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What Does it Mean to be ISO 13485 Certified?

Author: John Campbell | October 22, 2021

businessmen looking at computer discussing iso 13485 certificationCompliance with ISO 13485 and Quality System Regulation (QSR) ensure that your Quality Management System (QMS) is robust and meets the regulatory requirements on the international level. But beyond that, what does it mean to be ISO 13485 certified? Today, we’ll delve more into the topic of ISO 13485 certification with answers to some of the most frequently asked questions. 

Here’s what you need to know about getting ISO 13485 certified:

ISO 13484: An overview

As a medical device manufacturer, you are required to maintain an effective Quality Management System. ISO 13485 addresses this responsibility with specified requirements that analyze your processes and create a culture of continual improvement to ensure you consistently meet both the customer’s needs and regulatory requirements. Though it is considered the primary QMS standard for medical devices and related services, ISO 13484 is not a mandatory standard.

Who needs ISO 13485 certification?

ISO 13485 applies to any organization involved in designing, producing, installing and servicing medical devices. ISO 13485 is not a legal requirement; you can create any Quality Management System based on your organization’s needs as long as it meets the regulatory requirements for medical devices. Though not mandatory, the ISO 13485 certification helps medical device manufacturers improve performance, expand market opportunities, mitigate uncertainty and communicate its focus on quality to customers and regulators alike.

What are the ISO 13485 requirements?

While anyone can maintain compliance with the standard, becoming ISO 13485 certified requires adherence to a much more rigorous series of requirements, which will vary based on the risk class of the device and the regulatory system of the country. Identifying the regulatory requirements that apply to your device will form the basis of your QMS.

How does one achieve ISO 13485 certification?

To get your ISO 13485 certification, follow these five steps:

  1. Assess your current QMS: Perform a gap analysis to determine where and how your existing QMS needs to change in order to meet the requirements of ISO 13485
  2. Plan: Create a project plan that you intend to follow to create a QMS in accordance with ISO 13485 certification requirements
  3. Design and document: Design your ISO 13485 Quality Manual and Procedures per the requirements of the standard, and document how you plan to control the processes
  4. Audit performance: Conduct internal audits to see how your system is working and identify areas that need improvement. A full quality system audit must be documented that addresses applicable clauses of the ISO 13485 standard.
  5. Certification audit: To become ISO 13485 certified, you must undergo a full QMS audit by an independent certification body, known as a registrar.

ISO 13485 certification is the globally recognized gold standard for quality in the medical device industry. As an ISO 13485 certified company, you’ll not only enjoy more control over your processes with a highly efficient QMS, you will also boost your company’s brand image, improve customer satisfaction, more easily discover opportunities for improvements and more. If you don’t know where to start, we can help.

In addition, with decades of experience in regulated product development, our Polarion Consulting team will help you bridge the gap between fast-paced development, complex quality assurance and proof of compliance using Polarion software. With the ability to embed regulatory requirements into templates, Polarion lets you link standards to specific procedures or product requirements to ensure you satisfy applicable regulations.

For more information about how we can help you become ISO 13485 certified, contact us here.  


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