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Free ISO Quality Control Essay Sample

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Beckman Coulter is the world's number one in manufacturing and marketing of biomedical testing instrument systems, supplies, and tests that make simpler and automatize laboratory processes. Its products have various applications such as medical research, drug discovery and clinical trials, as well as diagnostic laboratories in hospitals. Researches involving complex biological problems comprising causes of illnesses and possible new therapies or drugs to counter the disease use products catered by Beckman Coulter. The company runs through two reportable business sections that is to say Life Science and Clinical Diagnostics. The company is headquartered in California and was received ISO 9000 quality standards certification in the 1990s (secinfo, 2010).

Beckman Coulter offers a wide range of instruments for distinguishing, testing and analyzing the components of life. The company can supply almost all routine blood test and 75% of other tests required in hospital clinical laboratory. More than 70% of our products hold top level market positions. This includes products in the area of; general chemistry systems, hematology, capillary electrophoresis, centrifugation, spectrophotometry, bio robotics, protein analysis, and rapid-testing
Products manufactured by Beckman coulter mainly used by universities, pharmaceutical and biotechnology companies, research institutions and medical schools, physicians' offices, hospitals, and diagnostic reference laboratories across the world. Beckman Coulter presently has about 200,000 major instrument systems in laboratories throughout the globe. Nearly 64% of total revenues are generated from after-market sales of chemistry kits, operating systems, and service contracts.


Before any company acquires ISO 9000 certification, it is required that it determines, provides, and holds the infrastructure required to attain conformity to product requirements. These infrastructures include buildings, process equipments and other supporting services such as communication and transport.

Beckerman coulter was no exception. In terms of buildings, the company has more than 30 facilities around the world. This helped the company to decentralize its manufacturing processes from the home plant of California. This not only helped the company acquire ISO certification but also helped in cutting down the cost of production in the presence of a rapidly expanding market. In 1982 Beckman Coulter merged with Smithkline Corporation to make Smithkline Beckman. This improved the infrastructure of the company in terms of buildings, workspace and information systems. It was at this time that the company was able to introduce landmark products such as System E4AT electrolyte analyzer, Auto ICST immunochemistry system, ARRAY© protein system, the SYNCHRON CX©3, 4 and 5 clinical systems and Paragon© electrophoresis system. During the same period the company was also able to launch significant bioresearch products including System 6300 Amino Acid analyzer, Biomek© 1000 automated laboratory workstation, and System 1 DNA synthesizer.

Beckman had a series of acquisitions in the 1950s and 1960s that complemented and flourished the company's business. Particularly in the 1970s the company made tremendous expansion of facilities. New sites were opened in Europe and a sales unit in china. Operations in the 1980s and 1990s focused on development of laboratory systems for the purpose of biological analysis and transformation of technology into solutions for the clinical labs was the company's operation focus in the 1980s and 1990s.

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In 1997, the company acquired yet another company, Coulter Corporation. Coulter Corporation was founded on Wallace Coulter's discovery of the "Coulter Principle". With this acquisition more products were manufactured in the areas of flow cytometry, hematology, and hemostasis. It also provided the Beckerman with process equipment such as laboratory testing instruments

Tools and Approaches

Beckerman coulter carries out research in collaboration with other partners such as universities and hospitals in the area of life sciences. The research then helps the company to make innovations and manufacturer of products in life sciences. In order for the company to be able to master product development challenges and accelerate the time to the market collaboratively and efficiently, it has Dassault SystŠmes 3D and Product Lifecycle Management (PLM) solutions.
Product Lifecycle Managementÿ(PLM) involves managing the full lifecycle of aÿproductÿas from its conception, through invention and manufacture, to service and disposal. PLM integrates people, data, business systems, processes and provides a product information backbone for companies and their extended enterprise Product lifecycle. PLM has been very beneficial to Beckerman coulter Inc. some of the benefits realized are; Reducedÿtime to market, Reduced waste, and Improved product quality.

