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The ISO 9000 family of standards relate to quality management systems and are
designed to help organizations ensure they meet the needs of customers and other
stakeholders (Poksinska et al, 2002 [1] ). The standards are published by ISO,
the International Organization for Standardization and available through
National standards bodies.
ISO 9000 deals with the fundamentals of quality management systems (Tsim et al,
2002 [2] ), including the eight management principles (Beattie and Sohal, 1999
[3] ; Tsim et al, 2002 [4]) on which the family of standards is based. ISO 9001
deals with the requirements that organizations wishing to meet the standard have
to meet.
Independent confirmation that organizations meet the requirements of ISO 9001
may be obtained from third party certification bodies. Over a million
organizations worldwide [5] are independently certified making ISO 9001 one of
the most widely used management tools in the world today.
Contents [hide]
1 Reasons for use
2 Background
3 Global adoption
4 Contents of ISO 9001
4.1 1.0 Scope
4.2 4.0 Quality management system
4.2.1 4.1 General
4.2.2 4.2 Documentation requirements
4.2.2.1 4.2.1 General Specifications
4.2.2.2 4.2.2 Quality manual
4.2.2.3 4.2.3 Control of documents
4.2.2.4 4.2.4 Control of records
4.3 5.0 Management responsibility
4.3.1 5.1 Management commitment
4.3.2 5.2 Customer focus
4.3.3 5.3 Quality policy
4.3.4 5.4 Planning
4.3.4.1 5.4.1 Quality objectives
4.3.4.2 5.4.2 Quality management system planning
4.3.5 5.5 Responsibility, authority and communication
4.3.5.1 5.5.1 Responsibility and authority
4.3.5.2 5.5.2 Management representative
4.3.5.3 5.5.3 Internal communication
4.3.6 5.6 Management Review
4.3.6.1 5.6.1 General
4.3.6.2 5.6.2 Review input
4.3.6.3 5.6.3 Review output
4.4 6.0 Resource management
4.4.1 6.1 Provision of resources
4.4.2 6.2 Human resource Management
4.4.2.1 6.2.1 General
4.4.2.2 6.2.2 Competence, training, and awareness
4.4.3 6.3 Infrastructure
4.4.4 6.4 Work environment
4.5 7.0 Product realization
4.5.1 7.1 Planning of product realization
4.5.2 7.2 Customer- related processes
4.5.2.1 7.2.1 Determination of requirements related to the product
4.5.2.2 7.2.2 Review of requirements related to the product
4.5.2.3 7.2.3 Customer communication
4.5.3 7.3 Design and development
4.5.3.1 7.3.1 design and development planning
4.5.3.2 7.3.2 Design and development inputs
4.5.4 7.4 Purchasing
4.5.4.1 7.4.1 Purchasing process
4.5.4.2 7.4.2 Purchasing Information
4.5.4.3 7.4.3 Verification of purchased product
4.5.5 7.5 Production and service provision
4.5.5.1 7.5.1 Control of production and service provision
4.5.5.2 7.5.2 Validation of processes for production and service
provision
4.5.5.3 7.5.3 Identification and traceability
4.5.5.4 7.5.4 Customer property
4.5.5.5 7.5.5 Preservation of product
4.5.6 7.6 Control of monitoring and measuring equipment
4.6 8.0 Measurement, analysis and improvement
4.6.1 8.1 General
4.6.2 8.2 Monitoring and measurement
4.6.2.1 8.2.1 Customer satisfaction
4.6.2.2 8.2.2 Internal audit
4.6.2.3 8.2.3 Monitoring and measurement of processes
4.6.2.4 8.2.4 Monitoring and measurement of product
4.6.3 8.3 Control of nonconforming product
4.6.4 8.4 Analysis of data
4.6.5 8.5 Improvement
4.6.5.1 8.5.1 Continual improvement
4.6.5.2 8.5.2 Corrective action
4.6.5.3 8.5.3 Preventive action
4.7 1987 version
4.8 1994 version
4.9 2000 version
4.10 Certification
5 Auditing
6 Industry-specific interpretations
7 Effectiveness
7.1 Advantages
7.2 Problems
7.3 Summary
8 See also
9 References
10 Further reading
11 See also
12 External links
Reasons for useThe global adoption of ISO 9001 may be attributable to a number
of factors. A number of major purchasers require their suppliers to hold ISO
9001 certification. In addition to several stakeholders’ benefits, a number of
studies have identified significant financial benefits for organizations
certified to ISO 9001. Corbett et al (2005) [6] showed that certified
organizations achieved superior return on assets [7] compared to otherwise
similar organizations without certification. Heras et al (2002) [8] found
similarly superior performance [9] and demonstrated that this was statistically
significant and not a function of organization size. Naveh and Marcus (2007)
[10] showed that implementing ISO 9001 led to superior operational performance
[11] . Sharma (2005) [12] identified similar improvements in operating
performance and linked this to superior financial performance. Chow-Chua et al
(2002) [13] showed better overall financial performance was achieved for
companies in Denmark. Rajan and Tamimi (2003) [14] showed that ISO 9001
certification resulted in superior stock market performance [15] and suggested
that shareholders were richly rewarded [16] for the investment in an ISO 9001
system.
While the connection between superior financial performance and ISO 9001 may be
seen from the above, there remains no proof of direct causation, though
longitudinal studies, such as those of Corbett et al (2005) [17] may suggest it.
Other writers such as Heras et al (2002) [18] have suggested that while there is
some evidence of this, the improvement is partly driven by the fact that there
is a tendency for better performing companies to seek ISO 9001 certification.
The mechanism for improving results has also been the subject of much research.
Lo et al (2007) [19] identified operational improvements (cycle time reduction,
inventory reductions, etc.) as following from certification. Buttle (1997) [20]
and Santos (2002) [21] both indicated internal process improvements in
organizations leading to externally observable improvements. Hendricks and
Singhal (2001) [22] results indicate that firms outperform their control group
during the post implementation period and effective implementation of total
quality management principles and philosophies leads to significant wealth
creation. The benefit of increased international trade and domestic market
share, in addition to the internal benefits such as customer satisfaction,
interdepartmental communications, work processes, and customer/supplier
partnerships derived, far exceeds any and all initial investment according to
Alcorn [23].
