Iso 9000
Iso 9000
Iso 9000
The TQM philosophy evolved from the continuous improvement philosophy with a focus
on quality as the main dimension of business.
Recognizes that everyone in the organization has owners/customers who are either
internal or external
Focuses on the way tasks are accomplished rather than simply what tasks are
accomplished
TQM beliefs
Analyzing the processes used to create products and services is key to quality
improvement
Measurement, a skilled use of analytical tools, and employee involvement are critical
sources of quality improvement ideas and innovations
Sustained total quality management is not possible without active, visible, consistent,
and enabling leadership by managers at all levels
If we do not continuously improve the quality of products and services that we provide
our owners/customers, someone else will
Deming’s Fourteen
Points
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Benefits of TQM
Reducing rework to zero is achievable: Using quality
management and CI to reduce rework to
nearly zero is an achievable goal. The negative cost of quality,
which includes errors, delays,
rework, etc., is estimated to be 30 percent of the cost of
construction. This figure does not include
dissatisfied owners/customers who do not come back for
repeat business.
Steps in implementing TQM
Steps in implementing
TQM
CEO and senior management roles
The roles of the CEO and Senior Management Team are to create an organizational
culture in which TQM can exist and flourish.
An excellent culture that management can create for TQM to exist and flourish contains
the eight cultural elements indicated in the figure below.
1 Quality information must be used for improvement, not to judge or control people.
The role of the steering committee and the processes the committee follows are listed
here.
Appoint task process improvement teams and ensure they receive proper
training.
Steering committee forms a team to examine the process and make necessary
recommendations for improvement
Team meets, reviews its mission, and determines how often it will meet. The
problem is assigned to the team following the procedures outlined in #10, The
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Owner/customer Satisfaction
Improved Safety
Continuous Improvement
Employee Empowerment
Staff Training
The successful TQM company provides training to employees in the order illustrated in
the figure below.
The training program must begin with upper management, then training must be
provided for the remaining management, and the in-house trainers and facilitators.
It cannot be emphasized enough that if upper management is not trained and is not a
viable, visible participant from the beginning, then the program will not survive.
A Upper Management
B Remaining Management
D Front-Line Supervisors
E Non-Supervisory Employees
F Team Training
Train management
Improve training
In establishing quality improvement teams, a smaller company might assign one quality
improvement team.
Larger firms might assign several, possibly with one quality lead team as a guide for the
other teams.
Areas where quality improvement teams could begin investigating for possible
improvement are:
informed Employees
Technical Training
Quality Training
Employee Suggestions
Employee Participation
Personal Development
Representatives who are selected to be quality-lead team members should possess the
following attributes:
The quality improvement team (QIT) is responsible for planning and managing the
TQM
Implementation process for the organization. The QIT is responsible for making
TQM happen.
The QIT must take the lead in managing the cultural changes that TQM will
require.
At least one member of the Senior Management Team (SMT) should be a member
of the QIT.
The QIT reports to the Chief Executive Officer (CEO) and the SMT.
The QIT and SMT should hold a joint meeting to review the TQM effort at least
quarterly.
ISO 9000
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. The rules are updated, as the requirements motivate changes over
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time.
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Some of the requirements in ISO 9001:2008 (which is one of the standards in the ISO 9000
family) include
Why ICS?
In today’s business climate, companies have realized that ISO 9001 certification and
industry specific quality management systems registration can add real value to their
organizations. Rather than just a simple checklist, the auditing process can help
highlight weaknesses as well as strengths, which allows companies to continually
improve their processes to stay competitive. ICS works with our clients to
understand their business and unique practices to ensure our clients get the most
out of the auditing process.
ICS also offers services and benefits that other registrars don't, like:
Dedicated Account Managers - An Account Manager is assigned to each client to
provide a single point of contact.
SWOT Analysis - A SWOT analysis is available with every audit which describes real
strengths, weaknesses, opportunities, and threats in terms executive management
can understand on top of the audit report which generally only explains compliance
to various parts of the ISO standards.
Client Portal - A secure client portal is available to house client documents such as
audit plans, reports, and certificates for 24-hour access.
Vibrant Auditor Mentoring & Customer Satisfaction Process - The professionals
delivering audits are key to our success. We obtain our Clients' feedback on each
auditor and work hard to incorporate our Client's improvement suggestions.
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 seeking and keep records to use as a tool to
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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.
1994 version
ISO 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.[
2000 version
ISO 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
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company's tasks and activities, instead of just inspecting the final product). The 2000
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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 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-compliances") 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. In
contrast to the Capability Maturity Model there are no grades of competence within
ISO 9001.
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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 this 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
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?". The ISO 19011 standard for auditing applies to ISO 9001
besides other management systems like EMS ( ISO 14001), FSMS (ISO 22000) etc.
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 counselling 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
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versions of ISO 9000 have their specific requirements, but also to try and ensure that
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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 16949:2002 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. 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/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
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Monogram annex.
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The 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?
Advantages
Problems
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A common criticism of ISO 9001 is the amount of money, time and paperwork
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required for registration. 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."
According to Seddon, ISO 9001 promotes specification, control, and procedures
rather than understanding and improvement. 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." Paraphrased, Wade's argument is that
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. Certifications are in fact often based on customer
contractual requirements rather than a desire to actually improve quality. "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. Certification by an independent auditor is often seen as the problem
area, and according to Barnes, "has become a vehicle to increase consulting
services." In fact, ISO itself advises that ISO 9001 can be implemented without
certification, simply for the quality benefits that can be achieved.
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