INTERNAL AUDIT CHECKLIST

DATE : 22 May 2018 REF. NO. : IA-2018-001

UNIT/DEPT. : Top Management AUDITOR : Rommel V. Villasfer & Regina D. Macaslang
AUDITEE : Jason Roland N. Valdez OBSERVER : -

PROCEDURE INPUT PROCESS APPROACH OUTPUT

 Does the management determine the external Yes, stated under QM-001 14.4.1
and internal issues?
 Does the external and internal issues Yes, stated under QM-001 14.4.1
determined are relevant to its strategic
direction? Determined internal and external issues are
 How does it affect to achieve the intended relevant because it will be the gauge on how
QM-001 Sec. 14 Quality Manual results of its QMS? to achieve clinic’s quality objectives. These
determined issues will be the basis in giving a
fast and accurate results.
ISO 9001:2015 Sec. 4 ISO 9001:2015 Yes, stated under QM-001
Context of the Standard  Does the external and internal issues includes 14.4.1
Organization positive and negative factors or conditions for
considerations? Yes, stated under QM-001 14.4.2
 Does the external context are facilitated by
considering issues arising from legal,
technological, competitive market, cultural,
social and economic environments, whether
internal, national or regional or local? Yes, stated under QM-001 14.4.2
 Does the internal context are facilitated by
considering issues related to values, culture,
knowledge and performance of the
organization?

Does the organization understand the needs and Yes

expectations of interested parties?

Does the organization determine the interested Yes

parties that are relevant to the QMS?

Yes
 Yearly review of QMS Manual is being
done. Every unit has an opportunity to
Does the organization monitor and review raise NCCPAR to improve the clinic’s
information of interested parties and their relevant QMS. Review, meeting, planning are
Quality Manual requirements? being done such as management
QM-001 Sec. 14 How? review, quarterly board meetings,
strategic planning, annual business and
ISO 9001:2015 Standard budget planning and periodic cluster
ISO 9001:2015 Sec. 4 meeting.
Context of the Revisions to QMS Manual; NCCPAR;
Organization Minutes of the Management Review;
Minutes of the Board; Minutes of the
Strategic Planning; Minutes of the
What are the objective evidences of monitoring and Budget and Business Planning
review?

 Does the org. determine the boundaries and Yes, stated under QM-001 7.4 , 14.4.3
applicability of the QMS?
QM-001 Sec. 14 Quality Manual  Does the scope of the QMS determines the ff: Yes
 External & internal issues
 Requirements of relevant interested Yes
ISO 9001:2015 Sec. 4 ISO 9001:2015 Standard parties
Context of the  Products and services of the Org Yes, stated under QM-001 14.4.3; QM-
Organization Does the org. apply all the requirements of ISO 001 Appx. 1
within the scope of its QMS?

Does the scope of QMS states the types of products Yes, stated under QM-001 14.4.3
and services covered?

Does the scope provides justification for any
requirements of ISO that is not applicable to?
Does the requirements determined as not applicable
does not affect the organization’s ability to ensure
the conformity of its products and services and the
enhancement of customer satisfaction?
Yes, stated under QM-001 14.4.3; QM-
001 7.4
Yes (for Clause 8.3), stated under QM-
001 7.4. Established scientific
procedures were being followed,
adheres with the medical examinations
required by the DOH and doesn’t
deviate any standard or requirement.
 Yes, stated under QM-001 5.1
QM Sec. 5 Quality Manual Does the management demonstrate leadership and Management is continuously investing
Organization ISO 9001:2015 commitment in implementing QMS? in Internal and External Quality Audit.

ISO 9001:2015 Sec. 5 How do you ensure that quality policy and quality
Leadership objectives are communicated to all employees?

All employees underwent to ISO 9001:

2015 Seminar and Risk Orientation
Is there an annual review of the quality policy and (inclusive dates: 8/12/17, 8/19/17 &
quality objectives? 8/26/17) to gain knowledge and be
When? ready with the changes in standards
Secure objective evidences : from 2008 to 2015. Employee
orientation is being conducted for new
employees through HR unit and specific
How the Top management promote the use of risk- Unit Heads. A copy of QMS Manual
based thinking? was provided for each unit.

