By Authority Of

THE UNITED STATES OF AMERICA

Legally Binding Document
By the Authority Vested By Part 5 of the United States Code 552(a) and
Part 1 of the Code of Regulations 51 the attached document has been duly
INCORPORATED BY REFERENCE and shall be considered legally
binding upon all citizens and residents of the United States of America.
HEED THIS NOTICE: Criminal penalties may apply for noncompliance.
Official Incorporator:
THE EXECUTIVE DIRECTOR
OFFICE OF THE FEDERAL REGISTER
WASHINGTON, D.C.
Document Name:
CFR Section(s):
Standards Body:
e
ASQC Q9001: Quality Assurance in Design, Development,
Production, Installation, and Servicing
33 CFR 96.430(a)(2)(ii)
American Society for Quality Control
Copyright American Society for Quality
Provided by IHS under license with ASQ
ANSI/ASQC Q9001
ADOPTION NOTICE
ANSIIASQC Q9001. -Quality Systems--Model for Quality Assurance in Design,
Development, Production, Installation. and Servicing, was adopted on 15 September
1994 for use by the Department of Defense (000). Proposed changes by 000
activities must be submitted to the 000 Adopting Activity: Office of the Assistant
Secretary of the Air Force for Acquisition. Deputy Assistant Secretary for Management
Policy and Program Integration, Manufacturing and Quality Division, ATTN:
SAF/AOXM. 1060 Air Force Pentagon, Washington, DC 20330-1060. 000 activities
may obtain copies of this standard from the Standardization Document Order Desk, 700
Robbins Avenue, Building 40, Philadelphia, PA 19111-5094. The private sector and
other Government agencies may purchase copies from The American Society for
Quality Control. 611 East Wisconsin Avenue. Milwaukee. WI 53202.
Custodians:
Army - AR
Navy - OS
Air Force - 05
Adopting Activity:
Air Force - 05
(Project QCIG-0185)
AREA OGIG
DISTRIBUTION STATEMENT A: Approved for public release; distribution is unlimited.
No reproduction or networking permitted wilhoullicense from IHS
Sold to:PUBLlC.RESQURCE.ORG, W1277250
2012/4/1821 :31 :52 GMT
ANSI/ASOC 09001-1994
AMERICAN NATIONAL STANDARD
Quality Systems-Model for Quality Assurance
in Design, Development, Production,
Installation, and Servicing
[Revision of first edition (ANSIIASOC 091-1987)]
Prepared by
American Society for Quality Control Standards Committee
for
American National Standards Committee Z-1 on Quality Assurance
An American National Standard Approved on August 1, 1994
Descriptors: quality assurance, quality assurance program, quality systems, design, development (work), production,
installation, after-sale services, reference models.
American National Standards: An American National Standard implies a consensus of those substantially concerned with
its scope and provisions. An American National Standard is intended as a guide to aid the the consumer,
and the general public. The existence of an American National Standard does not in any respect preclude anyone, whether .
he or she has approved the standard or not, from manufacturing, purchasing, or using products, processes, or procedures
not conforming to the standard. American National Standards are subject to periodic review and users are cautioned to
obtain the latest edition.
Caution Notice: This American National Standard may be revised or withdrawn at any time. The procedures of the
American National Standards Institute require that action be taken to reaffirm, revise, or withdraw this standard no later
than five years from the date of publication. Purchasers of American National Standards may receive current information
on all standards by calling or writing the American National Standards Institute.
Copyright American Society for Quality
Provided by IHS under license with ASQ
No reproduction or networking permitted without license from IHS
Sold to:PUBLIC RESOURCE.ORG, W1277250
2012/4/1821 :31:52 GMT
.. Ulb ..
1994 by ASQC
All rights reserved. No part of this bode may be reJIDduced in any furm or by any means, electronic, mechanical, photo-
<:q)ying, recording. or otherwise, without the prior written permission of the publishet
ASIJ.C Mission: 10 facilitate continuous impnnement and increase customer satisfaction by identifying. communicating.
and promoting the use of quality principles, concepts. and technologies; and thereby be recognized throughout the world
as the leading authority on, and champion fbr; quality. .
10987654321
Printed in the United States of America
@ Printed on acid-free
Publmed by:
ASQC
611 East Wisconsin Avenue
Milwaukee, Wisconsin 53202
Copyright American Society for Qualily
Provided by IHS under license with ASO
No reproduction or networking permitted without license from IHS
Sold to:PUBLlC.RESOURCE.ORG, W1277250
2312/4/18 21 :31 ;52 GMT
ANSI/ASQC Q9OO1-1994
Contents
Page
1 Scope ..........................................................................
2 Normative reference. . . . . . . . . . . . . . . ...
3 Definitions .... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ......
4 Quality-system requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
4.1 Management responsibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
4.2 Quality system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 2
4.3 Contract review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4.4 Design contIul . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 3
4.5 I>ocument and data contIul. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 4
4.6 Purchasing...................................................................... 4
4.7 Control of customer-supplied pnxiuct. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.8 Product identification and traceability ............................................. '. . 5
4.9 Process control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.10 Inspection and testing . . . . . . . . . . . . . . . . . . . . . . '6
4.11 Control of inspection, measuring, and test equipment.. .. . . . . . . .. . . .. . . . . . . . . . . . . . . . . .. . . . . 6
4.12 Inspection and test status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
4.13 Control of nonconfbnning pnxiuct. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 7
4.14 Corrective and preventive action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.15 Handling, storage, packaging, preservation, and delivery. . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 8
4.16 ContIol of quality records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 8
4.17 Internal quality audits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.18 1i'aining .................................................. :................... 9
4.19 Servicing....................................................................... 9
4.20 Statistical techniques. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Annex
A Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10
Copyright American Society for Quality
Provided by IHS under license with ASQ
No mnmdlJction or ne!workina oermitted without license from IHS
iii
Sold to:PUBLlC.RESQURCE.ORG, W1277250
2012/4/1821:31:52 GMT
A."l.lIt:\. W JUU..UI " - "-' I - ._-- ------- ..... -
Foreword
(This Foreword is not a pm: of American National Standard Quality Systems-Modelfor Quality Assurance in Design.
