Aerospace Standard: (R) Inspection and Test Quality Systems Requirements For Aviation, Space, and Defense Organizations
Aerospace Standard: (R) Inspection and Test Quality Systems Requirements For Aviation, Space, and Defense Organizations
Aerospace Standard: (R) Inspection and Test Quality Systems Requirements For Aviation, Space, and Defense Organizations
A
STANDARD
Issued 2001-10
Revised 2012-07
Superseding AS9003
(R) Inspection and Test Quality Systems
Requirements for Aviation, Space, and Defense Organizations
RATIONALE
This standard has been revised using AS9100:2009 as the baseline document. AS9100:2009 requirements
applicable to noncomplex products and manufacturing processes have been incorporated into this standard and
modified, as necessary, to reflect the intent of this standard. The standard’s clauses have been renumbered
accordingly.
FOREWORD
To assure customer satisfaction, aviation, space, and defense organizations must produce, and continually
improve safe, reliable products that meet or exceed customer and applicable statutory and regulatory
requirements. The globalization of the industry and the resulting diversity of regional and national requirements
and expectations have complicated this objective. Organizations have the challenge of purchasing products from
suppliers throughout the world and at all levels of the supply chain. Suppliers have the challenge of delivering
products to multiple customers having varying quality requirements and expectations.
This document standardizes, to the greatest extent possible, inspection and test quality system requirements for
suppliers that provide noncomplex products. Hereafter, the term “inspection and test quality system” is referred
to as “quality system”.
__________________________________________________________________________________________________________________________________________
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TABLE OF CONTENTS
RATIONALE ........................................................................................................................................................................... 1
FOREWORD .......................................................................................................................................................................... 1
1. SCOPE ............................................................................................................................................................................ 3
1.1 General ......................................................................................................................................................................... 3
1.2 Application .................................................................................................................................................................... 3
2. REFERENCES ................................................................................................................................................................ 3
9 NOTES .......................................................................................................................................................................... 12
1. SCOPE
1.1 General
This standard includes selected quality system requirements from ISO 9001:2008[1] and AS9100:2009 applicable
to noncomplex products and associated manufacturing processes. ISO 9001 text incorporated into this standard
appears in standard font; while aviation, space, and defense industry additional requirements, definitions, and
notes are presented in bold, italic text.
The requirements of this standard are intended to be applied in whole, without any exclusions. Compliance with
all corresponding AS9100 requirements is considered to meet/exceed compliance with the requirements of this
standard.
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The requirements specified in this standard are complementary (not alternative) to contractual and applicable
statutory and regulatory requirements. Should there be a conflict between the requirements of this standard and
applicable statutory or regulatory requirements, the latter shall take precedence.
The process approach described in ISO 9001 and AS9100 applies to this standard.
1.2 Application
The requirements of this standard are generic and are intended to be applicable to all organizations regardless of type
and size.
This standard is intended for use by organizations that produce noncomplex products for use in aviation, space,
and defense applications. This standard is not intended to apply to organizations that produce complex product
or have design responsibility.
2. REFERENCES
The following referenced documents are indispensable for the application of this document. For dated references, only
the edition cited applies. For undated references, the latest edition of the referenced document (including any
amendments) applies.
AS9100:2009 Quality Management Systems - Requirements for Aviation, Space and Defense Organizations
ISO 9004 Managing for the sustained success of an organization - A quality management approach
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1
With the permission of the International Organization for Standardization (ISO). The complete standard may be obtained from any ISO
member or from the ISO Central Secretariat: 1, ch. de la Voie-Creuse, Case postale 56, CH-1211 Geneva 20, SWITZERLAND.
Copyright remains with ISO.
For the purposes of this document, the terms and definitions given in ISO 9000 apply.
Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the product
realization and use of the product; including safety, performance, form, fit, function, producibility, service life,
etc.; that require specific actions to ensure they are adequately managed. Examples of critical items include
safety critical items, fracture critical items, mission critical items, key characteristics, etc.
An attribute or feature whose variation has a significant effect on product fit, form, function, performance,
service life, or producibility, that requires specific actions for the purpose of controlling variation.
A hardware item whose conformance to quality characteristics can be determined by simple measurement and
test of the end item, without uneconomical disassembly or destructive testing.
The organization shall establish, document, implement, and maintain a quality system in accordance with the
requirements of this standard.
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The quality system shall address customer, statutory, and regulatory requirements.
Where an organization chooses to outsource any process that affects product conformity to requirements, the
organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced
processes shall be defined.
The organization shall establish and maintain a quality manual that includes:
b) the documented procedures established for the quality system, or reference to them.
The term “documented procedure” means that the procedure is established, documented, implemented, and maintained.
c) to ensure that changes and the current revision status of documents are identified;
d) to ensure that relevant versions of applicable documents are available at points of use;
f) to ensure that documents of external origin determined by the organization to be necessary for the planning and
operation of the quality system are identified and their distribution controlled; and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained
for any purpose.
