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LASF08 Checklist for ISO IEC 17025

PAB assessment checklist for ISO/IEC 1725

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Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Document ID
Issue Number
Revision Number
Effectivity Date
Page

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INTRODUCTION
1.

Purpose

This checklist is prepared for the following purposes:
1.1 To assist both the laboratory staff and the assessment team in checking that all criteria for accreditation
are satisfied.
1.2 To index documentation of the quality system and use as part of the preparation for the introduction of
ISO/IEC 17025 and an assessment; and
1.3 To provide essential background information for briefing PAB assessment team and relevant
information during the assessment process.
This checklist provides only a brief summary of the clauses of the Standard.
2.

Structure and Use of the Checklist

2.1 Compliance with PAB General Requirements
2.2 All PAB accredited laboratories are required to comply with the accreditation requirements and the
basic technical and management system requirements for laboratories based on ISO/IEC 17025.
2.3 PAB needs to obtain and maintain information on the specific technical resources available in the
laboratory and to be aware of the desired scope of the accreditation by PAB (the approved classes of
test) and for approved signatories (the specific people authorized to sign PAB endorsed test reports).
3.

Preparation of Laboratory Quality Manuals

3.1 Each accredited laboratory is required to implement a documented quality management system as one
of the fundamental conditions for PAB accreditation.
3.2 The documented quality management system includes all of the laboratory’s policies and operational
procedures established to meet requirements for accreditation.
3.3 The manner in which a laboratory’s documented quality system is structured is the choice of the
laboratory. The purpose of the documentation is primarily to advice the laboratory’s staff of the policies
and procedures expected by its management to be implemented by all staff.
3.4 Typically, a laboratory’s quality management system is documented in a Laboratory Quality Manual
and supporting procedures and records. In some cases, a Laboratory Quality Manual includes
supporting procedures. In other cases, some of the subjects of a Laboratory Quality Manual may be
incorporated in an organization’s more general Quality Manual or procedures.

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

Requirement for Accreditation

4

Management Requirements

4.1
4.1.1 Legal
identity
4.1.2
Responsibility

Organization
an entity that can be held legally
responsible
Carry out testing or calibration
activities to meet requirements of
the standard, its customers,
regulatory authorities or
accreditation bodies
ensure management system
covers activities in the laboratory’s
permanent facility, sites away from
its permanent facilities, or in
associated temporary or mobile
facilities
when part of an organization
performing activities other than
testing and/or calibration, ensure
the laboratory defines the
responsibilities of key personnel
to identify potential conflicts of
interest
have managerial and technical
personnel, irrespective of other
responsibilities, with authority and
resources to carry out their duties
including implementation,
maintenance and improvement of
the management system; and to
identify occurrence of departures
from management system or from
tests or calibration procedures
ensure arrangements for
managerial and technical
personnel to make them free from
any undue internal and external
commercial, financial and other
pressures and influences that may
adversely affect the quality of work
ensure there are policies and
procedures related to customer’s
confidentiality of information and
proprietary rights, including
electronic storage and
transmission of results
ensure laboratory has policies and
procedures to avoid involvement in
activities that would diminish
confidence in its competence,

4.1.3
Scope of
management
system

4.1.4
Conflict of
interest

4.1.5a
Managerial
and technical
personnel

4.1.5b
Undue
pressure

4.1.5c
Customer
confidentiality

4.1.5d
Operational
integrity

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

4.1.5e
Organization
chart

4.1.5f
Responsibility
and authority

4.1.5g
Laboratory
supervision
4.1.5h
Technical
management
4.1.5i
Quality
manager

4.1.5j
Managerial
deputies
4.1.5.k
Importance of
roles

4.1.6
Appropriate
communication

4.2
4.2.1
Policies and
procedures

Requirement for Accreditation
impartiality, judgment or
operational integrity
define organization and
management structure including
relationships between quality
management, technical
operations, support services and
parent organization (if applicable)
specify the responsibility, authority
and interrelationships of all
personnel who manage, perform
or verify work affecting the quality
of the tests and/or calibrations
provide adequate supervision by
appropriate personnel of all staff
involved in calibration and testing
activities, including trainees
identify technical management
that has overall responsibility for
technical operations and provision
of resources
appoint a member of staff, with
direct access to senior
management, as quality manager
irrespective of other duties and
responsibilities, who has defined
responsibility and authority for
implementing and maintaining the
management system
appoint deputies for key
managerial personnel, where
practical
ensure personnel are aware of
relevance and importance of their
activities and how they contribute
to the objectives of the
management system
appropriate communication
processes established within the
laboratory and include the
effectiveness of the management
system
Management system
Establish, implement and maintain
management system appropriate
to scope of activities; document
policies and procedures as a
management system to ensure
quality of all work and that they are
communicated, understood,

