Beruflich Dokumente
Kultur Dokumente
A I U B
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ACKNOWLEDGEMENT:
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Table of Contents:
Contents: Page
4. Conclusion………………………………………………………………...…13
Debates on the effectiveness on the ISO 9000 standards…………………....13
5. Bibliography………………………………………………………………..15
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1: Introduction to Quality management system.
Most countries have adopted the ISO-9000 series as their national standards.
Likewise, thousands of organizations throughout the world have quality
systems registered to the standard. In the United States, the national
standards are published by the American national institute/American society
for Quality (ANSI/ASQ) as the ANSI/ASQQ9000 series. Government bodies
throughout the world, including the united states, are also using the
standards. U.S. Govt agencies using the series are the department of defense
(DOD) and the food & drug administration (FDA).
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1.1 Benefits of ISO Registration:
There are various reasons for implementing a quality system that conforms
to an ISO standard. The primary reason is that customers or marketing are
suggesting or demanding compliance to a quality system. Other reasons are
needed improvement in a process or systems and a desire for goal
deployment of product and services. As more and more organization become
registered, their requiring their subcontractors or supplier to be register,
creating a snowball effect. Consequently, In order to maintain or increase
market share, many organizations are finding they must be in conformance
with ISO standard. Internal benefits that can be received from developing
and implementing a well documented quality system can far outweigh the
external pressures.
A study of 100 Italian firms was undertaken to determine if there was any
improvements in performance after registration. Significant improvement
was noted in:
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1.2 ISO 9000 Series of standards
The ISO 9000 series of standard is generic in scope. By design, the series
can be tailored to feet any organizations needs, whether it is a large or small,
a manufacturer or a service organization. It can be applied to construction,
engineering, health care, legal, and other professional services as well as the
manufacturing of anything from nuts and bolts to spacecraft. Its purpose is to
unify quality terms and definitions used by industrialized nations and use
those terms to demonstrate a supplier ’s capability of controlling its
processes. In very simplified terms, the standards require and Organization
to say what it is doing to ensure quality, then do what it says, and, finally,
document or prove that it has done what it said. The three standards of the
series are described briefly in the following paragraphs:
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The first three clauses are for information. While last five are requirements
that an organization must meet. The numbering system used in standard. The
application of a system of processes within organization, together with
identification and interactions and the managing of these processes, is
referred to as the PROCESS APPROACH.
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4.2 Documentation:
5) Management responsibility:
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5.2 customer focus: ensure the customer requirement.
5.4 planning:
5.4.1 Quality objectives: top management set the organization objective and
quality maintaining policy which is linked up with quality
management system. And top management should establish the system
that quality implements in system and it can satisfy customers need.
5.4.2 Quality management system planning: top management shall ensure
that the planning of the quality management system. Is accomplished
in order to me
T the requirement of the QMC as stated in the genral requirements as
well as quality objectives.
5.5 responsibility, authority and communication:
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5.6: Management review
General Top management shall review the QMS at planned intervals to
ensure its continuing suitability, adequacy, and effectiveness. This review
shall include assessing opportunities for improvement and the need for
changes to the QMS including the quality policy and quality objectives.
Records from the reviews shall be maintained.
Review input: The input to the review shall include information on (a)
results of audits. (b) customer feedback. (c) Process performance and
product conformity, (d) status of corrective and preventative performance,
(e) follow-up actions from previous management reviews, (f) changes that
could affect the QMS, and (g) recommendations for improvement.
Review output: The output from the review shall include any decisions and
actions related to (a) improvement of the effectiveness of the QMS and its
processes, (b) improvement of the product related to customer requirement,
and (c) resource needs. Top management can use the outputs as inputs to
improvement opportunities.
6. Resource Management
6.2.1 General: Personnel performing work that affects product quality shall
be competent on the basis of appropriate education, training, skills and
experience.
6.2.2 Competence, Awareness and Training: The organization shall (a)
determine the necessary competence for personnel performing work affecting
product quality, (b) provide training or take other actions to satisfy these
needs. (c) evaluate the effectiveness of the action taken, (d) ensure that its
personnel are aware of the relevance and importance of their activities and
how they contribute to the achievement of the quality objectives, and (e)
maintain appropriate records of education, training, skills, and experience.
Competency is defined as the demonstrated ability to apply knowledge and
skills. It can be contained in the job description by function, group or
specific position. Training effectiveness can be determined by before and
after tests, performance, or turnover. ISO 10015 Guidelines for Training will
help organization comply with this standard.
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6.3: Infrastructure
The organization shall determine, provide, and maintain the infrastructure
needed to achieve conformity to product requirements. Infrastructure
includes, as applicable (a) buildings, workspace and associated utilities, (b)
process equipment (both hardware and software), and (c) supporting services
(such as transport or communication).
