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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,
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.
organizations worldwide [5] are independently certified making ISO 9001 one of
Contents [hide]
1 Reasons for use
2 Background
3 Global adoption
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
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
(2002) [13] showed better overall financial performance was achieved for
companies in Denmark. Rajan and Tamimi (2003) [14] showed that ISO 9001
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
The mechanism for improving results has also been the subject of much research.
Singhal (2001) [22] results indicate that firms outperform their control group
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
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
4578345103495617674979196601327738678969299514869828321064785
In recent years there has been a rapid growth in China which now accounts for
certificates
1China257076
2Italy130066
3Japan68484
4Spain59576
5Russian Federation53152
6Germany47156
7United Kingdom41193
8India37493
9USA28935
Page 1: Requirements
Section 1: Scope
Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO
9000)
Pages 2 to 14 132 1
Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards
Page 23: Bibliography
In addition to these, ISO 9001:2008 requires a Quality Policy and Quality Manual
1.0 Scope[example]
(Company Name) has developed and implemented this quality management system to
(Company Name):
determines the processes needed for the quality management system and their
determines criteria and methods needed to ensure that both the operation and
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
a quality manual,
Standard, and
documents, including records determined by (Company Name) to be necessary to
NOTE 1: Where the term ͞documented procedure͟ appears within the ISO 9001:2008
that includes
management system.
are controlled. Records required by the quality management system are controlled
to ensure that changes and the current revision status of documents are
identified,
points of use,
be necessary for the planning and operation of the quality management system
Supporting Documentation
Supporting Documentation
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.
Promote the safety, awareness, and well being of employees through training and
education.
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
and relative authority of the personnel who manage, perform, and verify the
activities affecting the QMS. Changes to the quality system are planned within
quality system.
Supporting Documentation
Organizational Chart
ensuring that processes needed for the quality management system are
(Company Name).
system.
opportunities for improvement and the need for changes to the quality management
system, including the quality policy and quality objectives. Records from
Supporting Documentation
results of audits,
customer feedback,
5.6.3 Review outputThe output from the management review includes any decisions
processes,
improvement of product related to customer requirements, and
resource needs.
necessary competence,
ensures that its personnel are aware of the relevance and importance of their
objectives, and
(see 4.2.4).
Supporting Documentation
Supporting Documentation
6.4 Work environment(Company Name) determines and manages the work environment
and develops the processes needed for product realization. Planning of product
the need to establish processes, and documents, and provide resources specific
to the product,
test activities specific to the product and the criteria for product
acceptance, and
The output of the planning is in a form suitable for (Company Name)s method of
operations.
NOTE 2 (Company Name) also applies the requirements given in 7.3 to the
Supporting Documentation
Supporting Documentation
resolved, and
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
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
advertising material.
Supporting Documentation
product information,
Supporting Documentation
plans and controls the design and development of product. During the design and
the review, verification and validation that are appropriate to each design
(Company Name) manages the interface between different groups involved in design
responsibility.
progresses.
The inputs are reviewed for adequacy. Requirements are complete, unambiguous and
control applied to the supplier and the purchased product is dependent upon the
product.
Supporting Documentation
QOP-74-01 Purchasing
Supporting Documentation
QOP-74-01 Purchasing
the inspection or other activities necessary for ensuring that purchased product
Supporting Documentation
provisionAs applicable, (Company Name) plans and carries out production and
product,
Supporting Documentation
QOP-75-01 Work Order and Production Records
QOP-75-06 Shipping
validates any processes for production and service provisions where the
or the service has been delivered. Validation demonstrates the ability of these
revalidation.
(Company Name) identifies the product status with respect to monitoring and
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
Note: Customer property can include intellectual property and personal data.
standards; where no such standards exist, the basis used for calibration or
verification shall be recorded,
safeguarded from adjustments that would invalidate the measurement result, and
storage.
In addition, (Company Name) assesses and records the validity of the previous
(Company Name) takes appropriate action on the equipment and any product
(see 4.2.4).
