Published 8 Dec 2020
What is MDSAP?
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.
MDSAP - ISO 13485 Audit Checklist
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 (iAuditor), quality managers can:
- Identify processes that don’t adhere with 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.
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:
- what are MDSAP audit checklists;
- the steps in working towards MDSAP certification;
- technology to help ensure that implemented QMS meets the requirements of ISO 13485:2016 and of RAs; and
- free MDSAP audit checklists.
What are MDSAP Audit Checklists?
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).
6 Steps to Prepare for MDSAP Certification
- 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.
Technological Solution to the Challenges of MDSAP Certification
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. SafetyCulture (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:
- Create mobile-ready MDSAP checklists.
- Empower teams to proactively conduct efficient monitoring procedures and analysis using a smartphone or tablet.
- Save time with the SafetyCulture (iAuditor) mobile app by generating comprehensive reports as internal quality officers finish audits.
- Secure all reports online and automatically share it with members of your organization. Preview a sample web and PDF report.
- Use for free with small teams. Unlimited reports and storage for premium accounts.
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.
MDSAP Audit Checklists
ISO 13485:2016 Standard Checklist
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:
- 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 converted digital checklist allows you to select “Done,” “In Progress,” “Not Started,” and, for sections 6, 7, & 8, “Not Applicable.”
MDSAP Audit Checklist (FDA)
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.
Essential Principles Checklist (TGA)
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.