Development. Production, Installation, and Servicing.)
This American National Standard corresponds to the Internafunal Standard ISO 9001:1994. The initial fi..e ISO 9000
series standards, ISO 9000. ISO 9001. ISO 9002, ISO 9003, and ISO 9004, when publiIDed in the United States as
American National Standards in 1987. were designated as ANSI! ASQC Q90 through ANSI! ASQC 094 respecfuely.
The fi..e 1987 standards in their 1994 international revisions are now designated ISO 9000-1, ISO 9001, ISO 9002,
ISO 9003. and ISO 9004-1 respectively. Their publication as American National Standards are now designated
ANSI!ASQ!2 Q9OOO-1-1994. ANSI!ASQC Q9001-1994. ANSI!AS0!2 Q9002-1994. ANSI!ASQ!2 Q9003-1994, and
ANSl/ASQ!2 Q9OO4-1-1994 ~ y . This new numbering system is intended to emphasize the word-for-word corre-
spondence of the International and American National Standards.
ISO (the International Organization for Standardization) is a v.urldwide federation of national standards bodies (ISO
member bodies). The \'tUde of prepuing Internaoonal Standards is normally carried out through ISO technical commit-
tees. Each member body interested in a subject for which a technical coounittee has been established has the right to be
represented on that COOlmittee. International organizafuns, governmental and nongmernmental, in liaison with ISO, also
take pm: in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization. The American National Standards Institute (ANSI) is the U.S. member body of ISO.
ASJJ.C is the U.S. member of ANSI responsible for quality management and related standards.
Users should note that all ANSI! ASQC standards undergo revision from time to time. In the case of International
Standards adopted as American National Standards, the revism timing isintluenced by the international revision timing.
Reference herein to any other standard implies the latea American National Standard revision unJesc; otherwise stated.
Comments concerning this standard are welcome. They should be sent to the ~ s o r of the standard, American Society
for Quality Control, 611 East Wisconsin Avenue, P.O. Box 3005, Milwaukee. WI 53201-3005, c/o Standards
Administratot
Copyright American Society for Quality
Provided by IHS under license with ASQ
No reproduction or networking permitted Without license from IHS
v
Sold to:PUBLlC.RESOURCE.ORG. W1277250
2012/4/18 21 :31 :52 GMT
.uu.u ., _ U'...,J ,""UC UUU.J.I.'::U;: J DU..:J _
Introduction
This American National Standard is one of three American National Standards dealing with quality-system requirements
that can be used for external quality-assurance purposes. The modcls, set out in the three American
National Standards listed below, represent three distinct forms of requirements suitable for the purpose of
a StlpIiier demonstrating its capability, and for the assessment of the capability of a supplier by external Jru1ies.
a) ANSI/ASQC Q9OO1-1994, Quality Systems-Modelfor Quality Assurance in Design. Development. Production.
Installation. and Servicing
-fur use when conformance to specified requirements is to be assured by the supplier during design, dewlopment,
production, installati>n, and servicing.
b) ANSI/ASCX- Q9OO2-1994. Quality System-Model for Quality Assurance in Production. Installation. and Servicing
-for use when conformance to specified requirements is to be assured by the rupplier during prodoction, installa-
tion, and servicing.
c) ANSI/ASCX- Q9003-1994, QualitySystems-Modelfor Quality Assurance in Final Inspection and Test
-for use when conformance to specified requirements is to be assured by the supplier sdely at final inspection and
test.
It is emphasized that the quality-system requirements specified in this American Natbnal Standard, ANSI/ASQ(::. Q9002-
1994, and ANSI/ASQC Q9003-1994 are complementary (not alternative) to the technical (product) specified require-
ments. They specify requirements which determine what elements quality systems have to encomlllSS, but it is not the
purpose of these American National Standards to enforce uniformity of quality systems. They are generic and indepen-
dent of any specific indtWy or economic sector: The design and implementation of a quality system will be influenced by
the varying needs of an organization, its particular objectives, the prodocts and services suwJied, and the processes and
specific practices employed.
It is intended that these American National Standards will be adopted in their present form, but on occasions they may
need to be tailored by adding or deleting certain quality-system requirements for specific contractual situations.
ANSI/ ASQC Q9000-1-1994 provides guidance on such tailoring as well as on selection of the appropriate quality-
assurance model, viz. ANSI/ASQC Q9001-1994, ANSI/ASQC Q9OO2-1994, or ANSI/ASQC Q9003-1994.
