Registrar Questionnaire

These are key questions  to ask potential ISO 13485 Registrars during your selection process. Selecting the right registrar is critical to a successful ISO 12485:2016 certification.

Opening Questions for the Registrar Representative

When choosing a registrar to work with, it is important that you ask them certain questions to ensure the registrar you choose will be beneficial for your organization to work with. Registrars need to have specific certifications themselves and be a member of IAF. Learn more about who is able to grant certification here. Below is a list of of opening questions we recommend asking the registrar representative: 

  • What accreditations do you have?
  • In which countries are you licensed?
  • Do you use the same lead auditor/auditors each time?
  • Where would the auditors of this project come from?
  • How many auditors would you use on this project?
  • Can we meet the auditors who would work on this project?
  • If we have questions and call in, can we talk to our auditor or do we talk to a different representative?
  • What relevant industry experience do you have?
  • How many and which similar companies have you registered?
  • How many auditors do you have in our SIC code?
  • Do you offer virtual or remote audits?

Technical Questions for the Registrar Representative

  • How do you interpret the standard? Do we have access to your interpretation?
  • How do you handle pre-assessment audits? Do you recommend them? Are they mandatory?
  • Do you have a checklist we can use to assess our own system?
  • What method do you use to do a full system audit?
  • What is the frequency of surveillance audits?
  • What is covered at each surveillance?
  • Is there advance notice of surveillance?
  • Do you do a full system audit every three years?
  • How do you determine how much time to spend on a full system/surveillance audit?
  • Describe how you determine major and minor nonconformances.
  • In what area of the standard do you find the most nonconformances?
  • How do you handle a major nonconformance? How long do we have to respond?
  • Will you return to audit that section? If so, will you look at any other areas?
  • What experience do each of the auditors who are assigned to us have?
  • What method do you follow when there is a need to change auditors?
  • How do we contact the auditors?
  • Review bios of lead and other auditors, i.e. education, experience, companies audited, references.

Questions for the Auditor


  • How do you make yourself available to people in the plant who have questions during the audit?
  • What do you do when someone is too nervous to answer your questions?
  • How do you set boundaries so everyone’s time is used effectively?

  • Describe a situation where you had to convey a point to a hostile or unreceptive audience.
  • How do you make difficult decisions?
  • How do you handle the unexpected?
Conflict Management

  • Describe a conflict you handled well, and one you didn’t handle well.
  • Describe a time when you had to deliver bad news, and the receiver didn’t take it well.
Ethics and Values

  • Have you ever had to represent a position you didn’t completely agree with?
  • Have you ever had to give feedback that was more negative than the requester was expecting?
  • What did you do?
  • How do you handle confidential information a requester knows you have, but you can’t or won’t disclose?

  • Have you worked with union and non-union facilities?
  • What are the differences?
  • How many major projects have you managed at the same time?
  • How have you managed projects with team members from other offices/locations/practices?
  • How do you keep organized during an assessment/audit?

Written Communications

  • Please provide with written examples of observations and non-conformances.

Download the Registrar Questionnaire