Indian Standard: Qualjty Systefds - Model For Quality Assurance in Final Inspection and Te ST
Indian Standard: Qualjty Systefds - Model For Quality Assurance in Final Inspection and Te ST
Indian Standard: Qualjty Systefds - Model For Quality Assurance in Final Inspection and Te ST
Indian Standard
QUALJTY SYSTEfdS - MODEL FOR QUALITY ASSURANCE IN FINAL INSPECTION AND TE~ST (First Revision)
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UDC 658562
0 BIS 1994
BUREAU
MANAK BHAVAN,
OF
INDIAN
STANDA-RDS
ZAFAR MARG
August 19 94
Price Group 4
Quality Management
Sectional
Committee,
MSD 2
NATIONAL
FOREWORD
This Indian Standard (First Revision) which is identical with IS0 9003 : 1994 Quality systems - Model for quality assurance in final inspection and~test, issued by the International Organization for Standardization (ISO), was adopted by the Bureau of Indian Standards on the recommendation of the Quality Management Sectional Committee (MSD 2) and approval of the Management and Systems Division Council. This standard was first published in 1988. In this revision, IS0 9003 has been adopted soas to make the Indian Standard identical with the International Standard. This will help India in projecting to the global market its competence to supply products of quality at par with the International Standards.
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The text of the IS0 Standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following: Wherever the words International as Indian Standard. Standard appear referring to this standard, they should be read
In the adopted standard, normative references appear to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in its place is listed below along with its degree of equivalence for this edition indicated: International IS0 8402) Standard Corresponding Indian Standard IS 13999*) Quality management and quality assurance - Vocabulary Degree of Equivalence Identical
In the adopted standard, informative reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their place are listed below along with their degree of equivalence for the editions indicated: International Standard IS0 9000-l : 1994 Corresponding Indian Standard IS 14000 (Part 1) : 1994 Quality management and quality assurance standards: Part 1 Guidelines for selection and use IS 14000 (Part 2) : 1994 Quality management and quality assurance standards: Part 2 Generic guidelines for the application of IS0 9001, IS0 9002 and IS0 9003. IS 14000 (Part 3) : 1991 Quality management and quality assurance standards: Part 3 Guidelines for the application of IS0 9001 to the development, supply and maintenance of software Degree of Equivalence Identical
Identical
Identical
) )
Indian Standard
QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN FINAL INSPECTION AND TEST (First Revision)
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scope
NOTES 2 A product may include service, hardware, materials, software or a combination thereof. processed
This International Standard specifies quality system requirements for use where a suppliers capability to detect and control the disposition of any product nonconformity during final inspection and test needs to be demonstrated. It is applicable in situations when the conformance of product to specified requirements can be shown with adequate confidence providing that certain suppliers capabilities for inspection and tests conducted on fin-
3 A product can be tangible (e.g. assemblies or processed materials) or intangible (e.g. knowledge or concepts). or a combination thereof. 4 For the purposes of this International Standard, the term product applies to the intended product offering only and not to unintended by-products affecting the environment. This differs from the definition given in IS0 8402. 3.2 tender: an invitation product. 3.3 Offer made by a supplier in response to to satisfy a contract award to provide
demonstrated.
Normative
reference
contract: Agreed requirements between a supplier and customer transmitted by any means.
The following standard contains provisions which, through reference in this text, constitute provisions of this international Standard. At the time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the standard indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 8402:1994, Quality surance - Vocabulary. management and quality as-
4
4.1
Quality
system
requirements responsibility
Management
Quality policy
4.1.1
The suppliers management with executive responsibility shall define and document its policy for quality, including objectives for quality and its commitment to quality. The quality policy shall be relevant to the suppliers organizational goals and the expectations and needs of its customers. The supplier shall ensure that this policy is understood, implemented and maintained at all levels of the organization. 4.1.2 Organization Responsibility and authority
Definitions
For the purposes of this International Standard, the definitions given in IS0 8402 and the following definitions apply. 3.1 product: Result of activities or processes.
4.1.2.1
The responsibility, authority and the ivTerrek&n of personnel who manage, perform and verify work that
c subject to the Standard shall be larly for personnel dom and authority a)
requirements of this International defined and documented, particuwho need the organizational freeto
manual shall include or make reference to the quality system procedures and outline the structure of the documentation used in the qvality system. quality NOTE 6 Guidance IS0 10013. on quality manuals is given in
b) ensure that finished product that does not conform to specified requirements is prevented from being used or delivered. -4.1.2.2 Resources
4.2.2
The supplier shall a) prepare documented procedures consistent with the requirements of this International Standard and the suppliers stated quality policy, and effectively implement the quality system and its documented procedures.
