AMERICAN NATIONAL STANDARD
Quality management systems—
Requirements
Approved as a American National Standard by
American Society for Quality
An American National Standard Approved on December 13 2000
American National Standards An American National Standard implies a consensus of those substantially concerned with its scope and provisions An American National Standard is intended as a guide to aid the manufacturer the consumer and the general public The existence of an American National Standard does not in any respect preclude anyone whether he or she has approved the standard or not from manufacturing purchasing or using products processes or procedures not conforming to the standard American National Standards are subject to periodic review and users are cautioned to obtain the latest edition
Caution NoticeThis American National Standard may be revised or withdrawn at any time The procedures of the American National Standards Institute require that action be taken to reaffirm revise or withdraw this standard no later than five years from the date of publication Purchasers of American
National Standards may receive current information on all standards by calling or writing the American National Standards Institute
ANSIISOASQ 090012000
Contents Page
1 Scope 1
11 General 1
12 Application 1
2 Normative reference 1
3 Terms and definitions 1
4 Quality management system 2
41 General requirements 2
42 Documentation requirements 2
5 Management responsibility 3
51 Management commitment 3
52 Customer focus 4
53 Quality policy 4
54 Planning 4
55 Responsibility authority and communication 4
56 Management review 5
6 Resource management 5
61 Provision of resources 5
62 Human resources 6
63 Infrastructure 6
64 Work environment 6
7 Product realization 6
71 Planning of product realization 6
72 Customerrelated processes 7
73 Design and development 8
74 Purchasing 9
75 Production and service provision 10
76 Control of monitoring and measuring devices 11
8 Measurement analysis and improvement 11
81 General 11
82 Monitoring and measurement 11
83 Control of nonconforming product 12
84 Analysis of data 13
85 Improvement 13
Annexes
A Correspondence between ISO 90012000 and ISO 140011996 15
B Correspondence between ISO 90012000 and ISO 90011994 19
Bibliography 23
Introduction
01 General
The adoption of a quality management system should be a strategic decision of an organization The design and implementation of an organization’s quality management system is influenced by varying needs particular objectives the products provided the processes employed and the size and structure of the organization It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation
The quality management system requirements specified in this International Standard are complementary to requirements for products Information marked NOTE is for guidance in understanding or clarifying the associated requirement
This International Standard can be used by internal and external parties Including certification bodies to assess the organization’s ability to meet customer regulatory and the organization’s own requirements
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard
02 Process approach
This International Standard promotes the adoption of a process approach when developing implementing and improving the effectiveness of a quality management system to enhance customer satisfaction by meeting customer requirements
For an organization to function effectively it has to identify and manage numerous linked activities An activity using resources and managed in order to enable the transformation of inputs Into outputs can be considered as a process Often the output from one process directly forms the input to the next
The application of a system of processes within an organization together with the identification and interactions of these processes and their management can be referred to as the process approach
An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes as well as over their combination and interaction
When used within a quality management system such an approach emphasizes the importance of
a) understanding and meeting requirements
b) the need to consider processes in terms of added value
C) obtaining results of process performance and effectiveness and
d) continual improvement of processes based on objective measurement
The model of a processbased quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8 This illustration shows that customers play a significant role in defining requirements as inputs Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements The model shown in Figure 1 covers all the requirements of this International Standard but does not show processes at a detailed level
ANSIISOASQ Q90012000
NOTE In addition the methodology known as PlanDoCheckAct (PDCA) can be applied to all processes PDCA can be briefly described as follows
Plan establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization’s policies
Do implement the processes
Check monitor and measure processes and product against policies objectives and requirements for the product and report the results
Act take actions to continually improve process performance
Key
Valueadding activities
Information flow
Figure 1 Model of a processbased quality management system
03 Relationship with ISO 9004
The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement each other but can also be used independently Although the two International Standards have different scopes they have similar structures in order to assist their application as a consistent pair
ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations or for certification or for contractual purposes It focuses on the effectiveness of the quality management system in meeting customer requirements
ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001 particularly for the continual improvement of an organization’s overall performance and efficiency as well as its effectiveness ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001 in pursuit of continual improvement of performance However it is not intended for certification or for contractual purposes
04 Compatibility with other management systems
This International Standard has been aligned with ISO 14001 1996 in order to enhance the compatibility of the two standards for the benefit of the user community
This International Standard does not include requirements specific to other management systems such as those particular to environmental management occupational health and safety management financial management or risk management However this International Standard enables an organization to align or integrate its own quality management system with related management system requirements It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard
INTERNATIONAL STANDARD
Quality management systems — Requirements
I Scope
11 General
This International Standard specifies requirements for a quality management system wnere an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements and
b) aims to enhance customer satisfaction through the effective application of the system including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements
NOTE In this International Standard the term product applies only to the product intended for or required by a customer
12 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations regardless of type size and product provided
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product this can be considered for exclusion
Where exclusions are made claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7 and such exclusions do not affect the organization’s ability or responsibility to provide product that meets customer and applicable regulatory requirements
2 Normative reference
The following normative document contains provisions which through reference in this text constitute provisions of this International Standard For dated references subsequent amendments to or revisions of any of these publications do not apply However parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below For undated references the latest edition of the normative document referred to applies Members of ISO and IEC maintain registers of currently valid International Standards
ISO 90002000 Quallty management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this International Standard the terms and definitions given in ISO 9000 apply
The following terms used in this edition of ISO 9001 to describe the supply chain have been changed to reflect the vocabulary currently used
supplier ~organization customer
The term organization’ replaces the term supplier used in ISO 90011994 and refers to the unit to which this International Standard applies Also the term supplier now replaces the term subcontractor
Throughout the text of this International Standard wherever the term product occurs it can also mean service
4 Quality management system
41 General requirements
The organization shall establish document implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard
The organization shall
a) identify the processes needed for the quality management system and their application throughout the organization (see 12)
b) determine the sequence and interaction of these processes
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes
e) monitor measure and analyze these processes and
f) implement actions necessary to achieve planned results and continual improvement of these processes
These processes shall be managed by the organization in accordance with the requirements of this International Standard
Where an organization chooses to outsource any process that affects product conformity with requirements the organization shall ensure control over such processes Control of such outsourced processes shall be identified within the quality management system
NOTE Processes needed for the quality management system referred to above should include processes for management activities provision of resources product realization and measurement
42 Documentation requirements
421 General
The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives
b) a quality manual
c) documented procedures required by this International Standard
d documents needed by the organization to ensure the effective planning operation and control of its processes and
e) records required by this International Standard (see 424)
NOTE I Where the term documented procedure appears within this International Standard this means that the procedure is established documented implemented and maintained
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
a) the size of organization and type of activities
b) the complexity of processes and their interactions and
c) the competence of personnel
NOTE 3 The documentation can be in any form or type of medium
422 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system including details of and justification for any exclusions (see 12)
b) the documented procedures established for the quality management system or reference to them and
c) a description of the interaction between the processes of the quality management system
423 Control of documents
Documents required by the quality management system shall be controlled Records are a special type of document
and shall be controlled according to the requirements given in 424
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue
b) to review and update as necessary and reapprove documents
C) to ensure that changes and the current revision status of documents are identified
d) to ensure that relevant versions of applicable documents are available at points of use
e) to ensure that documents remain legible and readily identifiable
f) to ensure that documents of external origin are identified and their distribution controlled and
