Digital MDSAP Audit Checklists
Determine gaps in the manufacturer’s QMS, implement corrective actions and achieve MDSAP certification using a mobile app
Determine gaps in the manufacturer’s QMS, implement corrective actions and achieve MDSAP certification using a mobile app
Published 8 Dec 2020
The Medical Device Single Audit Program (MDSAP) is a certification program for the Quality Management System (QMS) of manufacturers that wish to sell medical devices to the following MDSAP participating countries: USA, Australia, Japan, Brazil, and Canada.
An ISO 13485 audit checklist is used for MDSAP certification to determine if the organization’s QMS is aligned with the ISO 13485:2016 standard. It helps determine the readiness of medical device manufacturers for AO’s MDSAP certification audit. With iAuditor, quality managers can:
Initiated by the International Medical Device Regulators Forum (IMDRF), MDSAP intends to create a consolidated process for maintaining the safety and quality of medical devices by manufacturers that meet QMS international standards (ISO 13485:2016) and comply with the requirements of Regulatory Authorities (RA) of participating countries.
This article briefly discusses the following:
MDSAP audit checklists are tools used by quality managers to determine if the manufacturer’s QMS meets the requirements of ISO 13485:2016 and that of Regulatory Authorities. MDSAP audit checklists help quality managers determine the readiness of medical device manufacturers for MDSAP certification by recognized third-party Auditing Organizations (AO).
Working towards MDSAP certification can be costly and time-consuming, especially for manufacturers reliant on paper-based audits. Time spent on documentation of audits, reporting, and filing of records can be better spent working on gaps discovered and improving QMS to get certified for MDSAP. iAuditor, the world’s most powerful auditing app and software, can help manufacturers meet ISO 13485 and RA requirements and maintain the quality and safety of medical devices. Solve the challenges of MDSAP certification by doing the following:
Here is a collection of our carefully prepared MDSAP audit checklists you can browse and use as part of achieving MDSAP certification and ongoing compliance.
An ISO 13485:2016 standard checklist can help quality managers identify gaps in the organization’s current processes. Divided into 5 main sections, this checklist follows ISO 13485:2016’s key clauses:
Each section assesses your organization’s preparedness in implementing an ISO-certified Quality Management System. This converted digital checklist allows you to select “Done,” “In Progress,” “Not Started,” and, for sections 6, 7, & 8, “Not Applicable.”
Use this MDSAP audit checklist to assess how aligned is the company’s QMS with that of MDSAP. This digitized MDSAP template is based on the US FDA’s MDSAP QMS Internal Assessment Checklist.
This essential principles checklist template is based on Australia’s Therapeutic Goods Administration (TGA) Essential Principles Checklist. Use this checklist to help the company determine conformance with TGA’s requirements.