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

4.2.2
Quality policy
statement

4.2.2, 4.2.5,
4.2.6
Quality manual

4.2.3
Commitment
to
management
system
4.2.4
Customer
requirements
4.2.7
Changes to
management
system

Requirement for Accreditation
available to, and implemented
ensure the quality policy statement
is issued under the authority of top
management and includes at
least:
- the laboratory management’s
commitment to good professional
practice and quality of service to
customers
- statement of the laboratory’s
standard of service
- the purpose of the management
system related quality
- a requirement that all personnel
familiarize themselves with
quality documentation
- the laboratory management’s
commitment to compliance with
the Standard and to continually
improve the management
system
- these overall objectives are to be
reviewed as part of management
review
Maintain a quality manual that:
- defines management system
policies and objectives
- includes or makes reference to
supporting procedures, including
technical procedures and
outlines structure of the
documentation in the
management system
- defines the roles and
responsibilities of technical
management and the quality
manager
evidence of commitment to
development, implementation and
continual improvement of the
management system must be
available.
importance of meeting customer,
statutory and regulatory
requirements must be
communicated
integrity of the management
system must be maintained when
changes are made.

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

Requirement for Accreditation

4.3

Reference to
Laboratory Document
(To be completed by the
laboratory)

Document control

4.3.1
Procedures

ensure procedures to control all
documentation included in the
management system are
established and maintained
ensure documents are reviewed
and approved by authorized
personnel prior to issue, and are
included on a master list which
identifies the revision status and
distribution.
ensure all necessary quality
documentation is available where
required, reviewed and revised to
maintain suitability
ensure documents are removed
when obsolete and suitably
marked if retained for either legal
or knowledge preservation
purposes
all management system
documents must be uniquely
identified and include date of issue
and/or revision, identification, page
numbering, total number of pages
or a mark to signify the end of the
document, and the issuing
authority(ies)
ensure changes to documents are
reviewed and approved by the
same function that performed the
original review, or a designate
ensure where practical, the altered
or new text is identified in the
document or the appropriate
attachments
ensure if hand written
amendments are allowed, defined
procedures are available, which
include authorities, clear marking,
initialing, dating, and formal reissue
establish procedures to describe
how changes in documents
maintained electronically are
made and controlled

4.3.2.1
Approval and
issue

4.3.2.2
Availability

4.3.2.2
Obsolete
documents

4.3.2.3
Identification

4.3.3.1
Document
changes
4.3.3.2
Altered or new
text
4.3.3.3
Handwritten
amendments

4.3.3.4
Electronic
documents

Document ID
Issue Number
Revision Number
Effectivity Date
Page

4.4

Review of requests, tenders and contracts

4.4.1, 4.4.3
Policies and

ensure policies and procedures
related to review of requests,

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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

Requirement for Accreditation

procedures

Reference to
Laboratory Document
(To be completed by the
laboratory)

tenders and contracts are
established, maintained and
include:
- defining, documenting and
understanding customer
requirements before
commencing work
- laboratory's capability and
resources
- appropriate method selection
- work that is subcontracted by the
laboratory
maintain records of reviews,
including any significant
discussions and/or changes
throughout the contract
ensure customer is informed of
any deviation from the contract

4.4.2
Records of
review
4.4.4
Notification of
customer
4.4.5
Changes to
contracts

4.5
4.5.1, 4.5.4
Competency

4.5.2
Customer
approval
4.5.3
Responsibility

4.6
4.6.1
Policies and
procedures
4.6.2
Verification

Document ID
Issue Number
Revision Number
Effectivity Date
Page

ensure same contract review
process is repeated if a contract
has to be amended after work has
commenced and that all affected
staff are advised of the
amendment
Subcontracting of tests and calibrations
ensure that subcontractors are
competent (e.g. accredited
laboratory) and records are
maintained of subcontractors used
and their competency (e.g. terms
of accreditation)
ensure customer is advised in
writing and approval gained,
where appropriate
unless customer or a regulatory
authority specifies subcontractor,
laboratory is responsible for
subcontractors' work
Purchasing services and supplies
document policy and procedures
for selection, purchasing,
reception and storage of relevant
services and supplies
ensure all purchased supplies that
affect the quality are not used until
verified as complying with defined
specifications, and records of the
actions taken to demonstrate
compliance are maintained

