理标准
风靡全球
GLOBAL ACCEPTED MANAGEMENT STANDARD
——ISO9001：1994
ENGLISH VERSION
ISO9001：1994 Standard
Quality systeems—Model for quality assurance in designdevelopmentproductioninstallation 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 84021994 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 (eg assemblies or processed materials) or intangible (eg 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 byproducts 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
33 contract Agreed requirements between a supplier and customer transmitted by anymeans
4 Quality system requirements
41 Management responsibility
411 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
412 Organization
4121 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
4122 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
4123 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
413 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
42 Quality system
421 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
422 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
423 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
43 Contract review
431 General
The supplier shall establish and maintain documented procedures for contract review and for the coordination of these activities
432 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
423 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
433 Records
Records of contract reviews are maintained
44 Design control
441 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
442 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
443 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
444 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
445 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
446 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
447 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
448 Design validation
Design validation is performed to ensure that product conforms to defined used needs andor requirements
449 Design changes
All design changes and modifications are identified documented reviewed and approved by authorized personnel before their implementation
45 Document and data control
451 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
452 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 andor 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 andor 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 andor knowledgepreservation purposes are suitably identified
453 Document and data changes
Changes to documents and data are reviewed and approved by the same functionsorganizations that performed the original review and approval unless specifically designated otherwise
The designated functionsorganizations 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
46 Purchasing
461 General
The supplier shall establish and maintain documented procedures to ensure that purchased product conforms to specified requirements
462 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 andor quality records of the previously demonstrated capability and performance of the subcontractor
c) established and maintained quality records of acceptable subcontractors
463 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
464 Verification of purchased product
4641 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
4642 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
47 Control of customersupplied product
The supplier shall establish and maintain documented procedures for the control of verification storage and maintenance of customersupplied 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
48 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
49 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 standardscodes quality plans andor 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 (eg 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 andor 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
410 Inspection and testing
4101 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
4102 Receiving inspection and testing
41021
The supplier ensures that incoming product is not used or processed (except in 41023) 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 andor documented procedures
41022
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
41023
Where incoming product is released for urgent production purposes prior to verification it is positively identified and recorded (see 416) in order to permit immediate recall and replacement in the event of nonconformity to specified requirements
4103 Inprocess inspection and testing
The supplier
a) inspects and tests the product as required by the quality plan andor 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 positiverecall procedures (see 41023)
Release under positiverecall procedures does not preclude the activities outlined in 4103a)
4104 Final inspection and testing
The supplier carries out all final inspection and testing in accordance with the quality plan andor documented procedures to complete the evidence of conformance of the finished product to the specified requirements
The quality plan andor documented procedures for final inspection and testing require that all specified inspection and tests including those specified either on receipt of product or inprocess have been carried out and that the results meet specified requirements
No product is dispatched until all the activities specified in the quality plan andor documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized
4105 Inspection and test records
The supplier shall establish and maintains records which provide evidence that the product has been inspected andor tested
These records show clearly whether the product has passed or failed the inspections andor tests according to defined acceptance criteria
Where product fails to pass any inspection andor test the procedures for control of nonconforming product are applied(see 413)
Records identify the inspection authority responsible for the release of product
411 Control of inspection measuring and test equipment
4111 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
4112 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 calibratedadjusted 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
412 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 andor 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 4132)] is dispatched used or installed
The inspection and test status of product is in accordance with the procedure
413 Control of nonconforming product
4131 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
4132 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 4132b)] 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 416)
Repaired andor reworked product is reinspected in accordance with the quality plan andor documented procedures
414 Corrective and preventive action
4141 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
4142 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
4143 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 413)
Preventive actions have been completed in accordance with the procedures
415 Handling storage packaging preservation and delivery
4151 General
The supplier shall establish and maintained documented procedures for handling storage packaging preservation and delivery of product
4152 Handling
The supplier shall provide methods of handling product that prevent damage or deterioration
4153 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
4154 Packaging
The supplier controls packing packaging and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements
4155 Preservation
The supplier applies appropriate methods for preservation and segregation of product when the product is under the supplier’s control
4156 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
416 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 storedretained 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
417 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
Followup activities verify and record the implementation and effectiveness of the corrective action taken
418 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 andor experience as required
Appropriate records of training are maintained
419 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
420 Statistical techniques
4201 Identification of need
The supplier shall identify the need for statistical techniques required for establishing controlling and verifying process capability and product characteristics
4202 Procedures
The supplier shall establish and maintained documented procedures to implement and control the application of the statistical techniques identified in
4201
Statistical techniques are utilized in accordance with the procedures
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理标准
