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LASF09 Checklist for ISO IEC 17020
PAB assessment checklist for ISO IEC 1720
Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: Philippine Accreditation Bureau
Inspection body Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17020:2012
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INTRODUCTION
1.
Purpose
This checklist is prepared for the following purposes:
1.1 To assist both the inspection body 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 PNS 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.
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 inspection bodies are required to comply with the accreditation requirements
and the basic technical and management system requirements for inspection bodies based on
PNS ISO/IEC 17020:2012.
2.3 PAB needs to obtain and maintain information on the specific technical resources available in
the inspection body and to be aware of the desired scope of the accreditation by PAB and for
approved signatories (the specific people authorized to sign PAB endorsed test reports).
3.
Preparation of Inspection Body Quality Manuals
3.1 Each accredited inspection body 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 inspection body’s policies and
operational procedures established to meet requirements for accreditation.
3.3 The manner in which a inspection body’s documented quality system is structured is the choice
of the inspection body. The purpose of the documentation is primarily to advice the inspection
body’s staff of the policies and procedures expected by its management to be implemented by
all staff.
3.4 Typically, a inspection body’s quality management system is documented in a Inspection body
Quality Manual and supporting procedures and records. In some cases, an Inspection body
Quality Manual includes supporting procedures. In other cases, some of the subjects of an
Inspection body Quality Manual may be incorporated in an organization’s more general Quality
Manual or procedures.
Philippine Accreditation Bureau
Inspection body Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17020:2012
No.
4
4.1
4.1.1
4.1.2
4.1.3
4.1.4
4.1.5
4.1.6
a)
b)
c)
4.2
4.2.1
4.2.1
4.2.1
4.2.2
4.2.3
Requirements of
Accreditation/Description
General requirements
Impartiality and independence
Inspection activities shall be taken
impartially.
The inspection body shall be
responsible for the impartiality of its
inspection activities.
The inspection body shall identify
risk to its impartiality on an ongoing
basis.
The inspection body shall be able to
demonstrate how it eliminates or
minimizes risk.
The inspection body shall have top
management commitment to
impartiality.
Independent to the extent that is
contractually required
Type A Inspection Body
Fully independent of all consulting,
manufacturing involvement
Type B Inspection Body
A separate and identifiable part of
an organization, established to
supply inspection services to its
parent organization only
Type C Inspection Body
A separate and identifiable part of
an organization, may supply
inspection services to other parties
not being its parent organization
Confidentiality
Confidentiality and propriety rights
Shall be legally responsible for the
management of all information
obtained or created during the
performance of inspection activities.
IB shall inform the client of the
information it intends to place in the
public domain.
All information (except information
that the client make publicly or
agreed between the IB and the
client) are regarded as confidential.
The client of individual concern shall
be notified if the IB is required by
law or authorized by contractual
commitment to release confidential
information .
Information obtained from sources
other than the shall be treated
confidential.
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PAB Remarks
Philippine Accreditation Bureau
Inspection body Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17020:2012
No.
5.1
5.1.1
5.1.2
5.1.3
5.1.4
5.1.5
5.2
5.2.1
5.2.2
5.2.3
5.2.4
5.2.5
Requirements of
Accreditation/Description
Administrative requirements
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.
An inspection body that is part, of a
legal entity involved in activities
other than inspection shall be
identifiable within that entity.
The inspection body shall have
documentation which describes the
activities for which it is competent.
The inspection body shall have
adequate provision (eg insurance or
reserves) to cover liabilities arising
from its operations
Insurance
Insurer
Prof. Indemnity
Public liability
Other
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
Organization and management
The inspection body shall be
structured and managed so as to
safeguard impartiality.
The inspection body shall be
organized and managed so as to
enable it to maintain the capability to
perform its inspection activities.
The inspection body shall define and
document the responsibilities and
reporting structure of the
organization.
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.
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
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Philippine Accreditation Bureau
Inspection body Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17020:2012
No.
5.2.6
5.2.7
6
6.1
6.1.1
6.1.2
6.1.3
6.1.4
6.1.5
Requirements of
Accreditation/Description
out in accordance with this
international Standard.
Where the inspection body has more
than one technical manager, the
specific responsibilities of each
manager shall be defined and
documented.
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.
The inspection body shall have a job
description or other documentation
for each position category within its
organization involved in inspection
activities.
Resource requirements
Personnel
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,
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,
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.
The inspection body shall make
clear to each person their duties,
responsibilities and authorities.
