report in ExMC/1019/R |
| |
|Members agreed with the draft agenda as presented. |
|Report / Discussion on Action Items from the 2014 ExMC Meeting in The Hague |
|Members to action Decision 2014/40 from The Hague 2014 IECEx ExMC regarding the acceptance of ExMC WG1 Recommendation #6 (refer ExMC/948/R) |
|that the revision of IECEx OD 033 be allocated to ExMC WG5. |
| |
|WG5 to note that the revision should include |
|consideration of non-electric equipment |
|recognition and treatment of any differences between ‘batch testing’ and ‘unit verification’ |
|consideration of an alternative set of requirements as defined in ISO / IEC 80079-34 OR an alternative approach to the application of |
|80079-34 to assist the entry of non-electric equipment into the IECEx System noting the possibility of less experience with ISO 9001 in the |
|non-electric sector (and the potential impacts of the new edition of ISO 9001 under preparation). Also, it should be clear that IECEx does |
|not require Quality Management Systems to be certified |
| |
|The meeting considered the current edition of OD 033 in light of the new ISO 9001 and coverage of non-electrical equipment and resolved that|
|at this point in time there is no need to revise OD 033. |
| |
|Report / Discussion on Action Items from the 2015 Christchurch ExMC Meeting |
|Members to note the ExMC’s acceptance (via Decision 2015/54) of the WG5 recommendation in the WG1/WG5 report submitted to ExMC following the|
|2015 WG1 Toronto meeting as ExMC/1019/R. |
| |
|Documents for reference: |
|ExMC/1019/R – Report from WG1/WG5 2015 Meeting |
|ExMC/1083/RM – Report on 2015 ExMC Meeting |
|ExMC/1072/DL – 2015 ExMC Decision List |
| |
|The meeting noted the ExMC discussions from Christchurch concerning the need to update the audit report form F 001 and to review the audit |
|duration provisions that currently exist. In discussion the meeting felt at this point in time while F 001 would benefit from updating the |
|issue of intervals between audits needs further consideration. |
| |
| |
| |
| |
| |
| |
|Revision to IECEx Quality Assessment Report Form (F-001) |
|Members to note that the 2015 ExMC Meeting accepted the recommendations regarding the updating of the F-001 form and the need to review |
|current provisions of time differences for surveillance audits of manufacturers with and without ISO 9001 certification. |
| |
|Members to consider if the revised F-001 form needs to be revised again to accommodate it use for non-electrical Ex protection techniques. |
| |
| |
|The meeting considered the current audit Form F-001 and agreed to update this top address issues of audit duration and agreed to update the |
|F-001 form accordingly. |
| |
|ACTION #1: The IECEx Secretariat to update F-001 to ensure alignment with both IECEx 02 and OD 009, noting the proposed revision of OD 009 |
|pending ExMC approval. |
| |
|{Secretariat Note: F-001 Ed 2.0 is issued but may require updating pending any further changes to OD 009} |
|ISO 9001 and ISO / IEC 80079-34 |
|Members to receive a report from the IECEx Secretary on the status of development of IS0 / IEC 80079-34 and on any matters arising from the |
|publication of ISO 9001:2015 |
| |
|The meeting noted information concerning the status of the next edition of ISO/IEC 80079-34 with the expected publication in 2018. |
| |
|The meeting then considered options for dealing, now, with the new ISO 9001 and the current ISO/IEC 80079-34 (which is based on the |
|superseded edition of ISO 9001) and considered: |
| |
|Wait and continue to use current edition of ISO/IEC 80079-34; or |
|Use the draft next edition of 80079-34 as an IECEx OD for now |
| |
|The meeting concluded to stay with the current edition of ISO/IEC 80079-34 but to approach ExTAG for an ExTAG Decision Sheet on any items |
|that may require clarification. |
| |
| |
|RECOMMENDATION #1: that ExMC supports the interim approach (while awaiting for the next edition of ISO/IEC 80079-34) of using the current |