Background
With permission of BSI GroupISO 9001 was first published in 1987 [24]. It was
largely based on the previous standard BS 5750 that was developed by BSI Group
[25]. BSI has been certifying organizations for their quality management systems
since 1978. Its first certification [26] (FM 00001) is still extant and held by
the Tarmac company, a successor to the original company which held this
certificate. Today BSI claims to certify organizations at nearly 70,000 sites
globally[27]. The development of the ISO 9000 series is shown in the diagram to
the right.
Global adoptionThe growth in ISO 9001 certification is shown in the table below.
The worldwide total of ISO 9001 certificates can be found in the ISO Survey of
9001 in 2003, 2007, 2008 and 2009.
Worldwide total of ISO 9001:2000/2008 certificatesDec 2000Dec 2001Dec
2002Dec 2003Dec 2004Dec 2005Dec 2006Dec 2007Dec 2008Dec 2009
4578345103495617674979196601327738678969299514869828321064785
Source: ISO Survey 2009
In recent years there has been a rapid growth in China which now accounts for
approximately a quarter of the global certifications.
Top 10 countries for ISO 9001 certificates - 2009RankCountryNo. of
certificates
1China257076
2Italy130066
3Japan68484
4Spain59576
5Russian Federation53152
6Germany47156
7United Kingdom41193
8India37493
9USA28935
10Korea, Republic of23400
Source: ISO Survey 2009
Contents of ISO 9001
ISO 9001 certification of a fish wholesaler in TsukijiISO 9001:2008 Quality
management systems — Requirements is a document of approximately 30 pages which
is available from the national standards organization in each country. Outline
contents are as follows:
Page iv: Foreword
Pages v to vii: Section 0 Introduction
Page 1: Requirements
Section 1: Scope
Section 2: Normative references
Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO
9000)
Pages 2 to 14 132 1
Section 4: Quality management system
Section 5: Management responsibility
Section 6: Resource management
Section 7: Product realization
Section 8: Measurement, analysis and improvement
In effect, users need to address all sections 1 to 8, but only 4 to 8 need
implementing within a QMS.
Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards
Page 23: Bibliography
The standard specifies six compulsory documents:
Control of Documents (4.2.3)
Control of Records (4.2.4)
Internal Audits (8.2.2)
Control of Nonconforming Product / Service (8.3)
Corrective Action (8.5.2)
Preventive Action (8.5.3)
In addition to these, ISO 9001:2008 requires a Quality Policy and Quality Manual
(which may or may not include the above documents).
1.0 Scope[example]
(Company Name) has developed and implemented this quality management system to
demonstrate its ability to consistently provide a product that meets customer
and statutory and regulatory requirements, and to address customer satisfaction
through the effective application of the system.
1.3 Quality Policy
(Company Name) accepts responsibility for the complete satisfaction of its
customers. We exercise this responsibility through adequate training of our
employees, adherence to proven procedures, and total commitment to meeting and
exceeding customer requirements.
4.0 Quality management system4.1 GeneralThe Company establishes, documents,
implements, and maintains a quality management system and continually improves
its effectiveness in accordance with the requirements of the ISO 9001:2008
International Standard, that comprises:
(Company Name):
determines the processes needed for the quality management system and their
application throughout (Company Name),
determines the sequence and interaction of these processes,
determines criteria and methods needed to ensure that both the operation and
control of these processes are effective,
ensures the availability of resources and information necessary to support the
operation and monitoring of these processes,
monitors, measures where applicable and analyzes these processes,
implements actions necessary to achieve planned results and continual
improvement of these processes.
These processes are managed by (Company Name) in accordance with the
requirements of the ISO 9001:2008 International Standard. Where (Company Name)
chooses to outsource any process that affects product conformity with
requirements, (Company Name) ensures control over such processes. The type and
extent of control of such outsourced processes are identified within the quality
management system.
NOTE: Processes needed for the quality management system referred to above
include processes for management activities, provision of resources, product
realization, measurement, analysis, and improvement.
4.2 Documentation requirements4.2.1 General SpecificationsThe quality management
system documentation includes:
documented statements of a quality policy and quality objectives,
a quality manual,
documented procedures and records required by the ISO 9001:2008 International
Standard, and
documents, including records determined by (Company Name) to be necessary to
ensure the effective planning, operation and control of its processes
NOTE 1: Where the term “documented procedure” appears within the ISO 9001:2008
International Standard, means that a procedure is established, documented,
implemented and maintained.
NOTE 2: Documentation can be in any form or type of medium.
4.2.2 Quality manual(Company Name) establishes and maintains a quality manual
that includes
the scope of the quality management system, including details of and
justification for any exclusions,
the documented procedures established for the quality management system, or
reference to them, and
a description of the interaction between the processes of the quality
management system.
4.2.3 Control of documentsDocuments required by the quality management system
are controlled. Records required by the quality management system are controlled
according to the requirements given in 4.2.4. A documented procedure is
established to define the controls needed:
to approve documents for adequacy prior to issue,
to review and update as necessary and re-approve documents,
to ensure that changes and the current revision status of documents are
identified,
to ensure that relevant versions of applicable documents are available at
points of use,
to ensure that documents remain legible and readily identifiable,
to ensure that documents of external origin determined by the organization to
be necessary for the planning and operation of the quality management system
are identified and their distribution controlled, and
to prevent the unintended use of obsolete documents, and to apply suitable
identification to them if they are retained for any purpose.
Supporting Documentation
QOP-42-01 Control of Documents
4.2.4 Control of recordsRecords established to provide evidence of conformity to
requirements and or the effective operation of the quality management system
shall be controlled. (Company Name) will establish a documented procedure to
define the controls needed for the identification, storage, protection,
retrieval, retention time and disposition of records. Records will remain
legible, readily identifiable, and retrievable.
Supporting Documentation
QOP-42-02 Control of Records.
5.0 Management responsibility5.1 Management commitmentTop management is
committed to the development and implementation of the quality management system
and continually improves its effectiveness by:
communicating to (Company Name) the importance of meeting customer as well as
statutory and regulatory requirements,
establishing a quality policy,
ensuring that quality objectives are established,
conducting management reviews, and
ensuring the availability of resources.
5.2 Customer focusTop management ensures 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“(Company Name) is committed to Exceeding Customer
Expectations through Implementation and Continuous Improvement of our Quality
Management System. Absolute Customer Satisfaction is the expectation and, will
be achieved through supplying a Superior Product, On-time, at a Competitive
Price.” Top management ensures that the quality policy
is appropriate to the purpose of the quality policy,
includes a commitment to comply with requirements and continually improve the
effectiveness of the quality management system,
provides a framework for establishing and reviewing quality objectives,
is communicated and understood within (Company Name), and
is reviewed for continuing suitability.