g) to prevent the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose
424 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system Records shall remain legible readily identifiable and retrievable A documented procedure shall be established to define the controls needed for the identification storage protection retrieval retention time and disposition of records
5 Management responsibility
51 Management commitment
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements
b) establishing the quality policy
c) ensuring that quality objectives are established
d) conducting management reviews and
e) ensuring the availability of resources
52 Customer focus
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 721 and 821)
53 Quality policy
Top management shall ensure that the quality policy
a) is appropriate to the purpose of the organization
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system
c) provides a framework for establishing and reviewing quality objectives
d) is communicated and understood within the organization and
e) is reviewed for continuing suitability
54 Planning
541 Quality objectives
Top management shall ensure that quality objectives including those needed to meet requirements for product 71 a)] are established at relevant functions and levels within the organization The quality objectives shall be measurable and consistent with the quality policy
542 Quality management system planning
Top management shall ensure that
a) the planning of the quality management system is carried out in order to meet the requirements given in 41 as well as the quality objectives and
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented
55 Responsibility authority and communication
551 Responsibility and authority
Top management shall ensure that responsibilities and authorities are defined and communicated within the organization
552 Management representative
Top management shall appoint a member of management who irrespective of other responsibilities shall have responsibility and authority that includes
a) ensuring that processes needed for the quality management system are established implemented and maintained
b) reporting to top management on the performance of the quality management system and any need for improvement and
C) ensuring the promotion of awareness of customer requirements throughout the organization
NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system
553 Internal communication
Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system
56 Management review
561 General
Top management shall review the organization’s quality management system at planned intervals to ensure its continuing suitability adequacy and effectiveness This review shall include assessing opportunities for improvement and the need for changes to the quality management system including the quality policy and quality objectives
Records from management reviews shall be maintained (see 424)
562 Review input
The input to management review shall include information on
a) results of audits
b) customer feedback
c) process performance and product conformity
d) status of preventive and corrective actions
e) followup actions from previous management reviews
f) changes that could affect the quality management system and
g) recommendations for improvement
563 Review output
The output from the management review shall include any decisions and actions related to
a) improvement of the effectiveness of the quality management system and its processes
b) improvement of product related to customer requirements and
c) resource needs
6 Resource management
61 Provision of resources
The organization shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness and
b) to enhance customer satisfaction by meeting customer requirements
62 Human resources
621 General
Personnel performing work affecting product quality shall be competent on the basis of appropriate education training skills and experience
622 Competence awareness and training
The organization shall
a) determine the necessary competence for personnel performing work affecting product quality
b) provide training or take other actions to satisfy these needs
c) evaluate the effectiveness of the actions taken
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives and
e) maintain appropriate records of education training skills and experience (see 424)
631 Infrastructure
The organization shall determine provide and maintain the infrastructure needed to achieve conformity to product requirements Infrastructure includes as applicable
a) buildings workspace and associated utilities
b) process equipment (both hardware and software) and
c) supporting services (such as transport or communication)
64 Work environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements
7 Product realization
71 Planning of product realization
The organization shall plan and develop the processes needed for product realization Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 41)
In planning product realization the organization shall determine the following as appropriate
a) quality objectives and requirements for the product
b) the need to establish processes documents and provide resources specific to the product
c) required verification validation monitoring inspection and test activities specific to the product and the criteria for product acceptance
d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 424)
The output of this planning shall be in a form suitable for the organization’s method of operations
NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product project or contract can be referred to as a quality plan
NOTE 2 The organization may also apply the requirements given in 73 to the development of product realization processes
72 Customerrelated processes
721 Determination of requirements related to the product
The organization shall determine
a) requirements specified by the customer including the requirements for delivery and postdelivery activities
b) requirements not stated by the customer but necessary for specified or intended use where known
c) statutory and regulatory requirements related to the product and
d) any additional requirements determined by the organization
722 Review of requirements related to the product
The organization shall review the requirements related to the product This review snail be conducted prior to the organization’s commitment to supply a product to the customer (eg submission of tenders acceptance of contracts or orders acceptance of changes to contracts or orders) and shall ensure that
a) product requirements are defined
b) contract or order requirements differing from those previously expressed are resolved and
c) the organization has the ability to meet the defined requirements
Records of the results of the review and actions arising from the review shall be maintained (see 424)
Where the customer provides no documented statement of requirement the customer requirements shall be confirmed by the organization before acceptance
Where product requirements are changed the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements
NOTE In some situations such as internet sales a formal review is impractical for each order Instead the review can cover relevant product information such as catalogues or advertising material
723 Customer communication
The organization shall determine and implement effective arrangements for communicating with customers in relation to
a) product information
b) inquiries contracts or order handling including amendments and
c) customer feedback including customer complaints
73 Design and development
731 Design and development planning
The organization shall plan and control the design and development of product
During the design and development planning the organization shall determine
a) the design and development stages
b) the review verification and validation that are appropriate to each design and development stage and
c) the responsibilities and authorities for design and development
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility
Planning output shall be updated as appropriate as the design and development progresses
732 Design and development inputs
Inputs relating to product requirements shall be determined and records maintained (see 424) These inputs shall include
a) functional and performance requirements
b) applicable statutory and regulatory requirements
c) where applicable information derived from previous similar designs and
d) other requirements essential for design and development
These inputs shall be reviewed for adequacy Requirements shall be complete unambiguous and not in conflict with each other
733 Design and development outputs
The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release
Design and development outputs shall
a) meet the input requirements for design and development
b) provide appropriate information for purchasing production and for service provision
c) contain or reference product acceptance criteria and
d) specify the characteristics of the product that are essential for its safe and proper use
734 Design and development review
At suitable stages systematic reviews of design and development shall be performed in accordance with planned arrangements (see 731)
a) to evaluate the ability of the results of design and development to meet requirements and
b) to identify any problems and propose necessary actions
Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed Records of the results of the reviews and any necessary actions shall be maintained (see 424)
735 Design and development verification
Verification shall be performed in accordance with planned arrangements (see 731) to ensure that the design and development outputs have met the design and development input requirements Records of the results of the verification and any necessary actions shall be maintained (see 424)
736 Design and development validation
Design and development validation shall be performed in accordance with planned arrangements (see 731) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use where known Wherever practicable validation shall be completed prior to the delivery or implementation of the product Records of the results of validation and any necessary actions shall be maintained (see 424)
737 Control of design and development changes
Design and development changes shall be identified and records maintained The changes shall be reviewed verified and validated as appropriate and approved before implementation The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered
Records of the results of the review of changes and any necessary actions shall be maintained (see 424)
74 Purchasing
741 Purchasing process
The organization shall ensure that purchased product conforms to specified purchase requirements The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product
The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements Criteria for selection evaluation and reevaluation shall be established Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 424)
742 Purchasing information
Purchasing information shall describe the product to be purchased including where appropriate
a) requirements for approval of product procedures processes and equipment
b) requirements for qualification of personnel and
c) quality management system requirements
The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier
743 Verification of purchased product
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements
Where the organization or its customer intends to perform verification at the supplier’s premises the organization shall state the intended verification arrangements and method of product release in the purchasing information
75 Production and service provision
751 Control of production and service provision