The inspection body shall have
documented procedures for
selecting, training, formally
authorizing, and monitoring
inspectors and other personnel
involved in inspection activities.
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Philippine Accreditation Bureau
Inspection body Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17020:2012
No.
6.1.6
6.1.7
6.1.8
6.1.9
6.1.10
6.1.11
6.1.12
6.1.13
Requirements of
Accreditation/Description
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.
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).
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).
Each inspector shall be observed
on-site, unless there is sufficient
supporting evidence that the
inspector is continuing to perform
competently.
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,
The personnel involved in inspection
activities shall not be remunerated in
a way that influences the results of
inspections.
All personnel of the inspection body,
either internal or external, that could
influence the inspection activities
shall act impartially.
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.
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Inspection body Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17020:2012
No.
6.2
6.2.1
6.2.2
6.2.3
6.2.4
6.2.5
6.2.6
6.2.7
6.2.8
6.2.9
6.2.10
6.2.11
Requirements of
Accreditation/Description
Facilities and equipment
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.
The inspection body shall have rules
for the access to, and the use of,
specified facilities and equipment
used to perform inspections.
The inspection body shall ensure the
continued mentioned in 6.2.1 for
their intended use.
All equipment having a significant
influence on the results of the
inspection shall be defined and,
where appropriate, uniquely
identified
All equipment (see 6.2.4) shall be
maintained in accordance with
documented procedures and
instructions.
Equipment which have significant
influence on the results calibrated
before being put into service and
calibrated according to an
established program
Calibration program designed and
operated so that applicable
measurements are traceable to
national and international standards
of measurement
Reference standards used for
calibration only, Reference
standards calibrated providing
traceability to a national or
international standards of
measurement
Equipment subjected to in-service
checks between regular
recalibrations
Reference materials traceable to
national or international standard
reference materials
Where relevant, procedures for:
Selection and approval of
suppliers
Verification of incoming goods
Ensuring storage facilities
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Inspection body Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17020:2012
No.
6.2.12
6.2.13
6.2.14
6.2.15
6.3
6.3.1
6.3.2
6.3.3
6.3.4
7
7.1
7.1.1
Requirements of
Accreditation/Description
Stored items assessed at
appropriate intervals to detect
deterioration
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
Procedures for dealing with
defective equipment including
examining the effect of defects on
previous inspections
Equipment identification, calibration
and maintenance records
Subcontracting
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.
Inform client of the intention to
subcontract part of the inspection
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.
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
Process requirements
Inspection methods and procedures
Use methods and procedures which
are defined in the requirements
against which inspection is to be
performed
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Inspection body Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17020:2012
No.
7.1.2
7.1.3
7.1.4
7.1.5
7.1.6
7.1.7
7.1.8
7.1.9
7.2
7.2.1
7.2.2
7.2.3
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Requirements of
System reference
Accreditation/Description
When methods and procedures are
not defined, develop specific
methods and procedures to be used
Inform client if method proposed by
client is inappropriate
Use adequate documented
instructions on inspection planning
and on sampling and inspection
techniques
Where applicable, have sufficient
knowledge of statistical techniques
Non-standard methods or
procedures used appropriate and
fully documented
Instructions, standards or written
procedures, worksheets, checklists
and reference data maintained up to
date and readily available
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
Verify integrity of information
supplied by any other party as part
of the inspection
Observations or data obtained
recorded in a timely manner
Calculations and data transfers
subjected to appropriate checks
Documented instructions for carrying
out inspection in a safe manner
Handling inspection items and samples
Ensure items and samples to be
inspected are uniquely identified
Establish item to be inspected has
been prepared
Apparent abnormalities recorded
Contact the client about doubts as to
the item’s suitability or where item
does not conform to the description
provided
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Inspection body Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17020:2012
No.
7.2.4
7.3
7.3.1
7.3.2
7.4
7.4.1
7.4.2
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Requirements of
System reference
Accreditation/Description
Have documented procedures and
appropriate facilities to avoid
deterioration or damage to
inspection items.
Inspection records
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
photographs
e. The identify 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
Inspection report or certificate
traceable to the inspector(s) who
performed the inspection
Inspection report and inspection certificates
Retrievable inspection report or
inspection certificate
Inspection report/certificate include
the following:
a. Identification of the issuing body
b. Unique identification and date of
issue
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Inspection body Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17020:2012
No.
Requirements of
Accreditation/Description
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:
Designation of the document(i.e.
as inspection report or
inspection certificate)
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
a.
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Inspection body Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17020:2012
No.
