CHECKLIST GUIDE

CLAUSE DOCUMENTS REQUIRED AUDIT NOTES

4 CONTEXT OF THE ORGANIZATION

4.1 Understanding the Organization Quality Manuals Findings:
and its Context CIP: APMC-QMSM, Rev. No. ____
Date:
The organization shall determine
external and internal issues that are Strategic Plan/Strategic Findings:
relevant to its purpose and its strategic Deliverables (If available) CIP: Strategic Deliverables
direction and that affect its ability to Date:
achieve the intended result(s) of its Submitted by:
quality management system. Noted by:
Approved by:

4.2 Understanding the Needs and FOR TOP MANAGEMENT: (Interested parties are defined and its needs
Expectations of Interested Parties Performance of External and expectations. Evidence of monitoring
Due to their effect or potential effect on Providers and review):
the organization’s ability to consistently (Interested parties are defined Findings:
provide products and services that meet and its needs and CIP:
customer and applicable statutory and expectations. Evidence of
regulatory requirements monitoring and review)

Customer Satisfaction Survey Findings:

CIP: Customer Satisfaction % :_______

4.3 Determining the Scope of the FOR TOP MANAGEMENT: Findings:

Quality Management System QMS Manual CIP:
The scope of the organization’s quality - determined and documented
management system shall be available scope of the QMS
and be maintained as documented - internal and external issues
information. The scope shall state the - requirements of relevant
types of products and services covered, interested parties
and provide justification for any - products and services of the
requirement of this International organization
Standard that the organization
determines is not applicable to the
scope of its quality management
system.
4.4.1 The organization shall establish, WI Findings:
implement, maintain and continually CIP: APMC-WI-____- Rev. No. ____
improve a quality management Date:
system, including the processes Prepared by:
needed and their interactions, in Reviewed by:
accordance with the requirements of Approved by:
the International Standard
FMEA Findings:
CIP: APMC-FMEA-____- Rev. No. ____
Date:
Prepared by:
Reviewed by:
Approved by:

QO Findings:
CIP: APMC-QO-____- Rev. No. ____
Date:
Prepared by:
Reviewed by:
Approved by:

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 Strategic Plan/Strategic Findings:
Deliverables (If available) CIP: Strategic Deliverables
Date:
Submitted by:
Noted by:
Approved by:
5.1 LEADERSHIP AND COMMITMENT
5.1.1 Top management shall FOR TOP MANAGEMENT: Findings:
demonstrate leadership and Check on the demonstrative CIP:
commitment with respect to the involvement of the top mgt on
quality management system. the ff:
QP
QO
Monitoring Tool
Operational Plan
Strategic Plan
FMEA
Work and Financial Plan
Communication on QMS
(Distribution)
5.1.2 Customer Focus List of applicable statutory and
Top management shall demonstrate regulatory requirements such
leadership and commitment with as but not limited to:
respect to customer focus by PRC Findings:
ensuring that: Name of Staff:
PRC #:
a) customer and applicable statutory
Date of expiry:
and regulatory requirements are
determined, understood and PHIC Name of Staff:
consistently met; PHIC:
b) the risks and opportunities that Date of expiry:
can affect conformity of products Findings:
and services and the ability to
enhance customer satisfaction are BLS CIP: Name of Staff:
determined and addressed; BLS Certificate
c) the focus on enhancing customer Date:
satisfaction is maintained. Findings:

ACLS/PALS CIP: Name of Staff:

ACLS/PALS Certificate
Date:
Findings:

FMEA CIP: FMEA Title

Process Function:
Failure Mode:
Effect of Failure: (look for customer
complaint, and/or customer complaint with
legal implication)
Process Control:
RPN:
If RPN>=25, include the following:
Recommended Action:
Target Completion Date:
Findings:

Customer Satisfaction Survey Customer Satisfaction % (as seen on MT):

Findings:

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 Citizen’s Charter Findings:
(Check if posted or Service Name:
documented) Office /Division:
Classification:
Type of Transaction:

(Check if there is PWD / Senior Findings:

Citizen / Pregnant
Women Lane)

Proper Decorum: Findings:

Uniform CIP: Name of Staff:

Wearing of I.D Company ID #:
Well groomed Designation/Position:
5.2 POLICY
5.2.2 Communicating the Quality Policy Quality Policy
(Check if posted or
documented)

(Ask any staff about the QP Findings:

and how they understand it. CIP: Name of Staff:
Company ID #:

5.3 Organizational Roles, FOR TOP MANAGEMENT: CIP: Name of ISO Chair:
Responsibilities and Authorities Appointment of ISO Date of appointment:
Chairperson
Authorities and Findings:
responsibilities of ISO CIP: Job Description:
chairperson

GENERAL: Findings:
Organizational Chart
(Check if posted or
documented)

Citizen’s Charter Findings:

(Check if posted or
documented)

Customer Service Champion CIP: Name of Staff:

Customer Service Champion Certificate
Date:
Findings:

Job Description of the Findings:

Employee CIP: Name of Staff:
Company ID #:
Designation/Position:
Date of Order / Appointment:
Duties and Responsibilities:
1.
2.
3.
4.