The organization shall plan and carry out production and service provision under controlled conditions Controlled conditions shall include as applicable
a) the availability of information that describes the characteristics of the product
b) the availability of work instructions as necessary
c) the use of suitable equipment
d) the availability and use of monitoring and measuring devices
e) the implementation of monitoring and measurement and
f) the implementation of release delivery and postdelivery activities
752 Validation of processes for production and service provision
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered
Validation shall demonstrate the ability of these processes to achieve planned results
The organization shall establish arrangements for these processes including as applicable
a) defined criteria for review and approval of the processes
b) approval of equipment and qualification of personnel
c) use of specific methods and procedures
d) requirements for records (see 424) and
e) revalidation
753 Identification and traceability
Where appropriate the organization shall identify the product by suitable means throughout product realization
The organization shall identify the product status with respect to monitoring and measurement requirements
Where traceability is a requirement the organization shall control and record the unique identification of the product (see 424)
NOTE In some industry sectors configuration management is a means by which identification and traceability are maintained
754 Customer property
The organization shall exercise care with customer property while it is under the organization’s control or being used by the organization The organization shall identify verify protect and safeguard customer property provided for use or incorporation into the product If any customer property is lost damaged or otherwise found to be unsuitable for use this shall be reported to the customer and records maintained (see 424)
NOTE Customer property can include intellectual property
755 Preservation of product
The organization shall preserve the conformity of product during internal processing and delivery to the intended destination This preservation shall include identification handling packaging storage and protection Preservation shall also apply to the constituent parts of a product
76 Control of monitoring and measuring devices
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 721)
The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements
Where necessary to ensure valid results measuring equipment shall
a) be calibrated or verified at specified intervals or prior to use against measurement standards traceable to international or national measurement standards where no such standards exist the basis used for calibration or verification shall be recorded
b) be adjusted or readjusted as necessary
c) be identified to enable the calibration status to be determined
d) be safeguarded from adjustments that would invalidate the measurement result
e) be protected from damage and deterioration during handling maintenance and storage
In addition the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements The organization shall take appropriate action on the equipment and any product affected Records of the results of calibration and verification shall be maintained (see 424)
When used in the monitoring and measurement of specified requirements the ability of computer software to satisfy the intended application shall be confirmed This shall be undertaken prior to initial use and reconfirmed as necessary
NOTE See ISO 100121 and ISO 100122 for guidance
8 Measurement analysis and improvement
81 General
The organization shall plan and implement the monitoring measurement analysis and improvement processes needed
a) to demonstrate conformity of the product
b) to ensure conformity of the quality management system and
c) to continually improve the effectiveness of the quality management system
This shall include determination of applicable methods including statistical techniques and the extent of their use
82 Monitoring and measurement
821 Customer satisfaction
As one of the measurements of the performance of the quality management system the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements The methods for obtaining and using this information shall be determined
822 Internal audit
The organization shall conduct internal audits at planned intervals to determine whether the quality management system
a) conforms to the planned arrangements (see 71) to the requirements of this International Standard and to the quality management system requirements established by the organization and
b) is effectively implemented and maintained
An audit programme shall be planned taking into consideration the status and importance of the processes and areas to be audited as well as the results of previous audits The audit criteria scope frequency and methods shall be defined Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process Auditors shall not audit their own work
The responsibilities and requirements for planning and conducting audits and for reporting results and maintaining records (see 424) shall be defined in a documented procedure
The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes Followup activities shall include the verification of the actions taken and the reporting of verification results (see 852)
NOTE See ISO 100111 ISO 100112 and ISO 100113 forguidance
823 Monitoring and measurement of processes
The organization shall apply suitable methods for monitoring and where applicable measurement of the quality management system processes These methods shall demonstrate the ability of the processes to achieve planned results When planned results are not achieved correction and corrective action shall be taken as appropriate to ensure conformity of the product
824 Monitoring and measurement of product
The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 71)
Evidence of conformity with the acceptance criteria shall be maintained Records shall indicate the person(s) authorizing release of product (see 424)
Product release and service delivery shall not proceed until the planned arrangements (see 71) have been satisfactorily completed unless otherwise approved by a relevant authority and where applicable by the customer
83 Control of nonconforming product
The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure
The organization shall deal with nonconforming product by one or more of the following ways
a) by taking action to eliminate the detected nonconformity
b) by authorizing its use release or acceptance under concession by a relevant authority and where applicable by the customer
c) by taking action to preclude its original intended use or application
Records of the nature of nonconformities and any subsequent actions taken including concessions obtained shall be maintained (see 424)
When nonconforming product is corrected it shall be subject to reverification to demonstrate conformity to the requirements
When nonconforming product is detected after delivery or use has started the organization shall take action appropriate to the effects or potential effects of the nonconformity
84 Analysis of data
The organization shall determine collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made This shall include data generated as a result of monitoring and measurement and from other relevant sources
The analysis of data shall provide information relating to
a) customer satisfaction (see 821)
b) conformity to product requirements (see 721)
c) characteristics and trends of processes and products including opportunities for preventive action and
d) suppliers
85 Improvement
851 Continual improvement
The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy quality objectives audit results analysis of data corrective and preventive actions and management review
852 Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence Corrective actions shall be appropriate to the effects of the nonconformities encountered
A documented procedure shall be established to define requirements for
a) reviewing nonconformities (including customer complaints)
b) determining the causes of nonconformities
c) evaluating the need for action to ensure that nonconformities do not recur
d) determining and implementing action needed
e) records of the results of action taken (see 424) and
f) reviewing corrective action taken
853 Preventive action
The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence Preventive actions shall be appropriate to the effects of the potential problems
A documented procedure shall be established to define requirements for
a) determining potential nonconformities and their causes
b) evaluating the need for action to prevent occurrence of nonconformities
c) determining and implementing action needed
d) records of results of action taken (see 424) and
e) reviewing preventive action taken
Annex A
(informative)
Correspondence between ISO 9001 2000 and ISO 140011996
Table A1 — Correspondence between ISO 9001 2000 and ISO 14001 1996
ISO 90012000
ISO 140011996
Introduction
General
Process approach
Relationship with ISO 9004
Compatibility with other management systems
01
02
03
04
Introduction
Sc
Scope
General
Application
1
11
12
1
Normative reference
2
2
Normative references
Terms and definitions
3
3
Definitions
Quality management system
4
4
Environmental management system requirements
General requirements
41
41
General requirements
Documentation requirements
General
Quality manual
Control of documents
Control of records
42
421
422
423
424
444
444
445
453
Environmental management system documentation
Environmental management system documentation
Document control
Records
Management responsibility
5
441
Structure and responsibility
Management commitment
51
42
441
Environmental policy Structure and responsibility
Customer focus
52
431
432
Environmental aspects Legal and other requirements
Quality policy
53
42
Environmental policy
Planning
54
43
Planning
Quality objectives
541
433
Objectives and targets
Quality management system planning
542
434
Environmental management programme(s)
Responsibility authority and communication
55
41
General requirements
Responsibility and authority Management representative
551
552
441
Structure and responsibility
Internal communication
553
443
Communication
Management review
General
Review input
Review output
56
561
562
563
46
Management review
Resource management
Provision of resources
Human resources
General
6
61
62
621
441
Structure and responsibility
Competence awareness and training
622
442
Training awareness and competence
Infrastructure Work environment
Work environment
63
64
441
Structure and responsibility
Table A1 — Correspondence between ISO 9001 2000 and ISO 140011996 (continued)
ISO 9001 2000
Iso 140011996
Product realization
7
44
446
Implementation and operation Operational control
Planning of product realization Customerrelated processes
71
72
446
Operational control
Determination of requirements related to the product
721
431
432
446
Environmental aspects
Legal and other requirements
Operational control
Review of requirements related to the product
722
446
431
Operational control
Environmental aspects
Customer communication
723
443
Communications
Design and development
Design and development planning
Design and development inputs
Design and development outputs
Design and development review
Design and development verification
Design and development validation
Control of design and development changes
Purchasing
Purchasing process
Purchasing information
Verification of purchased product
Production and service provision
Control of production and service provision Validation of processes for production and service provision
Identification and traceability
Customer property
Preservation of product
73
731
732
