• ISO 13485 Supplier Control Kit: supplier control SOP and approved supplier list, weighted evaluation scorecard, quality agreements for FDA, EU MDR and generic use
  • What's inside the Supplier Control Kit: list of the 10 editable files
  • Preview of page 1 of the Supplier Control SOP Word template in the Supplier Control Kit (lower part blurred)
  • Preview of the Approved Supplier List Excel workbook, Approved Supplier List sheet, from the Supplier Control Kit (lower part blurred)
  • Preview of the Supplier Evaluation Scorecard Excel workbook, Scoring Criteria sheet, from the Supplier Control Kit (lower part blurred)
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ISO 13485 Supplier Control Kit

ISO 13485 Supplier Control 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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Quality manual pages, the gap assessment workbook and the Document Control SOP. Real, unedited pages so you can judge the files before you buy.

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

Select, approve, monitor and re-evaluate suppliers in proportion to risk, with quality agreements that require change notification and incoming inspection records that show purchased product meets requirements.

What's inside (10 files)

  • Procedures: Incoming Inspection SOP; Supplier Control SOP.
  • Evaluation and Approval: Approved Supplier List; Incoming Inspection Record; Supplier Audit Checklist; Supplier Evaluation Scorecard.
  • Quality Agreements: Supplier Quality Agreement - EU MDR; Supplier Quality Agreement - Generic; Supplier Quality Agreement - US FDA.

How to use it

  1. Classify suppliers by risk in the Supplier Control SOP.
  2. Score each supplier with the evaluation scorecard and record approval in the approved supplier list.
  3. Audit critical suppliers with the checklist.
  4. Sign a quality agreement that requires notification of changes before they are made.
  5. Verify purchased product at receipt in proportion to risk.

Who it's for

Manufacturers and virtual manufacturers that rely on suppliers and contract manufacturers.

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 Supplier Control 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.