IS0

INTERNATIONAL STANDARD 9001

First edition
1987-03-15

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

ORGANISATION INTERNATIONALE DE NORMALISATION
MEXfiYHAPOAHAR OPrAHM3AqMR no CTAHfiAPTH3Al.&lM

Quality systems - Model for quality assurance in

design/ deve1op ment , production, instaIlat ion and
servicing

". iTeh STANDARD PREVIEW

Systèmes quaiité - Modèle pour l'assurance de la qualité en conceptionldéveloppement,
(standards.iteh.ai)
production, installation et soutien après la vente

ISO 9001:1987
https://standards.iteh.ai/catalog/standards/sist/1c6f8027-b48f-4a94-92e0-
86562f54a923/iso-9001-1987

Reference number
IS0 9001 : 1987 (E)
1 Foreword
IS0 (the International Organization for Standardization) is a worldwide federation of
national standards bodies (IS0 member bodies). The work of preparing International
Standards is normally carried out through IS0 technical committees. Each member
body interested in a subject for which a techriical committee has been established has
the right to be represented on that committee. International organizations, govern-
~
mental and non-governmental, in liaison with ISO, also take part in the work.

Draft International Standards adopted by the technical committees are circulated to

the member bodies for approval before their acceptance as InternationalStandards by
the IS0 Council. They are approved in accordance with IS0 procedures requiring at
least 75 % approval by the member bodies voting.

International Standard I S 0 9001 was prepared by Technical Committee ISO/TC 176,

Quality assurance.

iTeh STANDARD PREVIEW

Users should note that all International Standards undergo revision from time to time
and that any reference made herein to any other International Standard implies its
(standards.iteh.ai)
latest edition, unless otherwise stated.

ISO 9001:1987
https://standards.iteh.ai/catalog/standards/sist/1c6f8027-b48f-4a94-92e0-
86562f54a923/iso-9001-1987

0 International Organization for Standardization, 1

W O
 SO 9001 : 1987 (E)

Contents
Page
O Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . ...................... 1

.............................. 1

1.1 Scope . . . . . . . ....................................... 1

1.2 Field of application . ............................. 1

.............................. 1

3 Definitions . . . . ................................................ 1

........................ 2

4.1 Management responsibility . .............................. 2

iTeh STANDARD PREVIEW
4.2 Quality system . ........................................ 2
(standards.iteh.ai)
4.3 Contract review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

4.4 ISO 9001:1987 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Designcontrol ......... 3
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4.5 Document control . . . . .
86562f54a923/iso-9001-1987 ................................. .. 3
4.6 Purchasing ......................................... 3

4.7 Purchaser supplied product . . . . . . . . . 4

4.8 Product identification and traceability ......................... 4

4.9 Process control ........................................... 4

4.10 Inspectionand testing ....................................... 4

4.11 Inspection, measuring and test equipment ................ .... 5

4.12 Inspectionand test status 5

4.13 Control of nonconforming product ................................. 5

4.14 Corrective action ............................................. 6

4.15 Handling, storage, packaging and delivery ................. 6

4.16 Quality records . . . . . . . . . . . . . . . . . . . . .............. 6

4.17 internal quality audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

4.18 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

4.19 Servicing . . . . . . . . . . . . . . . . . .......................... 7

4.20 Statisticaltechniques . . . . . . .............. 7

iii
INTERNATIONAL STANDARD I S 0 9001 : 1987 (E)

Quality systems - Model for quality assurance in

design/development, production, installation and
servicing

O Introduction 1 Scope and field of application

This International Standard is one of a series of three Inter- 1.1 Scope

national Standards dealing with quality systems that can be
used for external quality assurance purposes. The alternative This International Standard specifies quality system require-
quality assurance models, set out in the three International ments for use where a contract between two parties requires
Standards listed below, represent three distinct forms of the demonstration of a supplier's capability to design and
"functional or organizational capability" suitable for two-party supply product.
contractual purposes :

-
iTeh- STANDARD
I S 0 9001. Quality systems Model for quality
PREVIEW
The requirements specified in this International Standard are
aimed primarily at preventing nonconformity at all stages from
(standards.iteh.ai)
assurance in design/development, production,
and servicing.
installation design through to servicing.