The supplier shall identify resource requirements and provide adequate resources, including the assignment of trained personnel (see 4.18). for management, ~performance of work and verification activities including internal quality audits. 4.1.2.3 Management representative
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b)
The suppliers management with executive responsibility shall apppint a member of the suppliers own management who, irrespective of other responsibilities, shall have defined authority for a) ensuring that a quality system is established, implemented and maintained in accordance with this International Standard, and reporting on the performance of the quality system to the suppliers management for review and as a basis for improvement of the quality system.
For the purposes of this International Standard, the range and detail of the procedures that form part of the quality system shall be dependent upon the complexity of the work, the methods used, and the skills and training needed by personnel involved 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
b)
The supplier shall define and document how the requirements for quality of the finished product will be
NOTE 5 The responsibility of a management representative may also include liaison with external parties on matters relating to the suppliers quality system.
met. Quality planning shall be consistent with all other requirements of a suppliers quality system and shall be documented in a format to suit the suppliers method of operation. The supplier shall give consideration to the following activities, as appropriate: a) the preparation of a quality plan for final inspection and tests;
4.1.3
Management
review
The suppliers management with executive responsibility shall review the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of this International Standard and the suppliers stated quality policy and objectives (see 4.1 .l). Records of such reviews shall be maintained (see 4.16). 4.2 4.2.1
b) the identification and acquisition of any final inspection and test equipment, resources and skills that may be needed to achieve the required quality; c) the updating, wasnecessary, of final inspection and testing techniques;
The supplier shall establish, document and maintain a quality system as a means of ensuring that product on completion conforms to specified requirements. The supplier shall prepare a quality manual covering the requirements of this International Standard. The
2
d) the identification of any final inspection and test measurement requirement involving capability that exceeds the known state of the art in sufficient time for the needed capability to be developed;
e) the identification
at the fin-
f)
the clarification of standards of acceptability for all features and requirements, including those which contain a subjective eleme It; the identification ords (see 4.16). and preparation of quality rec-
4.4
Design control
g)
The scope of this International Standard does not include quality system requirements for design control. This subclause is included to align the clause nurnbering with IS0 9001.
NOTE 8 The quality plan referred to [see 4.2.3a)] may be in the form of a reference to the appropriate documented procedures that form an integral part of the suppliers quality system
4.5
Document anddsta
General
control
4.3.1
General
The supplier shall establish and maintain documented procedures for contract review and for the coordination of these activities.
The supplier shall establish and maintain documented procedures to control all documents and data that relate to the requirements of this International Standard including, to the extent applicable, documents of external origin such as standards and customer drawings.
NOTE 10 Documents and data may be in the form of any type of media, such as hard copy or electronic media.
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4.3.2
Before submission of a tender, or the acceptance of a contract or order (statement of requirement), the tender, contract or order shall be reviewed by the supplier to ensure that:
a) the requirements
are adequately defined and documented; where no written statement of requirement is available for an order received by verbal means, the supplier shall ensure that the order requirements are agreed before their acceptance;
The documents and data shall be reviewed and ap proved for adequacy by authorized personnel prior to issue. A master list or equivalent document control procedure identifying the current revision stab? 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 ar_e available at all locations where -operations essential to the effective functioning of the quality system are performed; invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use; any obsolete documents knowledge-preservation identified. retained for legal and/or purposes are Suitably
b) any differences between the contract or order requtrements and those in the tender are resolved; c) the supplier has the capability to meet the contract or order requirements for finished product.
b)
4.3.3
Amendment
to a contract c)
The supplier shall identify how an amendment to a contract is made and correctly transferred to the functions concerned within the suppliers organization.
Records of contract reviews shall be maintained (see 4.16). NOTE 9 Channels for communication and interfaces with the customers organization in these contract matters should be established. 3
Changes to documents and data shall be reviewed and approved by the same functions/organizations that performed the original review and approval, unless specifically designated otherwise. The designated functions/organizations shall have -access to pertinent background information upon which to base their review and approval.