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6.1 ACTIONS TO ADDRESS RISKS AND FMEA Findings:
OPPORTUNITIES (Check if updated) CIP: APMC-FMEA- -____- Rev. No. ____
Date:
CIP: FMEA Title
Process Function:
Failure Mode:
Effect of Failure:
Process Control:
RPN:
If RPN>=25, include the following:
Recommended Action:
Target Completion Date:

Prepared by:
Reviewed by:
Approved by:

Due of revision:
(Due of revision (RPN>=25: 6months after
target completion; no high RPN: 1yr after)

6.2 QUALITY OBJECTIVES & PLANNING Quality Objective and Plans Findings:
TO ACHIEVE THEM CIP: APMC-QO-____- Rev. No. ____
The organization shall establish quality Date:
objectives at relevant functions, levels Prepared by:
and processes needed for the quality Reviewed by:
management system. Approved by:

(Ask any staff about the QO Findings:

and how they understand it) CIP: Name of Staff:
Company ID #:
6.2.2 When planning how to achieve its Strategies and action plan for CIP: APMC-QO-____- Rev. No. ____
quality objectives, the organization the achievement of the QO Date:
shall determine: Responsibilities per action Prepared by:
a) what will be done; Date of implementation and Reviewed by:
b) what resources will be required; resources required Approved by:
c) who will be responsible; MT
d) when it will be completed; Findings:
e) how the results will be evaluated. QO #___,
Action plan:
Resources needed:
Responsible person:
Date of completion:

Findings:
CIP: MT on QO #_____,
Month:
Target:
Actual:
Prepared by:
Reviewed by:
Approved by:
6.3 Planning of Changes Document Change Notice Findings:
When the organization determines the Document Revised:
need for changes to the quality Document Change Notice if applicable:
management system, the changes shall C.I.P.: DCN No.:
be carried out in a planned manner (see Doc No.:
4.4) Title:
Detailed Description of Change:
From:
To:
Justification of change:
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 Originator/Signature:
_______________________________
Department/Date:
_______________________________
Reviewed by / Date:
_____________________________
Approval: Shalimar S. Rakiin / MCC II
7.1 RESOURCES
7.1.2 People Human Resources Findings:
The organization shall determine and CIP: Name of Staff:
provide the persons necessary for the 201 Files Company ID #:
effective implementation of its quality Designation/Position:
management system and for the PDS
operation and control of its processes
7.1.3 Infrastructure FOR TOP MGT:
The organization shall determine and Budget for Infrastructure
provide and maintain the infrastructure (Check for functionality of
necessary for the operation of its applicable infrastructure)
processes and to achieve conformity of
products and services. FOR ENGINEERING:
Master List of Equipment Findings:
C.I.P:
Master List of Equipment

List of Calibration of Medical Findings:

Equipment C.I.P: List of Calibration of Medical
Equipment

List of Motor vehicle and C.I.P.: List of Motor vehicle and Registration
Registration

Preventive Maintenance Preventive maintenance schedule:

•Medical equipment
•Motor Vehicle
•Building
•Water tank / reservoir
•Water supply / Deep well
•Generator set
•Oxygen plant
•Pyroclave
•Sewerage Treatment Plant
•Pneumatic tube
•Fire Extinguisher
•Paging system
•Audio Visual Room (Sound system)
including LED monitor
•Air conditioning

GENERAL
Preventive Maintenance Findings:
Logbook CIP: APMC-LB-____ __-_______
Last entry:
Date:

Waste Disposal Schedule of waste Disposal

•Infectious and Non-infectious
CIP:

Temperature Findings:
CIP:

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 Verification of infrastructure Findings:
CIP:

Checklist from engineering Findings:

CIP:

Strategic Deliverables Findings:

(Check if there is CIP:
Infrastructure)

Work and Financial Plan Findings:

CIP:

PPMP Findings:
CIP:

7.1.4 Environment for the Operation of (Observe for the environment)

Processes ENVIRONMENT
The organization shall determine, REQUIREMENT: Findings:
provide and maintain the environment • Personal Protective CIP:
necessary for the operation of its Equipment
processes and to achieve conformity of • Ventilation
the products and services. • Lighting
a) Social (e.g. non-discriminatory, • Fire exit
calm, non-confrontational); • Heat / Temperature of the
b) Psychological (e.g. stress- environment
reducing, burnout prevention, • Crowded
• Noise
emotionally protective);
• Humidity
c) Physical (e.g. temperature, heat,
• 5’S
humidity, light, airflow, hygiene,
noise).

