[labnetwork] Is your facility ISO certified?

[Jörg Hübner]

Hi
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.

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.

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.

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 :).

  Best
      Jørg



Jörg Hübner, Ph.D.

 Director

DTU Nanolab
National Center for Nanofabrication and Characterization



Technical University of Denmark

[http://www.dtu.dk/images/DTU_email_logo_01.gif]

DTU Nanolab

ØrstedsPlads

Building 347

2800  Kgs Lyngby

Direct   +45 4525 5762
Mobile  +45 22785157

jhub at .dtu.dk<mailto:jhub at .dtu.dk>


www.nanolab.dtu.dk<http://www.nanolab.dtu.dk>






From: labnetwork <labnetwork-bounces at mtl.mit.edu> On Behalf Of Peter Lomax
Sent: 23. marts 2023 15:36
To: Paolini, Steven <spaolini at cns.fas.harvard.edu>; Joseph Losby <joseph.losby at ucalgary.ca>; labnetwork at mtl.mit.edu
Subject: Re: [labnetwork] Is your facility ISO certified?

Hi Joseph,

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.

Best

Peter

From: labnetwork <labnetwork-bounces at mtl.mit.edu<mailto:labnetwork-bounces at mtl.mit.edu>> On Behalf Of Paolini, Steven
Sent: 22 March 2023 20:47
To: Joseph Losby <joseph.losby at ucalgary.ca<mailto:joseph.losby at ucalgary.ca>>; labnetwork at mtl.mit.edu<mailto:labnetwork at mtl.mit.edu>
Subject: Re: [labnetwork] Is your facility ISO certified?

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Joseph,
   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.
Becoming ISO certified is extremely expensive and disruptive, you must also allow annual "audits" to your facility which again are very expensive and disruptive.
Iso Certification, in simple terms is just an accreditation that you do what you document and document what you do.
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".
  Best of luck,
   Steve Paolini  Equipment Dood
Harvard University

________________________________
From: labnetwork <labnetwork-bounces at mtl.mit.edu<mailto:labnetwork-bounces at mtl.mit.edu>> on behalf of Joseph Losby <joseph.losby at ucalgary.ca<mailto:joseph.losby at ucalgary.ca>>
Sent: Wednesday, March 22, 2023 12:47 PM
To: labnetwork at mtl.mit.edu<mailto:labnetwork at mtl.mit.edu> <labnetwork at mtl.mit.edu<mailto:labnetwork at mtl.mit.edu>>
Subject: [labnetwork] Is your facility ISO certified?

Hello.

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?

The costs appear to be substantial, and we are still deciding whether or not we should go this route.

Cheers and thanks for your replies,
Joe


Joseph Losby, PhD.
Operations Manager, qLab
Quantum City, University of Calgary
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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