Yes
Management review was conducted
last 9.23.17 which was documented by
a minutes of the MR.
CarePoint got an external provider
which engaged all employees in a Risk
How does the Top Management establish unity of Orientation Course. Copy of Risk
purpose, direction and create conditions in which Registry for the following units were
people are engaged in achieving the organization’s maintained by the Med. Director/QMR:
objective?  Records
 Radiology
 Nursing
 Laboratory
 Dental
  QMS Manual cascaded to all
Units.
QM Sec. 5  Annual management review,
Organization periodic cluster meeting, and
Quality Manual annual team building being
ISO 9001:2015 Sec. 5 ISO 9001:2015 conducted to meet minds and
Leadership strengthen the unity in
achieving the organization’s
objective.
 Objective evidences such as
logbooks maintained in every
unit for recording/ monitoring
purposes; management memos
being cascaded to all staffs;
trainings provided such as
customer service related
trainings, ISO, etc.
 Duties and Responsibilities are
documented through JD (job
description) duly acknowledged
by each employee. This
document is a basis for a clear
direction on each employee’s
function.
Does the management demonstrate leadership and Yes, stated under QM-001 5.2
commitment with respect to customer focus?
QM Sec. 5 Quality Manual  Commitment with respect to
Organization ISO 9001:2015 How? customer focus is being attended
through customer service survey
and customer service orientation.
ISO 9001:2015 Sec. 5
Customer Focus  A management process review will
be conducted on the month of June
to enhance processes and develop
strategies in achieving clinic growth
and gaining a satisfied customer.

Yes, stated under QM-001 14.4.1

Yes
Does the risks and opportunities that can affect
conformity of products and services are Through Risk and Opportunity Registry
determined? and Treatment Plan (QM-001 sec.15)
And addressed? Yes
How?
 Is there an objective evidences in enhancing Quarterly Customer Survey and Annual
customer satisfaction? Client Survey were being conducted.
What?  March 13-26, 2018 - 1st Qtr.
QM Sec. 5 Quality Manual Customer Satisfaction Survey
Organization ISO 9001:2015  October 2017 – Client Satisfaction
Survey
Yes

ISO 9001:2015 Sec. 5 Does the management ensures the promotion of

Customer Focus customer focus throughout the organization?  Top Management ensures that
applicable customer, statutory and
How? regulatory requirements are
constantly met.
 Addresses immediately all concerns
arising from customer (patient /
client) service satisfaction survey.

Is the established Quality Policy are implemented Yes, stated under QM-001 3.3
and maintained?
QM-001 Sec. 3 Quality Manual
Quality Policy ISO 9001:2015 Is the established Quality Policy are appropriate to Yes. This is supported by a QMS
the purpose and context of the org. and supports its Manual and a Quality Plan. (QM-001
Quality Policy & strategic direction? Sec 7)
Quality Objectives
Provides framework for setting quality Yes. QM-001 3.1
objectives?

Does the Quality Policy includes a commitment Yes

to satisfy applicable requirements?

How do you ensure that Quality Policy are
communicated, understood and applied within
the organization?
Quality / Policy (QMS) Manual were
cascaded to all Units to ensure proper
communication. Orientation, trainings and
meetings were also conducted in helping
the employees in gaining a clear
understanding on organization’s policy /
objectives.
QM-001 Sec. 3 Quality Manual What are the objective evidences of the Top Objective evidences are as follows:
Quality Policy ISO 9001:2015 Management’s commitment in the continual  Annual Management Review
PROCEDURE INPUT improvementPROCESS
of QMS? APPROACH  Presentation ofOUTPUTPatient Census
Quality Policy & (Performance
Yes, stated in QM-001 5.3.1 Analysis)
& 5.3.2 to
Quality Objectives Does the responsibility, authority and inter-relation Board Meetings – Continual
QM Sec. 5 Quality Manual of all personnel are defined? growth of patients based on
Organization ISO 9001:2015 census presented were spot
Does the responsibility and authority assigned are on.
Yes  Compilation and Monitoring of
communicated and understood within the
organization? NCCPAR – Analysis of Data
Responsibility and authority
(monitoring done byassignedthe QMS are
ISO 9001:2015 Sec. 5
communicated
Officer) and understood within the
Organizational Roles, How?
organization through the following:
 Invested on internal and external
Responsibilities and
Authorities  QMS Manual
quality – cascaded
audit to to each unit
ensure
 Organizational
continuous Chart
commitment displayed
to in the
th
Reception area (4
comply with ISO 9001:2015. Floor)
 Transition
Duties andfromResponsibilities
ISO 9001:2008 defined in each
employee’s
to ISO 9001:2015JD (Job Description) – duly
acknowledged by employee
 Plan of expansion - to have a & maintained
by HRbigger
new Unit location that will
Is there an updated organizational chart? Yes. Updated
gain theOrganizational Chart displayed in
contract from Princess
the Reception
and to (4th Floor) services
area improve
rendered to patients and
Yes clients. This was discussed
Does CarePoint determine the organizational during the Nov. 2017 Budget &
QM Sec. 5 Quality Manual knowledge necessary for the operation? Business Planning
 Orientation conductedandby 2018 HR to equip
Organization ISO 9001:2015 Board Meetings.
employees with knowledge on HR related
How? policies.
 Internal and External Orientation /Trainings
needed being provided to employees to
ISO 9001:2015 Sec. 5 gain additional knowledge needed for the
Organizational Roles, operation.
Responsibilities and  For Nurses – there’s an endorsement being
Authorities done before rotation.
Yes
 Annual Budget Planning – discusses the
previous year’s budget vs actual,
Does the engagement of people at all levels projection of needs, strategies to be done
throughout the organization are capable to create in order to achieve fast and accurate
and deliver intended results? results
 Periodic Cluster Meeting – discussion of
How? current operation status, problem to be
solve and strategies on new transactions,
etc.
 Comparison of quality objectives vs KPI of
each Unit
 ISO 9001:2015 Does the organization includes risks and opportunities that Yes
Sec. 6 Annual Planning needs to address during planning?
Planning Yes. Through a contingency plan provided (W-CLN-003)
Budget Does actions to address risks and opportunities enhance & treatment plan (QM-001 15) to mitigate the risk.
desirable effects?
QM-001 Sec. 9 Risk registry and Yes, through Treatment Plan
Evaluation and treatment plan Does planning includes actions to prevent, reduce
Planning undesired effects of risk and opportunities?
Yes, based on Treatment Plan under Risk Registry
Does the actions taken in addressing the risks and
opportunities are proportionate to the potential impact on
the conformity of products and services? Yes

