Product Compliance Technical File Index Worksheet
A technical file is only as good as your ability to find what is in it. This worksheet is an index you keep alongside the file: one row per document, with owner, revision, status and the date it next needs review.
| Document | Category | Reference / doc ID | Revision | Owner | Status | Next review | Pages | |
|---|---|---|---|---|---|---|---|---|
Set the status to Missing for anything you have not yet collected, then filter or sort after export. The exact contents your product needs depend on the directive or regulation that applies, so confirm the list with your notified body or regulatory adviser.
Link change orders to your technical file
Optional: we can look at how engineering changes in your ERP could flag affected compliance documents.
Optional. The tool and every export work without this. No spam.
How to use the worksheet
Start with the example rows, delete what does not apply and add every document your regulation expects. Give each document a reference you can find in your document system, not a file path that will change. Set the status honestly: a Missing row is more useful than an empty one. Export to Excel for audits, or to CSV to load into a quality system. Update the revision whenever the underlying document changes, and move the next review date forward.
What technical files usually contain
Requirements differ by regulation, but most technical files cover the same ground: what the product is and is for, how it was designed, how risk was assessed, which standards were applied and what evidence shows conformity, what the labels and instructions say, and how the product is made consistently. Under EU product legislation, the technical documentation is generally held by the manufacturer and made available to market surveillance authorities on request, commonly for ten years after the product is placed on the market. Check the retention period in your specific act.
- Design and manufacturing information
- Risk assessment and mitigations
- Applied standards and test reports
- Declaration of conformity
- Labels, markings and instructions
- Supplier and component declarations
Keeping the file alive
The usual failure is a file built once for certification and never touched again. Tie the next review date to something real: a standard revision, an engineering change, a supplier change or an annual audit. When a change order is released, ask whether it touches any row in this index. If it does, the row goes back to In progress until the affected document is updated and the revision is bumped.
Common mistakes
Listing a document that the file does not actually hold, indexing test reports that were run on an earlier design revision, and forgetting supplier declarations are the three most common gaps. Another is storing the only copy on one engineer's laptop. Record where each document lives and who owns it, so the file survives staff changes.
Frequently Asked Questions
Is this index the technical file itself?
No. It is a controlled list of the documents that make up the file. The documents themselves stay in your document management or PLM system. The index tells you what exists, where it is, and what is out of date.
How long do I keep technical documentation?
It depends on the regulation. Many EU product acts require manufacturers to keep documentation available for around ten years after the product is placed on the market. Confirm the period in the act that applies to your product.
Can one index cover a product family?
Yes, if the products share design and evidence, but record which variants each document covers. Where variants differ in ways that affect compliance, keep separate rows or a separate index.
Who should own each row?
Assign the person who can actually update the document, such as a design engineer for drawings or a quality engineer for test reports. A named owner per row is what makes the review date meaningful.
If your engineering change process lives in your ERP, we can help connect change orders to the technical file so affected documents are flagged automatically.
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