USO/9001(1994)j

This International Standard is one of three International Standards dealing 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)ISO9001, Quality systems-Model for quality assurance in design, development, production, installation and servicing

- for use when conformance to specified requirements is to be assured by the supplier during design, development, production, installation and servicing.

b)ISO9002, Quality systems-Model for quality assurance in production, installation and servicing

- for use when conformance to specified requirements is to be assured by the supplier during production, installation and servicing.

c)ISO9003, Quality systems-Model for quality assurance in final inspection and test

- for use when conformance to specified requirements is to be assured by the supplier solely at final inspection and test.

It is emphasized that the quality system requirements specified in this International Standard, ISO9002 and ISO9003 are complementary(not alternative) to the technical (product)specified requirements. They specify requirements which determine 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 independent of any specific industry 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 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. ISO9000-1 provides guidance on such tailoring as well as on selection of the appropriate quality assurance model, viz.ISO9001,ISO9002 or ISO9003.

1 Scope

This International 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 achieving customer satisfaction by preventing nonconformity at all stages from design through to servicing.

This International Standard is applicable in situations 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 conformance can be attained by adequate demonstration of a supplier's capabilities in design, development, production, installation and servicing.

NOTE 1. For informative references, see annex A.

2 Normative reference

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 ISO maintain registers of currently valid International Standards.

ISO8402:1994,Quality management and quality assurance-Vocabulary．

3 Definitions

For the purpose of this International Standard, the definitions given in ISO8402 and the following definitions apply.

3.1 product:

Result of activities or processes．

NOTE 2. A product may include service, hardware, processed materials, software or a combination thereof.

NOTE 3. A product can be tangible(e.g. assemblies or processed materials)or intangible(e.g. knowledge or concepts) or a combination thereof.

NOTE 4. For the purpose 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 ISO8402.

3.2 tender:

Offer made by a supplier in response to an invitation to satisfy a contract award to provide product.

3.3 contract:

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 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 supplier's 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

4.1.2.1　Responsibility and authority

The responsibility, authority and the interrelation of personnel who manage, perform and verify work affecting quality shall be defined and documented, particularly for personnel who need the organizational freedom and authority to:

a)initiate action to prevent the occurrence of any nonconformities relating to the product, process and quality system;

b)identify and record any problems relating to the product, process and quality system;

c)initiate, recommend or provide solutions through designated channels;

d)verify the implementation of solutions;

e)control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.

4.1.2.2 Resources

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

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, implemented and maintained in accordance with this International Standard, and

b)reporting on the performance of the quality system to the supplier's management for review and as basis for improvement of the quality system.

NOTE 5. The responsibility of management representative 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 sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of this International Standard and the supplier's stated quality policy and objectives (see 4.1.1). Records of such reviews shall 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 conforms to specified requirements. The supplier shall prepare a quality manual covering the requirements of this International Standard. The quality manual shall include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system.

NOTE 6. Guidance on quality manual is given in ISO10013.

4.2.2 Quality system procedures

The supplier shall

a)prepare documented procedures consistent with the requirements of this International Standard and the supplier's stated quality policy, and

b)effectively implement the quality system and its documented procedures.

For the purpose 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

The supplier shall define and document how the requirements for quality will be 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 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 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 production process, installation, servicing, inspection and test procedures and the applicable documentation;

d)the updating, as necessary, of quality control, inspection and testing techniques, including the development of new instrumentation;

e)the identification of any measurement requirement involving capability that exceeds the known state of the art, in sufficient time for the needed capability to be developed;

f)the clarification of suitable verification at appropriate stages in the realization of product;

g)the clarification of standards of acceptability for all features and requirements, including those which contain a subjective element;

h)the identification and preparation of quality records(see 4.16).

NOTE 8. The quality plans referred to[see4.2.3a)] may be in the form of a reference to the appropriate documented procedures that form an integral part of the supplier'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 submission of 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;

b)any differences between the contract or order requirements and those in the tender are resolved;

c)the supplier has the capability to meet the contract or order requirements.