Copyright American Society for Quality
Provided by lHS under license with ASQ
No reproduction or networking permitted without license from IHS
vii
Sold to:PUBLlC.RESOURCE.ORG, W1277250
2012/4/1821:31:52 GMT
ANSI/ ASQC Q900 1-1994
QUALITY SYSTEMS-MODEL FOR QUALITY ASSURANCE IN DESIGN,
DEVELOPMENT, PRODUCTION, INSTALLATION, AND SERVICING
1 SCOPE
This American National Standard specifies quality-system
requirements for use where a supplier's capability to
design and supply conforming product needs to be
demonstrated.
The requirements specified are aimed primarily at achiev-
ing customer satisfaction by pre..enting noncon1Ormity at
all stages frool design through to servicing.
This American National Standard is applicable in situa-
tions when
a) design is required and the product requirements are
stated principally in perfOrmance terms, or they need
to be established, and
b) confidence in product confurmance can be attained by
adequate demonstration of a supplier's caJIlbilities in
design, development, production, installation, and
servicing.
NOTE 1 For informati..e references, see annex A.
2 NORMATIVE REFERENCE
The following standard contains provisions which,
through reference in this text.; constitute provisions of this
Amerom National Standard. At the time of publication,
the edition indicated was valid. All standards are subject
to revision, and parties to agreements based on this
American National Standard are encouraged to investigate
the posgbility of applying the most recent edition of the
standard indicated below. The American National
Standards Institute and members of me and ISO main-
tain registers of currently valid American National
Standards and International Standards.
ISO 8402:1994, Quality management and quality assur-

3 DEFINITIONS
For the purposes of this American National Standard, the
definitions given in ISO 8402 and the iilowing definitions
awly.
3.1 product: Result of activities or processes.
NOlES
2 A product may include service, hardware, processed
materials, software, or a combination thereof.
Copyright American Society for Quality
Provided by IHS under license with ASQ
No reproduction or networking permitted without license from IHS
1
3 A product can be tangible (e.g., assemblies or
processed materials) or intangible (e.g., knowledge or
concepts), or a combination thereof.
4 fur the purposes of this American National Standant,
the term ''product'' applies to the intended product
offering only and not to unintended "by-products"
affecting the environment This differs from the defini-
tion gi..en in ISO 8402.
3.2 tender: Offer made by a supplier in response to an
invitation to satisfy a contract award to provide prodoct.
3.3 contract; accepted order: Agreed requirements
between a supplier and customer transmitted by any
means.
4 QUALITY-SYSTEM REQUIREMENTS
4.1 Management responsibility
4.1.1 Quality policy
The supplier's management with executi\e responsibility
shall define and document its pdicy fur quality, including
objecti\eS fur quality and its commitment to quality. The
quality policy sball be relevant to the supplier's organiza-
tional goals and the expectations and needs of its cus-
tomers. The supplier shall ensure that this policy is
understood, implemented. and maintained at all levels of
the organization.
4.1.2 Organization
4.1.2.1 Responsibility and authority
The responsibility, authority, and the interrelation of per-
sonnel who manage, perlbrm, and verify \\Uk affecting
quality mall be defined and documented. particularly for
personnel who need the organizational freedom and
authority to:
a) initiate action to pre..ent the occurrence of any non-
conformities relating to product, process, and quality
system;
b) identify and record any problems rclating to the prod-
uct, process, and quality system;
Sold lo:PUBlIC.RESOURCE.ORG, W1277250
2012/4/1821:31:52 GMT
ANSI/ASQC Q9OO1-1994
c) initiate, recommend, or provide soluWns thmugh des-
ignated channels;
d) verify the implementation of solutions;
e) control fwther processing, delivery, or installation of
nonconforming product until the deficiency or unsatis-
factory condition has been corrected.
4.1.2.2 Resources
The supplier snail identify resource requirements and pr0-
vide adequate resources, including the assignment of
trained personnel (see 4.18), for management, perfor-
mance of work, and verification activities including inter-
nal quality audits.
4.1.2.3 Management representative
The supplier's management with executive responsibility
shall appoint a member of the supplier's own management
who, irrespective of other responsibilities, shall have
defined authority for
a) ensuring that a quality system is established, imple-
mented, and maintained in accordance with this
American National Standard, and
b) reporting on the performance of the quality system to
the supplier's management for review and as a basis for
improvement of the quality system.
N01E 5 The responsibility of a management represen-
tative may also include liaison with external parties on
matters relating to the supplier's quality system.
4.1.3 Management review
The supplier's management with executive responsibility
shall review the quality system at defined intervals suffi-
cient to ensure its continuing suitability and effectiw.ness
in satisfying the requirements of this American National
Standard and the supplier's stated quality policy and
objectives (see 4.1.1). Records of such reviews silall be
maintained (see 4.16).
4.2 QUALITY SYSTEM
4.2.1 General
The supplier shall establish, document, and maintain a
quality system as a means of ensuring that product COIl-
fonns to specified requirements. The supJiier shall prqme
a quality manual covering the requirements of this
American National Standard. The quality manual shall
include or make reference to the quality-system JIOCCdures
Copyright American Society for Quality
Provided by IHS under license with ASQ
No reproduction or networking permitted without license from IHS
2
and outline the structure of the documentation used in
the quality system.
N01E 6 Guidance on quality manuals is given in ISO
10013.
4.2.2 Quality-system procedures
The supplier shall
a) prepare documented procedures consistent with the
requirements of this American National Standard and
the supplier's stated quality policy, and
b) effecthely implement the quality system and its docu-
mented procedures.
fur the purposes of this American National Standard, the
range and detail of the procedures that form part of the
quality system depend on the complexity of the \\Ork, the
methods used, and the skills and training needed by per-
sonncl invdved in carrying out the activity.
