Quality management systems –Requirements
1 Scope
1.1 General
This International Standard specifies requirements for a quality management system where 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.
1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations,regardless of type,size ad product provided.
Where any requirements(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 9000:2000,Quality management systems – Fundamentals and vocabulary.
3 Terms
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 I ISO 9001:1994,and refers to the unit to which the 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
4.1 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 1.2),
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 ad information necessary to support the operation and monitoring of these processes,
e) monitor,measure and analyse 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.
4.2 Documentation requirements
4.2.1 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 4.2.4)
NOTE 1 Where the term,documented procedure, appears within this International Standard,this means that the procedure is established,documented,implemented and maintained.
NOTE2 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 ad their interactions,and
c) the competence of personnel.
NOTE 3 The documentation can be in any form or type of medium.
4.2.2 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 1.2),
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.
4.2.3 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 4.2.4.
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 re-approve 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.
4.2.4 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
5.1 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.
5.2 Customer focus
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).
5.3 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.
5.4 Planning
5.4.1 Quality objectives
Top management shall ensure that quality objectives,including those needed to meet requirements for product [see 7.1 a]],are established at relevant functions and levels within the organization,The quality objectives shall be measurable and consistent with the quality policy.
5.4.2 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.
5.5 Responsibility,authority and communication
5.5.1 Responsibility and authority
Top management shall ensure that responsibilities and authorities are defined and communicated within the organization,
5.5.2 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.
5.5.3 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.
5.6 Management review
5.6.1 General
Top management shall review the organization’s quality management system,at planed intervals,to ensure is 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 4.2.4).
5.6.2 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) follow-up actions from previous management reviews,
f) changes that could affect the quality management system,and
g) recommendations for improvement.
5.6.3 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
6.1 Provision of resources
The organization shall determine and provide the resources needed
to implement and maintain the quality management system and continually improve its effectiveness,and
to enhance customer satisfaction by meeting customer requirements.
6.2 Human resources
6.2.1 General
Personnel performing work affecting product quality shall be competent on the basis of appropriate education,training,skills and experience.
6.2.2 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 4.2.4).
6.3 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).
6.4 Work environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
7 Product realization
7.1 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 4.1).
In planning product realization,the organization shall determine the following,as appropriate:
a) quality objectives ad 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 4.2.4)
The output of this planning shall be in a from 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 7.3 to the development of product realization processes.
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
The organization shall determine
a) requirements specified by the customer,including the requirements for delivery and post-delivery activities,
b) requirements not stated by the4 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.
7,2.2 Review of requirements related to the product
The organization shall review the requirements related to the product,This review shall be conducted prior to the organization’s commitment to supply a product to the customer (e.g,submission o 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 actins arising from the review shall be maintained (see 4.2.4).
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.
7.2.3 Customer communication
The organization shall determine and implement effective arrangements for communicating with customers in relation to
a) product information,
b) enquiries,contracts or order handling,including amendments,and
c) customer feedback,including customer complaints.
7.3 Design and development
7.3.1 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.
7.3.2 Design and development inputs
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4),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.
7.3.3 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 productaccept6ance criteria,and
d) specify the characteristics of the product that are essential for its safe and proper use.
7.3.4 Design and development review
At suitable stages,systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)
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 4.2.4)
7.3.5 Design and development verification
Verification shall be performed in accordance with planned arrangements (see 7.3.1) 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 4.2.4)
7.3.6 Design and development validation
Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) 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 actins shall be maintained (see 4.2.4)
7.3.7 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 4.2.4).
7.4 Purchasing
7.4.1 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 purchase3d 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 re-evaluation shall be established,Records of the results of evaluations and any necessary actions arising form the evaluation shall be maintained (see 4.2.4)
7.4.2Purchasing 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.
7.4.3 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 performs verification at the supplier’s premises,the organization shall state the intended verification arrangements and method of product release in the purchasing information.
7.5 Production and service provision
7.5.1 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 post-delivery activities.
7.5.2 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 4.2.4) and
e) revalidation.
7.5.3 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 4.2.4)
NOTE In some industry sectors,configuration management is a means by which identification and traceability are maintained.
7.5.4 Customer property
The organization shall exercise care with customer property while it is under the organization’s control being used by the organization,The organization shall identify,verify,protect ad 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 4.2.4)
NOTE Customer property can include intellectual property.
7.5.5 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.
7.6 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 7.2.1)
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 re-adjusted 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 4.2.4).
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 an reconfirmed as necessary.
NOTE See ISO 10012-1 and ISO 100012-2 for guidance.
8 Measurement,analysis and improvement
8.1 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,
8.2 Monitoring and measurement
8.2.1 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.
8.2.2 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 7.1),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 defied,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 4.2.4) 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,Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).
NOTE See ISO 10011-1-2 and ISO 10011-3 for guidance.
8.2.3 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.
8.2.4 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 7.1)
Evidence of conformity with the acceptance criteria shall be maintained,Records shall indicate the person(s) authorizing release of product (see 4.2.4)
Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have beer satisfactorily completed,unless otherwise approved by a relevant authority and,where applicable,by the customer,
8.3 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 4.2.4).
When nonconforming product is corrected it shall be subject to re-verification 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.
8.4 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 ad from other relevant sources.
