GAP Analysis Checklist

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NO REQUIREMENT
Clause No.) Y N NOTES
4 GENERAL REQUIREMENTS
4.1 IMPARTIALITY AND INDEPENDENCE
Does the Inspection Body have procedure to ensure the
4.1.1 Yes -
impartiality of the undertaken inspection activities?
Does the IB have procedure to ensure that its inspection activities
4.1.2 are free from any commercial, financial and any other pressures Yes -
that might affect their inspection judgment?
Does the Inspection Body have documentation identifying risks to
4.1.3 Yes -
its impartiality?
Is the Inspection Body able to demonstrate how to eliminate or
4.1.4 Yes
minimize the identified risk of impartiality?
Inspection Body shall provide evidence of top management
4.1.5 Yes -
commitment to impartiality?
Is the IB independent to the extent that is required with regards
to the conditions under which it performs its operations?
4.1.6 Yes -
Does the type of IB meet the minimum requirements stipulated in
Annex A, as outlined below :
4.1.6 An Inspection Body providing third party inspections shall meet
Yes -
(a) the type A requirements of Clause A.1
An Inspection Body providing first party inspections, second party
inspections, or both, which forms a separate and identifiable part of an
organization involved in the design, manufacture, supply, installation, use
4.1.6 (b) -- --
or maintenance of the items it inspects and which supplies inspection
services only to its parent organization (in-house inspection body) shall
meet the type B requirements of Clause A.2
An Inspection Body providing first party inspections, second party
inspections, or both, which forms an identifiable but not necessarily a
separate part of an organization involved in the design, manufacture,
4.1.6 (c) -- --
supply, installation, use or maintenance of the items it inspects and which
supplies inspection services to its parent organization or to other parties,
or to both, shall meet the type C requirements of Clause A.3
4.2 Confidentiality
Does the Inspection Body provide legal responsible commitment
for the management of all information obtained or created during
4.2.1 the performance of inspection activities? Yes
Is the Inspection Body’s client informed in advance, of the
information it intends to place in the public domain?
When the inspection body is required by law or authorized by
contractual commitments to release confidential information,
4.2.2 Yes
does the Inspection Body (unless prohibited by law) notify the
client or individual concerned of the information provided?
Does the Inspection Body ensure that the information about the
4.2.3 client obtained from sources other than the client (e.g. Yes
complainant, regulators) is treated as confidential?
5 STRUCTURAL REQUIREMENTS

5.1 ADMINISTRATIVE REQUIREMENTS

Is the inspection Body legally identifiable, whether part of an
organization or not? ( A governmental inspection body is deemed
5.1.1 Yes
to be a legal entity on the basis of its governmental status)

Is the Inspection Body that is part of a legal entity involved in

5.1.2 Yes
activities other than inspection identifiable within that entity?
Does the inspection body have documentation which describes
5.1.3 the function and the technical scope of the activity for which it is Yes
competent?
Does the IB have adequate liability insurance? (The liability can be
5.1.4 assumed by the State in accordance with national laws, or by the Yes
organization of which the inspection body forms a part)

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Does the IB have documentation describing the conditions on
5.1.5 which it does business? (Not required when it is providing Yes
inspection services of which it is part to the legal entity
5.2 ORGANIZATION AND MANAGEMENT
Is the Inspection Body structured and managed so as to safeguard
5.2.1 Yes
impartiality?
Does the IB have an organization that enables it to maintain the
5.2.2 Yes
capability to perform its inspection activities satisfactory?
Does the IB define and document the responsibilities and
5.2.3 Yes
reporting structure of the organization?
Does the Inspection Body define the relationship between
inspection activities and other activities of parent organization?
5.2.4 Yes
(Required if Inspection Body forms a part of a legal entity
performing other activities)
Does the IB have one or more person(s) as technical manager,
however named, who is technically qualified and experienced in
operation of the Inspection Body and who has overall
5.2.5 responsibility that the inspection activities are carried out in Yes
accordance with ISO 17020? (Where the Inspection Body has
more than one technical manager, the specific responsibilities of
each manager shall be defined and documented)
Does the IB have named one or more person(s) who will deputize
5.2.6 in the absence of any Technical manager, however named, Yes
responsible for ongoing inspection activities?
Does the Inspection Body have a job description or other
5.2.7 documentation for each position category within its organization Yes
involved in inspection activities?
6 RESOURCE REQUIREMENTS