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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

Clause

Requirement for Accreditation

4.6.3
Purchasing
documents

ensure purchasing documents for
items affecting the quality of work
are reviewed and approved for
technical content prior to release
maintain list and records of the
evaluations and all approved
suppliers
Service to the customer
Cooperate with customers to
clarity requests and monitor
laboratory's performance provided
laboratory’s ensure confidentiality
to other customers
feedback must be sought and
used to improve the laboratory’s
activities
Complaints
document policy and procedure
for the resolution of complaints
from customers or other parties
and ensure records of the
complaints, investigations and
corrective actions (4.11) are
maintained
Control of nonconforming testing and/or calibration work
ensure policy and procedures are
implemented when work or results
do not conform to own procedures
or customer requirements and
include:
- defined responsibilities,
authorities and actions
- an evaluation of the significance
of the nonconforming work
- corrective actions and decision
about the acceptability of the
nonconforming work to be taken
immediately
- notification to the customer and
work recall, if necessary
- defined responsibility for
authorizing the resumption of
work
Corrective action procedures
(4.11) must be implemented when
evaluation indicates recurrence
could occur or there is doubt
regarding compliance of
laboratory's operations with own
policies and procedures

4.6.4
Approved
suppliers
4.7
4.7.1
Cooperation

4.7.2
Feedback
4.8
4.8
Policy,
procedure and
records

4.9
4.9.1
Policies and
procedures

4.9.2
Recurrence

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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

Requirement for Accreditation

4.10
4.10
Effectiveness

Improvement
continually improve the
effectiveness of the management
system
Corrective action
establish policy and procedures,
and designate appropriate
authorities for implementing
corrective actions which include:
- cause analysis to determine the
root cause (4.11.2)
- selection, implementation and
documentation of corrective
actions (4.11.3)
- monitoring results to ensure
effectiveness of corrective action
(4.11.4)
- areas affected are to be audited
(4.14) if nonconformities indicate
laboratory not complying with
own management system
(4.11.5)
Preventive action
ensure needed improvements and
potential sources of
nonconformities are identified and
action plans developed,
implemented and monitored, using
controls to ensure they are
effective
Control of records
establish and maintain procedures
covering aspects listed below for
control and quality and technical
records:
- identification
- collection
- indexing
- access
- filing
- storage
- maintenance
- disposal
- protect, back-up and prevent
unauthorised access to or
amendment of records stored
electronically (4.13.1.4)
ensure all records are:
- legible
- readily retrievable

4.11
4.11
Policies and
procedures

4.12
4.12
Identification
and action

4.13
4.13.1.1
Procedures

4.13.1.2
Record
integrity

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

4.13.2.1
Technical
records

4.13.2.2
Recording

4.13.2.3
Corrections to
records

4.14
4.14.1
Requirements

Requirement for Accreditation
- maintained in a suitable
environment
- retained for established time
- held secure and in confidence
(4.13.1.3)
ensure laboratory retains technical
records of:
- original observations
- derived data
- sufficient information to establish
an audit trail
- calibration records
- staff records
- copy of each test report or
calibration certificate issued
- identity of personnel responsible
for test/calibration
- identity of personnel responsible
for checking results
and that retained records of
each test or calibration contain
sufficient information to:
- identify factors affecting the
uncertainty
- enable the test or calibration to
be repeated using original
conditions
ensure observations, data and
calculations are recorded at the
time they are made and are
identifiable to the specific task
ensure any changes to the original
records (including electronic) are
made so that:
- original record is not obscurred
- correct value entered alongside
- alterations signed or initialled by
the person making the correction
- equivalent measures must be
taken for records stored
electronically
Internal audits
- internal audits shall be
conducted periodically and in
accordance with a
predetermined schedule and
procedure to verify continuing
compliance with the
requirements of PAB and the
management system

