ISO 9000

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ISO 9000 is a family of standards for quality management systems. ISO 9000 is
maintained by ISO, the International Organization for Standardization and is
administered by accreditation and certification bodies. Some of the requirements in
ISO 9001 (which is one of the standards in the ISO 9000 family) would include

• a set of procedures that cover all key processes in the business;

• monitoring processes to ensure they are effective;
• keeping adequate records;
• checking output for defects, with appropriate corrective action where
necessary;
• regularly reviewing individual processes and the quality system itself for
effectiveness; and
• facilitating continual improvement

A company or organization that has been independently audited and certified to be in

conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO
9001 registered." Certification to an ISO 9000 standard does not guarantee the
compliance (and therefore the quality) of end products and services; rather, it certifies
that consistent business processes are being applied.

Although the standards originated in manufacturing, they are now employed across a
wide range of other types of organizations. A "product", in ISO vocabulary, can mean
a physical object, or services, or software. In fact, according to ISO in 2004, "service
sectors now account by far for the highest number of ISO 9001:2000 certificates -
about 31% of the total" [1]

Contents
[hide]

• 1 ISO 9000 family

• 2 Contents of ISO 9001
o 2.1 Summary of ISO 9001:2000 in informal language
• 3 History of ISO 9000
o 3.1 Pre ISO 9000
o 3.2 1987 version
 o 3.3 1994 version
o 3.4 2000 version
o 3.5 Future Version: 2008
o 3.6 Certification
• 4 Auditing
• 5 Industry-specific interpretations
• 6 Debate on the effectiveness of ISO 9000
o 6.1 Advantages
o 6.2 Problems
o 6.3 Summary
• 7 See also
• 8 Further reading
• 9 References
• 10 External links

[edit] ISO 9000 family

ISO 9000 includes the following standards:

• ISO 9000:2005, Quality management systems - Fundamentals and

vocabulary. Covers the basics of what quality management systems are and
also contains the core language of the ISO 9000 series of standards. A
guidance document, not used for certification purposes.
• ISO 9001:2000 Quality management systems - Requirements is intended
for use in any organization which designs, develops, manufactures, installs
and/or services any product or provides any form of service. It provides a
number of requirements which an organization needs to fulfill if it is to
achieve customer satisfaction through consistent products and services which
meet customer expectations. It includes a requirement for the continual (i.e.
planned) improvement of the Quality Management System, for which ISO
9004:2000 provides many hints.

This is the only implementation for which third-party auditors may grant certification.
It should be noted that certification is not described as any of the 'needs' of an
organization as a driver for using ISO 9001 (see ISO 9001:2000 section 1 'Scope') but
does recognise that it may be used for such a purpose (see ISO 9001:2000 section 0.1
'Introduction').

• ISO 9004:2000 Quality management systems - Guidelines for

performance improvements. covers continual improvement. This gives you
advice on what you could do to enhance a mature system. This standard very
specifically states that it is not intended as a guide to implementation.

There are many more standards in the ISO 9001 family (see "List of ISO 9000
standards" from ISO), many of them not even carrying "ISO 900x" numbers. For
example, some standards in the 10,000 range are considered part of the 9000 family:
ISO 10007:1995 discusses Configuration management, which for most organizations
is just one element of a complete management system. ISO notes: "The emphasis on
certification tends to overshadow the fact that there is an entire family of ISO 9000
standards ... Organizations stand to obtain the greatest value when the standards in the
new core series are used in an integrated manner, both with each other and with the
other standards making up the ISO 9000 family as a whole".

Note that the previous members of the ISO 9000 family, 9001, 9002 and 9003, have
all been integrated into 9001. In most cases, an organization claiming to be "ISO 9000
registered" is referring to ISO 9001.

[edit] Contents of ISO 9001

ISO 9001:2000 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
• Pages 1 to 14: Requirements
o Section 1: Scope
o Section 2: Normative Reference
o Section 3: Terms and definitions (specific to ISO 9001, not specified in
ISO 9000)'
• Pages 2 to 14
o Section 4: General Requirements
o Section 5: Management Responsibility
o Section 6: Resource Management
o Section 7: Product Realization
o 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 9001:2000 requires a Quality Policy and Quality Manual
(which may or may not include the above documents).