Records established to provide evidence of conformity to requirements and of the effective operation of the
quality system shall be controlled. Examples of records include, but are not limited to, records created by and/or
retained by suppliers, and records relating to training, product realization, contract review, product traceability,
calibration, internal audit, product measurement, nonconforming material dispositon, and corrective action.
The organization shall establish a documented procedure to define the controls needed for the identification,
storage, protection, retrieval, retention, and disposition of records. Records shall remain legible, readily
identifiable, and retrievable.
5. MANAGEMENT RESPONSIBILITY
Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities,
shall have responsibility and authority that includes ensuring that processes needed for the quality system are
established, implemented, and maintained.
6. RESOURCE MANAGEMENT
Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate
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education, training, skills, and experience.
The organization shall determine and manage the work environment needed to achieve conformity to product
requirements.
Factors that may affect the conformity of the product include temperature, humidity, lighting, cleanliness,
protection from electrostatic discharge, etc.
7. PRODUCT REALIZATION
The organization shall plan and develop the processes needed for product realization.
In planning product realization, the organization shall determine the following, as appropriate:
b) the need to establish processes and documents, and provide resources specific to the product; and
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c) required verification, validation, monitoring, inspection, and test activities specific to the product and the criteria for
product acceptance.
NOTE: A document specifying the processes of the quality system (including the product realization processes) and the
resources to be applied to a specific product, project, or contract can be referred to as a quality plan.
The organization shall establish, implement, and maintain a documented process for controlling changes to the
as-defined configuration, including authorization from design authorites and records attesting to as-built
configuration.
Prior to the organization's commitment to supply a product to the customer, the organization shall review all
requirements related to the product, including statutory and regulatory requirements, to ensure that the
requirements are adequately defined and understood, and confirm that the organization has the ability to meet
the defined requirements.
7.4 Purchasing
The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent
of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product
on subsequent product realization or the final product.
The organization shall be responsible for the conformity of all products purchased from suppliers, including
product from sources defined by the customer.
The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the
organization's requirements. Criteria for selection, evaluation, and re-evaluation shall be established.
a) maintain a register of its suppliers that includes approval status (e.g., approved, conditional, disapproved)
and the scope of the approval (e.g., product type, process family); and
b) periodically review supplier performance; the results of these reviews shall be used as a basis for
establishing the level of controls to be implemented.
Purchasing information shall describe the product to be purchased, including, where appropriate:
e) requirements for test, inspection, verification (including production process verification), use of statistical
techniques for product acceptance, and related instructions for acceptance by the organization, and as
applicable critical items including key characteristics;
f) requirements for test specimens (e.g., production method, number, storage conditions) for
inspection/verification, investigation, or auditing;
− notify the organization of changes in product and/or process, changes of suppliers, changes of
manufacturing facility location, and, where required, obtain organization approval; and
− flow down to the supply chain the applicable requirements, including customer requirements.
i) right of access by the organization, their customer, and regulatory authorities to the applicable areas of all
facilities, at any level of the supply chain, involved in the order and to all applicable records.
The organization shall ensure the adequacy of specified purchase requirements, prior to their communication to the
supplier.
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased
product meets specified purchase requirements.
Based on supplier performance reviews [see 7.4.1(b)], verification activities shall include, as applicable:
a) obtaining objective evidence of the conformity of the product from the supplier (e.g., accompanying
documentation, certificate of conformity, test records, statistical records, process control records);
Where the certification test reports are utilized to verify purchased product, the organization shall assure that
data in the test reports is acceptable per applicable specifications.
For raw material that may be used in “critical item” applications, the organization shall independently validate
the accuracy of test reports in accordance with a statistically based sampling plan. Where validation is
outsourced, the test facility shall be formally qualified to perform the required product testing.
Where purchased product is released for production use pending completion of all required verification
activities, it shall be identified and recorded to allow recall and replacement if it is subsequently found that the
product does not meet requirements.
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7.5 Production
The organization shall plan and carry out production and service provision under controlled conditions. Controlled
conditions shall include, as applicable:
NOTE: This information can include drawings, parts lists, materials, and process specifications.
NOTE: Work instructions can include process flow charts, production documents (e.g., manufacturing plans,
travelers, routers, work orders, process cards), and inspection documents.
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d) accountability for all product during production (e.g., parts quantities, split orders, nonconforming product);
e) evidence that all production and inspection/verification operations have been completed as planned, or as
otherwise documented and authorized;
f) provision for the prevention, detection, and removal of foreign objects; and
g) criteria for workmanship, specified in the clearest practical way (e.g., written standards, representative
samples, illustrations).
− establishing, implementing, and maintaining appropriate processes to manage critical items, including
process controls where key characteristics have been identified; and
The organization shall use a representative item from the first production run of a new part or assembly to verify
that the production processes, documentation, and tooling are capable of producing parts and assemblies that
meet requirements. This process shall be repeated when changes occur that invalidate the original results (e.g.,
engineering changes, manufacturing process changes, tooling changes).
