ISO9001en|iso9001与14001

　 

　管理标准

　风靡全球的

　GLOBAL ACCEPTED MANAGEMENT STANDARD

　——ISO9001：1994

　ENGLISH VERSION

　ISO9001：1994 Standard

　Quality systeems—Model for quality assurance in design,development,production,installation and servicing

　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 prevent nonconformity at all stages from design through to servicing.

　This International Standard is applicable in situations when design is required and the product requirements are stated principally in performance terms, or they need to be established, and 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.

　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.

　ISO 8402:1994, Quality management and quality assurance—Vocabulary.

　Definitions

　For the purposes of this International Standard, the definitions given in ISO 8402 and the following definitions apply.

　product: Result of activities or processes.

　NOTES

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

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

　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 ISO 8402.

　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 anymeans.

　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 and 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 the 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 provided adequate resources, including the assignment of trained personnel 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 the quality system is established, implemented and maintained in accordance with the appropriate standard, and

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

　NOTE 5

　The responsibility of a 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 reviews the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of the appropriate standard and the supplier’s stated quality policy and objectives.

　Records of such reviews shall be maintained.

　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 the appropriate standard.

　The quality manual includes or makes reference to the quality system procedures and outlines the structure of the documentation used.

　4.2.2 Quality system procedures

　The supplier shall:

　a) prepare documented procedures consistent with the requirements of the appropriate standard and the suppliers stated quality policy, and

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

　4.2.3 Quality planning

　The supplier shall define and document how the requirements for quality will be met. Quality planning is consistent with all other requirements of the supplier’s quality system and is documented in a format to suit the suppliers method of operation.

　The supplier shall give consideration to the following activities, as appropriate, in meeting the specified requirements for products, projects or contracts:

　a) the preparation of quality plans;

　b) the identification and acquisition of any controls, processes, equipment (including inspection and test equipment), fixtures, resources and skills that may be needed to achieve the required quality;

　c) ensuring the compatibility of the design, the 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 identification 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.

　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 a tender, or the acceptance of a contract or order (statement of requirement), the tender, contract or order is 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.

　4.2.3 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 organization.

　4.3.3 Records

　Records of contract reviews are maintained.

　4.4

　Design control

　4.4.1 General

　The supplier shall establish and maintain documented procedures to control and verify the design of the 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 describe or reference design activities, and define responsibility for their implementation.

　The design and development activities are assigned to qualified personnel equipped with adequate resources.

　The plans are be updated as the design evolves.

　4.4.3 Organizational and technical interfaces

　Organizational and technical interfaces between different groups which input into the design process are 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, are identified, documented and their selection reviewed by the supplier for adequacy.

　Incomplete, ambiguous or conflicting requirements are resolved with those responsible for imposing the requirements.

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

　4.4.5 Design output

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

　Design output:

　a) meets the design input requirements;

　b) contains or makes reference to acceptance criteria;

　c) identifies those characteristics of the design that are crucial to the safe and proper functioning of the product.

　Design output documents are reviewed before release.

　4.4.6 Design review

　At appropriate stages of design, formal documented reviews of the design results are planned and conducted.

　Participants at each design review include representatives of all functions concerned with the design stage being reviewed, as well as other specialist personnel, as required.

　Records of such reviews are maintained.

　4.4.7

　Design verification

　At appropriate stages of design, design verification is performed to ensure that the design stage output meets the design stage input requirements.

　The design verification measures are recorded.

　4.4.8 Design validation

　Design validation is performed to ensure that product conforms to defined used needs and/or requirements.

　4.4.9 Design changes

　All design changes and modifications are 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 the appropriate standard including, to the extent applicable, documents of external origin such as standards and customer drawings.

　4.5.2 Document and data approval and issue

　The documents and data are 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 is readily available to preclude the use of invalid and/or obsolete documents.

　The control ensures 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 purposes are suitably identified.

　4.5.3 Document and data changes

　Changes to documents and data are reviewed and approved by the same functions/organizations that performed the original review and approval, unless specifically designated otherwise.

　The designated functions/organizations have access to pertinent background information upon which to base their review and approval.

　The nature of changes is identified

　in the document or on appropriate attachments, whichever is practical.

　4.6 Purchasing

　4.6.1 General

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

　4.6.2 Evaluation of subcontractors

　The supplier shall:

　a) evaluated and selected subcontractors on the basis of their ability to meet subcontract requirements including the quality system and any specific quality assurance requirements;

　b) defined the type and extent of control exercised over subcontractors.

　the control is 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 the subcontractor;

　c) established and maintained quality records of acceptable subcontractors.

　4.6.3 Purchasing data

　Purchasing documents 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 reviews and approves 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

　When the supplier verifies purchased product at the subcontractors premises, verification arrangements and the method of product release are specified in the purchasing documents.

　4.6.4.2 Customer verification of subcontracted product

　Where specified in the contract, the supplier’s customer of the customer’s representative is afforded the right to verify at the subcontractor’s premises and the supplier’s premises that subcontracted

　 product conforms to specified requirements.

　Such verification is not used by the supplier as evidence of effective control of quality by the subcontractor.

　Verification by the customer does not absolve the supplier of the responsibility to provide acceptable product, nor does 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 is recorded and reported to the customer.

　Verification by the supplier does not absolve the customer of the responsibility to provide acceptable product.

　Customer supplied product is controlled in accordance with the procedure.

　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.

　Product is identified in accordance with the procedures.

　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.

　Product traceability is maintained in accordance with the procedures.

