AS9120-2002 Audit Checklist, CRS-02-02R

AS9120-2002 AUDIT CHECKLIST
AUDIT NO.:
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Requirement Audit Point Reference
Assessor Notes
*S/U/OFI
4 Quality management system
4.1 General Requirements

The organization shall establish, document, 1) Has the organization established and
implement and maintain a quality management maintained an quality management system, the
system and continually improve its effectiveness in requirements of which are described in the
accordance with the requirements of this whole of clause 4?
International Standard. v
The organization shall
a) identify the process needed for the quality Note: The organization is requested to submit
management system and their application documentation to support compliance with the
throughout the organization, criteria identified in a) and b) with the quality
b) determine the sequence and interaction of policy manual to SAI for review. Examples of
these processes, acceptable documentation are:
c) determine criteria and methods needed to 1) Process map(s)
ensure that both the operation and control 2) Procedures
of these processes are effective, Flow Chart(s)
d) ensure the availability of resources and
information necessary to support the
operation and monitoring of these
processes,
e) monitor, measure and analyses these
processes, and
f) implement actions necessary to achieve
planned in accordance with the
requirements of this International
Standard.
Where an organization chooses to outsource any
process that affects product conformity with
requirements, the organization shall ensure
control over such processes. Control of such
outsourced process shall be identified within the
quality management system.
NOTE: Processes needed for the quality management
system referred to above should include processes for
management, provision, product realization and
measurement.
CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

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4.2 Documentation requirements
4.2.1 General
The quality management system documentation 1) Does the quality management system
shall include documentation include
a) documented statements of a quality policy a) documented statements of a quality policy
and quality objectives, and quality objectives,
b) a quality manual, b) a quality manual,
c) documented procedures required by this c) documented procedures required by this
International Standard, International Standard,
d) documents needed by the organization to d) documents needed by the organization to
ensure the effective planning, operation ensure the effective planning, operation
and control of its processes, and and control of its processes,
e) records required by the International e) records required by the International
Standard. Standard, and
f) quality system requirements imposed by f) quality system requirements imposed by
the applicable regulatory authorities. the applicable regulatory authorities?
The organization shall ensure that personnel have 2) Does the organization ensure that personnel have
access to quality management system access to quality management system
documentation and are aware of relevant documentation and are aware of relevant
procedures. Customer and/or regulatory authorities procedures, and that customer and/or regulatory
representatives shall have access to quality authorities representatives shall have access to
management system documentation. quality management system documentation?
NOTE 1 Where the term documented procedure

appears within this International Standard, this means
that the procedure established, documented,
implemented, and maintained.
NOTE 2 The extent of the quality management system

documentation can differ from one organization to
another due to
a) the size of organization and type of activities,
b) the complexity of process and their
interactions, and
c) the competence of personal.
NOTE 3 The documentation can be in any form or type

of medium.
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4.2.2 Quality manual
The organization shall establish and maintain a 1) Has the organization established and
quality manual that includes maintained a quality manual that includes
a) the scope of the quality management
system, including details of and a) the scope of the quality management
justification for any exclusions system, including details of and
b) the documented procedures established justification for any exclusions
for the quality management system, or b) the documented procedures established for
reference to them, and the quality management system, or
reference to them, and
when referencing the documented procedures, the
relationship between the requirements of this Is the relationship between the requirements of this
International Standard and the documented International Standard and the documented
procedures shall be clearly shown. procedures clearly shown?
c) a description of the interaction between c) a description of the interaction between the

the processes of the quality management processes of the quality management
system. system.

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4.2.3 Control of documents
Documents required by the quality management 1) Are documents required by the quality
system shall be controlled. Records are special management system controlled?
type of document and shall be controlled according
to the requirements.
A document procedure shall be established to 2) Has a documented procedure been established

define the controls needed to define the controls needed
a) to approve documents for adequacy prior a) to approve documents for adequacy prior to
to issue, issue,
b) to review and update as necessary and re- b) to review and update as necessary and re-
approve documents, approve documents,
c) to ensure that changes and the current c) to ensure that changes and the current
revision status of documents are revision status of documents are identified,
identified, d) to ensure that relevant versions of
d) to ensure that relevant versions of applicable documents are available at
applicable documents are available at points of use,
points of use, e) to ensure that documents remain legible
e) to ensure that documents remain legible and readily identifiable,
and readily identifiable, f) to ensure that documents of external origin
f) to ensure that documents of external are identified and their distribution
origin are identified and their distribution controlled, and
controlled, and g) to prevent the unintended use of obsolete
g) to prevent the unintended use of obsolete documents, and to apply suitable
documents, and to apply suitable identification to them if they are retained
identification to them if they are retained for any purpose.
for any purpose.
The organization shall maintain appropriate Has the organization maintained appropriate
documentation to verify the status of the product documentation to verify the status of the product
(e.g., manufacturers data, standards, (e.g., manufacturers data, standards, airworthiness
airworthiness data.) data)?
The organization shall coordinate document Does the organization coordinate document
changes with customers and/or regulatory changes with customers and/or regulatory
authorities in accordance with contract or authorities in accordance with contract or
regulatory requirements. regulatory requirements?

