ISO 13485:2003 is a Management System Standard focused towards manufactures of Medical Devices.The ISO 13485:2003 Certificate was published by ISO in 2003.
The ISO 13485 standards outline a Comprehensive Management System for medical device manufacturers. The ISO standard primarily facilitates medical device regulatory requirements that are essential for any organization operating in the Medical, Pharmaceutical, and Healthcare supply chain.
It is especially relevant to manufacturers who wish to demonstrate applicable regulatory requirements, and by organizations whose, services support medical device manufacturers.
ISO 13485:2016 is a quality management certification for medical and healthcare organizations. The ISO 13485 standard for medical devices specifies certain requirements for organizations to have a quality management system in place.
Organizations must demonstrate its ability to provide medical devices and related services that consistently meet the specified regulatory requirements and customer likes.
Companies across any stage of the life-cycle are eligible for the ISO 13485:2016 certification for Medical Devices. i.e.
ISO 13485:2016 can be also used by suppliers or external parties that provide products and services (including quality management system-related) to a medical organization.
A Quality Management System (QMS) is based on a four-step management model (Plan-Do-Check-Act). It is a set of procedures, policies, and processes that help the organization to meet the requirements expected by its stakeholders.
In business scenario, it is used for continuous improvement of processes and better control of operations.
In the healthcare and medical devices segment, QMS is a regulatory requirement in most of the countries such as Canada, Europe, US, etc.
ISO 13485 Certificate for medical devices enables an organization globally and in the UAE, and Dubai, Abu Dhabi, emirates of Sharjah, Fujairah, Um al Quwain to consistently produce safe and effective medical devices and fulfill customer and regulatory requirements.
It is also flexible enough to meet the individual needs of different types of medical device manufacturers and medical service providers. Regulations differ widely across the globe, hence ISO 13485 does not set detailed requirements, but insists the medical devices organizations identify relevant regulatory requirements specific to the product or service and incorporate them into the QMS. Moreover, the standard is compatible with an organization’s existing management systems too.
Safety and performance of medical devices are paramount in the healthcare industry. Hence, a quality management system is a regulatory or legal requirement in many countries.
ISO 13485 Certificate for medical devices can aid companies located in Dubai, Abu Dhabi, Sharjah and rest of the UAE & globally, that are associated with any part of a medical device’s life journey to:
ISO 13485 certification for medical devices requires the quality system to pass a third-party audit. This can be a way of showcasing to your stakeholders and regulatory authorities your ability to fulfill the requirements. Also, conforming to the best practices and getting ISO certified will aid in raising your trust among the customers and thereby business excellence.
So why wait, if you are into the healthcare & medical field and wish to be globally recognized as an ISO certified healthcare organization, be part of the ISO 13485:2016 certification.
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