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<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D">Hi<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D">At DTU Nanolab we have been ISO certified since 2011. The initial effort is quite substantial but keeping it alive actually balances cost and benefit for us.
We are an University owned cleanroom with work going from TRL2 to TRL9 (basic research to small scale production). We allow students (B.Sc. to Ph.D.) as well as commercial companies direct access to almost all our tools, of which the majority is also used
for small scale production. In order to manage the variety, keep knowledge in house, track changes in procedures etc, the procedures required to that certification are very useful. Most of all the CAPA (Corrective And Preventive Action) system is a very
useful tool to learn from mistakes and avoid repeating unwanted actions. Also all calibrations, safety procedures, cleaning procedures etc are described, version tracked, verified and sent to hearing to the relevant persons via that system.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D">We have a smaller number of tools that are classified “research only tool” they are exempt from the certification and are not commonly accessible, often tools
that are purchased with initial exclusive use for one specific research project only so you can confine the certification to some of the operation.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D">Both academic and industrial customers benefit greatly from that system. Regarding resources: Around 2 FTE’s in total, distributed among many engineers and technicians
with 0.5 FTE for a Quality Manager. My feeling is that we get more out of it than we put in by preventing mistakes, learning from incidents and keep track of safety procedures, calibrations and preventive maintenance. This is for an operating state, gearing
up to a certification from scratch is a another story. <o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D">Essentially ISO 9001 is a certification that you get when you can document that you keep what you promise your users/customers. So it also depends what you promise
</span><span style="font-size:11.0pt;font-family:Wingdings;color:#1F497D">J</span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D">.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D"> Best
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D"> Jørg<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:10.5pt;font-family:"Calibri",sans-serif;color:black"><o:p> </o:p></span></p>
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<b><span style="font-size:8.0pt;font-family:"Arial",sans-serif">Jörg Hübner, Ph.D.</span></b><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
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<span style="font-size:8.0pt;font-family:"Arial",sans-serif;color:#9B9B9B"> Director</span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
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<span style="font-size:8.0pt;font-family:"Arial",sans-serif">DTU Nanolab</span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
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<span style="font-size:8.0pt;font-family:"Arial",sans-serif">National Center for Nanofabrication and Characterization</span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
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<span style="font-size:8.0pt;font-family:"Arial",sans-serif"> </span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
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<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:black"><o:p> </o:p></span></p>
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<b><span style="font-size:8.0pt;font-family:"Arial",sans-serif">Technical University of Denmark</span></b><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
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<span style="font-size:8.0pt;font-family:"Arial",sans-serif"><img width="36" height="53" style="width:.375in;height:.552in" id="Picture_x0020_1" src="cid:image001.png@01D95E50.4289C4E0" alt="http://www.dtu.dk/images/DTU_email_logo_01.gif"></span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
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<span style="font-size:8.0pt;font-family:"Arial",sans-serif">DTU Nanolab</span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
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<span style="font-size:8.0pt;font-family:"Arial",sans-serif">ØrstedsPlads</span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
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<span style="font-size:8.0pt;font-family:"Arial",sans-serif">Building 347</span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
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<span style="font-size:8.0pt;font-family:"Arial",sans-serif">2800 Kgs Lyngby</span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
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<span style="font-size:8.0pt;font-family:"Arial",sans-serif">Direct +45 4525 5762</span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
<p class="MsoNormal" style="mso-element:frame;mso-element-frame-hspace:2.25pt;mso-element-wrap:around;mso-element-anchor-vertical:paragraph;mso-element-anchor-horizontal:column;mso-height-rule:exactly">
<span style="font-size:8.0pt;font-family:"Arial",sans-serif">Mobile +45 22785157</span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
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<span style="font-size:8.0pt;font-family:"Arial",sans-serif"><a href="mailto:jhub@.dtu.dk"><span style="color:blue">jhub@.dtu.dk</span></a></span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
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<span style="font-size:8.0pt;font-family:"Arial",sans-serif"><a href="http://www.nanolab.dtu.dk"><span style="color:blue">www.nanolab.dtu.dk</span></a></span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p></o:p></span></p>
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<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D"> </span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:black"><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D"> </span><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:black"><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D"><o:p> </o:p></span></p>
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<p class="MsoNormal"><b><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">From:</span></b><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"> labnetwork <labnetwork-bounces@mtl.mit.edu>
<b>On Behalf Of </b>Peter Lomax<br>
<b>Sent:</b> 23. marts 2023 15:36<br>
<b>To:</b> Paolini, Steven <spaolini@cns.fas.harvard.edu>; Joseph Losby <joseph.losby@ucalgary.ca>; labnetwork@mtl.mit.edu<br>
<b>Subject:</b> Re: [labnetwork] Is your facility ISO certified?<o:p></o:p></span></p>
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<p class="MsoNormal"><o:p> </o:p></p>