The analysis of data shall provide information relating to
a) customer satisfaction (see 8.2.1)
b) conformity to product requirements (see 7.2.1)
c) characteristics and trends of processes and products including opportunities for preventive action,and
d) suppliers,
8.5 Improvement
8.5.1 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.
8.5.2 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 4.2.4),and
f) reviewing corrective action taken.
8.5.3 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 4.2.4),and
e) reviewing preventive action taken.
Annex A
(informative)
Correspondence between ISO9001:2000 and ISO 14001:1996
Table A.1 – Correspondence between ISO9001:2000 and ISO14001:1996
ISO9001:2000
ISO14001:1996
Introduction
General
Process approach
Relationship with ISO 9004
Compatibility with other management systems
0.1
0.2
0.3
0.4
Introduction
Scope
General
Application
1
1.1
1.2
1
Scope
Normative reference
2
2
Normative references
Terms and definitions
3
3
Definitions
Quality Management system
4
4
Environmental management system requirements
General requirements
4.1
4.1
General requirements
Documentation requirements
General
Quality manual
Control of documents
Control of records
4.2
4.2.1
4.2.2
4.2.3
4.2.4
4.4.4
4.4.4
4.4.5
4.5.3
Environmental management system documentation
Environmental management system documentation
Document control
Records
Management responsibility
5
4.4.1
Structure and responsibility
Management commitment
5.1
4.2
4.4.1
Environmental policy
Structure and responsibility
Customer focus
5.2
4.3.1
4.3.2
Environmental aspects
Legal and other requirements
Quality policy
5.3
4.2
Environmental policy
Planning
5.4
4.3
Planning
Quality objectives
5.4.1
4.3.3
Objectives and targets
Quality management system planning
5.4.2
4.3.4
Environmental management programme(s)
Responsibility,authority and communication
5.5
4.1
General requirements
Responsibility and authority
Management representative
5.5.1
5.5.2
4.4.1
Structure and responsibility
Internal communication
5.5.3
4.4.3
Communication
Management review
General
Review input
Review output
5.6
5.6.1
5.6.2
5.6.3
4.6
Management review
Resource management
Provision of resources
Human resources
General
6
6.1
6.2
6.2.1
4.4.1
Structure and responsibility
Competence,awareness and training
6.2.2
4.4.2
Training,awareness and competence
Infrastructure
Work environment
6.3
6.4
4.4.1
Structure and responsibility
Table A.1 – Correspondence between ISO9001:2000 and ISO 14001:1996 (continued)
ISO9001:2000
ISO14001:1996
Product realization
7
4.4
4.4.6
Implementation and operation
Operational control
Planning of product realization
Customer-related processes
7.1
7.2
4.4.6
Operational control
Determination of requirements related to the product
7.2.1
4.3.1
4.3.2
4.4.6
Environmental aspects
Legal and other requirements
Operational control
Review of requirements related to the product
7.2.2
4.4.6
4.3.1
Operation control
Environmental aspects
Customer communication
7.2.3
4.4.3
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
7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
7.4
7.4.1
7.4.2
7.4.3
7.5
7.5.1
7.5.2
7.5.3
7.5.4
7.5.5
4.4.6
4.4.6
4.4.6
Operational control
Operational control
Operational control
Control of monitoring and measuring devices
7.6
4.5.1
Monitoring and measurement
Measurement,analysis and improvement
8
4.5
Checking and corrective action
General
Monitoring and measurement
Customer satisfaction
8.1
8.2
8.2.1
4.5.1
Monitoring and measurement
Internal audit
8.2.2
4.5.4
Environmental management system audit
Monitoring and measurement of processes
Monitoring and measurement of product
8.2.3
8.2.4
4.5.1
Monitoring and measurement
Control of nonconforming product
8.3
4.5.2
4.4.7
Nonconformance and corrective and preventive action
Emergency preparedness and response
Analysis of data
8.4
4.5.1
Monitoring and measurement
Improvement
8.5
4.2
Environmental policy
Continual improvement
8.5.1
4.3.4
Environmental management programme(s)
Corrective action
Preventive action
8.5.2
8.5.3
4.5.2
Nonconformance and corrective and preventive action
Table A.2 – Correspondence between ISO 14001,1996 and ISO 9001:2000
ISO9001:1996
ISO9001:2000
Introduction
-
0
0.1
0.2
0.3
0.4
Introduction
General
Process approach
Relationship with ISO9004
Compatibility with other management systems
Scope
1
1
1.1
1.2
Scope
General
Application
Normative references
2
2
Normative reference
Definitions
3
3
Terms and definitions
Environmental management system
requirement
4
4
Quality management system
General requirements
4.1
4.1
5.5
5.5.1
General requirements
Responsibility,authority and communication
Responsibility and authority
Environmental policy
4.2
5.1
5.3
8.5
Management commitment
Quality policy
Improvement
Planning
4.3
5.4
Planning
Environmental aspects
4.3.1
5.2
7.2.1
7.2.2
Customer focus
Determination of requirements related to the product