Where practicable, the nature of the change shall be identified in the document or the appropriate attachments. 4.8
Purchasing
The scope of this International Standard does not include quality system requirements for purchasing. This subclause is included to align the clause numbering with IS0 9001. 4.7
records to complete the evidence of conformance of product to the specified requirements. When conformance to the specified requirements cannot be fully verified on the finished product, then a verification of acceptable results of other necessary inspection and tests performed previously shall be included for the purpose of verifying conformance to product requirements at final inspection and test. Records shall identify the inspection sponsible for the release of conforming 4.16). 4.11 Control authority reproduct (see
Control of customer-supplied
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 finished product or for related activities. Any such product that is lost, damaged or is otherwise unsuitable for use shall be recorded and reported to the customer (see 4.16). Verification by the supplier does not absolve the customer of the responsibility to provide acceptable product. 4.8
of inspection,
measuring
and
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test equipment
4.11.1 General
Product identification
and traceability
Where and to the extent that traceability is a specified requirement, the supplier shall establish and maintain documented procedures for unique identification of individual product or batches. This identification shall be recorded (see 4.16). 4.9 Process control
The supplier shall establish and maintain documented procedures to control, calibrate and maintain final inspection, measuring and test equipment (including test software) used by the supplier to demonstrate the conformance of product to the specified requirements. Inspection, measuring 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. , Where test software or comparative references such as test hardware are used as suitable forms of inspection, they shall be checked to prove that they are capable of verifying the acceptability of product, prior to release for use during final inspection and testing 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 inspection, measuring and test equipment is a specified requirement, such data shall be made available, when required by the customer or customers representative, for verification that the inspection, measuring and test equipment is functionally adequate. NOTE 11 For the purposes of this International Standard, the term measuring equipment includes measurement devices. 4.11.2 Control procedure
The scope of this International Standard does not include quality system requirements for process control. This subclause is included to align the clause numbering with IS0 9001. 4.10 4.10.1
The supplier shall establish and maintain documented procedures for final inspection and testing activities in order to verify that the specified requirements for finished product are met. The required final inspection and testing, and the records to be established, shall be detailed in the quality plan or documented procedures. 4.10.2 Final inspection and testing
The supplier shall: a) The supplier shall carry out all final inspection and testing in accordance with the quality plan and/or documented procedures and maintain appropriate
4
determine the measurements to be made and the accuracy required, and select the appropriate- inspection, measuring and test equipment that is capable of the necessary accuracy and precision;
b)
identify all inspection, measuring 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 relationship to internationally or nationally recognized standards. Where no such standards exist, the basis used for calibration shall be documented; define the process employed for the calibration of inspection, measuring and test equipment, including details of equipment type, unique identification, location, frequency of checks, check method, acceptance criteria and the action to be taken when results are unsatisfactory; identify inspection, measuring and test equipment with a suitable indicator or approved identification record to show the calibration status; maintain calibration records for inspection, measuring and test equipment (see 4.16); assess and document the validity of previous inspection and test results when inspection, measuring or test equipment is found to be out of calibration; ensure that the environmental conditions are inspections, suitable for the calibrations, measurements and tests being carried out; ensure that the handling, preservation and storage of inspection, measuring and test equipment is such that the accuracy and fitness for use are maintained; safeguard inspection, measuring and test facilities, including both test hardware and test software, from adjustments which would ir:lalidate the calibration setting.
4.13
Control of nonconforming
product
The supplier shall establish and maintain control of product that does not conform to specified requirements to ensure that unintended use or delivery is avoided. Control shall provide for identification, documentation, evaluation, segregation (when practical), disposition of nonconforming product and for notification to the functions concerned. The description of repairs, and of any nonconformity that has been accepted under authorized concession, 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.
c)
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d)
e)
4.14
Corrective action
f)
The supplier shall: a) investigate nonconformities that have been identified from the analysis of final inspection and test reports and customer complaints of product; corrective
9)
h)
ensure that relevant information on the actions taken is submitted for management review (see 4.1.3).
i)
General
NOTE 12 The metrological confirmation system for measuring equipment given in IS0 10012 may be used for guidance.
4.12
The supplier shall establish and maintain documented procedures for handling, storage, packaging, preservation and delivery of completed product after final inspection and test. 4.152
The inspection and test status of product shall be identified by suitable means, which indicate the conformance or nonconformance of product with regard to inspection and tests performed. The identification of inspection and test status shall Abe maintained, as defined in the quality plan and/or documented procedures to ensure that only product that has passed the required final inspection and test [or released under an authorized concession (see 4.1311) is dispatched.
5
Handling
The supplier shall provide methods of handling product that prevent damage or deterioration. 4.15.3 Storage
The supplier shall use designated storage areas nor stock rooms to prevent damage or deterioration of product, pending delivery. Appropriate methods for
authorizing receipt to and dispatch from such areas shall be stipulated. In order to detect deterioration, the condition of product in stock shall be assessed at appropriate intervals. 4.15.4 Packaging
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 responsibility 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).
