[organization name]
Appendix 2 – ISO/IEC 17025:2017 Internal Audit Checklist
Clause
4.0
4.1.1
4.1.2
4.1.3
4.1.4
4.1.5
4.2.1
4.2.2
4.2.3
4.2.4
4.2.5
5.0
5.1
Requirement
YES
GENERAL REQUIREMENTS
Are laboratory activities
undertaken impartially and
managed to safeguard impartiality?
Is laboratory management
committed to impartiality?
Does the laboratory prevent
commercial, financial or other
pressures from compromising
impartiality?
Does the laboratory identify risks
to its impartiality on an on- going
basis?
If a risk is identified, can the
laboratory demonstrate how to
eliminate or minimize that risk?
Does the laboratory ensure the
protection of its customer’s
confidential information,
proprietary rights, electronic
storage and transmission of
results?
Is the laboratory responsible,
through legally enforceable
commitments, for the
management of all information
obtained or created during the
performance of its activities?
When legally allowed, does the
laboratory notify its customer of
any release of confidential
information?
Is information about its customers
from sources other than the
customer held in confidence?
Do all personnel, including
committee members, contractors
and other persons acting on behalf
of the laboratory, keep confidential
all information obtained or created
by the laboratory, except if
required by law?
STRUCTURAL REQUIREMENTS
Is the laboratory a legal entity or a
defined part of a legal entity that is
responsible for all its activities?
Appendix 2 – Internal Audit Checklist
NO
Comments
x
ver. [version] from [date]
e.g. Management has implemented
a suitable program
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5.2
5.3
5.4
5.5
5.6
Has the laboratory identified
management who have overall
responsibility for the laboratory?
Does the laboratory carry out its
activities in such a way as to meet
the requirements of this standard,
its customers, regulatory
authorities and organizations
providing recognition? Is the
laboratory responsible for activities
performed in all its facilities, away
sites and temporary and mobile
facilities or customer facilities?
Has the laboratory defined and
documented the range of
laboratory activities for which it
conforms to this ISO standard?
Has the laboratory:
a. Defined the organization
and management
structure, its place in any
parent organization and
relationships between
management, technical
operations and support
activities?
b. Specified the responsibility,
authority and
interrelationships of all
personnel who manage,
perform or verify work
affecting the results of
laboratory activities?
c. Documented its
procedures to the extent
necessary to assure the
consistent application of its
activities and validity of the
results?
Does the laboratory have
personnel who have authority and
resources needed to carry out their
duties, including:
a. Implementation,
maintenance and
improvement of the
management system?
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Identification of deviations
from the management
system or from procedures
for performing laboratory
activities?
c. Initiation of actions to
prevent or minimize such
deviations?
d. Reporting to management
on the performance of the
management system and
any need for
improvement?
e. Ensuring the required
validity of laboratory
activities?
Does laboratory management
ensure:
a. The integrity of the
management system is
maintained when changes
to the management system
are implemented?
b. That communication takes
place regarding the
effectiveness of the
management system and
the importance of meeting
customer and other
requirements?
RESOURCE REQUIREMENTS
In general, does the laboratory
have available personnel, facilities,
equipment, systems and support
services to perform its laboratory
activities?
Personnel:
Do all personnel, internal or
external, that could influence
laboratory activities act impartially,
receive supervision and are they
competent and working in
accordance with the management
system?
Does the laboratory document
competence requirements for each
function influencing the results of
laboratory activities, including
requirements for education,
b.
5.7
6.0
6.1
6.2
6.2.1
6.2.2
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6.2.3
6.2.4
6.2.5
6.2.6
6.3
6.3.1
6.3.2
6.3.3
qualification, training, technical
knowledge, skills and experience?
Does the laboratory ensure that
the personnel have the
competence to perform the
laboratory activities for which they
are responsible and understand the
significance of, and response to
deviations in laboratory activities?
Does the laboratory communicate
to each person their duties,
responsibilities and authorities?
Does the laboratory have
procedures and maintain records
for:
a. Determining the
competence
requirements?
b. Selection of personnel?
c. Training of personnel?
d. Supervision of personnel?
e. Authorization of
personnel?
f. Monitoring of competence
of personnel?
