The ISO 13485 standard is a fundamental certification for manufacturers of medical devices. Therefore, knowing closely what it consists of and what its effects are is information to keep in mind in the course of this activity.

At IP Triana, we take our work very seriously and our intention is to develop it by following precisely the exact quality indications raised to the standard level in our sector. Therefore, during the following lines, we are going to try to explain how we work.

Have you heard of ISO 13485 standard? If you haven’t done it yet, you are about to.

What is and what is the function of an ISO standard?

Shortly after the end of World War II, in 1945, the world witnessed the revival of the industry. In this historical scenario, in the year 1947, the Organization for Standardization (ISO) was created and its birth marked a before and after in the management of business quality systems.

At the beginning of 1980, framed in the work of different technical committees, the ISO 9000 standards were born, all of them with the intention of directly marking rules that should be used in a common way. And this is precisely the spirit of this entire normative set: common use or, what is the same, standardization, to achieve, through it, established homogeneous criteria for all business entities.

Compliance with these standards provides multiple benefits to those who achieve the corresponding certification. Well, aspects such as achieving a better competitive position, or reaching a larger and more important number of customers, are directly influenced by the ISO, as well as the establishment of continuous improvement processes or the guarantee that processes and products meet the necessary requirements for their use. Now, you can get an idea of how we work at IP Triana. But there is still more. We invite you to a true immersion in the quality culture of our company: to optimize the quality of our processes and products. Take a deep breath and dive in with us!

What is the ISO 13485 standard?

ISO standards are divided into groups or families and the ISO 13485 standard is part of the texts related to the medical industry. Well, it is in charge of guaranteeing something essential for the medical sector: the quality of medical devices. In this way, the certification of medical devices, under their quality criteria, means that they comply with the regulations applicable to their manufacture. And, in addition, that they will be able to satisfy the needs of the clients. Working with suppliers of articles that comply with these standards is a basic guarantee. Above all, taking into account that we are talking about especially sensitive environments such as medical areas of various kinds, hospitals, clinics and other healthcare settings.

The ISO 9000 series for quality management and the development of ISO 13485

The ISO 13485 standard derives from the ISO 9000 family for quality management. In fact, it uses the latter as a basis to develop, in turn, the quality management specified in a sector: the manufacture of medical devices.

In its approach, some specific requirements are added to ISO 9001. To focus its scope, certain aspects are specified. Thus, certain obligations are declared such as having files to contain the documentation related to medical devices; developing and validating all phases of the design and manufacturing process following certain requirements; preserving the product from possible contamination; carrying out risk management throughout the product’s life cycle and guaranteeing its identification and traceability.

The fulfilment of all these conditions supposes the certification of the company and, consequently, that the manufactured product complies with a sanitary guarantee and with the regulatory requirements.

IP Triana

In our work, we apply a strict quality control from the first moment. Thus, from the design itself to the final finish, everything is carried out in compliance with very specific parameters. Our facilities, the materials we use and the certification of the ISO 13485 standard are an added bonus to the safety of our clients. We put our experience at your disposal. Let’s talk!


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