5.4 Planning5.4.1 Quality objectivesTop management ensures that quality
objectives, including those needed to meet requirements for product [see 7.1 a],
are established at relevant functions and levels within (Company Name). The
quality objectives are measurable and consistent with the quality policy. 1.
Meet or exceed customer expectations by effective communication and review of
customer requirements. 2. Provide our customers high quality products and
services, on time delivery, and at a reasonable cost. 3. Effectively manage our
products, processes, and services to provide superior customer satisfaction. 4.
Promote the safety, awareness, and well being of employees through training and
education.
5.4.2 Quality management system planningTop management ensures that:
the planning of the quality management system is carried out in order to meet
the requirements given in 4.1, as well as the quality objectives, and
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 communication5.5.1 Responsibility and
authorityTop management ensures that responsibilities and authorities are
defined and communicated within (Company Name) to promote effective management
of the quality system. An Organizational Chart illustrates the responsibility
and relative authority of the personnel who manage, perform, and verify the
activities affecting the QMS. Changes to the quality system are planned within
the framework of management reviews. These changes may be in response to
changing circumstances, such as product, process, capacity, or other operational
or organizational changes; or to improve the effectiveness and efficiency of the
quality system.
Supporting Documentation
Organizational Chart
5.5.2 Management representativeTop management has appointed a member of the
organization’s management who, irrespective of other responsibilities, has the
responsibility and authority that includes
ensuring that processes needed for the quality management system are
established, implemented and maintained,
reporting to top management on the performance of the quality management
system and any need for improvement, and
ensuring the promotion of awareness of customer requirements throughout
(Company Name).
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 communicationTop management ensures that appropriate
communication processes are established within (Company Name) and that
communication takes place regarding the effectiveness of the quality management
system.
5.6 Management Review5.6.1 GeneralTop management reviews (Company Name)’s
quality management system, at planned intervals, to ensure its continuing
suitability, adequacy and effectiveness. The review includes 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 are maintained (see 4.2.4).
Supporting Documentation
QOP-56-01 Management Review
5.6.2 Review inputThe input to management review includes information on below:
results of audits,
customer feedback,
process performance and product conformity,
status of preventive and corrective actions,
follow-up actions from previous management reviews,
changes that could affect the quality management system, and
recommendations for improvement.
5.6.3 Review outputThe output from the management review includes any decisions
and actions related to:
improvement of the effectiveness of the quality management system and its
processes,
improvement of product related to customer requirements, and
resource needs.
6.0 Resource management6.1 Provision of resources(Company Name) determines and
provides the resources needed
to implement and maintain the quality management system and continually
improve its effectiveness
to enhance customer satisfaction by meeting customer requirements.
6.2 Human resource Management6.2.1 GeneralPersonnel performing work affecting
conformity to product requirements are competent on the basis of appropriate
education, training, skills and experience.
6.2.2 Competence, training, and awareness(Company Name) :
determines the necessary competence for personnel performing work affecting
conformity to product requirements,
where applicable, provides training or takes other actions to achieve the
necessary competence,
evaluates the effectiveness of the actions taken,
ensures 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
maintains appropriate records of education, training, skills and experience
(see 4.2.4).
Supporting Documentation
QOP-62-01 Competence, Training, and Awareness
6.3 Infrastructure(Company Name) determines, provides for, and maintains the
infrastructure needed to achieve conformity to product requirements.
Infrastructure includes, as applicable:
buildings, workspace and associated utilities,
Process equipment (both hardware and software), and
Supporting services (such as transport, communication or information systems).
Supporting Documentation
QOP-63-01 Equipment Maintenance.
6.4 Work environment(Company Name) determines and manages the work environment
needed to achieve conformity to product requirements.
7.0 Product realization7.1 Planning of product realization(Company Name) plans
and develops the processes needed for product realization. Planning of product
realization is consistent with the requirements of the other processes of the
quality management system (see 4.1). In planning product realization, (Company
Name) determines the following, as appropriate:
quality objectives and requirements for the product,
the need to establish processes, and documents, and provide resources specific
to the product,
required verification, validation, monitoring, measurement, inspection and
test activities specific to the product and the criteria for product
acceptance, and
records needed to provide evidence that the realization processes and
resulting product meet requirements (see 4.2.4).
The output of the planning is in a form suitable for (Company Name)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, is referred to as the quality plan.
NOTE 2 (Company Name) also applies the requirements given in 7.3 to the
development of product realization processes.
Supporting Documentation
QOP-71-01 Planning of Product Realization
7.2 Customer- related processes7.2.1 Determination of requirements related to
the product(Company Name) determines:
requirements specified by the customer, including the requirements for
delivery and post-delivery activities,
requirements not stated by the customer but necessary for specified or
intended use, where known,
statutory and regulatory requirements applicable to the product, and
any additional requirements considered necessary by (Company Name).
Supporting Documentation
QOP-72-02 Order Processing & Review
7.2.2 Review of requirements related to the product(Company Name) reviews the
requirements related to the product. This review is conducted prior to (Company
Name)s commitment to supply a product to the customer (e.g. submission of
tenders, acceptance of contracts or orders, acceptance of changes to contracts
or orders) and ensures that:
product requirements are defined,
contract or order requirements differing from those previously expressed are
resolved, and
(Company Name) has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the review are
maintained (see 4.2.4). Where the customer provides no documented statement of
requirement, the customer requirements are confirmed by (Company Name) before
acceptance. Where product requirements are changed, (Company Name) ensures that
relevant documents are amended and that relevant personnel are made aware of the
changed requirements.
NOTE In some situations, a formal review is impractical for each order. Instead
the review can cover relevant product information such as catalogues or
advertising material.
Supporting Documentation
QOP-72-02 Order Processing & Review
7.2.3 Customer communication(Company Name) determines and implements effective
arrangements for communicating with customers in relation to:
product information,
enquiries, contracts or order handling, including amendments, and
customer feedback, including customer complaints.
Supporting Documentation
QOP-72-02 Order Processing & Review
QOP-85-02 Customer Complaints
7.3 Design and development7.3.1 design and development planning(Company Name)
plans and controls the design and development of product. During the design and
development planning, (Company Name) determines:
the design and development stages.
the review, verification and validation that are appropriate to each design
and development stage, and
the responsibilities and authorities for design and development.
