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MDSAP Audit Checklists

Determine gaps in the manufacturer’s Quality Management System (QMS), implement corrective actions, and achieve Medical Device Single Audit Program (MDSAP) certification with the help of an MDSAP audit checklist.

MDSAP Audit Checklist (FDA)

  • Eliminate paperwork with digital checklists
  • Generate reports from completed checklists
  • Free to use for up to 10 users
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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 United States Food and Drug Administration (US FDA)’s MDSAP QMS Internal Assessment Checklist. Using this template in SafetyCulture (formerly iAuditor), quality managers can do the following and more:

  1. Verify if the manufacturer adheres to the MDSAP QMS scope and requirements, including having measures in place to record and control QMS-related information and evaluate QMS performance.
  2. Check if the manufacturing site is engaged in continuous improvement efforts and has processes to plan and manage them.
  3. Provide descriptions and other details on how the organization provides education and training to its employees on their roles and responsibilities in the QMS.
  4. Complete the audit report by providing comments and recommendations on the QMS and how to help prepare for MDSAP certification. Also, include the name and signature of the one who conducted the audit.
  5. Export the completed report into an MDSAP audit checklist PDF file. You can also use other formats, including CSV, Excel, and Word.
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Published 1 Mar 2024
Article bySafetyCulture Content Team
|3 min read

What is an MDSAP Audit Checklist?

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).

What is MDSAP and Why is it Important?

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.

How to Prepare for MDSAP Certification

To guide you as you prepare for acquiring this certification, here are some steps and tips you can follow:

  1. Gain an understanding of the ISO 13485:2016 standard and the RA requirements of the country where you are to sell medical devices.
  2. 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.
  3. Conduct quality monitoring audits and maintain a record of results.
  4. Define your organization’s competencies and determine training requirements for MDSAP certification based on the audit results.
  5. Ensure competency needs are met and that all parties involved are kept in the loop.
  6. Partner with an Auditing Organization for MDSAP certification.

What to Include in an MDSAP Audit Checklist

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

FAQs About MDSAP Audits

Currently, the MDSAP certification is voluntary in Australia, Japan, Brazil, and the United States. However, the program is mandatory for medical device manufacturers in Canada. Since the MDSAP only has these 5 participating countries, its requirements aren’t necessarily adopted by other nations and regions.

An average of 15 minutes is usually spent on the actual auditing process in a medical device manufacturing company to check its compliance with MDSAP. However, the entire process of an MDSAP audit consists of a series of 3 audits throughout a 3-year period:

  • Initial certification audit
  • Surveillance audit
  • Recertification audit

In most cases, being ISO-certified is a prerequisite for acquiring an MDSAP certification. However, ISO and MDSAP are two different programs that follow similar requirements. While some countries can be compliant with ISO standards, only the 5 participating countries recognize the MDSAP certification.

Complement Your Efforts in Getting MDSAP-Certified with an Auditing App

Why use SafetyCulture?

Working towards MDSAP certification can be costly and time-consuming, especially for manufacturers reliant on paper-based audits. Time consumed 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, 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 and templates.
  • Capture QMS issues and recommend actions to resolve them.
  • Empower teams to proactively conduct efficient monitoring procedures and analysis using a smartphone or tablet.
  • Save time with the SafetyCulture mobile app by generating comprehensive reports in various formats, including PDF, CSV, and Word, as internal quality officers finish audits.
  • Secure all reports online and automatically share them with members of your organization.
  • Use for free with small teams. Unlimited reports and storage for premium accounts.

Try SafetyCulture for free!

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.

Related MDSAP Audit Checklists

Inspection template
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ISO 13485:2016 Standard Checklist

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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.”

Inspection template
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MDSAP - ISO 13485 Audit Checklist

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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:

  1. Identify processes that don’t adhere to ISO 13485:2016 requirements. This checklist has items with the corresponding ISO 13485:2016 clauses.
  2. Create relevant notes for corrective actions on QMS gaps found.
  3. Assign corrective actions with deadlines.
  4. Generate and submit reports using mobile devices.
  5. Download this converted ISO 13485:2016 checklist to suit the needs of the manufacturer for MDSAP certification.

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SafetyCulture Content Team
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SafetyCulture Content Team

SafetyCulture Content Team
The SafetyCulture content team is dedicated to providing high-quality, easy-to-understand information to help readers understand complex topics and improve workplace safety and quality. Our team of writers have extensive experience at producing articles for different fields such as safety, quality, health, and compliance.

Explore more templates

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 - 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, 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.
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.

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