• ISO 13485 Production & Traceability Kit: production control SOP and batch records, product acceptance and release workbook, traceability, UDI and 10 work instructions
  • What's inside the Production & Traceability Kit: list of the 27 editable files
  • Preview of page 1 of the Production Control SOP Word template in the Production & Traceability Kit (lower part blurred)
  • Preview of the Batch Manufacturing Record Excel workbook, BMR_BPR sheet, from the Production & Traceability Kit (lower part blurred)
  • Preview of the Device History Record Index Excel workbook, DHR_Index sheet, from the Production & Traceability Kit (lower part blurred)
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ISO 13485 Production & Traceability Kit

ISO 13485 Production & Traceability Kit

$99.00 USD
$99.00 USD
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Instant download. Editable files. One-organization licence. 5-day fit guarantee.

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This kit is one of 15 in the ISO 13485 Complete QMS Kit: every kit for $449 instead of $1,375 bought separately.

See the ISO 13485 Complete QMS Kit
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5-day fit guarantee. If it does not fit your QMS, ask for a refund within 5 days. Conditions.

Control production and prove every batch was made, inspected and released correctly: batch and device history records, an inspection and test plan with a release decision, identification and traceability through distribution, and ten ready-to-use work instructions.

What's inside (27 files)

  • Production Control: Batch Manufacturing Record; Cleanliness of Product Records; Cleanliness of Product SOP; Device History Record Index; Pre-Production Checklist; Production Control SOP; Router Traveler; Yield Reconciliation.
  • Acceptance and Release: Product Acceptance and Release Workbook (inspection and test plan, batch record review with automatic release decision, release log).
  • Identification, Traceability and Storage: Identification and Traceability Toolkit; Identification, Traceability and Preservation SOP (including UDI); Status and Identification Labels; Traceability and Warehousing Registers.
  • Work Instructions: WI Courier Carrier Handover; WI Customer Property Intake Return; WI Dispatch and Proof of Delivery; WI Environmental Logger Use; WI Incoming Goods Inspection; WI Labelling Status Marking; WI Quarantine Handling; WI Returns Evaluation; WI Sterilization Load Indicator Review; WI Vehicle Inspection.
  • Installation and Servicing: Installation Activities SOP; Service Report; Servicing Activities SOP.

How to use it

  1. Adapt the production control SOP and set up the batch record and router for one product.
  2. Define inspections and tests in the release workbook's inspection and test plan, and review each batch record before release.
  3. Set identification, status and traceability rules and apply the labels.
  4. Issue the work instructions that apply to your warehouse and distribution.
  5. Add installation and servicing procedures if your devices need them.

Who it's for

Manufacturers and contract manufacturers who need production, release and traceability records.

Good to know

  • Instant download. Editable Microsoft Office files, no macros.
  • Includes a Start Here guide with the contents and how to use them.
  • Licensed for one organization, including its sites.
  • Templates don't reproduce ISO standards. You need your own licensed copies.
  • Validating a process? See the Process Validation IQ/OQ/PQ Pack.
  • Also in the ISO 13485 Complete QMS Kit, which costs less than buying kits separately.
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What every download includes

Instant downloadLink on the confirmation page and by email within minutes.
Fully editableWord, Excel and PDF. No macros. Works in Microsoft 365 and Google Workspace.
5-day fit guaranteeIf the files do not fit your QMS, ask for a refund within 5 days. Conditions apply.
Free updatesRevised files for this edition of the standard are sent to you at no charge. One-organization licence.

Templates refer to clause numbers and describe requirements in our own words. They do not reproduce the text of any ISO standard, so you need your own licensed copy. Templates support your system; they do not guarantee certification.

Questions about ISO 13485 Production & Traceability Kit

How will I receive the files?

A download button appears on the order confirmation page and the same link is emailed to you within a few minutes. Bundles arrive as one ZIP file.

Can I get a refund?

Yes. With our 5-day fit guarantee, if the files do not fit your quality management system you can ask for a full refund within 5 days of your order. It applies once per customer and organization, covers the whole product, and requires you to confirm you have deleted the files. We also refund non-delivery, defective files, wrong items and duplicate purchases within 30 days. Read the full refund policy.

Can I see the files before I buy?

Yes. The images above show real pages from the files, and most kits have free sample pages you can download with your email address.

Can I use the templates with more than one company?

Each purchase is licensed to one organization. Consultants and groups need one licence per client or legal entity. See the licence agreement.

Also transitioning to ISO 9001:2026?

Many medical device manufacturers hold both certifications. If your quality system needs to cover the 2026 update to ISO 9001 as well as ISO 13485, these cover the same ground for the base standard.