ISO 9001:1987
For use when conformance to specified requirements is to 1.2 Field of application
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be assured by the supplier during several stages which may
86562f54a923/iso-9001-1987
include design/development, production, installation and This International Standard is applicable in contractual situa-
servicing. tions when

- IS0 9002, Quality systems - Model for quality a) the contract specifically requires design effort and the
assurance in production and installation. product requirements are stated principally in performance
terms or they need to be established;
For use when conformance to specified requirements is to
be assured by the supplier during production and installa- b) confidence in product conformance can be attained by
tion. adequate demonstration of certain supplier's capabilities in
design, development, production, installationand servicing.
- IS0 9003, Quality systems - Model for quality
assurance in final inspection and test.
2 References
For use when conformance to specified requirements is to
be assured by the supplier solely at final inspectionand test. IS0 8402, Quality - Vocabulary.

I S 0 9ooo, Quality management and quality assurance stan-

It is emphasized that the quality system requirements specified dards - Guiùelines for selection and use.
in this InternationalStandard, IS0 9002 and IS0 9003 are com-
plementary (not alternative) to the technical (product/service)
specified requirements.
3 Definitions
It is intended that these International Standards will normally
be adopted in their present form, but on occasions they may For the purposes of this International Standard, the definitions
need to be tailored for specific contractual situations. IS0 9ooo given in IS0 8402 apply.
provides guidance on such tailoring as well as selection of the
appropriate quality assurance model, wiz IS0 9001, IS0 9002 or NOTE - For the purposes of this International Standard, the term
IS0 9003. "product" is also used to denote "service", as appropriate.

1
I S 0 9001 : 1987 (E)

4 Quality system requirements NOTE - Management reviews normallyincludeassessment of the

results of internal quality audits, but are carried out by, or on behalf
of, the supplier's management, viz management personnel having
4.1 Management responsibility direct responsibility for the system. (See 4.17.)

4.1.1 Quality policy

The supplier's management shall define and document its

4.2 Quality system
policy and objectives for, and commitment to, quality. The sup-
plier shall ensure that this policy is understood, implemented The supplier shall establish and maintain a documented
and maintained at all levels in the organization. quality system as a means of ensuring that product con-
forms to specified requirements. This shall include

4.1.2 Organization a) the preparation of documented quality system pro-

cedures and instructions in accordance with the re-
4.1.2.1 Responsibility and authority quirements of this International Standard;

The responsibility, authority and the interrelation of all person- b) the effective implementationof the documented quality
nel who manage, perform and verify work affecting quality system procedures and instructions.
shall be defined; particularly for personnel who need the
organizational freedom and authority to NOTE - In meeting specified requirements, timely consideration
needs to be given to the following activities :
a) initiate action to prevent the occurrence of product a) the preparation of quality plans and a quality manual in ac-
nonconformity; cordance with the specified requirements;
b) the identification and acquisition of any controls, processes,
b) identify and record any product quality problems; inspection equipment, fixtures, total production resources and
skills that may be needed to achieve the required quality;

designated channels;
iTeh STANDARDtesting
c) initiate, recommend or provide solutions through c) PREVIEW
the updating, as necessary, quality control, inspection and
of
techniques, including the development of new instrumenta-
tion;
d) verify the implementation of solutions;
(standards.iteh.ai)
d) the identification of any measurement requirement involving
capability that exceeds the known state of the art in sufficient time
e) control further processing, delivery or installationISO for the needed capability to be developed;
of 9001:1987
nonconforming product untilhttps://standards.iteh.ai/catalog/standards/sist/1c6f8027-b48f-4a94-92e0-
the deficiency or unsatisfac- e) the clarification of standards of acceptability for all features
tory condition has been corrected. and requirements, including those which contain a subjective ele-
86562f54a923/iso-9001-1987
ment;
4.1.2.2 Verification resources and personnel f) the compatibility of the design, the production process, in-
stallation, inspection and test procedures and the applicable
documentation:
The supplier shall identify in-house verification requirements,
provide adequate resources and assign trained personnel for g) the identification and preparationof quality records isee 4.16).
verification activities isee 4.18).

Verification activities shall include inspection, test and monitor-

ing of the design, production, installation and servicing pro- 4.3 Contract review
cesses and/or product: design reviews and audits of the quality
system, processes and/or product shall be carried out by per- The supplier shall establish and maintain procedures for con-
sonnel independent of those having direct responsibilityfor the tract review and for the coordination of these activities.
work being performed.
Each contract shall be reviewed by the supplier to ensure that

4.1.2.3 Management representative a) the requirements are adequately defined and docu-
mented;
The supplier shall appoint a management representative who,
irrespective of other responsibilities, shall have defined author-
b) any requirements differing from those in the tender are
ity and responsibilityfor ensuring that the requirements of this
resolved;
International Standard are implemented and maintained.
c) the supplier has the capability to meet contractual re-
quirements.
4.1.3 Management review
Records of such contract reviews shall be maintained (see
The quality system adopted to satisfy the requirements of this 4.16).
International Standard shall be reviewed at appropriate inter-
vals by the supplier's management to ensure its continuing NOTE - The contract review activities, interfaces and communication
suitability and effectiveness. Records of such reviews shall be within the supplier's organizationshould be coordinatedwith the pur-
maintained isee 4.16). chaser's organization, as appropriate.

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 I S 0 9001 : 1987 (E)

4.4 Design control a) holding and recording design reviews (see 4.16);

4.4.1 General b) undertaking qualification tests and demonstrations;

The supplier shall establish and maintain procedures to control c) carrying out alternative calculations;
and verify the design of the product in order to ensure that the
specified requirements are met. d) comparing the new design with a similar proven design,
if available.
4.4.2 Design and development planning
4.4.6 Design changes
The supplier shall draw up plans that identify the responsibility
for each design and development activity. The plans shall The supplier shall establish and maintain procedures for the
describe or reference these activities and shall be updated as identification, documentation and appropriate review and ap-
the design evolves. proval of all changes and modifications.

4.4.2.1 Activity assignment

4.5 D o c u m e n t control
The design and verification activities shall be planned and
assigned to qualified personnel equipped with adequate 4.5.1 Docurnent approval and issue
resources.
The supplier shall establish and maintain procedures to control
all documents and data that relate to the requirements of this
4.4.2.2 Organizational and technical interfaces International Standard. These documents shall be reviewed
and approved for adequacy by authorized personnel prior to
Organizational and technical interfaces between different issue. This control shall ensure that
groups shall be identified and the necessary information
documented, transmitted and regularly reviewed. a) the pertinent issues of appropriate documents are
iTeh STANDARD PREVIEW
available at all locations where operations essential to the
4.4.3 Design input effective functioning of the quality system are performed;
(standards.iteh.ai)
Design input requirements relating to the product shall be iden- b) obsolete documents are promptly removed from all
tified, documented and their selection reviewed by the supplier points of issue or use.
ISO 9001:1987
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4.5.2 Document changes/modifications
86562f54a923/iso-9001-1987
Incomplete, ambiguous or conflicting requirements shall be
resolved with those responsible for drawing up these re- Changes to documents shall be reviewed and approved by the
quirements. same functions/organizations that performed the original
review and approval unless specifically designated otherwise.
The designated organizations shall have access to pertinent
4.4.4 Design output background information upon which to base their review and
approval.
Design output shall be documented and expressed in terms of
requirements, calculations and analyses. Where practicable, the nature of the change shall be identified
in the document or the appropriate attachments.
Design output shall

a) meet the design input requirements; A master list or equivalent document control procedure shall be
established to identify the current revision of documents in
b) contain or reference acceptance criteria; order to preclude the use of non-applicabledocuments.

c) conform to appropriate regulatory requirements Documents shall be re-issued after a practical number of
whether or not these have been stated in the input informa- changes have been made.
tion;

d) identify those characteristics of the design that are 4.6 Purchasing

crucial to the safe and proper functioning of the product.
4.6.1 General
4.4.5 Design verification
The supplier shall ensure that purchased product conforms to
The supplier shall plan, establish, document and assign to com- specified rrquirements.
petent personnel functions for verifying the design.
4.6.2 Assessment of sub-contractors
Design verification shall establish that design output meets the
design input requirement (see 4.4.4) by means of design con- The supplier shall select sub-contractors on the basis of their
trol measures such as : ability to meet sub-contract requirements, including quality

3
I S 0 9001 : 1987 (E)

requirements. The supplier shall establish and maintain records Where, and to the extent that, traceability is a specified require-
of acceptable sub-contractors (see 4.16). ment, individual product or batches shall have a unique iden-
tification. This identification shall be recorded isee 4.16).
The selection of sub-contractors, and the type and extent of
control exercised by the supplier, shall be dependent upon the
type of product and, where appropriate, on records of sub- 4.9 Process control
contractors' previously demonstrated capability and perfor-
mance. 4.9.1 General

The supplier shall ensure that quality system controls are effec- The supplier shall identify and plan the production and, where
tive. applicable, installation processes which directly affect quality
and shall ensure that these processes are carried out under con-
trolled conditions. Controlled conditions shall include the
4.6.3 Purchasing data
following :
Purchasing documents shall contain data clearly describing the
a) documented work instructions defining the manner of
product ordered, including, where applicable,
production and installation, where the absence of such in-
structions would adversely affect quality, use of suitable
a) the type, class, style, grade or other precise identifica-
production and installationequipment, suitable working en-
tion;
vironment, compliance with reference standards/codesand
quality plans;
b) the title or other positive identification, and applicable
issue of specifications, drawings, process requirements,
b) monitoring and control of suitable process and product
inspection instructions and other relevant technical data,
characteristics during production and installation;
including requirements for approval or qualification of
product, procedures, process equipment and personnel; ci the approval of processes and equipment, as ap-
propriate;
c) the title, number and issue of the quality system Inter-
iTeh STANDARDd) PREVIEW
national Standard to be applied to the product. criteria for workmanship which shall be stipulated, to
the greatest practicable extent, in written standards or by
The supplier shrill review and approve purchasing documents
(standards.iteh.ai)
for adequacy of specified requirements prior to release.
means of representative samples.

4.9.2 Special processes

ISO 9001:1987
4.6.4 Verification of purchased product
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These are processes, the results of which cannot be fully
Where specified in the contract, the purchaser or his86562f54a923/iso-9001-1987
represen-
verified by subsequent inspection and testing of the product
tative shall be afforded the right to vorify at source or upon
and where, for example, processing deficiencies may become
receipt that purchased product conforms to specified re-
apparent only after the product is in use. Accordingly, con-
quirements. verification by the purchaser shall not absolve the
tinuous monitoring and/or compliance with documented pro-
supplier of the responsibilityto provide acceptable product nor
cedures is required to ensure that the specified requirements
shall it preclude subsequent rejection.
are met. These processes shall be qualified and shall also
comply with the requirements of 4.9.1.
When the purchaser or his representative elects to carry out
verification at the sub-contractor's plant, such verification shall
Records shall be maintained for qualified processes, equipment
not be used by the supplier as evidence of effective control of
quality by the sub-contractor. and personnel, as appropriate.

4.7 Purchaser supplied product 4.10 Inspection and testing

The supplier shall establish and maintain procedures for 4.10.1 Receiving inspection and testing
verification, storage and maintenance of purchaser supplied
product provided for incorporation into the supplies. Any such 4.10.1.1 The supplier shall ensure that incoming product is
product that is lost, damaged or is otherwise unsuitablefor use not used or processed (except in the circumstances described
shall be recorded and reported to the purchaser (see 4.16). in 4.10.1.2) until it has been inspected or otherwise verified as
conforming to specified requirements. Verification shall be in
NOTE - Verification by the supplier does not absolve the purchaser of accordance with the quality plan or documented procedures.
the responsibility to provide acceptable product.

