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ISO 13485

The ISO 13485 Standard is a special standard for quality management systems for manufacturers for medical devices (and services) where the primary goal is to protect the public's health and safety based on the medical device and its use.

The ISO 13485 Standard puts the international, national or/and regulatory requirements for medical devices at the first priority. After these requirements come all the rest. So, his objectives (it's still a standard for quality management system) is to harmonize regulatory requirements with quality management system requirements. Utopia!

What do they mean by harmonizing? To harmonize is to bring several things into harmony, or to make several things compatible. In the quality management case, you are required to bring the international, national or/and regulatory requirements into consonance with your quality management system: the main processes, the procedures, documentation requirements etc, are should be planned and performed according to the regulatory requirements.

As well, the ISO 13485 Standard is here to verify that the manufacturer and service supplier are under agreed supervised criteria. And so, another objective of the standard is to establish a quality management system that is oriented towards the design, development, production, and installation of medical devices and related services. The ISO 13485 Standard is not a product standard, it is process oriented. It focuses on implementing a set of criteria and controls over your processes according to the requirements – regulatory and customer's. Therefore, it's not enough to establish a quality management system that complies with the ISO 13485 Standard; you are also required to comply with all relevant products and services, technical standards and regulations from the regional region of the manufacturing or/and the installation.   

The main difference between the ISO 13485 Standard and the ISO 9001 Standard derives from the main objective of the standard. While the ISO 9001 Standard regards customers' requirements as the main objective, the ISO 13485 Standard regards competing with regulatory requirements as the main objective.

One example that indicates the main difference is the approach towards customer's satisfaction. Where the ISO 9001 Standard relates to the customer's satisfaction from the product as one mean of improvement, the ISO 13485 Standard regards the customer's feedback, to whether the medical device compete with the requirements – regulatory and customer's.  The reason for the difference is that satisfaction is a subjective matter where achieving customers or regulatory requirements are objective matters that could be assessed and measured. The medical device shall first apply to the regulatory and then to the customers' requirements. The measurement of the feedback is to be conducted on a continuous manner in order to maintain its effectiveness.

That is another main difference – the effectiveness. Throughout the ISO 13485 Standard, it requires to maintain the effectiveness rather than just implement and measure it. The reason is that maintaining the effectiveness would surely achieve the desired improvement.

My website 13485Quality provides you with a tool that has two significances:
Interpretation for the ISO 13485 Standard requirements
A comparison between the ISO 9001 Standard and the ISO 13485 Standard requirements.

Why a comparison? Because the ISO 13485 Standard born out of the ISO 9001 Standard. And where organizations had implemented the ISO 9001 Standard, they would have some challenges to integrate and implement the requirements of the ISO 13485 Standard. At this point 13485Quality is here to help. Brows the articles. They present both requirements of the 9001 and the 13485 with specific explanations for the differences. You may also respond to me here. I would highly appreciate it.

Benefits of ISO 13485 Certification
Certification to the quality management system standard ISO 13485 provides medical device organizations a process-based model and approach towards developing, implementing and improving the effectiveness of a quality management system in order to meet customer and global regulatory requirements.
In addition, ISO 13485:

  • Is recognized globally as the best quality practices from organizations within the medical device industry
  • enables you to work within many countries where it is a regulatory requirement and with many organizations where it is a contractual obligation or expectation
  • helps create a systematic framework in which organizations monitor, measure and analyze their processes and customer feedback



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