The organization shall control, document, and assess changes affecting production processes, equipment, tools,
or software programs to preclude adverse effects to product conformity.
Where appropriate, the organization shall identify the product by suitable means throughout product realization.
The organization shall maintain the identification of the configuration of the product in order to identify any
differences between the actual configuration and the agreed configuration.
The organization shall identify the product status with respect to monitoring and measurement requirements throughout
product realization.
When acceptance authority media are used (e.g., stamps, electronic signatures, passwords), the organization
shall establish appropriate controls for the media.
Where traceability is a requirement, the organization shall control the unique identification of the product and maintain
records.
b) the ability to trace all products manufactured from the same batch of raw material, or from the same
manufacturing batch, to the destination (e.g., delivery, scrap);
c) for an assembly, the ability to trace its components to the assembly and then to the next higher assembly;
and
The organization shall preserve the product during internal processing and delivery to the intended destination in order to
maintain conformity to requirements. As applicable, preservation shall include identification, handling, packaging, storage,
and protection. Preservation shall also apply to the constituent parts of a product.
Preservation of product shall include, where applicable in accordance with product specifications and applicable
statutory and regulatory requirements, provisions for cleaning, shelf life control, and stock rotation.
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring
equipment needed to provide evidence of conformity of product to determined requirements.
The organization shall maintain a register of the monitoring and measuring equipment and define the process
employed for their calibration/verification, including details of equipment type, unique identification, location,
frequency of checks, check method, and acceptance criteria.
The organization shall ensure that environmental conditions are suitable for the calibration, inspection,
measurement, and testing being carried out.
a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to
international or national measurement standards; where no such standards exist, the basis used for calibration or
verification shall be recorded;
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e) be protected from damage and deterioration during handling, maintenance, and storage.
The organization shall establish, implement, and maintain a process for the recall of monitoring and measuring
equipment requiring calibration or verification.
In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is
found not to conform to requirements. The organization shall take appropriate action on the equipment and any product
affected.
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the
intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.
The organization shall monitor and measure the characteristics of the product to verify that product requirements have
been met. This shall be carried out at appropriate stages of the product realization process in accordance with the
planned arrangements. Evidence of conformity with the acceptance criteria shall be maintained.
Measurement requirements for product acceptance shall be documented and shall include:
c) required records of the measurement results (at a minimum, indication of acceptance or rejection); and
d) any specific measurement instruments required and any specific instructions associated with their use.
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When critical items, including key characteristics, have been identified the organization shall ensure they are
controlled and monitored in accordance with the established processes.
When the organization uses sampling inspection as a means of product acceptance, the sampling plan shall be
justified on the basis of recognized statistical principles and appropriate for use (i.e., matching the sampling plan
to the criticality of the product and to the process capability).
The organization shall ensure that product which does not conform to product requirements is identified and controlled to
prevent its unintended use or delivery. A documented procedure shall be established to define the controls and related
responsibilities and authorities for dealing with nonconforming product.
The organization’s documented procedure shall define the responsibility and authority for the review and
disposition of nonconforming product, and the process for approving personnel making these decisions.
Where applicable, the organization shall deal with nonconforming product by one or more of the following ways:
b) by authorizing its use, release, or acceptance under concession by a relevant authority and, where applicable, by the
customer; and/or
The organization’s nonconforming product control process shall provide for timely reporting of delivered
nonconforming product.
Dispositions of use-as-is or repair shall only be used, after approval by an authorized representative of the
organization responsible for design. The organization shall not use dispositions of use-as-is or repair, unless
specifically authorized by the customer, if the nonconformity results in a departure from the contract
requirements.
Product dispositioned for scrap shall be conspicuously and permanently marked, or positively controlled, until
physically rendered unusable.
When nonconforming product is corrected, it shall be subject to re-verification to demonstrate conformity to the
requirements.
The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective
actions shall be appropriate to the effects of the nonconformities encountered.
b) evaluating the need for action to ensure that nonconformities do not recur;
e) determining if additional nonconforming product exists based on the causes of the nonconformities and
taking further action, when required.
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The organization shall conduct internal audits at planned intervals to determine whether the quality system:
a) conforms to planned arrangements and quality system requirements established by the organization, and
The audit program shall be planned and documented to the extent necessary, taking into consideration the
status and importance of the processes and areas to be audited, as well as the results of previous audits. The
audit criteria, scope, frequency, and methods shall be defined and documented.
9. NOTES
A change bar (l) located in the left margin is for the convenience of the user in locating areas where technical revisions,
not editorial changes, have been made to the previous issue of this document. An (R) symbol to the left of the document
title indicates a complete revision of the document, including technical revisions. Change bars and (R) are not used in
original publications, nor in documents that contain editorial changes only.
PREPARED BY SAE COMMITTEE G-14, AMERICAS AEROSPACE QUALITY STANDARDS COMMITTEE (AAQSC)
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