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

4.14.2
Corrective
action and
notification of
customers
4.14.3
Records
4.14.4
Follow-up
audits
4.15
4.15.1
Objectives

4.15.1
Contents

Requirement for Accreditation
- quality manager is responsible
for planning and organizing
audits to be carried out by
trained and qualified personnel
independent of activity being
audited (where resources permit)
where validity of results has been
questioned, timely corrective
action must be taken and
customers notified in writing if it is
shown that laboratory results have
been affected
records of area audited, the audit
findings and corrective actions
must be retained
follow-up audit shall verify and
record implementation and
effectiveness of corrective action
Management reviews
ensure the laboratory's
management conducts a review
yearly of the management system
and testing/calibration activities,
based on a predetermined
schedule and procedure to ensure
continuing suitability and
effectiveness and to introduce
necessary changes or
improvements
ensure the review includes:
- suitability of policies and
procedures
- reports from managerial and
supervisory personnel
- outcome of recent internal audits
- corrective and preventive actions
- assessments by external bodies
- results of interlaboratory
comparisons or proficiency tests
- changes in the volume and type
of work
- customer feedback
- complaints
- recommendations for
improvement
- other relevant factors (e.g.
quality control activities,
resources and staff training)

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

Requirement for Accreditation

4.15.2
Actions and
records

ensure findings and actions are
recorded and carried out within an
appropriate and agreed timescale
Technical Requirements
General
Personnel
ensure personnel performing
specific tasks are qualified on the
basis of education, training,
experience and/or demonstrated
skills and that when staff are being
trained appropriate supervision is
provided
policy and procedures must be
implemented for identifying
training needs, providing training
and evaluating its effectiveness
ensure personnel are employed or
contracted by the laboratory, and
ensure contracted personnel are
supervised, competent and work in
accordance with the management
system
maintain current job descriptions
for managerial, technical and key
support staff
Ensure management has
authorized specific personnel to:
- perform specific sampling,
testing and/or calibration
activities
- issue test reports and/or
calibration certificates and that
PAB signatory approval has
been taken into consideration
- give opinions and interpretations
- operate particular types of
equipment and that records of all
technical personnel (including
contracted personnel) are
maintained for:
- relevant authorization(s)
including date on which
authorization and/or
competence is confirmed
- competence
- educational and professional
qualifications
- training, skills and experience

5
5.1
5.2
5.2.1
Competence

5.2.2
Training policy

5.2.3
Employees

5.2.4
Job
descriptions
5.2.5
Authorized
personnel

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause
5.3
5.3.1
Facility

5.3.2
Monitoring

5.3.3
Incompatible
activities
5.3.4
Access
5.3.5
Housekeeping
5.4
5.4.1
Methods and
procedures

5.4.1
Method

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
Requirement for Accreditation
(To be completed by the
laboratory)
Accommodation and environmental conditions
ensure the laboratory or off-site
facility(ies) and environmental
conditions do not compromise the
quality of results and that the
technical requirements for critical
accommodation and
environmental conditions are
documented
ensure laboratory monitors,
controls and records
environmental conditions, where
applicable and that tests and/or
calibrations are stopped when
results are jeopardized by the
environmental conditions
ensure there is effective
separation between areas of
incompatible activities.
ensure access to office and
laboratory areas are controlled
ensure housekeeping measures
are adequate
Test and calibration methods and method validation
ensure laboratory uses
appropriate methods and
procedures for all calibrations and
test activities covered by scope of
accreditation
(including sampling, handling,
transport, storage and preparation
of items to be tested and/or
calibrated, and where appropriate,
an estimation of the measurement
of uncertainty as well as statistical
techniques for analysis of test
and/or calibration data) and that
all instructions, standards,
manuals, and reference data are
current and available to personnel.
(instructions on the use and
operation of all relevant
equipment, on the handling and
preparation of items for testing
and/or calibration, or both, where
the absence of such instructions
could jeopardize the result of tests
and/or calibrations)
ensure deviations from test
calibration methods are:

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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

Requirement for Accreditation

deviations

-

5.4.2
Method
selection

ensure laboratory selects and
uses test and/or calibration
methods, including methods of
sampling that:
- meet the needs of the customer;
and
- are appropriate for the tests
and/or calibrations
- the customer has been informed
of the method chosen (if not
specified)
- where appropriate, are based on
latest international, regional or
national standards, or by
reputable technical
organizations, or in relevant
scientific texts or journals, or as
specified by the manufacturer of
the equipment and where
necessary the standard be
supplemented with additional
details to ensure consistent
approach
- laboratory developed methods or
methods adopted by the
laboratory may be used if they
are appropriate for intended use
and validated
- have been verified for use in the
laboratory, if a standard method
(if the standard method changes,
the confirmation shall be
repeated)
ensure laboratory informs the
customer if method proposed by
the customer is inappropriate or
out of date
ensure introduction of these
methods is planned and assigned
to qualified personnel with
adequate resources and that plans
are updated as development
proceeds and communicated as
necessary
- when methods are used that are
not covered by standard

