• ISO 13485 Quality Manual & Management System Kit: quality manual, policy and objectives, management review and data analysis, roles, RACI and change control
  • What's inside the Quality Manual & Management System Kit: list of the 21 editable files
  • Preview of page 1 of the Quality Manual Word template in the Quality Manual & Management System Kit (lower part blurred)
  • Preview of the Quality Objective Register and Tracker Excel workbook, Objective Register sheet, from the Quality Manual & Management System Kit (lower part blurred)
  • Preview of page 1 of the Management Review SOP Word template in the Quality Manual & Management System Kit (lower part blurred)
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ISO 13485 Quality Manual & Management System Kit

ISO 13485 Quality Manual & Management System 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 six in the ISO 13485 Starter Kit. Get all six for $249 instead of $504 bought separately.

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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.

The documents that hold an ISO 13485 quality management system together: the quality manual, policy and objectives, responsibilities, change control, and a management review and data analysis cycle that covers every input the standard asks for.

What's inside (21 files)

  • Quality Manual and Policy: Management Representative Appointment Letter; Management Representative Terms of Reference; Organizational Chart; Quality Manual; Quality Policy; RACI Matrix; Roles and Responsibility Matrix.
  • Objectives, Planning and Change: Change Control Form; Customer Contract Review Checklist; Customer Focus SOP; KPI Dashboard; Planning and Change Control SOP; Quality Objective Register and Tracker.
  • Management Review and Data Analysis: Data Analysis Dashboard; Data Analysis Plan; Data Analysis SOP; Management Review Action Plans; Management Review Meeting Minutes Template; Management Review SOP; Monthly Quality Data Review Deck.

How to use it

  1. Adapt the quality manual first: scope, regulatory role, and justified exclusions and non-applications.
  2. Approve the quality policy and set measurable objectives in the Quality Objective Register.
  3. Fill in the organization chart, responsibility matrix and RACI, and appoint the management representative.
  4. Run monthly data reviews with the dashboard and slide deck; carry actions into the management review.
  5. Hold management review using the SOP and minutes template, which cover every required input and output.

Who it's for

New and growing medical device companies writing their quality system, and quality managers rebuilding a manual and management review that auditors keep questioning.

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 Starter Kit and the Complete QMS Kit, which cost 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 Quality Manual & Management System 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.