WORKPLACE Findings:
 Non-discriminatory CIP:
 Calm work area
 Burnout prevention
 Stress-reducing

7.1.5 Monitoring and Measuring Calibration and measurement Findings:

Resources traceability C.I.P:
The organization shall determine and Calibration certs Name of equipment:
provide the resources needed to ensure Brand/Model/Serial No.:
valid and reliable results when Certificate No.:
monitoring or measuring is used to Date of Calibration:
verify the conformity of products and Validity of Calibration:
services to requirements. Due Date of Calibration:
Sticker:
Remarks:
7.2 Competence PDS (personal file) CIP: List of personnel with license numbers
a) Determine the necessary Updated licenses and expiry
competence of persons doing work Statutory and regulatory Name of Staff:
under its control that affects the requirements PRC #:
performance and effectiveness of Date of expiry:
the quality management system;
b) Ensure that these persons are
Certificates of trainings and Name of Staff:
competent on the basis of attendance Company ID No.:
appropriate education, training, or Trainings attended:
experience; Title and date
c) Where applicable, take actions to
acquire the necessary competence,
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and evaluate the effectiveness of the
actions taken;
d) the implications of not
conforming with the quality
management system requirements.
7.3 Awareness ISO awareness attendance or CIP: Name of Staff:
The organization shall ensure that ISO awareness certificate or Company ID #:
persons doing work under the Check with any staff about the Date:
organization’s control are aware of: ISO and how they understand
a) the quality policy it. OR
b) relevant quality objectives;
CIP: Name of Staff:
c) their contribution to the
ISO Awareness Certificate or
effectiveness of the quality ISO Awareness Attendance
management system, including the Date:
benefits of improved performance;
d) the implications of not PRIME- HRM CIP:
conforming with the quality (Program to Institutionalize Date of Cascading:
management system requirements. Meritocracy and Excellence in
Human Resource OR
Management)
CIP: Name of Staff:
PRIME- HRM Awareness Certificate or
PRIME- HRM Awareness Attendance
Date:

PGS (Performance CIP:

Governance System) Date of Cascading:

OR

CIP: Name of Staff:

PGS Awareness Certificate or
PGS Awareness Attendance
Date:

Logbook CIP: APMC-LB-________-_________

(Included in the agenda of minutes of
meeting)
Tittle/Subject:
Agenda:

Date of the meeting:

Conducted by:
Findings:
7.4 Communication General: APMC Order No.____, S. ______
Hospital Order/ Date:
Memorandum To:
Subject:
or
Memorandum No.____, S. ______
Date:
To:
Subject:
Findings:

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 Endorsement Logbook CIP: APMC – LB- ______- ______
Title:

Last entry:

Detailed:

Staff and signature:

Findings:

7.5 DOCUMENTED INFORMATION

7.5.1 General Check if all Documented CIP: Document Title:
The organization's quality Information Required are Control Number:
management system shall include: readily available Date Effective:
a) documented information required QMS Manual Prepared:
by the International Standard; Department/Section/Unit Reviewed:
Manual Approved:
b) documented information
QO Findings:
determined by the organization as
FMEA
being necessary for the effectiveness WI
of the quality management system.
Logbooks

CIP:APMC-LB-___-_____
Title:
Date:

7.5.2 Creating and Updating Look for any newly created or Document Title:
When creating and updating updated/revised Documented Control Number:
documented information, the Information such as but not Date Effective:
organization shall ensure limited to: QMS Manual, Prepared:
appropriate: FMEA, WI, QO Reviewed:
Approved:
a) Identification and description (e.g.
Format/Fonts:
a title, date, author, or reference
Findings:
number);
b) Format (e.g. language, software
version, graphics) and media (e.g.
paper, electronic);
c) Review and approval for suitability
and adequacy.
7.5.3 CONTROL OF DOCUMENTED Controlled Documented Findings:
INFORMATION Information CIP: List of stamp controlled documents:
1.
(Make sure documents are 2.
protected from loss of
confidentiality and not open
to all) List of to be stamp controlled documents:
1.
2.