6.1 PERSONNEL
Does the personnel of the IB involved in the inspection activities
have defined and documented competence requirements
6.1.1 Yes
including requirements for education, trainings, technical
knowledge, skills and experience?
Does the Inspection Body have a sufficient number of
employed/contracted personnel with the required competencies,
6.1.2 including, where needed, the ability to make professional Yes
judgments, to perform the type, range and volume of its
inspection activities?
Does the Inspection Body personnel have appropriate
competence requirements and relevant knowledge of the
following:
 the technology used for the manufacture of the
products inspected, the operation of processes and the
delivery of services;
 the way in which products are used, processes are
6.1.3 Yes
operated and services are delivered;
 any defects which may occur during the use of the
product, any failures in the operation of the process and
any deficiencies in the delivery of services
 Understand the significance of deviations found with
regard to the normal use of the products, the operation
of the processes and the delivery of services.
Is the duties, responsibilities and authorities of each Inspection
6.1.4 Yes
Bodies person clear?
Has the Inspection Body established documented procedures for
6.1.5 selecting, training, formally authorizing, and monitoring Yes
inspectors and other personnel involved in inspection activities?
6.1.6 Does the Inspection Body addressed the following stages in their Yes
training procedures:
 an induction period;
 a mentored working period with experienced
inspectors;

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 continuing training to keep pace with developing
technology and inspection methods
Do the training requirements depend upon the ability,
qualifications and experience of each inspector and other
6.1.7 Yes
personnel involved in inspection activities, and upon the results of
monitoring?
Does the IB provide effective supervision to its inspectors and
other personnel involved in inspection activities by persons
6.1.8 familiar with the inspection methods and procedures, Yes
Does the Inspection Body use the results of monitoring as a
means of identifying training needs?
Does the Inspection Body ensure that each inspector observed
6.1.9 on-site? (not required if there is sufficient supporting evidence Yes
that the inspector is continuing to perform competently)
Are records of monitoring, education, training, technical
6.1.10 knowledge, skills, experience and authorization of each member Yes
of its personnel involved in inspection activities maintained?
Does the Inspection Body ensure that the remuneration of
6.1.11 persons engaged in inspection activities not influencing the result Yes
of inspections?
Does the Inspection Body ensure the impartiality of all personnel
6.1.12 of the inspection body, either internal or external, that could Yes
influence the inspection activities?
Does the Inspection Body ensures that all personnel of the
inspection body, including sub-contractors, personnel of external
6.1.13 Yes
bodies, and individuals acting on the inspection body's behalf,
protect confidentiality, except as required by law
6.2 FACILITIES AND EQUIPMENT
Does the IB have available to it and suitable and adequate
facilities and equipment to permit all activities associated with
the inspection activities to be carried out in a competent and safe
6.2.1 manner? Yes
(the responsibility for the suitability and the calibration status of
the equipment used in inspection, whether owned by the
inspection body or not, lies solely with the inspection body)
Does the IB have clear rules for the access to and use of specified
6.2.2 Yes
facilities and equipment?
Does the IB ensure the continued suitability of the facilities and
6.2.3 Yes
the equipment mentioned in 6.2.1 for their intended use?
Are all equipment having significant influence on the results of
6.2.4 the inspection properly defined and, where appropriate, uniquely Yes
identified?
Are the equipment properly maintained in accordance with
6.2.5 Yes
documented procedures and instructions?
Does the Inspection Body ensure that where appropriate,
6.2.6 equipment is calibrated before being out into service and Yes
thereafter according to establish program?
Is the overall program for calibration of equipment designed and
operated so as to ensure that whatever applicable measurements
made by the Inspection Body are traceable to national or
6.2.7 international standards of measurement where available? (Where Yes
traceability to national or international standards of
measurement is not applicable, IB shall provide satisfactory
evidence of correlation or accuracy of results)
Are the reference standards of measurement held by Inspection
Body used for calibration only and for no other purpose?
6.2.8 Are the reference standards of measure calibrated providing Yes
traceability to a national or international standard of
measurement?
Where relevant, are equipment subjected to in-service checks
6.2.9 Yes
between regular re-calibrations?
Are reference materials, where possible, traceable to national or
6.2.10 Yes
international reference materials?

