Digital ISO 13485 Audit Checklists

Identify gaps in the current QMS and determine corrective actions

Achieve ISO 13485 certification using a mobile app

ISO 13485:2016 is an international standard for the Quality Management System (QMS) of organizations involved in the manufacturing, distribution, servicing, and disposal of medical devices. Organizations with ISO 13485:2016 certification are recognized to produce medical devices that are at par with industry standards.

An ISO 13485:2016 audit checklist is a tool used by quality managers to determine if the QMS of organizations align with the ISO 13485:2016 standard. This checklist is useful in evaluating readiness for a third-party ISO 13485:2016 certification audit.

This article briefly discusses (1) the steps in preparing for an ISO 13485:2016 certification audit; (2) technology to help ensure that implemented QMS is consistently aligned with the ISO 13485:2016 standard; and (3) free ISO 13485 audit checklists.

Click here to browse and download the best ISO 13485 audit checklists

  1. Obtain a copy and gain an understanding of the ISO 13485:2016 standard.
  2. Identify areas for improvement in the current QMS by conducting a gap analysis or a readiness audit to ensure adherence to ISO 13485:2016 requirements.
  3. Perform quality monitoring audits and maintain a record of results.
  4. Define your organization’s competencies and determine training requirements for ISO 13485:2016 certification based on the audit results.
  5. Ensure competence needs are met and that all parties involved are kept in the loop.

Paper-based audits can be burdensome and time-consuming. Time spent on documentation and manual filing of records can be better spent working on gaps found in the current QMS and working towards getting certified for ISO 13485. iAuditor, the world’s most powerful mobile auditing app, can help organizations meet ISO requirements and maintain the quality of medical devices. Be ready for third-party ISO certification by doing the following:

  • Create mobile-ready ISO checklists.
  • Empower teams to conduct efficient monitoring procedures and analysis using a smartphone or tablet.
  • Save time with a mobile app that generates comprehensive reports as you finish an audit.
  • Save all reports online and automatically share it with members of your organization. Preview a sample report here.
  • Use for free with small teams. Unlimited reports and storage for premium accounts.

Here is a collection of our carefully prepared ISO 13485 audit checklists you can browse and use as part of achieving ISO 13485 certification and ongoing compliance.

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ISO 13485 Audit Checklists

1. ISO 13485 Audit Checklist

An ISO 13485 audit checklist is utilized by quality managers to determine if the organization’s QMS is aligned with the ISO 13485:2016 standard. It helps evaluate an organization’s readiness for a third-party ISO 13485:2016 certification audit. With iAuditor, quality managers can:

  • 1. Identify processes that don’t adhere with the corresponding ISO 13485:2016 requirement/s.
  • 2. Create notes for corrective actions related to specific gaps discovered.
  • 3. Assign corrective actions with deadlines.
  • 4. Generate and submit reports using mobile devices.
  • 5. Download this converted checklist to suit the needs of the business for ISO 13485 certification.

2. ISO 13485:2016 Standard Checklist

An ISO 13485:2016 standard checklist can help quality managers find gaps in the organization’s current processes. This digital checklist is divided into 5 sections following ISO 13485:2016’s key clauses:

  • 4) Quality management system
  • 5) Management responsibility
  • 6) Resource management
  • 7) Product realization
  • 8) Measurement, analysis, and improvement

Each section assesses your organization’s preparedness in implementing an ISO-certified Quality Management System. This digitized checklist allows you to select “Done,” “In Progress,” “Not Started,” and, for sections 6, 7, & 8, “Not Applicable.”


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