Medical Device ISO 13485. Implementation and Internal Audit
Medical Device ISO 13485. Implementation and Internal Audit
Manufacturers of Medical Devices and In Vitro Diagnostic Medical Devices need to implement a ISO 13485 Quality Management System to control, record, and demonstrate the control of their processes. The implementation of ISO 13485 is a requirement of the Regulation (Regulation (EU) 745/2017 MDR and Regulation (EU) 745/2017 MDR, for In Vitro Diagnostic Medical Devices (IVDR). deviCE Sistemas adapts the requirements of the ISO 13485 standard to the company’s needs, ensuring the development of an efficient, useful, and easy-to-use Quality Management System.The UNE-EN-ISO 13485 Standard is the reference standard for the development and implementation of a Quality Management System for manufacturers and other stakeholders involved in the life cycle of a Medical Device and an In Vitro Diagnostic Medical Device. ISO 13485. It is a European Harmonized Standard aimed at establishing requirements for regulatory compliance, as specified in its title.
This does not mean that its implementation definitively demonstrates legal compliance, but rather that its implementation is directed towards that compliance.The fundamental and basic pillar of the ISO 13485 Quality Management System is the management of medical device risks, meaning the identification and evaluation of Medical Device risks is the basis that will determine the need for necessary resources in the organization for the design, manufacture, preservation, etc. of the product, both in terms of infrastructure and specially trained personnel.Once the characteristics of the product are known based on the requirements established by the client and regulatory requirements, the risk it may have will be determined according to the production processes and, as mentioned, its own characteristics and usage.This graphic establishes the dynamics that ISO 13485 determines.
The scope of the ISO 13485 Management System can include the design, development, production, storage, distribution, installation, technical assistance, deinstallation, and disposal of medical devices, and therefore, the manufacturer or actor implementing the Standard must clearly establish which of their processes it will apply to. The exact definition of the scope, as well as the determination of exemptions or non-applications, is fundamental.If the company decides to certify against the ISO 13485 Standard, the scope of the Quality Management System will be clearly identified in the Certificate. This scope can be expanded in subsequent certifications if the company so desires.ISO 13485 can be implemented by all agents participating in the life cycle of the medical device, including agents related to manufacturing or development, as well as service providers, such as sterilizers, warehouse managers, medical device distributors, equipment calibration laboratories, etc.
The ISO 13485 Quality Management System is a system based on the PDCA cycle or Deming Wheel. That is, once the products to be made or the services the company will provide, their characteristics and requirements are known, it first proposes a planning of the system itself, determining the processes that will be carried out to meet the needs of the company and the product. Along with the processes, the management’s policy regarding this will be determined, as well as the specific objectives and the establishment of the necessary resources for this by Management. Human and infrastructure resources.
Next, the realization of the product or service itself is proposed, also starting with a planning of its development and ending with a validation of it and all the processes that contributed to its development.Once the product is made or the service is provided, it must be checked or verified that everything has gone according to plan, establishing, if necessary, non-conformities from internal audits or managing customer complaints or incidents that occurred with the product. And finally, action will be taken to resolve complaints, incidents, or claims or established non-conformities.deviCE Sistemas has extensive experience in the implementation and adaptation of the ISO 13485 standard to the characteristics of different types of organizations (manufacturers, importers, distributors, etc.).Additionally, the entire deviCE Sistemas team is trained and certified as internal auditors of ISO 13485, allowing us to conduct Internal Audits for companies that already have the standard implemented and need to outsource this process.