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Where relevant to the outcome of inspection activities, does the
IB have procedures for:
6.2.11  Selection and approval of suppliers Yes
 Verification of incoming goods and services
 Ensuring appropriate storage facilities
Where applicable, is the condition of stored items assessed at
6.2.12 Yes
appropriate intervals to detect deterioration?
Do the IB use computers or automated equipment in connection
with inspections? Does it ensure that?
 Computer software is tested in order to confirm that it
is adequate for use?
6.2.13 Yes
 Procedures are established and implemented for
protecting the integrity and security of data?
 Computer and automated equipment is maintained in
order to ensure proper function?
Does the Inspection Body have documented procedures for
dealing with defective equipment? (Defective equipment shall be
removed from service by segregation, prominent labeling or
6.2.14 Yes
marking. The Inspection Body shall examine the effect of defects
on previous inspections and, when necessary, take appropriate
corrective action )
Is relevant information on the equipment, including software,
6.2.15 recorded? (This will normally include identification and, where Yes
appropriate, information on calibration and maintenance)
6.3 SUBCONTRACTING
Does the Inspection Body itself normally perform the inspection
which it contracts to undertake?
When the Inspection Body subcontracts any part of inspection,
does it ensure and is it able to demonstrate that its 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
6.3.1 assessment standards? Yes
( The terms “subcontracting” and “outsourcing” are considered to
be synonyms)
( Where the Inspection Body engages individuals or employees of
other organizations to provide additional resources or expertise,
these individuals are not considered to be subcontractors
provided they are formally contracted to operate under the
inspection body's management system (see 6.1.2) )
Does the Inspection Body advise the client of its intention to
6.3.2 subcontract any part of the inspection? Yes

Whenever subcontractors carry out work that forms part of an

inspection, does the responsibility for any determination of
6.3.3 Yes
conformity of the inspected item with the requirements rest
within the inspection body itself?
Does the Inspection Body record and retain details of its
investigation of the competence and compliance of
subcontractors and of their conformity with the applicable
6.3.4 requirements of this International Standard or in other relevant Yes
conformity assessment standards?
Does the Inspection Body maintain a register of all
subcontracting?
7 PROCESS REQUIREMENTS

7.1 INSPECTION METHODS AND PROCEDURES

7.1.1 Does the Inspection Body use the methods and procedures for Yes
inspection, which are defined in the requirements, against which
inspection is to be performed?
(Where these are not defined, the Inspection Body shall develop specific
methods and procedures to be used (see 7.1.3). The Inspection Body shall
inform the client if the inspection method proposed by the client is
considered to be inappropriate)

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(The requirements against which the inspection is performed are normally
specified in regulations, standards or specifications, inspection schemes or
contracts. Specifications can include client or in-house requirements)

Does the Inspection Body have and use adequate documented

instructions on inspection planning and on sampling and
inspection techniques where the absence of such instructions
could jeopardize the effectiveness of the inspection process?
(where the absence of such instructions could jeopardize the
7.1.2 Yes
effectiveness of the inspection process. Where applicable, the
inspection body shall have sufficient knowledge of statistical
techniques to ensure statistically sound sampling procedures and
the correct processing and interpretation of results)

