Digital ISO 13485 Audit Checklists & PDF Reports
Identify gaps in the current QMS and determine corrective actions
Achieve ISO 13485 certification using a mobile app
Identify gaps in the current QMS and determine corrective actions
Achieve ISO 13485 certification using a mobile app
Published December 8th, 2020
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 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:
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:
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.”
This article briefly discusses
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.
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, a cloud-based 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:
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.
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.”