NOTE 7 Documented procedures may make reference
to work instructions that define how an activity is
perfOrmed.
4.2.3 Quality planning
The supplier shall define and document how the require-
men.ts fur quality will be met Quality planning shall be
consistent with all other requirements of a supplier's qual-
ity system and mall be documented in a format to suit the
supplier's method of operation. The supplier shall give
consideration to the fOllowing activities, as appropriate, in
meeting the specified requirements for products, projects,
or contracts:
a) the preparation of quality plans;
b) the identification and acquisition of any controls,
processes, equipment (including inspection and test
equipment), fixtures, resources, and skills that may be
needed to achieve the required quality;
c) ensuring the compatibility of the design, the produc-
tion process, installation, servicing, inspection, and test
procedures, and the applicable documentation;
d) the updating, as nece&my, of quality contrci, inspec-
tion, and testing techniques, including the development
of new instrumentaron;
e) the identification of any measurement requirement
invdving C8JXlbility that exceeds the known state of the
art, in sufficient time for the needed capability to be
de\eloped;
Sold !o:PUBUC RESOURCE.ORG, W1277250
2012/4/1821 :31:52 GMT
ANSI/ASQC Q9OO1-1994
f) the identification of suitable verification at apptOJ!l iate
stages in the realization of product;
g) the clarification of standards of acceptability for all
features and requirements, including those which con-
tain a subjective element;
h) the identification and preparation of quality records
(see 4.16).
Nom 8 The quality plans referred to (see 4.2.3a) may
be in the form of a reference to the appropriate docu-
mented procedures that form an integral put of the sup-
plier's quality system.
4.3 CONTRACT REVIEW
4.3.1 General
The supplier shall establish and maintain documented
procedures for contract review and for the coordination of
these activities.
4.3.2 Review
Before submissDn of a or at the acceptance of a
contract or order (statement of requirement), the
contract or order shall be reviewed by the supplier to
ensure that:
a) the requirements are adequately defined and docu-
mented; where no written statement of requirement is
available for an order received by verbal means, the
supplier shall ensure that the oIder requirements are
agreed before their acceptance;
b) any differences between the contract or occepted order
requirements and those in the tender are resolved;
c) the supplier has the captbility to meet the contract or
accepted order requirements.
4.3.3 Amendment to contract
The suwlier shall identify how an amendment to a con-
tract is made and correctly transferred to the functions
concerned within the supplier's organization.
4.3.4 Records
Records of contract reviews shall be maintained (see
4.16).
NOW 9 Channels for communication and interfaces
with the customer's organization in these contract matters
should be established.
Copyright American Society for Quality
Provided by lHS under license with ASQ
No reproduction or networking permitted without license from IHS
3
4.4 DESIGN CONTROL
4.4.1 General
The supplier shall establish and maintain documented
procedures to control and verify the design of the prod-
uct in order to ensure that the specified requirements are
met.
4.4.2 Design and development planning
The supplier shall prepare plans for each design and
development octivity. The plans shall describe or reference
these activities, and define responsibility for their imple-
mentation. The design and de\dopment octivities shall be
assigned to qualified personnel equipped with adequate
resources. The plans shall be updated, as the design
emlves.
4.4.3 Organizational and technical interfaces
Organizational and technical interfaces between different
groups which input into the design process shall be
defined and the necessary information documented, trans-
mitted, and regularly
4.4.4 Design input
Design-input requirements relating to the product, includ-
ing applicable statutory and regulatory requirements, shall
be identified, documented, and their selection reviev.ed by
the suwIier for ambiguous, or con-
flicting requirements shall be resolved with those respon-
sible for imposing these requirements.
Design input shall take into consideration the results of
any contracHeview activities.
4.4.5 Design output
Design output shall be documented and expressed in
tenos that can be verified against design-input require-
ments and validated (see 4.4.8).
Design output shall:
a) meet the design-input requiJ:laments;
b) contain or make reference to acceptance criteria;
c) identify those characteristics of the design that are cru-
cial to the safe and proper fWlCtiooing of the product
(e.g., operating, storage, handling, maintenance, and
disposal requirements).
Design-output documents shall be reviewed before
release.
Sold to:PUBlIC.RESQURCE.ORG, W1277250
2012/4/1821 :31:52 GMT
ANSJ/ASQC Q9OO1-1994
4.4.6 Design review
At apptqn iate stages of design, tbrmal OOcumented reviews
of the design results shall be planned and conducted.
Participants at each design review shall include rep-esenta-
tM>s of all functDns concerned with the design &tage being
reviewed, as well as other specia1ist personnel, as required.
RecooJs of such shall be maintained (see 4.16).
4.4.7 Design verification
At appropriate stages of design, design verification shall
be performed to eI1SW'e that the de.'iign-gage output meets
the design-stage input requirements. The
lion measures shal1 be recorded (see 4.16).
N01E 10 In addition to conducting design reviews (see
4.4.6), design \erification may include activities such as
-performing altemati\e calculations,
-comparing the new design with a similar proven
design, if available,
-undertaking tests and demonstrations, and
-reviewing the de.<ign-stage documents befiJre release.
4.4.8 Design validation
Design Vdlidation shall be performed to eI1SW'e that prod-
uct conforms to defined user needs and/or requirements.