8.1 Operational Planning and Control FOR TOP MGT: Findings:

The organization shall plan, implement QO
and control the process (see 4.4) MT
needed to meet the requirements for FMEA
the provision of products and services, WI
and to implement the actions (determined resources
determined in Clause 6

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 Identified outsourced
processes and methods of
control such as:
Laboratory, Security, Contract
/ MOA required of Terms of
Reference, Online System

GENERAL:
Citizen’s Charter

FOR CLINICAL: Findings:

Patient’s chart (check if orders C.I.P:
are carried out) Patient X Hospital No.:
Date admitted:
Date discharged:
Attending Physician:
Diagnose:
Classification:
Disposition:

Medication:

Medicine:
Expiry date:

Diagnostic result and Laboratory:

WI Findings:
(Check if the Process Flow is CIP: APMC-WI-____- Rev. No. ____
followed) Title:
Process Flow:

Responsibility:
Date:
Prepared by:
Reviewed by:
Approved by:

Clinical pathways Findings:

CIP:

Pharmacy Order Sheet Findings:

CIP:
Patient X Hospital No.:
Order Date:
Case No.:
Item No.:
Quantity:
8.2.1 Customer Communication GENERAL:
Communication with customers shall Citizens Charter Findings:
include: CIP: Process of services:
a) providing information relating to
products and services;
b) handling enquiries, contracts or
Statutory and Regulatory Findings:
orders, including changes;
Requirements CIP: Cover Sheet:
c) obtaining customer feedback Patient X Hospital No.:
relating to products and services, Classification:
including customer complaints;
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d) handling or controlling customer (Any Posted Instructional Findings:
property; Materials or similar to it) CIP:
e) establishing specific requirements Title:
for contingency actions, when
Customer Satisfaction Survey Customer Satisfaction % (as seen on MT):
relevant.
Customer Feedback and Customer Feedback and Complaint:
Complaint

CLINICAL: Findings:
also health education or CIP:
information
8.2.2 Determining the Requirements Citizens Charter Findings:
for Products and Services CIP: Process of services:

Statutory and Regulatory Findings:

Requirements CIP:

Licensing Findings:
(License to Operate or the CIP:
likes)

CLINICAL: Findings:
NBB CIP: NBB (No Balance Bill Policy)
No Deposit laws

Patient Chart (cover sheet) Findings:

CIP:
Patient X Hospital ID No.:
Chief complaint:
Date admitted:
Date discharged:
Attending Physician:
Diagnose:

8.2.3 REVIEW FOR THE REQUIREMENTS Patient’s charts are reviewed Findings:
FOR PRODUCTS AND SERVICES by doctors/nurses. CIP:
Patient X Hospital ID No.:
Date admitted:
Date discharged:
Attending Physician:
Diagnose:
Must be name stamped

Pricing of medicines and

medical supplies are reviewed

Statutory and Regulatory

Requirements
8.2.4 Changes to Requirements for DCN Findings:
Products and Services CIP:
The organization shall ensure that Document Revised:
relevant documented information is Document Change Notice if applicable:
amended, and that relevant persons are C.I.P.: DCN No.: __________
made aware of the changed Doc No.: ________________
requirements, when the requirements Title: ___________________
for products and services are changed.

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 Patient chart (All changes are informed thru doctor’s
orders and carried out by nurses)
C.I.P:
Patient X Hospital No.:
Date admitted:
Date discharged:
Attending Physician:
Diagnose:
Classification:
Disposition:

Medication:

Medicine:
Expiry date:

Diagnostic result and Laboratory:

8.5.1 Changes to Requirements for WI Findings:

Products and Services (trail a purchase request till CIP: APMC-WI-____- Rev. No. ____
issuance of order) Title
Date:
Prepared by:
Reviewed by:
Approved by:

Calibration Report Findings:

CIP:
Calibrated Equipment:
Date Calibrated:
Next due date:

8.5.2 Identification and Traceability Patient chart Findings:

(Make sure no expired meds CIP:
in the area; properly identified Patient X Hospital No.:
drugs/supplies) Date admitted:
Date discharged:
Room:
Attending Physician:
Diagnose:

Medication:

Medicine:
Expiry date:
Any equipment used:

Bin Card Findings:

CIP: Bin Card
Description:
Latest Date Entry:
Recent Balance:
8.5.3 Property Belonging to Customers Logbook Findings:
or External Providers CIP:APMC-LB-___-_____
Title:
Date:

Diagnostic Result Findings:

