• ISO 13485 Equipment, Calibration & Work Environment Kit: calibration register and impact assessment, maintenance and infrastructure logs, work environment, gowning and hygiene
  • What's inside the Equipment, Calibration & Work Environment Kit: list of the 22 editable files
  • Preview of page 1 of the Equipment Management SOP Word template in the Equipment, Calibration & Work Environment Kit (lower part blurred)
  • Preview of the Calibration Master Register Excel workbook, Master Register sheet, from the Equipment, Calibration & Work Environment Kit (lower part blurred)
  • Preview of the Out-of-Tolerance Impact Assessment Excel workbook, Impact Assessment sheet, from the Equipment, Calibration & Work Environment Kit (lower part blurred)
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ISO 13485 Equipment, Calibration & Work Environment Kit

ISO 13485 Equipment, Calibration & Work Environment Kit

$79.00 USD
$79.00 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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Get free sample pages from the Process Validation IQ/OQ/PQ Pack

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5-day fit guarantee. If it does not fit your QMS, ask for a refund within 5 days. Conditions.

Keep measuring equipment calibrated, infrastructure maintained and the work environment under control, with the registers and logs auditors ask for under clauses 6.3, 6.4 and 7.6.

What's inside (22 files)

  • Equipment and Calibration: Calibration Master Register; Calibration Request and Result Form; Calibration Status Labels; Equipment Check Log; Equipment Data Sheet; Equipment Management SOP; Equipment Registers; Out-of-Tolerance Impact Assessment.
  • Infrastructure and Maintenance: Asset Register; Generator Maintenance Log; HVAC Maintenance Log; Infrastructure and Maintenance SOP; Maintenance Request Log; Preventive Maintenance Log.
  • Work Environment and Contamination Control: Area Hygiene Log; Gowning Checklist; Gowning SOP; PPE Register; Pest Control Log; Warehouse Hygiene Log; Work Environment and Contamination Control SOP.

How to use it

  1. List all monitoring and measuring equipment in the calibration master register with intervals.
  2. Label calibration status and record checks between calibrations.
  3. When equipment is found out of tolerance, assess the effect on product already made.
  4. Set preventive maintenance for equipment that affects product quality.
  5. Define work environment and gowning requirements and keep the hygiene and pest control logs.

Who it's for

Manufacturing sites with measuring equipment, controlled areas or cleanrooms.

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.
  • 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 Equipment, Calibration & Work Environment 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.