Title

Start to carry out all internal audits and write audit reports

Why

The complete quality management system and all the examinations performed must be audited to see if the practice complies with documentation (and vice versa) and if both comply with ISO 15189.

What

Start to carry out internal audits according to the annual planning made in the previous activity.

How & who

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 identified one year ago.
  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).
  5. Make a report of the audit that describes what was audited, which documents were seen, 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 can have a negative effect on the quality management system over the long term 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 Manager beforehand, especially the time frames for solving nonconformities per score.
  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.

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This activity belongs to the QSE Assessment

 

ISO15189:2012: 4.10 4.11 4.14.1 4.14.5
ISO15190:2003: