LA/SF 07: Assessment Checklist for ISO/IEC 17020:2012
INTRODUCTION
1. Purpose
This checklist is prepared for the following purposes:
1.1 To assist both the staff of the Conformity Assessment Body (CAB) 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 17020:2012 and an assessment; and
1.3 To provide essential background information for briefing PAB assessment team and
relevant information during the assessment process.
2. Structure and Use of the Checklist
2.1 Compliance with PAB General Requirements
2.2 All PAB accredited CABs are required to comply with the accreditation requirements
and the basic technical and management system requirements for CAB based on
ISO/IEC 17020:2012.
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 classification of scopes) and for approved signatories (the specific
people authorized to sign PAB endorsed test reports).
3. Preparation of Documented Management System
3.1 Each accredited CAB 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 the policies and operational
procedures established to meet requirements for accreditation.
3.3 The manner in which a documented quality system is structured is the choice of the
CAB. The purpose of the documentation is primarily to advice the staff of the policies
and procedures expected by its management to be implemented by all staff.
3.4 Typically, a quality management system is documented in a Quality Manual and
supporting procedures and records. In some cases, a Quality Manual includes
supporting procedures. In other cases, some of the subjects of a Quality Manual may be
incorporated in an organization’s more general Quality Manual or procedures.
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LA/SF 07: Assessment Checklist for ISO/IEC 17020:2012
Reference to CAB’s
Documents and/or
Clause Requirements Information on the PAB Remarks
Implementation
(to be completed by the CAB)
4 General requirements
4.1 Impartiality and independence
4.1.1 Inspection activities shall be taken
impartially.
4.1.2 The inspection body shall be
responsible for the impartiality of its
inspection activities.
4.1.3 The inspection body shall identify
risk to its impartiality on an ongoing
basis.
4.1.4 The inspection body shall be able to
demonstrate how it eliminates or
minimizes risk.
4.1.5 The inspection body shall have top
management commitment to
impartiality.
4.1.6 Independent to the extent that is
contractually required
a) Type A Inspection Body
Fully independent of all consulting,
manufacturing involvement
b) Type B Inspection Body
A separate and identifiable part of
an organization, established to
supply inspection services to its
parent organization only
c) Type C Inspection Body
A separate and identifiable part of
an organization, may supply
inspection services to other parties
not being its parent organization
4.2 Confidentiality
4.2.1 Confidentiality and propriety rights
Shall be legally responsible for the
management of all information
obtained or created during the
performance of inspection activities.
4.2.1 IB shall inform the client of the
information it intends to place in the
public domain.
4.2.1 All information (except information
that the client makes publicly or
agreed between the IB and the
client) are regarded as confidential.
4.2.2 The client of individual concern shall
be notified if the IB is required by
law or authorized by contractual
commitment to release confidential
information.
4.2.3 Information obtained from sources
other than the shall be treated
confidential.
5.1 Administrative requirements
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LA/SF 07: Assessment Checklist for ISO/IEC 17020:2012
Reference to CAB’s
Documents and/or
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Implementation
(to be completed by the CAB)
5.1.1 The inspection body shall be a legal
entity, or a defined part of a legal
entity, such that it can be held
legally responsible for all its
inspection activities.
5.1.2 An inspection body that is part, of a
legal entity involved in activities
other than inspection shall be
identifiable within that entity.
5.1.3 The inspection body shall have
documentation which describes the
activities for which it is competent.
5.1.4 The inspection body shall have
adequate provision (eg insurance or
reserves) to cover liabilities arising
from its operations
Insurance Insurer Policy Number Value Expiry
Prof. Indemnity
Public liability
Other
5.1.5 The inspection body shall have
documentation describing the
contractual conditions under which it
provides the inspection, except
when it provides inspection services
to the legal entity of which it is a part
5.2 Organization and management
5.2.1 The inspection body shall be
structured and managed so as to
safeguard impartiality.
5.2.2 The inspection body shall be
organized and managed so as to
enable it to maintain the capability
to perform its inspection activities.
5.2.3 The inspection body shall define
and document the responsibilities
and reporting structure of the
organization.
5.2.4 Where the inspection body forms a
part of a legal entity performing
other activities, the relationship
between these other activities and
inspection activities shall be
defined.
5.2.5 The inspection body shall have
available one or more person(s) as
technical manager(s) who have
overall responsibility to ensure that
the inspection activities are carried
out in accordance with this
international Standard.