Review of requirements related to the product
Legal and other requirements
4.3.2
5.2
7.2.1
Customer focus
Determination of requirements related to the product
Objectives and targets
4.3.3
5.4.1
Quality objectives
Environmental management programme(s)
4.3.4
5.4.2
8.5.1
Quality management system planning
Continual improvement
Implementation and operation
4.4
7
7.1
Product realization
Planning of product realization
Structure and responsibility
4.4.1
5
5.1
5.5.1
5.5.2
6
6.1
6.2
6.2.1
6.3
6.4
Management responsibility
Management commitment
Responsibility and authority
Management representative
Resource management
Provision of resources
Human resources
General
Infrastructure
Work environment
Training,awareness and competence
4.4.2
6.2.2
Competence,awareness and training
Communication
4.4.3
5.5.3
7.2.3
Internal communication
Customer communication
Environmental management system documentation
4.4.4
4.2
4.2.1
4.2.2
Documentation requirements
General
Quality manual
Table A.2 – Correspondence between ISO 14001:1996 and ISO 9001:2000 (continued)
ISO 14001,1996
ISO 9001:2000
Document control
4.4.5
4.2.3
Control of documents
Operational control
4.4.6
7
7.1
7.2
7.2.1
7.2.2
7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
7.4
7.4.1
7.4.2
7.4.3
7.5
7.5.1
7.5.3
7.5.4
7.5.5
7.5.2
Product realization
Planning of product realization
Customer-related 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
4.4.7
8.3
Control of nonconforming product
Checking and corrective action
4.5
8
Measurement,analysis and improvement
Monitoring and measurement
4.5.1
7.6
8.1
8.2
8.2.1
8.2.3
8.2.4
8.4
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
4.5.2
8.3
8.5.2
8.5.3
Control of nonconforming product
Corrective action
Preventive action
Records
4.5.3
4.2.4
Control of records
Environmental management system audit
4.5.4
8.2.2
Internal audit
Management review
4.6
5.6
5.6.1
5.6.2
5.6.3
Management review
General
Review input
Review output
Annex B
(informative)
Correspondence between ISO 9001:2000 and ISO 9001:1994
Table B.1 – Correspondence between ISO 9001:1994 and ISO 9001:2000
ISO 9001:1994
ISO 9001:2000
1Scope
1
2Normative reference
2
3Definitions
3
4Quality system requirements [title only]
4.1 Management responsibility [title only]
4.1.1 Quality policy
4.1.2 Organization [title only]
4.1.2.1 Responsibility and authority
4.1.2.2 Resources
4.1.2.3 Management representative
4.1.3 Management review
5.1+5.3+5.4.1
5.5.1
6.1+6.2.1
5.5.2
5.6.1+8.5.1
4.2 Quality system [title only]
4.2.1General
4.2.2Quality system procedures
4.2.3Quality planning
4.1+4.2.2
4.2.1
5.4.2+7.1
4.3Contract review [title only]
4.3.1General
4.3.2 Review
4.3.3 Amendment to a contract
4.3.4 Records
5.2+7.2.1+7.2.2+7.2.3
7.2.2
7.2.2
4.4 Design control [title only]
4.4.1 General
4.4.2 Design and development planning
4.4.3 Organizational and technical interfaces
4.4.4 Design input
4.4.5 Design output
4.4.6 Design review
4.4.7 Design verification
4.4.8 Design validation
4.4.9 Design changes
7.3.1
7.3.1
7.2.1+7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
4.5 Document and data control [title only]
4.5.1 General
4.5.2 Document and data approval and issue
4.5.3 Document ad data changes
4.2.3
4.2.3
4.2.3
4.6 Purchasing [title only]
4.6.1 General
4.6.2 Evaluation of subcontractors
4.6.3 Purchasing data
4.6.4 Verification of purchased product
7.4.1
7.4.2
7.4.3
Table B.1 – Correspondence between ISO9001:1994 and ISO 9001:2000 (continued)
ISO 9001:1994
ISO 9001:2000
4.7 Control of customer-supplied product
7.5.4
4.8 Product identification and traceability
7.5.3
4.9 Process control
6.3+6.4+7.5.1+7.5.2
4.10 Inspection and testing [title only]
4.10.1 General
4.10.2 Receiving inspection and testing
4.10.3 In-process inspection and testing
4.10.4 Final inspection and testing
4.10.5 Inspection and test records
7.1+8.1
7.4.3+8.2.4
8.2.4
8.2.4
7.5.3+8.2.4
4.11 Control of inspection,measuring and test equipment [title only]
4.11.1 General
4.11.2 Control procedure
7.6
7.6
4.12 Inspection and test status
7.5.3
4.13 Control of nonconforming product [title only]
4.13.1 General
4.13.2 Review and disposition of nonconforming product
8.3
8.3
4.14 Corrective and preventive action [title only]
4.14.1 General
4.14.2 Corrective action
4.14.3 Preventive action
8.5.2+8.5.3
8.5.2
8.5.3
4.15 Handling,storage,packaging,preservation & delivery [title only]
4.15.1 General
4.15.2 Handling
4.15.3 Storage
4.15.4 Packaging
4.15.5 Preservation
4.15.6 Delivery
7.5.5
7.5.5
7.5.5
7.5.5
7.5.1
4.16 control of quality records
4.2.4
4.17 Internal quality audits
8.2.2+8.2.3
4.18 Training
6.2.2
4.19 Servicing
7.5.1
4.20 Statistical techniques [title only]
4.20.1 Identification of need
4.20.2 Procedures
8.1+8.2.3+8.2.4+8.4
8.1+8.2.3+8.2.4+8.4
Table B.2 – Correspondence between ISO 9001:2000 and ISO 9001:1994
ISO 9001:2000
ISO 9001:1994
1 Scope
1
1.1General