When the Inspection Body has to use inspection methods or

procedures which are non-standard, is such methods and
procedures appropriate and fully documented? (A standard
inspection method is one that has been published, for example, in
international, regional or national standards, or by reputable
7.1.3 Yes
technical organizations or by co-operation of several inspection
bodies or in relevant scientific text or journals. This means that
methods developed by any other means, including by the
Inspection Body itself or by the client, are considered to be non-
standard methods)
Are all instructions, standards or written procedures, worksheets,
checklist and reference data relevant to the work of the
7.1.4 Yes
Inspection Body maintained up to date and be readily available to
the personnel?
Does the Inspection Body have a contract or work order control
system which ensure that:
 Work to be undertaken is within its expertise and that
the organization has adequate resources to meet the
requirements? (Resources can include, but are not
limited to, facilities, equipment, reference
documentation, procedures or human resources)
 The requirements of those seeking the Inspection Body
7.1.5 Yes
services are adequately defined and that special
conditions are understood, so that unambiguous
instructions can be issued to personnel performing the
duties to be required?
 Work undertaken is controlled by regular review and
corrective action?
 The requirements of the contract or work order have
been met?
When the inspection body uses information supplied by any other
7.1.6 party as part of the inspection process, Does the Inspection Body Yes
verify the integrity of such information?
Are observations or data obtained in the course of inspections
7.1.7 recorded in a timely manner to prevent loss of relevant
information?
Are all calculations and data transfers subjected to appropriate
7.1.8 Yes
checks?
Does the Inspection Body have documented instructions for
7.1.9 carrying out inspections safely? Yes

7.2 HANDLING INSPECTION ITEMS AND SAMPLES

Does the Inspection Body ensure that samples and items to be
7.2.1 inspected are uniquely identified to avoid confusion regarding the Yes
identity of such items and samples?
Does the I inspection Body establishes whether the item to be
7.2.2 Yes
inspected has received all the necessary preparation?
7.2.3 Are any apparent abnormalities notified to or notified by the Yes
inspector recorded? (Where there is any doubt as to the items
suitability for the inspection to be carried out, or when the item

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does not conform to the description provided, the inspection
body shall consult the client before proceeding)
Does the IB have documented procedures and appropriate
7.2.4 facilities to avoid deterioration or damage to inspection items Yes
while under its responsibility?
7.3 INSPECTION RECORDS
Does the IB maintain a record system (see 8.4) to demonstrate
7.3.1 the effective fulfillment of the inspection procedures and to Yes
enable an evaluation of the inspection?
Are the inspection reports or certificate internally traceable to the
7.3.2 inspector(s) who performed the inspection? Yes

7.4 RECORDS
Is the work carried out by the Inspection Body covered by a
7.4.1 Yes
retrievable inspection report/certificate?
Does the Inspection Body 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 of approval, by authorized
7.4.2 personnel; Yes
f) a statement of conformity where applicable;
g) the inspection results, except where detailed in
accordance with 7.4.3 .
(Optional elements that can be included in inspection reports or
certificates are listed in Annex B )
Does the inspection body issue an inspection certificate that does
not include the inspection results [see 7.4.2 g)]? In such cases
7.4.3 does the inspection body produce an inspection report containing Yes
the inspection results, and both the inspection certificate and
inspection report are traceable to each other?
Does the Inspection Body report all the information listed in 7.4.2
correctly, accurately, and clearly? Does the Inspection Body
7.4.4 Yes
clearly identify results supplied by subcontractors in the
inspection report or inspection certificate?
Are the corrections or additions to an inspection report or
inspection certificate after issue recorded and justified in
7.4.5 accordance with the relevant requirements of this sub clause Yes
(7.4)? ( An amended report or certificate shall identify the report
or certificate replaced)
7.5 COMPLAINTS AND APPEALS
Does the inspection body have a documented process to receive,
7.5.1 evaluate and make decisions on complaints and appeals? Yes

