Republic of the Philippines

Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

ASSESSMENT TOOL FOR LICENSING A LABORATORY FOR DRINKING WATER ANALYSIS

Name of Laboratory:

Address:
Number & Address Barangay/ Municipality

Province/City Region

Contact No./Fax No./E-mail Address:

Application for: Initial

Renewal Accreditation No: Date Issued:
Expiry Date:

GENERAL INFORMATION:

Name of Owner or Governing Body (if corporation):

Name of Head of Laboratory:

Classification according to:

Ownership: Government Private

Institutional Character: Institution-Based Freestanding

1
Service Capability : Bacteriological Analysis Chemical Analysis
Physical Analysis Radiological Analysis
Instructions:
(1) Encircle (+) if item indicated is present, and (-) if item indicated is absent/ present but non-functional.
(2) All items with (*) shall be posted in a conspicuously designated area.
(3) Regulatory Officers will use this checklist during inspection/ monitoring prior to issuance of accreditation (initial/ renewal).

1
Refer to Annex A – List of Parameters for Each Service Capability
2
Philippine Nuclear Research Institute (PNRI) regulated
DOH-LDWA-COA-AT
Revision:02
04/13/2015
Page 1 of 11
 FINDINGS
STANDARDS REFERENCE REMARKS
INSPECTION MONITORING

1. M ANAGEMENT STANDARDS

1.1 APPLICATION DOCUMENTS AO No.

2006 – 0024
All application documents shall be valid and properly filled
up.

1.1.1 Documentary Requirements:

1.1.1.1 List of Personnel (+) (-) (+) (-)

! Name
! Position
! Status: P-Permanent/ T-Temporary
! Educational attainment
! PRC registration number and validity (where applicable)
! Training
! Signature

1.1.1.2 List of Equipment/Instruments (+) (-) (+) (-)

! Name of equipment
! Date acquired with proof of purchase
! Quantity
! Functional status

1.1.1.3 Floor Layout (+) (-) (+) (-)

! Properly labeled areas with appropriate scale to include

spatial relationship with adjacent areas if present.
 FINDINGS
FINDINGS
STANDARDS
STANDARDS REFERENCE
REFERENCE FINDINGS REMARKS
REMARKS
STANDARDS REFERENCE INSPECTION
INSPECTION MONITORING
MONITORING REMARKS
INSPECTION MONITORING
1.2.2 ManCertificates
1.1.1.4 agement/ Sand taff Permits
Meetings: (+) (-) (+) (-)
1.3 M ANPOWER AO No.
1.2.2.1 Held at least
The laboratory shalltwice a yearwith
comply or astheneeded.
following certificates 2006 – 0024; (+) (-) (+) (-)
Personnel and practices shall
and permits, which shall be valid and current. be in place toThey ensureshallthe
be PNS ISO/IEC
achievement
1.2.2.2
filled upDocumented of the mission of the
minutes of the meeting
and posted conspicuously laboratory. (reflectingarea.
at the reception the date, 17025 (+) (-) (+) (-)
time, attendance, agenda, and action taken) shall be
1.3.1 S t a
! DTI/ff ing SEC
present Pattanderegistration
rnproperly
: filed
* (forwprivate
ithin thelab)
lab.
! Enabling Act (for national government lab)
1.3.1.1
! Organizational
Board Resolution chart
(for* local government lab) (+) (-) (+) (-)
1.2.3 C ont i nu i n g Pr
! Proof of qualification og r a m forfor
Stthe
aff De
*: velopment and Training:
! •Organizational
Head of Laboratory chart shall be clearly structured indicating
the
1.2.3.1 •There names
Analyst with pictures and designation.
shall be a written continuing program on staff (+) (-) (+) (-)
! Thereofshall
! development
Proof be training.
and
ownership aof minimum
the premises of (valid
threeand (3)notarized
laboratory
to
3
personnel for
include location map) each service capability . (+) (-) (+) (-)
! There
1.2.3.2 Proof shall be a minimum
of training throughof certificates,
five (5) laboratory
memos, personnel
written
for multi-service
reports, budgetary
1.1.1.5 Self –Assessment Tool capability.
allocations, etc.