Does the laboratory authorize
personnel to:
a. Develop, modify, verify and
validate methods?
b. Perform specific laboratory
activities?
c. Report results?
Facilities and environmental
conditions:
Are the facilities and
environmental conditions suitable
for the laboratory activities? Do
they not adversely affect the
validity of results?
Are the requirements for facility
and environmental conditions
necessary for the performance of
laboratory activities documented?
Does the laboratory monitor,
control and record environmental
conditions as required by relevant
specifications, methods and
procedures or where they
influence the validity of results?
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6.3.4
Are measures to control facilities
implemented, monitored and
periodically reviewed, including,
but not limited to:
a. Access to and use of areas
affecting laboratory
activities?
b.
c.
6.3.5
6.4
6.4.1
6.4.2
6.4.3
Prevention of
contamination,
interference or adverse
influences on laboratory
activities?
Effective separation
between areas in which
there are incompatible
laboratory activities?
When the laboratory performs
activities at facilities outside its
permanent control, does it ensure
that the requirements related to
facilities and environmental
conditions of this ISO standard are
met?
Equipment:
Does the laboratory have access to
equipment required for the correct
performance of its laboratory
activities:
a. Measurement
instruments?
b. Software?
c. Measurement standards?
d. Reference materials?
e. Reference data?
f. Reagents and
consumables?
g. Auxiliary apparatus?
h. Combinations of the
above?
When the laboratory uses
equipment outside its permanent
control, does it ensure that the
requirements for equipment in this
ISO standard are met?
Does the laboratory have a
procedure for handling, transport,
storage, use and planned
maintenance of equipment to
ensure proper functioning and in
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6.4.4
6.4.5
6.4.6
6.4.7
6.4.8
6.4.9
6.4.10
order to prevent contamination or
deterioration?
Does the laboratory verify that
equipment complies with specified
requirements before being placed
into service?
Is the equipment used for
measurement capable of achieving
the measuring accuracy and
measurement uncertainty required
to provide a valid result?
When the measurement accuracy
and measurement uncertainty
affect the validity of the reported
result, or metrological traceability
is a requirement, is the measuring
equipment calibrated?
Did the laboratory establish a
calibration program to ensure
metrological traceability of the
measurement results is
maintained?
Is the calibration program
reviewed and adjusted as
necessary in order to maintain
confidence in the status of
calibration?
Is all equipment requiring
calibration labeled, coded or
otherwise identified to allow the
user to readily the status of the
calibration or period of validity?
When equipment is subjected to
overloading or mishandling, gives
questionable results, or has been
shown to be defective or outside
specified requirements, is it taken
out of service?
Is that equipment isolated to
prevent its use and/or clearly
labeled or marked as being out of
service?
Does the laboratory examine the
effect of the defect or deviation
and initiate the nonconforming
work procedure?
When intermediate checks are
necessary to maintain confidence
in the performance of the
equipment, are these checks
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6.4.11
6.4.12
6.4.13
carried out according to a
procedure?
For calibration and reference
material, does the laboratory
ensure the correction factors and
reference values are updated and
implemented as appropriate, to
meet specified requirements?
Does the laboratory ensure
practicable measures are taken to
prevent unintended adjustments of
equipment which would invalidate
results?
Are records maintained for
equipment which can influence the
laboratory’s activities? Do the
records include at least the
following:
a. The identity of equipment,
including software?
b.
c.
d.
e.
f.
g.
h.
The manufacture’s name,
type identification, serial
number or other unique
identification?
Evidence of verification
that equipment conforms
with specified
requirements?
The current locations,
where appropriate?
Calibration dates, results of
all calibrations,
adjustments, acceptance
criteria and due date of the
next calibration or the
calibration frequency?
Dates, results and
documentation of
reference materials,
acceptance criteria and the
period of validity?
Maintenance plan and
maintenance carried out to
date, where relevant to the
performance of the
equipment?
Details of any damage,
malfunction, modification
or repair to the
equipment?
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6.5
6.5.1
6.5.2
6.5.3
6.6
Metrological Traceability:
Does the laboratory establish and
maintain metrological traceability
of its measurement results by
means of a documented unbroken
chain of calibration each
contributing to the measurement
uncertainty, linking them to an
appropriate reference?
