What is an ISO 13485:2016 Audit Checklist?
An ISO 13485:2016 audit checklist is a tool used by quality managers to determine if the organizations’ QMS for medical devices aligns with the requirements of the ISO 13485:2016 standard. The checklist includes a comprehensive list of questions, criteria, or statements that are useful in evaluating readiness for a third-party ISO 13485:2016 certification audit.
Why are ISO 13485 audits important?
ISO 13485 audit checklists play a crucial role in ensuring the effectiveness and compliance of an organization’s QMS for medical devices, as well as its process of auditing. Apart from that, here are more key reasons why using these checklists is important:
Helps auditors conduct a thorough evaluation of the QMS
Verifies compliance with the standard’s requirements
Promotes standardization and consistency across audits
Assists auditors to identify areas of non-compliance, gaps, and areas for continuous improvement within the organization’s current practices
Ensures proper documentation and evidence collection during audits
Prepares organizations for external audits and certification assessments
Whether you’re on the audit floor or reviewing results from the boardroom, Mitti (by SafetyCulture) gives your team one place to track ISO 13485 readiness.
What should be included in an ISO 13485 audit checklist?
An ISO 13485 audit checklist should cover various aspects of a quality management system (QMS) for medical devices to ensure compliance with the ISO 13485 standard. While the specific items on the checklist may vary based on the organization’s unique processes and activities, here are key areas that should typically be included:
Management responsibility
Design and development/design controls
Control of non-conforming products
Medical Device Reporting (MDR)
Production and Process Controls (P&PC)
Monitoring and measurement
Sterilization process controls
Purchasing controls
Documentation and records
Customer requirements
Technical files
Risk management (per ISO 14971 requirements)
5 steps to prepare for ISO 13485:2016 certification
Now, what must organizations keep in mind and consider when getting ready to obtain a certification in ISO 13485? Here are some steps they can take:
Obtain a copy and gain an understanding of the ISO 13485:2016 standard.
Identify areas for improvement in the current QMS by conducting a gap analysis or a readiness audit to ensure compliance with the ISO 13485:2016 regulatory requirements.
Perform quality monitoring audits and maintain a record of the results.
Define your organization’s competencies and determine training requirements for ISO 13485:2016 certification based on the internal audit results.
Ensure competence needs are met and that all parties involved are kept in the loop.
It’s also crucial to note that these steps aim to guide your organization on what to prioritize doing toward an ISO 13485 certification. However, you may add more processes or necessary audits to complement your efforts in maintaining a working and safe QMS.
How to use a checklist for ISO 13485 compliance
Here’s a step-by-step guide on how to use an ISO 13485 audit checklist:
Get familiar with the checklist. Read through the questions and criteria before you start, and make sure you understand what ISO 13485 requires.
Assess your current processes. Compare what you do against each checklist item and flag where your organization has gaps.
Document your evidence. Records, procedures, work instructions, and training logs all count as proof of compliance.
Run a self-assessment. Decide where your QMS meets the bar and where it still needs work.
Log corrective actions. Fill in the table with specific fixes, and build an organized action plan with deadlines.
Act on the plan. Work through corrective actions on schedule so improvements actually land.
Check your work. Run internal audits or reviews to confirm the fixes closed the gap and improved your QMS.
Keep monitoring. ISO 13485 compliance isn’t a one-time event — review your QMS on an ongoing basis.
Update the checklist. Revise it whenever the standard changes or your own processes evolve.
Thermosash was able to achieve ISO certification in six months using the Mitti Platform by centralizing workflows, boosting visibility, enhancing accountability, and streamlining quality control through QA checks and automatic corrective action alerts.
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