5.4.2
Inappropriate
methods
5.4.3, 5.4.4
Laboratorydeveloped
methods and
non-standard
methods

documented
technically justified
authorized
accepted by the customer

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

5.4.5.2
Method
validation

5.4.5.3
Range and
accuracy

5.4.6.1
Uncertainty of
measurement

5.4.6.2

Requirement for Accreditation
methods, then:
- purpose of the test and/or
calibration must be identified
- method developed must be
validated before use
- customer agreement must be
obtained and include
specification of customer
requirements
laboratory must validate:
- non-standard methods
- laboratory designed/ developed
methods
- standard methods outside their
intended scope
- amplifications and modifications
of standard methods
- to confirm that the methods are
fit for the intended use
- records for method validation
must include
- results obtained
- procedure used
- statement as to whether the
method is fit for the intended use
ensure the range and accuracy of
the values obtainable from
validated methods (e.g. the
uncertainty of the results,
detection limit, 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/test object)
are relevant to the customers’
needs
calibration laboratories or testing
laboratories performing their own
calibrations must have and
implement procedures for
estimating the uncertainty of
measurement for all calibrations
testing laboratories must
document and implement
procedures for estimating
uncertainty of measurement
(refer to PAB Policy for application
of this clause)

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

Requirement for Accreditation

5.4.6.3

all uncertainty components which
are of importance in the given
situation shall be taken into
account using appropriate
methods of analysis when
estimating uncertainty of
measurement
ensure calculations and data
transfers are checked in a
systematic manner

5.4.7.1
Calculations
and data
transfers
5.4.7.2
Computers
and automated
equipment

5.5
5.5.1 to 5.5.4
Operation

Ensure when computers or
automated equipment are used for
the acquisition, processing,
recording, reporting, storage or
retrieval of test or calibration data,
the laboratory shall ensure that:
- laboratory developed software is
sufficiently documented and
suitably validated
- procedures are established and
implemented for protecting the
data and include
- integrity and confidentiality of
data entry or collection
- data storage
- data transmission
- data processing;
- computers and automated
equipment are maintained to
ensure proper functioning
- appropriate environmental and
operating conditions are
provided
Equipment
Ensure all equipment and its
software (including that outside the
laboratory’s permanent control)
required for all testing and/or
calibration activities:
- is available and functioning
properly
- is capable of achieving the
accuracy
- comply with the specifications
- has calibration program
established for the key quantities
or values
- is calibrated or checked before
being placed into service

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

LA/SF08
01
00
01 August 2018
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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

5.5.5
Records

5.5.6, 5.5.11
Procedures

5.5.7
Out-of-service

Requirement for Accreditation
- is checked and/or calibrated
before use (see 5.6 also)
- is operated by authorized
personnel
- has current instructions on the
use and maintenance available
- is uniquely identified, where
practicable
ensure records of equipment are
maintained and include:
- identity of the equipment and its
software
- manufacturer's name, model and
serial number or other unique
identification
- evidence that equipment
complies with the accuracy
requirements and with
specification relevant to the tests
or calibrations
- current location, where
appropriate
- the manufacturer's instructions, if
available, or reference to their
location
- calibration history and due date
of nest calibration
- the maintenance plan, where
appropriate, and maintenance
carried out to date
- any damage, malfunction,
modification or repair to the
equipment.
ensure procedures for measuring
equipment are documented and
include:
- safe handling
- transport
- storage
- use
- planned maintenance
- where applicable, that copies of
correction factors are correctly
updated
ensure equipment subjected to
overloading or mishandling, giving
suspect results, or shown to be
defective or outside specified
limits, is taken out of service and
is:
- isolated or clearly labeled or

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

LA/SF08
01
00
01 August 2018
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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