(Company Name) manages the interface between different groups involved in design
and development to ensure effective communication and clear assignment of
responsibility.
Planning output is updated, as appropriate, as the design and development
progresses.
7.3.2 Design and development inputsInputs relating to product requirements are
determined and records maintained. these inputs include:
functional and performance requirements.
applicable statutory and regulatory requirements.
where applicable information derived from previous similar designs, and
other requirements essential for design and development.
The inputs are reviewed for adequacy. Requirements are complete, unambiguous and
not in conflict with each other.
7.4 Purchasing7.4.1 Purchasing process(Company Name) ensures that purchased
product conforms to specified purchase requirements. The type and extent of
control applied to the supplier and the purchased product is dependent upon the
effect of the purchased product on subsequent product realization or the final
product.
Supporting Documentation
QOP-74-01 Purchasing
7.4.2 Purchasing InformationPurchasing information describes the product to be
purchased, including where appropriate
requirements for approval of product, procedures, processes and equipment,
requirements for qualification of personnel, and
quality management system requirements.
(Company Name) ensures the adequacy of specified purchase requirements prior to
their communication to the supplier.
Supporting Documentation
QOP-74-01 Purchasing
7.4.3 Verification of purchased product(Company Name) establishes and implements
the inspection or other activities necessary for ensuring that purchased product
meets specified purchase requirements. Where (Company Name) or its customer
intends to perform verification at the supplier’s premises, (Company Name)
states the intended verification arrangements and method of product release in
the purchasing information.
Supporting Documentation
QOP-74-02 Verification of Purchase Product
7.5 Production and service provision7.5.1 Control of production and service
provisionAs applicable, (Company Name) plans and carries out production and
service provisions under controlled conditions. Controlled conditions include:
the availability of information that describes the characteristics of the
product,
the availability of work instructions, as necessary,
the use of suitable equipment,
the availability and use of monitoring and measuring equipment,
the implementation of monitoring and measurement activities, and
the implementation of product release, delivery and post-delivery activities.
Supporting Documentation
QOP-75-01 Work Order and Production Records
QOP-63-01 Equipment Maintenance
QOP-76-01 Measuring and Monitoring Equipment
QOP-84-02 Final Inspection
QOP-75-06 Shipping
7.5.2 Validation of processes for production and service provision(Company Name)
validates any processes for production and service provisions where the
resulting output cannot be verified by subsequent monitoring or measurement and,
as a consequence, deficiencies become apparent only after the product is in use
or the service has been delivered. Validation demonstrates the ability of these
processes to achieve planned results. As applicable, (Company Name) establishes
arrangements for these processes including:
defined criteria for review and approval of the processes,
approval of equipment and qualification of personnel,
use of specific methods and procedures,
requirements for records (see 4.2.4), and
revalidation.
Note: (Company Name) has no Special Processes at this time.
7.5.3 Identification and traceabilityWhere appropriate, (Company Name)
identifies the product by suitable means throughout product realization.
(Company Name) identifies the product status with respect to monitoring and
measurement requirements throughout product realization. Where traceability is a
requirement, (Company Name) controls the unique identification of the product an
maintain records (4.2.4).
Supporting Documentation
QOP-75-04 Product Identification and Traceability
7.5.4 Customer property(Company Name) exercises care with customer property
while it is under (Company Name)s control or being used by (Company Name).
(Company Name) identifies, verifies, protects and safeguards 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, (Company Name) will
report this to the customer and maintain records (see 4.2.4).
Note: Customer property can include intellectual property and personal data.
Note: (Company Name) has no Customer Property at this time.
7.5.5 Preservation of product(Company Name) preserves the product during
internal processing and delivery to the intended destination in order to
maintain conformity to requirements. As applicable, preservation includes
identification, handling, packaging, storage and protection. Preservation also
applies to the constituent parts of a product.
7.6 Control of monitoring and measuring equipment(Company Name) determines the
monitoring and measurement to be undertaken and the monitoring and measuring
equipment needed to provide evidence of conformity of product to determined
requirements. (Company Name) establishes processes to ensure that monitoring and
measurement can be carried out, and is carried out in a manner that is
consistent with the monitoring and measurement requirements. Where necessary to
ensure valid results measuring equipment is:
calibrated, verified or both 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,
adjusted or re-adjusted as necessary,
have identification in order to determine it’s calibration status,
safeguarded from adjustments that would invalidate the measurement result, and
protected from damage and deterioration during handling, maintenance and
storage.
In addition, (Company Name) assesses and records the validity of the previous
measuring results when the equipment is found not to conform to requirements.
(Company Name) takes appropriate action on the equipment and any product
affected. Records of the results of calibration and verification are 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 is confirmed.
This is undertaken prior to initial use and reconfirmed as necessary.
Note: Confirmation of the ability of computer software to satisfy the intended
application will typically include its verification and configuration management
to maintain its suitability for use.
Supporting Documentation
QOP-76-01 Monitoring and Measuring Equipment
8.0 Measurement, analysis and improvement8.1 General(Company Name) plans and
implements the monitoring, measurement, analysis and improvement processes
needed:
to demonstrate conformity to product requirements,
to ensure conformity of the quality management system, and
to continually improve the effectiveness of the quality management system.
This includes determination of applicable methods, including statistical
techniques, and the extent of their use.
8.2 Monitoring and measurement8.2.1 Customer satisfactionAs one of the
measurements of the performance of the quality management system, (Company Name)
monitors information relating to customer perception as to whether (Company
Name) has met customer requirements. The methods for obtaining and using this
information are determined.
Supporting Documentation
QOP-82-01 Customer Satisfaction
8.2.2 Internal audit(Company Name) conducts internal audits at planned intervals
to determine whether the quality management system:
conforms to the planned arrangements (see 7.1), to the requirements of ISO
9001:2008 and to the quality management system requirements established by
(Company Name), and
is effectively implemented and maintained.
An audit program is 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 are defined. The
selection of auditors and conduct of audits ensures objectivity and impartiality
of the audit process. Auditors do 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) are defined in a
documented procedure.
The management responsible for the area being audited ensures that any necessary
correction and corrective actions are taken without undue delay to eliminate
detected nonconformities and their causes. Follow-up activities include the
verification of the actions taken and the reporting of verification results (see
8.5.2).