风靡全球
GLOBAL ACCEPTED MANAGEMENT STANDARD
——ISO9001：1994
ENGLISH VERSION
ISO9001：1994 Standard
Quality systeems—Model for quality assurance in designdevelopmentproductioninstallation 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 84021994 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 (eg assemblies or processed materials) or intangible (eg 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 byproducts 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
33 contract Agreed requirements between a supplier and customer transmitted by anymeans
4 Quality system requirements
41 Management responsibility
411 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
412 Organization
4121 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
4122 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
4123 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
413 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
42 Quality system
421 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
422 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
423 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
43 Contract review
431 General
The supplier shall establish and maintain documented procedures for contract review and for the coordination of these activities
432 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
423 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
433 Records
Records of contract reviews are maintained
44 Design control
441 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
442 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
443 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
444 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
445 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
446 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
447 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
448 Design validation
Design validation is performed to ensure that product conforms to defined used needs andor requirements
449 Design changes
All design changes and modifications are identified documented reviewed and approved by authorized personnel before their implementation
45 Document and data control
451 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
452 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 andor 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 andor 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 andor knowledgepreservation purposes are suitably identified
453 Document and data changes
Changes to documents and data are reviewed and approved by the same functionsorganizations that performed the original review and approval unless specifically designated otherwise
The designated functionsorganizations 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
46 Purchasing
461 General
The supplier shall establish and maintain documented procedures to ensure that purchased product conforms to specified requirements
462 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 andor quality records of the previously demonstrated capability and performance of the subcontractor
c) established and maintained quality records of acceptable subcontractors
463 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
464 Verification of purchased product
4641 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
4642 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
47 Control of customersupplied product
The supplier shall establish and maintain documented procedures for the control of verification storage and maintenance of customersupplied 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
48 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
49 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 standardscodes quality plans andor 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 (eg 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 andor 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
410 Inspection and testing
4101 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
4102 Receiving inspection and testing
41021
The supplier ensures that incoming product is not used or processed (except in 41023) 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 andor documented procedures
41022
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
41023
Where incoming product is released for urgent production purposes prior to verification it is positively identified and recorded (see 416) in order to permit immediate recall and replacement in the event of nonconformity to specified requirements
4103 Inprocess inspection and testing
The supplier
a) inspects and tests the product as required by the quality plan andor 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 positiverecall procedures (see 41023)
Release under positiverecall procedures does not preclude the activities outlined in 4103a)
4104 Final inspection and testing
The supplier carries out all final inspection and testing in accordance with the quality plan andor documented procedures to complete the evidence of conformance of the finished product to the specified requirements
The quality plan andor documented procedures for final inspection and testing require that all specified inspection and tests including those specified either on receipt of product or inprocess have been carried out and that the results meet specified requirements
No product is dispatched until all the activities specified in the quality plan andor documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized
4105 Inspection and test records
The supplier shall establish and maintains records which provide evidence that the product has been inspected andor tested
These records show clearly whether the product has passed or failed the inspections andor tests according to defined acceptance criteria
Where product fails to pass any inspection andor test the procedures for control of nonconforming product are applied(see 413)
Records identify the inspection authority responsible for the release of product
411 Control of inspection measuring and test equipment
4111 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
4112 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 calibratedadjusted 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
412 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 andor 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 4132)] is dispatched used or installed
The inspection and test status of product is in accordance with the procedure
413 Control of nonconforming product
4131 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
4132 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 4132b)] 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 416)
Repaired andor reworked product is reinspected in accordance with the quality plan andor documented procedures
414 Corrective and preventive action
4141 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
4142 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
4143 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 413)
Preventive actions have been completed in accordance with the procedures
415 Handling storage packaging preservation and delivery
4151 General
The supplier shall establish and maintained documented procedures for handling storage packaging preservation and delivery of product
4152 Handling
The supplier shall provide methods of handling product that prevent damage or deterioration
4153 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
4154 Packaging
The supplier controls packing packaging and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements
4155 Preservation
The supplier applies appropriate methods for preservation and segregation of product when the product is under the supplier’s control
4156 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
416 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 storedretained 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
417 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
Followup activities verify and record the implementation and effectiveness of the corrective action taken
418 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 andor experience as required
Appropriate records of training are maintained
419 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
420 Statistical techniques
4201 Identification of need
The supplier shall identify the need for statistical techniques required for establishing controlling and verifying process capability and product characteristics
4202 Procedures
The supplier shall establish and maintained documented procedures to implement and control the application of the statistical techniques identified in
4201
Statistical techniques are utilized in accordance with the procedures
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