　4.9

　Process control

　The supplier shall identify and plan the production, installation and servicing processes which directly affect quality and has ensured that these processes are carried out under controlled conditions.

　Controlled conditions 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); and

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

　Where the results 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 are carried out by qualified operators and/or 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, are specified.

　Records are maintained for qualified processes, equipment and personnel, as appropriate.

　4.10 Inspection and testing

　4.10.1 General

　The supplier shall establish and

　maintained documented procedures for inspection and testing activities in order to verify that specified requirements for the product are met.

　The required inspection and testing, and the records to be established, are be detailed in the quality plan or documented procedures.

　4.10.2 Receiving inspection and testing

　4.10.2.1

　The supplier ensures that incoming product is not used or processed (except 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 is 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 is 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:

　a) inspects and tests the product as required by the quality plan and/or documented procedures;

　b) holds 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-recall procedures does not preclude the activities outlined in 4.10.3a).

　4.10.4 Final inspection and testing

　The supplier carries 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

　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 is 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 maintains records which provide evidence that the product has been inspected and/or tested.

　These records show clearly whether the product has passed or failed the inspections and/or tests according to defined acceptance criteria.

　Where product fails to pass any inspection and/or test, the procedures for control of nonconforming product are applied(see 4.13).

　Records identify the inspection authority responsible for the release of product.

　4.11 Control of inspection, measuring and test equipment

　4.11.1 General

　The supplier shall establish and maintained 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 is 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 are checked to prove that they are capable of verifying the acceptability of product, prior to release for use during production, installation or servicing, and are rechecked at prescribed intervals.

　The suppliers shall establish the extent and frequency of such checks and maintains records as evidence of control.

　Where the availability of technical data pertaining to the inspection, measuring and test equipment is a specified requirement, such data is be made available, when required by the customer or customer’s representative, for verification that the inspection, measuring and test equipment is functionally adequate.

　4.11.2 Control procedure

　The supplier shall:

　a) determine the measurements to be made and the accuracy required, and selected 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 calibrated/adjusted 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 is 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;

　f) assesse 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.

　4.12 Inspection and test status

　The inspection and test status of product is 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 is maintained, as defined in the quality plan and/or documented procedures, throughout production, installation and servicing of the product to ensure that only product that has passed the required inspections and tests [or released under an authorized concession (see 4.13.2)] is dispatched, used or installed.

　The inspection and test status of product is in accordance with the procedure.

　4.13 Control of nonconforming product

　4.13.1 General

　The supplier shall establish and maintained documented procedures to ensure that product that does not conform to specified requirements is prevented from unintended use or installation.

　This control provides for identification, documentation, evaluation, segregation (when practical), disposition, 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 is defined.

　Nonconforming product is 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) regraded for alternative applications, or

　d) rejected or scrapped.

　Where required by contract, the proposed use or repair of product [see 4.13.2b)] which does not conform to specified requirements is reported for concession to the customer or customer’s representative.

　The description of the nonconformity that has been accepted, and of repairs, is recorded to denote the actual condition (see 4.16).

　Repaired and/or reworked product is 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 maintained documented procedures for implementing corrective and preventive action.

　Any corrective or preventive action taken to eliminate the causes of actual or potential nonconformities is 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 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;

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

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

　Corrective actions have been completed in accordance with the procedures.

　4.14.3 Preventive action

　The procedures for preventive action 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, analyze and eliminate potential causes on 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).

　Preventive actions have been completed in accordance with the procedures.

　4.15 Handling, storage, packaging, preservation and delivery

　4.15.1 General

　The supplier shall establish and maintained 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 uses 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 are stipulated.

　In order to detect deterioration, the condition of product in stock is assessed at appropriate intervals.

　4.15.4 Packaging

　The supplier controls packing, packaging and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements.

　4.15.5 Preservation

　The supplier applies appropriate methods for preservation and segregation of product when the product is under the supplier’s control.

　4.15.6 Delivery

　The supplier arranges for the protection of the quality of product after final inspection and test.

　Where contractually specified, this protection is extended to include delivery to destination.

　 4.16 Control of quality records

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

　Quality records are maintained to demonstrate conformance to specified requirements and the effective operation of the quality system.

　Pertinent quality records from the subcontractor are an element of the data.

　All quality records are legible and stored/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 are established and recorded.

　Where agreed contractually, quality records are made available for evaluation by the customer or the customer’s

　representative for an agreed period.

　Records are stored in accordance with the procedures.

　4.17 Internal quality audits

　The supplier shall establish and maintained 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 are scheduled on the basis of the status and importance of the activity to be audited.

　Internal audits are carried out by personnel independent of those having direct responsibility for the activity being audited.

　The results of the audits are recorded and brought to the attention of the personnel having responsibility in the area audited.

　The management personnel responsible for the area take timely corrective action on deficiencies found during the audit.

　Follow-up activities verify and record the implementation and effectiveness of the corrective action taken.

　4.18 Training

　The supplier shall establish and maintained documented procedures for identifying training needs and provide for the training of all personnel performing activities affecting quality.

　Personnel performing specific assigned tasks are qualified on the basis of appropriate education, training and/or experience, as required.

　Appropriate records of training are maintained.

　4.19 Servicing

　Where servicing is a specified requirement, the supplier shall establish and maintained documented procedures for performing, verifying and reporting that the servicing meets the specified requirements.

　Servicing is performed in accordance with the procedures.

　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 maintained documented procedures to implement and control the application of the statistical techniques identified in

　 4.20.1.

　Statistical techniques are utilized in accordance with the procedures.