Supporting Documentation
QOP-82-02 Internal Quality Audits
8.2.3 Monitoring and measurement of processes(Company Name) applies suitable
methods for monitoring and where applicable, measurement of the quality
management system processes. These methods demonstrate the ability of the
processes to achieve planned results. When planned results are not achieved,
correction and corrective action is taken, as appropriate.
8.2.4 Monitoring and measurement of product(Company Name) monitors and measures
the characteristics of the product to verify that product requirements have been
met. This is 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 is maintained. Records indicate the
person(s) authorizing release of product for delivery to the customer (see
4.2.4). The release of product and delivery of service to the customer does not
proceed until the planned arrangements (see 7.1) have been satisfactorily
completed, unless otherwise approved by a relevant authority and where
applicable, by the customer.
Supporting Documentation
QOP-82-03 In Process Inspections
QOP-82-04 Final Inspection
8.3 Control of nonconforming product(Company Name) ensures that product which
does not conform to product requirements is identified and controlled to prevent
its unintended use or delivery. A documented procedure is established to define
the controls and related responsibilities and authorities for dealing with
nonconforming products. Where applicable (Company Name) deals with nonconforming
product by one or more of the following ways:
by taking action to eliminate the detected nonconformity,
by authorizing its use, release or acceptance under concession by a relevant
authority and, where applicable, by the customer, and
by taking action to preclude its original intended use or application.
by taking action appropriate to the effects, or potential effects, of the
nonconformity when nonconforming product is detected after delivery or use has
started.
When nonconforming product is corrected the product is subjected to
re-verification to demonstrate conformity to the requirements. When
nonconforming product is detected after delivery or use has started, (Company
Name) takes action appropriate to the effects, or potential effects, of the
nonconformity. Records of the nature of nonconformities and any subsequent
actions taken, including concessions obtained, are maintained (see 4.2.4).
Supporting Documentation
QOP-83-01 Control of Nonconforming Product
8.4 Analysis of data(Company Name) determines, collects and analyzes 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 includes data generated as a result
of monitoring and measurement and from other relevant sources. The analysis of
data provides information relating to:
customer satisfaction (see 8.2.1),
conformity to product requirements (see 8.2.4),
characteristics and trends of processes and products including opportunities
for preventive action (see 8.2.3 and 8.2.4),
suppliers (see 7.4),
Supporting Documentation
QOP-56-01 Management Review
8.5 Improvement8.5.1 Continual improvement(Company Name) continually improves
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 reviews.
Supporting Documentation
QOP-85-01 Continual Improvement
8.5.2 Corrective action(Company Name) takes action to eliminate the causes of
nonconformities in order to prevent recurrence. Corrective actions are
appropriate to the effects of the nonconformities encountered. A documented
procedure is established to define requirements for:
reviewing nonconformities (including customer complaints),
determining the causes of nonconformities,
evaluating the need for action to ensure that nonconformities do not recur,
determining and implementing action needed,
records of the results of action taken (see 4.2.4), and
reviewing the effectiveness of the corrective action taken.
Supporting Documentation
QOP-85-02 Customer Complaints
QOP-85-03 Corrective and Preventive Actions
8.5.3 Preventive action(Company Name) determines actions to eliminate the causes
of potential nonconformities in order to prevent their occurrence. Preventive
actions are appropriate to the effects of the potential problems. A documented
procedure is established to define requirements for:
determining potential nonconformities and their causes,
evaluating the need for action to prevent occurrence of nonconformities,
determining and implementing action needed,
records of results of action taken (see 4.2.4), and
reviewing the effectiveness of the preventive action taken.
Supporting Documentation
QOP-85-03 Corrective and Preventive Actions
1987 versionISO 9000:1987 had the same structure as the UK Standard BS 5750,
with three 'models' for quality management systems, the selection of which was
based on the scope of activities of the organization:
ISO 9001:1987 Model for quality assurance in design, development, production,
installation, and servicing was for companies and organizations whose
activities included the creation of new products.
ISO 9002:1987 Model for quality assurance in production, installation, and
servicing had basically the same material as ISO 9001 but without covering the
creation of new products.
ISO 9003:1987 Model for quality assurance in final inspection and test covered
only the final inspection of finished product, with no concern for how the
product was produced.
ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards
("MIL SPECS"), and so was well-suited to manufacturing. The emphasis tended to
be placed on conformance with procedures rather than the overall process of
management—which was likely the actual intent.[citation needed]
1994 versionISO 9000:1994 emphasized quality assurance via preventive actions,
instead of just checking final product, and continued to require evidence of
compliance with documented procedures. As with the first edition, the down-side
was that companies tended to implement its requirements by creating shelf-loads
of procedure manuals, and becoming burdened with an ISO bureaucracy. In some
companies, adapting and improving processes could actually be impeded by the
quality system.[citation needed]
2000 versionISO 9001:2000 combines the three standards 9001, 9002, and 9003 into
one, called 9001. Design and development procedures are required only if a
company does in fact engage in the creation of new products. The 2000 version
sought to make a radical change in thinking by actually placing the concept of
process management front and center ("Process management" was the monitoring and
optimizing of a company's tasks and activities, instead of just inspecting the
final product). The 2000 version also demands involvement by upper executives,
in order to integrate quality into the business system and avoid delegation of
quality functions to junior administrators. Another goal is to improve
effectiveness via process performance metrics — numerical measurement of the
effectiveness of tasks and activities. Expectations of continual process
improvement and tracking customer satisfaction were made explicit.
The ISO 9000 standard is continually being revised by standing technical
committees and advisory groups, who receive feedback from those professionals
who are implementing the standard.[1]
ISO 9001:2008 only introduces clarifications to the existing requirements of ISO
9001:2000 and some changes intended to improve consistency with ISO 14001:2004.
There are no new requirements. Explanation of changes in ISO 9001:2008. A
quality management system being upgraded just needs to be checked to see if it
is following the clarifications introduced in the amended version.
CertificationISO does not itself certify organizations. Many countries have
formed accreditation bodies to authorize certification bodies, which audit
organizations applying for ISO 9001 compliance certification. Although commonly
referred to as ISO 9000:2000 certification, the actual standard to which an
organization's quality management can be certified is ISO 9001:2008. Both the
accreditation bodies and the certification bodies charge fees for their
services. The various accreditation bodies have mutual agreements with each
other to ensure that certificates issued by one of the Accredited Certification
Bodies (CB) are accepted worldwide.
