MDSAP Audit with QMII

Are you or your organization preparing for an MDSAP audit? If so, then you're not alone. Many medical device manufacturers around the world are gearing up to meet the Medical Device Single Audit Program (MDSAP) standards set forth by the International Medical Device Regulators Forum (IMDRF). One of the best ways to ensure a successful audit is to use the QMII system to help manage and document all regulatory compliance requirements. In this blog post, we'll discuss what exactly is included in an MDSAP audit with QMII and how it can help your organization make sure everything is in order before the big day arrives.

What is MDSAP?

MDSAP is short for the Medical Device Single Audit Program. It's a program developed by Health Canada, the U.S. Food and Drug Administration (FDA), Brazil's ANVISA, Japan's MHLW, and Australia's TGA to streamline audits of medical device manufacturers.

The goal of MDSAP is to provide a single audit approach that meets the requirements of all participating regulatory authorities (RAs). This reduces the number of repetitive audits manufacturers must undergo and makes it easier for them to do business in multiple countries.

To participate in MDSAP, manufacturers must first be registered with one of the participating RAs. They then undergo an initial audit by a recognized Auditing Organization (AO). Once they've been approved, they're placed on an active surveillance list and are subject to periodic audits by the AO.

What is QMII?

The Quality Management International Institute (QMII) is a not-for-profit, international organization dedicated to promoting quality management principles and practices. QMII provides certification, training, publications, and other resources to help organizations improve their quality management systems.

Benefits of an MDSAP audit

An MDSAP audit with QMII provides many benefits for your organization, including:

1. Streamlined audits – An MDSAP audit with QMII can help streamline your organization's audits by allowing you to use a single audit report to satisfy the requirements of multiple regulatory authorities. This can save you time and money by reducing the number of audits you need to complete.

2. Improved quality – An MDSAP audit with QMII can help improve the quality of your products and services by ensuring that they meet the requirements of multiple regulatory authorities. This can help you avoid costly recalls and other quality issues.

3. Enhanced reputation – An MDSAP audit with QMII can help enhance your organization's reputation by demonstrating your commitment to quality and safety. This can make it easier to win new business and keep existing customers loyal.

The benefits of an MDSAP audit with QMII

The benefits of an MDSAP audit with QMII are many. An MDSAP audit ensures that your medical device organization is in compliance with international quality standards. QMII brings years of experience and expertise to the table, providing a comprehensive and independent assessment of your organization’s quality management system.

An MDSAP audit with QMII can help you:

- Achieve and maintain compliance with international quality standards
- Demonstrate your commitment to patient safety and quality
- Improve your organization’s overall performance
- Gain a competitive edge in the global marketplace

How to prepare for an MDSAP audit with QMII

MDSAP is a new audit approach that will be implemented in 2019. QMII has been working with MDSAP since its inception and is proud to be one of the first Certification Bodies to be accredited by MDSAP.

As we get closer to the go-live date, we would like to share some tips on how you can prepare for your MDSAP audit with QMII.

1. Review your documentation: One of the most important things you can do to prepare for your MDSAP audit is to review your quality management system documentation. This includes your quality manual, procedures, work instructions, and records. Make sure that all of your documentation is up-to-date and compliant with the requirements of the standard(s) you are registered to.

2. Train your staff: It is important that all members of your staff are trained on the requirements of the quality management system and their role in maintaining compliance. Make sure that everyone understands what is expected of them and that they know where to find information if they have questions.

3. Gather evidence: In order to demonstrate compliance with the requirements of the standard(s), you will need to gather evidence throughout your organization. This could include things like quality records, training records, audits, etc. Be prepared to present this evidence to the auditor during the course of the audit.

4. Schedule time for the audit: Once you have received confirmation from QM

Why MDSAP audit ?

The MDSAP audit is a requirement for any organization seeking to market their medical device in certain global markets. The certification demonstrates that the company has a Quality Management System (QMS) in place that meets international standards. This audit provides greater assurance to patients, healthcare providers, and regulators that the devices are safe and effective. In addition, the MDSAP audit can help improve efficiency and reduce costs for companies by streamlining the process of obtaining multiple certifications.

What to expect during an MDSAP audit with QMII

An MDSAP audit with QMII is a process that can help you ensure your quality management system (QMS) meets international medical device standards.

During an MDSAP audit, a QMII auditor will assess your QMS against the requirements of the International Organization for Standardization (ISO) 13485 standard. The auditor will also review your QMS documentation and observe how you operate your business.

You can expect the auditors to be professional and courteous, and to ask questions about your QMS and how it is implemented. The audit will usually take two to three days, but may be longer if the auditor has observations or recommendations.

At the end of the audit, the auditor will provide you with a report that includes their findings and recommendations. You should review the report carefully and take action to address any areas of concern. If you make changes to your QMS as a result of the audit, be sure to document these changes so that you can show them to future auditors.


In conclusion, MDSAP auditing with QMII is an efficient way to ensure the quality of your medical device products. The audit process provides a comprehensive review that covers all aspects of product manufacturing and development. With their extensive knowledge and experience in medical device compliance audits, QMII's team can help you identify areas for improvement as well as provide assistance in creating corrective action plans that are tailored to meet your specific needs. Whether you're just starting out on your journey towards gaining certification or have decided it's time to re-certify existing products, MDSAP audit with QMII can help take care of all your compliance requirements.