NOTES
11 Design validation fullows successful design verifica-
tion (see 4.4.7).
12 Validation is normally performed under defined
operating conditions.
13 .ilidation is normally pertbrmed on the final prod-
uct, but may be necessary in earlier stages prior to
product completion.
14 Multiple validations may be performed if there are
different intended uses.
4.4.9 Design changes
All design changes and modifications shall be identified,
documented, revkwed. and appmed by authorized per-
sonnel bem their implementation.
4.5 DOCUMENT AND DATA CONTROL
4.5.1 General
The supplier shall establish and maintain documented
procedures to control all documents and data that relate to
the requirements of this American National Standard
Copyright American Society for Quality
Provided by IHS under license with ASQ
No reproduction or networking permitted wilhoullicense from IHS
4
including, to the alent applicable, documents of atemal
origin such as standards and customer drawings.
NOTE 15 Documents and data can be in the form of
any type of media, such as hard copy or electronic media.
4.5.2 Document and data approval and issue
The documents and data shall be reviewed and
lOr adequacy by authorized personnel prior to issue. A
master list or equivalent document-control procedure
identifying the current revision status of documents shall
be established and be readily available to preclude the use
of invalid and/or obsolete documents.
This control shall ensure that
a) the pertinent issues of appropriate documents are
available at all locations where operations essential
to the effecti\e functioning of the quality system are
performed;
b) invalid and/or obsolete documents are promptly
remoYed fran all points of issue or use, or otherwise
assured against unintended use;
c) any obsolete documents retained for legal and/or
knowledge-preservafun purposes are suitably identified.
4.5.3 Document and data changes
Changes to documents and data shall be reviewed and
appl1(M:d by the same functionS/organizations that per-
tbrmed the original review and approval, unless specifi-
cally designated otherwise. The designated functions!
organizations shall ha\e access to pertinent background
intbrmation upon which to base their review and approwl.
Where practicable, the nature of the change shall be iden-
tified in the document or the appropriate attachmentS.
4.6 PURCHASING
4.6.1 General
The supplier shall establish and maintain documented
procedures to ensure that purchased product (see 3.1)
confurms to specified requirements.
4.6.2 Evaluation or subcontractors
The supplier shall:
a) evaluate and select subcontractors on the basis of their
ability to meet subcontract requirements including the
quality system and any specific quality-assurance
requirements;
Soldto:PUBLlC.RESQURCE.QRG, W1277250
2012/4/1821 :31 :52 GMT
ANSI/ASQC Q900 1-1994
b) define the type and extent of control by the
supplier mer subcontractors. This shall be dependent
upon the type of product, the impact of subcontracted
product on the quality of final product, and, where
applicable. on the quality audit reports and/or quality
records of the previously demonstrated capability and
performance of subcontractors;
c) establish and maintain quality records of acceptable
subcontractors (see 4.16).
4.6.3 Purchasing data
Purchasing documents shall contain data clearly describ-
ing the prodoct ordered, including where applicable:
a) the type, class, grade, or other precise identification;
b) the title or other posithe identification, and applicable
issues of specifications, drawings, process require-
ments, inspection i.nstIu:tions, and other relevant tech-
nical data, including requirements for approval or
qualification of product, procedures, process equip-
ment, and personnel;
c) the title, and of the quality-system SIan-
dard to be applied.
The supplier shall review and appro\e purchasing docu-
ments fur adeqwq of the specified requirements prior to
rclease.
4.6.4 Verification of purchased product
4.6.4.1 Supplier verification at subcontractor's
premises
Where the supplier p:oposes to \erify pUIChased JIOduct
at the subcontractor's premises, the supplier shall specify
verification arrangements and the method of product
release in the puIChasing documents.
4.6.4.2 Customer verirlCation of subcontracted
product
Where specified in the contract, the suwlier's customer or
the custooler's representathe shall be afforded the right to
\erify at the subcontractor's premises and the supplier's
premises that subcontracted product confbrms to specified
requirements. Such verification shall not be used by the
suppIier as evidence of effecthe control of quality by the
subcontractoJ:
\erification by the customer shall not absohe the supplier
of the to provide acceptable product, nor
shall it preclude subsequent rejection by the customer:
Copyright American Society for Quality
Provided by IHS under license with ASQ
No reproduction or networking without license from IHS
5
4.7 CONTROL OF CUSTOMERSUPPLIED
PRODUCT
The supplier shall establish and maintain documented
procedures for the control of verification, storage, and
maintenance of customer-supplied product provided for
incorporation into the supplies or for related activities.
Any such product that is lost, damaged, or is otherwise
unsuitable tOr use shall be recorded and reported to the
customer (see 4.16).
\\!rification by the supplier does not absdve the custooler
of the responsibility to provide acceptable product
4.8 PRODUCT IDENTIFICATION AND
TRACEABILITY
Where awropriate, the supplier shall establish and main-
tain documented procedures for identifying the product
by suitable means from receipt and during all stages of
prodoction, delivery, and installation.
Where and to the extent that traceability is a specified
requirement, the supplier shall establish and maintain doc-
umented procedures fur unique identification of individual
product or batches. This identification shall be recorded
(see 4.16).
