The Registration Audit

When the day of your Registration Audit has arrived, it is time to showcase your Quality Management System. The Auditor or Auditors are coming in to see how you have addressed the requirements of ISO 9001, and how you have designed your QMS.

Preparing for the Audit

Prepare the employees

Before the Audit you will want to make sure that all employees know that the audit will be taking place, and the purpose of the audit. This will help them understand how to respond to the auditors' questions. You want employees to respond openly and honestly to the auditor.  The auditor is looking for evidence that you are complying with the requirements of ISO 9001, your employees are the ones that will be providing that evidence. Preparing them to answer the auditors questions will make the audit go more smoothly.

  • This is not a test. If the auditor asks a question, they are looking for information on how something works, not if the employee has all the answers but how the employee goes about finding answers and information. Do procedures provide information? If the information is not in a procedure, where does the employee go next, do they ask a supervisor?

Prepare the facility

  • Make sure all areas of the facility are clean and neat; there are potential nonconformances hiding in any given mess.
  • Make sure documents are available where every they need to be used.
  • Check bulletin boards, counters, cupboards, drawers for uncontrolled documents, un calibrated measuring and monitoring instruments and unidentified parts or supplies.

Prepare for the Auditor

  • Have a copy of the Quality Manual and Quality System Procedures available for the auditor.
  • Designate a place for them to work when they are not out in the facility. They will need to work on their documentation and reporting.
  • Assign someone to go with the Auditor to show them where different areas and departments are. Coach this person to let employees answer the auditors questions, not answer the questions themselves unless the question was directed to them.