4.10.1.2 Where incoming product is released for urgent pro-

duction purposes, it shall be positively identified and recorded
4.8 Product identification and traceability isee 4.16) in order to permit immediate recall and replacement
in the event of nonconformance to specified requirements.
Where appropriate, the supplier shall establish and maintain
procedures for identifying the product from applicable draw- NOTE - In determining the amount and nature of receiving inspec-
ings, specifications or other documents, during all stages of tion, consideration should be given to the control exercised at source
production, delivery and installation. and documented evidence of quality conformance provided.

4
 : 1987 (E)

4.10.2 In-process inspection and testing tified equipment having a known valid relationship to na-
tionally recognized standards - where no such standards
The supplier shall exist, the basis used for calibration shall be documented;

c) establish, document and maintain calibration pro-

a) inspect, test and identify product as required by the
cedures, including details of equipment type, identification
quality plan or documented procedures;
number, location, frequency of checks, check method,
acceptance criteria and the action to be taken when results
b) establish product conformance to specified re-
are unsatisfactory;
quirements by use of process monitoring and control
methods: d) ensure that the inspection, measuring and test equip-
ment is capable of the accuracy and precision necessary;
c) hold product until the required inspection and tests
have been completed or necessary reports have been e) identify inspection, measuring and test equipment with
received and verified except when product is released under a suitable indicator or approved identification record to
positive recall procedures (see 4.10.1 i . Release under show the calibration status;
positive recall procedures shall not preclude the activities
outlined in 4.10.2a); f ) maintain calibration records for inspection, measuring
and test equipment (see 4.16);
d) identify nonconforming product.
g) assess and document the validity of previous inspection
and test results when inspection, measuring and test equip-
4.10.3 Final inspection and testing ment is found to be out of calibration;

The quality plan or documented procedures for final inspection h) ensure that the environmental conditions are suitable
and testing shall require that all specified inspection and tests, for the calibrations, inspections, measurements and tests
including those specified either on receipt of product or in- being carried out;
process, have been carried out and that the data meets il ensure that the handling, preservation and storage of
specified requirements. inspection, measuring and test equipment is such that the
iTeh STANDARD
The supplier shall carry out all final inspection and testing in ac-
PREVIEW
accuracy and fitness for use is maintained;
cordance with the quality plan or documented (standards.iteh.ai)
procedures
to complete the evidence of conformance of the finished pro-
j) safeguard inspection, measuring and test facilities,
including both test hardware and test software, from ad-
duct to the specified requirements. justments which would invalidate the calibration setting.
ISO 9001:1987
No product shall be despatched until all the activities specified Where test hardware (e.g. jigs, fixtures, templates, patterns)or
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in the quality plan or documented procedures have been test software is used as suitable forms of inspection, they shall
86562f54a923/iso-9001-1987
satisfactorily completed and the associated data and documen- be checked to prove that they are capable of verifying the ac-
tation is available and authorized. ceptability of product prior to release for use during production
and installation and shall be rechecked at prescribed intervals.
The supplier shall establish the extent and frequency of such
4.10.4 Inspection and test records checks and shall maintain records as evidence of control
(see 4.16). Measurement design data shall be made available,
The supplier shall establish and maintain records which give when required by the purchaser or his representative, for
evidence that the product has passed inspection and/or test verification that it is functionally adequate.
with defined acceptance criteria (see 4.16).

4.12 inspection and test status

4.11 Inspection, measuring and test equipment The inspection and test status of product shall be identified by
using markings, authorized stamps, tags, labels, routing cards,
The supplier shall control, calibrate and maintain inspection, inspection records, test software, physical location or other
measuring and test equipment, whether owned by the supplier, suitable means, which indicate the conformance or nonconfor-
on loan, or provided by the purchaser, to demonstrate the con- mance of product with regard to inspection and tests per-
formance of product to the specified requirements. Equipment formed. The identification of inspection and test status shall be
shall be used in a manner which ensures that measurement maintained, as necessary, throughout production and installa-
uncertainty is known and is consistent with the required tion of the product to ensure that only product that has passed
measurement capability. the required inspections and tests is despatched, used or in-
stalled.
The supplier shall
Records shall identify the inspection authority responsible for
a) identify the measurements to be made, the accuracy the release of conforming product (see 4.16).
required and select the appropriate inspection, measuring
and test equipment;
4.13 Control of nonconforming product
b) identify, calibrate and adjust all inspection, measuring
and test equipment and devices that can affect product The supplier shall establish and maintain procedures to ensure
quality at prescribe0 intervals, or prior to use, against cer- that product that does not conform to specified requirements is

