Document Type Document Code:

QMS-QM-009
STANDARD OPERATING Effective Date:
PROCEDURE September 2017
Document Title Revision Number:
0
PHILIPPINE INTERNAL QUALITY AUDIT Page:
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REVISION HISTORY

Rev Date of Next

Review Date Description of Change
No. Review

Reviewed by: Approved by: JOEL M. ABANILLA, MD

ISO Chairperson Executive Director
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1. OBJECTIVE

1.1. To determine whether the management system conforms to the requirements of ISO
9001:2015 .

1.2. To evaluate whether the management system objectives and targets reflect the policy
statements and that it is working effectively, understood, and has been effectively
implemented and maintained.

1.3. To contribute to the continual improvements and performance of the overall management
system and performance.

2. SCOPE

2.1. This procedure covers the entire Quality Management System of the Philippine Heart Center

3. RESPONSIBILITY

3.1. The Internal Quality Audit Team shall be responsible in checking whether the QMS :

3.1.1.Conforms to the planned arrangements as established and documented and with the
requirements of ISO 9001:2015.

3.1.2.Is effectively implemented and maintained

3.1.3.Provides information on the results of audits to management

3.2. The Internal Quality Audit Lead Auditor prepares and maintains an Annual Audit Plan and
oversees its implementation
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3.3. Internal Auditors perform the scheduled audit, report to the Lead Auditor and conduct follow-
up audits to verify implementation and effectiveness of corrective actions stated in the
corrective action report

3.4. Auditees shall be responsible for providing corrective action to detected non-conformity.

4. DEFINITIONS

4.1. Audit refers to a systematic, independent and documented process for obtaining audit
evidence and evaluating it objectively to determine the extent to which the audit criteria are
fulfilled.

4.2. Audit criteria are set of policies, procedures or requirements. These are used as reference
against which audit evidence is compared.

4.3. Audit evidence – records, statements of facts or other information, which are relevant to the
audit criteria and verifiable.

4.4. Audit Findings refer to results of the evaluation of the collected audit evidence against audit
criteria.

4.5. Nonconformity refers to non-fulfillment of a requirement.

4.5.1. NC Major (N) refers to a breakdown in the system due to failure to fulfill one or more
requirements of the management system standards or a situation that raises significant
doubt about the ability of the QMS to achieve its intended outputs.

4.5.2.NC Minor (MiN) refers to isolated lapse or some of the requirements of the management
system standards are not fulfilled completely. However, this does not jeopardize the
effectiveness of the QMS element.

4.6. Opportunity for Improvement (OFI) refers to Hints. These are not actual non-conformities at
the time of audit but suggestions for system optimization with respect to a requirement of the
 Document Type Document Code:
QMS-QM-009
STANDARD OPERATING Effective Date:
PROCEDURE September 2017
Document Title Revision Number:
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PHILIPPINE INTERNAL QUALITY AUDIT Page:
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standard. In some cases, it may also serve as a warning for items bordering minor NC.

4.7. Positive Finding (P) refers to positive aspects of the management system meriting special
mention.

4.8. Auditee refers to the department/division or unit being audited.

4.9. Auditor refers to the person who conducts an audit and follows the directions of and supports
the lead auditor.

4.10. Internal Quality Audit team (IQA Team) – one or more auditors conducting an audit,
supported by technical experts.
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5. PROCEDURES OUTLINE

RESPONSIBLE ACTIVITY INTERFACE DOCUMENTS

START

Lead Auditor Plan the Audit Procedure Detail Annual Audit Plan
6.1 Audit Itinerary

IQA Team & Procedure Detail

Departments/ Auditees Prepare for the Audit 6.2 Audit Itinerary

Audit Checklist
IQA Team &
Procedure Detail Initial Action Request
Departments/Process Conduct the Audit 6. 3 Form/ Corrective
Owners
Action Request