733
734
735
736
737
74
741
742
743
75
751
752
753
754
755
446
446
446
Operational control
Operational control
Operational control
Control of monitoring and measuring devices
76
451
Monitoring and measurement
Measurement analysis and improvement
8
45
Checking and corrective action
General
Monitoring and measurement
Customer satisfaction
81
82
821
451
Monitoring and measurement
Internal audit
822
454
Environmental management system audit
Monitoring and measurement of processes Monitoring and measurement of product
823
824
451
Monitoring and measurement
Control of nonconforming product
83
452
447
Nonconformance and corrective and preventive action Emergency preparedness and response
Analysis of data
84
451
Monitoring and measurement
Improvement
85
42
Environmental policy
Continual improvement
851
434
Environmental management programme(s)
Corrective action
Preventive action
852
853
452
Nonconformance and corrective and preventive action
Table A2 — Correspondence between ISO 14001 1996 and ISO 9001 2000
ISO 140011996
ISO 9001 2000
Introduction
0
01
02
03
04
Introduction
General
Process approach
Relationship with ISO 9004
Compatibility with other management systems
Scope
1I
1
11
12
Scope
General
Application
Normative references
2
2
Normative reference
Definitions
3
3
Terms and definitions
Environmental management system requirements
4
4
Quality management system
General requirements
41
41
55
551
General requirements
Responsibility authority and communication
Responsibility and authority
Environmental policy
42
51
53
85
Management commitment
Quality policy
Improvement
Planning
43
54
Planning
Environmental aspects
431
52
721
722
Customer focus
Determination of requirements related to the product
Review of requirements related to the product
Legal and other requirements
432
52
721
Customer focus
Determination of requirements related to the product
Objectives and targets
433
541
Quality objectives
Environmental management programme(s)
434
542
851
Quality management system planning Continual improvement
Implementation and operation
44
7
71
Product realization
Planning of product realization
Structure and responsibility
441
5
51
551
552
6
61
62
621
63
64
Management responsibility
Management commitment
Responsibility and authority
Management representative
Resource management
Provision of resources
Human resources
General
Infrastructure
Work environment
Training awareness and competence
442
622
Competence awareness and training
Communication
443
553
723
Internal communication
Customer communication
Environmental management system documentation
444
42
421
422
Documentation requirements
General
Quality manual
Table A2 — Correspondence between ISO 140011996 and ISO 9001 2000 (continued)
1S0140011996
lSO900l2000
Document control
445
423
Control of documents
Operational control
446
7
71
72
721
722
73
731
732
733
734
735
736
737
74
741
742
743
75
751
753
754
755
752
Product realization
Planning of product realization
Customerrelated processes
Determination of requirements related to the product
Review of requirements related to the product
Design and development
Design and development planning
Design and development inputs
Design and development outputs
Design and development review
Design and development verification
Design and development validation
Control of design and development changes
Purchasing
Purchasing process
Purchasing information
Verification of purchased product
Production and service provision
Control of production and service provision
Identification and traceability
Customer property
Preservation of product
Validation of processes for production and service provision
Emergency preparedness and response
447
83
Control of nonconforming product
Checking and corrective action
45
8
Measurement analysis and improvement
Monitoring and measurement
451
76
81
82
821
823
824
84
Control of monitoring and measuring devices
General
Monitoring and measurement
Customer satisfaction
Monitoring and measurement of processes
Monitoring and measurement of product
Analysis of data
Nonconformance and corrective and preventive action
452
83
852
853
Control of nonconforming product
Corrective action
Preventive action
Records
453
424
Control of records
Environmental management system audit
454
822
Internal audit
Management review
46
56
561
562
563
Management review
General
Review input
Review output
Annex B
(informative)
Correspondence between ISO 90012000 and ISO 90011994
Table B1 Correspondence between ISO 90011994 and ISO 90012000
ISO 90011994
ISO 90012000
1 Scope
1
2 Normative reference
2
3 Definitions
3
4 Quality system requirements [title only]
41 Management responsibility [title only]
411 Quality policy
51 + 53 + 541
412 Organization [title only]
4121 Responsibility and authority
551
4122 Resources
61 +621
4123 Management representative
552
413 Management review
561 + 851
42 Quality system [title only]
421 General
41 +422
422 Quality system procedures
421
423 Quality planning
542+71
43 Contract review [title only]
431 General
432 Review
52 + 721 + 722 + 723
433 Amendment to a contract
722
434 Records
722
44 Design control [title only]
441 General
442 Design and development planning
731
443 Organizational and technical interfaces
731
444 Design input
721 +732
445 Design output
733
446 Design review
734
447 Design verification
735
448 Design validation
736
449 Design changes
737
45 Document and data control [title only]
451 General
423
452 Document and data approval and issue
423
453 Document and data changes
423
46 Purchasing [title only]
461 General
462 Evaluation of subcontractors
741
463 Purchasing data
742
464 Verification of purchased product
743
Table B1 Correspondence between ISO 90011994 and ISO 90012000 (continued)
ISO 90011994
ISO 90012000
47 Control of customersupplied product
754
48 Product identification and traceability
753
49 Process control
63 + 64 + 751 + 752
410 Inspection and testing [title only]
4101 General
71 +81
4102 Receiving inspection and testing
743 + 824
4103 Inprocess inspection and testing
824
4104 Final inspection and testing
824
4105 Inspection and test records
753 + 824
411 Control of inspection measuring and test equipment [title only]
4111 General
76
4112 Control procedure
76
412 Inspection and test status
753
413 Control of nonconforming product [title only]
4131 General
83
4132 Review and disposition of nonconforming product
83
414 Corrective and preventive action [title only]
4141 General
852 + 853
4142 Corrective action
852
4143 Preventive action
853
415 Handling storage packaging preservation & delivery [title only]
4151 General
4152 Handling
755
4153 Storage
755
4154 Packaging
755
4155 Preservation
755
4156 Delivery
751
416 Control of quality records
424
417 Internal quality audits
822 + 823
418 Training
622
419 Servicing
751
420 Statistical techniques [title only]
4201 Identification of need
81 + 823 + 824 + 84
4202 Procedures
81 + 823 + 824 + 84
Table B2 Correspondence between ISO 90012000 and ISO 90011994
ISO 90012000
ISO 90011994
1 Scope
I
11 General
12 Application
2 Normative reference
2
3 Terms and definitions
3
4 Quality management system [title only]
41 General requirements
421
42 Documentation requirements [title only]
421 General
422
422 Quality manual
421
423 Control of documents
451 452 453
424 Control of records
416
5 Management responsibility [title only]
51 Management commitment
411
52 Customer focus
432
53 Quality policy
411
54 Planning [title only]
541 Quality objectives
411
542 Quality management system planning
423
55 Responsibility authority and communication [title only]
551 Responsibility and authority
4121
552 Management representative
4123
553 Internal communication
56 Management review [title only]
561 General
413
562 Review input
563 Review output
6 Resource management [title only]
61 Provision of resources
4122
62 Human resources [title only]
621 General
4122
622 Competence awareness and training
418
63 Infrastructure
49
64 Work environment
49
7 Product realization [title only]
71 Planning of product realization
423 + 4101
72 Customerrelated processes [title only]
721 Determination of requirements related to the product
432 + 4A4
722 Review of requirements related to the product
432 + 433 + 434
723 Customer communication
432
73 Design and development [title only]
731 Design and development planning
442 + 443
732 Design and development inputs
444
Table B2 Correspondence between ISO 90012000 and ISO 90011994 (continued)
ISO 90012000
ISO 90011994
733 Design and development outputs
445
734 Design and development review
446
735 Design and development verification
447
736 Design and development validation
448
737 Control of design and development changes
449
74 Purchasing [title only]
741 Purchasing process
462
742 Purchasing information
463
743 Verification of purchased product
464 + 4102
75 Production and service provision [title only]
751 Control of production and service provision
49 + 4156 + 419
752 Validation of processes for production and service provision
49
753 Identification and traceability
48 + 4105 + 412
754 Customer property
47
755 Preservation of product
4152 + 4153 + 4154 +4155
76 Control of monitoring and measuring devices
4111 + 4112
8 Measurement analysis and improvement [title only]
81 General
4101 + 4201 + 4202
82 Monitoring and measurement [title only]
821 Customer satisfaction
822 Internal audit
417
823 Monitoring and measurement of processes
417 + 4201 + 4202
824 Monitoring and measurement of product
4102 + 4103 + 4104 + 4105 4201 4202
83 Control of nonconforming product
4131 +4132
84 Analysis of data
4201 +4202
85 Improvement [title only]
851 Continual improvement
413
852 Corrective action
4141 + 4142
853 Preventive action
4141 + 4143
Bibliography
[1] ISO 9000 31997 Quality management and quality assurance standards Part 3 Guidelines for the application of ISO 90011994 to the development supply installation and maintenance of computer software
[2] ISO 90042000 Quality management systems Guidelines for performance improvements
[3] ISO 100051995 Quality management Guidelines for quality plans
[4] SO 100061997 Quality management Guidelines to quality in project management
[5] ISO 100071995 Quality management Guidelines for configuration management
[6] ISO 100 11 1 1990 Guidelines for auditing quality systems Part 1 Auditing 1)
[7] ISO 100 11 21991 Guidelines for auditing quality systems Part 2 Qualification criteria for quality systems auditors 1)
[8] ISO 100 11 31991 Guidelines for auditing quality systems Part 3 Management of audit programmes 1)
[9] ISO 10012 11992 Quality assurance requirements for measuring equipment Part 1 Metrological confirmation system for measuring equipment
[10] ISO 10012 21997 Quality assurance for measuring equipment Part2 Guidelines for control of measurement processes
[11] ISO 100131995 Guidelines for developing quality manuals
[12] ISOTR 100 141998 Guidelines for managing the economics of quality
[13] ISO 100151999 Quality management Guidelines for training
[14] ISOTR 100171999 Guidance on statistical techniques for ISO 90011994
[15] ISO 140011996 Environmental management systems Specification with guidance for use
[16] IEC 60300 12) Dependability management Part 1 Dependability programme management
)
[17] Quality Management Principles Brochure 3
[18] ISO 9000 + ISO 14000 News (a bimonthly publication which provides comprehensive coverage of international developments relating to ISO's management system standards including news of their implementation by diverse organizations around the world) 4)
[19] Reference websites httpwwwisoch
hftpwwwbsiorgukiso tcl76 sc2
1) To be revised as ISO 19011 Guidelines on quality andor environmental management systems auditing
2) To be published (Revision of ISO 9000 41993)
3) Available from website httpwwwisoch
4) Available from ISO Central Secretariat (sales@isoch)
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AMERICAN NATIONAL STANDARD