The applying organization is assessed based on an extensive sample of its sites,
functions, products, services and processes; a list of problems ("action
requests" or "non-compliance") is made known to the management. If there are no
major problems on this list, or after it receives a satisfactory improvement
plan from the management showing how any problems will be resolved, the
certification body will issue an ISO 9001 certificate for each geographical site
it has visited.
An ISO certificate is not a once-and-for-all award, but must be renewed at
regular intervals recommended by the certification body, usually around three
years. There are no grades of competence within ISO 9001: either a company is
certified (meaning that it is committed to the method and model of quality
management described in the standard), or it is not. In this respect, it
contrasts with measurement-based quality systems such as the Capability Maturity
Model.
AuditingTwo types of auditing are required to become registered to the standard:
auditing by an external certification body (external audit) and audits by
internal staff trained for this process (internal audits). The aim is a
continual process of review and assessment, to verify that the system is working
as it's supposed to, find out where it can improve and to correct or prevent
problems identified. It is considered healthier for internal auditors to audit
outside their usual management line, so as to bring a degree of independence to
their judgments.
Under the 1994 standard, the auditing process could be adequately addressed by
performing "compliance auditing":
Tell me what you do (describe the business process)
Show me where it says that (reference the procedure manuals)
Prove that this is what happened (exhibit evidence in documented records)
The 2000 standard uses a different approach. Auditors are expected to go beyond
mere auditing for rote "compliance" by focusing on risk, status and importance.
This means they are expected to make more judgments on what is effective, rather
than merely adhering to what is formally prescribed. The difference from the
previous standard can be explained thus:
Under the 1994 version, the question was broadly "Are you doing what the
manual says you should be doing?", whereas under the 2000 version, the
question is more "Will this process help you achieve your stated objectives?
Is it a good process or is there a way to do it better?"
Industry-specific interpretationsThe ISO 9001 standard is generalized and
abstract. Its parts must be carefully interpreted, to make sense within a
particular organization. Developing software is not like making cheese or
offering counseling services; yet the ISO 9001 guidelines, because they are
business, management guidelines can be applied to each of these. Diverse
organizations—police departments (US), professional soccer teams (Mexico) and
city councils (UK)—have successfully implemented ISO 9001:2000 systems.
Over time, various industry sectors have wanted to standardize their
interpretations of the guidelines within their own marketplace. This is partly
to ensure that their versions of ISO 9000 have their specific requirements, but
also to try and ensure that more appropriately trained and experienced auditors
are sent to assess them.
The TickIT guidelines are an interpretation of ISO 9000 produced by the UK
Board of Trade to suit the processes of the information technology industry,
especially software development.
AS9000 is the Aerospace Basic Quality System Standard, an interpretation
developed by major aerospace manufacturers. Those major manufacturers include
AlliedSignal, Allison Engine, Boeing, General Electric Aircraft Engines,
Lockheed-Martin, McDonnell Douglas, Northrop Grumman, Pratt & Whitney,
Rockwell-Collins, Sikorsky Aircraft, and Sundstrand. The current version is
AS9100.
PS 9000 is an application of the standard for Pharmaceutical Packaging
Materials. The Pharmaceutical Quality Group (PQG) of the Institute of Quality
Assurance (IQA) has developed PS 9000:2001. It aims to provide a widely
accepted baseline GMP framework of best practice within the pharmaceutical
packaging supply industry. It applies ISO 9001: 2000 to pharmaceutical printed
and contact packaging materials.
QS 9000 is an interpretation agreed upon by major automotive manufacturers
(GM, Ford, Chrysler). It includes techniques such as FMEA and APQP. QS 9000 is
now replaced by ISO/TS 16949.
ISO/TS 16949:2009 is an interpretation agreed upon by major automotive
manufacturers (American and European manufacturers); the latest version is
based on ISO 9001:2008. The emphasis on a process approach is stronger than in
ISO 9001:2008. ISO/TS 16949:2009 contains the full text of ISO 9001:2008 and
automotive industry-specific requirements.
TL 9000 is the Telecom Quality Management and Measurement System Standard, an
interpretation developed by the telecom consortium, QuEST Forum. The current
version is 4.0 and unlike ISO 9001 or the above sector standards, TL 9000
includes standardized product measurements that can be benchmarked. In 1998
QuEST Forum developed the TL 9000 Quality Management System to meet the supply
chain quality requirements of the worldwide telecommunications industry.
ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2000. Whereas
the standards it replaces were interpretations of how to apply ISO 9001 and
ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard.
Compliance with ISO 13485 does not necessarily mean compliance with ISO
9001:2000.
ISO/IEC 90003:2004 provides guidelines for the application of ISO 9001:2000 to
computer software.
ISO/TS 29001 is quality management system requirements for the design,
development, production, installation and service of products for the
petroleum, petrochemical and natural gas industries. It is equivalent to API
Spec Q1 without the Monogram annex.
EffectivenessThe debate on the effectiveness of ISO 9000 commonly centers on the
following questions:
Are the quality principles in ISO 9001:2000 of value? (Note that the version
date is important: in the 2000 version ISO attempted to address many concerns
and criticisms of ISO 9000:1994).
Does it help to implement an ISO 9001:2000 compliant quality management
system?
Does it help to obtain ISO 9001:2000 certification?
Effectiveness of the ISO system being implemented depends on a number of
factors, the most significant of which are:
Commitment of Senior Management to monitor, control, and improve quality.
Organizations that implement an ISO system without this desire and commitment,
often take the cheapest road to get a certificate on the wall and ignore
problem areas uncovered in the audits.
How well the ISO system integrates into their business practices. Many
organizations that implement ISO try to make their system fit into a
cookie-cutter quality manual rather than create a manual that documents
existing practices and only adds new processes to meet the ISO standard when
necessary.
How well the ISO system focuses on improving the customer experience. The
broadest definition of quality is "Whatever the customer perceives good
quality to be". This means that you don't necessarily have to make a product
that never fails, some customers will have a higher tolerance for product
failures if they always receive shipments on-time, or some other dimension of
customer service. Your ISO system should take into account all areas of the
customer experience, the industry expectations, and seek to improve them on a
continual basis. This means taking into account all processes that deal with
the three stakeholders (your customers, your suppliers, and your
organization), only then will you be able to sustain improvements in your
customer experience.
