ISO 13485 Certification for those not making Medical Devices
Where do I start if I want to get Certified to ISO 13485?
This is a question frequently asked by those involved in the medical device supply chain (e.g. component manufacturers and logistics companies) who have no experience with medical device manufacture.
With a steady, if slow, increase in medical device companies requiring ISO 13485 certification of their suppliers, this is a question that is being asked more and more often.
You may go to Consultants or to Certification Bodies and Notified Bodies for the answer. But a fast source of dependable, and unbiased, information is the ISO Technical Committee for Medical Devices (ISO/TC 210).
Two essential ISO 13485 Guidance Documents
Two documents they have published on this topic are …
- ISO 13485 - Quality management for medical devices: A free brochure with tips for getting started with ISO 13485.
- ISO 13485:2016 - Medical devices - A practical guide: Published in 2017, this 200+ page guide is a solid source of information on the implementation and maintenance of a Medical Device Management System (MDMS) and a solid basis on which to defend your interpretation of the Standard with Certification Bodies, Notified Bodies and Regulatory Bodies.
It will benefit all organizations active in the medical device sector, including manufacturers, importers, distributors, service providers, certification bodies or regulatory bodies.
You can purchase a copy on the ISO website.
Here is part of the introductory text that spells out the purpose of this publication:
This handbook has been written by a task group of technical experts from ISO’s Technical Committee TC 210. A draft was circulated to all the member national standards bodies and liaison organizations of ISO/TC 210 to obtain feedback and comments; these have been considered by the task group prior to the release of the final text.
The requirements of ISO 13485 are general in nature and, with the exception of a few sub-clauses that are applicable to specific medical device types, are intended to be applicable to all medical device organizations, regardless of their type, size, or the product they provide.
This handbook is intended to guide organizations that provide products, including services, that affect any part of the life cycle or supply chain of a medical device. Such organizations can be manufacturers, importers, distributors, service providers or authorized representatives. In addition, this handbook can be useful to regulatory authorities and certification bodies concerned with conformity to ISO 13485. (our emboldening)
So now you know where to start
Having familiarised yourself with the basics of applying ISO 13485 to your organization, you will then be ready to talk with Consultants, Certification Bodies (for Class 1 or Class A Devices) and/or Notified Bodies (for all other classes of device).
If you’d like to implement and maintain a Medical Device Management System yourself, consider our online ISO 13485 Lead Implementer Course. This is one of the eight ISO 13485 Courses we offer.
First published August 2019; revised and updated in April 2022.
- ISO 13485 for Suppliers to the Medical Device Sector
- ISO 13485 Certification Process: How and What to Prepare
- Standalone Software & Apps as a Medical Device
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