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4.2.4 Control of records
Records shall be established and maintained to 1) Are records established and maintained to
provide evidence of conformity to requirements provide evidence of conformity to requirements
and of the effective operation of the quality and of the effective operation of the quality
management system. Records shall remain legible, management system?
readily identifiable and retrievable. A documented
procedure shall be established to define the 2) Are records legible, readily identifiable and
controls needed for the identification, storage, retrievable?
protection, retrieval, retention time and disposition
or records. 3) Has a documented procedure been established
to define the controls needed for the
These records shall include where applicable: identification, storage, protection, retrieval,
retention time and disposition or records?
a) manufacturer, distributor, repair station,
test and inspection reports; Do these records include:
b) original certificates of conformity a) manufacturer, distributor, repair station,
(manufacturer, sub-tier distributor), test and inspection reports;
copies or airworthiness certificates; b) original certificates of conformity
c) non-conformance, concession and (manufacturer, sub-tier distributor), copies
corrective action records; or airworthiness certificates;
d) lot traceability records; c) non-conformance, concession and
e) environmental or shelf life condition corrective action records;
records d) lot traceability records;
e) environmental or shelf life condition
Where records are stored in an electronic form, the records
integrity of the system and the back-up procedures,
shall be appropriately validated. These records, Where records have been stored in an electronic
without possibility of change by software, shall be form, has the integrity of the system and the back-
traceable to the original documentation. up procedures been appropriately validated?
Records of product origin, conformity, and Have records of product origin, conformity, and
shipment shall be maintained for a minimum of shipment been maintained for a minimum of seven
seven years, or as required by contract. years, or as required by contract?
Records shall be available for review by customers Are records available for review by customers and
and regulatory authorities in accordance with regulatory authorities in accordance with contract
contract or regulatory requirements. or regulatory requirements?

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5 Management responsibility
1) Is there evidence of top managements
5.1 Management commitment commitment to the development and
Top management shall provide evidence of its implementation of the quality management
commitment to the development and system and continually improving its
implementation of the quality management system effectiveness by
and continually improving its effectiveness by
a) communicating to the organization the a) communicating to the organization the
importance of meeting customer as well importance of meeting customer as well as
as statutory and regulatory requirements, statutory and regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are b) establishing the quality policy,
established,
d) conducting management reviews, and
e) ensuring the availability of resources. c) ensuring that quality objectives are
established,
d) conducting management reviews, and
e) ensuring the availability of resources?
5.2 Customer focus

Top management shall ensure that customer 1) Has top management ensured that customer
requirements are determined and are met with the requirements are determined and are met with the
aim of enhancing customer satisfaction (see 7.2.1 aim of enhancing customer satisfaction?
and 8.2.1).

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5.3 Quality policy 1) Has top management ensured that the quality
Top management shall ensure that the quality policy
policy
a) is appropriate to the purpose of the a) is appropriate to the purpose of the
organization, organization,
b) includes a commitment to comply with
requirements and continually improve the b) includes a commitment to comply with
effectiveness of the quality management requirements and continually improve the
system, effectiveness of the quality management
c) provides a framework for establishing and system,
reviewing quality objectives,
d) is communicated and understood within c) provides a framework for establishing and
the organization, and reviewing quality objectives,
e) is reviewed for continuing suitability.
d) is communicated and understood within
the organization, and
e) is reviewed for continuing suitability?
5.4 Planning
5.4.1 Quality objectives 1) Has top management ensured that quality

Top management shall ensure that quality objectives, including those needed to meet
objectives, including those needed to meet requirements for product are established at
requirements for product are established at relevant functions and levels within the
relevant functions and levels within the organization?
organization. The quality objectives shall be
measurable and consistent with the quality policy. 2) Are the quality objectives measurable and
consistent with the quality policy?

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5.4.2 Quality management system planning
Top management shall ensure that 1) Has top management ensured that
a) the planning of the quality management
system is carried out in order to meet the a) the planning of the quality management
requirements as well as the quality system is carried out in order to meet the
objectives, and requirements as well as the quality
b) the integrity of the quality management objectives, and
system is maintained when changes to the
quality management system are planned b) the integrity of the quality management
and implemented. system is maintained when changes to the
quality management system are planned
and implemented?
5.5 Responsibility, authority, and

communication
5.5.1 Responsibility and authority 1) Has top management ensured that

Top management shall ensure that responsibilities responsibilities and authorities are defined and
and authorities are defined and communicated communicated within the organization?
within the organization.

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5.5.2 Management representative
Top management shall appoint a member of 1) Has top management appointed a member of
management who, irrespective of other management who, irrespective of other
responsibilities, shall have responsibility and responsibilities, shall have responsibility and
authority that include authority that include
a) ensuring that processes needed for the
quality management system are a) ensuring that processes needed for the
established, implemented and maintained, quality management system are
b) reporting to management on the established, implemented and maintained,
performances of the quality management
system and any need for improvement, b) reporting to management on the
c) ensuring the promotion of awareness of performances of the quality management
customer requirements throughout the system and any need for improvement,
organization, and
d) the organizational freedom to resolve c) ensuring the promotion of awareness of
matters pertaining to quality and customer requirements throughout the
maintain product conformity. organization, and
NOTE: The responsibility of management representative d) the organizational freedom to resolve

can include liaison with external parties on matters matters pertaining to quality and maintain
relating to the quality management system. product conformity?
5.5.3 Internal communication 1) Has top management ensured that appropriate

Top management shall ensure that appropriate communication processes are established within the
communication processes are established within organization and that communication takes place
the organization and that communication takes regarding the effectiveness of the quality
place regarding the effectiveness of the quality management system?
management system.

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5.6 Management review
5.6.1 General
Top management shall review the organizations 1) Has top management reviewed the
quality management system, at planned intervals, organizations quality management system, at
to ensure its continuing stability, adequacy and planned intervals, to ensure its continuing
effectiveness. This review shall include assessing stability, adequacy and effectiveness?
opportunities for improvement and the need for
changes to the quality management system, 2) Does this review include assessing
including the quality policy and quality objectives. opportunities for improvement and the need for
changes to the quality management system,
Records from management reviews shall be including the quality policy and quality
maintained. objectives?
5.6.2 Review input 3) Are records from management reviews

The input to management review shall include maintained?
information on
a) results of audits 4) Does the input to management review include
b) customer feedback information on
c) process performance and product a) results of audits
conformity b) customer feedback
d) status of preventive management reviews c) process performance and product
e) follow-up actions from previous conformity
management reviews d) status of preventive management reviews
f) changes that could affect the quality e) follow-up actions from previous
management system, and management reviews
g) recommendations for improvement. f) changes that could affect the quality
management system, and
g) recommendations for improvement?