The supplier shall control packing, packaging and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements. 4.15.5 Preservation for the
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The supplier shall apply appropriate methods presentation and segregation of product when product is under the suppliers control. 4.15.6 Delivery
NOTES 14 The results of internal quality audits form an integral pan of the input to management review activities (see 4.1.3).
The supplier shall arrange for the protection of the quality of product after final inspection and test. Where contractually specified, this protection shall be extended to include delivery to destination. 4.16 Control of quality records
system
audits is given
in
The supplier shall establish and maintain control of appropriate quality records to demonstrate conformance of the finished product to specified requirements and the effective operation of the quality system. Quality records shall be legible and identifiable to the product involved. Quality records that SUbst8ntiate conformance of the finished product with the specified requirements and the effective operation of the quality system shall be retained for an agreed period and made 8Vaitabte on request. NOTE 13 Records may be in the form of any type of media, such as hard copy or electronic media. internal quality audits
Personnel performing fin81 inspection and test activities covering the requirements of this International Standard shall have appropriate experience and/or training, including any necessary qualification for specific assigned tasks. Appropriate records of training shall be maintained (see 4.16). 4.18 Servicing
The scope of this International Standard does not include quality system requirements for servicing. This SUbCl8USeis included to align the clause numbering with IS0 9001. 4.20 Statistical techniques
4.17
The supplier shall carry out internal quality audits to verify whether quality activities and related results comply with planned arrangements covering the requirements of this International Standard and to determine the effectiveness of the quality system.
8) identify
the need for statistical techniques required for the acceptability of product characteristics; implement and control the application of the statistical techniques.
b)
IS 14003 : 1994
IS0
9003 : 1994
management and quality assurance standards - Part 1: Guidelines for selection and use.
[S] IS0 1001 l-l :1990,Guidelines for auditing quality systems - Part 7: Auditing. [7] IS0 1001l-2: 1991, Guidelines for auditing qua/ity systems - Pafl 2: Qualification criteria for quality systems auditors. [8] IS0 1001 l-3: 1991, Guidelines for auditing qualitysystems - Part 3: Management of audit programmes. [9] IS0 10012-l : 1992, Quality assurance requirements for measuring equipment Part 7: Metrological confirmation system for measuring equipment. 2 [lo] IS0 10013:--'I. Guidelines for developing quality manuals. [ll] ISO/TR 13425:-l, Guidelines for the selection of statistical methods in standardization and specification.
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[23 IS0 9000-2:1993, Ouality management and quality assurance standards - Part 2: Generic guidelines for the application of ISO 9007, IS0 9002 and IS0 9003. [S] IS0 9000-3:1991, Oualiry management and quality assurance standards - Part 3: Guidelines for the application of IS0 9001 to the developmen t, and maintenance of suPPlY software. [43 IS0 9001:1994, Quality systems - Model for quality assurance in design, development, production, installation and servicing. [5] IS0 9002:1994, Quality systems - Model for quality assurance in production, installation and servicing.
International
Standard
Corresponding
Indian Standard
IS 14001 : 1994 Quality systems Model for quality assurance in design, development, production, installation and servicing IS 14002 : 1994 Quality systems Model for quality assurance in production, installation and servicing IS 1401 l(Part 1) : 1991 Guidelines for auditing quality systems: Part 1 Auditing IS 14011(Part 2) : 1991 Guidelines for auditing quality systems: Part 2 Qualification criteria for quality systems auditors IS1401 1 (Part 3) : 1991 Guidelines for auditing quality systems: Part 3 Management of audit programmes IS 14012 (Part 1) : 1993 Quality assurance requirements for measuring equipment: Part 1 Metrological confirmation system for measuring equipment IS 10013) Guidelines ing quality manuals for develop-
Identical
: 1990
Identical
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IS0 10011-2:
1991
Identical
Identical
IS0 10012-l
: 1992
Identical
is0
10013)
Identical
In the adopted standard, informative reference appears to of statistical methods in standardization and specification, as an International Standard. The Committee would review as and when it is published whether it may be adopted as
ISOIl% 13425 Guidelines for the selection which is under consideration for publication the provisions of this International Standard Indian Standard.
To be published.