Quality management systems—
Requirements
Approved as a American National Standard by
American Society for Quality
An American National Standard Approved on December 13 2000
American National Standards An American National Standard implies a consensus of those substantially concerned with its scope and provisions An American National Standard is intended as a guide to aid the manufacturer the consumer and the general public The existence of an American National Standard does not in any respect preclude anyone whether he or she has approved the standard or not from manufacturing purchasing or using products processes or procedures not conforming to the standard American National Standards are subject to periodic review and users are cautioned to obtain the latest edition
Caution NoticeThis American National Standard may be revised or withdrawn at any time The procedures of the American National Standards Institute require that action be taken to reaffirm revise or withdraw this standard no later than five years from the date of publication Purchasers of American
National Standards may receive current information on all standards by calling or writing the American National Standards Institute
ANSIISOASQ 090012000
Contents Page
1 Scope 1
11 General 1
12 Application 1
2 Normative reference 1
3 Terms and definitions 1
4 Quality management system 2
41 General requirements 2
42 Documentation requirements 2
5 Management responsibility 3
51 Management commitment 3
52 Customer focus 4
53 Quality policy 4
54 Planning 4
55 Responsibility authority and communication 4
56 Management review 5
6 Resource management 5
61 Provision of resources 5
62 Human resources 6
63 Infrastructure 6
64 Work environment 6
7 Product realization 6
71 Planning of product realization 6
72 Customerrelated processes 7
73 Design and development 8
74 Purchasing 9
75 Production and service provision 10
76 Control of monitoring and measuring devices 11
8 Measurement analysis and improvement 11
81 General 11
82 Monitoring and measurement 11
83 Control of nonconforming product 12
84 Analysis of data 13
85 Improvement 13
Annexes
A Correspondence between ISO 90012000 and ISO 140011996 15
B Correspondence between ISO 90012000 and ISO 90011994 19
Bibliography 23
Introduction
01 General
The adoption of a quality management system should be a strategic decision of an organization The design and implementation of an organization’s quality management system is influenced by varying needs particular objectives the products provided the processes employed and the size and structure of the organization It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation
The quality management system requirements specified in this International Standard are complementary to requirements for products Information marked NOTE is for guidance in understanding or clarifying the associated requirement
This International Standard can be used by internal and external parties Including certification bodies to assess the organization’s ability to meet customer regulatory and the organization’s own requirements
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard
02 Process approach
This International Standard promotes the adoption of a process approach when developing implementing and improving the effectiveness of a quality management system to enhance customer satisfaction by meeting customer requirements
For an organization to function effectively it has to identify and manage numerous linked activities An activity using resources and managed in order to enable the transformation of inputs Into outputs can be considered as a process Often the output from one process directly forms the input to the next
The application of a system of processes within an organization together with the identification and interactions of these processes and their management can be referred to as the process approach
An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes as well as over their combination and interaction
When used within a quality management system such an approach emphasizes the importance of
a) understanding and meeting requirements
b) the need to consider processes in terms of added value
C) obtaining results of process performance and effectiveness and
d) continual improvement of processes based on objective measurement
The model of a processbased quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8 This illustration shows that customers play a significant role in defining requirements as inputs Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements The model shown in Figure 1 covers all the requirements of this International Standard but does not show processes at a detailed level
ANSIISOASQ Q90012000
NOTE In addition the methodology known as PlanDoCheckAct (PDCA) can be applied to all processes PDCA can be briefly described as follows
Plan establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization’s policies
Do implement the processes
Check monitor and measure processes and product against policies objectives and requirements for the product and report the results
Act take actions to continually improve process performance
Key
Valueadding activities
Information flow
Figure 1 Model of a processbased quality management system
03 Relationship with ISO 9004
The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement each other but can also be used independently Although the two International Standards have different scopes they have similar structures in order to assist their application as a consistent pair
ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations or for certification or for contractual purposes It focuses on the effectiveness of the quality management system in meeting customer requirements
ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001 particularly for the continual improvement of an organization’s overall performance and efficiency as well as its effectiveness ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001 in pursuit of continual improvement of performance However it is not intended for certification or for contractual purposes
04 Compatibility with other management systems
This International Standard has been aligned with ISO 14001 1996 in order to enhance the compatibility of the two standards for the benefit of the user community
This International Standard does not include requirements specific to other management systems such as those particular to environmental management occupational health and safety management financial management or risk management However this International Standard enables an organization to align or integrate its own quality management system with related management system requirements It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard
INTERNATIONAL STANDARD
Quality management systems — Requirements
I Scope
11 General
This International Standard specifies requirements for a quality management system wnere an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements and
b) aims to enhance customer satisfaction through the effective application of the system including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements
NOTE In this International Standard the term product applies only to the product intended for or required by a customer
12 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations regardless of type size and product provided
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product this can be considered for exclusion
Where exclusions are made claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7 and such exclusions do not affect the organization’s ability or responsibility to provide product that meets customer and applicable regulatory requirements
2 Normative reference
The following normative document contains provisions which through reference in this text constitute provisions of this International Standard For dated references subsequent amendments to or revisions of any of these publications do not apply However parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below For undated references the latest edition of the normative document referred to applies Members of ISO and IEC maintain registers of currently valid International Standards
ISO 90002000 Quallty management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this International Standard the terms and definitions given in ISO 9000 apply
The following terms used in this edition of ISO 9001 to describe the supply chain have been changed to reflect the vocabulary currently used
supplier ~organization customer
The term organization’ replaces the term supplier used in ISO 90011994 and refers to the unit to which this International Standard applies Also the term supplier now replaces the term subcontractor
Throughout the text of this International Standard wherever the term product occurs it can also mean service
4 Quality management system
41 General requirements
The organization shall establish document implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard
The organization shall
a) identify the processes needed for the quality management system and their application throughout the organization (see 12)
b) determine the sequence and interaction of these processes
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes
e) monitor measure and analyze these processes and
f) implement actions necessary to achieve planned results and continual improvement of these processes
These processes shall be managed by the organization in accordance with the requirements of this International Standard
Where an organization chooses to outsource any process that affects product conformity with requirements the organization shall ensure control over such processes Control of such outsourced processes shall be identified within the quality management system
NOTE Processes needed for the quality management system referred to above should include processes for management activities provision of resources product realization and measurement
42 Documentation requirements
421 General
The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives
b) a quality manual
c) documented procedures required by this International Standard
d documents needed by the organization to ensure the effective planning operation and control of its processes and
e) records required by this International Standard (see 424)
NOTE I Where the term documented procedure appears within this International Standard this means that the procedure is established documented implemented and maintained
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
a) the size of organization and type of activities
b) the complexity of processes and their interactions and
c) the competence of personnel
NOTE 3 The documentation can be in any form or type of medium
422 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system including details of and justification for any exclusions (see 12)
b) the documented procedures established for the quality management system or reference to them and
c) a description of the interaction between the processes of the quality management system
423 Control of documents
Documents required by the quality management system shall be controlled Records are a special type of document
and shall be controlled according to the requirements given in 424
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue
b) to review and update as necessary and reapprove documents
C) to ensure that changes and the current revision status of documents are identified
d) to ensure that relevant versions of applicable documents are available at points of use
e) to ensure that documents remain legible and readily identifiable
f) to ensure that documents of external origin are identified and their distribution controlled and
