Gloved hand with syringe

ISO 13485: My journey to certification – infrastructure

I work from home, where I have a comfortable office, small lab and well-equipped workshop

As far as the ISO 13485 standard is concerned, these rooms (two spare bedrooms and my garage) and the equipment, tools, machinery, IT systems and services I use in client projects are all part of the infrastructure used for product realisation, and I should therefore identify and maintain them. Clearly this requires a pragmatic rather than comprehensive approach. So I started by appointing myself to the role of Facilities Manager. I then identified infrastructure categories, and within those categories those elements of infrastructure that could have the largest impact on the quality of my product realisation.

The short-list goes something like this:

  • The spaces themselves, and the furniture and utilities in them. They need to be clean and comfortable. Have enough storage space. Lights and electricity need to work.
  • My ICT systems, mainly workstations, laptop, server, and network. Kept updated, anti-virus protected, and backed-up.
  • My test & measurement instruments. Kept maintained and calibrated or referenced—suitable for the purpose of my measurements.
  • My workshop tools used for building models and prototypes. Machine tools require maintenance. Hand tools mostly don’t need maintenance, just need to be checked prior to use and repaired or replaced when required.

So far so good…

Starting with the easy bit I wrote a brief Procedure on the “working environment” which covers the first point.

Switching to my IT-manager cap I proceeded to produce a network diagram in Visio to identify my ICT hardware infrastructure. Each piece of hardware carries its own maintenance record in the form of a log-file of software and anti-virus installs/updates—no need to duplicate that information. I then wrote down the data security and backup arrangements I already had in place in the form of a procedure. I think that’s all I need to do on IT.

Moving on to the slightly trickier issue of test & measurement equipment. I already had an excel sheet listing most of my electronic measurement instruments, but I realised that I also had a lot of calipers, micrometers and rulers in the workshop which needed to be included. Plus screw thread, radius and feeler gauges. Quite a list.

I also had 25mm and 100mm calibration bars, and used them to check all micrometers, rulers and calipers. I sent my multimeter off for calibration; when it comes back I’ll use it to reference my other electrical measurement instruments. I referenced my thermometers to melting ice and boiling water. Other equipment remains uncalibrated for now, and marked as such.

And lastly, I listed my (machine) tools that might require maintenance: Lathe, milling machines, 3-D printer, reflow oven, manual injection moulder and a few more. For each of I wrote a one-page maintenance plan and established associated records as evidence of maintenance according to plan.

That should cover the “Infrastructure” non-conformance.

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