Is a description of the handling process for complaints and

7.5.2 Yes
appeals available to any interested party upon request?
Upon receipt of a complaint, the inspection body shall confirm
7.5.3 whether the complaint relates to inspection activities for which it Yes
is responsible and, if so, shall deal with it
Does the inspection body responsible for all decisions at all levels
7.5.4 Yes
of the handling process for complaints and appeals?
Investigation and decision on appeals shall not result in any
7.5.5 Yes
discriminatory actions
7.6 COMPLAINTS AND APPEALS PROCESS
7.6.1 Are the handling process for complaints and appeals include at Yes
least the following elements and methods:

a) a description of the process for receiving, validating,

investigating the complaint or appeal, and deciding
what actions are to be taken in response to it;

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b) tracking and recording complaints and appeals,
including actions undertaken to resolve them;
c) Ensuring that any appropriate action is taken.
d)
Is the inspection body receiving the complaint or appeal
responsible for gathering and verifying all necessary information
7.6.2 Yes
to validate the complaint or appeal?

Whenever possible, does the inspection body acknowledge

receipt of the complaint or appeal, and does provide the
7.6.3 Yes
complainant or appellant with progress reports and the outcome?

Is the decision to be communicated to the complainant or

appellant made by, or reviewed and approved by, individual(s)
7.6.4 Yes
not involved in the original inspection activities in question?

Whenever possible, does the inspection body give formal notice

of the end of the complaint and appeals handling process to the
7.6.5 Yes
complainant or appellant?

8 MANAGEMENT SYSTEM REQUIREMENTS

8.1 OPTIONS
General

Does the inspection body establish and maintain a management

8.1.1 system that is capable of achieving the consistent fulfillment of Yes
the requirements of this International Standard in accordance
with either Option A or Option B?

OPTION (A)

Does the management system of the inspection body address the

following:
 management system documentation (e.g. manual,
policies, definition of responsibilities, see 8.2);
8.1.2  control of documents (see 8.3); Yes
 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 (see 7.5 and 7.6).
OPTION (B)
Does the inspection body that has established and maintains a management system,
in accordance with the requirements of ISO 9001, and that is capable of supporting
8.1.3 and demonstrating the consistent fulfillment of the requirements of this
International Standard, fulfils the management system clause requirements (see 8.2
to 8.8)?
8.2 MANAGEMENT SYSTEM DOCUMENTATION (OPTION A)
Does the inspection body's top management establish, document,
and maintain policies and objectives for fulfillment of this
8.2.1 International Standard and does it ensure the policies and Yes
objectives are acknowledged and implemented at all levels of the
inspection body's organization?
Does the top management provide evidence of its commitment to
the development and implementation of the management system
8.2.2 Yes
and its effectiveness in achieving consistent fulfillment of this
International Standard?
8.2.3 Does the inspection body's top management appoint a member Yes
of management who, irrespective of other responsibilities, have
responsibility and authority that include the following:
 ensuring that processes and procedures needed for the
management system are established, implemented and
maintained; and
 reporting to top management on the performance of
the management system and any need for

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improvement.
All documentation, processes, systems, records, etc. related to
the fulfillment of the requirements of this International Standard
8.2.4 Yes
shall be included, referenced, or linked to documentation of the
management system.
Does all personnel involved in inspection activities have access to
8.2.5 the parts of the management system documentation and related Yes
information that are applicable to their responsibilities
8.3 CONTROL OF DOCUMENTS (OPTION A)
Does the inspection body establish procedures to control the
documents (internal and external) that relate to the fulfillment of
8.3.1 Yes
this International Standard?

