ISO 13485 for Medical Device Quality and Safety

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About ISO 13485

ISO 13485 is a collection of international standards for medical device producers and certifiers. ‘ISO 13485 Medical Devices’ denotes that the medical devices adhere to all ISO 13485 criteria. ISO 13485:2016 is the latest version of this standard and provides the standards for a Quality Management System that demonstrates an organization’s capacity to produce medical devices that fulfill the device’s regulatory requirements and, if appropriate, patient safety goals.

A Medical Device – Defined

A “medical device” is defined by ISO 13485 as an instrument, equipment, appliance, software, substance, or other object intended for human use for the diagnosis, prevention, monitoring, treatment, or relief of disease. Medical equipment covered by the ISO 13485 standard include:

  • Hospital Beds
  • Surgical Masks/Gloves
  • X-Ray Machines
  • Stethoscopes
  • Sterilizers

What is ISO 13485 Certification?

The ISO 13485 certification procedure verifies that your company’s medical device complies with ISO 13485 requirements. Many agencies demand ISO certification in response to the ISO 13485 Medical Devices Directive. ISO certification ensures that your medical equipment satisfy stringent quality standards and are safe for patients.

Process of ISO 13485 Certification

Once all of the processes and procedures are in place, you’ll need to run the QMS for a while. You’ll be able to gather the information you need to proceed to the following phases, which include a system audit and review, as well as ISO 13485 certification. Following the completion and execution of all of your paperwork, your company should take the following steps to get successful certification:

  • Internal audit – The purpose of the internal audit is to check that your QMS procedures are in excellent functioning order. The goal is to ensure that records are preserved so that process compliance can be certified and defects and vulnerabilities may be identified that would otherwise go unreported.
  • Management review – A formal assessment by your management of the important facts about the management system processes in order to make suitable decisions and allocate resources.
  • Corrective actions – Following the internal audit and management review, you must address the underlying cause of any issues found and document how they were resolved.

Once you have completed the above-mentioned steps, it’s time to hire a certification body. The certification body will conduct two audits before issuing ISO 13485 certification:

  • Stage One (preliminary audit): Auditors from your selected certification body will check to determine if your paperwork meets ISO 13485 criteria and perform a preliminary audit to ensure the QMS is correctly implemented.
  • Stage 2 (implementation audit): The certification body auditors will examine your paperwork, records, and corporate procedures to verify if your actual activities are in compliance with ISO 13485 and your own documentation. Any non-conformities discovered during the first stage 1 audit will be reviewed to see whether they have been addressed. Once your company passes the stage 2 audit, ISO 13485 accreditation for medical devices will be given.

ISO 13485 Training

All of the knowledge you need to comprehend ISO 13485, get started on your ISO QMS, and pass ISO certification audits is accessible in the ISO 13485 training courses offered. ISO 13485 is a complicated standard that might be challenging to apply if you don’t understand what it requires. This ISO 13485 course is provided to assist you in learning more about ISO 13485 without the need to read multiple books or study manuals.

The ISO 13485 training courses are particularly advantageous since they offer you with a certificate upon completion, demonstrating to your employers that you have what it takes to be successful in ISO medical device quality management system audits. The following is a list of ISO 13485 training that is available:

  1. ISO 13485 Lead Auditor Course – This is a five-day training course designed to assist participants to understand the ISO 13485 QMS standard and how to apply it to auditing management systems against it. An individual may only become allowed to audit for a certifying body after finishing an accredited course, which includes an exam at the end to assess knowledge and competence.
  2. ISO 13485 Internal Auditor Training – This is a two-day training that is based on the lead auditor course above, but it does not include how to perform external third-party audits in depth. As a result, it is ideal for someone who is just beginning out in the field of internal auditing.
  3. ISO 13485 Awareness and Implementation Training – These courses will teach you the basics of ISO 13485 and how to put it into practice. These seminars might last one or two days and are required for all workers who implement a quality management system in their workplace.

Advantages of ISO 13485 Certification

ISO 13485 certification is advantageous because it demonstrates to the rest of the world that your company’s products are manufactured in line with ISO standards, allowing you to obtain more worldwide commercial possibilities. When it comes to certifying manufacturing firms all around the world, ISO has a strong reputation for competence and expertise. Some of the advantages of ISO 13485 certification are as follows:

  • Demonstrates compliance to legal and industry requirements
  • Allows for the creation of more efficient manufacturing processes
  • Increases productivity
  • Improves product quality, reliability, and safety
  • Strengthens consumer confidence in your organization’s products
  • Gives you a distinguishing advantage over competitors who aren’t ISO accredited

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