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5.6.3 Review output
The output from the management review shall 1) Does the output from the management review
include any decisions and actions related to include any decisions and actions related to
a) improvement of the effectiveness of the
quality management system and the a) improvement of the effectiveness of the
process, quality management system and the
b) improvement of product related to process,
customer requirements, and b) improvement of product related to
c) resource needs. customer requirements, and
c) resource needs?
6 Resource management
6.1 Provisions of resources 1) Has the organization determined and provided

The organization shall determine and provide the the resources needed
resources needed
a) to implement and maintain the quality a) to implement and maintain the quality
management system and continually management system and continually
improve its effectiveness, and improve its effectiveness, and
b) to enhance customer satisfaction by
meeting customer requirements. b) to enhance customer satisfaction by
meeting customer requirements?

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6.2 Human resources
1) Are personnel performing work affecting
6.2.1 General product quality competent on the basis of
Personnel performing work affecting product appropriate education, training, skills and
quality shall be competent on the basis of experience?
appropriate education, training, skills and
experience. 2) Has the organization
6.2.2 Competence, awareness and

training a) determined the necessary competence for
The organization shall personnel performing work affecting
a) determine the necessary competence for product quality,
personnel performing work affecting
product quality, b) provided training or take other actions to
b) provide training or take other actions to satisfy these needs,
satisfy these needs,
c) evaluate the effectiveness of the actions c) evaluated the effectiveness of the actions
taken taken
d) ensure that its personnel are aware of the
relevance and importance of their d) ensured that its personnel are aware of the
activities and how they contribute to the relevance and importance of their activities
achievement of the quality objectives, and and how they contribute to the
e) maintain appropriate records of achievement of the quality objectives, and
education, training, skills, and
experience. e) maintained appropriate records of
education, training, skills, and experience?

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6.3 Infrastructure
The organization shall determine, provide and
maintain the infrastructure needed to achieve 1) Has the organization determined, provided and
conformity to product requirements. Infrastructure maintained the infrastructure needed to achieve
include, as applicable conformity to product requirements.
a) buildings, workspace and associated Infrastructure include, as applicable
utilities
b) process equipment (both hardware and a) buildings, workspace and associated
software), and utilities
c) supporting services (such as transport or b) process equipment (both hardware and
communication). software), and
c) supporting services (such as transport or
communication)?
6.4 Work environment 1) Has the organization determined and managed

The organization shall determine and manage the the work environment needed to achieve conformity
work environment needed to achieve conformity to to product requirements?
product requirements.
NOTE: Factors that may affect the conformity of the

product include temperature, humidity, lighting,
cleanliness, protection from electrostatic discharge, etc .

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7 Product Realization
7.2 Customer-related processes
7.2.1 Determination of requirements 1) Has the organization determined

related to the product
The organization shall determine a) requirements specified by the customer,
a) requirements specified by the customer, including the requirements for delivery
including the requirements for delivery and post-delivery activities,
and post-delivery activities,
b) requirements not stated by the customer b) requirements not stated by the customer
but necessary for specified or intended but necessary for specified or intended use,
use, where known, where known,
c) statutory and regulatory requirements
related to the product, and c) statutory and regulatory requirements
d) any additional requirements by the related to the product, and
organization.
d) any additional requirements by the
organization?

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7.2.2 Review or requirements related to the
product 1) Has the organization reviewed the requirements
The organization shall review the requirements related to the product and is this review
related to the product. This review shall be conducted prior to the organizations
conducted prior to the organizations commitment commitment to supply a product to the
to supply a product to the customer (e.g. customer (e.g. submission of tenders,
submission of tenders, acceptance of contracts or acceptance of contracts or orders, acceptance of
orders, acceptance of changes to contracts or changes to contracts or orders)?
orders) and shall ensure that
a) product requirements are defined, 2) Does the review ensure that
b) contract or order requirements differing
from those previously expressed are a) product requirements are defined,
resolved, and b) contract or order requirements differing
c) the organization has the ability to meet from those previously expressed are
the defined requirements. resolved,
d) Risks (e.g., new technology, short delivery c) the organization has the ability to meet the
time scale) have been evaluated. defined requirements, and
d) risks have been evaluated?
Records of the results of the review and actions
arising from the review shall be maintained 3) Are records of the results of the review and
actions arising from the review maintained?
Where the customer provides no documented
statement of requirement, the customer 4) Where the customer provides no documented
requirements shall be confirmed by the statement of requirement, are the customer
organization before acceptance. requirements confirmed by the organization
before acceptance?
Where product requirements are changed, the
organization shall ensure that relevant documents 5) Where product requirements are changed, does
are amended and that relevant personnel are made the organization ensure that relevant
aware of the changed requirements. documents are amended and that relevant
personnel are made aware of the changed
NOTE: In some situations, such as Internet sales, a requirements?
formal review is impractical for each order. Instead the
review can cover relevant product information such as
catalogues or advertising material.

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7.2.3 Customer communication
The organization shall determine and implement 1) Does the organization determine and
effective arrangements for communication with implement effective arrangements for
customers in relation to communication with customers in relation to
a) product information,
b) inquiries, contracts or order handling, a) product information,
including amendments, and
c) customer feedback, including customer b) inquiries, contracts or order handling,
complaints. including amendment, and
c) customer feedback, including customer

complaints?

