A Guide To Digital ISO 13485 Audit Checklist: How to Make One and Achieve ISO 13485 Certification

A Guide To Digital ISO 13485 Audit Checklist How to Make One and Achieve ISO 13485 Certification

Last Updated on September 25, 2022 by Ossian Muscad

ISO 13485 is an internationally recognized standard that specifies requirements for a quality management system (QMS) when manufacturing medical devices. A well-documented QMS ensures that your products comply with ISO 13485 and meet the safety and regulatory requirements of the medical device industry. In this article, we will discuss an ISO 13485 audit checklist and how to make one using a digital format.

 

What is ISO 13485:2016?

ISO 13485:2016 standardizes the Quality Management System (QMS) for organizations involved in every stage of medical device production—from distribution to servicing and disposal. Organizations with ISO 13485:2016 certification are recognized for producing medical devices on par with current industry standards.

In other words, an ISO 13485:2016 certification is a badge of quality that lets your customers know that you’re serious about product safety and quality. With this certification, you can ensure that your customers receive the best possible product while reducing liability risk.

 

What is an ISO 13485 Audit Checklist?

An ISO 13485 audit checklist is a tool used by auditors to assess whether an organization’s QMS meets the standard’s requirements. The checklist is used to identify gaps in the QMS and determine corrective actions. In addition, It also aids in preparation for a third-party ISO 13485:2016 accreditation audit. With this checklist, quality managers can:

  • Look for areas in your processes that don’t comply with ISO 13485:2016 requirements.
  • Draft important notes for corrective actions related to the discovered gaps.
  • Assign corrective actions with corresponding deadlines.
  • Generate and submit reports on time.

With an ISO 13485:2016 audit checklist, quality managers can ensure that their organization is prepared for a third-party ISO 13485:2016 accreditation audit.

 

Essential Steps To Prepare for ISO 13485:2016 Certification

Becoming ISO 13485:2016 certified can be challenging, but the reward makes it a worthwhile investment. And if you know the essential steps to take, you can make the process smoother. Here are five essential steps you need to take when preparing for ISO 13485:2016 certification:

  1. Download a copy of the ISO 13485:2016 standard to understand its requirements better.
  2. Determine where the current quality management system (QMS) needs improvement by conducting a gap analysis or readiness audit to ensure compliance with ISO 13485:2016 regulatory requirements.
  3. Carry out quality monitoring audits and keep track of the outcomes.
  4. Identify your organization’s competencies and establish training requirements for ISO 13485:2016 certification based on the internal audit findings.
  5. Ensure that the task’s requirements are satisfied and that all parties are kept informed.

 

What’s Included in an ISO 13485 Audit Checklist?

When creating an ISO 13485 audit checklist, it’s important to include all the elements required for compliance with the standard. Here are some of the elements that you should include in your checklist:

  • Management responsibility
  • Quality policy
  • Organizational structure and responsibilities
  • Resource management 
  • Product realization
  • Measurement, analysis, and improvement

Each element is given a specific rating to ensure that all standard aspects are addressed.

 

How to Make an ISO 13485 Audit Checklist?

You can make an ISO 13485 audit checklist in a few different ways. One way is to create a checklist using a word processing program like Microsoft Word or Google Docs.n Another way is to use quality management software (QMS) that includes a checklist template.

This approach is ideal for organizations that want to automate their ISO 13485 audit checklist process. Once you’ve decided how you want to create your ISO 13485 audit checklist, the next step is to populate it with the relevant information. Here’s a quick overview of what you’ll need to include:

  • The name and contact details of the ISO 13485 auditor
  • The ISO 13485 audit scope
  • A list of ISO 13485 requirements
  • A list of ISO 13485 non-conformities
  • A list of ISO 13485 corrective actions

When you’ve finished creating your ISO 13485 audit checklist, please review it and ensure all the required information is included.

 

Why Use Digital ISO 13485:2016 Audit Checklists

Paper-based audits can be inconvenient and time-consuming. Time spent on documentation and manual records filing may be better utilized by focusing on QMS gaps and working towards ISO 13485 certification. With a digital ISO 13485 audit checklist, you can:

  • Eliminate paper-based audits and the hassle of managing physical records.
  • Access your digital checklist with an internet connection anytime, anywhere.
  • Generate real-time reports to identify QMS gaps and areas for improvement.
  • Assign corrective actions with corresponding deadlines and monitor progress.
  • Create a digital iso 13485 audit checklist specific to your organization’s needs.

Achieving ISO 13485:2016 certification requires a commitment to quality from every organization member. Using a digital ISO 13485 audit checklist ensures that your QMS meets the standard’s requirements and that your organization is prepared for a third-party ISO 13485:2016 accreditation audit.

 

Create an ISO 13485 Audit Checklist Using DATAMYTE

Digitizing your checklist isn’t enough—you should use a platform that can help you streamline your iso 13485 certification process from start to finish. DATAMYTE offers a complete solution for iso 13485 certification. With its Digital Clipboard feature, you can create an entire ISO 13485 workflow dedicated to your iso 13485 audit process.

The DataMyte Digital Clipboard is a workflow automation software that will help you with your ISO 13485 compliance. It offers the following features:

  • Create a comprehensive ISO 13485 compliance workflow
  • Create digital ISO 13485 audit checklist templates
  • Collect data and automatically generate reports
  • Monitor and assign corrective actions
  • Achieve ISO 13485 certification

The DataMyte Digital Clipboard is the perfect tool for streamlining your ISO 13485 audit process. With its comprehensive features, you can create a digital ISO 13485 audit checklist specific to your organization’s needs and achieve ISO 13485 certifications. Book a demo now to learn more.

 

Conclusion

If you’re in the process of ISO 13485 certification, you must have a full checklist. Creating a digital ISO 13485 audit checklist is the best way to streamline your ISO 13485 certification process and ensure that your organization is prepared for a third-party audit.

 

 

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