1.2 Application
2 Normative reference
2
3 Terms and definitions
3
4 Quality management system [title only]
4.1 General requirement
4.2.1
4.2 Documentation requirements [title only]
4.2.1 General
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of records
4.2.2
4.2.1
4.5.1+4.5.2+4.5.3
4.16
5 Management responsibility [title only]
5.1 Management commitment
4.1.1
5.2 Customer focus
4.3.2
5.3 Quality policy
4.1.1
5.4 Planning [title only]
5.4.1 Quality objectives
5.4.2 Quality management system planning
4.1.1
4.2.3
5.5 Responsibility,authority and communication [title only]
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
4.1.2.1
4.1.2.3
5.6 Management review [title only]
5.6.1 General
5.6.2 Review input
5.6.3 Review output
4.1.3
6 Resource management [title only]
6.1 Provision of resources
4.1.2.2
6.2 Human resources [title only]
6.2.1 General
6.2.2 Competence,awareness and training
4.1.2.2
4.18
6.3 Infrastructure
4.9
6.4 Work environment
4.9
7 Product realization [title only]
7.1 Planning of product realization
4.2.3+4.10.1
7.2 Customer-related processes [title only]
7.2.1 Determination of requirements related to the product
7.2.2 Review of requirements related to the product
7.2.3 Customer communication
4.3.2+4.4.4
4.3.2+4.3.3+4.3.4
4.3.2
7.3 Design and development [title only]
7.3.1 Design and development planning
7.3.2 Design and development inputs
4.4.2+4.4.3
4.4.4
Table B.2 – Correspondence between ISO 9001:2000 and ISO 9001:1994 (continued)
ISO 9001:2000
ISO 9001:1994
7.3.3 Design and development outputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 control of design and development changes
4.4.5
4.4.6
4.4.7
4.4.8
4.4.9
7.4 Purchasing [title only]
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 verification of purchased product
4.6.2
4.6.3
4.6.4+4.10.2
7.5 Production and service provision [title only]
7.5.1 Control of production and service provision
7.5.2 Validation of processes for production and service provision
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product
4.9+4.15.6+4.19
4.9
4.8+4.10.5+4.12
4.7
4.15.2+4.15.3+4.15.4+4.15.5
7.6 Control of monitoring and measuring devices
4.11.1+4.11.2
8 Measurement,analysis and improvement [title only]
8.1 General
4.10.1+4.20.1+4.20.2
8.2 Monitoring and measurement [title only]
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and measurement of processes
8.2.4 Monitoring and measurement of product
4.17
4.17+4.20.1+4.20.2
4.10.2+4.10.3+4.10.4+4.10.5 + 4.20.1 +4.20.2
8.3 Control of nonconforming product
4.13.1+4.13.2
8.4 Analysis of data
4.20.1+4.20.2
8.5 Improvement [title only]
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action
4.1.3
4.14.1+4.14.2
4.14.1+4.14.3
Bibliography
[1] ISO 9000-3:1997,quality management and quality assurance standards – Part 3,Guidelines for the application of ISO 9001:1994 to the development,supply,installation and maintenance of computer software.
[2] ISO 9004:2000,Quality management systems – Guidelines for performance improvements.
[3] ISO 10005:1995,Quality management – Guidelines for quality plans.
[4] ISO 10006:1997,Quality management – Guidelines to quality in project management.
[5] ISO 10007:1995,Quality management – Guidelines for configuration management.
[6] ISO 10011-1:1990,Guidelines for auditing quality systems – Part 1,Auditing1).
[7] ISO10011-2:1991,Guidelines for auditing quality systems – Part 2,Qualification criteria for quality systems auditors1).
[8] ISO 10011-3:1991,guidelines for auditing quality systems – Part 3, Management of audit programmes1).
[9] ISO10012-1:1992,Quality assurance requirements for measuring equipment – Part 1,Metrological confirmation system for measuring equipment.
[10] ISO 10012-2:1997,Quality assurance for measuring equipment – Part 2,Guidelines for control of measurement processes.
[11] ISO 10013:1995,Guidelines for developing quality manuals.
[12] ISO/TR 10014:1998,Guidelines for managing the economics of quality.
[13] ISO 10015:1999,Quality management – Guidelines for training.
[14]ISO/TR 10017:1999,Guidance on statistical techniques for ISO 9001:1994.
[15]ISO 14001:1996,Environmental management systems – Specification with guidance for use.
[16] ICE 60300-1,- 2) Dependability management – Part 1, Dependability programme management.
[17] Quality Management Principles Brochure3).
[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,http://www.iso.ch
http://www.bsi.org.uk/iso-tc176-sc2
1) To be revised as ISO 19011,Guidelines on quality and/or environmental management systems auditing.
2) To be published,(Revision of ISO 9000-4:1993)
3) Available from website,http://www.iso.ch
4) Available from ISO Central Secretariat (sale@iso.ch)
1 Scope
1.1 General
This International Standard specifies requirements for a quality management system where 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.
