LAB-QM-012 — Internal Audit Policy

1.0 Purpose

This policy establishes a systematic, objective, and documented internal audit process for the Tarangnan Community Hospital (TCH) Clinical Laboratory. It verifies that laboratory operations and the Quality Management System (QMS) conform to planned arrangements, approved standard operating procedures, DOH licensing standards, and ISO 15189:2022 requirements, while assessing system effectiveness to provide actionable findings for Management Review and continual improvement.

2.0 Scope

This policy applies to all Medical Technologists and Laboratory Aides across all sections of the TCH Clinical Laboratory. It encompasses internal audits of governance, pre-examination, examination, and post-examination processes, point-of-care testing (POCT), personnel competence, equipment and reagent management, information management, facilities, biosafety, and external referral services.

3.0 Definitions

• Internal Audit — a systematic, independent, and documented process for obtaining objective audit evidence and evaluating it impartially against audit criteria to determine the extent to which requirements are fulfilled.
• Audit Criteria — the set of policies, standard operating procedures, statutory regulations, and accreditation standards used as a reference against which audit evidence is compared.
• Audit Evidence — verifiable records, statements of fact, observations, or measurements relevant to the audit criteria.
• Audit Finding — the result of evaluating collected audit evidence against the established audit criteria.
• Nonconformity (NC) — the non-fulfilment of an applicable procedural, regulatory, or quality standard requirement (classified as Minor or Major).
• Opportunity for Improvement (OFI) — an identified situation where a process or practice fulfills minimum requirements but could be enhanced to improve efficiency, quality, or risk mitigation.

4.0 Responsibility

4.1 Hospital Director

• Approves the Annual Internal Audit Schedule and allocates necessary administrative resources to support the audit program.
• Reviews internal audit summaries, nonconformity trends, and resource recommendations during Management Review.

4.2 Pathologist

• Clinically evaluates audit findings impacting examination accuracy, diagnostic interpretation, or patient safety.
• Ensures auditor impartiality and reviews corrective action closures for major clinical nonconformities.

4.3 Chief Medical Technologist / Laboratory Quality Manager

• Manages the Internal Audit Program, establishes the annual schedule, prepares audit plans, and maintains F-QM-012-A-V0.
• Assigns qualified internal auditors, applying impartiality safeguards within TCH's small laboratory team structure.
• Tracks audit nonconformities to resolution, verifies CAPA effectiveness, and presents audit reports at Management Review.

4.4 Medical Technologists

• Qualified Medical Technologists serve as internal auditors: they plan and conduct audits objectively, gather objective evidence, document findings impartially, and submit audit reports promptly.
• Auditors shall not audit their own immediate technical work or approve corrective actions for audits they conducted.
• As auditees, Medical Technologists cooperate fully during audits, provide requested records promptly, and implement assigned corrective actions.

4.5 Laboratory Aides

• Cooperate with internal auditors during audits of specimen transport, waste segregation, cleaning, and environmental temperature logging.
• Laboratory Aides do not conduct technical audits, evaluate analytical compliance, or authorize audit conclusions.

5.0 Policy / Procedure

5.1 Audit Principles & Impartiality Safeguards

• Objective and Evidence-Based: Internal audits shall evaluate actual laboratory practice against approved written procedures using verifiable objective evidence (records, direct observation, interviews, and vertical process tracing).
• Constructive Quality Focus: Auditing is conducted to evaluate system effectiveness and uncover improvement opportunities rather than assign individual blame.
• Impartiality in Small Teams: Auditors shall be independent of the specific activity being audited whenever practicable. In TCH's primary hospital laboratory structure, where full operational independence is constrained by staffing, cross-auditing between workstations (e.g., Hematology MT auditing Clinical Microscopy/Chemistry) and supervisory oversight by the Chief Medical Technologist or Pathologist shall serve as documented impartiality safeguards in F-QM-012-A-V0.

5.2 Internal Audit Program & Annual Schedule

• Annual Audit Program: The Chief Medical Technologist / Laboratory Quality Manager shall develop and maintain an Annual Internal Audit Schedule (F-QM-012-A-V0), approved annually by the Hospital Director (see Figure 1).