How well the auditor finds and communicates areas of improvement. Now, ISO
auditors may not provide consulting to the clients they audit, however, there
is the potential for auditors to point out areas of improvement. Many auditors
simply rely on submitting reports that indicate compliance or non-compliance
with the appropriate section of the standard, however, to most executives,
this is like speaking a foreign language. Auditors that can clearly identify
and communicate areas of improvement in language and terms executive
management understands allows the companies they audit to act on improvement
initiatives. When management doesn't understand why they were non-compliant
and the business implications, they simply ignore the reports and focus on
what they do understand.
AdvantagesIt is widely acknowledged that proper quality management improves
business, often having a positive effect on investment, market share, sales
growth, sales margins, competitive advantage, and avoidance of litigation.The
quality principles in ISO 9000:2000 are also sound, according to Wade and
Barnes, who say that "ISO 9000 guidelines provide a comprehensive model for
quality management systems that can make any company competitive implementing
ISO often gives the following advantages:
Create a more efficient, effective operation
Increase customer satisfaction and retention
Reduce audits
Enhance marketing
Improve employee motivation, awareness, and morale
Promote international trade
Increases profit
Reduce waste and increases productivity.
ProblemsA common criticism of ISO 9001 is the amount of money, time and
paperwork required for registration.[28] According to Barnes, "Opponents claim
that it is only for documentation. Proponents believe that if a company has
documented its quality systems, then most of the paperwork has already been
completed."[29]
ISO 9001 is not in any way an indication that products produced using its
certified systems are any good. A company can intend to produce a poor quality
product and providing it does so consistently and with the proper documentation
can put an ISO 9001 stamp on it. According to Seddon, ISO 9001 promotes
specification, control, and procedures rather than understanding and
improvement.[30][31] Wade argues that ISO 9000 is effective as a guideline, but
that promoting it as a standard "helps to mislead companies into thinking that
certification means better quality, ... [undermining] the need for an
organization to set its own quality standards." [32] Paraphrased, Wade's
argument is that reliance on the specifications of ISO 9001 does not guarantee a
successful quality system.
While internationally recognized, most US consumers are not aware of ISO 9000
and it holds no relevance to them. The added cost to certify and then maintain
certification may not be justified if product end users do not require ISO 9000.
The cost can actually put a company at a competitive disadvantage when competing
against a non ISO 9000 certified company.
The standard is seen as especially prone to failure when a company is interested
in certification before quality.[30] Certifications are in fact often based on
customer contractual requirements rather than a desire to actually improve
quality.[29][33] "If you just want the certificate on the wall, chances are, you
will create a paper system that doesn't have much to do with the way you
actually run your business," said ISO's Roger Frost.[33] Certification by an
independent auditor is often seen as the problem area, and according to Barnes,
"has become a vehicle to increase consulting services." [29] In fact, ISO itself
advises that ISO 9001 can be implemented without certification, simply for the
quality benefits that can be achieved.[34]
Another problem reported is the competition among the numerous certifying
bodies, leading to a softer approach to the defects noticed in the operation of
the Quality System of a firm.
Abrahamson[35] argued that fashionable management discourse such as Quality
Circles tends to follow a lifecycle in the form of a bell curve, possibly
indicating a management fad.
SummaryA good overview for effective use of ISO 9000 is provided by Barnes:
"Good business judgment is needed to determine its proper role for a company. Is
certification itself important to the marketing plans of the company? If not, do
not rush to certification Even without certification, companies should utilize
the ISO 9000 model as a benchmark to assess the adequacy of its quality
programs."
See alsoConformity assessment—Containing ISO published standards
ISO 10006—Quality management—Guidelines to quality management in projects
ISO 14001—Environmental management standards
ISO 19011—Guidelines for quality management systems auditing and environmental
management systems auditing
ISO/TS 16949—Quality management system requirements for automotive-related
products suppliers
ISO/IEC 27001—Information security management
AS 9100 - aerospace industry implementation of ISO 9000/1
List of ISO standards
Quality management system
Test management
Verification and Validation
References^ Poksinska, B.; Kahlgaard, J.J.; Antoni, M. (2002), "The state of
ISO 9000 certification: A study of Swedish organisations", The TQM Magazine 14
(5),
http://www.emeraldinsight.com/journals.htm?articleid=842040&show=abstract,
retrieved 2010-11-22
^ Tsim, Y.C.; Yeung, V. W. S.; Leung, E. T. C. (2002), "An adaptation to ISO
9001: 2000 for certified organisations", Managerial Auditing Journal 17 (5),
http://www.emeraldinsight.com/journals.htm?articleid=868561&show=abstract,
retrieved 2010-11-22
^ Beattie, K.R.; Sohal, A.S. (1999), "Implementing ISO 9000: A study of its
benefits among Australian organizations", Total Quality Management 10 (1):
95–106, http://www.informaworld.com/smpp/content~db=all~content=a713600335,
retrieved 2010-11-22
^ Tsim, Y.C.; Yeung, V. W. S.; Leung, E. T. C. (2002), "An adaptation to ISO
9001: 2000 for certified organisations", Managerial Auditing Journal 17 (5),
http://www.emeraldinsight.com/journals.htm?articleid=868561&show=abstract,
retrieved 2010-11-22
^ http://www.iso.org/iso/pressrelease.htm?refid=Ref1363 ISO Press Release, 25
October 2010]
^ Corbett, C.J.; Montes-sancho, M.J.; Kirsch, D.A. (2005), "The financial