1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations,regardless of type,size ad product provided.
Where any requirements(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 9000:2000,Quality management systems – Fundamentals and vocabulary.
3 Terms
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 I ISO 9001:1994,and refers to the unit to which the 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
4.1 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 1.2),
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 ad information necessary to support the operation and monitoring of these processes,
e) monitor,measure and analyse 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.
4.2 Documentation requirements
4.2.1 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 4.2.4)
NOTE 1 Where the term,documented procedure, appears within this International Standard,this means that the procedure is established,documented,implemented and maintained.
NOTE2 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 ad their interactions,and
c) the competence of personnel.
NOTE 3 The documentation can be in any form or type of medium.
4.2.2 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 1.2),
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.
4.2.3 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 4.2.4.
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 re-approve 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.
4.2.4 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
5.1 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.
5.2 Customer focus
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).
5.3 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.
5.4 Planning
5.4.1 Quality objectives
Top management shall ensure that quality objectives,including those needed to meet requirements for product [see 7.1 a]],are established at relevant functions and levels within the organization,The quality objectives shall be measurable and consistent with the quality policy.
5.4.2 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.
5.5 Responsibility,authority and communication
5.5.1 Responsibility and authority
Top management shall ensure that responsibilities and authorities are defined and communicated within the organization,
5.5.2 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.
5.5.3 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.
5.6 Management review
5.6.1 General
Top management shall review the organization’s quality management system,at planed intervals,to ensure is 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 4.2.4).
5.6.2 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) follow-up actions from previous management reviews,
f) changes that could affect the quality management system,and
g) recommendations for improvement.
5.6.3 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
6.1 Provision of resources
The organization shall determine and provide the resources needed
to implement and maintain the quality management system and continually improve its effectiveness,and
to enhance customer satisfaction by meeting customer requirements.
6.2 Human resources
6.2.1 General
Personnel performing work affecting product quality shall be competent on the basis of appropriate education,training,skills and experience.
6.2.2 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 4.2.4).
6.3 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).
6.4 Work environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
7 Product realization
7.1 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 4.1).
In planning product realization,the organization shall determine the following,as appropriate:
a) quality objectives ad 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 4.2.4)
The output of this planning shall be in a from 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 7.3 to the development of product realization processes.
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
The organization shall determine
a) requirements specified by the customer,including the requirements for delivery and post-delivery activities,
b) requirements not stated by the4 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.
7,2.2 Review of requirements related to the product
The organization shall review the requirements related to the product,This review shall be conducted prior to the organization’s commitment to supply a product to the customer (e.g,submission o 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 actins arising from the review shall be maintained (see 4.2.4).
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.
7.2.3 Customer communication
The organization shall determine and implement effective arrangements for communicating with customers in relation to
a) product information,
b) enquiries,contracts or order handling,including amendments,and
c) customer feedback,including customer complaints.
7.3 Design and development
7.3.1 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.
7.3.2 Design and development inputs
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4),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.
7.3.3 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 productaccept6ance criteria,and
d) specify the characteristics of the product that are essential for its safe and proper use.
7.3.4 Design and development review
At suitable stages,systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)
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 4.2.4)
7.3.5 Design and development verification
Verification shall be performed in accordance with planned arrangements (see 7.3.1) 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 4.2.4)
7.3.6 Design and development validation
Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) 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 actins shall be maintained (see 4.2.4)
7.3.7 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 4.2.4).
7.4 Purchasing
7.4.1 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 purchase3d 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 re-evaluation shall be established,Records of the results of evaluations and any necessary actions arising form the evaluation shall be maintained (see 4.2.4)
7.4.2Purchasing 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.
7.4.3 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 performs verification at the supplier’s premises,the organization shall state the intended verification arrangements and method of product release in the purchasing information.
7.5 Production and service provision
7.5.1 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 post-delivery activities.
7.5.2 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 4.2.4) and
e) revalidation.
7.5.3 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 4.2.4)
NOTE In some industry sectors,configuration management is a means by which identification and traceability are maintained.
7.5.4 Customer property
The organization shall exercise care with customer property while it is under the organization’s control being used by the organization,The organization shall identify,verify,protect ad 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 4.2.4)
NOTE Customer property can include intellectual property.
7.5.5 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.
7.6 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 7.2.1)
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 re-adjusted 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 4.2.4).
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 an reconfirmed as necessary.
NOTE See ISO 10012-1 and ISO 100012-2 for guidance.
8 Measurement,analysis and improvement
8.1 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,
8.2 Monitoring and measurement
8.2.1 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.
8.2.2 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 7.1),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 defied,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 4.2.4) 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,Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).
NOTE See ISO 10011-1-2 and ISO 10011-3 for guidance.
8.2.3 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.
8.2.4 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 7.1)
Evidence of conformity with the acceptance criteria shall be maintained,Records shall indicate the person(s) authorizing release of product (see 4.2.4)
Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have beer satisfactorily completed,unless otherwise approved by a relevant authority and,where applicable,by the customer,
8.3 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 4.2.4).
When nonconforming product is corrected it shall be subject to re-verification 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.
8.4 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 ad from other relevant sources.
