Internal Audits

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Internal Audits

• 4.14 ISO 15189 Internal Audits
• 4.14.1 In order to verify that operations
• continue to comply with the requirements of
• the Quality Management System, internal
• audits of all elements of the system, both
• managerial and technical, shall be conducted
• at intervals defined by the system itself.

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Internal Audits

• 4.14.2 Audits shall be formally planned,
• organised and carried out by the Quality
• Manager or designated qualified personnel.
• The procedures for internal audits shall be
• defined and documented and include the types
• of audit, frequencies, methodologies and
• required documentation.
• 4.14.3 The results of internal audits shall be
• submitted to Laboratory Management for
• review.

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Internal Audits

• Internal audit provides evidence to
• demonstrate that the Quality Management
• System has been effectively established,
• implemented and maintained.

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Internal Audits

• Internal audit of pre examination, examination
• and post examination processes is required to
• ensure that they are being conducted
• according to agreed procedures. Internal
• quality control helps to ensure that the
• examinations are being correctly performed.

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Internal Audits

• Plan the audit
• Records results of the audit
• Evaluate results and make decisions

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Internal Audits

• SOP on internal audits
• Audit schedule
• Checklist for vertical audit
• Checklist for horizontal audit
• Audit report lead sheet
• Audit report sheet

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Internal Audits

• Internal Quality Audit Procedure
• Frequency and type
• Performance
• Non conformities minor/ major classification
• Entry and exit meeting
• Interval between audit/ report/ close out
• Follow up corrective actions

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Internal Audits

• Internal Quality Audit Procedure
• Role of Quality Assurance Officer
• Issued to
• Records are archived

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Internal Audits

• Vertical Audit
• Select a single request form and its associated
• sample (the input) and following through
• every element of the process until the report is
• produced (the output).

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Internal Audits

• Horizontal Audit
• Select one element of the process for example
• the report and examine a number of reports to
• see whether appropriate interpretation
• comments and/ or follow up of abnormal
• results had been provided.

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Internal Audits

• Checklist for Vertical Audit
• Audit No. Dept. Date
• __________ __________ ___/___/___
• Auditor Process/ Scope
• __________ ______________________
• Lab. Report No. Hosp. No. Date Tested
• __________ __________ ___/___/___
• Lab. Report No. Hosp. No. Date Tested
• __________ __________ ___/___/___

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Internal Audits

• The minimum criteria for form/ specimen
  acceptance are in compliance with.
• Review non conforming specimen form issues for
  that day.
• Review centrifugation, aliquoting, quality
  checks.
• Any modifications are recorded in the final test
  report.

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Internal Audits

• 5. Review the test method including-
• Maintenance files on IT system
• Review of results on the instrument
• Release of results to patients file
• QC performed prior to release of results.
• EQA scheme in place for test.
• Turnaround time.

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Internal Audits

• Verify the Laboratory instrument is secure from
  uncontrolled access.
• Data on instruments and the Laboratory
  Information System is backed up at defined
  intervals.
• Back up discs are labelled properly and stored
  securely.

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Internal Audits

• 10. Equipment file-
• Calibration records
• PM status labelling
• User requirement specification
• IQ, OQ data
• Procedure in place for the set-up and
• maintenance of the equipment.
• Follow up non conformances traceable
• to the test.

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Internal Audits

• 13. Environmental monitoring.
• 14. The sample was correctly stored before and
  after testing.
• 15. Personnel
• Review records of personnel who performed the
  test method.
• 16. Test report
• Meets the requirements of the Quality Manual
  (5.8)

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Internal Audits

• 17. Review test reports.
• 18. Perform audit trail on processing an urgent
  specimen.

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Internal Audits
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Internal Audits
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Internal Audits
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Internal Audits
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Internal Audits
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Internal AuditsINAB Audit Findings
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Internal AuditsINAB Audit Findings
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Internal AuditsINAB Audit Findings
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Internal AuditsINAB Audit Findings
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Internal AuditsINAB Audit Findings