impact of ISO 9000 certification in the United States: An empirical analysis",
Management Science 51 (7): 1046–1059,
http://personal.anderson.ucla.edu/charles.corbett/papers/does_iso_9000_pay.pdf,
retrieved 2010-11-22
^ http://www.bsi-emea.com/Quality/CaseStudies/Interstate.pdf Interstate ISO
9000 Case Study]
^ Heras, I.; Dick, G.P. M.; Casadesus, M. (2002), "ISO 9000 registration's
impact on sales and profitability - A longitudinal analysis of performance
before and after accreditation", International Journal of Quality and
Reliability Management 19 (6): 774–791,
http://eps.udg.es/oe/webmarti/p774.pdf, retrieved 2010-11-22
^ http://www.bsi-emea.com/Quality/CaseStudies/Hardies.pdf Hardies ISO 9000
Case Study ]
^ Naveh, E.; Marcus, A. (2007), "Financial performance, ISO 9000 standard and
safe driving practices effects on accident rate in the U.S. motor carrier
industry", Accident Analysis & Prevention 39 (4): 731–742,
http://www.ncbi.nlm.nih.gov/pubmed/17166474, retrieved 2010-11-22
^ http://www.bsi-emea.com/Quality/CaseStudies/DFDSTransport.pdf DFDS Transport
ISO 9000 Case Study ]
^ Sharma, D.S. (2005), "The association between ISO 9000 certification and
financial performance", The international Journal of Accounting 40: 151–172,
http://masp.bus.ku.ac.th/files/ISO%209000%20and%20performamce.pdf, retrieved
2010-11-22
^ Chow-chua, C.; Goh, M.; Wan, T.B. (2002), "Does ISO 9000 certification
improve business performance?", The International Journal of Quality &
Reliability Management 20 (8): 936–953,
http://www.emeraldinsight.com/journals.htm?articleid=840633&show=abstract,
retrieved 2010-11-22
^ Rajan, M.; Tamimi, N. (2003), "Payoff to ISO 9000 registration", Journal of
Investing 12 (1), http://www.iijournals.com/doi/abs/10.3905/joi.2003.319536,
retrieved 2010-11-22
^ http://www.bsi-emea.com/Quality/CaseStudies/Accenture.pdf Accenture ISO 9000
Case Study ]
^ http://www.bsi-emea.com/Quality/CaseStudies/BritishGas.pdf British Gas ISO
9000 Case Study ]
^ Corbett, C.J.; Montes-sancho, M.J.; Kirsch, D.A. (2005), "The financial
impact of ISO 9000 certification in the United States: An empirical analysis",
Management Science 51 (7): 1046–1059,
http://personal.anderson.ucla.edu/charles.corbett/papers/does_iso_9000_pay.pdf,
retrieved 2010-11-22
^ Heras, I.; Dick, G.P. M.; Casadesus, M. (2002), "ISO 9000 registration's
impact on sales and profitability - A longitudinal analysis of performance
before and after accreditation", International Journal of Quality and
Reliability Management 19 (6): 774–791,
http://eps.udg.es/oe/webmarti/p774.pdf, retrieved 2010-11-22
^ Lo, Chris K.Y.; Yeung, Andy C.L.; Cheng, T.C. Edwin (2007), "Impact of ISO
9000 on time-based performance: An event study", World Academy of Science,
Engineering and Technology 30 (7): 35 - 40,
http://www.waset.org/journals/waset/v30/v30-7.pdf, retrieved 2010-11-22
^ Buttle, F. (1997), "ISO 9000: marketing motivations and benefits",
International Journal of Quality & Reliability Management 14 (9): 936 - 947,
http://www.emeraldinsight.com/journals.htm?articleid=1502750&show=abstract,
retrieved 2010-11-22
^ Santos, L. (2002), "Benefits of the ISO 9000:1994 system: Some consideration
to reinforce competitive advantage", International Journal of Quality &
Reliability Management 19 (3): 321 - 344,
http://www.emeraldinsight.com/journals.htm?articleid=840553&show=abstract,
retrieved 2010-11-22
^ Hendreicks, K.B.; Singhal, V.R. (2001), "The long-run stock price
performance of firms with effective TQM programs", Management Science 47 (3):
359 - 368, http://www.jstor.org/pss/2661504, retrieved 2010-11-22
^ Alcorn, J. E. (1995), "Benefits of ISO 9000 Certification", Ceramic
Engineering and Science Proceedings 16 (2): 15–18,
http://md1.csa.com/partners/viewrecord.php?requester=gs&collection=TRD&recid=WCA103967WC&q=Benefits+of+ISO+9000+Certification&uid=788436682&setcookie=yes,
retrieved 2010-11-18
^ http://www.bsieducation.org/Education/about/brief-history.shtml History of
the BSI Group
^ http://www.bsigroup.com/en/About-BSI/News-Room/BSI-Fast-Facts2/ Fast Facts
About BSI Group
^ Tarmac Certificate of Registration
^ http://www.bsigroup.com/en/About-BSI/About-BSI-Group/ More About BSI Group
^ "So many standards to follow, so little payoff". Stephanie Clifford. Inc
Magazine, May 2005.
^ a b c "Good Business Sense Is the Key to Confronting ISO 9000" Frank Barnes
in Review of Business, Spring 2000.
^ a b "The 'quality' you can't feel", John Seddon, The Observer, Sunday
November 19, 2000
^ "A Brief History of ISO 9000: Where did we go wrong?". John Seddon. Chapter
one of "The Case Against ISO 9000", 2nd ed., Oak Tree Press. November 2000.
ISBN 1-86076-173-9
^ "Is ISO 9000 really a standard?" Jim Wade, ISO Management Systems – May–June
2002
^ a b "ISO a GO-Go." Mark Henricks. Entrepreneur Magazine Dec 2001.
^ The ISO Survey – 2005 (abridged version, PDF, 3 MB), ISO, 2005
^ Abrahamson, E. (1996). "Managerial fashion." Academy of Management Review.
21(1):254-285.
Further readingBamford, Robert; Deibler, William (2003). ISO 9001: 2000 for
Software and Systems Providers: An Engineering Approach (1st ed.). CRC-Press.
ISBN 0849320631, ISBN 978-0849320637
Naveh. E., Marcus, A. (2004). "When does ISO 9000 Quality Assurance standard
lead to performance improvement?", IEEE Transactions on Engineering
Management, 51(3), 352–363.
http://www.iso.org/iso/survey2007.pdf - An abstract of the 2007's ISO survey
of certificates
http://www.iso.org/iso/survey2008.pdf - An abstract of the 2008's ISO survey
of certificates
See alsoInternational Organization for Standardization
External linksISO 9000 at the Open Directory Project
Introduction to ISO 9000 and ISO 14000
International Organization for Standardization
ISO's Technical Committee 176 on Quality Management and Quality Assurance
Technical Committee No. 176, Sub-committee No. 2, which is responsible for
developing ISO 9000 standards.
Basic info on ISO 9000 development
ISO 9000 FAQs
[show]v • d • eISO standards
Lists: List of ISO standards · List of ISO romanizations · List of
IEC standards
Categories: Category:ISO standards · Category:OSI protocols
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ViệtYorùbá 中文 This page was last modified on 30 November 2010 at 11:43.
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