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7.4 Purchasing 1) Does the organization ensure that purchased
product conforms to specified purchase
7.4.1 Purchasing process requirements?
The organization shall ensure that purchased
product conforms to specified purchase 2) Is the type and extent of control applied to the
requirements. The type and extent of control supplier and the purchased product dependent
applied to the supplier and the purchased product upon the effect of the purchased product on
shall be dependent upon the effect of the purchased subsequent product realization or the final
product on subsequent product realization or the product?
final product.
3) Does the organization evaluate and select
The organization shall evaluate and select suppliers based on their ability to supply
suppliers based on their ability to supply product product in accordance with the organizations
in accordance with the organizations requirements?
requirements. Criteria for selection, evaluation and
re-evaluation shall be established. Records of the 4) Is the criteria for selection, evaluation and re-
results of evaluations and any necessary actions evaluation established?
arising from the evaluation shall be maintained.
5) Are records of the results of evaluations and
The organization shall: any necessary actions arising from the
a) maintain a register of approved sources of evaluation maintained?
supply that includes the scope of the
approval; Does the organization:
b) periodically review source of supply a) maintain a register of approved sources of
performance, records of these reviews supply that includes the scope of the
shall be used as a basis for establishing approval,
the level of controls to be implemented; b) periodically review source of supply
c) define the necessary actions to take when performance, records of these reviews shall
dealing with suppliers that do not meet be used as a basis for establishing the level
requirements; of controls to be implemented,
d) prevent the purchase of c) define the necessary actions to take when
counterfeit/suspect unapproved products. dealing with suppliers that do not meet
requirements, and
The organization shall be responsible for the d) prevent the purchase of counterfeit/suspect
quality of all products purchased from suppliers, unapproved products?
including customer-designated sources.
Is the organization responsible for the quality of all
products purchased from suppliers, including
customer-designated sources?
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7.4.2 Purchasing information
Purchasing information shall describe the product 1) Does purchasing information describe the
to be purchased, including where appropriate product to be purchased, including where
a) requirements for approval of appropriate
product, procedures, processes a) requirements for approval of
and equipment, product, procedures, processes
b) requirements for qualification of and equipment,
personnel, and b) requirements for qualification of
c) quality management system personnel,
requirements, c) quality management system
d) the name/product description or requirements,
other positive identification, and d) the name/product description or
applicable issues of other positive identification, and
specifications, drawings, process applicable issues of specifications,
requirements, inspection drawings, process requirements,
instructions and other relevant inspection instructions and other
technical data (e.g., revision relevant technical data (e.g.,
level), revision level),
e) requirements relative to supplier e) requirements relative to supplier
notification to organization of notification to organization of
nonconforming product, nonconforming product,
f) requirements for the supplier to f) requirements for the supplier to
notify the organization of notify the organization of changes
changes in product definition, in product definition,
g) right of access by the g) right of access by the
organization, their customer, and organization, their customer, and
regulatory authorities to all regulatory authorities to all
facilities involved in the order facilities involved in the order and
and to all applicable records, and to all applicable records, and
h) requirements for a certificate of h) requirements for a certificate of
conformity, test reports, and/or conformity, test reports, and/or
airworthiness approval from the airworthiness approval from the
approved manufacturer or approved manufacturer or
approved repair station. approved repair station?
The organization shall ensure the adequacy of 2) Does the organization ensure the adequacy of
specified purchase requirements prior to their specified purchase requirements prior to their
communication to the supplier. communication to the supplier?

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7.4.3 Verification of purchased product
The organization shall establish and implement 1) Has the organization established and
the inspection or other activities necessary for implemented the inspection or other activities
ensuring that purchased product meets specified necessary for ensuring that purchased product
purchase requirements. meets specified purchase requirements?
Verification activities may include 2) Where the organization or its customer intends
a) obtaining objective evidence of the quality to perform verification at the suppliers
of the product from suppliers and premises, has the organization stated the
verifying the authenticity of the intended verification arrangements and method
accompanying documentation (e.g., of product release in the purchasing
certificate of conformity from the information?
manufacturer, airworthiness certificate,
test reports, statistical records, process 3) Where specified in the contract, is the customer
control), or the customers representative afforded the
b) review of the required documentation, right to verify at the suppliers premises and
and the organizations premises that subcontracted
c) inspection of products upon receipt. product conforms to specified requirements?
Where the organization or its customer intends to

perform verification at the suppliers premises, the
organization shall state the intended verification
arrangements and method of product release in the
purchasing information.
Where specified in the contract, the customer or

the customers representative shall be afforded the
right to verify at the suppliers premises and the
organizations premises that subcontracted product
conforms to specified requirements.
Verification by the customer shall not be used by

the organization as evidence of effective control of
quality by the supplier and shall not absolve the
organization of the responsibility to provide
acceptable product, nor shall it preclude
subsequent rejection by the customer.

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7.5 Production and service provision
7.5.1 Control of production and service

provision
The organization shall plan and carry out 1) Has the organization planned and carried out
production and service provision under controlled production and service provision under
conditions. Controlled conditions shall include, as controlled conditions?
applicable
a) the availability of information 2) Do controlled conditions include, as applicable
that describes the characteristics
of the product, a) the availability of information that
b) the availability of work describes the characteristics of the
instructions, as necessary, product,
c) the use of suitable equipment,
d) the availability and use of b) the availability of work
monitoring and measuring instructions, as necessary,
devices,
e) the implementation of c) the use of suitable equipment,
monitoring and measurement,
and d) the availability and use of
f) the implementation of release, monitoring and measuring
delivery and post-delivery devices,
activities.
e) the implementation of monitoring
and measurement, and
f) the implementation of release,

delivery and post-delivery
activities?

