The building shall be free of roof leaks, etc.To meet product requirements, the building must maintain a temp range of 65 - 75 deg F, and humidity of 40-70%.Building maintenance is the responsibility of XYZ Mgr.For example, for the section on the building: You might want to consider PDCA format for the high-level overview in one doc. 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. 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. Logically, then, you will need to meet these requirements - so maybe follow up with a report or otherwise showing that the infrastructure exists. 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. As others have noticed, strictly speaking, you are only required to document the requirements for these things. Read carefully, understand the spirit, and decide where the information makes the most sense for your company practically. 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. 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. The #1 cause of headaches where I have worked is using canned, templated or otherwise derivative SOPs.
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