5
I S 0 9001 : 1987 (E)

prevented from inadvertent use or installation. Control shall 4.15.2 Handling

provide for identification, documentation, evaluation, segrega-
tion (when practical), disposition of nonconforming product The supplier shall provide methods and means of handling that
and for notification to the functions concerned. prevent damage or deterioration.

4.15.3 Storage
4.13.1 Nonconformity review and disposition
The supplier shall provide secure storage areas or stock rooms
The responsibility for review and authority for the disposition of to prevent damage or deterioration of product, pending use or
nonconforming product shall be defined. delivery. Appropriate methods for authorizing receipt and the
despatch to and from such areas shall be stipulated. In order to
Nonconfcrming product shall be reviewed in accordance with detect deterioration, the condition of product in stock shall be
documented procedures. It may be assessed at appropriate intervals.

a) reworked to meet the specified requirements, or

4.15.4 Packaging
b) accepted with or without repair by concession, or
The supplier shall control packing, preservation and marking
processes (including materials used) to the extent necessary to
c) re-graded for alternative applications, or
ensure conformance to specified requirements and shall iden-
tify, preserve and segregate all product from the time of receipt
d) rejected or scrapped.
until the supplier’s responsibility ceases.
Where required by the contract, the proposed use or repair of
product [see 4.13.lb)l which does not conform to specified re- 4.15.5 Delivery
quirements shall be reported for concession to the purchaser or
his representative. The description of nonconformity that has The supplier shall arrange for the protection of the quality of
been accepted, and of repairs, shall be recorded to denote the
actual condition (see 4.16).
iTeh STANDARD PREVIEW
product after final inspection and test. Where contractually
specified, this protection shall be extended to include delivery
to destination.
(standards.iteh.ai)
Repaired and reworked product shall be re-inspected in ac-
cordance with documented procedures.
ISO 9001:1987
4.16 Quality records
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4.14 Corrective action The supplier shall establish and maintain procedures for
86562f54a923/iso-9001-1987 iden-
tification, collection, indexing, filing, storage, maintenance and
The supplier shall establish, dccument and maintain pro- disposition of quality records.
cedures for
Quality records shall be maintained to demonstrate achieve-
a) investigating the cause of nonconforming product and ment of the required quality and the effective operation of the
the corrective action needed to prevent recurrence; quality system. Pertinent sub-contractor quality records shall
be an element of these data.
b) analysing all processes, work operations, concessions,
quality records, service reports and customer complaints to All quality records shall be legible and identifiable to the pro-
detect and eliminate potential causes of nonconforming duct involved. Quality records shall be stored and maintained in
product; such a way that they are readily retrievable in facilities that pro-
vide a suitable environment to minimize deterioration or
c) initiating preventative actions to deal with problems to a damage and to prevent loss. Retention times of quality records
level corresponding to the risks encountered; shall be established and recorded. Where agreed contractually,
quality records shall be made available for evaluation by the
di applying controls to ensure that corrective actions are purchaser or his representative for an agreed period.
taken and that they are effective;

e) implementing and recording changes in procedures 4.17 Internal quality audits

resulting from corrective action.
The supplier shall carry out a comprehensive system of planned
and documented internal quality audits to verify whether qual-
ity activities comply with planned arrangements and to deter-
4.15 Handling, storage, packaging and delivery mine the effectiveness of the quality system.

4.15.1 General Audits shall be scheduled on the basis of the status and impor-
tance of the activity.
The supplier shall establish, document and maintain pro-
cedures for handling, storage, packaging and delivery of The audits and follow-up actions shall be carried out in accord-
product. ance with documented procedures.