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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