4.9 PROCESS CONTROL
The supplier shall identify and plan the production,
installation, and servicing processes which directly affect
quality and shall ensure that these processes are carried
out under controlled conditions. Controlled conditions
shall include the fdlowing:
a) documented procedures defining the manner of pro-
duction, installation, and servicing, where the
absence of such procedures could adversely affect
quality;
b) use of suitable production, installation, and servicing
equipment, and a suitable working environment;
c) compliance with reference standards/codes, quality
plans, and/or documented procedures;
d) monitoring and control of suitable process parameters
and product characteristics;
e) the of processes and equipment, as
f) criteria fur workmanship, which shall be stipulated in
the clearest practical manner (e.g., written standards,
rep-esentative samples, or illustrations);
g) suitable maintenance of equipment to ensure continu-
ing process C3JIIbility.
Sold to:PUBLlC.RESOURCE.ORG, W1277250
2012/4/1821:31:52 GMT
ANSI/ASQC Q9OO1-1994
Where the results of cannot be fully ..erified by
subsequent inspection and testing of the product and
where, for example, processing deficiencies may become
apparent only after the product is in use, the processes
shall be carried out by qualified operators and/or shall
require continoous monitaing and contni of process pml-
meters to ensure that the specified requirements are met.
The requirements for any qualification of process ~ r a
tions, including 8S'lOCiated equipment and personnel (see
4.18), shall be specified.
NOTE 16 Such processes requiring prequalification of
their process capability are frequently referred to as spe-
cial processes.
Records shall be maintained for qualified processes,
equipment, and personnel, as appropriate (see 4.16).
4.10 INSPECTION AND TESTING
4.10.1 General
The supplier shall establish and maintain documented
procedures for inspection and testing activities in order to
verify that the specified requirements for the pOOuct are
met. The required inspection and testing, and the records
to be established, !bal1 be detailed in the quality plan or
documented procedures.
4.10.1 Receiving inspection and testing
4.10.1.1 The supplier man ensure that incaning prodoct is
not used or processed (except in the circumstances
de<mbed in 4.10.2.3) until it has been inspected <r other-
wise verified as conforming to specified requirements.
\bification of the ~ requirements man be in accor-
dance with the quality plan an<V<r documented p:ocedures.
4.10.1.1 In determining the amount and nature of receiv-
ing inspection, consideration shall be given to the amount
of contni exercised at the subcontractor's premises and
the recorded evidence of conformance puvided.
4.10.1.3 Where incoming product is released for urgent
production purposes prior to verification, it mn be posi-
tively identified and recorded (see 4.16) in order to permit
immediate recall and replacement in the event of noncon-
lOrmity to specified requirements.
4.10.3 In-process inspection and testing
The supplier shall:
a) inspect and test the prodoct as required by the quality
plan and/or documented procedures;
Copyright American Society for Quality
ProVIded by IHS under license with ASQ
No reproduction or nelworkinQ permitted without license from IHS
6
b) hold product until the required inspection and tests
ha..e been completed or necessary reports have been
received and verified, except when product is released
under positive-recall procedures (see 4.10.2.3).
ReIease under positive-recall procedures shall not pre-
clude the activities outlined in 4.10.3a
4.10.4 Final inspection and testing
The supplier shall carry out all final inspection and test-
ing in accordance with the quality plan and/or docu-
mented procedures to complete the evidence of
conformance of the finished product to the specified
requirements.
The quality plan and/or documented procedures for final
inspection and testing shall require that all specified
inspection and tests, including those specified either on
receipt of pOOuct or in-process, have been carried out and
that the results meet specified requirements.
No product shall be disJxttched until all the activities spec-
ified in the quality plan and/or documented procedures
have been satisfactorily completed and the associated data
and documentation are available and authorized.
4.10.5 Inspection and test records
The supplier sball establish and maintain records which
provide evidence that the product has been inspected
an<Vor tested. These records shall show clearly whether
the product has passed or failed the inspections and/or
tests according to defined acceptance criteria. Where the
product fails to pass any inspection and/or test, the proce-
dures for control of nonconfOrming product shall apply
(see 4.13).
Records shall identify the inspection authority responsible
for the release of product (see 4.16).
4.11 CONTROL OF INSPECTION, MEASURING,
AND TEST EQUIPMENT
4.11.1 General
The supplier shall establish and maintain documented
proced\D'eS to control, calIbrate, and maintain inspection,
measuring, and test equipment (including test software)
used by the supplier to dernoru>trate the confonnance of
product to the specified requirements. Inspection, measur-
ing, and test equipment shall be used in a manner which
ensures that the measurement uncertainty is known and is
consistent with the required measurement capability.
Sold to:PUBLlC.RESOURCE.ORG, W1277250
2012/4/1821 :31 :52 GMT
c.l'1UU.II '1 .... lIB U (.!J'1.!JUb UUUJd,jb T .... .!J -
ANSI! ASQC Q900 1-1994
Where test software or COffi{mathe references such as test
hardware are used as suitable ronns of inspection, they
shall be checked to pi'O\e that they are capable of verify-
ing the acceptability of product, prior to release for use
dwing production, installation, or servicing, and shall be
rechecked at prescribed intervals. The supplier shall
establish the extent and frequency of such checks and
shall maintain records as evidence of control (see 4.16).
Where the availability of technical data pertaining to the
measurement equipment is a specified requirement, such
data shall be made available, when required by the cus-
tomer or customer's rep-esentame, for \erification that the
measuring equipment is functionally adequate.
N01E 17 For the purposes of this American National
Standard, the tenn measuring equipment" includes mea-
surement devices.
