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ISO 13485:2016 Medical Devices QMS Implementation Kit

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ISO 13485:2016 Medical Devices QMS Implementation Kit

Original price was: $449.00.Current price is: $349.00.

A complete, audit-ready documentation pack for ISO 13485:2016 — the quality management system for medical devices. 54 documents: quality manual, 24 procedures, forms, registers, logs, and practical guidance — built by auditors, ready to tailor.

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Description

📥 Free sample: download a free sample of this pack — one complete procedure, one form, and the full contents list. Download the free sample (ZIP)

The ISO 13485:2016 Medical Devices QMS Implementation Kit gives your organization a complete, professional starting point for building a quality management system for medical devices — 54 documents across 28 organized folders: a clause-by-clause quality manual with a full process-approach section (including a 20-process interaction map), 24 step-by-step procedures (document control, design and development, purchasing and supplier control, production control, sterile devices and sterile barrier systems, traceability, installation and servicing, complaint handling, advisory notices, CAPA, and more), 13 forms, 5 registers, 4 logs, and 4 practical guidance documents — including a worked-examples companion, a form-completion guide, a 13485-vs-9001 differences guide, and a guide to identifying and monitoring the regulatory requirements of your target markets (with a device risk-classification method and a regulatory requirements register). Every procedure includes RACI tables, inputs and outputs, failure modes, and assessor expectations. A clause-to-document traceability matrix proves full coverage of every sub-clause. This pack is for small and medium organizations; larger organizations should obtain direct consulting. Note: the official text of ISO 13485:2016 is not included (copyright) — purchase it separately from ISO or your national standards body.

Licence: this pack is licensed to the purchasing organization for its own internal use. Redistribution, resale, or sharing of the pack or its contents is prohibited.