[edit] Summary of ISO 9001:2000 in informal language

 • The quality manual is a formal statement from management, closely linked to
the business and marketing plan and to customer needs. The quality manual is
understood and followed at all levels and by all employees. Each employee
needs measurable objectives to work towards.
• Decisions about the quality system are made based on recorded data and the
system is regularly audited and evaluated for conformance and effectiveness.
• You need a documented procedure to control quality documents in your
company. Everyone must have access to up-to-date documents and be aware
of how to use them.
• To maintain the quality system and produce conforming product, you need to
provide suitable infrastructure, resources, information, equipment, measuring
and monitoring devices, and environmental conditions.
• You need to map out all key processes in your company; control them by
monitoring, measurement and analysis; and ensure that product quality
objectives are met. If you can’t monitor a process by measurement, then make
sure the process is well enough defined that you can make adjustments if the
product does not meet user needs.
• For each product your company makes, you need to establish quality
objectives; plan processes; and document and measure results to use as a tool
for improvement. For each process, determine what kind of procedural
documentation is required. (Note: a “product” is hardware, software, services,
processed materials, or a combination of these.)
• You need to determine key points where each process requires monitoring and
measurement, and ensure that all monitoring and measuring devices are
properly maintained and calibrated.
• You need to have clear requirements for purchased product.
• You need to determine customer requirements and create systems for
communicating with customers about product information, inquiries,
contracts, orders, feedback and complaints.
• When developing new products, you need to plan the stages of development,
with appropriate testing at each stage. You need to test and document whether
the product meets design requirements, regulatory requirements and user
needs.
• You need to regularly review performance through internal audits and
meetings. Determine whether the quality system is working and what
improvements can be made. Deal with past problems and potential problems.
Keep records of these activities and the resulting decisions, and monitor their
effectiveness. (Note: you need a documented procedure for internal audits.)
• You need documented procedures for dealing with actual and potential
nonconformances (problems involving suppliers or customers, or internal
problems). Make sure no one uses bad product, determine what to do with bad
product, deal with the root cause of the problem and keep records to use as a
tool to improve the system.

[edit] History of ISO 9000

[edit] Pre ISO 9000
During WWII, there were quality problems in many British high-tech industries such
as munitions, where bombs were exploding in factories during assembly. The adopted
solution was to require factories to document their manufacturing procedures and to
prove by record-keeping that the procedures were being followed. The name of the
standard was BS 5750, and it was known as a management standard because it did not
specify what to manufacture, but how to manage the manufacturing process.
According to Seddon, "In 1987, the British Government persuaded the International
Organization for Standardization to adopt BS 5750 as an international standard. BS
5750 became ISO 9000." [2] [3]

[edit] 1987 version

ISO 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]

[edit] 1994 version

ISO 9000:1994 emphasized quality assurance via preventative 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]

[edit] 2000 version

ISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one, now
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 centre. ("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.

[edit] Future Version: 2008

TC 176, the ISO 9001 technical committee , has started its review on the next version
of ISO 9001, which will in all likelihood be termed the ISO 9001:2008 standard,
assuming its planned release date of 2008 is met. Early reports are that the standard
will not be substantially changed from its 2000 version.

As with the release of previous versions, organizations registered to ISO 9001 will be
given a substantial period to transition to the new version of the standard, assuming
changes are needed; organizations registered to 9001:1994 had until December of
2003 to undergo upgrade audits.

[edit] Certification

ISO 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 9001:2000. 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 world-wide.

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-compliances") is made known to the management. If there are no major
problems on this list, the certification body will issue an ISO 9001 certificate for each
geographical site it has visited, once it receives a satisfactory improvement plan from
the management showing how any problems will be resolved.

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. In
contrast to the Capability Maturity Model there are no grades of competence within
ISO 9001.

[edit] Auditing
Two 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 that is what happened (exhibit evidence in documented records)

How this led to preventive actions was not clear.

The 2000 standard uses the process approach. While auditors perform similar
functions, they 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
judgements 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?".

The ISO 19011 standard for auditing applies to ISO 9001 besides other management
systems like EMS ( ISO 14001), FSMS (ISO 22000) etc .

[edit] Industry-specific interpretations

The 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.
• AS 9000 is the Aerospace Basic Quality System Standard, an interpretation
developed by major aerospace manufacturers. The current version is AS 9100.
• PS 9000 is an application of the standard for Pharmaceutical 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 16949:2002 is an interpretation agreed upon by major automotive
manufacturers (American and European manufacturers); the latest version is
 based on ISO 9001:2000. The emphasis on a process approach is stronger than
in ISO 9001:2000. ISO/TS 16949:2002 contains the full text of ISO
9001:2000 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.
• 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 IS0 9001:2000.