4.3.3　Amendment to a contract

The supplier shall identify how an amendment to a contract 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).

NOTE 9. Channels for communication and interfaces with the customer's organization in these contract matters should be established.

4.4 Design control

4.4.1 General

The supplier shall establish and maintain documented procedures to control and verify the design of product 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 activity. The plans shall describe or reference these activities, and define responsibility for their implementation. The design and development activities shall be assigned to qualified personnel equipped with adequate resources. The plans shall be updated as the design evolves.

4.4.3 Organizational and technical interfaces

Organization and technical interfaces between different groups which input into the design process shall be defined and the necessary information documented, transmitted and regularly reviewed.

4.4.4　Design input

Design input requirements relating to the product, including applicable statutory and regulatory requirements, shall be identified, documented and their selection reviewed by the supplier for adequacy. Incomplete, ambiguous or conflicting requirements shall be resolved with those responsible for imposing these requirements.

Design input shall take into consideration the results of any contract review activities.

4.4.5　Design output

Design output shall be documented and expressed in terms that can be verified and validated against design input requirements.

Design output shall:

a)meet the design input requirements;

b)contain or make reference to acceptance criteria;

c)identify those characteristics of the design that are crucial to the safe and proper functioning of the product(e.g. operating, storage, handling, maintenance and disposal requirements).

Design output documents shall be reviewed before release.

4.4.6　Design review

At appropriate stages of design, formal documented reviews of the design results shall be planned and conducted. Participants at each design review shall include representatives of all functions concerned with the design stage being reviewed, as well as other specialist personnel, as required. Records of such reviews shall be maintained(see 4.16).

4.4.7　Design verification

At appropriate stage of design, design verification shall be performed to ensure that the design stage output meets the design stage input requirements. The design verification measures shall be recorded (see 4.16).

NOTE 10. In addition to conducting design reviews(see 4.4.6), design verification may include activities such as

- performing alternative calculations,

- comparing the new design with a similar proven design, if available,

- undertaking tests and demonstrations, and

- reviewing the design stage documents before release.

4.4.8　Design validation

Design validation shall be performed to ensure that product conforms to defined user needs and/or requirements.

NOTE 11. Design validation follows successful design verification(see 4.4.7).

NOTE 12. Validation is normally performed under defined operating conditions.

NOTE 13. Validation is normally performed on the final product, but may be necessary in earlier stages prior to product completion.

NOTE 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, reviewed and approved by authorized personnel before 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 International Standard including, to the extent applicable, documents of external 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 approved for 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 effective functioning of the quality system are performed;

b)invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use;

c)any obsolete documents retained for legal and/or knowledge-preservation purpose are suitably identified.

4.5.3　Document and data changes

Changes to documents and data shall be reviewed and approved by the same functions/organizations that performed the original review and approval, unless specifically designed otherwise. The designate 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.

4.6　Purchasing

4.6.1　General

The supplier shall establish and maintain documented procedures to ensure that purchased product(see 3.1) conforms to specified requirements.

4.6.2　Evaluations of 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;

b)define the type and extent of control exercise d by the supplier over 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 describing the product ordered, including, where applicable:

a)the type, class, grade or other precise identification;

b)the title or other positive identification, and applicable issues of specifications, drawings, process requirements, inspection instructions and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment and personnel;

c)the title, number and issue of the quality system standard to be applied.

The supplier shall review and approve purchasing documents for adequacy of the specified requirements prior to release.

4.6.4　Verification of purchased product

4.6.4.1 Supplier verification at subcontractor's premises

Where the supplier proposes to verify purchased product at the subcontractor's premises, the supplier shall specify verification arrangements and the method of product release in the purchasing documents.

4.6.4.2 Customer verification of subcontracted product

Where specified in the contract, the supplier's customer or the customer's representative shall be afforded the right to verify at the subcontractor's premises and the supplier's premises that subcontracted product conforms to specified requirements. Such verification shall not be used by the supplier as evidence of effective control of quality by the subcontractor.