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7.5.3 Identification and tractability
Where appropriate, the organization shall identify 1) Where appropriate, has the organization
the product by suitable means throughout product identified the product by suitable means
realization. throughout product realization?
The organization shall identify the product status
with respect to monitoring and measurement 2) Has the organization identified the product
requirements. status with respect to monitoring and
measurement requirements?
When acceptance authority media are used (e.g.,
stamps, electronic signatures, passwords), the 3) When acceptance authority media are used, has
organization shall establish and document controls the organization established and documented
for the media. controls for this media?
Where traceability is a requirement, the
organization shall control and record the unique 4) Where traceability is a requirement, has the
identification of the product. organization controlled and recorded the
unique identification of the product?
The organization shall establish and maintain
documented procedures for product identification 5) Has the organization established and
and traceability by suitable means, (e.g., labels, bar maintained documented procedures for product
codes, or other) from receipt; during splitting, identification and traceability by suitable means
storage packaging, and preservation operations; from receipt; during splitting, storage
and until delivery (including subcontracted packaging, and preservation operations; and
handling or packaging operations). until delivery?
The organizations processes shall provide for:
a) maintaining the manufacturers Do these processes provide for:
identification and batch/lot traceability; a) maintaining the manufacturers
b) the ability to identify and trace products identification and batch/lot traceability;
manufactured from the same batch of raw b) the ability to identify and trace products
material or from the same manufacturing manufactured from the same batch of raw
batch, as well as the ability to trace the material or from the same manufacturing
product to the ultimate destination batch, as well as the ability to trace the
(delivery, scrap) product to the ultimate destination, and
c) maintaining the identification of the c) maintaining the identification of the
configuration of the product in order to configuration of the product in order to
identify any differences between the identify any differences between the actual
actual configuration and the agreed configuration and the agreed
configuration. configuration?
NOTE: In some sectors, configuration management is a
means by which identification and traceability are
maintained.
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7.5.4 Customer property

The organization shall exercise care with customer 1) Does the organization exercise care with
property while it is under the organizations customer property while it is under the
control or being used by the organization. The organizations control or being used by the
organization shall identify, verify, protect and organization?
safeguard customer property provided for use or
incorporation into the product. If any customer 2) Does the organization identify, verify, protect
property is lost, damaged or otherwise found to be and safeguard customer property provided for
unsuitable for use, this shall be reported to the use or incorporation into the product?
customer and records maintained.
3) If any customer property is lost, damaged or
NOTE: Customer property can include intellectual otherwise found to be unsuitable for use, is this
property. reported to the customer and records
maintained?

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7.5.5 Preservation of product 1) Does the organization preserve the conformity
The organization shall preserve the conformity of of product during internal processing and
product during internal processing and delivery to delivery to the intended destination?
the intended destination. This preservation shall
include identification, handling, packaging, 2) Does this preservation include identification,
storage and protection. Preservation shall also handling, packaging, storage and protection?
apply to the constituent parts of a product.
3) Does preservation also apply to the constituent
Preservation of product shall also include, where parts of a product?
applicable in accordance with product
specifications and/or applicable regulations, Does preservation of product also include, where
provisions for: applicable in accordance with product specifications
a) cleaning, and/or applicable regulations, provisions for:
b) prevention, detection and removal of a) cleaning,
foreign objects, b) prevention, detection and removal of
c) special handling for sensitive products, foreign objects,
d) marking and labeling including safety c) special handling for sensitive products,
warnings, d) marking and labeling including safety
e) shelf life control and stock rotation, warnings,
f) special handling for hazardous materials, e) shelf life control and stock rotation,
and f) special handling for hazardous materials,
g) environmental controls (e.g., temperature, and
humidity). g) environmental controls?
The organization shall ensure that documents Does the organization ensure that documents
required by the contract/order to accompany the required by the contract/order to accompany the
product are present at delivery and are protected product are present at delivery and are protected
against loss and deterioration. against loss and deterioration?

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7.6 Control of monitoring and measuring 1) Has the organization determined the
devices monitoring and measurement to be undertaken
The organization shall determine the monitoring and the monitoring and measuring devices
and measurement to be undertaken and the needed to provide evidence of conformity of
monitoring and measuring devices needed to product to determine requirements?
provide evidence of conformity of product to
determined requirements. 2) Does the organization maintain a register of
The organization shall maintain a register of these these monitoring and measuring devices, and
monitoring and measuring devices, and define the define the process employed for their
process employed for their calibration, including calibration, including details of equipment
details of equipment type, unique identification, type, unique identification, location, frequency
location, frequency of checks, check method and of checks, check method and acceptance
acceptance criteria. criteria?
The organization shall establish processes to 3) Has the organization established processes to
ensure that monitoring and measurement can be ensure that monitoring and measurement can
carried out and are carried out in a manner that is be carried out and are carried out in a manner
consistent with the monitoring and measurement that is consistent with the monitoring and
requirements. measurement requirements?
The organization shall ensure that environmental
conditions are suitable for the calibrations, 4) Does the organization ensure that
inspections, measurements and tests being carried environmental conditions are suitable for the
out. calibrations, inspections, measurements and
tests being carried out?
Where necessary to ensure valid results, measuring
equipment shall 5) Where necessary to ensure valid results, is
a) be calibrated or verified at measuring equipment
specified intervals, or prior to a) calibrated or verified at specified
use, against measurement intervals, or prior to use, against
standards traceable to measurement standards traceable
international or national to international or national
measurements standards, where measurements standards, and
no such standards exist, the basis where no such standards exist, the
used for calibration or basis used for calibration or
verification shall be recorded; verification recorded;
b) be adjusted or re-adjusted as b) adjusted or re-adjusted as
necessary necessary
c) be identified to enable the c) identified to enable the calibration
calibration status to be status to be determined;
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d) be safeguarded from adjustments d) safeguarded from adjustments that
that would invalidate the would invalidate the measurement
measurement result; result;
e) be protected from damage and e) protected from damage and
deterioration during handling, deterioration during handling,
maintenance and storage; maintenance and storage, and
f) be recalled to a defined method f) be recalled to a defined method
when requiring calibration . when requiring calibration?
In addition, to organization shall assess and record 6) Does the organization assess and record the
the validity of the previous measuring results when validity of the previous measuring results when
the equipment is found not to conform to the equipment is found not to conform to
requirements. The organization shall take requirements and take appropriate action on
appropriate action on the equipment and any the equipment and any product affected?
product affected. Records of the results of
calibration and verification shall be maintained. 7) Are records of the results of calibration and
verification maintained?
When used in the monitoring and measurements
of specified requirements, the ability of computer 8) When used in the monitoring and
software to satisfy the intended application shall be measurements of specified requirements, is the
confirmed. This shall be undertaken prior to initial ability of computer software to satisfy the
use and reconfirmed as necessary. intended application confirmed?
NOTE: See ISO 10012-1 and ISO 10012-2 for guidance. 9) Is this undertaken prior to initial use and
reconfirmed as necessary?