5.5.8, 5.5.10
Calibration
status

5.5.9
Return to
service

5.5.12
Adjustments

5.6
5.6.1
Calibration
program

5.6.2.1
Calibration
laboratories

Requirement for Accreditation
marked as being out of service
- examined for the effect of the
defect or departure from
specified limits on previous tests
and/or calibrations
- addressed under the "Control of
nonconforming work" procedure
(see 4.9)
ensure equipment calibration
status is identified, where
practicable and where
intermediate checks are needed to
maintain confidence in calibration
status that a procedure is
documented to carry out these
checks
ensure when equipment goes
outside the direct control of the
laboratory, that the function and
calibration status are checked
before the equipment is returned
to service
ensure equipment, both hardware
and software is safeguarded from
adjustments which could invalidate
the test and/or calibration results
Measurement Traceability
ensure all equipment used in
testing and/or calibration activities
is calibrated before being put into
service and is included in the
equipment calibration program
must ensure the program for
calibration of equipment is shall be
designed and operated so that
calibrations and measurements
are traceable to the International
System of Units (SI units),
however where traceability cannot
be strictly made in SI units,
traceability can be established by
use of:
- certified reference materials
- specified methods and/or
consensus standards that are
clearly described and agreed by
all parties concerned
Participation in suitable
interlaboratory comparisons is
required where possible.

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

LA/SF08
01
00
01 August 2018
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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

Requirement for Accreditation

5.6.2.2
Testing
laboratories

the requirements given in 5.6.2.1
apply for measuring and test
equipment unless it has can be
established that the associated
contribution from the calibration
contributes little to the total
uncertainty of the test result
- program and procedure for
calibration of reference standards
- reference standards must include
traceability as described in 5.6.2.1
- reference standards of
measurement must be used for
calibration only
- reference standards shall be
calibrated before and after any
adjustment
where possible, reference
materials must be traceable to SI
units or certified reference
materials internal reference
materials must be checked as far
as is technically and economically
practicable
procedures and schedules must
be available to carry out
intermediate checks on reference,
primary, transfer or working
standards and reference materials
to maintain confidence in the
calibration status
procedures for safe handling,
transport, storage and use of
reference standards and materials
must be available
Sampling
ensure procedures for sampling
are available at sampling location
and include:
- a sampling plan (based on
appropriate statistical methods,
wherever reasonable)
- factors to be controlled to ensure
validity of test/calibration results
ensure customer -requested
deviations, additions or exclusions
from the documented sampling
procedures are recorded
communicated to the appropriate
personnel

5.6.3.1
Reference
standards

5.6.3.2
Reference
materials

5.6.3.3
Intermediate
checks

5.6.3.4
Transport and
storage
5.7
5.7.1
Procedures
and plan

5.7.2
Deviations

Document ID
Issue Number
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Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

LA/SF08
01
00
01 August 2018
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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Reference to
Laboratory Document
(To be completed by the
laboratory)

Clause

Requirement for Accreditation

5.7.3
Records

ensure laboratory has procedures
for recording sampling data and
operations and that the records
include:
- sampling procedure used
- identification of the sampler
- environmental conditions (if
relevant)
- diagrams (or equivalent) to
identify sampling location
- statistics that sampling
procedure is based on, if
appropriate
Handling of test and calibration items
document procedures for test
and/or calibration item
management which ensure
protection of integrity of the item
and the interests of the laboratory
and client and cover:
- transportation
- receipt
- handling
- protection
- storage
- retention and/or disposal
ensure laboratory has a system for
identifying test and/or calibration
items both physically and in the
records and accommodate a subdivision of groups of items if
applicable
- ensure abnormalities or
deficiencies on item received are
recorded
- if there is doubt about the
suitability of item, or it does not
conform to description provided,
or the test or calibration required
is not specified, ensure that the
customer is contacted and that
the instructions are recorded
ensure laboratory has procedures
and appropriate facilities to
maintain item integrity, and the
protection of secured items and
when specified environmental
conditions are required, that these
are maintained, monitored and
recorded

5.8
5.8.1
Procedures

5.8.2
Identification

5.8.3
Deficiencies

5.8.4
Facilities

Document ID
Issue Number
Revision Number
Effectivity Date
Page

LA/SF08
01
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01 August 2018
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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

