ISO 13485:2016 Quality Navigator-ISO 13485 Compliance Tool

Example

Utilizing built-in templates and guidelines, the Navigator can prepare users for regulatory audits by simulating the audit process. This includes generating potential nonconformity reports and grading them according to severity to help prepare corrective action plans.

Scenario

A medical device manufacturer preparing for an upcoming ISO audit uses the Navigator to conduct a pre-audit assessment. The simulation helps identify gaps in documentation and processes, allowing the company to address these issues before the actual audit.

Example

The Navigator offers detailed risk management strategies and documentation practices, aligning with ISO 14971, which is crucial for medical device manufacturers to evaluate and control product-related risks.

Scenario

In designing a new medical device, a company uses the Navigator to integrate risk management into its design and development process. By following the Navigator’s guidance, the company systematically identifies, analyzes, and mitigates risks associated with the device throughout its lifecycle.

Example

It provides tools and metrics for continuous monitoring and improvement of the QMS, ensuring compliance with evolving regulations and standards.

Scenario

A company uses the Navigator’s continuous improvement tools to regularly update its QMS in response to internal audit findings and external regulatory changes. This proactive approach helps maintain compliance and enhances overall product quality.