Where the inspection body has
more than one technical manager,
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LA/SF 07: Assessment Checklist for ISO/IEC 17020:2012
Reference to CAB’s
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Implementation
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the specific responsibilities of each
manager shall be defined and
documented.
5.2.6 The inspection body shall have one
or more named person(s) who will
deputize in the absence of any
technical manager responsible for
ongoing inspection activities.
5.2.7 The inspection body shall have a
job description or other
documentation for each position
category within its organization
involved in inspection activities.
6 Resource requirements
6.1 Personnel
6.1.1 The inspection body shall define
and document the competence
requirements for all personnel
involved in inspection activities,
including requirements for
education, training, technical
knowledge, skills and experience,
6.1.2 The inspection body shall employ,
or have contracts with, a sufficient
number of persons with the required
competencies, including, where
needed, the ability to make
professional judgements, to perform
the type, range and volume of its
inspection activities,
6.1.3 The personnel responsible for
inspection shall have appropriate
qualifications, training, experience
and a satisfactory knowledge of the
requirements of the inspections to
be carried out.
6.1.4 The inspection body shall make
clear to each person their duties,
responsibilities and authorities.
6.1.5 The inspection body shall have
documented procedures for
selecting, training, formally
authorizing, and monitoring
inspectors and other personnel
involved in inspection activities.
6.1.6 The documented procedures for
training (see 6.1.5) shall address
the following stages:
a) an induction period; b) a
mentored working period with
experienced inspectors; c)
continuing training to keep pace
with developing technology and
inspection methods.
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LA/SF 07: Assessment Checklist for ISO/IEC 17020:2012
Reference to CAB’s
Documents and/or
Clause Requirements Information on the PAB Remarks
Implementation
(to be completed by the CAB)
6.1.7 The training required shall depend
upon the ability, qualifications and
experience of each inspector and
other personnel involved in
inspection activities, and upon the
results of monitoring (see 6.1.8).
6.1.8 Personnel familiar with the
inspection methods and procedures
shall monitor all inspectors and
other personnel involved in
inspection activities for satisfactory
performance. Results of monitoring
shall be used as a means of
identifying training needs (see
6.1.7).
6.1.9 Each inspector shall be observed
on-site, unless there is sufficient
supporting evidence that the
inspector is continuing to perform
competently.
6.1.10 The inspection body shall maintain
r6cotds of monitoring, education,
training, technical knowledge, skills,
experience and authorization to
each member of its personnel
involved in inspection activities,
6.1.11 The personnel involved in
inspection activities shall not be
remunerated in a way that
influences the results of inspections.
6.1.12 All personnel of the inspection body,
either internal or external, that could
influence the inspection activities
shall act impartially.
6.1.13 All personnel of the inspection body,
including sub-contractors, personnel
of external bodies, and individuals
acting on the inspection body's
behalf, shall keep confidential all
information obtained or created
during the performance of the
inspection activities, except as
required by law.
6.2 Facilities and equipment
6.2.1 The inspection body shall have
available, suitable and adequate
facilities and equipment to permit all
activities associated with the
inspection activities to be carried out
in a competent and safe manner.
6.2.2 The inspection body shall have
rules for the access to, and the use
of, specified facilities and equipment
used to perform inspections.
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LA/SF 07: Assessment Checklist for ISO/IEC 17020:2012
Reference to CAB’s
Documents and/or
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Implementation
(to be completed by the CAB)
6.2.3 The inspection body shall ensure
the continued mentioned in 6.2.1 for
their intended use.
6.2.4 All equipment having a significant
influence on the results of the
inspection shall be defined and,
where appropriate, uniquely
identified
6.2.5 All equipment (see 6.2.4) shall be
maintained in accordance with
documented procedures and
instructions.