Does the laboratory ensure that
measurement results are traceable
to the International System of
Units (SI) through:
a. Calibration?
b. Certified values of certified
reference materials with
stated metrological
traceability to the SI?
c. Direct realization of the SI
units which conform with
the mises en pratique, as
described in the SI
Brochure?
When metrological traceability to
the SI units is not technically
possible, does the laboratory
demonstrate traceability to an
appropriate reference such as:
a. Certified values of certified
reference materials
provided by a competent
producer?
b. Results of reference
measurement procedures,
specified methods or
consensus standards that
are clearly described and
accepted by an
authoritative body as
providing measurement
results fit for their
intended use and ensured
by suitable comparison?
Externally Provided Products and
Services:
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6.6.1
6.6.2
6.6.3
Does the laboratory assure the
suitability of externally provided
products and services that affect
laboratory activities, when they:
a. Are intended for
incorporation into the
laboratory’s own activities?
b. Are provided, in part or in
full, directly to the
customer by the
laboratory, as received
from the external supplier?
c. Are used to support the
operation of the
laboratory?
Does the laboratory have a
procedure and records for:
a. Defining, reviewing and
approving the laboratory’s
requirements for externally
provided products and
services?
b. Defining the criteria for
evaluation, selection,
monitoring of performance
and re-evaluation of the
external providers?
c. Ensuring that externally
provided products and
services conform to the
laboratory’s established
requirements or, when
applicable, the relevant
requirements of the
international standard
before they are used or
directly provided to the
customer?
d. Taking any actions arising
from evaluations,
monitoring and reevaluations?
Does the laboratory communicate
to external providers, its
requirements for:
a. The products and services
to be provided?
b. The acceptance criteria?
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Competence, including any
required qualification of
personal?
d. Activities that the
laboratory, or its customer,
intends to perform at the
external provider’s
premises?
PROCESS REQUIREMENTS
Review of Requests, Tenders and
Contracts:
Does the laboratory have a
procedure for the review of
requests, tenders and contracts?
Does it contain:
a. Requirements that are
adequately defined,
documented and
understood?
b. Does the laboratory have
the capability and
resources to meet the
requirements and the
requirements of clause 6.6
when external sources are
used?
c. Does the laboratory use
the appropriate methods
and procedures that are
capable of meeting
customer requirements?
Does the laboratory have a
procedure to cover the activities of
external providers?
Does the laboratory advise the
customer of specific laboratory
activities to be performed by the
external provider and gain the
customer’s approval?
Does the laboratory take
responsibility for externally
provided laboratory activities?
Does the laboratory ensure that
laboratory activities that are
externally provided meet customer
requirements and the relevant
requirements of the standard?
Does the laboratory inform the
customer when the method
requested by the customer is
c.
7.0
7.1
7.1.1.1
7.1.1.2
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7.1.1.3
7.1.1.4
7.1.1.5
7.1.1.6
7.1.1.7
7.1.1.8
7.2
7.2.1
7.2.1.1
7.2.1.2
7.2.1.3
considered to be inappropriate or
out of date?
Are decision rules for conformity to
a specification or standard
(pass/fail, etc.) clearly defined?
Are differences between requests
and contracts resolved before
laboratory activities begin? Is each
contract accepted by both the
customer and the laboratory?
Is the customer informed of any
deviation from the contract?
Is the contract review repeated if
the contract is amended after work
has commenced? Are
amendments communicated to all
affected personnel?
Does the laboratory cooperate
with customers in clarifying the
customer’s request and in
monitoring the laboratory’s
performance in relation to the
work performed?
a. Providing reasonable
access to relevant areas of
the laboratory?
b. Preparation, packaging and
dispatch of items needed
by the customer for
verification purposes?
Are records of reviews, discussions
including changes, maintained?
Selection, Verification and
Validation of Methods:
Selection and verification of
methods:
Does the laboratory use
appropriate methods and
procedures for all laboratory
activities?
Are all methods, procedures and
supporting documentation kept up
to date?
Does this include instructions,
standards, manuals and reference
data?
Are all deviations from methods
and procedures documented and
technically justified, authorized and
accepted by the customer?