7. Product Realization
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7.2.2: Review of Requirements Related to the Product: The organization
shall review the requirements related to the product. This review shall be
conducted prior to the organization’s commitment to supply a product to the
customer (for example, submission of tenders, acceptance of contracts or
orders, acceptance of changes to contracts or orders) and shall ensure that (a)
product requirements are defined. (b) Contract or order requirements
differing from those previously expressed are resolved, and (c)the
organization has the ability to meet the defined requirements. Records of the
results of the review and actions arising from the review shall be maintained.
Where the customer provides no documented statement of requirement, the
customer requirements shall be confirmed by the organization before
acceptance. Where product requirements are changed, the organization shall
ensure that relevant documents are amended and that relevant personnel are
made aware of the changed requirements. In some situations, such as Internet
sales, a formal review is impractical for each order. Instead, the review can
cover relevant product information such as catalogs or advertising material.
7.3.1 Design and Development Planning: The organization shall plan and
control the design and development of the product. During the design and
development planning, the organization shall determine (a)the design and
development stages, (b) the review, verification and validation that are
appropriate to each design and development stage, and (c) the
responsibilities and authorities for design and development stage, and (c) the
responsibilities and authorities for design and development. The organization
shall manage the interfaces between different groups involved in design and
development to ensure effective communication and clear assignment of
responsibility. Planning output shall be updated, as appropriate, as the design
and development progresses.
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and for service provision. (c) Contain or reference product acceptance
criteria, and (d) specify the characteristics of the product that are essential
for its safe and proper use.
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7.6: Control of monitoring and measuring devices:
The organization shall determine the monitoring and measurement to be
undertaken and the monitoring and measuring devices needed to provide
evidence of conformity of product to determined requirements.
8.1 General: the organization shall plan and implement the monitoring,
measurement, analysis, and improvement processes needed (a) to
demonstrate conformity of the product, (b)to ensure conformity of the QMS
and (c) to continually improve the effectiveness of the QMS, and (c) to
continually improve the effectiveness of the QMS. This shall include
determination of applicable method, including statistical techniques, and the
extent of their use.
8.2.2Internal Audit:
The organization shall conduct internal audits at planned intervals to
determine whether the QMS (a) conforms to the planned arrangements (b) is
effectively implemented and maintained
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8.3: Control of Nonconforming Product:
8.5: Improvement:
8.5.2: Corrective Action: The organization shall take action to eliminate the
cause of nonconformities in order to prevent recurrence.
In 2001 Ambee Pharmaceuticals Ltd. became ISO 9001 certified company. ISO 9001
certificate is the international recognition of the quality management system of this
organization that complies with the standard of ISO 9001 system. This certificate was
awarded by United Registrar of Systems Ltd.(URS) of UK. In Bangladesh among 250
pharmaceutical companies only few have become ISO 9001 certified and Ambee is one
of them.
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3.2: Northern Corporation Ltd. was founded and established in the year of 1987. The
company started with the knitting and dyeing unit and later on start producing knit
garment for the export market. The capacity has grown from 3000 pcs of garment per day
to 25000 pcs of garment per day at the present. This company is now one of the few
companies in Bangladesh, which ensures high end dyeing, and finishing of knitted fabrics
facilitated by the state of the art dyeing and finishing machineries. NCL is ISO certified
and OKO-tex certified company. This provides a leading edge to the foreign buyers while
it comes to marketing. The well-educated group of work-study and production
engineering team, which makes NCL a modern company of its kind, runs the garment
unit. The company’s yearly turnover stood at 16.5 million US in the financial year of
2005-2006. The production unit for knitting, Dyeing and Garment is situated nearby
Dhaka at Tongi, BSCIC, and Gazipur, Bangladesh.
3.3: Bangladesh Internet Press Limited (BIPL) is the first CMMI Maturity Level 3
company in Bangladesh. The company has reached maturity Level 3 after working for
several years on combining its own vast experience and accumulating best practices in
implementing software engineering processes with SEI CMMI recommendations. BIPL
is also a Microsoft Gold and ISO 9001:2000 certified global IT enterprise with key focus
on client-server technology, open source platforms & e-business solutions.
4: Conclusion:
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.[2][3] The quality principles in ISO
9000:2000 are also sound, according to Wade,[4] and Barnes, [3] 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 which indicated that ISO 9000 increased net profit, and another by Deloitte-
Touche which reported that the costs of registration were recovered in three years.
According to the Providence Business News [5], implementing ISO often gives the
following advantages:
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However, a broad statistical study of 800 Spanish companies found that ISO 9000
registration in itself creates little improvement because companies interested in it have
usually already made some type of commitment to quality management and were
performing just as well before registration.
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.
Problems:
A common criticism of ISO 9001 is the amount of money, time and paperwork required
for registration.[7] 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."[3]
According to Seddon, ISO 9001 promotes specification, control, and procedures rather
than understanding and improvement. [8] [9] 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, Wada’s argument is that reliance on the
specifications of ISO 9001 does not guarantee a successful quality system.
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5. Bibliography
II. ISO 9000. Wikipedia- The free Encyclopedia. Retrived in April 11, 2009, from
http://en.wikipedia.org/wiki/ISO_9000#ISO_9000_series_of_standards.
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