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8 Measurement, analysis and improvement
8.1 General 1) Has the organization planned and implemented

The organization shall plan and implement the the monitoring, measurement, analysis and
monitoring, measurement, analysis and improvement processes needed
improvement processes needed
a) to demonstrate conformity of the a) to demonstrate conformity of the
product, product,
b) to ensure conformity of the b) to ensure conformity of the quality
quality management system, and management system, and
c) to continually improve the c) to continually improve the
effectiveness of the quality effectiveness of the quality
system. system?
This shall include determination of applicable 2) Does this include determination of applicable
methods, including statistical techniques, and the methods, including statistical techniques, and the
extent of their use. extent of their use?
NOTE: According to the nature of the product and the

activities performed statistical techniques may be used
for:
inspection: matching sampling rate to the
criticality of the product;
quality management: use of statistical
techniques to determine required
improvement activities.

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8.2 Monitoring and measurement
8.2.1 Customer satisfaction

As one of the measurements of the performance of 1) As one of the measurements of the performance
the quality management system, the organization of the quality management system, does the
shall monitor information relating to customer organization monitor information relating to
perception as to whether the organization has met customer perception as to whether the
customer requirements. The methods for obtaining organization has met customer requirements?
and using this information shall be determined.
2) Are the methods for obtaining and using this
information determined?

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8.2.2 Internal audit 1) Does the organization conduct internal audits
The organization shall conduct internal audits at at planned internal audits to determine whether
planned internal audits to determine whether the the quality management system
quality management system a) conforms to the planned arrangements, to
a) conforms to the planned the requirements of this International
arrangements, to the Standard and to the quality management
requirements of this system requirements established by the
International Standard and to the organization, and
quality management system b) is effectively implemented and
requirements established by the maintained?
organization, and
b) is effectively implemented and 2) Is the audit programme planned, taking into
maintained. consideration the status and importance of the
processes and areas to be audited, as well as the
An audit programme shall be planned, taking into results of previous audits?
consideration the status and importance of the 3) Are the audit criteria, scope, frequency and
processes and areas to be audited, as well as the methods defined?
results of previous audits. The audit criteria, scope, 4) Does the selection of auditors and conduct of
frequency and methods shall be defined. Selection audits ensure objectivity and impartially of the
of auditors and conduct of audits shall ensure audit process?
objectivity and impartially of the audit process. 5) Do Auditors monitor their own work?
Auditors shall not monitor their own work. 6) Is the responsibilities and requirements for
planning and conducting audits, and for
The responsibilities and requirements for planning reporting and maintained records defined in a
and conducting audits, and for reporting and documented procedure?
maintained records shall be defined in a 7) Does the management responsible for the area
documented procedure. being audited ensure that actions are taken
without undue delay to eliminate detected
The management responsible for the area being nonconformitys and their causes?
audited shall ensure that actions are taken without 8) Do follow-up activities include the verification
undue delay to eliminate detected nonconformitys of the actions taken and the reporting of
and their causes. Follow-up activities shall include verification results?
the verification of the actions taken and the 9) Do internal audits meet contract and/or
reporting of verification results. regulatory requirements?
Internal audits shall also meet contract and/or

regulatory requirements.

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8.2.3 Monitoring and measurement of processes
The organization shall apply suitable methods for 1) Does the organization apply suitable methods
monitoring and, where applicable, measurement of for monitoring and, where applicable,
the quality management system processes. These measurement of the quality management
methods shall demonstrate the ability of the system processes?
processes to achieve planned results. When
planned results are not achieved, correction and 2) Do these methods demonstrate the ability of the
corrective action shall be taken, as appropriate, to processes to achieve planned results.
ensure conformity of the product.
3) When planned results are not achieved is
correction and corrective action taken, as
appropriate, to ensure conformity of the
product?
In the event of process nonconformity, the In the event of process nonconformity, does the
organization shall: organization:
a) take appropriate action to correct the a) take appropriate action to correct the
nonconforming process, nonconforming process,
b) evaluate whether the process b) evaluate whether the process
nonconformity has resulted in product nonconformity has resulted in product
nonconformity, and nonconformity, and
c) identify and control the nonconforming c) identify and control the nonconforming
product in accordance with clause 8.3. product in accordance with clause 8.3?

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8.2.4 Monitoring and measurement of product 1) Does the organization monitor and measure the
The organization shall monitor and measure the characteristics of the product to verify that
characteristics of the product to verify that product product requirements have been met?
requirements have been met. This shall be carried
out at appropriate stages of the product realization 2) Is this carried out at appropriate stages of the
process in accordance with the planned product realization process in accordance with
arrangements. the planned arrangements?
When inspections are performed to verify product 3) When inspections are performed to verify
status and the organization uses sampling product status and the organization uses
inspection as a means of verification, the plan sampling inspection as a means of verification,
shall be statistically valid and appropriate for use. is the plan statistically valid and appropriate
The plan shall preclude the acceptance of lots for use?
whose samples have known nonconformities.
When required, the plan shall be submitted for 4) Does the plan preclude the acceptance of lots
customer approval. whose samples have known nonconformities?
5) When required, is the plan submitted for

customer approval?
Evidence of conformity with the acceptance 6) Is evidence of conformity with the acceptance
criteria shall be maintained. Records shall indicate criteria maintained?
the person(s) authorizing release of product. (see
4.2.4) 7) Do records indicate the person(s) authorizing
release of product?
Product release and service delivery shall not
proceed until the planned arrangements have been 8) Does product release and service delivery not
satisfactorily completed, unless otherwise proceed until the planned arrangements have
approved by a relevant authority and, where been satisfactorily completed, unless otherwise
applicable, by the customer. approved by a relevant authority and, where
applicable, by the customer?