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7.2.1.4
7.2.1.5
7.2.1.6
7.2.1.7
7.2.2
7.2.2.1
7.2.2.2
7.2.2.3
7.2.2.4
Does the laboratory use methods
that meet customer requirements?
Does the laboratory ensure that it
is using the latest edition or a
method?
When the customer does not
specify a method, does the
laboratory select an appropriate
method and inform the customer
of the method used?
Does the laboratory verify that it
can properly perform a method
before introducing it?
When method development is
required, is it a planned activity
assigned to qualified personnel
equipped with adequate
resources?
As method development proceeds,
are there periodic reviews to verify
that the needs of the customer are
being met?
Validation of Methods:
Does the laboratory validate nonstandard methods, laboratory
developed methods and standard
methods used outside their
intended scope?
Is the validation as extensive as
necessary to meet requirements?
Are the validation results
recorded?
When changes are made to
validated methods, are the
changes documented and a new
validation performed?
Are the range and accuracy of
values obtained from validated
methods assessed to ensure they
are relevant to customer
requirements?
Does the laboratory record the
following as evidence of validation:
a. The validation procedure
used?
b. Specification of the
requirements?
c. Determination of the
performance
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characteristics of the
method?
d.
Results obtained?
e.
Verification that the
requirements can be
fulfilled by using the
method?
A statement on the validity
of the method, detailing its
fitness for the intended
use?
f.
7.3
7.3.1
Sampling
Is there a Sampling procedure?
Does it address factors to be
controlled to ensure the validity of
subsequent testing or calibration
results?
Is there a sampling plan and
procedure for sampling when
carried out for substances,
materials or products for
subsequent testing or calibration?
Is the sampling plan or method
available at the site where
sampling is undertaken?
Are sampling plans, where
reasonable, based on appropriate
statistical methods?
7.3.2
Do sampling methods describe the
selection of samples or sites,
sampling plan, withdrawal and
preparation of a sample from its
source?
Is there a process in place once the
sample reaches the laboratory?
7.3.3
Does the laboratory record
relevant sampling data that forms
part of the testing or calibration
that is undertaken?
Do these records include:
a. The reference to the
sampling procedure?
b. Date and where required,
time of sampling?
c. Relevant data to identify
and describe the sample?
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Identification of the
sampler?
e. If relevant, environmental
conditions?
f. Diagrams or other
equivalent means to
identify the sampling
location when
appropriate?
Handling of Test or Calibration
Items:
Is there a procedure for the
transportation, receipt, handling,
protection, storage, retention and
disposal and/or return of test or
calibration items to protect the
interests of the laboratory and the
customer?
d.
7.4
7.4.1
Is special care taken to avoid loss
or damage during transport?
Are handling instructions provided
with the item followed?
7.4.2
7.4.3
7.4.4
7.5
7.5.1
Does the laboratory have a system
for identifying test and/or
calibration items?
Upon receipt, does the laboratory
have a system to identify and
record abnormalities or deviations
from specified conditions?
When items have to be stored
under specified environmental
conditions, are these conditions
maintained, monitored and
recorded?
Technical Records:
Does the laboratory ensure that
technical records for each
laboratory activity contain the
report of results, if possible,
identification of factors affecting
the measurement uncertainty?
Do technical records include the
date and identity of personnel
responsible for each laboratory
activity and for checking data and
results?
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7.5.2
7.6
7.6.1
7.6.2
7.6.3
7.7
7.7.1
Are original observations, data and
calculations recorded at the time
they are made?
Does the laboratory ensure
amendments to technical records
can be traced back to either
previous versions and to original
observations? Are the files kept?
Evaluation of Measurement
Uncertainty:
If the laboratory is performing
calibrations, including of its own
equipment, does it evaluate the
measurement uncertainty for all of
the calibrations?
If the laboratory is performing
sampling or testing activities, does
the laboratory identify all the
contributions to measurement
uncertainty?
Does it make a reasonable
estimation of their magnitude?
When evaluating the measurement
uncertainty, are all components of
significance identified and taken
into account using the appropriate
methods of analysis?
Ensuring the Validity of Results:
Does the laboratory have a
procedure for regularly monitoring
the validity of laboratory activities
and the quality of the laboratory/s
output?