6.2.6 Equipment which have significant
influence on the results calibrated
before being put into service and
calibrated according to an
established program
6.2.7 Calibration program designed and
operated so that applicable
measurements are traceable to
national and international standards
of measurement
6.2.8 Reference standards used for
calibration only, Reference
standards calibrated providing
traceability to a national or
international standards of
measurement
6.2.9 Equipment subjected to in-service
checks between regular
recalibrations
6.2.10 Reference materials traceable to
national or international standard
reference materials
6.2.11 Where relevant, procedures for:
- Selection and approval of
suppliers
- Verification of incoming goods
- Ensuring storage facilities
6.2.12 Stored items assessed at
appropriate intervals to detect
deterioration
6.2.13 Computers/automated equipment
used in connection with inspections
ensure:
a. Computer software adequate
b. Procedures established and
implemented for protecting
integrity and security of data
c. Computer and automated
equipment maintained
6.2.14 Procedures for dealing with
defective equipment including
examining the effect of defects on
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LA/SF 07: Assessment Checklist for ISO/IEC 17020:2012
Reference to CAB’s
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Implementation
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previous inspections
6.2.15 Equipment identification, calibration
and maintenance records
6.3 Subcontracting
6.3.1 Where an inspection body
subcontracts any part of the
inspection, it shall ensure and be
able to demonstrate that the
subcontractor is competent to
perform the activities in question
and, where applicable, complies
with the relevant requirements
stipulated in this International
Standard or in other relevant
conformity assessment standards.
6.3.2 Inform client of the intention to
subcontract part of the inspection
6.3.3 Whenever subcontractors. Carry out
*work that forms part of an
inspection, the responsibility for any
determination of conformity of the
inspected item with the
requirements shall remain with the
inspection body.
6.3.4 Record and retain subcontractors’
competence and conformity with
applicable requirements of ISO/IEC
17020 or in other relevant
conformity assessment standards
Maintain a register of all
subcontractors
7 Process requirements
7.1 Inspection methods and procedures
7.1.1 Use methods and procedures which
are defined in the requirements
against which inspection is to be
performed
When methods and procedures are
not defined, develop specific
methods and procedures to be used
Inform client if method proposed by
client is inappropriate
7.1.2 Use adequate documented
instructions on inspection planning
and on sampling and inspection
techniques
Where applicable, have sufficient
knowledge of statistical techniques
7.1.3 Non-standard methods or
procedures used appropriate and
fully documented
7.1.4 Instructions, standards or written
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LA/SF 07: Assessment Checklist for ISO/IEC 17020:2012
Reference to CAB’s
Documents and/or
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Implementation
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procedures, worksheets, checklists
and reference data maintained up to
date and readily available
7.1.5 Contract or work order control
system ensures:
a. Work is within available
expertise and adequate
resources
b. Requirements adequately
defined and special conditions
understood so that
unambiguous instructions can
be issued to personnel
c. Work is controlled by regular
review and corrective action
d. Requirements of the contract or
work have been met
7.1.6 Verify integrity of information
supplied by any other party as part
of the inspection
7.1.7 Observations or data obtained
recorded in a timely manner
7.1.8 Calculations and data transfers
subjected to appropriate checks
7.1.9 Documented instructions for
carrying out inspection in a safe
manner
7.2 Handling inspection items and samples
7.2.1 Ensure items and samples to be
inspected are uniquely identified
7.2.2 Establish item to be inspected has
been prepared
7.2.3 Apparent abnormalities recorded
Contact the client about doubts as
to the item’s suitability or where item
does not conform to the description
provided
7.2.4 Have documented procedures and
appropriate facilities to avoid
deterioration or damage to
inspection items.