<p class="MsoNormal"><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D">Hi Joseph,<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D">At SMC in Edinburgh we did consider this but decided it wasn’t worth the effort involved for an open access facility. We do try to have decent systems
with good documentation in place and regularly do work for large ISO9000 certified organisations and have always managed to satisfy them with an audit.<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D">Best<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal"><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D">Peter<o:p></o:p></span></p>
<p class="MsoNormal"><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D"><o:p> </o:p></span></p>
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<p class="MsoNormal"><b><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">From:</span></b><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"> labnetwork <</span><a href="mailto:labnetwork-bounces@mtl.mit.edu"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">labnetwork-bounces@mtl.mit.edu</span></a><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">>
<b>On Behalf Of </b>Paolini, Steven<br>
<b>Sent:</b> 22 March 2023 20:47<br>
<b>To:</b> Joseph Losby <</span><a href="mailto:joseph.losby@ucalgary.ca"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">joseph.losby@ucalgary.ca</span></a><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">>;
</span><a href="mailto:labnetwork@mtl.mit.edu"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">labnetwork@mtl.mit.edu</span></a><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><br>
<b>Subject:</b> Re: [labnetwork] Is your facility ISO certified?<o:p></o:p></span></p>
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<p class="MsoNormal"><span lang="EN-GB"><o:p> </o:p></span></p>
<div style="border:dotted #FF884D 1.5pt;padding:0cm 0cm 0cm 0cm">
<p class="MsoNormal" style="background:#FFF2E6"><b><span lang="EN-GB" style="font-family:"Arial",sans-serif;color:black">This email was sent to you by someone outside the University.</span></b><span lang="EN-GB">
<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:#FFF2E6"><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial",sans-serif">You should only click on links or attachments if you are certain that the email is genuine and the content is safe.<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black">Joseph,<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black"> ISO certification is primarily for a manufacturing facility. I don't know of any benefit a shared use facility (I'm assuming that's what
you have) would gain.<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black">Becoming ISO certified is extremely expensive and disruptive, you must also allow annual "audits" to your facility which again are very expensive
and disruptive.<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black">Iso Certification, in simple terms is just an accreditation that you do what you document and document what you do.<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black">I remember confronting the CEO of a company that I used to work for and asking him if it made the facility any better, his answer was a firm
"NO". I then inquired as to why we do it and the answer was "Because our competition has it".<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black"> Best of luck,<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black"> Steve Paolini Equipment Dood<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black">Harvard University<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black"><o:p> </o:p></span></p>
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<hr size="2" width="98%" align="center">
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<p class="MsoNormal"><b><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:black">From:</span></b><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:black"> labnetwork <</span><a href="mailto:labnetwork-bounces@mtl.mit.edu"><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif">labnetwork-bounces@mtl.mit.edu</span></a><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:black">>
on behalf of Joseph Losby <</span><a href="mailto:joseph.losby@ucalgary.ca"><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif">joseph.losby@ucalgary.ca</span></a><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:black">><br>
<b>Sent:</b> Wednesday, March 22, 2023 12:47 PM<br>
<b>To:</b> </span><a href="mailto:labnetwork@mtl.mit.edu"><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif">labnetwork@mtl.mit.edu</span></a><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:black">
<</span><a href="mailto:labnetwork@mtl.mit.edu"><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif">labnetwork@mtl.mit.edu</span></a><span lang="EN-GB" style="font-size:11.0pt;font-family:"Calibri",sans-serif;color:black">><br>
<b>Subject:</b> [labnetwork] Is your facility ISO certified?</span><span lang="EN-GB">
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<p class="MsoNormal" style="background:white"><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black">Hello.<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black">Is your cleanroom facility ISO certified? What are your reasons for having or not having ISO certification? Are there any particular changes
you have had to make to your facility to adhere to standards?<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black">The costs appear to be substantial, and we are still deciding whether or not we should go this route.<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black">Cheers and thanks for your replies,<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black">Joe<o:p></o:p></span></p>
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<p class="MsoNormal"><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial",sans-serif;color:#666666">Joseph Losby, PhD.</span><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black"><o:p></o:p></span></p>
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<p class="MsoNormal"><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial",sans-serif;color:#666666">Operations Manager, qLab</span><span lang="EN-GB" style="color:black"><o:p></o:p></span></p>
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<p class="MsoNormal"><span lang="EN-GB" style="font-size:10.0pt;font-family:"Arial",sans-serif;color:#666666">Quantum City, University of Calgary</span><span lang="EN-GB" style="font-family:"Calibri",sans-serif;color:black"><o:p></o:p></span></p>
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<p class="MsoNormal"><span lang="EN-GB">The University of Edinburgh is a charitable body, registered in Scotland, with registration number SC005336. Is e buidheann carthannais a th’ ann an Oilthigh Dhùn Èideann, clàraichte an Alba, àireamh clàraidh SC005336.
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