g) to prevent the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose
424 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system Records shall remain legible readily identifiable and retrievable A documented procedure shall be established to define the controls needed for the identification storage protection retrieval retention time and disposition of records
5 Management responsibility
51 Management commitment
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements
b) establishing the quality policy
c) ensuring that quality objectives are established
d) conducting management reviews and
e) ensuring the availability of resources
52 Customer focus
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 721 and 821)
53 Quality policy
Top management shall ensure that the quality policy
a) is appropriate to the purpose of the organization
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system
c) provides a framework for establishing and reviewing quality objectives
d) is communicated and understood within the organization and
e) is reviewed for continuing suitability
54 Planning
541 Quality objectives
Top management shall ensure that quality objectives including those needed to meet requirements for product 71 a)] are established at relevant functions and levels within the organization The quality objectives shall be measurable and consistent with the quality policy
542 Quality management system planning
Top management shall ensure that
a) the planning of the quality management system is carried out in order to meet the requirements given in 41 as well as the quality objectives and
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented
55 Responsibility authority and communication
551 Responsibility and authority
Top management shall ensure that responsibilities and authorities are defined and communicated within the organization
552 Management representative
Top management shall appoint a member of management who irrespective of other responsibilities shall have responsibility and authority that includes
a) ensuring that processes needed for the quality management system are established implemented and maintained
b) reporting to top management on the performance of the quality management system and any need for improvement and
C) ensuring the promotion of awareness of customer requirements throughout the organization
NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system
553 Internal communication
Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system
56 Management review
561 General
Top management shall review the organization’s quality management system at planned intervals to ensure its continuing suitability adequacy and effectiveness This review shall include assessing opportunities for improvement and the need for changes to the quality management system including the quality policy and quality objectives
Records from management reviews shall be maintained (see 424)
562 Review input
The input to management review shall include information on
a) results of audits
b) customer feedback
c) process performance and product conformity
d) status of preventive and corrective actions
e) followup actions from previous management reviews
f) changes that could affect the quality management system and
g) recommendations for improvement
563 Review output
The output from the management review shall include any decisions and actions related to
a) improvement of the effectiveness of the quality management system and its processes
b) improvement of product related to customer requirements and
c) resource needs
6 Resource management
61 Provision of resources
The organization shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness and
b) to enhance customer satisfaction by meeting customer requirements
62 Human resources
621 General
Personnel performing work affecting product quality shall be competent on the basis of appropriate education training skills and experience
622 Competence awareness and training
The organization shall
a) determine the necessary competence for personnel performing work affecting product quality
b) provide training or take other actions to satisfy these needs
c) evaluate the effectiveness of the actions taken
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives and
e) maintain appropriate records of education training skills and experience (see 424)
631 Infrastructure
The organization shall determine provide and maintain the infrastructure needed to achieve conformity to product requirements Infrastructure includes as applicable
a) buildings workspace and associated utilities
b) process equipment (both hardware and software) and
c) supporting services (such as transport or communication)
64 Work environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements
7 Product realization
71 Planning of product realization
The organization shall plan and develop the processes needed for product realization Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 41)
In planning product realization the organization shall determine the following as appropriate
a) quality objectives and requirements for the product
b) the need to establish processes documents and provide resources specific to the product
c) required verification validation monitoring inspection and test activities specific to the product and the criteria for product acceptance
d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 424)
The output of this planning shall be in a form suitable for the organization’s method of operations
NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product project or contract can be referred to as a quality plan
NOTE 2 The organization may also apply the requirements given in 73 to the development of product realization processes
72 Customerrelated processes
721 Determination of requirements related to the product
The organization shall determine
a) requirements specified by the customer including the requirements for delivery and postdelivery activities
b) requirements not stated by the customer but necessary for specified or intended use where known
c) statutory and regulatory requirements related to the product and
d) any additional requirements determined by the organization
722 Review of requirements related to the product
The organization shall review the requirements related to the product This review snail be conducted prior to the organization’s commitment to supply a product to the customer (eg submission of tenders acceptance of contracts or orders acceptance of changes to contracts or orders) and shall ensure that
a) product requirements are defined
b) contract or order requirements differing from those previously expressed are resolved and
c) the organization has the ability to meet the defined requirements
Records of the results of the review and actions arising from the review shall be maintained (see 424)
Where the customer provides no documented statement of requirement the customer requirements shall be confirmed by the organization before acceptance
Where product requirements are changed the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements
NOTE In some situations such as internet sales a formal review is impractical for each order Instead the review can cover relevant product information such as catalogues or advertising material
723 Customer communication
The organization shall determine and implement effective arrangements for communicating with customers in relation to
a) product information
b) inquiries contracts or order handling including amendments and
c) customer feedback including customer complaints
73 Design and development
731 Design and development planning
The organization shall plan and control the design and development of product
During the design and development planning the organization shall determine
a) the design and development stages
b) the review verification and validation that are appropriate to each design and development stage and
c) the responsibilities and authorities for design and development
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility
Planning output shall be updated as appropriate as the design and development progresses
732 Design and development inputs
Inputs relating to product requirements shall be determined and records maintained (see 424) These inputs shall include
a) functional and performance requirements
b) applicable statutory and regulatory requirements
c) where applicable information derived from previous similar designs and
d) other requirements essential for design and development
These inputs shall be reviewed for adequacy Requirements shall be complete unambiguous and not in conflict with each other
733 Design and development outputs
The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release
Design and development outputs shall
a) meet the input requirements for design and development
b) provide appropriate information for purchasing production and for service provision
c) contain or reference product acceptance criteria and
d) specify the characteristics of the product that are essential for its safe and proper use
734 Design and development review
At suitable stages systematic reviews of design and development shall be performed in accordance with planned arrangements (see 731)
a) to evaluate the ability of the results of design and development to meet requirements and
b) to identify any problems and propose necessary actions
Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed Records of the results of the reviews and any necessary actions shall be maintained (see 424)
735 Design and development verification
Verification shall be performed in accordance with planned arrangements (see 731) to ensure that the design and development outputs have met the design and development input requirements Records of the results of the verification and any necessary actions shall be maintained (see 424)
736 Design and development validation
Design and development validation shall be performed in accordance with planned arrangements (see 731) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use where known Wherever practicable validation shall be completed prior to the delivery or implementation of the product Records of the results of validation and any necessary actions shall be maintained (see 424)
737 Control of design and development changes
Design and development changes shall be identified and records maintained The changes shall be reviewed verified and validated as appropriate and approved before implementation The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered
Records of the results of the review of changes and any necessary actions shall be maintained (see 424)
74 Purchasing
741 Purchasing process
The organization shall ensure that purchased product conforms to specified purchase requirements The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product
The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements Criteria for selection evaluation and reevaluation shall be established Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 424)
742 Purchasing information
Purchasing information shall describe the product to be purchased including where appropriate
a) requirements for approval of product procedures processes and equipment
b) requirements for qualification of personnel and
c) quality management system requirements
The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier
743 Verification of purchased product
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements
Where the organization or its customer intends to perform verification at the supplier’s premises the organization shall state the intended verification arrangements and method of product release in the purchasing information
75 Production and service provision
751 Control of production and service provision