1.3.1.2
! Duties
Properly and responsibilities
accomplished and completed (+) (-) (+) (-)
1.2.4 Procedures for handling complaints and client feedback: (+) (-) (+) (-)
! There shall be documented duties and responsibilities of
all personnel reflecting lines of for
authority, accountability,
1.2 1.2.4.1
M ANAGThere
EMENT shall
REbe SPO aNwritten
SIBILIprotocol
TY handling complaints/ AO No.
communication,
client feedback. and interrelationship. (+) (-) (+) (-)
2006 – 0024;
! Managerial and technical personnel shall have authority
The Laboratory shall be managed effectively, efficiently and PNS ISO/IEC
1.2.4.2 and resources
Forms for complaints/ needed
client to perform duties and
feedback (+) (-) (+) (-)
in accordance with its mission, vision and objectives. 17025
responsibilities.
1.2.4.3
1.2.1 Suggestion
Missi on, Visionbox andand/
Objor
ecequivalent,
tives *: visible to clients (+) (-) (+) (-)

1.2.4.4
1.2.1.1 Records of complaints/
Mission, vision client feedback
and objectives and
shall be in actions taken
accordance with (+) (-) (+) (-)
PD 856

3
When the head of the laboratory is not a registered chemist, there shall be a minimum of four (4) laboratory personnel for chemical/ physical analysis.

FINDINGS
STANDARDS REFERENCE REMARKS
INSPECTION MONITORING
1.3.2 Personnel Records:

All records shall be within the laboratory premises.

1.3.2.1 Curriculum vitae (+) (-) (+) (-)

! Personal background
! Education
! Experience & Training

1.3.2.2 Job description (+) (-) (+) (-)

! Detailed description of tasks, responsibilities and

accountabilities

1.3.2.3 Health status (+) (-) (+) (-)

! Medical/ health certificate

1.3.2.4 List of Personnel Designation (+) (-) (+) (-)

1.3.3 Policies For Hiring, Orientation and Promotion:

1.3.3.1 There shall be a written policy for hiring, orientation and (+) (-) (+) (-)
promotion for all levels of personnel.

1.3.4 Policies For Violation/ Suspension/ Termination:

1.3.4.1 There shall be a written policy for violation/ suspension/ (+) (-) (+) (-)
termination for all levels of personnel.
 FINDINGS
STANDARDS
STANDARDS REFERENCE REMARKS
INSPECTION MONITORING

TE2.1.2
2. 1.4 CHNI
DOCUCAnEal
ML SNyTTsAtAN
: ND
DARE
DCSORDS RA
AO 754
No.
Regulation on the
2006 – 0024;
2.1.2.1
PERThe Proof ofshall
SONlaboratory
N EL qualification
maintain records in a manner that allows Practice
AO No.
PNS ISO/IEC of (+) (-) (+) (-)
reconstruction of all activities, easy retrieval and minimum Chemistry
2006 in the
– 0024;
17025
The ! PRC ID shall ensure personnel performing specific
laboratory
retention. Philippines
PNS ISO/IEC
tasks! arePRC Board Certificate
qualified on the * basis of education, training, 17025
D!
experience
1.4.1 Fornand/
ocume t Cont Bacteriological
orrol:demonstrated Analysis: RA 9297
Registered
skills, and appropriate
Medical
supervision Technologist/
is provided when Microbiologist/ Chemical
Other Allied Health
staff is being trained.
Professionals
1.4.1.1 There shall be a written policy to control all documents Engineering Law (+) (-) (+) (-)
! For
It shall that
ensure Chemical/
form part ofPhysical
personnel itsare Analysis:
employed
quality system Registered
or both Chemist/
contracted,
internal and
and
4
contractedChemical
personnel
external and Technician
areensure
shall (forthe
supervised,chemical analysis)and work in PRC Modernization
competent
following:
! PAMwith
accordance Registration
the quality (forsystem.
bacteriological analysis) Act of 2000
!! Availability
Record of of Work Experienceeditions
the authorized (minimum of 2 years) in the
of documents
It shall theory
maintain
! Periodic and
review practice
current of
jobwater
and revision ofanalysis
descriptions
the documentsfor managerial,
technical
! Removal
and key ofsupport
invalid orstaff.
obsolete documents
2.1.2.2
! All Proof
hand of amendments
employment (appointment/
clearly marked, contract)
initialed and dated (+) (-) (+) (-)
2.1.1 !Head of thof
Copies eL abo
the ratoManual
SOP ry: available at the bench or work
2.1.2.3 area
Certifying lab results (+) (-) (+) (-)
2.1.1.1
! Proof
Work of instructions
qualification of the SOP match the SOP Manual
! For Bacteriological Analysis: Registered (+) (-) (+) (-)
! Medical
PRC ID,
1.4.2 Control of Records: Technologist/
if applicable Microbiologist/ Other Allied Health
! PRCProfessionals
Board Certificate *
!! PSP
1.4.2.1 For Chemical/
There shall be aPhysical
Certificate (Clinical Analysis:
policy for Registered
written Pathology) *
handling ofChemist
quality and (+) (-) (+) (-)
! technical
PAM Registration
records, *including but not limited to:
! Certificate of Training in Laboratory Management *
2.1.3 ! LaRecords
boratorof
Record ymaintenance
A ide/ TExperience
Work echnician:(minimum of 3 years) in the
theory and practice
! Security and confidentiality of water analysis
2.1.3.1 Proof of qualification
! Protection and back-up (+) (-) (+) (-)
2.1.1.2
! Proof
Audit of employment (appointment/ contract)
trail
!! Corrections/
Transcript ofalterations
Records (finished at least 2 years of college)
! Certificate of Training/ Record of Work Experience
(minimum
1.4.2.2 Records of 6be
shall months)
legible,instored
clericaland
andreadily
laboratory supportin
retrievable (+) (-) (+) (-)
suitable environment to prevent damage, deterioration
2.1.3.2 and
Proof of employment (appointment/ contract)
loss.

