Exemplar Global’s Medical Device Management Systems Auditor certification program provides international recognition for auditors who conduct external/third party audits against medical device management system standards.
Through extensive examination of your knowledge and personal attributes, our Medical Device Management Systems certification program will give you proof of your competence to effectively audit management systems of organizations that produce medical devices. It also provides you with assurance that your audits will be accepted globally.
Built in liaison with industry representatives in accordance with ISO 19011:2018, the program will confirm that you have the critical capabilities needed to effectively manage medical device issues.
So what are you waiting for? Download the requirements and Apply Now via Exemplar LINK.
Our Medical Device Management Systems Auditor certification program will:
Exemplar Global recognizes training completed with training providers who have held or currently 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. These are for our management system schemes, such as QMS, EMS, OHS, etc.
Some of our schemes require a 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 may need to complete a relevant knowledge examination, if available. If a knowledge examination is not available, this may be substituted 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. Importantly, the audit dates captured in your log need to have been conducted within the past three years.
There are current agreements with ICRA/CQI, PECB, and the CCAA to recognize certification. Applicants must be able to demonstrate holding a current certification with one of the above mentioned bodies in order to qualify.
You can check on the status of your application for certification via our Exemplar LINK platform at www.exemplarlink.org. At the top-level navigation, select the ‘Manage My Certifications’ button and from the drop- down menu choose the Exemplar Global option. From there, select the ‘Current Certifications’ tab. You will then be taken through to the ‘Applications in Progress’ page where you can check the status of your certification application.
Once you submit your application for certification, you will not be able to see the documents you have uploaded to support your application. Please contact your certification specialist or firstname.lastname@example.org if you need assistance.
It usually takes between seven to 10 business days to complete this process. However, this is provided that all supporting documents have been uploaded by the applicant.
Before you apply for certification, please ensure that you meet all the requirements specific to the scheme you wish to apply for. You can review those requirements on our website. These can be found by clicking on the ‘Individual Auditors’ tab at the top-level navigation of our homepage. From the drop-down menu, select the ‘Browse All Certifications’ option. From there, you will be taken to a page that features the different categories of certifications we offer, including Education Systems, Food Safety Systems etc. Select the scheme you are are interested in and click the ‘Learn More’ button. You will then be taken through to your selected scheme page. From there, click on the ‘Download Certification Requirements’ button on the right hand side of the page. Please review the requirements carefully to ensure that you meet the scheme, grade and scope requirements.
If you are a new customer, you will need to create an account with Exemplar LINK, our customer portal platform. You can access Exemplar LINK via www.exemplarlink.org or via the Exemplar LINK login button on our website. 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 these steps:
Once we have received your application, an Exemplar Global certification specialist will contact you if any additional information or steps are required.
Download the “Certification Requirements” document from the certification page you wish to apply for.
Carefully review the requirements to see if you have the qualification (training) needed and have met the scheme, grade, and scope.
Once you have met all the requirements, you’re ready to begin your 5 Steps to Certification!
Go on to Exemplar LINK to sign up and register your details
Login to Exemplar LINK & continue to: Manage My Certification > Exemplar Global > Apply for Certification
Select the Certification you want to apply for
Upload your auditor training certificate requirements & pay your fee
Complete the Work Style Assessment