The organization shall plan and carry out production and service provision under controlled conditions Controlled conditions shall include as applicable
a) the availability of information that describes the characteristics of the product
b) the availability of work instructions as necessary
c) the use of suitable equipment
d) the availability and use of monitoring and measuring devices
e) the implementation of monitoring and measurement and
f) the implementation of release delivery and postdelivery activities
752 Validation of processes for production and service provision
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered
Validation shall demonstrate the ability of these processes to achieve planned results
The organization shall establish arrangements for these processes including as applicable
a) defined criteria for review and approval of the processes
b) approval of equipment and qualification of personnel
c) use of specific methods and procedures
d) requirements for records (see 424) and
e) revalidation
753 Identification and traceability
Where appropriate the organization shall identify the product by suitable means throughout product realization
The organization shall identify the product status with respect to monitoring and measurement requirements
Where traceability is a requirement the organization shall control and record the unique identification of the product (see 424)
NOTE In some industry sectors configuration management is a means by which identification and traceability are maintained
754 Customer property
The organization shall exercise care with customer property while it is under the organization’s control or being used by the organization The organization shall identify verify protect and safeguard customer property provided for use or incorporation into the product If any customer property is lost damaged or otherwise found to be unsuitable for use this shall be reported to the customer and records maintained (see 424)
NOTE Customer property can include intellectual property
755 Preservation of product
The organization shall preserve the conformity of product during internal processing and delivery to the intended destination This preservation shall include identification handling packaging storage and protection Preservation shall also apply to the constituent parts of a product
76 Control of monitoring and measuring devices
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 721)
The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements
Where necessary to ensure valid results measuring equipment shall
a) be calibrated or verified at specified intervals or prior to use against measurement standards traceable to international or national measurement standards where no such standards exist the basis used for calibration or verification shall be recorded
b) be adjusted or readjusted as necessary
c) be identified to enable the calibration status to be determined
d) be safeguarded from adjustments that would invalidate the measurement result
e) be protected from damage and deterioration during handling maintenance and storage
In addition the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements The organization shall take appropriate action on the equipment and any product affected Records of the results of calibration and verification shall be maintained (see 424)
When used in the monitoring and measurement of specified requirements the ability of computer software to satisfy the intended application shall be confirmed This shall be undertaken prior to initial use and reconfirmed as necessary
NOTE See ISO 100121 and ISO 100122 for guidance
8 Measurement analysis and improvement
81 General
The organization shall plan and implement the monitoring measurement analysis and improvement processes needed
a) to demonstrate conformity of the product
b) to ensure conformity of the quality management system and
c) to continually improve the effectiveness of the quality management system
This shall include determination of applicable methods including statistical techniques and the extent of their use
82 Monitoring and measurement
821 Customer satisfaction
As one of the measurements of the performance of the quality management system the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements The methods for obtaining and using this information shall be determined
822 Internal audit
The organization shall conduct internal audits at planned intervals to determine whether the quality management system
a) conforms to the planned arrangements (see 71) to the requirements of this International Standard and to the quality management system requirements established by the organization and
b) is effectively implemented and maintained
An audit programme shall be planned taking into consideration the status and importance of the processes and areas to be audited as well as the results of previous audits The audit criteria scope frequency and methods shall be defined Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process Auditors shall not audit their own work
The responsibilities and requirements for planning and conducting audits and for reporting results and maintaining records (see 424) shall be defined in a documented procedure
The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes Followup activities shall include the verification of the actions taken and the reporting of verification results (see 852)
NOTE See ISO 100111 ISO 100112 and ISO 100113 forguidance
823 Monitoring and measurement of processes
The organization shall apply suitable methods for monitoring and where applicable measurement of the quality management system processes These methods shall demonstrate the ability of the processes to achieve planned results When planned results are not achieved correction and corrective action shall be taken as appropriate to ensure conformity of the product
824 Monitoring and measurement of product
The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 71)
Evidence of conformity with the acceptance criteria shall be maintained Records shall indicate the person(s) authorizing release of product (see 424)
Product release and service delivery shall not proceed until the planned arrangements (see 71) have been satisfactorily completed unless otherwise approved by a relevant authority and where applicable by the customer
83 Control of nonconforming product
The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure
The organization shall deal with nonconforming product by one or more of the following ways
a) by taking action to eliminate the detected nonconformity
b) by authorizing its use release or acceptance under concession by a relevant authority and where applicable by the customer
c) by taking action to preclude its original intended use or application
Records of the nature of nonconformities and any subsequent actions taken including concessions obtained shall be maintained (see 424)
When nonconforming product is corrected it shall be subject to reverification to demonstrate conformity to the requirements
When nonconforming product is detected after delivery or use has started the organization shall take action appropriate to the effects or potential effects of the nonconformity
84 Analysis of data
The organization shall determine collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made This shall include data generated as a result of monitoring and measurement and from other relevant sources
The analysis of data shall provide information relating to
a) customer satisfaction (see 821)
b) conformity to product requirements (see 721)
c) characteristics and trends of processes and products including opportunities for preventive action and
d) suppliers
85 Improvement
851 Continual improvement
The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy quality objectives audit results analysis of data corrective and preventive actions and management review
852 Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence Corrective actions shall be appropriate to the effects of the nonconformities encountered
A documented procedure shall be established to define requirements for
a) reviewing nonconformities (including customer complaints)
b) determining the causes of nonconformities
c) evaluating the need for action to ensure that nonconformities do not recur
d) determining and implementing action needed
e) records of the results of action taken (see 424) and
f) reviewing corrective action taken
853 Preventive action
The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence Preventive actions shall be appropriate to the effects of the potential problems
A documented procedure shall be established to define requirements for
a) determining potential nonconformities and their causes
b) evaluating the need for action to prevent occurrence of nonconformities
c) determining and implementing action needed
d) records of results of action taken (see 424) and
e) reviewing preventive action taken
Annex A
(informative)
Correspondence between ISO 9001 2000 and ISO 140011996
Table A1 — Correspondence between ISO 9001 2000 and ISO 14001 1996
ISO 90012000
ISO 140011996
Introduction
General
Process approach
Relationship with ISO 9004
Compatibility with other management systems
01
02
03
04
Introduction
Sc
Scope
General
Application
1
11
12
1
Normative reference
2
2
Normative references
Terms and definitions
3
3
Definitions
Quality management system
4
4
Environmental management system requirements
General requirements
41
41
General requirements
Documentation requirements
General
Quality manual
Control of documents
Control of records
42
421
422
423
424
444
444
445
453
Environmental management system documentation
Environmental management system documentation
Document control
Records
Management responsibility
5
441
Structure and responsibility
Management commitment
51
42
441
Environmental policy Structure and responsibility
Customer focus
52
431
432
Environmental aspects Legal and other requirements
Quality policy
53
42
Environmental policy
Planning
54
43
Planning
Quality objectives
541
433
Objectives and targets
Quality management system planning
542
434
Environmental management programme(s)
Responsibility authority and communication
55
41
General requirements
Responsibility and authority Management representative
551
552
441
Structure and responsibility
Internal communication
553
443
Communication
Management review
General
Review input
Review output
56
561
562
563
46
Management review
Resource management
Provision of resources
Human resources
General
6
61
62
621
441
Structure and responsibility
Competence awareness and training
622
442
Training awareness and competence
Infrastructure Work environment
Work environment
63
64
441
Structure and responsibility
Table A1 — Correspondence between ISO 9001 2000 and ISO 140011996 (continued)
ISO 9001 2000
Iso 140011996
Product realization
7
44
446
Implementation and operation Operational control
Planning of product realization Customerrelated processes
71
72
446
Operational control
Determination of requirements related to the product
721
431
432
446
Environmental aspects
Legal and other requirements
Operational control
Review of requirements related to the product
722
446
431
Operational control
Environmental aspects
Customer communication
723
443
Communications
Design and development
Design and development planning
Design and development inputs
Design and development outputs
Design and development review
Design and development verification
Design and development validation
Control of design and development changes
Purchasing
Purchasing process
Purchasing information
Verification of purchased product
Production and service provision
Control of production and service provision Validation of processes for production and service provision
Identification and traceability
Customer property
Preservation of product
73
731
732