Supporting Documentation
needed:
Name) has met customer requirements. The methods for obtaining and using this
Supporting Documentation
An audit program is planned, taking into consideration the status and importance
audits. The audit criteria, scope, frequency and methods are defined. The
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
processes to achieve planned results. When planned results are not achieved,
the characteristics of the product to verify that product requirements have been
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
Supporting Documentation
the controls and related responsibilities and authorities for dealing with
started.
Supporting Documentation
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
Supporting Documentation
the effectiveness of the quality management system through the use of the
Supporting Documentation
evaluating the need for action to ensure that nonconformities do not recur,
Supporting Documentation
Supporting Documentation
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
servicing had basically the same material as ISO 9001 but without covering the
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
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
compliance with documented procedures. As with the first edition, the down-side
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
process management front and center ("Process management" was the monitoring and
final product). The 2000 version also demands involvement by upper executives,
in order to integrate quality into the business system and avoid delegation of
committees and advisory groups, who receive feedback from those professionals
9001:2000 and some changes intended to improve consistency with ISO 14001:2004.
accreditation bodies and the certification bodies charge fees for their
services. The various accreditation bodies have mutual agreements with each
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.
years. There are no grades of competence within ISO 9001: either a company is
Model.
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
their judgments.
Under the 1994 standard, the auditing process could be adequately addressed by
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
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?
offering counseling services; yet the ISO 9001 guidelines, because they are
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
AS9100.
(GM, Ford, Chrysler). It includes techniques such as FMEA and APQP. QS 9000 is
ISO 9001:2008. ISO/TS 16949:2009 contains the full text of ISO 9001:2008 and
version is 4.0 and unlike ISO 9001 or the above sector standards, TL 9000
QuEST Forum developed the TL 9000 Quality Management System to meet the supply
the standards it replaces were interpretations of how to apply ISO 9001 and
Compliance with ISO 13485 does not necessarily mean compliance with ISO
9001:2000.
computer software.
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
system?
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
How well the ISO system integrates into their business practices. Many
organizations that implement ISO try to make their system fit into a
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
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
continual basis. This means taking into account all processes that deal with
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
this is like speaking a foreign language. Auditors that can clearly identify
and the business implications, they simply ignore the reports and focus on
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
Reduce audits
Enhance marketing
Increases profit
ProblemsA common criticism of ISO 9001 is the amount of money, time and
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
argument is that reliance on the specifications of ISO 9001 does not guarantee a
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
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
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
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
the ISO 9000 model as a benchmark to assess the adequacy of its quality
programs."
products suppliers
Test management
(5),
http://www.emeraldinsight.com/journals.htm?articleid=842040&show=abstract,
retrieved 2010-11-22
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
retrieved 2010-11-22
http://www.emeraldinsight.com/journals.htm?articleid=868561&show=abstract,
retrieved 2010-11-22
October 2010]
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
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
^ Sharma, D.S. (2005), "The association between ISO 9000 certification and
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
http://www.emeraldinsight.com/journals.htm?articleid=840633&show=abstract,
retrieved 2010-11-22
retrieved 2010-11-22
Case Study ]
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
^ Lo, Chris K.Y.; Yeung, Andy C.L.; Cheng, T.C. Edwin (2007), "Impact of ISO
http://www.emeraldinsight.com/journals.htm?articleid=1502750&show=abstract,
retrieved 2010-11-22
http://www.emeraldinsight.com/journals.htm?articleid=840553&show=abstract,
retrieved 2010-11-22
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
^ a b c "Good Business Sense Is the Key to Confronting ISO 9000" Frank Barnes
^ a b "The 'quality' you can't feel", John Seddon, The Observer, Sunday
^ "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 ʹ MayʹJune
2002
^ The ISO Survey ʹ 2005 (abridged version, PDF, 3 MB), ISO, 2005
21(1):254-285.
Further readingBamford, Robert; Deibler, William (2003). ISO 9001: 2000 for
Naveh. E., Marcus, A. (2004). "When does ISO 9000 Quality Assurance standard
lead to performance improvement?", IEEE Transactions on Engineering
of certificates
of certificates
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