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Medical Device Single Audit Program (MDSAP) Internal Auditor

Do you conduct internal audits in a medical device organization that has MDSAP quality management system certification? Want to demonstrate that you have competency in the medical device QMS requirements for the MDSAP participating countries? IRAB-QSA MDSAP Internal Auditor Certification can give you the recognition you need to stand out from the crowd.

Through extensive examination of your knowledge and personal attributes, IRAB-QSA MDSAP Internal Auditor Certification can give you proof of your competency to effectively audit following the MDSAP Audit Model.

Built in liaison with industry representatives, IRAB-QSA MDSAP Internal Auditor Certification provides individuals with proof of their competency to effectively audit the quality management systems of MDSAP certified organizations.

Program Objectives

IRAB-QSA MDSAP Internal Auditor Certification has been developed to:

  • Assist organizations to demonstrate competency of internal QMS auditors for the applicable regulations of MDSAP-participating countries.
  • Enhance the professional recognition of internal auditors working with organizations who hold MDSAP QMS certification.

About the Medical Device Single Audit Program

The Medical Device Single Audit Program allows an MDSAP recognized auditing organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

Frequently Asked Questions

Apply for Certification


How long is my training certificate valid?

IRAB-QSA recognizes training completed with training providers who held/hold certification with us under our current name or previous trading names (RABQSA, QSA, RAB) for 10 years from the date the training was completed for our management system schemes, such as QMS, EMS, OHS, etc. Some of our schemes require that the training certificate to have been issued within the last three years. Please check the specific certification requirements for the scheme you wish to apply for. If your training was completed outside of the training requirement time, you will need to complete a relevant knowledge examination, if available.

If a knowledge examination is not available, you may substitute the knowledge exam with an audit log showing relevant audit experience. If you choose this method, we require that you show evidence of 10 audit days reflecting the specific scheme (e.g, QMS, EMS, OHS, etc.) and grade (i.e., auditor or lead auditor) you wish to apply for. Audits need to have been conducted within the past three years.


Do you recognize certification from other bodies?

There are current agreements with IRCA/CQI, PECB, and the CCAA. Applicants must be able to demonstrate holding a current certification with one of the above mentioned bodies in order to qualify.


How do I check on the status of my application?

You can check on the status of your application in your customer portal. To do so, visit the IRAB-QSA website at irab-qsa.com In the upper right-hand corner, click on the login button. This will take you to your online portal. From there, log into your online portal. Once logged in, select the Current Certifications tab. Then select the Applications in Progress button.


Where are the documents I uploaded in support of my application?

You will not see the documents you upload in support of your application. Please contact your certification specialist or info@irab-qsa.com if you need assistance.


How long does it take to process my application?

It usually takes between 7-10 business days, assuming all supporting documents have been uploaded by the applicant.


How do I access my IRAB-QSA account?

You can access your IRAB-QSA account through your online portal, which is available through the IRAB-QSA website at irab-qsa.com In the upper right-hand corner, click on the login button. This will take you to your online portal. From there, you will be able to download your certificate, upload documents, pay fees, access assessments, calculate fees, apply for certification, add schemes or scopes to your account, and more.


How do I apply for certification?

Before you apply for certification, please be sure that you meet all the requirements specific to the scheme you wish to apply for. It is best to review the requirements specific to the scheme you are interested in. You can find those on the IRAB-QSA website. Click on the Certifications tab in the upper left-hand corner. A large menu will appear showing all of our schemes. Select the scheme you are interested in. From there, click on the Certification Requirements button on the right side of the screen. Please review those requirements carefully to be sure that you meet the scheme, grade, and scope requirements.

If you are new customer, you will need to create an account on the IRAB-QSA website in order to access your customer portal. Click on the Login button in the upper right-hand corner of the screen. From there you can enter your contact details and create your account.

Once you have an account, either as a new customer or as an existing customer, you can apply for certification by following the steps below:

  1. Be sure you are logged into your online portal.
  2. Click on the Apply for Certification button.
  3. Click on the category of certification you are interested in, such as Quality Systems.
  4. Click on the specific certification you want to apply for, such as Quality Management System Auditor.
  5. Select Qualification-Based certification, if prompted. This will vary by scheme. 
  6. Choose the grade desired. Note: Only existing customers with at least 12 years of continuous certification with IRAB-QSA may choose the Master Auditor grade.
  7. Review the certification, recertification, and expansion requirements relevant to your scheme and grade, and click Continue to Scopes. Please refer to the PDF Scope document for criteria.
  8. Select any scopes you wish to apply for and click Continue to Code of Conduct.
  9. Tick the box next to each item in the Code of Conduct. By doing so, you agree to adhere to this code. Failure to do so, may result in the termination of your certification. Click Continue to Authorisation.
  10. If your organization has given you an authorisation code, please enter it here and click Validate. If not, click Continue to Payment.
  11. Carefully review your application info and payment options. 
  12. Select a payment option and enter your payment details. Note that you may choose to pay your annual fees monthly. However, this will only take effect with your next annual fee.
  13. Click Pay Now. Note: All fees are non-refundable, so please be sure you meet the certification requirements before applying for certification. Also, we are required to collect GST from our Australian customers. GST will be added to your certification fees.

Once we have received your application, an IRAB-QSA certification specialist will contact you if any additional information or steps are required.

More Questions?

Visit our full FAQs page here or use the Chat/Contact Us button in the lower right corner of the screen to ask your question. If we’re not around, leave your question there and we’ll get back to you as soon as we’re back online.