The procedures shall define the controls needed to:

 approve documents for adequacy prior to issue;
 review and update (as necessary) and re-approve documents;
 ensure that changes and the current revision status of
documents are identified;
 ensure that relevant versions of applicable documents are
8.3.2 available at points of use; Yes
 ensure that documents remain legible and readily identifiable;
 ensure that documents of external origin are identified and
their distribution controlled;
 prevent the unintended use of obsolete documents, and apply
suitable identification to them if they are retained for any
purpose.
8.4 CONTROL OF RECORDS (OPTION A)
Does the inspection body establish procedures to define the
controls needed for the identification, storage, protection,
8.4.1 Yes
retrieval, retention time and disposition of its records related to
the fulfillment of this International Standard?
Does the inspection body establish procedures for retaining
8.4.2 records for a period consistent with its contractual and legal
obligations?. Access to these records shall be consistent with the
confidentiality arrangements.
8.5 MANAGEMENT REVIEW (OPTION A)
8.5.1 General
Does the inspection body's top management establish procedures
to review its management system at planned intervals, in order to
8.5.1.1 ensure its continuing suitability, adequacy and effectiveness, Yes
including the stated policies and objectives related to the
fulfillment of this International Standard?
These reviews shall be conducted at least once a year.
8.5.1.2 Alternatively, a complete review broken up into segments (a Yes
rolling review) shall be completed within a 12-month time frame.
8.5.1.3 Are the records of reviews maintained? Yes
Review Inputs

The input to the management review shall include information

related to the following:
a) results of internal and external audits;
b) feedback from clients and interested parties related to the
8.5.2 Yes
fulfillment of this International Standard;
c) the status of preventive and corrective actions;
d) follow-up actions from previous management reviews;
e) the fulfillment of objectives;
f) changes that could affect the management system;
g) appeals and complaints.
Review outputs
The outputs from the management review shall include decisions
and actions related to:
a) improvement of the effectiveness of the management system
8.5.3 Yes
and its processes;
b) improvement of the inspection body related to the fulfillment
of this International Standard;
c) resource needs.

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8.6 INTERNAL AUDITS (OPTION A)
Does the inspection body establish procedures for internal audits
to verify that it fulfils the requirements of this International
8.6.1 Yes
Standard and that the management system is effectively
implemented and maintained?
Does the inspection body carry out planned audit program taking
8.6.2 into consideration the importance of the processes and areas to Yes
be audited, as well as the results of previous audits?
Does the inspection body conduct periodic internal audits
covering all procedures in a planned and systematic manner, in
8.6.3 Yes
order to verify that the management system is implemented and
is effective?
Internal audits shall be performed at least once every 12 months.
The frequency of internal audits may be adjusted depending on
8.6.4 Yes
the demonstrable effectiveness of the management system and
its proven stability.
Does the inspection body ensure that:
a) internal audits are conducted by qualified personnel
knowledgeable in inspection, auditing and the requirements of
this International Standard;
b) auditors do not audit their own work;
c) personnel responsible for the area audited are informed of the
8.6.5 outcome of the audit; Yes
d) any actions resulting from internal audits are taken in a timely
and appropriate manner;
e) any opportunities for improvement are identified;
f) the results of the audit are documented.

8.7 CORRECTIVE ACTIONS (OPTION A)

Doe the inspection body establish procedures for identification
8.7.1 Yes
and management of nonconformities in its operations?
Does the inspection body, where necessary, take actions to
8.7.2 eliminate the causes of nonconformities in order to prevent Yes
recurrence?
Are the Corrective actions taken appropriate to the impact of the
8.7.3 Yes
problems encountered?
The 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
8.7.4 Yes
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)
Does the inspection body establish procedures for taking
8.8.1 preventive actions to eliminate the causes of potential Yes
nonconformities?
Are preventive actions taken appropriate to the probable impact
8.8.2 Yes
of the potential problems?
The procedures for preventive actions define requirements for
the following:
 identifying potential nonconformities and their causes;
 evaluating the need for action to prevent the
8.8.3 occurrence of nonconformities; Yes
 determining and implementing the action needed;
 recording the results of actions taken;
 Reviewing the effectiveness of the preventive actions
taken.

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