Verification by the customer shall not absolve the supplier of the responsibility to provide acceptable product, nor shall it preclude subsequent rejection by the customer.

4.7 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 supplies 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 supplier dose not absolve the customer of the responsibility to provide acceptable product.

4.8 Product identification and traceability

Where appropriate, the supplier shall establish and maintain documented procedures for identifying the product by suitable means from receipt and during all stages of production, delivery and installation.

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 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 following:

a)documented procedures defining the manner of production, 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 approval of processes and equipment, as appropriate;

f)criteria for workmanship, which shall be stipulated in the clearest practical manner (e.g. written standards, representative samples or illustrations);

g)suitable maintenance of equipment to ensure continuing process capability.

Where the result of processes cannot be fully verified 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 continuous monitoring and control of process parameters to ensure that the specified requirements are met.

The requirements for any qualification of process operations, including associated equipment and personnel(see 4.18),shall be specified.

NOTE 16. Such processes requiring pre-qualification of their process capability are frequently referred to as special 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 product are met. The required inspection and testing, and the records to be established, shall be detailed in the quality plan or documented procedures.

4.10.2 Receiving inspection and testing

4.10.2.1 the supplier shall ensure that incoming product is not used or processed(expect in the circumstances described in 4.10.2.3) until it has been inspected or otherwise verified as conforming to specified requirements. Verification of conformance to the specified requirements shall be in accordance with the quality plan and/or documented procedures.

4.10.2.2 In determining the amount and nature of receiving inspection, consideration shall be given to the amount of control exercised at the subcontractor's premises and the recorded evidence of conformance provided.

4.10.2.3 Where incoming product is released for urgent production purposes prior to verification, it shall be positively identified and recorded (see 4.16) in order to permit immediate recall and replacement in the event of nonconformity to specified requirements.

4.10.3 In-process inspection and testing

The supplier shall:

a)inspect and test the product as required by the quality plan and/or documented procedures;

b)hold product until the required inspection and tests have been completed or necessary reports have been received and verified, except when product is released under positive-recall procedures(see 4.10.2.3). Release under positive-re call procedures shall not preclude the activities outlined in 4.10.3.a).

4.10.4 Final inspection and testing

The supplier shall carry out all final inspection and testing in accordance with the quality plan and/or documented 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 product or in-process, have been carried out and that the results meet specified requirements.

No product shall be dispatched until all the activities specified 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 shall establish and maintain records which provide evidence that the product has been inspected and/or 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 procedures 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 procedures to control, calibrate and maintain 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 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 inspection, measuring and test equipment is a specified requirement, such data shall be made available, when required by the customer or customer's representative, for verification that the inspection, measuring and test equipment is functionally adequate.

NOTE 17. For the purposes of this International Standard, the term "measuring equipment" includes measurement devices.

4.11.2 Control procedure

The supplier shall:

a)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;

c)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;

d)identify inspection, measuring and test equipment with a suitable indicator or approved identification record to show the calibration status;

e)maintain calibration records for inspection, measuring and test equipment(see 4.16);

f)assess and document the validity of previous inspection and test results when inspection, measuring or test equipment is found to be out of calibration;

g)ensure that the environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out;

h)ensure that the handling, preservation and storage of inspection, measuring and test equipment is such that the accuracy and fitness for 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 ISO10012 may be used for guidance.

4.12 Inspection and test status

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 be maintained, as defined in the quality plan and/or documented procedures, throughout production, installation and servicing of 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 dispatched, used or installed.

4.13 Control of nonconforming product

4.13.1 General

The supplier shall establish and maintain documented procedures to ensure that product that does not conform to specified requirements is prevented from unintended use or installation. This control shall provide for identification, documentation, evaluation, segregation(when practical), disposition of nonfonforming product, and for notification to the functions concerned.

4.13.2 Review and disposition of nonconforming product

The responsibility for review and authority for the disposition of nonconforming product shall be defined.