|edition of ISO/IEC 80079-34 and requests ExTAG to prepare any Decision Sheet that may be necessary as an interim. |
| |
| |
| |
|Revision to IECEx OD 025 |
|Members to consider the draft revision of IECEx OD 025, Guidelines on the Management of Assessment and Surveillance programs for the |
|assessment of Manufacturer’s Quality Systems, in accordance with the IECEx Scheme. |
| |
|Documents for consideration: |
|Draft of IECEx OD 025 Edition 3.1 |
| |
|The meeting noted information from the Secretary of their readiness to update the current edition of OD 025 as part of a maintenance cycle |
|and to provide consistency in terminology, eg that an Audit is a part of the overall assessment process. |
| |
|The meeting appreciated this work but also noted that a more substantial revision of the OD 025 will be required once the new ISO/IEC |
|80079-34 is finalised and agreed to hold off further review until that time. |
|Revision to IECEx OD 026 |
|Members to consider a draft revision of IECEx OD 026, Guidelines for the qualification of Lead Auditor and Auditors, in accordance with the |
|IECEx System. |
| |
|Documents for consideration: |
|Draft of IECEx OD 026 Edition 3.0 |
| |
|The meeting noted information from the Secretary of their readiness to update the current edition of OD 026 as part of a maintenance cycle |
|and to provide guidance to ExCBs concerning audit days when progressing as a Lead Auditor. |
|The meeting appreciated this work but also noted that a more substantial revision of the OD 026 will be required once the new ISO/IEC |
|80079-34 is finalised and agreed to hold off further review until that time. |
|Revision to IECEx OD 005 Series |
|Members to consider the need for revisions of IECEx OD 005-1 and OD 005-2 to reflect the decision to apply ISO/IEC 80079-34 in the IECEx |
|System. |
| |
|The meeting noted information from the Secretary concerning the current status of the audit checklists that are based on the previous |
|edition of ISO 9001. |
| |
|The meeting undertook a discussion of the various options going forward and agreed to task Mr Thierry Houeix with creating a new Checklist |
|for ISO/IEC 80079-34 and the latest edition of ISO 9001. |
| |
|ACTION #2: Mr Thierry Houeix to update the Checklists OD 005-1 and OD 005-2 for alignment with the latest edition of ISO 9001. |
| IECEx Audit Assessments |
|Reminder to ExCBs concerning audit timeframes |
|Update to members on Action Item 5 from Paris 2012 meeting of WG5 (refer ExMC/743/R, Item 9). |
| |
|The meeting noted the ExMC Decision 2015/54 for WG5 to review the interval period between surveillance audits of manufacturers holding IECEx|
|Certification of their Products. |
| |
|The meeting undertook a general discussion with some also raising the issue of site sampling that occurs within the ISO 9001 QMS |
|certification process by various CBs. |
| |
|The meeting was also reminded of the requirements of Clause 8.3.7 of IECEx 02 regarding the intervals between surveillance audits BUT that |
|audit intervals should be based on evidence found during the audits and not just a black and white approach. |
| |
|Following further discussion the meeting agreed NOT to recommend any changes to the current provisions, noting that IECEx is aligned with |
|the process of other similar Schemes, eg ATEX. |
| |
| |
|Feedback on IECEx Audit Assessments |
|Members to raise any matters regarding feedback from manufacturer audits under IECEx. |
| |
|The Chairman called for any specific matters concerning audit assessments with none being raised. |
| Other Business |
| |
|No other General Business was raised |
| Next Working Group 5 Meeting |
| |
|To be aligned with ExMC WG1 |
| Close of Working Group 5 Meeting |
| |
|The Chairman closed the meeting at 3.35pm thanking all for being present and also expressed the WG’s appreciation to UL for their excellent |
|hosting. |
| |
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ExMC/1168/R
25 July 2016
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