SOP Template needed for ISO 13485 6.3 Infrastructure


one of he nonconformities in our latest audit was the fact that we don't have a SOP on infrastructure, so I now have to write one and need your help.

We have lots of IT-Guidelines, production instructions and machine maintenance instruction, but the Auditor wanted to see the "General, above all" document.
This is what he wrote: "According to section 6.3 of EN ISO 13485:2016, the organization shall document the requirements for the infrastructure needed to achieve conformity to product requirements, prevent product mix-up and ensure orderly handling of products. During the internal Audit such documentation which outlines
the requirements was not available."

So, as I have all the Information but struggle to put the SOP together - could you please provide a template/a copy of your SOP/whatever helps.

Thanks in advance!
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The standard doesn't require an SOP; only that the requirements be documented.

What are your requirements to achieve all those things? Just document them! (Personally, I have a 'Management' SOP which contains the requirements and covers things like management review and such.)


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You should be careful to separate which items need validation, PM, calibration etc and which do not. For example, water for washing implants needs utilities qualification. Clean rooms need IQ, OQ, PQ and have periodic maintenance on hepa systems. Alot of gages and alarms need calibration and PM as well.
Calibrations are described in another SOP. What I have to cover is IT, buildings & storage, transort & logistics, machines and supply of needed media in production. We manufacture class II devices.


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I include these requirements in the various other procedures of the company.
The procedures for receipt of incoming goods, and the procedures for production control state that items must be placed on separate shelves and in different bins relating to their stages of processing and inspection - this is part of the infrastructure requirements for preventing mix-ups.


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The #1 cause of headaches where I have worked is using canned, templated or otherwise derivative SOPs. They don't fit what is intuitively best practice, and therefore quickly become nonsense in practice, and get ignored or despised - not only is this ineffective, but it also decreases confidence and commitment to the system as a whole. There is a reason a lot of 13485 requirements are generally so vague and nonprescriptive - take that as a license to tailor it to your needs as much as you are able.

Read carefully, understand the spirit, and decide where the information makes the most sense for your company practically. As others have noticed, strictly speaking, you are only required to document the requirements for these things. That does not imply an SOP or any other particular format, it just means you need figure out what you need in terms of infrastructure to achieve those minimum items (which you should already be doing in order to run a competent business) and then simply record those requirements in some way.

Logically, then, you will need to meet these requirements - so maybe follow up with a report or otherwise showing that the infrastructure exists.

One relatively proactive way to do this could be, for example, to make it part of your annual review or an internal audit to identify what infrastructure requirements have changed and need resourcing.

If you've got a massive warehouse handling tons of different products then it might be worth having some instructions and procedures around to facilitate this; but do spend some time actually considering the words of the requirement and what they entail.
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...and study closely what your colleagues are already doing.
This is critical. Your process should match what you're actually doing. If you're already doing a good job of infrastructure, there's no reason to alter things - just improve the documentation of what you already do. An "ideally compliant" process that's completely divorced from reality does nothing to actually improve quality.


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You might want to consider PDCA format for the high-level overview in one doc. For example, for the section on the building:

  • Building
    • Plan:
      • Building maintenance is the responsibility of XYZ Mgr.
      • To meet product requirements, the building must maintain a temp range of 65 - 75 deg F, and humidity of 40-70%.
      • The building shall be free of roof leaks, etc.
      • HVAC maintenance is scheduled biannually and records are maintained <here>.
      • Contract cleaners approved by ABC Mgr will be used for weekly cleaning off-hours, and as-needed.
      • The lighting shall be.....etc.
    • Do:
      • HVAC maintenance: see SOP-12345.
      • Cleaning crews perform weekly scheduled cleaning of all areas.
      • Etc.
    • Check:
      • Temp/humidity is monitored by Acme monitoring system, which sends an email alert to XYZ Manager if the system is over/under thresholds.
      • Monthly 5S audits monitor for cleanliness, leaks, etc.
      • Contract cleaners are also monitored in supplier review process SOP-45678.
      • Etc.
    • Act:
      • If temp/humidity is over/under thresholds, then XYZ Mgr shall immediately investigate and contract HVAC service as needed to correct the issue.
      • XYZ Mgr is responsible for addressing 5S findings related to the building in a timely manner.
      • Etc.
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