The analysis of data shall provide information relating to
a) customer satisfaction (see 8.2.1)
b) conformity to product requirements (see 7.2.1)
c) characteristics and trends of processes and products including opportunities for preventive action,and
d) suppliers,
8.5 Improvement
8.5.1 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.
8.5.2 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 4.2.4),and
f) reviewing corrective action taken.
8.5.3 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 4.2.4),and
e) reviewing preventive action taken.
Annex A
(informative)
Correspondence between ISO9001:2000 and ISO 14001:1996
Table A.1 – Correspondence between ISO9001:2000 and ISO14001:1996
ISO9001:2000
ISO14001:1996
Introduction
General
Process approach
Relationship with ISO 9004
Compatibility with other management systems
0.1
0.2
0.3
0.4
Introduction
Scope
General
Application
1
1.1
1.2
1
Scope
Normative reference
2
2
Normative references
Terms and definitions
3
3
Definitions
Quality Management system
4
4
Environmental management system requirements
General requirements
4.1
4.1
General requirements
Documentation requirements
General
Quality manual
Control of documents
Control of records
4.2
4.2.1
4.2.2
4.2.3
4.2.4
4.4.4
4.4.4
4.4.5
4.5.3
Environmental management system documentation
Environmental management system documentation
Document control
Records
Management responsibility
5
4.4.1
Structure and responsibility
Management commitment
5.1
4.2
4.4.1
Environmental policy
Structure and responsibility
Customer focus
5.2
4.3.1
4.3.2
Environmental aspects
Legal and other requirements
Quality policy
5.3
4.2
Environmental policy
Planning
5.4
4.3
Planning
Quality objectives
5.4.1
4.3.3
Objectives and targets
Quality management system planning
5.4.2
4.3.4
Environmental management programme(s)
Responsibility,authority and communication
5.5
4.1
General requirements
Responsibility and authority
Management representative
5.5.1
5.5.2
4.4.1
Structure and responsibility
Internal communication
5.5.3
4.4.3
Communication
Management review
General
Review input
Review output
5.6
5.6.1
5.6.2
5.6.3
4.6
Management review
Resource management
Provision of resources
Human resources
General
6
6.1
6.2
6.2.1
4.4.1
Structure and responsibility
Competence,awareness and training
6.2.2
4.4.2
Training,awareness and competence
Infrastructure
Work environment
6.3
6.4
4.4.1
Structure and responsibility
Table A.1 – Correspondence between ISO9001:2000 and ISO 14001:1996 (continued)
ISO9001:2000
ISO14001:1996
Product realization
7
4.4
4.4.6
Implementation and operation
Operational control
Planning of product realization
Customer-related processes
7.1
7.2
4.4.6
Operational control
Determination of requirements related to the product
7.2.1
4.3.1
4.3.2
4.4.6
Environmental aspects
Legal and other requirements
Operational control
Review of requirements related to the product
7.2.2
4.4.6
4.3.1
Operation control
Environmental aspects
Customer communication
7.2.3
4.4.3
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
7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
7.4
7.4.1
7.4.2
7.4.3
7.5
7.5.1
7.5.2
7.5.3
7.5.4
7.5.5
4.4.6
4.4.6
4.4.6
Operational control
Operational control
Operational control
Control of monitoring and measuring devices
7.6
4.5.1
Monitoring and measurement
Measurement,analysis and improvement
8
4.5
Checking and corrective action
General
Monitoring and measurement
Customer satisfaction
8.1
8.2
8.2.1
4.5.1
Monitoring and measurement
Internal audit
8.2.2
4.5.4
Environmental management system audit
Monitoring and measurement of processes
Monitoring and measurement of product
8.2.3
8.2.4
4.5.1
Monitoring and measurement
Control of nonconforming product
8.3
4.5.2
4.4.7
Nonconformance and corrective and preventive action
Emergency preparedness and response
Analysis of data
8.4
4.5.1
Monitoring and measurement
Improvement
8.5
4.2
Environmental policy
Continual improvement
8.5.1
4.3.4
Environmental management programme(s)
Corrective action
Preventive action
8.5.2
8.5.3
4.5.2
Nonconformance and corrective and preventive action
Table A.2 – Correspondence between ISO 14001,1996 and ISO 9001:2000
ISO9001:1996
ISO9001:2000
Introduction
-
0
0.1
0.2
0.3
0.4
Introduction
General
Process approach
Relationship with ISO9004
Compatibility with other management systems
Scope
1
1
1.1
1.2
Scope
General
Application
Normative references
2
2
Normative reference
Definitions
3
3
Terms and definitions
Environmental management system
requirement
4
4
Quality management system
General requirements
4.1
4.1
5.5
5.5.1
General requirements
Responsibility,authority and communication
Responsibility and authority
Environmental policy
4.2
5.1
5.3
8.5
Management commitment
Quality policy
Improvement
Planning
4.3
5.4
Planning
Environmental aspects
4.3.1
5.2
7.2.1