Clause

Requirement for Accreditation

5.9

Assuring the quality of test and calibration results

5.9.1
Quality control

ensure laboratory has quality
control procedures for monitoring
validity of tests and calibration, it
must be planned activity, reviewed
and includes:
- regular use of certified reference
materials and/or secondary
reference materials
- participation in interlaboratory
comparison or proficiency-testing
programs
- replicates using the same or
different methods
- retesting or recalibration of
retained items
- correlation of results for different
characteristics of an item
resulting data must be recorded
so as trends are detectable and
statistical techniques must be
applied to the reviewing of the
results where practicable
Analyse and take appropriate
action on quality control data that
falls outside pre-defined criteria

5.9.2
Action on
quality control
data
5.10
5.10.1, 5.10.8
Test reports
and calibration
certificates

Reporting the results
- results of tests and calibrations
must be reported accurately,
clearly, unambiguously and
objectively, and in accordance
with any specific instructions in
the methods
- test reports and calibration
certificates must include all
information requested by the
customer, required by the
method and necessary for the
interpretation of the test or
calibration results
- results may be reported in a
simplified way when performed
for internal customers or in the
case of a written agreement with
the customer, however, any
information not reported to the
customer, but is normally
required to be, must be readily

LA/SF08
01
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01 August 2018
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PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

5.10.2, 5.10.3
Test report

5.10.2, 5.10.4
Calibration
certificates

Requirement for Accreditation
available in the laboratory
- test reports and calibration
certificates must be designed to
accommodate each type of test
or calibration carried out and to
minimize the possibility of
misunderstanding or misuse
- for details on the use of PAB
endorsement refer to PAB/SR11
- test reports must include the
information listed in the Standard
under 5.10.2 items (a) to (k)
- where necessary for the
interpretation of the test results,
the items included in 5.10.3.1 (a)
to (e) must be included in the
test report
- test reports containing the results
of sampling must also include
the additional requirements listed
in 5.10.3.2 (a) to (k) as
necessary for the interpretation
of the test results
- calibration certificates must
include the information listed in
the Standard under 5.10.2 items
(a) to (k)
- where necessary for the
interpretation of calibration
results, the requirements
included in 5.10.4.1 (a) to (c)
must also be included in the
calibration certificate
- if a statement of compliance
with a specification is made, the
clauses of the specification
which are met or not met must
be identified (5.10.4.2)
- where statement of compliance
is made omitting the
measurement results and
associated uncertainties, the
laboratory must record and retain
those results (5.10.4.2)
- the uncertainty of measurement
must be taken into account when
statements of compliance are
made (5.10.4.2)
- calibration results before and
after adjustment or repair, if
available, must be reported

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

LA/SF08
01
00
01 August 2018
21 of 23

PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025

Clause

5.10.5
Opinions and
interpretations

5.10.6
Testing and calibration
results
obtained from
subcontractors

5.10.7
Electronic
transmission of
results
5.10.9
Amendments
to test reports
and calibration
certificates

Requirement for Accreditation
(5.10.4.3)
- calibration certificates or labels
must not contain any
recommendation on the
calibration interval except when
requested by the customer
(5.10.4.4)
- must document the basis the
opinions and interpretations are
made
- must be clearly marked in a test
report
- results of tests performed by
subcontractors must be clearly
identified
- where calibration work has been
subcontracted, the laboratory
performing the work shall issue
the calibration certificate to the
contracting laboratory
Where results are transmitted
electronically or
electromagnetically the
requirements set out in the
Standard must be met
- amendments to a test report or
calibration certificate after issue
must be made in the form of a
further document, or data
transfer and include reference to
the original as detailed in the
Standard
- when a complete new test report
or calibration certificate is
required, it must be uniquely
identified and include a reference
to the original it replaces

PAB Supplementary Requirements
LA/SR (01, 02, 03, 04, 07) whichever is applicable
01 – Chemical Testing Laboratory
02 – Biological Testing Laboratory
03 – Electrical Testing Laboratory
04 – Mechanical Testing Laboratory
07 – Calibration Laboratory

Document ID
Issue Number
Revision Number
Effectivity Date
Page

Reference to
Laboratory Document
(To be completed by the
laboratory)

LA/SF08
01
00
01 August 2018
22 of 23

PAB Remarks

Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17025
PAB Supplementary Requirements
LA/SR 09 (Supplementary Requirements for
Participation to Proficiency Testing)

LA/SR 10 (Supplementary Requirements on
Traceability of Measurement)
LA/SR 11 (Supplementary Requirements on the Use
of PAB Laboratory and Inspection Body
Accreditation Symbol)

Document ID
Issue Number
Revision Number
Effectivity Date
Page

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01 August 2018
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