Procedure Detail Audit Findings

Lead Auditor
Report the Results 6.4 Summary Report

IQA Team & Process Verify the Actions Procedure Detail Corrective Action
Owners/Auditees 6.5 Request Form
Taken

END
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6. PROCEDURES DETAIL

6.1. Plan the Audit

6.1.1.A Semi-Annual Audit Plan is prepared by the Lead Auditor, typically at the start of the
calendar year

6.1.2.IQA is conducted at least twice a year. Decision for initiating unplanned internal audits
may be based on but not limited to the following:

6.1.2.1. Unusual increases of quality related problems

6.1.2.2. Introduction of new services; and
6.1.2.3. Changes on the quality management system, personnel and processes

6.1.3. The Annual Audit Plan is approved by the Executive Director and disseminated to all
concerned Departments/ Process Owners

6.1.4.Prior to the conduct of an audit, a notice shall be given to all affected departments/
process owners at least seven (7) working days before the conduct of the audit. The
announcement shall be in the form of an Audit Itinerary prepared by the Lead Auditor.
The Audit Itinerary shall include:

6.1.4.1. Purpose of the Audit

6.1.4.2. Audit Scope
6.1.4.3. Assigned Auditors
6.1.4.4. Date and Time of the Audit; and
6.1.4.5. Other Arrangements for the Audit, if any.

6.1.5. Auditees shall confirm their availability at least three (3) working days prior to the date
of audit. In case of postponement due to conflict of schedule, the Lead Auditor shall be
informed of the justification through e-mail. The Audit Itinerary shall be revised and re-
distributed.
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6.1.6.Auditors who are tasked to conduct audit shall be selected from the pool of qualified
auditors listed on the Office Memorandum duly signed by the Executive Director.
Auditors are qualified and evaluated based on appropriate education, training and
experience (refer to Table 1)

6.1.6.1. The IQA Team are evaluated by the external auditor in terms of appropriate
education, training and experience, considering their knowledge, skills and
attitude. Evaluation is conducted at least once a year.

6.1.6.2. To maintain and improve auditor competence, the IQA Team is subject to
continual professional development through participation in audits, trainings
etc.

6.1.6.3. The auditors selected to perform internal quality audits are objective and
impartial of the process to be audited. No auditor will be permitted to audit his
or her own work.

6.2. Prepare for the Audit

6.2.1.Auditors review necessary documented information e.g. Quality Manual, Department

Policy Manuals, Standard Operating Procedures etc.

6.2.2.Taking into account the audit scope, objective and the information gained from the
review of various documents and records, the IQA Team develops the Audit Checklists
based on the Audit Itinerary.

6.2.3.The Auditee Departments prepare for the audit by ensuring the availability of the
Auditees (unless with justifiable reasons, refer to 6.1.5) and QMS Documented
Information. The Department’s Documented Information include:

6.2.3.1.1. Standard Operating Procedures/ Policy Manuals and its supporting forms
6.2.3.1.2. Risk Registers and /or Compliance Registers
6.2.3.1.3. Evidence of Implementation (e.g. reports, records of corrective actions, etc)
6.2.3.1.4. Regulatory Documents that apply
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6.3. Conduct of Audit

6.3.1.An opening meeting is conducted prior to actual audit to confirm audit schedule, basis
for the audit and audit participants.

6.3.2. Conduct of the audit is through interview, observation and examination of established
documented information.

6.3.3.It is important that auditors record all the objective evidence available, both deficiencies
and conformance with the procedures. This enables the findings to be reviewed
subsequently with the other members of the team. If a deficiency has been observed,
make sure that the department representative agrees at least to the facts of what has
been observed. It is not usually appropriate at this stage to try and reach agreement
with the representative regarding the interpretation of these facts. The Lead Auditor
shall have the final decision on the record of the audit findings, when a consensus is not
reached.

6.3.4.At the end of the audit, the auditors shall discuss and validate the findings against the
requirement of ISO 9001:2015.