Does the management evaluate the effectiveness of these

actions?

Does the management determines the need for changes to Yes, stated in PRAI-003 6.3.9
ISO 9001:2015 Quality Manual QMS?  Changes maybe determine through the use of
Sec. 6 How? NCCPAR.
Planning ISO 9001:2015  Changes will be discussed during the
Standard Management Review.
Yes
ISO 9001:2015 If there are changes, does planning includes :
Yes.
Sec. 6  Purpose of the changes
 ISO 9001:2008 TO 2015 version
Planning of  Potential consequences
Changes  Statutory accreditation based on 2015 version
Yes. Through internal and external quality auditing
 Integrity of the QMS Yes. Management allocated resources for ISO
requirements. Trainings were provided.
 Availability of resources Yes. All employees were sent to ISO 9001:2015 seminar
to have an awareness and clear understanding of the
latest version.
 The allocation or reallocation of responsibilities and Yes, stated in PRAI-003 6.3.9
authorities.
Yes.
Does the Top Management ensure that changes that may  NCCPAR
have great impact/effect on QMS shall be part of  Minutes of the MR
Management Review meetings?  Revisions to QMS
-subject to formal change control under P-DRC-
Is there a documented information relating to such 001 / F-DRC-001
changes? -master record of original and revision on
documented informations are maintained
 Yes.
Is there an annual planning? Annual Budget & Business Planning; Strategic
QM-001 Sec. 9 Annual Planning Planning ; Quarterly Board meetings
Evaluation and Does the annual planning consider the following?
Planning Budget Yes
 Revenue forecast
Manpower  Evaluation of performances vs. objectives and targets Yes
 Review of compliance to regulatory and customer Yes
requirements
 Training and Development Planning
 New Clients Discussed also during Management Review
 Improvement to QMS

Yes
Inventory Is there an inventory planning that includes the
Planning materials/supplies on medical services forecast?
QM-001 Sec. 9
Yes. Properly monitored through Inventory Control
Evaluation and Is there a monitoring on medical services rendered vs.
Monitoring.
Planning forecasted materials/supplies to verify if there will be
Medical changes?
Equipment & Yes
Supplies Does the Top Management has the ability to identify
applicable areas for potential improvement?

QM-001 Sec. 6
Quality Plan Quality Plan Is there a record of evidences where quality objectives are
met as defined in the Quality Plan? Yes. There is a Performance Evaluation being done.
Quality objectives vs. KPI of Unit Heads.

 Does the Top management ensures the availability of

resources and information necessary to fulfill the quality Yes
objectives are met?
 Human Resource Yes.
(appropriate education, training and skills)  Personnel Requisition (employee requirements/
credentials needed)
 Maintenance of 201 files
 Validity of PRC IDs and PTR is being monitored
Compliance to statutory/legal Does the Top Management demonstrate ability to DOH Permit #13-013-18 MF-2
requirements comply
 with the applicable statutory and regulatory and
Infrastructure Valid until 12/31/2020
Yes
QM-001 Sec. 6 Quality Plan contractual requirements?
Yes
Quality Plan  (process equipment: hardware & software) Business Permit # 2018025520
 Software
Valid until 12/31/18: PIMS and Weblis
 Hardware – maintenance done by MMC IT
Fire Safety Inspection Certificate # In Process
Permits and Licenses Yes. Conducive and equipped environment.
 Work Environment Sanitary Permit Control # 13623 D5 1505
Valid Until 12/31/18
Certificate of Tax Exemption
# COOP-00038-17-RR-06-RDO-033
Valid Until 6/20/2022
City Treasurers OR Permit Fee U035028470B

Brgy. Clearance No. 18-635

Valid until 12/31/18
Remarks :
Compliance AUDIT FINDINGS :
Yes No Needs Improvement Observation
Minor NC
/
Major NC

F-RAI-004 Rev. 0
08/01/15