Senior managers of the company use the approach to make critical decisions about the company. Decision Focus software is a product of Decision Focus Inc. Decision Focus 7.0 is the most recent desktop companion for the Decision Focus tools suite (Decision Focus 7.0). Decision Focus software helps you consistently make the right decisions - by including features that give you more speed, more control and more opportunities to apply your best thinking. Improve your ability to handle more kinds of decisions than ever before - all in a convenient, easy to use desktop toolkit.
The software has several benefits such as: ability to connect other sources of information to every Decision Focus worksheet; enables sharing of Decision focus worksheet containing many links; can create a Ms Word summary document of decision focus analysis; and helps one to think beyond the decision to ensure that objectives are met; risks are looked at and plans to mitigate the risks are addressed before making critical decisions. An instance where the software was used is when the company's Director of Worldwide Technical Operations used Decision Focus to choose suppliers to oversee a major program.

Issues in implementation of ISO

Beckerman Coulter Inc faced several hurdles in implementing ISO across its organization. Some of these include quality management, management responsibility and resource management. Quality management includes requirements such as documentation. Since the time Beckman coulter was launched it was rapidly growing, merging and acquiring other competing companies. For example the company merged with Smithkline Company to form Smithkline Beckman. Both companies could be using different ways of documentation and therefore making a common way of documentation in terms of developing a quality manual, control of records and control of documents could have been hectic.

Management responsibility includes customer focus, quality policy, planning, and management commitment. According to ISO quality standards a company should have a common quality policy throughout its facilities. This could have been difficult for Beckman Coulter especially after merging with another. Then it was necessary that the company agree on a common quality policy. In terms of planning the company needed to quality management system planning which could be difficult for the company to implement across its facilities throughout the world.
Resource management includes provision of resources, infrastructure, and work environment. Beckman coulter needed to provide enough resources to its facilities. Resources are necessary for the company to develop, design and manufacture its products. Since the company was fast expanding resources could have been a challenge. Infrastructure such as buildings should provide enough working space. With ISO quality standards, the company could have had to renovate their buildings to meet the requirements.

Tools of analyzing data

In 2004ÿBeckman Coulter launched the CEQT 8800 Software v.9 that provided new tools for genetic data analysis. In 2006 Genetic Analysis System, GenomeLabT GeXP, was introduced. The aim of introducing the system was to perform multiplex, cost effective, quantitative, and high-thoroughput gene expression analysis. The system comprises of software, hardware, and chemistries for manifold gene expression analysis. It was later improved to GenomeLabT SNP Start Kit which was more cost effective and can carry out a more robust genetic data analysis. In 2006, Beckman Coulter also released version 8.0 of 32 Karat Software formalized for use on XP workstations.

Beckman Coulter Inc. also makes use of Kaluza Flow Cytometry Analysis Software, which significantly reduces time used in processing and analysis of data thus allowing researchers to concentrate in exploring their data. Kaluza Software makes use of new tools that make the management of multiple complex data sets easier. It also allows visualization of high-content information in different spatial proportions on a single plot.

Processes used in ISO strategic planning

One of the processes involved in ISO strategic planning is the use of SWOT analysis. Before carrying out a SWOT analysis it is important that an objective is defined. SWOT analysis helps to understand a company's strength, weaknesses, opportunities and threats. Strengths are the characteristics of a company that provides it with an advantage over other companies in the same industry. Beckerman coulter enjoys a bigger market share than many of its competitors since it a leading manufacturer and marketer of clinical laboratory and life science products. Weaknesses are characteristics that place a company at a disadvantage relative to its competitors. Opportunities are external chance existing in the environment to make more sales and greater profits. Threats are external factors in the environment that could stimulate trouble for the company.
Performance management applies to organizations, too, and includes recurring activities to establish organizational goals, monitor progress toward the goals, and make adjustments to achieve those goals more effectively and efficiently. Those recurring activities are much of what leaders and managers inherently do in their organizations - some do them far better than others.

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