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Determine gaps in manufacturer’s quality management system and achieve MDSAP certification with MSAP audit checklist.
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Published 1 Mar 2024
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3 min read
An MDSAP audit checklist is a tool used by quality managers to determine if the manufacturer’s QMS meets the requirements of ISO 13485:2016 and that of Regulatory Authorities participating in the MDSAP. MDSAP audit checklists also help quality managers determine the readiness of medical device manufacturers for MDSAP certification by recognized third-party Auditing Organizations (AO).
The MDSAP is a certification program for the QMS of manufacturers that wish to sell medical devices to the following MDSAP participating countries: the USA, Australia, Japan, Brazil, and Canada. With that, the Regulatory Authorities (RAs) participating in this program are the following:
Australian Therapeutic Goods Administration (TGA)
Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
Health Canada
Ministry of Health, Labour and Welfare (MHLW)/Pharmaceuticals and Medical Devices Agency (PMDA) (Japan)
US FDA
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 (like ISO 9001 and ISO 13485:2016) and comply with the requirements of Regulatory Authorities (RA) of participating countries.
To guide you as you prepare for acquiring this certification, here are some steps and tips you can follow:
Gain an understanding of the ISO 13485:2016 standard and the RA requirements of the country where you are to sell medical devices.
Identify areas for improvement in the current QMS by performing a gap analysis or a readiness audit to ensure adherence to ISO 13485:2016 and other requirements.
Conduct quality monitoring audits and maintain a record of results.
Define your organization’s competencies and determine training requirements for MDSAP certification based on the audit results.
Ensure competency needs are met and that all parties involved are kept in the loop.
Partner with an Auditing Organization for MDSAP certification.
Sample MDSAP Audit Checklist PDF Report | SafetyCulture
To help you conduct an in-depth QMS audit according to MDSAP requirements, use the following guide on what you must put in your MDSAP audit checklist:
Title Page – includes the manufacturing site name, date and location of the audit, and name of the auditor
Individual Sections for Each QMS Requirement – allows you to verify if the manufacturing site follows the standards stated in the MDSAP quality manual
Completion Page – where you can provide comments and recommendations, if any, and sign off the report by including the name and signature of the auditor
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This 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.
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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 SafetyCulture, quality managers can:
Identify processes that don’t adhere to ISO 13485:2016 requirements. This checklist has items with the corresponding ISO 13485:2016 clauses.
Create relevant notes for corrective actions on QMS gaps found.
Assign corrective actions with deadlines.
Generate and submit reports using mobile devices.
Download this converted ISO 13485:2016 checklist to suit the needs of the manufacturer for MDSAP certification.
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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.
