inspection checklists


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Medical Device QMS Compliance Checklist

The Medical Device QMS Compliance Checklist from Certainty Software prepares organizations for ISO 13485: 2016 compliance audits. We’ve created this exhaustive compliance checklist for companies in the medical device sector pursuing ISO 13485 certification and in need of a tool to set them on the right path before an ISO audit.

The standards for a quality management system in the medical device industry include several manufacturing-related activities, such as the design, development, production, installation, and maintenance of medical equipment. Compliance with this checklist ensures that your organization’s operations meet the demanding quality and safety requirements required in the medical business.

Download the Medical Device QMS Compliance Checklist

What the Checklist Includes

This checklist ensures conformity in areas relating to medical device quality management systems that include:

  • Record maintenance
  • Quality policy and objectives
  • Internal communication
  • Management responsibilities
  • Infrastructure
  • Contamination control
  • Product realization planning
  • Design and development planning
  • Complaint handling
  • Monitoring and measuring
  • Corrective actions
  • And much more…

How Certainty Improves Medical Device QMS Compliance Inspections

Using Certainty Software, performing Medical Device QMS compliance inspections becomes easier and generates better actionable information. Whether using our checklist templates or creating your unique forms, Certainty gives its users the freedom and customizability to support every company’s special inspection and auditing needs.

Reporting checklist findings at an enterprise-wide level can be filtered to your needs by inspection type, users, site, region, question, or answer. Within your configurable dashboard, you can track issues identified, set up automated notifications and actions, and so much more.

Learn more about quality audit software.

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