7.3 Inspection records
7.3.1 Maintain a record system to
demonstrate the effective fulfilment
of the inspection procedures and
comply with applicable regulations
Consider:
a. Contract review negotiations
b. Client/work instructions
c. All original notes and
calculations taken by the
inspector and/or other staff
during an inspection
d. Original copies or negatives of
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LA/SF 07: Assessment Checklist for ISO/IEC 17020:2012
Reference to CAB’s
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photographs
e. The identity of the staff
undertaking part(s) or the whole
of the inspection
f. Computer data files and/or
software programs
g. Reports on sampling, tests and
measurements including copies
of reports on sub-contracted
inspection, sampling and/or
testing work conducted
h. A copy of the inspection report
and a record of its distribution
i. Records of all discussions with
clients during or after the
inspection relevant to the
preparation of the inspection
report
j. Date and time of inspection
Consider management of electronic
records
Sufficient information to permit
satisfactory evaluation of the
inspection report
7.3.2 Inspection report or certificate
traceable to the inspector(s) who
performed the inspection
7.4 Inspection report and inspection certificates
7.4.1 Retrievable inspection report or
inspection certificate
7.4.2 Inspection report/certificate include
the following:
a. Identification of the issuing body
b. Unique identification and date
of issue
c. Date(s) of inspection
d. Identification of the item(s)
inspected
e. Signature or other indication
approval, by authorized
personnel
f. A statement of conformity
where applicable
g. The inspection results, except
where detailed in accordance
with 7.4.3
Optional elements of inspection
reports and certificates:
a. Designation of the document
(i.e. as inspection report or
inspection certificate)
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LA/SF 07: Assessment Checklist for ISO/IEC 17020:2012
Reference to CAB’s
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b. Identification of the client
c. Description of the inspection
work ordered
d. Information on what has been
omitted
e. Identification or brief description
of the inspection method(s) and
procedure(s) used, mentioning
the deviations
f. Identification of equipment used
for measuring/testing
g. Reference to or description of
the sampling method and
information on where, when,
how and by whom the samples
were taken
h. Information on where the
inspection was carried out
i. Information on environmental
conditions during the inspection
j. A statement that the inspection
results relate exclusively to the
work ordered or the item(s) or
lot inspected
k. A statement that the inspection
report should not be
reproduced, except in full
l. The inspector’s mark or seal
m. Names (or unique identification)
of the personnel members who
have performed the inspection
and, in cases when secure
electronic authentication is not
undertaken, their signature
7.4.3 Issue an inspection certificate that
does not include the inspection
results only when inspection report
containing the inspection results can
be produced, and when both the
inspection certificate and inspection
report are traceable to each other
7.4.4 All information reported correctly,
accurately, and clearly
Results supplied by subcontractors
clearly identified in the inspection
report or inspection certificate.
7.4.5 Record corrections or additions to
an inspection report or inspection
certificate
Identify the report or certificate
replaced in amended report or
certificate
7.5 Complaints and appeals
7.5.1 Documented process to receive,
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LA/SF 07: Assessment Checklist for ISO/IEC 17020:2012
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evaluate and make decisions on
complaints and appeals
7.5.2 Description of the handling process
for complaints and appeals
available to interested
7.5.3 Confirm whether the complaint
relates to inspection activities and
deal with it
7.5.4 Be responsible for all decisions at
all levels of the handling process for
complaints and appeals
7.5.5 Investigation and decision on
appeals does not result in any
discriminatory actions
7.6 Complaints and appeals process
7.6.1 Handling complaints and appeals
include the following:
a. Process for receiving,
validating, investigating the
complaint or appeal and
deciding actions to be taken
b. Tracking and recording
complaints and appeal,
including actions undertaken
c. Appropriate action is taken
7.6.2 Responsible for gathering and
verifying information to validate
complaint or appeal
7.6.3 Acknowledge receipt of complaint or
appeal and provide the complainant
or appellant progress reports and
outcome
7.6.4 Decisions communicated to the
complainant or appellant are
reviewed and approved by
individuals not involved in the
original inspection activities in
question
7.6.5 Give formal notice of the end of the
complaint and appeals handling
process to the complainant or
appellant
8 Management system requirements
8.1.1 Establish and maintain a
management system capable of
achieving the consistent fulfilment of
the requirements of ISO/IEC 17020
in accordance with either Option A
or Option B
8.1.2 Option A
The management system shall
address the following:
- Management system
documentation ( e.g. manual,
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LA/SF 07: Assessment Checklist for ISO/IEC 17020:2012
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Implementation
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policies, definition of
responsibilities)
- Control of documents ( see 8.3)
- Control of records ( see 8.4)
- Management review ( see 8.5)
- Internal audit ( see 8.6)
- Corrective actions ( see 8.7)
- Preventive actions ( see 8.8)
- Complaints and appeals ( 7.5
and 7.6)
8.1.3 Option B
IB that has established and
maintains a management system in
accordance with the requirements of
ISO 9001 and is capable of
supporting and demonstrating the
fulfilment of ISO/IEC 17020 fulfills
the management system clause
requirements ( see 8.2 to 8.8 )
8.2.1 Top management establish,
document, and maintain policies
and objectives
Ensure policies and objectives are
acknowledged and implemented at
all levels
8.2.2 Top management provide evidence
of commitment to the development
and implementation of the
management system and its
effectiveness
8.2.3 Top management appoint a
member of management with the
responsibility and authority that
include the following:
a. Ensuring that processes and
procedures are established,
implemented and maintained
b. Reporting to top management
on the performance of the
management system and any
need for improvement
8.2.4 All documentation, processes,
systems, records are included,
referenced, or linked to
documentation of the management
system.
