Total Lean Management (TLM) has extended its Custom Forms builder to do something medical device makers ask for constantly: build a Device History Record (DHR) for lot and unit history — on your own terms, under full document control. If you’ve ever tried to force per-lot production history into a rigid template or a spreadsheet, this one’s for you.

A quick recap: Custom Forms in TLM

Most QMS platforms lock you into the predictable data they expect for ISO 9001, ISO 13485, ISO 17025, and similar standards, offering at best a few custom fields. TLM’s Custom Forms feature goes further: you design fully personalized quality forms directly in the TLM Web App, with

• custom headers and footers,
• multiple field types (text, dropdowns, checkboxes, and more),
• required-field rules,
• font and color customization, and
• integrated revision control through our document control module.

In short, TLM adapts to your processes instead of forcing your processes into its templates. And that flexibility is exactly what makes the next part possible.

New: build your Device History Record (lot & unit history)

Under the FDA’s Quality Management System Regulation (QMSR) and ISO 13485, medical device manufacturers must maintain a Device History Record — the production record that proves each unit or lot was built in conformance with the Device Master Record (DMR). A DHR captures the real story of how a device was made: quantities and dates, acceptance and test results, labeling used, and the identification and control numbers that make a unit or lot traceable.

The trouble is that DHRs are inherently specific — every product, line, and lot has its own shape — so a one-size-fits-all form never quite fits, and a spreadsheet can’t be controlled. That’s the gap Custom Forms now closes:

• Design the record to your product. Build a Device History Record form with exactly the fields, sections, and acceptance records your process requires — not a template you have to work around.
• Flag it as a Device History Record. A single setting marks a form as lot/unit history, so TLM knows it’s a DHR.
• Get a dedicated DHR screen. Flagged records live on their own Device History Record screen — separate from your everyday forms — so lot and unit history is in one controlled, searchable place.
• Keep it under control. Every DHR form carries the same revision control, review, and approval as the rest of your medical device document control — not a loose file on a drive.

Because the DHR lives on the same controlled-document backbone as your DHF, DMR, RMF, and HFE records, it’s part of the same audit-ready evidence set that feeds a 510(k) submission — readiness you can see, not a binder you rebuild. The capability appears when TLM’s medical-device mode is enabled, so it’s there for the teams who need it and out of the way for those who don’t.

Where this lives: the TLM Web App

The Device History Record module and Custom Forms both run in the TLM Web App — the mobile-responsive operational hub of TLM’s quality management software. Alongside DHR and custom forms, the Web App covers audits, corrective actions, document management, risk management, employee evaluations, equipment maintenance, training, and more, with role-based applications and seamless integration to document control. It supports compliance with major standards including ISO 9001, ISO 13485, ISO 17025, and IATF 16949 — across manufacturing, medical devices, automotive, laboratories, and food safety. (AI is arriving across the suite, too — see AI-powered QMS.)

Schedule a demo and we’ll show you a Device History Record built in Custom Forms, on one of your own processes.

Frequently asked questions

What is a Device History Record (DHR)?
A Device History Record is the production record that demonstrates a medical device unit or lot was manufactured in conformance with its Device Master Record (DMR). Required under the FDA QMSR and ISO 13485, it captures quantities, dates, acceptance and test results, labeling used, and the identification/control numbers that make each unit or lot traceable.

How is a DHR different from a DMR or a Design History File (DHF)?
They’re three different records. The Design History File (DHF) documents how a device was designed; the Device Master Record (DMR) is the recipe for building it; the Device History Record (DHR) is the proof each unit or lot was actually built to that recipe. TLM flags and controls all of them, but they answer different questions.

Can I build a custom Device History Record in TLM?
Yes. With TLM’s Custom Forms you design a Device History Record form with the exact fields and acceptance records your product needs, flag it as lot/unit history, and it appears on a dedicated DHR screen under full revision control and approval — available when TLM’s medical-device mode is enabled.