7.2.2
Customer focus
Determination of requirements related to the product
Review of requirements related to the product
Legal and other requirements
4.3.2
5.2
7.2.1
Customer focus
Determination of requirements related to the product
Objectives and targets
4.3.3
5.4.1
Quality objectives
Environmental management programme(s)
4.3.4
5.4.2
8.5.1
Quality management system planning
Continual improvement
Implementation and operation
4.4
7
7.1
Product realization
Planning of product realization
Structure and responsibility
4.4.1
5
5.1
5.5.1
5.5.2
6
6.1
6.2
6.2.1
6.3
6.4
Management responsibility
Management commitment
Responsibility and authority
Management representative
Resource management
Provision of resources
Human resources
General
Infrastructure
Work environment
Training,awareness and competence
4.4.2
6.2.2
Competence,awareness and training
Communication
4.4.3
5.5.3
7.2.3
Internal communication
Customer communication
Environmental management system documentation
4.4.4
4.2
4.2.1
4.2.2
Documentation requirements
General
Quality manual
Table A.2 – Correspondence between ISO 14001:1996 and ISO 9001:2000 (continued)
ISO 14001,1996
ISO 9001:2000
Document control
4.4.5
4.2.3
Control of documents
Operational control
4.4.6
7
7.1
7.2
7.2.1
7.2.2
7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
7.4
7.4.1
7.4.2
7.4.3
7.5
7.5.1
7.5.3
7.5.4
7.5.5
7.5.2
Product realization
Planning of product realization
Customer-related 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
4.4.7
8.3
Control of nonconforming product
Checking and corrective action
4.5
8
Measurement,analysis and improvement
Monitoring and measurement
4.5.1
7.6
8.1
8.2
8.2.1
8.2.3
8.2.4
8.4
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
4.5.2
8.3
8.5.2
8.5.3
Control of nonconforming product
Corrective action
Preventive action
Records
4.5.3
4.2.4
Control of records
Environmental management system audit
4.5.4
8.2.2
Internal audit
Management review
4.6
5.6
5.6.1
5.6.2
5.6.3
Management review
General
Review input
Review output
Annex B
(informative)
Correspondence between ISO 9001:2000 and ISO 9001:1994
Table B.1 – Correspondence between ISO 9001:1994 and ISO 9001:2000
ISO 9001:1994
ISO 9001:2000
1Scope
1
2Normative reference
2
3Definitions
3
4Quality system requirements [title only]
4.1 Management responsibility [title only]
4.1.1 Quality policy
4.1.2 Organization [title only]
4.1.2.1 Responsibility and authority
4.1.2.2 Resources
4.1.2.3 Management representative
4.1.3 Management review
5.1+5.3+5.4.1
5.5.1
6.1+6.2.1
5.5.2
5.6.1+8.5.1
4.2 Quality system [title only]
4.2.1General
4.2.2Quality system procedures
4.2.3Quality planning
4.1+4.2.2
4.2.1
5.4.2+7.1
4.3Contract review [title only]
4.3.1General
4.3.2 Review
4.3.3 Amendment to a contract
4.3.4 Records
5.2+7.2.1+7.2.2+7.2.3
7.2.2
7.2.2
4.4 Design control [title only]
4.4.1 General
4.4.2 Design and development planning
4.4.3 Organizational and technical interfaces
4.4.4 Design input
4.4.5 Design output
4.4.6 Design review
4.4.7 Design verification
4.4.8 Design validation
4.4.9 Design changes
7.3.1
7.3.1
7.2.1+7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
4.5 Document and data control [title only]
4.5.1 General
4.5.2 Document and data approval and issue
4.5.3 Document ad data changes
4.2.3
4.2.3
4.2.3
4.6 Purchasing [title only]
4.6.1 General
4.6.2 Evaluation of subcontractors
4.6.3 Purchasing data
4.6.4 Verification of purchased product
7.4.1
7.4.2
7.4.3
Table B.1 – Correspondence between ISO9001:1994 and ISO 9001:2000 (continued)
ISO 9001:1994
ISO 9001:2000
4.7 Control of customer-supplied product
7.5.4
4.8 Product identification and traceability
7.5.3
4.9 Process control
6.3+6.4+7.5.1+7.5.2
4.10 Inspection and testing [title only]
4.10.1 General
4.10.2 Receiving inspection and testing
4.10.3 In-process inspection and testing
4.10.4 Final inspection and testing
4.10.5 Inspection and test records
7.1+8.1
7.4.3+8.2.4
8.2.4
8.2.4
7.5.3+8.2.4
4.11 Control of inspection,measuring and test equipment [title only]
4.11.1 General
4.11.2 Control procedure
7.6
7.6
4.12 Inspection and test status
7.5.3
4.13 Control of nonconforming product [title only]
4.13.1 General
4.13.2 Review and disposition of nonconforming product
8.3
8.3
4.14 Corrective and preventive action [title only]
4.14.1 General
4.14.2 Corrective action
4.14.3 Preventive action
8.5.2+8.5.3
8.5.2
8.5.3
4.15 Handling,storage,packaging,preservation & delivery [title only]
4.15.1 General
4.15.2 Handling
4.15.3 Storage
4.15.4 Packaging
4.15.5 Preservation
4.15.6 Delivery
7.5.5
7.5.5
7.5.5
7.5.5
7.5.1
4.16 control of quality records
4.2.4
4.17 Internal quality audits
8.2.2+8.2.3
4.18 Training
6.2.2
4.19 Servicing
7.5.1
4.20 Statistical techniques [title only]
4.20.1 Identification of need
4.20.2 Procedures
8.1+8.2.3+8.2.4+8.4
8.1+8.2.3+8.2.4+8.4