4.11.2 Control procedure
The supplier shall:
a) determine the measurements to be made and the accu-
racy required. and select the appropriate inspection,
measuring, and test equipment that is of the
necessary accuracy and precision;
b) identify all inspection, measwing, and test equipment
that can affect product quality, and calibrate and adjust
them at prescribed intervals, or prior to use, against
certified equipment having a known valid reJationship
to internationally or nationally recognized standaIds.
Where no such standards exist, the basis used fur cali-
bration shall be documented;
c) define the process employed for the calibration of
inspection, measuring, and test equipment, including
details of equipment type. unique identification. loca-
tion, frequency of checks. check method. acceptance
criteria. and the action to be taken when results are
unsatisfactory;
d) identify inspection. measuring. and test equipment
with a suitable indicator or approved identification
record to show the calibration status;
e) maintain calibration records fur inspection, measuring,
and test equipment (see 4.16);
t) assess and document the validity of previowl inspec-
tion and test results when inspection, measming, and
test equipment is round to be out of calibration;
g) ensure that the environmental conditions are suitable
for the calibrations, inspections, measurements, and
tests being carried out;
Copyright American Society for Quality
Provided by IHS under license With ASQ
No reproductlon or networking permitted without license from IHS
7
h) ensure that the handling, preservation, and storage of
inspection, measuring, and test equipment is such that
the accuracy and fitness ror use are maintained;
i) safeguard inspection, measuring, and test facilities,
including both test hardware and test software, from
adjustments which would invalidate the calibration
setting.
NOTE 18 The metrological confirmation system for
measuring equipment given in ISO 10012 may be used
fOr guidance.
4.12 INSPECTION AND TEST STATUS
The inspection and test status of product shall be identi-
fied by suitable means, which indicate the confurmance or
nonconformance of product with regard to inspection and
tests perfOrmed. The identification of inspection and test
status shall be maintained. as defined in the quality plan
and/or documented procedures, throughout production,
installation, and servicing of the product to ensure that
only product that has passed the required inspections and
tests [or released under an authorized concession (see
4.13.2)] is disJlltched, used, or installed.
4.13 CONfROL OF NONCONFORMING PROOUcr
4.13.1 General
The supplier shall establish and maintain documented
procedures to ensure that product that does not confurm
to specified requirements is prevented from unintended
use or installation. This contrd shall provide fOr identifi-
cation, documentation, evaluation, segregation (when
practical), disposition of nonconfbnning product, and fOr
notification to the functions concerned.
4.13.2 Review and disposition of nonconforming
product
The responsibility ror review and authority fOr the disp0-
sition of nonconforming shall be defined.
Nonconforming product shall be revie\W.d in accordance
with documented procedures. It may be
a) mrorked to meet the specified requirements.
b) accepted with or without repair by
c) regraded for alternative applications, or
d) rejected or ocrapped.
Where required by the contract, the proposed use or
reprir of product (see 4.13.2b) which does not confurm to
Sold to:PUBLlC.RESOURCE.ORG, W1277250
2012/4/1821:31 :52 GMT
ANSI! ASQC Q900 1-1994
specified requirements shall be reported fur concession to
the customer or customer's representatiw. The descripfun
of the nonconformity that has been accepted, and of
reJXlirs, shall be recorded to denote the actual condition
(see 4.16).
Repaired and/or reworked product shall be reinspected
in accordance with the quality plan and/or documented
procedures.
4.14 CORRECTIVE AND PREVENTIVE ACTION
4.14.1 General
The supplier shall establish and maintain documented
procedures for implementing corrective and preventive
action.
Any corrective or pre\entive action taken to eliminate the
causes of actual or potential nonconformities shall be to a
degree appropriate to the magnitude of problems and
COOlmensurate with the risks encountered.
The supplier shall implement and record any changes to
the documented procedmes resulting fum corrective and
pre\enti\e action.
4.14.2 Corrective action
The procedures for corrective action shall include:
a) the effective handling of customer complaints and
reports of product nonconfurmities;
b) investigation of the cause of nonconfurmities relating to
product. process, and quality system, and recording the
results of the in\eSligation (see 4.16);
c) determination of the corrective action needed to elimi-
nate the cause of nonconfonnities;
d) awJication of controls to ensure that correcti\e action
is taken and that it is effective.
4.14.3 Preventive action
The procedures for preventi\e action shall include:
a) tlie use of appropriate sources of information such as
processes and work operations which affect product
quality. audit results. quality records. ser-
vice reports, and cm10mer complaints to detect, ana-
lyze, and climinate potential causes of 1lOllCOIlfmniti;
b) determination of the steps needed to deal with any
problems requiring preventi\e action;
c) initiation of preventive action and application of con-
trols to ensure that it is effective;
Copyright American Society for Quality
Provided by IHS under license with Asa
No reproduction or networking permitted without license from IHS
8
d) confinnation that relevant information on actions taken
is submitted for management review (see 4.1.3).
4.15 HANDLING, STORAGE, PACKAGING,
PRESERVATION, AND DELIVERY
4.15.1 General
The supplier shall establish and maintain documented
procedures fur handling, storage, paclQtging, preservation,
and of product
4.15.2 Handling
The suWlier shall provide methods of handling product
that pre..ent damage or deterioration.
4.15.3 Storage
The supplier shall use designated storage areas or stock
rooms to prevent damage or deterioration of product,
pending use or delivery. Appropriate methods for autho-
rizing receipt to and dispatch from such areas shall be
&ipulated.