8.2.5 All personnel involved in inspection
activities have access to the parts of
the management system
documentation and related
information applicable to their
responsibilities.
8.3 Control of documents ( Option A )
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LA/SF 07: Assessment Checklist for ISO/IEC 17020:2012
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Implementation
(to be completed by the CAB)
8.3.1 Establish procedures to control
documents
8.3.2 Procedures define the controls
needed to:
a. Approve documents for
adequacy prior to issue
b. Review and update and re-
approve documents
c. Ensure that changes and the
current revision status of
documents identified
d. Ensure relevant versions are
available at points of use
e. Ensure that documents remain
legible and readily identifiable
f. Ensure that documents of
external origin are identified and
distribution controlled
g. Prevent unintended use of
obsolete documents, apply
suitable identification if retained
for any purpose
8.4 Control of records ( Option A )
8.4.1 Establish procedures to define
controls needed for identification,
storage, protection, retrieval,
retention time and disposition of
records
8.4.2 Establish procedures for retaining
records for a period consistent with
its contractual and legal obligations
Access to records consistent with
the confidentiality arrangements
8.5 Management review ( Option A )
8.5.1 General
[Link] Top management establish
procedures to review its
management system at planned
intervals
[Link] Management review conducted at
least once a year. Complete review
broken into segments be completed
within a 12-month time frame.
[Link] Records of review maintained
8.5.2 Review Inputs
The input include the following:
a. Results of internal and external
audits
b. Feedback from clients and
interested parties
c. Status of preventive and
corrective actions
d. Follow-up actions from previous
management review
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LA/SF 07: Assessment Checklist for ISO/IEC 17020:2012
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e. Fulfilment of objectives
f. Changes that could affect the
management system
g. Appeals and complaints
8.5.3 Review outputs
Management review outputs include
decisions and actions related to:
a. Improvement of the
effectiveness of the
management system and its
processes
b. Improvement of the inspection
body
c. Resource needs
8.6 Internal audits ( Option A )
8.6.1 Establish procedures for internal
audits
8.6.2 Planned audit programme taking
into consideration the importance of
processes and areas audited, as
well as results of previous audits
8.6.3 Conduct periodic internal audits
covering all procedures
8.6.4 Internal audits performed at least
once every 12 months
8.6.5 Ensure that:
a. Internal audits are conducted by
qualified personnel
b. Auditors do not audit their own
work
c. Personnel responsible for the
area audited are informed of the
outcome of the audit
d. Any actions resulting from
internal audits are taken in a
timely and appropriate manner
e. Any opportunities for
improvement identified
f. The results of the audit are
documented
8.7 Corrective actions ( Option A )
8.7.1 Establish procedures for
identification and management of
nonconformities
8.7.2 Take actions to eliminate the
causes of nonconformities in order
to prevent recurrence
8.7.3 Corrective actions appropriate to the
impact of the problems encountered
8.7.4 Procedures define requirements for
the following:
a. Identifying nonconformities
b. Determining the causes of
nonconformity
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c. Correcting nonconformities
d. Evaluating the need for actions
to ensure that nonconformities
do not recur
e. Determining the actions needed
and implementing them in a
timely manner
f. Recording the results of actions
taken
g. Reviewing the effectiveness of
corrective actions
8.8 Preventive actions ( Option A )
8.8.1 Establish procedures for taking
preventive actions
8.8.2 Preventive actions appropriate to
the probable impact of the potential
problems
8.8.3 Procedures for preventive actions
define the requirements for the
following:
a. Identifying potential
nonconformities and their
causes
b. Evaluating the need for action
to prevent the occurrence of
nonconformities
c. Determining and implementing
the action needed
d. Recording the results of actions
taken
e. Reviewing the effectiveness of
the preventive actions taken
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Reference to CAB’s
PAB Supplementary Documents and/or
Information on the PAB Remarks
Requirements
Implementation
(To be completed by the CAB)
LA/SR 01 (Supplementary
Requirements for Participation
to Proficiency Testing)
LA/SR 02 (Supplementary
Requirements on Traceability
of Measurement)
LA/SR 03 (Supplementary
Requirements on the Use of
PAB Laboratory and Inspection
Body Accreditation Symbol)
ILAC-P15:05/2020 Application
of ISO/IEC 17020:2012 for the
Accreditation of Inspection
Bodies
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