Quality Officer:

1. Coordinate the preparation and conduct of each audit: remind the Internal Auditors assigned to an upcoming audit timely of the fact that they need to perform the audit and provide them with the topic of the audit and some initial materials such as quality manual chapters and SOPs that need to be audited.

Staff members assigned to perform an audit:

1. Prepare the audit: read all the documentation available in the laboratory on the element/procedure that will be audited. These can be SOPs, quality manual chapters, Biosafety Manual chapters, filled-out work forms, registers, Bench Aids, reports, etc. After the first year of auditing it is also important to consult audit reports of the previous year on the same laboratory procedures. In these reports you read which nonconformities were identified during previous audits on the same topic and you can focus on these points during the next audit to see if the corrective actions, controls and preventive actions have worked in solving/correcting the nonconformities.
2. Determine the structure of the audit: what do you want to start with and how will the audit go further. Determine which staff members you need to interview and contact these staff members to request their availability.
3. Perform the audit and record the observations.
4. End the audit with a debriefing on the same day in which you summarize the findings (both positive and negative) and mention the nonconformities with scores 3 and 4. This is especially important for score 4 nonconformities as these need to be solved directly.
5. Make a report of the audit that describes what was audited, which documents were checked, who was interviewed and what was observed. Give to each observation a score. A good system (but not obligatory) is a 4-graded scoring system:
   1: Finding does not deviate from the standard/documentation.
   2: Finding is a nonconformity that will have a negative effect on the quality management system in the long run when not solved, but is not a direct threat to the correct functioning of the quality management system. The nonconformity needs to be solved/corrected within 1 year.
   3: Finding has a direct negative effect on the correct functioning of the quality management system. The nonconformity must be solved within 3 months.
   4: Finding has a direct critical effect on the correct functioning of the quality management system and the correctness of examination results cannot be assured when the nonconformity is not solved. The normal work of the laboratory must therefore directly be halted until the nonconformity is solved/corrected. Note that this scoring system needs to be discussed with laboratory management beforehand, especially the time frames set per score for solving nonconformities.
6. Submit the report to the laboratory manager who has to draft a SMART action plan within 2 weeks to solve the nonconformities identified during the audit: see next activity.