ISO 13485 is a quality system for the medical device industry, and it effectively covers ISO 9001 with some additional requirements.

What many medical device manufacturers fail to realize, however, is that comparing ISO 9001 and ISO 13485 is a valuable exercise. By understanding the differences between these two standards, you learn where device manufacturers need to raise the bar on quality.

ISO 13485 and ISO 9001 for Medical Devices: How They Differ

The primary difference between ISO 13485 and ISO 9001 for medical devices is the scope of these quality standards.

ISO 9001 is the international standard which provides specifications for a quality management system which can be applied at any organization regardless of industry, product or service, or company size. ISO 9001 documents package is designed based on the best quality manufacturing practices and processes approach.

ISO 13485 is a comprehensive management system specifically for the manufacture of medical devices. It places a more significant focus on regulatory compliance and offers less flexibility in the organizational process.  Medical devices - Quality management systems - Requirements for regulatory purposes represent the requirements that the medical device manufacturers must incorporate into their management systems, ISO 13485 documents kit to comply with Medical Devices manufacturing QMS.

There are significant similarities between the two standards, including:

·         The standard’s role in helping organizations achieve a quality management system

·         Risk mitigation and assessment is a significant focus in both standards

·         A focus on the realization of quality products through understanding the customer

·         Both 9001 and 13485 use Deming cycles (Plan-Do-Check-Act)

·         13485 and 9001 emphasize employee competency and infrastructure for quality

Measurement, Analysis, and Improvement

ISO 9001 takes a process-driven approach to continual improvement. ISO 13485 creates a more granular definition of the types of improvement activities device manufacturers need to ensure products are safe and effective. Some key differences between 9001 and 13485 include standards for customer feedback, monitoring product performance, and how to address a non-conforming product.

·         Create a procedure for a feedback system which provides early warning of non-conformances

·         Review non-conformances within the feedback system

·         Monitor and measure products for quality throughout production

·         Verify all quality requirements are met before the product is released or delivered

·         Document rework activities and the release of nonconforming product which meets regulatory requirements

·         Create formal procedures for quality data collection, analysis, and retention

·         Document the implementation of advisory notices

·         Justify customer complaints which don't result in CAPA

·         Create documented procedures for notifying regulators of adverse events

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