--- id: KB-NO-024 url: https://app.codecontract.io/help/regulation/the-products-technical-file idioma: en categoria: normativa subcategoria: producto audiencia: usuario nivel: avanzado actualizado: 2026-08-13 tambienEn: [es] relacionados: [KB-NO-015, KB-NO-007] citadoPor: [KB-NO-025, KB-AL-026, KB-IU-017, KB-IU-019] --- # The product's technical file _The declaration of conformity is the cover page. The technical file is what sits behind it, and it is what gets asked for when someone doubts._ **Responde a:** what is a product technical file · what documentation to keep for a product i make · asked for the technical file · how long to keep technical documentation A declaration of conformity fits on one page and is signed in a minute. That is why it gets signed cheerfully. What almost nobody looks at on signing day is the awkward question behind it: **and on what basis?** The set of answers to that question is the technical file. **Technical file** — The set of documents showing WHY the product complies: tests, calculations, drawings, standards applied and the risk assessment. It does not ship with the product; it is kept and produced on request. ## What it usually holds, and where it usually fails | Piece | Who holds it | Where it gets lost | | --- | --- | --- | | Laboratory test reports | The lab and you | Left in the inbox of whoever commissioned it | | Risk assessment | Whoever designed it | Never written down — it was «done mentally» | | Drawings for the version sold | Engineering | The new drawing exists; the sold version's does not | | Standards applied and their edition | Quality | The standard was cited without saying which year | | Documentation for bought-in components | Purchasing | Each supplier sends their own format and it scatters | > [!IMPORTANT] > The mistake that turns this into a serious problem is one of timing: **the file gets assembled when someone asks, and by then half of it is missing**. The lab closed, the engineer who did the calculations left, the component supplier changed hands. None of that is recoverable afterwards. A technical file is built the day the declaration is signed, not the day the question arrives — because on the day the question arrives you can no longer manufacture the past. ## Building it so it outlives the people 1. **One file per product and per version** — «The file for model X» without a version is the door to producing the wrong paper. 2. **Every document dated and attributed** — A test report with no date and no identifiable lab supports nothing. 3. **The edition of the standard, not just its number** — Standards get revised; citing the 2014 one when 2021 applied is a classic. 4. **And component documentation inside, not linked** — A link to the supplier's website expires when they redesign it. > [!WARNING] > One costly confusion, easily undone: **the instruction manual is not the technical file**. The manual travels with the product and is read by the customer; the file stays with you and is read by whoever investigates. Mixing them means over-delivering to customers —including calculations and supplier names you would rather not publish— and missing what actually matters when the question comes from an authority. ## And how long it is kept **En corto** - Measured from the last unit sold, not from the declaration date: two different clocks. - And for long-lived products —machinery, installations— far beyond the lifespan of any office computer. - Which is why the file does not live on anyone's laptop or in a folder that depends on who is still around. > [!NOTE] > Exactly what the file must contain, who may demand it and for how many years it must be kept depends on the product type and the rules applying to it. **Your adviser or notified body settles that**; here we explain why it is assembled on signing day and not on question day. **Do I have to hand the file to my customers?** Normally no: it is kept and shown to those entitled to ask for it. **Are my suppliers' certificates enough?** They are one part. The file explains your product, not only its pieces. **What if someone else manufactures for me?** Then agree in writing who keeps what, before you start selling. ## Ejemplos **An authority asks for the file on a product sold four years ago and the testing laboratory no longer exists.** - Keeps a copy of each test report in the file the day it arrives, not a link to the lab → The file stays complete even though the test provider has vanished. **The model X file is produced and turns out to be the current version's, not the unit sold.** - Opens one file per version and freezes each at launch → Every unit sold has the documentation that belongs to it behind it, not someone else's. **The engineer who ran the calculations has left and nobody can find the risk assessment.** - Requires the assessment to be written and filed before the declaration is signed → What lived in one person's head moves into the company's file. **The declaration is issued and there is no file behind it.** - Gathers what backs it into one file → The cover page has what supports it behind. **The file lives on the machine of whoever made it.** - Stores it off personal machines → Somebody leaving does not take the file. **The file is requested and a supplier's contribution is missing.** - Keeps third-party material with its own → The file is complete.