The paperwork ships with the parts. Not after them.
Medtech or another regulated field: you need the file with the part, not after it. Tell us which documents your QA needs and they are produced with the order.
Why the documentation decides the release date.
Under a regulation the document is not administration around the order. It is part of what you bought.
Which documents, on which dimensions, in which form. It is written into the order, so the file is produced while the part is made and not reconstructed afterwards.
FME holds ISO 9001:2015, certified by SQS under Reg.-Nr. 47629 and valid to 06.05.2027, for precision components for the medical, chemical, laboratory and machinery industries.
What is agreed before anything is cut.
High precision requirements
The critical tolerance is named in the feasibility answer, before anything is quoted.
Extensive regulatory documentation
Material certificate, measurement report and first article inspection, specified per order and delivered with the parts.
Per batch, on the delivery note
Each batch stays identifiable from the material certificate through to the parts you release.
Name the documents in the inquiry.
The documents are quoted with the part, so nothing is added to the invoice afterwards.
Answer within TODOThe interval belongs here, on every form on the site, and it is the last thing a buyer reads before deciding whether to attach the drawing. Nothing FME publishes states one, so the form asks for a drawing and promises nothing back. /contact#form
Drawings stay confidential · NDA on request
Common questions about regulated parts
When the documentation counts as much as the part.
- Which documents can FME supply?
- The inspection report on the tolerances you named, the material certificate for the batch, the delivery note carrying the batch reference, and the first-article inspection report where it was agreed before the series.TODO: confirm what is standard on every order and what is charged separatelyThe same question as on the Quality page, asked here by the buyer it costs the most. A regulated part is quoted together with its file, so what is standard and what is charged separately is part of the price on this page, not a detail settled afterwards. /quality#documents
- Who decides which dimensions are inspected?
- You do. You name the tolerances that carry the function, and exactly those appear in the inspection report with their actual values. We do not guess which dimension matters to you.
- What belongs in an inquiry for a regulated part?
- On top of the drawing, quantity, material and date: which documents have to accompany the delivery, and whether a first-article inspection report is required before the series. Both change the price and the date, which is why they belong in the first e-mail.
We can also help with…
A part rarely fits one situation only. If two of them apply to yours, say so in the inquiry and we will price it that way.
Complex assembly
Several components, several processes, and no single supplier who can take all of it.
Inquire about an assemblyDeadline at risk
A load peak your own shop cannot absorb, or a date that cannot move.
Inquire with a deadlineOne-off or small batch
A prototype, a spare, or fifty pieces that other suppliers will not run.
Inquire for a small batchSend the drawing. Get a price and a date. It can be that simple.
One component or a complete assembly. You get one price and one date.