(Lab or Radio) CIP:
Diagnostic:
Patient X Hospital ID No.:
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 Date/Time Radiology Request:
Date/Time Release of Result:
8.5.4 Preservation Product review and inspection Findings:
The organization shall preserve the Inventory/List of medicine CIP:
outputs during production and service (Storage and handling of Medicine:
provision, to the extent necessary to products; take note of expiry) Date Expiration:
ensure conformity to requirements.
Medicine Refrigerator Findings:
CIP: Medicine Refrigerator
Temperature:

8.5.5 Post-Delivery Activities Statutory and regulatory Findings:

The organization shall meet requirements like NBB, PHIC CIP: NBB
requirements for post-delivery activities
associated with the products and
services. Discharge Order/Slip Findings:
C.I.P: APMC-F-ADM-04, Rev 1
Patient X Hospital No.:
Date admitted:
Date discharged:
Signed by:

Customer Satisfaction Survey Findings:

Form CIP:

8.5.6 Control of Changes DCN Findings:

The organization shall review and CIP: DCN No.:
control changes for production or Title: ___________________
service provision, to the extent Detailed Description of Change:
necessary to ensure continuing From:
conformity with requirements. To:
8.6 Release of Products and Services (Trace release of Findings:
The organization shall implement, products/supplies or release CIP: Laboratory Result
planned arrangements, at appropriate of lab/radio results.) Patient X Hospital ID No.:
stages, to verify that the products and Laboratory Result Date/Time Laboratory Request:
service requirements have been met. Date/Time Release of Result:

Findings:
Radiology Result CIP: Radiology Result
Patient X Hospital ID No.:
Date/Time Radiology Request:
Date/Time Release of Result:

Discharge Order/Slip Findings:

C.I.P: APMC-F-ADM-04, Rev 1
Patient X Hospital No.:
Date admitted:
Date discharged:
Signed by:
8.7 CONTROL OF NON-CONFORMING NCAR Findings:
OUTPUTS (Any non-conforming output CIP: NCAR No.:
The organization shall ensure that as a result of customer Date:
outputs that do not conform to the complaints, incident reports Department:
requirements are identified and control must be dealt with NCAR) Description of Improvement:
to prevent their and intended use of Responsible:
delivery. Follow-up on Implementation Action:

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9.1 MONITORING, MEASUREMENT,
ANALYSIS AND EVALUATION
9.1.2 Customer Satisfaction Customer satisfaction survey Findings:
The organization shall monitor CIP: MT on QO #_____, (Customer
customer’s perceptions of the degree to Satisfaction)
which their needs and expectations Month:
have been fulfilled. The organization Target:
shall determine the methods for Actual:
obtaining, monitoring and reviewing
this information.
9.1.3 Analysis and Evaluation Customer Complaint Findings:
The organization shall analyze and CIP: MT on QO #_____, (Customer
evaluate appropriate data and Complaint)
information arising from monitoring Month:
and measurement. Target:
Actual:

FMEA Findings:
(Look for the analysis and CIP: FMEA Title
evaluation of the ff: (from A to Process Function:
G in the section clause 9.1.3) Failure Mode:
Effect of Failure: (look for customer
complaint, and/or customer complaint with
legal implication)
Process Control:
RPN:
If RPN>=25, include the following:
Recommended Action:
Target Completion Date:
10.2 NON-CONFORMITY AND NCAR Findings:
CORRECTIVE ACTION CIP: NCAR No.:
Date:
when a nonconformity occurs, Department:
including any arising from complaints, Description of Improvement:
the organization shall; Status:
a) react to the non-conformity and,
as applicable;
1. take action to control and correct
it
2. deal with the consequences
b) evaluate the need for action to
eliminate the cause(s) of the
nonconformity, in order that is not
recur or occur elsewhere, by:
1. reviewing and analyzing the
nonconformity
2. determining the causes of the
nonconformity
3. determining if similar
nonconformities exist, or could
potentially occur
c) implement any action needed;
d) review the effectiveness of any
corrective action taken;
e) update risks and opportunities
determined during planning, if
necessary;
f) make changes to the quality
management system if necessary.

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10.3 Continual Improvement FOR TOP MGT: CIP: Management Review Meeting Minutes
The organization shall continually Opportunities for
improve the suitability, adequacy and improvement in the mgt
effectiveness of the quality review minutes if the meeting
management system.
GENERAL:
Training Certificates Findings:
CIP: Name of Staff:
Company ID No.:
Trainings attended:
Title and date

Continuous Quality Findings:

Improvement Orientation CIP: Name of Staff:
Continuous Quality Improvement
Orientation Certificate or attendance
Date:

CQI Study Findings:

CIP:
CQI Study Title:
Action Plan:
Timeline of Accomplishment:

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