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AMENDMENT NO. 1 DECEMBER i994 TO QUALITY SYSTEMS - MODEL FOR 1s 14003 : 1994 QUALITY ASSURANCE IN FINAL INSPECTION AND TEST ( First Revision )
The number of the standard IS 14003 : 1994/ISO 9003 : 1994 is replaced by the
number IS/IS0 9003 : 1994. Wherever the number IS 14003 : 1994 is occurring in the standard, it will be read as IS/IS0 9003 : 1994.
(MSD2)
Reprography Unit, BIS, New Delhi, India
IS/IS0
NO. 2 JULY 1996 TO 9003 : 1994 QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN FINAL INSPECTION AND TEST ( First Revision )
AMENDMENT
[ Formerly IS 14003 : 1994/ISO 9003 : 1994 inspection and test (first revision ) 1.
Quality
systems
assumnce
in final
the following
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This Indian Standard (First Revision) which is identical with IS0 9003:1994 Quality systems - Model for quality assurance in final inspection and test, issued by the International Organization for Standardization (ISO), was adopted by the Bureau of Indian Standards on the recommendation of the Quality Management Sectional Committee (MSD 2), and approval of the Management and Systems Division Council. This standard was first published in 1988. In this revision, Indian Standard identical with the International Standard. IS0 9003 has been adopted so as to make the
The text of the IS0 Standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following: Wherever the words International Indian Standard. Standard appear referring to this standard, they should be read as
In the adopted standard, normative refeiences appear to certain International Standards for which Indian Standards also exist. >The corresponding Indian Standard which is to be substituted in its place is listed below along with its degree of equivalence for the edition indicated:
International Standard
IS0 8402: 1994
Degree of Equivalence
Identical
In the adopted standard, informative reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their place are listed below along with their degree equivalence for the editions indicated:
of
International
Standard
IS0 9000-l : 1994
Degree of Equivalence
Identical
IS/IS0 9000-2 : 1993 Quality management and quality assurance standards - Part 2 : Generic guidelines for the application of IS.0 9001, IS0 9002 and ISO 9003 IS/IS0 9000-3 : 1991 Quality management and quality assurance standards Part 3 : Guidelines for the application of IS0 9001 tb the development, supply and maintenance of software IS/&SO 9001 : 1994 Quality systems - Model for quality assurance in design, development, production, installation and servicing (first revision ) IS/IS0 9002 : 1994 Quality systems - Model for quality assurance in production, installation and servicing ( first
Identical
Identical
Identical
Identical
revision )
1
IS/IS0 10011-l : 1990 Guidelines systems - Part 1 : Auditing IS/IS0 10011-2 : 1991 Guidelines systems Part 2 : Qualification systems auditors
IS/E0 10011-3 : 1991 Guidelines for audit@ quality systems -Part 3 : Management of audit programmes IS/IS0 10012-1 : 1992 Quality assurance requirements for measuring equipment Part 1 : Metrological confirmation system for measuring equipment IS/IS0 10013 : 1995 Guidelines manuals for developing quality
Identical Identical
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Identical
In the adopted standard, informative reference appears statistical methods in standardization and specification?, International Standard. The Committee would review when it is published whether it may be adopted as Indian (Second coverpage, National Foreword ) -
to ISO/TR 13425 Guidelines for the selection of which is under consideration for publication as an the provisions of this International Standard as and Standard. after National Foreword:
INTRODUCTION
This International Standard is one of three International Standardsdealing with quality system requirements that can be used for external quality assurance purposes. The quality assurance models, set out in the three International Standards listed below, represent three distinct forms of quality system requirements suitable for the purpose of ~a supplier demonstrating its capability, and for the assessment of the capability of a supplier by external parties. a) IS0 9001, Quality systems installation and servicing b) Model for quality assurance in, design, development, production,
for use~when conformance to specified requirements development, production, installation and servicing for quality assurance
inproduction,
requirements
is to be assured
c)
for quality assurance in final inspection and test is to be assured by the supplier solely at final
to specified requirements
It is emphasized that the quality system requirements specified in this International Standard, IS0 9001 and IS0 9002 are complementary (not alternative) to the technical (product) specified requirements. They specify requirements which detennine what elements quality systems have to encompass, but it is not the purpose of these International Standards to enforce uniformity of quality systems. They are generic and of a quality independent of any specific industry or economic sector. The design and implementation system will be influenced by the varying needs of an organization, its particular objectives, the products and services supplied, and the processes and specific practices employed. It is intended that these International 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. IS0 9000-l provides guidance on such tailoring as well as as on selection of the appropriate quality assurance model, viz. IS0 9001, IS0 9002 or IS0 9003.