6.3.5. The Lead Auditor shall consolidate the findings for presentation to the process owners
during the closing meeting. A closing meeting is conducted to present the audit findings
to the Auditees one (1) day after the consolidation conference among auditors.
Clarifications are discussed with the closing meeting and agreements reached upon
between the Auditors and the Auditees.

6.4. Report the Audit Finding

6.4.1.The summary of the audit findings in the form of an Action Request Form (ARF)/
Corrective Action Request (CAR) is issued within three (3) working days from the
closing meeting. This serves as the Audit Report.
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6.4.2.The assigned Auditors shall accomplish three copies (3) of the Action Request Form
(ARF)/ Correction Action Request (CAR) and issue the same to the concerned auditees
the same day as the issuance of the Summary of the Audit Findings.

6.4.3.Auditees shall make a detailed analysis of the causes and reasons and propose an
action to address the non-conformity or potential conformity. Causes, proposed action
and implementation date shall be reflected in ARF/CARF issued by the assigned
Auditor.

6.4.4.Auditees must submit the duly accomplished CAR/ARF to their assigned Auditors within
three (3) days from date of issuance.

6.4.5.Assigned Auditors must submit copies of the accomplished CAR/ARFs to : (1) the Lead
Auditor, (2) Document Controller and (3) retain a copy for his reference. Auditees
should also keep a copy for their reference and monitoring.

6.4.6. The Assigned Auditor must review the submitted accomplished ARF/CARF before
acceptance. Return of the ARF to the auditee department means non-acceptance and
that the ARF must be subject to revision. In case of disagreement between the auditee
and Auditor as to revisions, final decision shall rest upon the Lead Auditor.

6.4.7.Results of Audits shall be reported by the Lead Auditor with the IQA Team to the
Executive Committee during the Management Review. Initial copies of the audit findings
should however be already given to the Execom after the closing meeting.

6.5. Verify the Actions

6.5.1.A follow-up of actions take shall be conducted by the assigned auditor after one (1)
month of issuance of the ARF/CAR. In case the assigned auditor is unable to perform
his function, any qualified auditor shall be assigned by the Lead Auditor to conduct the
audit follow-up.

6.5.1.1. If the proposed action has been implemented, then the audit finding
is closed out.
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6.5.1.2. If not, the auditor must ask the process owner/ auditee to undertake
another round of root cause analysis, redefine their proposed action
plans and would be mandated to go through another round of
implementation-monitoring effectiveness check.
nd
6.5.2.Prior to the conduct of the 2 bi-annual audit, the IQA Team must sit as a body to
review the status of all findings issued during the first round of audit. Auditors are
required to conduct follow-ups on the previous audit findings to verify the results or to
check whether proposed actions were effective.

6.6. Audit of the Internal Audit

Audit of the IQA Team is conducted at least once a year after the conduct of the IQA.
Planning is done through the Semi-Annual Audit Plan and reflected in the Audit Itinerary.
Findings are issued via the Action Request Form and reported along with the status of audit
findings during Management Review.

7. RELATED DOCUMENTED INFORMATION

7.1. Audit Plan

7.2. Audit Itinerary Form

7.3. Audit Checklist Form

7.4. Action Request Form/ Corrective Action Request

7.5. Summary of Audit Findings

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8. ANNEX

Table 1. IQA Team Competencies

Particular QMS Auditor QMS Lead Auditor
(Minimum Requirements) (Minimum Requirements)

Bachelors Degree Bachelors Degree

Education

2 years 10 years
Total Work Experience

6 months 3 years
Work Experience QMS Related
Certificate of Attendance on the
ISO 9001 Requirements
following trainings :
Internal Quality Audit
Auditor Training
1. ISO 9001 Requirements
Lead Auditor Training
2. Internal Quality Audit

Competed at least 1 audit as Completed at 4 Audits as QMS

Audit Experience Auditor/ Auditee
QMS Auditor/ Auditees