733
734
735
736
737
74
741
742
743
75
751
752
753
754
755
446
446
446
Operational control
Operational control
Operational control
Control of monitoring and measuring devices
76
451
Monitoring and measurement
Measurement analysis and improvement
8
45
Checking and corrective action
General
Monitoring and measurement
Customer satisfaction
81
82
821
451
Monitoring and measurement
Internal audit
822
454
Environmental management system audit
Monitoring and measurement of processes Monitoring and measurement of product
823
824
451
Monitoring and measurement
Control of nonconforming product
83
452
447
Nonconformance and corrective and preventive action Emergency preparedness and response
Analysis of data
84
451
Monitoring and measurement
Improvement
85
42
Environmental policy
Continual improvement
851
434
Environmental management programme(s)
Corrective action
Preventive action
852
853
452
Nonconformance and corrective and preventive action
Table A2 — Correspondence between ISO 14001 1996 and ISO 9001 2000
ISO 140011996
ISO 9001 2000
Introduction
0
01
02
03
04
Introduction
General
Process approach
Relationship with ISO 9004
Compatibility with other management systems
Scope
1I
1
11
12
Scope
General
Application
Normative references
2
2
Normative reference
Definitions
3
3
Terms and definitions
Environmental management system requirements
4
4
Quality management system
General requirements
41
41
55
551
General requirements
Responsibility authority and communication
Responsibility and authority
Environmental policy
42
51
53
85
Management commitment
Quality policy
Improvement
Planning
43
54
Planning
Environmental aspects
431
52
721
722
Customer focus
Determination of requirements related to the product
Review of requirements related to the product
Legal and other requirements
432
52
721
Customer focus
Determination of requirements related to the product
Objectives and targets
433
541
Quality objectives
Environmental management programme(s)
434
542
851
Quality management system planning Continual improvement
Implementation and operation
44
7
71
Product realization
Planning of product realization
Structure and responsibility
441
5
51
551
552
6
61
62
621
63
64
Management responsibility
Management commitment
Responsibility and authority
Management representative
Resource management
Provision of resources
Human resources
General
Infrastructure
Work environment
Training awareness and competence
442
622
Competence awareness and training
Communication
443
553
723
Internal communication
Customer communication
Environmental management system documentation
444
42
421
422
Documentation requirements
General
Quality manual
Table A2 — Correspondence between ISO 140011996 and ISO 9001 2000 (continued)
1S0140011996
lSO900l2000
Document control
445
423
Control of documents
Operational control
446
7
71
72
721
722
73
731
732
733
734
735
736
737
74
741
742
743
75
751
753
754
755
752
Product realization
Planning of product realization
Customerrelated processes
Determination of requirements related to the product
Review of requirements related to the product
Design and development
Design and development planning
Design and development inputs
Design and development outputs
Design and development review
Design and development verification
Design and development validation
Control of design and development changes
Purchasing
Purchasing process
Purchasing information
Verification of purchased product
Production and service provision
Control of production and service provision
Identification and traceability
Customer property
Preservation of product
Validation of processes for production and service provision
Emergency preparedness and response
447
83
Control of nonconforming product
Checking and corrective action
45
8
Measurement analysis and improvement
Monitoring and measurement
451
76
81
82
821
823
824
84
Control of monitoring and measuring devices
General
Monitoring and measurement
Customer satisfaction
Monitoring and measurement of processes
Monitoring and measurement of product
Analysis of data
Nonconformance and corrective and preventive action
452
83
852
853
Control of nonconforming product
Corrective action
Preventive action
Records
453
424
Control of records
Environmental management system audit
454
822
Internal audit
Management review
46
56
561
562
563
Management review
General
Review input
Review output
Annex B
(informative)
Correspondence between ISO 90012000 and ISO 90011994
Table B1 Correspondence between ISO 90011994 and ISO 90012000
ISO 90011994
ISO 90012000
1 Scope
1
2 Normative reference
2
3 Definitions
3
4 Quality system requirements [title only]
41 Management responsibility [title only]
411 Quality policy
51 + 53 + 541
412 Organization [title only]
4121 Responsibility and authority
551
4122 Resources
61 +621
4123 Management representative
552
413 Management review
561 + 851
42 Quality system [title only]
421 General
41 +422
422 Quality system procedures
421
423 Quality planning
542+71
43 Contract review [title only]
431 General
432 Review
52 + 721 + 722 + 723
433 Amendment to a contract
722
434 Records
722
44 Design control [title only]
441 General
442 Design and development planning
731
443 Organizational and technical interfaces
731
444 Design input
721 +732
445 Design output
733
446 Design review
734
447 Design verification
735
448 Design validation
736
449 Design changes
737
45 Document and data control [title only]
451 General
423
452 Document and data approval and issue
423
453 Document and data changes
423
46 Purchasing [title only]
461 General
462 Evaluation of subcontractors
741
463 Purchasing data
742
464 Verification of purchased product
743
Table B1 Correspondence between ISO 90011994 and ISO 90012000 (continued)
ISO 90011994
ISO 90012000
47 Control of customersupplied product
754
48 Product identification and traceability
753
49 Process control
63 + 64 + 751 + 752
410 Inspection and testing [title only]
4101 General
71 +81
4102 Receiving inspection and testing
743 + 824
4103 Inprocess inspection and testing
824
4104 Final inspection and testing
824
4105 Inspection and test records
753 + 824
411 Control of inspection measuring and test equipment [title only]
4111 General
76
4112 Control procedure
76
412 Inspection and test status
753
413 Control of nonconforming product [title only]
4131 General
83
4132 Review and disposition of nonconforming product
83
414 Corrective and preventive action [title only]
4141 General
852 + 853
4142 Corrective action
852
4143 Preventive action
853
415 Handling storage packaging preservation & delivery [title only]
4151 General
4152 Handling
755
4153 Storage
755
4154 Packaging
755
4155 Preservation
755
4156 Delivery
751
416 Control of quality records
424
417 Internal quality audits
822 + 823
418 Training
622
419 Servicing
751
420 Statistical techniques [title only]
4201 Identification of need
81 + 823 + 824 + 84
4202 Procedures
81 + 823 + 824 + 84
Table B2 Correspondence between ISO 90012000 and ISO 90011994
ISO 90012000
ISO 90011994
1 Scope
I
11 General
12 Application
2 Normative reference
2
3 Terms and definitions
3
4 Quality management system [title only]
41 General requirements
421
42 Documentation requirements [title only]
421 General
422
422 Quality manual
421
423 Control of documents
451 452 453
424 Control of records
416
5 Management responsibility [title only]
51 Management commitment
411
52 Customer focus
432
53 Quality policy
411
54 Planning [title only]
541 Quality objectives
411
542 Quality management system planning
423
55 Responsibility authority and communication [title only]
551 Responsibility and authority
4121
552 Management representative
4123
553 Internal communication
56 Management review [title only]
561 General
413
562 Review input
563 Review output
6 Resource management [title only]
61 Provision of resources
4122
62 Human resources [title only]
621 General
4122
622 Competence awareness and training
418
63 Infrastructure
49
64 Work environment
49
7 Product realization [title only]
71 Planning of product realization
423 + 4101
72 Customerrelated processes [title only]
721 Determination of requirements related to the product
432 + 4A4
722 Review of requirements related to the product
432 + 433 + 434
723 Customer communication
432
73 Design and development [title only]
731 Design and development planning
442 + 443
732 Design and development inputs
444
Table B2 Correspondence between ISO 90012000 and ISO 90011994 (continued)
ISO 90012000
ISO 90011994
733 Design and development outputs
445
734 Design and development review
446
735 Design and development verification
447
736 Design and development validation
448
737 Control of design and development changes
449
74 Purchasing [title only]
741 Purchasing process
462
742 Purchasing information
463
743 Verification of purchased product
464 + 4102
75 Production and service provision [title only]
751 Control of production and service provision
49 + 4156 + 419
752 Validation of processes for production and service provision
49
753 Identification and traceability
48 + 4105 + 412
754 Customer property
47
755 Preservation of product
4152 + 4153 + 4154 +4155
76 Control of monitoring and measuring devices
4111 + 4112
8 Measurement analysis and improvement [title only]
81 General
4101 + 4201 + 4202
82 Monitoring and measurement [title only]
821 Customer satisfaction
822 Internal audit
417
823 Monitoring and measurement of processes
417 + 4201 + 4202
824 Monitoring and measurement of product
4102 + 4103 + 4104 + 4105 4201 4202
83 Control of nonconforming product
4131 +4132
84 Analysis of data
4201 +4202
85 Improvement [title only]
851 Continual improvement
413
852 Corrective action
4141 + 4142
853 Preventive action
4141 + 4143
Bibliography
[1] ISO 9000 31997 Quality management and quality assurance standards Part 3 Guidelines for the application of ISO 90011994 to the development supply installation and maintenance of computer software
[2] ISO 90042000 Quality management systems Guidelines for performance improvements
[3] ISO 100051995 Quality management Guidelines for quality plans
[4] SO 100061997 Quality management Guidelines to quality in project management
[5] ISO 100071995 Quality management Guidelines for configuration management
[6] ISO 100 11 1 1990 Guidelines for auditing quality systems Part 1 Auditing 1)
[7] ISO 100 11 21991 Guidelines for auditing quality systems Part 2 Qualification criteria for quality systems auditors 1)
[8] ISO 100 11 31991 Guidelines for auditing quality systems Part 3 Management of audit programmes 1)
[9] ISO 10012 11992 Quality assurance requirements for measuring equipment Part 1 Metrological confirmation system for measuring equipment
[10] ISO 10012 21997 Quality assurance for measuring equipment Part2 Guidelines for control of measurement processes
[11] ISO 100131995 Guidelines for developing quality manuals
[12] ISOTR 100 141998 Guidelines for managing the economics of quality
[13] ISO 100151999 Quality management Guidelines for training
[14] ISOTR 100171999 Guidance on statistical techniques for ISO 90011994
[15] ISO 140011996 Environmental management systems Specification with guidance for use
[16] IEC 60300 12) Dependability management Part 1 Dependability programme management
)
[17] Quality Management Principles Brochure 3
[18] ISO 9000 + ISO 14000 News (a bimonthly publication which provides comprehensive coverage of international developments relating to ISO's management system standards including news of their implementation by diverse organizations around the world) 4)
[19] Reference websites httpwwwisoch
hftpwwwbsiorgukiso tcl76 sc2
1) To be revised as ISO 19011 Guidelines on quality andor environmental management systems auditing
2) To be published (Revision of ISO 9000 41993)
3) Available from website httpwwwisoch
4) Available from ISO Central Secretariat (sales@isoch)
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