1.4.2.3 All observations, data and calculations shall be recorded. (+) (-) (+) (-)
4
Registered with PRC
 FINDINGS
STANDARDS REFERENCE REMARKS
INSPECTION MONITORING

2.2 PHYSICAL PLANT AO No.

2006 – 0024;
Adequate facility shall be in place for the safe and efficient PNS ISO/IEC
operation of the laboratory. 17025

2.2.1 Floor Area:

2.2.1.1 Work Area (+) (-) (+) (-)

! The work area shall correlate with the volume and type of
analysis to be undertaken including provision for periods
of peak workload.
! It shall have a minimum of twenty (20) square meters of
work area for free-standing laboratories.
! It shall have sufficient
• Counter top for sample processing
• Storage cabinet for equipment, instruments, reagents
and supplies
• Sink with strong water supply for cleaning and
sterilizing
• Fume hoods for handling of acids and organic
chemicals
• Containment facility for bacteriological analysis

2.2.2 Utilities:

2.2.2.1 The laboratory shall be housed in a permanent building (+) (-) (+) (-)
with adequate power supply, water supply, and
ventilation.

! There shall be adequate running water in the work area.

! Air conditioning unit may be used for improved ventilation.
 STANDARDS REFERENCE FINDINGS
FINDINGS REMARKS
STANDARDS REFERENCE INSPECTION MONITORING REMARKS
INSPECTION MONITORING
2.3
2.4 E
AQNUI
AW
LYPMTE NT, IN
MiS
EtTyR UMENTS, REAGENTS AND SUPPLIES
2.2.3 asItCeAFLac li H
: ODS AO No.
2006 – 0024;
Necessary equipment, instruments,
The laboratory reagentsmethods
and supplies PNS ISO/IEC
2.2.3.1 There shall shall
be a use writtenappropriate
policy for laboratory and
waste (+) (-) (+) (-)
shall be in place
procedures for all for the safe and
calibrations and tests.
efficient operation of the 17025
management following universal guidelines.
laboratory.
2.4.1
2.2.3.2MeThere
thod Sshall
elecbe
tionan: implementation plan. (+) (-) (+) (-)
2.3.1 Equipment/ Instruments:
2.4.1.1 The laboratory
2.2.3.3 There shall be an shall select of
inventory analytical methods including
waste chemicals that are (+)
(+) (-)
(-) (+)
(+) (-)
(-)
2.3.1.1 There shall
appropriate be functional and operational
estimate concentration, means of disposal/ on
for the analyte sample equipment/
matrix based or (+) (-) (+) (-)
instruments.
the current andPNSDW and ofthe latest locally available
containment, frequency disposal.
Standard Method for the Examination of Water and Waste (+) (-) (+) (-)
2.3.1.2 There
Water,shall be a readily
AWWA, APHA,available
WPCF inventory
that of equipment/
produce the
5
instruments.
appropriate
2.2.4 Housekeeping: quantitative levels . (+) (-) (+) (-)

