Internal Quality Audits (4.14) - PowerPoint PPT Presentation

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Internal Quality Audits (4.14)


Internal Quality Audits (4.14) - ISO 15189 Requirements for Internal Audits - The Audit Process - Templates for Meeting Requirements Requirements for Internal Quality ... – PowerPoint PPT presentation

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Title: Internal Quality Audits (4.14)

Internal Quality Audits (4.14)
  • - ISO 15189 Requirements for Internal Audits
  • - The Audit Process
  • - Templates for Meeting Requirements

Requirements for Internal Quality Audits
  • All elements 15 management and 8 technical of ISO
    15189 should be audited during a calendar year.
  • Must have a procedure for planning and
    implementing internal quality audits so as to
    verify the elements and systems of the quality
    management system are implemented and effective.

Requirements for Internal Quality Audits
  • Audits should be planned and performed by the
    Quality Manager/ Officer or nominee
  • You cannot audit your own activities
  • The procedure for internal audits should define-
  • - Audit types vertical/ horizontal to be
  • - Frequency of these audits (schedule)

Requirements for Internal Quality Audits
  • The procedure for internal audits should define-
  • - Methodology for performing the audit
    including reporting and close out processes
  • - Corrective action/ preventative action must
    be documented and taken within an agreed time
  • Results of internal audits form part of the
    Quality Management System review process

The Audit Process
  • What is an audit?
  • It is a planned or documented activity planned
  • in accordance with written procedures and
  • checklists, to verify by examination and
  • investigation of objective evidence, that
  • applicable elements of a quality programme or
  • plan have been developed, documented and
  • effectively implemented in accordance with
  • specified requirements.

The Audit Process
  • Depth of Audit
  • Horizontal audit (system audit)
  • Will verify that each element of the quality
  • management system are described,
  • implemented and effective e.g.
  • 4.1 to 4.15 15
  • 5.1 to 5.8 8
  • Total of 23 elements

The Audit Process (Depth of Audit)
  • Vertical Audit
  • - Will review in detail the testing
    departments in a laboratory.
  • - All testing departments should be audited
    over the course of 12 months.
  • - A vertical audit is designed to cover
    activities from procurement of specimen to
    issue of results.
  • - The audit uses the details of 2 known

The Audit Process (Depth of Audit)
  • Vertical Audit
  • The auditors must consider-
  • Man (trained, competent, motivated)
  • Materials (traceable, correct type, passed
    incoming inspection, correctly used, cleaned
  • Machine (calibrated, validated, maintenance QC)
  • Method (clear, up to date, correct version)
  • Mileau (temperature, particulate count, humidity

The Audit Process (Depth of Audit)
System audit e.g. 4.1 (horizontal)
  • What are we looking for-

Vertical audit e.g. haematology
Which has more depth horizontal or vertical?
The Audit Process
  • Audit process (same for internal, supplier or
  • extrinsic audits)-
  • Preparation and planning
  • Performance of the audit
  • Exit meeting
  • Audit report
  • Follow up

The Audit Process
  • Audit Planning
  • Audit schedule (12 month plan) horizontal and
    vertical is issued to Laboratory Management
  • Appoint trained personnel to perform the audits
    lead auditor (independent)
  • Notify the auditee at least 1 week in advance.
    Confirm in writing the timetable and personnel

The Audit Process (Planning)
  • Identify, obtain and review all relevant
    documentation prior to the audit relevant to the
    scope of the audit.
  • - previous audit reports (follow up)
  • - quality manual
  • - procedures
  • Develop audit checklist or have them pre prepared
    for horizontal or vertical audits. The audit
    checklist controls the continuity and depth of
    the audit.

The Audit Process (Performance)
  • Entry meeting (2 mins)-
  • - Introductions
  • - Confirm purpose/ scope
  • - Timetable including time for exit meeting
  • - Confirm escorts for duration of the audit

The Audit Process (Performance)
  • 1 hour to 1 day
  • Obtain objective evidence to verify compliance/
    non compliance and document same on checklist
  • Questions should be asked to illicate full
  • Following completion of the audit and before the
    closing meeting the audit team will meet to
    evaluate the evidence and agree on non
    conformances found and their classification.
  • A list of non compliances is then made.

The Audit Process (Performance)
  • Exit Meeting (5 mins)
  • The lead auditor controls the exit meeting.
  • The exit meeting will focus on-
  • - the outcome of the audit
  • - ensure the auditee understands and accepts
    the findings.
  • - agree date for the final release of the audit
  • - agree dates for close out of non conformances

The Audit Process
  • Audit Report
  • The formulation of the audit report must
  • - cover sheet.
  • - a report sheet with corrective action report
    and agreed action and close out dates.
  • - non conformances (corrective action requests)
    including classification.

The Audit Process
  • Audit Report contd
  • General observations should be noted including-
  • areas audited
  • activities found satisfactory
  • activities with concerns

The Audit Process
  • Follow up
  • Quality Assurance Manager/ Officer/ Nominee
    verifies actions are closed out within an agreed
    time frame.
  • Upgrade to major if not closed out within the
    agreed time frame.

The Audit Process
  • Characteristics of a Good Auditor
  • Good knowledge of the activity being audited
  • Communication skills (articulate)
  • Objective (stick to the facts)
  • Open minded
  • Good listener
  • Observant
  • A process approach
  • Meticulous

The Audit Process
  • Characteristics of a Good Auditor contd
  • Impartial
  • Professional
  • Diplomatic
  • High degree of integrity
  • Patient
  • Self driven and disciplined
  • The auditor should never be aggressive no matter
    what happens

The Audit Process
  • Characteristics of a Good Auditor contd
  • Summary
  • A good auditor should be a guide, philosopher
    and a friend.

The Audit Process
  • Number of Trained Auditors
  • At least one per discipline
  • Auditors must write their own reports and
  • follow up the close out of corrective actions

Templates for Meeting Requirements
  • Templates provided are-
  • Template 1 Internal Quality Audit Schedule
  • Template 2 Internal Audit Report Lead
  • Sheet
  • Template 3 Checklist for Vertical Audit
  • Template 4 Checklist for Horizontal Audit
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