Is the resulting data recorded in
such a way that trends are
detectable?
Is this monitoring planned and
reviewed and include where
appropriate, but not limited to:
a. Regular use of reference
materials of quality control
materials.
b. Regular use of alternative
instrumentation that has
been calibrated to provide
traceable results.
c. Functional check of
measuring and test
equipment.
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Use of check or working
standards with control
charts where applicable.
e. Periodic intermediate
checks on measuring
equipment.
f. Replicate tests or
calibrations using the same
or different methods.
g. Retesting or recalibration
of retained items.
h. Correlation of results for
different characteristics of
an item.
i. Review of reported data by
competent laboratory
personnel.
j. Intra-laboratory
comparisons.
k. Blind test.
Does the laboratory monitor the
quality of the laboratory’s
performance by comparing with
output of other laboratories?
(Proficiency Testing)
Is this monitoring planned and
reviewed?
Is data from monitoring activities
analyzed and used to both control
and improve the laboratory’s
activities?
Reporting the Results:
Are the results provided accurately,
clearly, unambiguously and
objectively in a report?
Do they contain all the information
agreed with the customer?
Are issued reports maintained as
technical records?
Reports – Common Requirements:
Does each report include the
following information?
a. A title.
b. The name and address of
the laboratory.
d.
7.7.2
7.7.3
7.8
7.8.1.1
7.8.2
7.8.2.1
c. The location where the
tests/calibrations were
performed.
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d. A unique identification
number for the report.
e. The name and contact
information of the
customer.
f. Identification of the
method used.
g. A description,
unambiguous identification
and when necessary, the
condition of the item.
h. The date of receipt of the
test item and/or dates of
sampling.
i. The date of the test or
calibration.
j.
The date the report was
issued.
k. Reference to sampling
plans if relevant.
l.
A statement to the effect
that the results relate only
to the items tested or
calibrated.
m. The test or calibration
results and where
appropriate the units of
measurement.
n. Identification of the person
authorizing the report.
7.8.2.2
7.8.3
7.8.3.1
o. Clear identification when
the results are from an
external provider.
Does the laboratory take
responsibility for all information
provided in the test or calibration
report or calibration certificate?
Specific requirements for test
reports:
Where necessary, do test reports
contain the following:
a. Specific test conditions
such as environmental?
b. A statement of
conformity?
c. Measurement uncertainty?
d. Opinions and/or
Interpretations?
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7.8.3.2
7.8.4
7.8.4.1
7.8.5
7.8.6
7.8.6.1
7.8.6.2
e. Additional requested
information?
Do sampling activity on test reports
meet the requirements listed in
7.8.2?
Specific requirements for
calibration certificates:
In addition to the requirements
listed in 7.8.2, do calibration
certificates include the following:
a. Measurement
Uncertainty?
b. Environmental conditions?
c. Statement of Metrological
Traceability?
d. Results before and after
adjustment?
Reporting Sampling:
Where the laboratory is
responsible for the sampling stage,
do the results contain the
following?
a. The date of sampling.
b. Identification of the items
sampled.
c. Location of the sampling.
d. Reference to the sampling
plan.
e. Details of environmental
conditions during
sampling.
f. Information required to
evaluate measurement
uncertainty for subsequent
testing or calibration.
Statements of Conformity:
When a statement of conformity is
issued, does the laboratory take
into account the level of risk
associated with statements of
conformity?
Does the statement of conformity
clearly identify:
a. To which results the
statement applies?
b. Which specification,
standard or parts thereof
are met or not met?
c. The decision rule applied?
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7.8.7
7.8.7.1
7.8.7.2
7.8.7.3
7.8.8
7.8.8.1
7.8.8.2
7.8.8.3
7.9
7.9.1
7.9.2
Reporting Opinions and
Interpretations:
Are opinions and interpretations
based on the results obtained from
tested or calibrated items and
clearly marked as such?
Does the laboratory ensure that
only personnel authorized for
expression of opinions and
interpretations, releases the
statement?
Does the laboratory document the
basis upon which the opinion
and/or interpretation is made?
Does the laboratory communicate
directly with the customer about
opinions and interpretations? Is
there a record of that
communication?