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8.2.4.1 Inspection Documentation
Measurement requirements for product or service 1) Are measurement requirements for product or
acceptance shall be documented and include: service acceptance documented and including:
a) criteria for acceptance and/or rejection, a) criteria for acceptance and/or rejection,
b) a record of the measurement results, and b) a record of the measurement results, and
c) type of measurement instruments c) type of measurement instruments
required and any specific instructions required and any specific instructions
associated with their use. associated with their use?
Test records shall show actual test results when 2) Do test records show actual test results when
required by specification or acceptance test plan. required by specification or acceptance test plan?
8.2.5 Evidence of Conformance

Certificate of conformity: when required, the 1) When required, does the organization provide
organization shall provide the customer with the customer with evidence of the products
evidence of the products conformity to its conformity to its technical specifications?
technical specifications. This may include the
manufacturers conformance documents, the
original airworthiness certificate, test analysis,
and/or test reports.
When splitting product, copies of original 2) When splitting product, are copies of original
documents shall be annotated with the following documents annotated with the following
information: amount delivered relative to amount information: amount delivered relative to amount
received, purchase order number, customers received, purchase order number, customers
name, and suppliers name. name, and suppliers name?
Where there is a formal agreement with the 3) When there is a formal agreement with the
customer, the organization may deliver a customer, does the organization deliver a
certificate of conformity created by the certificate of conformity created by the
organization that references the original organization that references the original
manufacturers conformance documents that are manufacturers conformance documents that are
retained and traceable by the organization. retained and traceable by the organization?

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8.3 Control of nonconforming product 1) Does the organization ensure that product
The organization shall ensure that product which which does not conform to product
does not conform to product requirements is requirements is identified and controlled to
identified and controlled to prevent its unintended prevent its unintended use or delivery?
use or delivery. The controls and related
responsibilities and authorities for dealing with 2) Are the controls and related responsibilities
nonconforming product shall be defined in a and authorities for dealing with
documented procedure. nonconforming product defined in a
documented procedure?
NOTE: The term nonconforming product includes
nonconforming product returned from a customer and
suspected unapproved parts.
3) Does the organizations documented
The organizations documented procedure shall procedure define the responsibility for review
define the responsibility for review and authority and authority for the disposition of
for the disposition of nonconforming product and nonconforming product and the process for
the process for approving personnel making these approving personnel making these decisions?
decisions.
4) Does the organization deal with
The organization shall deal with nonconforming nonconforming product by one or more of the
product by one or more of the following ways: following ways:
a) by taking action to eliminate the a) by taking action to eliminate the
detected nonconformity; detected nonconformity;
b) by authorizing its use, release or b) by authorizing its use, release or
acceptance under concession by acceptance under concession by
a relevant authority and, where a relevant authority and, where
applicable, by the customer; applicable, by the customer;
c) by taking action to preclude its c) by taking action to preclude its
original intended use or original intended use or
application. application?

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Dispositions shall be limited to: Are dispositions limited to:
scrap; scrap;
rejection for return to the supplier; rejection for return to the supplier;
rejection for revalidation by the rejection for revalidation by the
manufacturer; manufacturer;
submittal to design authority and submittal to design authority and
customer for USE AS IS disposition. customer for USE AS IS disposition?
NOTE: The stocklist distributor has no authority to

rework or repair product.
Product dispositioned for scrap shall be 5) Is product dispositioned for scrap

conspicuously and permanently marked, or conspicuously and permanently marked, or
positively controlled, until physically rendered positively controlled, until physically
unusable. rendered unusable?
6) Does the organization ensure, with the
The organization shall ensure, with the manufacturer where necessary, that similar
manufacturer where necessary, that similar supplies are not similarly affected and shall
supplies are not similarly affected and shall inform inform the customer of any nonconformities
the customer of any nonconformities affecting affecting product already delivered?
product already delivered.
7) Are records of the nature of nonconformitys
Records of the nature of nonconformitys and any and any subsequent actions taken, including
subsequent actions taken, including concessions concessions obtained, maintained?
obtained, shall be maintained.
8) When nonconforming product is corrected is
When nonconforming product is corrected it shall it subject to re-verification to demonstrate
be subject to re-verification to demonstrate conformity to the requirements?
conformity to the requirements.
9) When nonconforming product is detected
When nonconforming product is detected after after delivery or use has started, does the
delivery or use has started, the organization shall organization take action appropriate to the
take action appropriate to the effects, or potential effects, or potential effects, of the
effects, of the nonconformity. nonconformity?

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In addition to any contract or regulatory authority 10) In addition to any contract or regulatory
reporting requirements, the organizations system authority reporting requirements, does the
shall provide for timely reporting of delivered organizations system provide for timely
nonconforming product that may affect reliability reporting of delivered nonconforming product
or safety. Notification shall include a clear that may affect reliability or safety?
description of the nonconformity, which includes
as necessary parts affected, customer and/or 11) Does notification include a clear description
organization part numbers, quantity, and date(s) of the nonconformity, which includes as
delivered. necessary parts affected, customer and/or
organization part numbers, quantity, and
NOTE: Parties requiring notification of nonconforming date(s) delivered?
product may include suppliers, internal organizations,
customers, distributors, and regulatory authorities.