Table B.2 – Correspondence between ISO 9001:2000 and ISO 9001:1994
ISO 9001:2000
ISO 9001:1994
1 Scope
1
1.1General
1.2 Application
2 Normative reference
2
3 Terms and definitions
3
4 Quality management system [title only]
4.1 General requirement
4.2.1
4.2 Documentation requirements [title only]
4.2.1 General
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of records
4.2.2
4.2.1
4.5.1+4.5.2+4.5.3
4.16
5 Management responsibility [title only]
5.1 Management commitment
4.1.1
5.2 Customer focus
4.3.2
5.3 Quality policy
4.1.1
5.4 Planning [title only]
5.4.1 Quality objectives
5.4.2 Quality management system planning
4.1.1
4.2.3
5.5 Responsibility,authority and communication [title only]
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
4.1.2.1
4.1.2.3
5.6 Management review [title only]
5.6.1 General
5.6.2 Review input
5.6.3 Review output
4.1.3
6 Resource management [title only]
6.1 Provision of resources
4.1.2.2
6.2 Human resources [title only]
6.2.1 General
6.2.2 Competence,awareness and training
4.1.2.2
4.18
6.3 Infrastructure
4.9
6.4 Work environment
4.9
7 Product realization [title only]
7.1 Planning of product realization
4.2.3+4.10.1
7.2 Customer-related processes [title only]
7.2.1 Determination of requirements related to the product
7.2.2 Review of requirements related to the product
7.2.3 Customer communication
4.3.2+4.4.4
4.3.2+4.3.3+4.3.4
4.3.2
7.3 Design and development [title only]
7.3.1 Design and development planning
7.3.2 Design and development inputs
4.4.2+4.4.3
4.4.4
Table B.2 – Correspondence between ISO 9001:2000 and ISO 9001:1994 (continued)
ISO 9001:2000
ISO 9001:1994
7.3.3 Design and development outputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 control of design and development changes
4.4.5
4.4.6
4.4.7
4.4.8
4.4.9
7.4 Purchasing [title only]
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 verification of purchased product
4.6.2
4.6.3
4.6.4+4.10.2
7.5 Production and service provision [title only]
7.5.1 Control of production and service provision
7.5.2 Validation of processes for production and service provision
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product
4.9+4.15.6+4.19
4.9
4.8+4.10.5+4.12
4.7
4.15.2+4.15.3+4.15.4+4.15.5
7.6 Control of monitoring and measuring devices
4.11.1+4.11.2
8 Measurement,analysis and improvement [title only]
8.1 General
4.10.1+4.20.1+4.20.2
8.2 Monitoring and measurement [title only]
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and measurement of processes
8.2.4 Monitoring and measurement of product
4.17
4.17+4.20.1+4.20.2
4.10.2+4.10.3+4.10.4+4.10.5 + 4.20.1 +4.20.2
8.3 Control of nonconforming product
4.13.1+4.13.2
8.4 Analysis of data
4.20.1+4.20.2
8.5 Improvement [title only]
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action
4.1.3
4.14.1+4.14.2
4.14.1+4.14.3
Bibliography
[1] ISO 9000-3:1997,quality management and quality assurance standards – Part 3,Guidelines for the application of ISO 9001:1994 to the development,supply,installation and maintenance of computer software.
[2] ISO 9004:2000,Quality management systems – Guidelines for performance improvements.
[3] ISO 10005:1995,Quality management – Guidelines for quality plans.
[4] ISO 10006:1997,Quality management – Guidelines to quality in project management.
[5] ISO 10007:1995,Quality management – Guidelines for configuration management.
[6] ISO 10011-1:1990,Guidelines for auditing quality systems – Part 1,Auditing1).
[7] ISO10011-2:1991,Guidelines for auditing quality systems – Part 2,Qualification criteria for quality systems auditors1).
[8] ISO 10011-3:1991,guidelines for auditing quality systems – Part 3, Management of audit programmes1).
[9] ISO10012-1:1992,Quality assurance requirements for measuring equipment – Part 1,Metrological confirmation system for measuring equipment.
[10] ISO 10012-2:1997,Quality assurance for measuring equipment – Part 2,Guidelines for control of measurement processes.
[11] ISO 10013:1995,Guidelines for developing quality manuals.
[12] ISO/TR 10014:1998,Guidelines for managing the economics of quality.
[13] ISO 10015:1999,Quality management – Guidelines for training.
[14]ISO/TR 10017:1999,Guidance on statistical techniques for ISO 9001:1994.
[15]ISO 14001:1996,Environmental management systems – Specification with guidance for use.
[16] ICE 60300-1,- 2) Dependability management – Part 1, Dependability programme management.
[17] Quality Management Principles Brochure3).
[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,http://www.iso.ch
http://www.bsi.org.uk/iso-tc176-sc2
1) To be revised as ISO 19011,Guidelines on quality and/or environmental management systems auditing.
2) To be published,(Revision of ISO 9000-4:1993)
3) Available from website,http://www.iso.ch
4) Available from ISO Central Secretariat (sale@iso.ch)