Amendments to Reports:
When a report needs to be
changed, is the changed
information clearly identified?
Are amendments made only in the
form of a further well identified
document?
Does it contain the title
“Amendment to Report”?
When new reports are issued, do
they contain references to the
original that it replaces?
Complaints:
Does the laboratory have a
documented process to receive,
evaluate and make decisions of
complaints?
Is a description of the handling
process available to any interested
party on request?
Does the laboratory confirm that
the complaint relates to laboratory
activities?
Does the laboratory take
responsibility for the complaint
process?
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7.9.3
7.9.4
7.9.5
7.9.6
7.9.7
7.10
7.10.1
Does the complaint handling
process include:
a. A description of the
receiving, validating and
investigating of the
complaint?
b. Tracking and recording of
the complaints?
c. Ensuring that any
appropriate action is
taken?
Does the laboratory gather and
verify all necessary information to
validate the complaint?
Does the laboratory acknowledge
receipt of the complaint and
provide progress reports and the
outcome?
Are outcomes reviewed and
approved by individuals not
involved in the original laboratory
activities?
Does the laboratory give formal
notice at the end of the complaint
handling?
Nonconforming Work:
Does the laboratory have a
procedure that covers any aspect
of laboratory activities that results
in nonconforming work?
Does the procedure ensure that:
a. Responsibilities and
authorities for the
management of
nonconforming work are
defined?
b. All actions are based upon
risk levels established by
the laboratory?
c. An evaluation is made of
the significance of the
nonconforming work,
including an impact
analysis on previous
results?
d. A decision is taken on the
acceptability of the
nonconforming work?
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[organization name]
Where necessary, the
customer is notified and
work is recalled?
f. The responsibility for
authorizing the resumption
of work is defined?
Does the laboratory retain records
of the non-conforming work and
actions?
Where evaluation indicates that
nonconforming work could recur or
doubt about compliance in
laboratory operations, does the
laboratory implement corrective
action?
Control of Data – Information
Management:
Does the laboratory have access to
data and information needed to
provide laboratory activities?
Was the current management
information system validated by
the laboratory before being
introduced?
Are changes to the MIS authorized,
documented and validated before
implementation?
Does the laboratory MIS:
a. Protect from
unauthorized access?
b. Safeguard against
tampering or loss?
c. Operates in an
environment of
compliance with
specifications?
d. Maintained in a manner
that ensures integrity of
data and information.
e. A recording system for
failures and for
corrective action?
Is off-site management of the MIS
managed and does it comply with
the requirements of the ISO 17025
standard?
Does the laboratory ensure that
instructions, manuals and
reference data are relevant to the
e.
7.10.2
7.10.3
7.11
7.11.1
7.11.2
7.11.3
7.11.4
7.11.5
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7.11.6
8.0
8.2
8.2.1
8.2.2
8.2.3
8.2.4
8.2.5
8.3
8.3.1
8.3.2
MIS and made available to
personnel?
Are calculations and data transfers
subject to appropriate checks in a
systematic manner?
MANAGEMENT REQUIREMENTS
FOR OPTION ‘A’ LABORATORIES
Management System
Documentation:
Has the laboratory established
documented and maintained
policies and objectives for
fulfillment of the ISO 17025
standard?
Are its policies and objectives
acknowledged and implemented at
all levels?
Do the policies and objectives
address competence, impartiality
and consistent operation of the
laboratory?
Does laboratory management
provide evidence of commitment
to the development and
implementation of the QMS and to
continually improving its
effectiveness?
Are all documentation, processes,
systems and records related to the
fulfillment of the ISO 17025
standard and referenced or linked
to the QMS?
Do all personnel involved in
laboratory activities have access to
the parts of the QMS
documentation and related
information that are applicable to
their responsibilities?
Control of Management Systems
Documents:
Does the laboratory control all
documents, internal and external,
that relate to the management
system and ISO standard?
Does the laboratory ensure:
a. Documents are approved
prior to issue?
b. Documents are periodically
reviewed and updated?
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[organization name]
c. Changes and current
revision status is
identified?
d. Documents are available at
points where there use if
necessary and distribution
is controlled?
e. All documents are uniquely
identified?
f.