2.3.1.3 There shall

2.2.4.1 There shallbe abewritten
a program
written for preventive/
policy corrective
for laboratory (+) (-) (+) (-)
(+) (-) (+) (-)
2.4.2 Unmaintenance
cer t ai n t y o f of
M equipment/
eas u r em ent instruments.
:
housekeeping following universal guidelines.
(+) (-) (+) (-)
2.3.1.4
2.4.2.1 There shall shall be
be a written procedures
program for forcalibration of
2.2.4.2 The laboratory shallwritten
be kept clean, dust-free, estimating
odor-free, (+) (-) (+) (-)
equipment of
uncertainty designed and operated so that calibrations
measurement.
safe and secured. (+) (-) (+) (-)
and measurements are traceable to the International
System of Units (SI Units).
2.2.4.3 There shall be a written program for vermin control.
2.3.2 Calc
2.4.3 Reaguelanttis/
onSsupp
andlieDs:
ata Transfers:
2.3.2.1 (+) (-) (+) (-)
2.4.3.1PerThere
2.2.5 The shall be appropriate reagents/ supplies to perform
sonnlaboratory
el Safety: shall ensure calculations and data (+)
(+) (-)
(-) (+)
(+) (-)
(-)
the water analysis.
transfers are checked in a systematic manner. (+) (-) (+) (-)
2.2.5.1 There shall be a written policy for safety of personnel
! The reagents/ supplies shall conform to the requirements
following universal guidelines.
of NRL, PNSDW, AWWA, APHA, and WPCF.
2.2.5.2 Personnel safety devices such as safety gloves, safety
2.3.2.2 There shall be a readily available inventory of reagents/ (+) (-) (+) (-)
glasses, laboratory gowns, and face masks, shall be
supplies.
available when appropriate.
(+) (-) (+) (-)
2.3.2.3 There shall be a written program for calibration of
volumetric laboratory wares designed and operated so
that calibrations and measurements are traceable to the
International System of Units (SI Units).
5
Refer to Annex C – Minimum Equipment, Reagent and Laboratory Ware for Specific Test
 FINDINGS
STANDARDS REFERENCE REMARKS
INSPECTION MONITORING
2.4.4 Method Validation:

2.4.4.1 Modification of analytical methods is allowed provided (+) (-) (+) (-)
that these are validated and approved by the NRL prior to
its use. (+) (-) (+) (-)

2.4.4.2 The laboratory shall validate

! Non-standard methods
! Laboratory designed/ developed methods
! Standard methods outside their intended scope (+) (-) (+) (-)
! Amplifications and modifications of standard methods
! Confirm that the methods are fit for the intended use

2.4.4.3 The laboratory shall ensure the range and accuracy of the
values obtainable from validated methods are relevant
based on:

! Uncertainty of the results

! Limit of detection
! Limit of quantification
! Selectivity of the method
! Linearity
! Limit of repeatability and/ or reproducibility
! Robustness against external influences and/ or cross-
sensitivity against interference from the matrix of the
sample

