In a sector as regulated as healthcare, complying with international quality and safety standards is not optional: it is a necessity. ISO standards allow companies to demonstrate their commitment to excellence, efficient process management, and patient protection. Among all of them, ISO 13485 and ISO 14971 stand out as key pillars for those who develop, manufacture, or distribute medical devices.
In this article, we explain what ISO standards are, which ones are most relevant in the healthcare field, and how you can train with Ambit Iberia to apply them effectively in your organization.
What are ISO standards?
ISO standards are international standards developed by the International Organization for Standardization (ISO), an entity founded in 1947 and headquartered in Geneva. Their objective is to establish global reference frameworks that guarantee the quality, safety, and efficiency of products, services, and systems.
Currently, there are more than 22,000 published standards covering almost all industrial and business sectors. They are designed to facilitate international trade, improve organizations' internal management, and reinforce customer trust.
What advantages does ISO certification provide?
Implementing and becoming certified in an ISO standard offers multiple benefits:
Main highlighted ISO standards
Some of the most recognized and globally used standards are:
However, when it comes to medical devices, two standards deserve special attention: ISO 13485 and ISO 14971.
Fundamental ISO standards for the healthcare sector
For those who develop, manufacture, or distribute medical devices, two standards serve as fundamental pillars: ISO 13485 and ISO 14971. Below, we explain the main characteristics of each in detail.
ISO 13485: Sistema de gestión de calidad para productos sanitarios
This standard is specifically designed for organizations involved in the lifecycle of a medical device, from design to distribution. It aligns with the requirements of the European Medical Devices Regulation (MDR) and is an essential tool for obtaining the CE mark.
Implementing ISO 13485 allows you to:
ISO 14971: Risk management for medical devices
This standard provides a comprehensive framework for the identification, evaluation, control, and monitoring of risks associated with medical devices throughout their lifecycle. It is also an essential requirement within the MDR.
With ISO 14971, you can:
Learn from anywhere with Ambit Iberia
At Ambit Iberia, we offer specialized and up-to-date online training for professionals in the regulated healthcare sector. Our courses are designed by regulatory experts and adapt to your schedule and experience level.
Below are the essential training courses you should take if you want to get certified in these regulations:
Curso online de Sistema de Gestión de Calidad para dispositivos médicos según ISO 13485
Duration: 1 hour
Format: 100% online, 24/7 access for 30 days
Includes: Evaluation test, materials, and downloadable certificate
Ideal for: Manufacturers, distributors, technical, or regulatory personnel in the healthcare sector
Online course on Risk Management for medical devices according to ISO 14971
Duration: 1.5 hours Format: 100% online, 24/7 access for 30 days Includes: Evaluation test, materials, and downloadable certificate Aimed at: Quality managers, regulatory teams, and technicians in healthcare companies
Additionally, we offer a 15% discount for:
Your opportunity for growth
Adopting ISO standards is not just a regulatory requirement; it is an opportunity to elevate the quality, safety, and competitiveness of your organization. In a sector as demanding as healthcare, being prepared makes all the difference.
With Ambit Iberia’s courses on ISO 13485 and ISO 14971, you can train flexibly and acquire the necessary knowledge to comply with European legislation and improve your internal processes.
Start your training today and become a benchmark in quality and risk management for medical devices.
If you need support, contact us.
En Ambit Iberia we have been experts for over 20 years in developing IT strategies and solutions. We help the pharmaceutical, medical device, and IVD (in vitro diagnosis) medical device sectors comply with regulations throughout the product lifecycle. We design and implement innovative infrastructures thanks to a comprehensive service offering acting as a key enabler for digital transformation.