ISO and GLP

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ISO and GLP

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Dear listservers,

I am interested to find out what sort of service standards, if any, are
applied in core microscopy facilities around the world. Is it common for
ISO's and GLP to be implemented and followed?

For those that have undertaken it, what was the motivation or who was
requiring it, and what opportunities has it afforded? Beyond the obvious
work involved in undertaking it has it resulted in any restrictions to what
you can do?

I've looked back through the list and read some interesting discussions on
ISO 9001:2008 and ISO 1345:2003.

Thanks in advance,
Graham

--
Graham Wright, PhD
Head, Microscopy Unit
Institute of Medical Biology, A*STAR
Singapore
Peter O'Toole Peter O'Toole
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Re: ISO and GLP

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Hi Graham

We operated under a third parties ISO9001 (equivalent at time) for some
years. It was laborious to set up due to the level of documentation that
was required for Standard Operating Procedures etc. Each time something was
changed on the system, the SOP would need to be updated. We used the paper
work to work under ISO for 2 different companies that outsourced to
ourselves.

It was not long until the outsource company realised that much of the
research services being requested did not require ISO accreditation as it
was for pure R&D. However, we still hold on to elements of the ISO process
as it did leave a valuable legacy...if kept updated, which may not be worth
the time. However, past documentation is very quickly updated if needed.

We undertook the ISO process to open up to more external customers, but as
said above, although one of the main companies that outsourced to us was
ISO accredited and they wanted us to work on the same level so that they
could seamlessly offer a wider range of work, ultimately,  most work was
more pure R&D and not quality control that required the ISO system.

It did not restrict anything we could do as we kept the brief on the
documents fairly wide ranging. However, if we were to have gone deeper and
into GMP, then this would restrict what experiments could be undertaken on
the system unless changes to documentation were made and verified not to
alter anything for the following experiments. This was not taken up due to
being too expensive and too restrictive for a multi-user facility.

Best

Pete

On 1 August 2017 at 09:42, Graham Wright <[hidden email]> wrote:

> *****
> To join, leave or search the confocal microscopy listserv, go to:
> http://lists.umn.edu/cgi-bin/wa?A0=confocalmicroscopy
> Post images on http://www.imgur.com and include the link in your posting.
> *****
>
> Dear listservers,
>
> I am interested to find out what sort of service standards, if any, are
> applied in core microscopy facilities around the world. Is it common for
> ISO's and GLP to be implemented and followed?
>
> For those that have undertaken it, what was the motivation or who was
> requiring it, and what opportunities has it afforded? Beyond the obvious
> work involved in undertaking it has it resulted in any restrictions to what
> you can do?
>
> I've looked back through the list and read some interesting discussions on
> ISO 9001:2008 and ISO 1345:2003.
>
> Thanks in advance,
> Graham
>
> --
> Graham Wright, PhD
> Head, Microscopy Unit
> Institute of Medical Biology, A*STAR
> Singapore
>



--
Latest Publication: Correlative super-resolution fluorescence and electron
microscopy using conventional fluorescent proteins in vacuo.
<http://www.sciencedirect.com/science/article/pii/S104784771730093X>


<http://www.linkedin.com/pub/peter-o-toole/1b/b79/444>
Dr Peter O'Toole
Director of the Bioscience Technology Facility
Head of Imaging and Cytometry
Bioscience Technology Facility
Department of Biology (Area 15)
University of York
YORK
YO10 5DD

Tel : +44 (0)1904 328722
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