2.4.5 Policies for Outsourcing of Tests:

2.4.5.1 The laboratory shall conform to the guidelines for (+) (-) (+) (-)
outsourcing of tests set by the NRL.
(+) (-) (+) (-)
2.4.5.2 The laboratory shall attach the results of the tests
outsourced from other accredited laboratories to the
principal test results/ reports.
 FINDINGS
STANDARDS REFERENCE FINDINGS
FINDINGS REMARKS
STANDARDS
STANDARDS REFERENCE
REFERENCE INSPECTION MONITORING
FINDINGS REMARKS
REMARKS
STANDARDS REFERENCE INSPECTION
INSPECTION MONITORING
MONITORING REMARKS
INSPECTION MONITORING
2.7 QUALHa IT YndAliSnSgUoRf A SN CE PROGRAM AO No.
2.52.5.2
SAMPLING am ple: PNS
2006 ISO/IEC
2.6 REPORTING THE RESULT S AO–No.
0024;
The laboratory shall prepare and adopt a quality assurance PNS17025
ISO/IEC
2.5.2.1shall
There shall be written procedures for the management of 2006 – 0024; (+) (-) (+) (-)
There
program to be a system
establish, for receiving,
maintain and accessioning,
improve collection
the quality of
Results shall
sample be reported
to ensure accurately,
protection clearly,
of unambiguously
integrity of the and
sample PNS17025
ISO/IEC
and
datadisposal
generated of sample.
by
objectively,
andand in the
the interests
laboratory.
accordance with specific
of the laboratory and instructions
client. in the 17025
methods.
2.5.1
2.7.1 S am
Int erpnle
al CQuollaelictytion
As:surance:
! Receipt
2.7.1.1Test
2.6.1 The Reslaboratory
ults/ Repshall orts: have written procedures on quality (+) (-) (+) (-)
2.5.1.1! control
Handling
There shall be writtenvalidity
for monitoring procedures forand
of tests collection of sample
calibrations. (+) (-) (+) (-)
! atProtection
sampling location.
! Regular
2.6.1.1! All use of certified reference materials
observations, data and calculations shall be recorded.
Storage (+) (-) (+) (-)
! Replication using the same or different methods (+) (-) (+) (-)
2.5.1.2! Retention
The laboratory and/ or disposal
shall ensure client-requested deviations,
! There
2.6.1.2 Retesting shallorbe recalibration
logbooks and/or of samples
worksheets that include: (+) (-) (+) (-)
additions
! Correlation or exclusions
of results forfrom the documented
different characteristics sampling
of a
2.5.2.2 There
procedures shall are be a
recorded system and for identifying sample
communicated to the (+) (-) (+) (-)
! Datesample of the test
for calibration and/ or test.
! appropriate
! Recording
Name
personnel.
of
of analyst results so as trends are detectable and (+) (-) (+) (-)
(+) (-) (+) (-)
statistical
! Analyte
2.5.2.3 The laboratory techniques may beabnormalities
applied to the or reviewing of
2.5.1.3 There
the shallwhere
results be shall
written ensure
procedures for recording
practicable
deficiencies
sample
! Sample
on sample details (source,
received are recorded. date and time of sampling,
data and operations.
sample code)
2.7.1.2
!! TheTest laboratory
observations
If there isprocedure
doubt shall
aboutconduct an internal quality audit at
! least
Samplingonce a year. usedthe suitability of the sample, or it
! All rough
does notcalculations
conform to description provided, or the test/ (+) (-) (+) (-)
! Identification of the sample
! Relevant
calibration instrument
is nottraces
specified, the laboratory shall
! All
2.7.1.3 Environmental
quality conditions
control charts shall beanddisplayed in a
! Relevant
ensure calibration
that the data
client istocontacted thelocation
instructions (+) (-) (+) (-)
(-)
! conspicuous
Diagrams (orplace equivalent)
in the identify sampling
laboratory.
are recorded. (+) (-) (+) (-)
2.6.1.3 Test results/ reports shall include, but not limited to, the
2.7.2 Extfollowing
2.5.2.4 erThere
nal Quinformation
ali ty Asbe
shall suraappropriate
nce: facilities to maintain
the integrity of the sample and the protection of the (+) (-) (+) (-)
! The
2.7.2.1 Date
securedof the
laboratory test shall
sample participate in proficiency testing
and records.
! Client
programs. details (name, address, contact number)
!
! Name and of
Certificate signature of analyst
Participation in EQAS (+) (-) (+) (-)
! Name and signature of laboratory head/ certifying officer
2.7.2.2 It shall maintain a record of receipt of samples for EQAS
! Analyte (+) (-) (+) (-)
! fromSample NRL. details (source if available, date and time of (+) (-) (+) (-)
2.7.2.3 Itsampling,
shall submit sample a record
code)of results to NRL.
2.7.2.4
! It shall used
Method keep a record of corrective action taken when
! evaluation
Test resultsof performance is below satisfactory.
! PNSDW values, if applicable

Name of Facility :

Date of Inspection:
RECOMMENDATIONS:
A. For Licensing Process:
[ ] For issuance of Certificate of Accreditation as Laboratory for Drinking Water Analysis.

Validity from to

[ ] Issuance depends upon compliance to the recommendations given and submission of the following within
days from the date of inspection:

[ ] Non-Issuance: Specify reason/s.

Inspected by:
Printed Name Signature Position/Designation

Received by:
Signature
Printed Name
Position/Designation
Date

Name of Laboratory:

Date of Monitoring:

RECOMMENDATIONS:
B. For Monitoring Process:
[ ] For issuance of Notice of Violation

[ ] Non- Issuance of Notice of Violation

[ ] Others (Specify)

Monitored by:
Printed Name Signature Position/Designation

Received by:
Signature
Printed Name
Position/Designation
Date