7.4.3
7.4.4
7.4.5
7.5
7.5.1
7.5.2
7.5.3
7.5.4
7.5.5
7.6
7.6.1
7.6.2
7.6.3
Requirements of
Accreditation/Description
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
All information reported correctly,
accurately, and clearly
Results supplied by subcontractors
clearly identified in the inspection
report or inspection certificate.
Record corrections or additions to
an inspection report or inspection
certificate
Identify the report or certificate
replaced in amended report or
certificate
Complaints and appeals
Documented process to receive,
evaluate and make decisions on
complaints and appeals
Description of the handling process
for complaints and appeals available
to interested
Confirm whether the complaint
relates to inspection activities and
deal with it
Be responsible for all decisions at all
levels of the handling process for
complaints and appeals
Investigation and decision on
appeals does not result in any
discriminatory actions
Complaints and appeals process
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
Responsible for gathering and
verifying information to validate
complaint or appeal
Acknowledge receipt of complaint or
appeal and provide the complainant
or appellant progress reports and
outcome
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Inspection body Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17020:2012
No.
7.6.4
7.6.5
8
8.1.1
8.1.2
8.1.3
8.2.1
8.2.2
Requirements of
Accreditation/Description
Decisions communicated to the
complainant or appellant are
reviewed and approved by
individuals not involved in the
original inspection activities in
question
Give formal notice of the end of the
complaint and appeals handling
process to the complainant or
appellant
Management system requirements
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
Option A
The management system shall
address the following:
Management system
documentation ( e.g. manual,
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)
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 )
Top management establish,
document, and maintain policies and
objectives
Ensure policies and objectives are
acknowledged and implemented at
all levels
Top management provide evidence
of commitment to the development
and implementation of the
management system and its
effectiveness
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Inspection body Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17020:2012
No.
8.2.3
8.2.4
8.2.5
8.3
8.3.1
8.3.2
8.4
8.4.1
Requirements of
Accreditation/Description
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
All documentation, processes,
systems, records are included,
referenced, or linked to
documentation of the management
system.
All personnel involved in inspection
activities have access to the parts of
the management system
documentation and related
information applicable to their
responsibilities.
Control of documents ( Option A )
Establish procedures to control
documents
Procedures define the controls
needed to:
a. Approve documents for
adequacy prior to issue
b. Review and update and reapprove 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
Control of records ( Option A )
Establish procedures to define
controls needed for identification,
storage, protection, retrieval,
retention time and disposition of
records
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Inspection body Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17020:2012
No.
8.4.2
8.5
8.5.1
8.5.1.1
8.5.1.2
8.5.1.3
8.5.2
8.5.3
8.6
8.6.1
8.6.2
8.6.3
8.6.4
8.6.5
Requirements of
Accreditation/Description
Establish procedures for retaining
records for a period consistent with
its contractual and legal obligations
Access to records consistent with
the confidentiality arrangements
Management review ( Option A )
General
Top management establish
procedures to review its
management system at planned
intervals
Management review conducted at
least once a year. Complete review
broken into segments be completed
within a 12-month time frame.
Records of review maintained
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
e. Fulfilment of objectives
f. Changes that could affect the
management system
g. Appeals and complaints
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
Internal audits ( Option A )
Establish procedures for internal
audits
Planned audit programme taking
into consideration the importance of
processes and areas audited, as
well as results of previous audits
Conduct periodic internal audits
covering all procedures
Internal audits performed at least
once every 12 months
Ensure that:
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ISO/IEC 17020:2012
No.
8.7
8.7.1
8.7.2
8.7.3
8.7.4
8.8
8.8.1
8.8.2
8.8.3
Requirements of
Accreditation/Description
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
Corrective actions ( Option A )
Establish procedures for
identification and management of
nonconformities
Take actions to eliminate the causes
of nonconformities in order to
prevent recurrence
Corrective actions appropriate to the
impact of the problems encountered
Procedures define requirements for
the following:
a. Identifying nonconformities
b. Determining the causes of
nonconformity
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
Preventive actions ( Option A )
Establish procedures for taking
preventive actions
Preventive actions appropriate to the
probable impact of the potential
problems
Procedures for preventive actions
define the requirements for the
following:
a. Identifying potential
nonconformities and their
causes
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Inspection body Accreditation Form
Assessment Checklist for PNS
ISO/IEC 17020:2012
No.
Requirements of
Accreditation/Description
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
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
System reference
LA/SF09
01
00
01 August 2018
16 of 16
PAB Remarks
