How a Good Corrective Action Plan Helps You to Comply with ISO 13485:2016

ISO 13485, Uncategorized February 28, 2018 Leave a comment

ISO 13485:2016 is the latest revision of the standards for quality management systems in medical device manufacturers and their suppliers.

ISO 13485 Corrective Action and Compliance

In addition to being mandated by medical device manufacturing regulations, a corrective action system may be the best tool to fix problems in your toolkit, if done correctly.

Corrective Action helps your organization to continuously reduce risks and ensure that they operate according to ISO 13485: 2016 standards.

A good corrective action system:

  • Links to compliance records
  • Has a defined workflow with action items
  • Links to risk assessment
  • Closes the loop

As companies have until September 2018 to comply with these standards, it’s important to understand ISO 13485 Corrective Action Plans and the main conclusions of the latest revision:

  • The standard provides a step-by-step framework for creating or evaluating a Quality Management System (QMS).
  • The ultimate goal of the standard is to protect consumers from the risk of defective medical devices.
  • Emphasis is placed on improving operational efficiency by examining current processes, identifying gaps and implementing new processes.
  • ISO 13485:2016 incorporates most items from ISO 9001:2015, but adds additional requirements on ISO 13485:2016 documentation of regulatory requirements for medical devices.
  • ISO 13485:2016 lacks the high-level structure of other standards (including 9001:2015) in favor of a more direct requirement approach.

ISO 13485 and the Need for Problem Solving

One of the most important updates in the 2016 revision of ISO 13485 was the emphasis on risk. The updated standard adopts a risk-based approach to the development of a QMS as well as product realization and post-market feedback.

This encourages organizations to improve their quality issues and cultures according to new standards. The standards suggest that organizations take a “Plan-Do-Check-Act” approach to problem solving, but that alone may not be enough.

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