8.4
8.4.1
8.4.2
8.5
8.5.1
8.5.2
Use of obsolete
documents is prevented?
Control of Records:
Does the laboratory establish and
maintain legible records to
demonstrate compliance to the ISO
17025 Standard?
Did the laboratory implement
controls for the identification,
storage, protection, back-up,
retention times and disposal of its
records?
Is access to these records
consistent with confidentiality
arrangements?
Actions to Address Risks and
Opportunities:
Did the laboratory consider risks
and opportunities associated with
laboratory activities in order to:
a. Give assurance that the
management system can
achieve its intended
results?
b. Enhance opportunities to
achieve the purpose and
objectives of the
laboratory?
c. Prevent or reduce
undesired impacts and
potential failures in the
laboratory’s activities?
d. Achieve improvement?
Does the laboratory planning
a. Actions to address these
risks and opportunities?
b. How to:
1.
Integrate and
implement actions into
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[organization name]
its management
system?
Evaluate the
effectiveness of these
actions?
Are actions taken to address risks
and opportunities proportional to
the potential impact on the validity
of laboratory results?
Improvement:
Has the laboratory identified and
selected opportunities for
improvement and implemented
necessary actions?
Does the laboratory seek feedback
both positive and negative, from its
customers?
2.
8.5.3
8.6
8.6.1
8.6.2
8.7
8.7.1
Is the feedback analyzed and used
to improve the management
system, laboratory activities and
customer service?
Corrective Action:
When nonconformity occurs, does
the laboratory:
a. React to the
nonconformity and
1. Take action to control
and correct it?
2. Deal with the
consequences?
b. Evaluate the need for
action to eliminate the
cause in order that it does
not reoccur 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
the corrective action?
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[organization name]
e.
f.
8.7.2
8.7.3
Update risks and
opportunities determined
during planning?
Make changes to the QMS
if necessary?
Are corrective actions appropriate
to the effects of nonconformities
encountered?
Does the laboratory retain records
as evidence of
1. The nature of the
nonconformities, cause
and subsequent actions?
2.
The results of any
corrective actions?
8.8
8.8.1
Internal Audits:
Does the laboratory conduct
internal audits at planned intervals
to provide information on whether
the management system:
a. Conforms to:
1. The laboratory’s own
requirements for the
management system,
including laboratory
activities?
2. The requirements of
the ISO 17025
standard?
b. Is effectively implemented
and maintained?
8.8.2
Does the laboratory
1.
Plan, establish, implement
and maintain an audit
program including the
frequency, methods,
responsibilities, planning
requirements and
reporting, which takes into
consideration the
importance of the
laboratory activities
concerned, changes
affecting the laboratory
and the results of previous
audits?
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[organization name]
2.
Define the audit criteria
and scope for each audit?
Ensure the results of the
audits are reported to
relevant management?
4. Implement appropriate
correction and corrective
actions without undue
delay?
5. Retain records as evidence
of the implementation of
the audit program and the
audit results?
Management Reviews:
Does laboratory management
review its management system at
planned intervals in order to
ensure its continuing suitability,
adequacy and effectiveness,
including the stated policies and
objectives related to compliance
with the ISO 17025 standard?
Are inputs to management review
recorded and include information
related to the following:
1. Changes in internal and
external issues that are
relevant to the laboratory?
2. Fulfillment of objectives/
3. Suitability of policies and
procedures?
4. Status of actions from
previous management
reviews?
5. Outcome of recent internal
audits?
6. Corrective actions?
3.
8.9
8.9.1
8.9.2
Assessments by external
bodies?
8. Changes in the volume and
type of the work or in the
range of laboratory
activities?
9. Customer feedback?
7.
10. Complaints?
11. Effectiveness of any
implemented
improvements?
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[organization name]
12. Adequacy of recourses?
13. Results of risk
identification?
14. Outcomes of the assurance
8.9.3
of quality results?
15. Other relevant factors,
such as monitoring
activities and training?
Do the outputs from management
review record all decisions and
actions related to:
1. The effectiveness of the
management system and
its processes?
2. Improvement of laboratory
activities related to the
fulfillment of requirements
of the ISO 17025 standard
3. Provision of required
resources?
4. Any need for change?
[job title]
[name]
_________________________
[signature]
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