[edit] Debate on the effectiveness of ISO 9000

The debate on the effectiveness of ISO 9000 commonly centres on the following
questions:

1. Are the quality principles in ISO 9000:2000 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.)
2. Does it help to implement an ISO 9001:2000 compliant quality management
system?
3. Does it help to obtain ISO 9001:2000 certification?

[edit] Advantages

It 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.[4][5] The quality principles in ISO
9000:2000 are also sound, according to Wade,[6] and Barnes, [5] who says "ISO 9000
guidelines provide a comprehensive model for quality management systems that can
make any company competitive." Barnes also cites a survey by Lloyd's Register
Quality Assurance that indicated ISO 9000 increased net profit, and another by
Deloitte-Touche that reported that the costs of registration were recovered in three
years. According to the Providence Business News [7], implementing ISO often gives
the following advantages:

1. Create a more efficient, effective operation

2. Increase customer satisfaction and retention
3. Reduce audits
4. Enhance marketing
5. Improve employee motivation, awareness, and morale
6. Promote international trade
7. Increases profit
8. Reduce waste and increases productivity
However, a broad statistical study of 800 Spanish companies [8] found that ISO
registration in itself creates little improvement because companies interested in ISO
have usually already made some type of commitment to quality and were performing
just as well before registration.[4]

In today's service sector driven economy, more and more companies are using ISO
9000 as a business tool. Through the use of properly stated quality objectives,
customer satisfaction surveys and a well-defined continual improvement program
companies are using ISO 9000 processes to increase their efficiency and profitability.

[edit] Problems

A common criticism of ISO 9001 is the amount of money, time and paperwork
required for registration.[9] 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."[5]

According to Seddon, ISO 9001 promotes specification, control, and procedures

rather than understanding and improvement. [2] [3] 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." [6] Paraphrased, Wade's
argument is that total, blind reliance on the specifications of ISO 9001 does not
guarantee a successful quality system.

The standard is seen as especially prone to failure when a company is interested in

certification before quality.[2] Certifications are in fact often based on customer
contractual requirements rather than a desire to actually improve quality.[5][10] "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.[10] Certification by an independent auditor is often seen as the problem
area, and according to Barnes, "has become a vehicle to increase consulting services."
[5]
In fact, ISO itself advises that ISO 9001 can be implemented without certification,
simply for the quality benefits that can be achieved. [11]

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.

[edit] Summary

A good overview for effective use of ISO 9000 is provided by Barnes: [5]

"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."

[edit] See also

 • ISO 10006 Quality management - Guidelines to quality management in
projects
• ISO 14000 - 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
• Verification and Validation
• Quality management system

[edit] Further reading

• Bamford, Robert; Deibler, William (2003). ISO 9001: 2000 for Software and
Systems Providers: An Engineering Approach (1st ed.). CRC-Press. ISBN-10:
0849320631 ISBN-13: 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.

[edit] References
1. ^ the ISO Survey 2004
2. ^ a b c "The 'quality' you can't feel", John Seddon, The Observer, Sunday
November 19, 2000
3. ^ a b "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
4. ^ a b "Probing the Limits: ISO 9001 Proves Ineffective". Scott Dalgleish.
Quality Magazine April 1, 2005.
5. ^ a b c d e f "Good Business Sense Is the Key to Confronting ISO 9000" Frank
Barnes in Review of Business, Spring 2000.
6. ^ a b "Is ISO 9000 really a standard?" Jim Wade, ISO Management Systems –
May-June 2002
7. ^ "Reasons Why Companies Should Have ISO Certification", Providence
Business News, August 28, 2000.
8. ^ "ISO 9000 registration's impact on sales and profitability: A longitudinal
analysis of performance before and after accreditation." Iñaki Heras, Gavin
P.M. Dick, and Martí Casadesús. International Journal of Quality and
Reliability Management Vol 19, No. 6, 2002.
9. ^ "So many standards to follow, so little payoff". Stephanie Clifford. Inc
Magazine, May 2005.
10. ^ a b "ISO a GO-Go." Mark Henricks. Entrepreneur Magazine Dec 2001.
11. ^ The ISO Survey – 2005 (abridged version, PDF, 3 MB), ISO, 2005

[edit] External links

• ISO (International Organization for Standardization)
 o Introduction to ISO 9000 and ISO 14000
o List of national ISO member organizations.
• ISO's Technical Committee 176 on Quality Management and Quality
Assurance
o Basic info on ISO 9000 development
o ISO 9000 FAQs
• Technical Committee No. 176, Sub-committee No. 2, which is responsible for
developing ISO 9000 standards.
• ISO9000Council general information on ISO 9000 implementation

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