ISO 13485:2016

ISO 13485:2016

ISO 13485 Certification

Quality Management System for Medical Devices

The ISO 13485 certification is an invaluable credential for medical arenas like hospitals, clinics, and nursing homes. It also applies to medical devices. It is mainly based on the already existing process model ISO 9001 and concerns the management of medical equipment. The 13485 certification is the medical fraternity’s optimal international standard. It oversees that all the medical equipment and devices used in clinical settings meet all the regulatory compliances.

The ISO certification for medical devices aims to keep all the professionals and customers safe and secure in clinics and other hospital settings. You should know the primary objectives of the standard so that you can implement it in any organization in your jurisdiction.

Medical Devices Quality Management System Framework

ISO 13485 contains all the information pertaining to the manufacture, installation, and servicing of the various medical devices and equipments. Find out the basic principles and tenets of the ISO 13485 accreditation today.
● Any eQMS software can support the standard with all its components. However, it should undergo some customization to meet the ISO 13485 standards.
● It also includes document management systems. Many organizations regularly face backlash from the authorities due to improper document
management systems. Many documents have time and again, been found to be inadequate and inaccurate in clinical trials. Documentation is one of the core modules of the ISO 13485 framework.
● It also takes training management in its purview. The ISO 13485 certification mainly drives forward a culture that relies on quality deliverables. The main outcome of the L&D function, is to align with the goals of en ISO 13485. Learning should be designed in such a manner, so as to impact the policies under the scope of the framework.
● It also includes risk management under its wings. Under the framework, the organization has to implement proper risk management practices, that include steps like risk assessment, risk analysis, and reduction in the occurrence of risks.
● Quality is one of the main aspects of the medical industry, and so ISO 13485 medical devices assumes prime importance here. Your company’s product development must adhere to the quality guidelines enlisted by the standard. The 13485 medical device management is of primary importance under the clear directives.
This is the basic framework upon which the ISO 13485 certification process is based.

Benefits Of the ISO 13485 Accreditation

Any organization in the medical fraternity can implement the guideline at a low ISO 13485 certification cost. Some of the benefits are listed herein.
● It leads to better customer satisfaction.
● Moreover, operational costs are reduced to a huge extent. Any organization can get the ISO 13485 auditor certification with minimal effort.
● It also helps your organization to maintain legal compliance.
● The ISO 13485 lead auditor certification leads to improved risk management for the organization as a whole.

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