Nonconforming product shall be reviewed in accordance with documented procedures. It may be

a)reworked to meet the specified requirements,

b)accepted with or without repair by concession,

c)regarded for alternative applications, or

d)rejected or scrapped.

Where required by the contract, the proposed use or repair of product[see 4.13.2b)] which does not conform to specified requirements shall be reported for concession to the customer or customer's representative. The description of the nonconformity that has been accepted, and of repairs, shall be recorded to denote the actual condition(see 4.16).

Repaired and/or reworked product shall be re-inspected 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 preventive action taken to eliminate the causes of actual or potential nonconformities shall be to a degree appropriate to the magnitude of problems and commensurate with the risks encountered.

The supplier shall implement and record any changes to the documented procedures resulting from corrective and preventive action.

4.14.2 Corrective action

The procedures for corrective action shall include:

a)the effective handling of customer complaints and reports of product nonconformities;

b)investigation of the cause of nonconformities relating to product, process and quality system, and recording the results of the investigation (see 4.16);

c)determination of the corrective action needed to eliminate the cause of nonfonformities;

d)application of controls to ensure that corrective action is taken and that it is effective.

4.14.3 Preventive action

The procedures for preventive action shall include:

a)the use of appropriate sources of information such as processes and work operations which affect product quality, concessions, audit results, quality records, service reports and customer complaints to detect, analyse and eliminate potential causes of nonconformities;

b)determination of the steps needed to deal with any problems requiring preventive action;

c)initiation of preventive action and application of controls to ensure that it is effective;

d)ensuring 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 for handling, storage, packaging, preservation and delivery of product.

4.15.2 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 or stock rooms to prevent damage or deterioration of product, pending use or 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

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

The supplier shall apply appropriate methods for preservation and segregation of product when the product is under the supplier's control.

4.15.6　Delivery

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

The supplier shall establish and maintain documented procedures for identification, collection, indexing, access, filings, storage, maintenance and disposition of quality records.

Quality records shall be maintained to demonstrate conformance to specified requirements and the effective 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 stored 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 shall be established and recorded. Where agreed contractually, quality records shall be made available for evaluation by the customer or the customer's representative for an agreed period.

NOTE 19. Records may be in the form 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 determine 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 result 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 the 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).

NOTE 20. The results of internal quality audits form an integral part of the input to management review activities(see 4.1.3)

NOTE 21. Guidance of quality system audits is given in ISO10011.

4.18 Training

The supplier shall establish and maintain documented procedures for identifying training needs and provide for the training of all personnel performing activities affecting quality. Personnel 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 techniques required for establishing, controlling and verifying process capability 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.

Annex A, (informative)

Bibliography,

[1] ISO9000-1:1994,Quality management and

quality assurance standards-Part 1:

Guidelines for selection and use.

[2] ISO9000-2:1993,Quality management and

quality assurance standards-Part 2: Generic

guidelines for the application of ISO9001,

ISO9002 and ISO9003

[3] ISO9000-3:1991,Quality management and

quality assurance standards-Part 3:

Guidelines for the application of ISO9001 to

the development, supply and maintenance of

software.

[4] ISO9002:1994,Quality systems-Model for

quality assurance in production, installation

and servicing.

[5] ISO9003:1994,Quality systems-Model for

quality assurance in final inspection and test.

[6] ISO10011-1:1990,Guideline for auditing

quality systems-Part 1:Auditing.

[7] ISO10011-2:1991,Guidelines for auditing

quality systems-Part 2:Qualification

criteria for quality systems auditors.

[8] ISO10011-3:1991,Guideline for auditing

quality systems-Part 3:Management of

audit programmes.

[9] ISO10012-1:1992,Quality assurance

requirements for measuring equipment-

Part 1:Metrological confirmation system for

measuring equipment.

[10]ISO10013：-1),Guidelines for developing

quality manuals.

[11]ISO/TR13425:-1),Guidelines for the selection

of statistical methods in standardization and

specification.

-1)To be published