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8.4 Analysis of data 1) Does the organization determine, collect and
The organization shall determine, collect and analyze appropriate data to demonstrate the
analyze appropriate data to demonstrate the suitability and effectiveness of the quality
suitability and effectiveness of the quality management system and to evaluate where
management system and to evaluate where continual improvement of the effectiveness of
continual improvement of the effectiveness of the the quality management system can be made?
quality management system can be made. This
shall include data generated as a result of 2) Does this include data generated as a result of
monitoring and measurements and from other monitoring and measurements and from other
relevant sources. relevant sources?
The analysis of data shall provide information 3) Does the analysis of data provide information
relating to relating to
a) customer satisfaction a) customer satisfaction
b) conformity to product b) conformity to product
requirements requirements
c) characteristics and trends of c) characteristics and trends of
processes and products including processes and products including
opportunities for preventive opportunities for preventive
action, and action, and
d) suppliers. d) suppliers?

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8.5 Improvement
8.5.1 Continual improvement 1) Does the organization continually improve the

The organization shall continually improve the effectiveness of the quality management system
effectiveness of the quality management system through the use of the quality policy, quality
through the use of the quality policy, quality objectives, audit results, analysis of data, corrective
objectives, audit results, analysis of data, and preventive actions and management review?
corrective and preventive actions and management
review.

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8.5.2 Corrective action 1) Does the organization take action to eliminate
The organization shall take action to eliminate the the cause of nonconformities in order to
cause of nonconformities in order to prevent prevent reoccurrence?
reoccurrence. Corrective actions shall be
appropriate to the effects of the nonconformities 2) Are corrective actions appropriate to the effects
encountered. of the nonconformities encountered?
A documented procedure shall be established to 3) Has a documented procedure been established

define requirements for to define requirements for
a) reviewing nonconformities a) reviewing nonconformities
(including customer complaints) (including customer complaints)
b) determining the causes of b) determining the causes of
nonconformitys nonconformitys
c) evaluating the need for action to c) evaluating the need for action to
ensure that nonconformities do ensure that nonconformities do
not recur, not recur,
d) determining and implementing d) determining and implementing
action needed, action needed,
e) records of the results of action e) records of the results of action
taken, taken,
f) reviewing corrective action f) reviewing corrective action taken
taken. i) flow down of the corrective action
g) flow down of the corrective requirement to a supplier and/or
action requirement to a supplier the manufacturer, when it is
and/or the manufacturer, when it determined that the supplier
is determined that the supplier and/or the manufacturer is
and/or the manufacturer is responsible for the root cause, and
responsible for the root cause, g) specific actions where timely
and and/or effective corrective actions
h) specific actions where timely are not achieved?
and/or effective corrective
actions are not achieved.

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8.5.3 Preventive Action 1) Has the organization determined action to
The organization shall determine action to eliminate the cause of nonconformities in order
eliminate the cause of nonconformities in order to to prevent their occurrence?
prevent their occurrence. Preventive actions shall
be appropriate to the effects of the potential 2) Are preventive actions appropriate to the effects
problems. of the potential problems?
A documented procedure shall be established to 3) Has a documented procedure been established

define requirements for to define requirements for
a) determining potential a) determining potential

nonconformities and their causes, nonconformities and their causes,
b) evaluating the need for action to b) evaluating the need for action to
prevent occurrence of prevent occurrence of
nonconformities, nonconformities,
c) determining and implementing c) determining and implementing
action needed, action needed,
d) records of the results of action d) records of the results of action
taken (see 4.2.4), taken,
e) reviewing preventive action e) reviewing preventive action taken,
taken, and and
f) the withdrawal of product(s) from f) the withdrawal of product(s) from
stock that are suspected of a stock that are suspected of a
noncompliance (or returned by a noncompliance (or returned by a
customer), including notification customer), including notification
of all customers of the action(s) of all customers of the action(s)
taken who have purchased the taken who have purchased the
product from the same lot or product from the same lot or
batch. batch?

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AS9120-2002 Audit Checklist, CRS-02-02R

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AS9120-2002 AUDIT CHECKLIST

4.1 General Requirements

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

NOTE 1 Where the term documented procedure

NOTE 2 The extent of the quality management system

NOTE 3 The documentation can be in any form or type

c) a description of the interaction between c) a description of the interaction between the

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

A document procedure shall be established to 2) Has a documented procedure been established

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

d) conducting management reviews, and

e) ensuring the availability of resources?

5.2 Customer focus

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

e) is reviewed for continuing suitability?

5.4.1 Quality objectives 1) Has top management ensured that quality

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

5.5 Responsibility, authority, and

5.5.1 Responsibility and authority 1) Has top management ensured that

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

NOTE: The responsibility of management representative d) the organizational freedom to resolve

5.5.3 Internal communication 1) Has top management ensured that appropriate

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

5.6.2 Review input 3) Are records from management reviews

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

6.1 Provisions of resources 1) Has the organization determined and provided

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

6.2.2 Competence, awareness and

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

6.4 Work environment 1) Has the organization determined and managed

NOTE: Factors that may affect the conformity of the

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

7.2 Customer-related processes

7.2.1 Determination of requirements 1) Has the organization determined

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

c) customer feedback, including customer

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

Where the organization or its customer intends to

Where specified in the contract, the customer or

Verification by the customer shall not be used by

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

7.5.1 Control of production and service

f) the implementation of release,

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

7.5.4 Customer property

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

8 Measurement, analysis and improvement

8.1 General 1) Has the organization planned and implemented

NOTE: According to the nature of the product and the

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

8.2.1 Customer satisfaction

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

Internal audits shall also meet contract and/or

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

5) When required, is the plan submitted for

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for

CRS-02-02R-R1 * S = Satisfactory; U = Unsatisfactory; OFI = Opportunity for