Member Article

Understanding ISO 13485:2003 as a management systems

Globally, the medical industry is continuously growing and is highly dependent on technological advancements and essential procedures aimed at producing the best treatments. To make sure proper diagnosis and treatment, the medical world is reliant on high quality medical devices.

This is where an apex body like the FDA which lays down the regulatory framework in the medical industry. The FDA is an organization that guides and controls the usage and implementation of medical device regulations.

Among the wide range of responsibilities the FDA is entrusted with, the supervision and enforcement of medical devices keeping in mind the far reaching implications on public health. To ensure quality as per medical device regulations, FDA has issued a list of regulatory guidelines, fda ISO 13485, for manufacturing and sale of medical devices in the United States.

ISO 13485:2003 is a management systems specifically developed for the manufacture of Medical Devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.

ISO 13485:2003 contains specific requirements for the manufacture, installation, servicing of medical devices. The ISO 13485 regulations include the implementation of a QMS with several enhancements, risk management approach to product development and product realization, validation of processes, compliance with statutory and regulatory requirements and effective product traceability and recall systems.

As per the ISO 13485 requirements, in order to achieve ISO 13485:2003 certification, one must develop written policies for document and record controls, internal auditing procedures, controls for non-conformance, corrective and preventative actions, process and design controls, record retention, and accountability and traceability

To implement ISO 13485, it is important to bear in mind that ISO standards are updated periodically and so one should make sure that the QMS keeps up with those updates in order to remain in compliance.

The medical device manufacturers can gain from having an ISO 13485 certification a faster and easier market access to other countries that recognize the certification, a reduce operational costs, improving efficiency, increase customer satisfaction, consistently delivering quality products and systematically addressing complaints.

For the professionals who wish to learn about the ISO 13485:2003 standard, beginning at the introductory level, ISO 13485 training courses are available both offline and online. This training provides one with an overview of the purpose and requirements of ISO 13485 and how to improve customer relationships, operations and corporate culture by the effective use of a QMS.

The training is an introduction for anyone involved in the development, implementation and management of a QMS based on ISO 13485. Upon completing the training, one will be able to interpret all clauses of ISO 13485:2003 and recognize the role of management in implementing and maintaining ISO 13485.

Both the regular class and ISO 13485 training online courses comprises lecture and workshop exercises.

This was posted in Bdaily's Members' News section by ComplianceOnline .