In order to detect deterioration, the condition of product in
stock shall be assessed at appropriate intervals.
4.15.4 Packaging
The SUWIier shall control packing, packaging, and mark-
ing processes (including materials used) to the extent nec-
essary to ensure conformance to specified requirements.
4.15.5 Preservation
The supplier shall apply appropriate methods for preser-
vation and segregation of product when the product is
under the supplier's cont:rd.
4.15.6 Delivery
The supplier shall arrange for the protection of the quality
of product after final inspection and test Where contrac-
tually specified, this protection shall be extended to
include delivery to destination.
4.16 CONTROL OF QUALITY RECORDS
The supplier shall establish and maintain documented
procedures for identification, collection, indexing, access,
filing, storage, maintenance, and disposition of quality
records.
Quality records shall be maintained to demonstrate con-
formance to specified requirements and the effective
Sold to:PUBLlC.RESQURCE.ORG, W1277250
2012/4/1821 :31 52 GMT
ANSI/ ASQC Q900 1-1994
operation of the quality system. Pertinent quality records
from the subcontractor shall be an element of these
data.
All quality records shall be legible and shall be &ored and
retained in such a way that they are readily retrievable in
facilities that provide a suitable environment to prevent
damage or deterioration and to prevent loss. Retention
times of quality records man be established and recorded.
Where agreed contractually, quality records shall be made
available for evaluation by the customer or the customer's
representative fur an agreed period.
N01E 19 Records may be in the furm of any type of
media, such as hard copy or electronic media.
4.17 INTERNAL QUAliTY AUDITS
The supplier shall establish and maintain documented
procedures for planning and implementing internal quality
audits to verify whether quality activities and related
results comply with planned arrangements and to deter-
mine the effectiveness of the quality system.
Internal quality audits shall be scheduled on the basis of
the status and importance of the activity to be audited
and shall be carried out by personnel independent of
those having direct responsibility for the activity being
audited.
The results of the audits shall be recorded (see 4.16) and
brought to the attention of the personnel having responsi-
bility in the area audited. The management personnel
responsible for the area shall take timely corrective action
on deficiencies found during the audit
Follow-up audit activities shall verify and record the
implementation and effectiveness of the corrective action
taken (see 4.16).
Copyright American Society for Quality
Provided by IHS under license with ASO
No reproduction or networking permitted wilhoullicense from IHS
9
NOlES
20 The results of internal quality audits form an integral
part of the input to management review activities
(see 4.1.3).
21 Guidance on quality-system audits is given in
ANSI/ASQC Q10011-1-1994, ANSI/ASQC
Ql0011-2-1994, and ANSI/ASQC Ql0011-3-1994.
4.18 TRAINING
The supplier shall establish and maintain documented
procedures tOr identifying training needs and provide for
the training of all personnel performing activities affecting
quality. fusonnel performing specific assigned tasks shall
be qualified on the basis of appropriate education,.training
and/or experience, as required. Appropriate records of
training shall be maintained (see 4.16).
4.19 SERVICING
Where servicing is a specified requirement, the supplier
shall establish and maintain documented procedures for
performing, verifying, and reporting that the servicing
meets the specified requirements.
4.20 STATISTICAL TECHNIQUES
4.20.1 Identification of need
The supplier shall identify the need for statistical tech-
niques required for establishing, controlling. and verifying
process C<lJllbility and product characteristics.
4.20.2 Procedures
The supplier shall establish and maintain documented
procedures to implement and control the application of the
statistical techniques identified in 4.20.1.
Sold to:PUBLlC.RESQURCE.ORG, W1277250
2012/4/1821:31 :52 GMT
ANSI/ASQC Q9OO1-1994
ANNEX A (INFORMATIVE)
BIBLIOGRAPHY
[1] ANSI/ASQC Q9OOO-1-1994, Quality Management and Quality Assurance Standards-Guidelines for Selection
and Use.
[2] ANSI/ASQC Q9OO2-1994, Quality Syslems-Model/or Quality Assurance in Production. Installation. and
Servicing.
[3] ANSl/ASC:X: Q9003-1994, Quality Systent.'f--Model/or Quality Assurance in Final Inspection and Test.
[4] ANSI/ASQC Ql0011-I-I994, Guidelinesfor Auditing Quality Systems-Auditing.
[5] ANSI/ASQC Ql0011-2-1994, GUidelines/or Auditing Quality Systems-Quali/ication Criteria for Quality
Systems Auditors.
[6] ANSI/ASQC Ql0011-3-1994, Guidelines/or Auditing Quality Systems-Management a/Audit Programs.
[7] ISO 9000-2:1993, Quality management and quality assurance standards-Part 2: Generic guidelines for the
application of [SO 9001. ISO 9002 and ISO 9003.
[8] ISO 9000-3:1991, Quality management and quality assurance standards-Part 3: Guidelines/or the application
0/ ISO 9001 to the developmenl. supply and maintenance of software.
[9] ISO 10012-1: 1992, Quality assurance requirements/or measuring equipmenl---Part 1: Metrological confirmation
systemfor measuring equipment.
[10] ISO 10013:-
1
), Guidelines/or developing quality manuals.
1) 1b be published.
Copyright American Society for Quality
Provided bV IHS under license with ASQ
No reproduction or networking permitted without license from IHS
10
Sold lo:PUBLlC.RESOURCE.ORG. W1277250
2012/4/1821:31:52 GMT