Figure 1 — Annual internal audit execution and nonconformity closure flow

• Risk-Based Frequency: All laboratory sections and QSE domains shall be audited at least once annually. High-risk processes, sections undergoing method/equipment changes, or areas with recurring occurrences shall be audited more frequently.
• Auditor Qualifications: Internal auditors shall be qualified Medical Technologists who have completed training in QMS internal auditing principles, audit methods, and nonconformity reporting. Competency records are maintained in staff files.

5.3 Audit Criteria & Planning

• Pre-Audit Planning: Each internal audit shall have a documented plan in F-QM-012-A-V0 defining the audit scope, objectives, dates, assigned auditors, and specific auditees.
• Defined Audit Criteria: Audits shall evaluate operations against documented criteria established prior to the audit: - Approved TCH Quality Policies and Standard Operating Procedures; - DOH Licensing Regulations (A.O. 2021-0037 Annex B1 and DOH QMS Tool); - ISO 15189:2022 standards; - Manufacturer instrument operation and reagent instructions.
• Audit Communication: The audit schedule and scope shall be communicated to section staff in advance of scheduled audits.

5.4 Audit Conduct, Evidence Collection, and Auditor Competence

• Evidence Collection Methods: Auditors shall collect objective evidence using four primary techniques: - Direct Observation: Observing phlebotomy, specimen handling, analyzer maintenance, and staining procedures; - Record Review: Examining IQC logs, calibration records, maintenance logs, patient reports, and temperature logs; - Staff Interviews: Questioning staff regarding procedures, safety rules, and error escalation; - Vertical Process Tracing: Tracing a patient specimen from initial requisition and phlebotomy through analysis, verification, and LIS release.
• Evidence Sufficiency: Findings shall be supported by specific, verifiable sample identifiers, dates, and observed facts recorded in F-QM-012-A-V0.

5.5 Audit Finding Classification

Audit findings shall be classified into standard categories to support consistent evaluation and trending:

5.6 Audit Reporting, Follow-up, and Management Review

• Audit Report: The lead auditor shall compile findings and issue the formal Internal Audit Report in F-QM-012-A-V0 within 5 working days of audit completion.
• Routing to CAPA: Nonconformities shall be transferred to the CAPA log under Corrective and Preventive Action Policy. The auditee and section staff shall perform root-cause analysis and implement approved corrective actions within the assigned deadline.
• Follow-Up and Verification: The Chief Medical Technologist / Laboratory Quality Manager shall conduct on-site follow-up verification to evaluate objective evidence of corrective action completion and effectiveness before closing the finding.
• Management Review Input: Annual audit completion rates, major nonconformities, and recurring systemic findings shall be compiled and presented to the Hospital Director and Pathologist during Management Review under Management Review.

6.0 Records

All records generated under this policy, including annual audit schedules, audit plans, checklists, gathered evidence, audit reports, and finding closure records, shall be controlled in accordance with Control of Records and retained per Laboratory Retention Schedule Policy.

7.0 References

• DOH-Philippines QMS Tool, Section 4 — Monitoring Performance (Internal Quality Audit sub-area)
• DOH Administrative Order No. 2021-0037, Annex B1 — Technical Standards for Clinical Laboratories
• ISO 15189:2022, Clause 8.8 — Evaluations (8.8.1 General; 8.8.3 Internal audits)
• WHO LQMS Handbook, Chapter 11 — Assessment: Audits

Companion policies:

• Corrective and Preventive Action Policy — root cause analysis, CAPA planning, and follow-up verification for audit nonconformities
• Management Review — executive review of internal audit findings and program performance
• Continual Improvement and Performance Improvement Program Policy — continual improvement initiatives and quality indicators derived from audit findings

Controlled visual annex:

• IG-08 — The Quality Year — one-page visual annex to this policy (shared annex with LAB-QM-013), controlled under Document Control Policy Section 5.2.6 and registered in F-QM-002-B-V0. Master files: infographics/IG-08-The-Quality-Year-LAB-QM-012-013.png (PNG, print PDF, and editable HTML).