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ISO 13485:2016 Certification

ISO 13485 is the most widely used for medical devices throughout the world. Successful design and manufacture of medical devices and supplies entails Quality Management System based on ISO 13485.

The EU device directives require medical device companies to employ a quality system consistent with this standard, and Canada requires device manufacturers marketing their products in Canada to have a quality system certified to ISO 13485. Adoption of the standard is still under consideration by the FDA.

ISO 13485: 2016, “specifies necessities for a quality management system where an organization needs to demonstrate its ability to offer medical devices and related services that consistently meet client requirements and regulatory necessities applicable to medical devices and related services.”

As you implement ISO 13485, it is important to bear in mind that ISO standards are updated periodically — revisions and updates do occur and ISO 13485 is due for an update in the next few years. As quality system standards are updated, you must confirm that your own QMS keeps up with those updates in order to remain in compliance.

However, some organizations are pressured or decide to implement ISO 13485 even though they don’t actually make medical devices but because they serve the medical device industry, are a subcontractor to a medical device manufacturer and make components (or provide services) for them. They want to demonstrate their understanding of and commitment to quality in a medical device environment. And thus getting ISO 13485 does this.

For instance one of the additional requirements in ISO 13485 is for the manufacturer to implement a procedure to issue advisory notices. These are technical bulletins to alert users and patients if relevant technical issues are discovered with a device. The more extreme version would be to have a system to recall devices if safety issues are discovered. ISO 13485 does not mandate recall although it does need the organization to implement an appropriate level of traceability.

Benefits of ISO 13485

  • Supports offer a framework for implementation of actions (where necessary) to confirm achievement of planned results and to confirm maintenance of effectiveness of those procedures with applicable client, quality and regulatory necessities.
  • Meets regulatory necessities in many countries, as well as contractual obligations of many organizations, allowing you to do business with new customers.
  • Can decrease costs as a result of minimizing product failures.
  • Is acknowledged internationally as the best quality practices within the medical device industry.
  • Helps create a systematic framework in which organizations monitor, measure and analyze their procedures and client feedback.
  • Can provide better performance in areas such as sales, product delivery, and procedure efficiency.

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