Quality Assurance Standards and Business Excellence Models

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Table of Contents

Introduction
Importance of standards to international trade
Importance of standards to Health, Safety and consumer rights
Quality Assurance Standards
Conclusion
Reference List

Introduction

Standards are the generally agreed ways of doing something which can be repeated over and over again. They are set as rules for guidance on how to produce an item or how a certain activity is to be conducted. Standards help to make life easier and always increase the effectiveness and the reliability of goods and services produced.

Both national and international trade are governed by standards covering environment, labor, products and other commodities; they are applied so as to mitigate against such risks associated with the environment as the health of the population, prevention of deceptive and unethical practices and finally to reduce the transactional costs in business.

The standards always provide a common reference points for quality, authenticity, safety and sustainability.

Standards will always be used as a strategic to enhance competitiveness of organizations and countries. Lack of standards can be a major impediment for trade putting other traders at a very disadvantaged position; harmonized standards promote a fair competition in the market (Australian Business Awards 2011).

Standards facilitate trade through quality and reliability of the products. Human beings engage in trade or the exchange of goods and services and deal with incorrect measures and misrepresentation throughout the history though systems are developed to enforce honesty. The earliest standards in the past were basically to enforce honesty between people.

Importance of standards to international trade

Over the years, there has been a major development in trade, especially on the international level, that is why there has been a rising need by the manufacturers to develop a single worldwide accepted standards and conformity tests.

The health, environment concerns and the safety standards differ among the countries, and therefore governments have accommodated all this when developing global standards. Our societies relies heavily on standards, and all the products and services we consume every day have been subjected to some form of standards.

International standardization has grown tremendously and helped in eliminating of ambiguity in business transactions. Standardization has helped in major progress towards trade liberalization across the globe by providing a common reference that is recognized in different countries. Standards have also enhanced the quality of products and their reliability by providing confidence in the products and services.

For instance, we have the mandatory, obligatory, preferential and even business of marketing standards. ISO the International Organization for Standardization is a voluntary standard setting body which membership is recognized by the authorities in their countries (International Organization for Standardization n. d.). It began in 1942 and has undergone many changes; currently, it offers different standard certification all over the world.

Importance of standards to Health, Safety and consumer rights

The Australians Competition and Consumer Commission (ACCC) is an independent government statutory body in charge of ensuring national consumer protections law. These laws concern unsafe products and unfair trade and therefore guarantee on quality goods and services for the consumers. This commission ensures consumer’s safety and health across countries.

This is the way of ensuring that unsafe products that do not meet the required standards are not sold to the unsuspecting consumers. Every business operation is required to report to ACCC immediately when they realize that the products they supplied may have caused any harm or illness to the consumers.

These are the standards that have been set by the government to ensure that the safety, health and the rights of consumers are guaranteed. This also meets certain standards for the products that are sold to the consumers.

The consumer rights covered here does not involve problems arising through misuse or the act of carelessness on the part of the consumer. All these standards and measures that have been put in place serve also to guarantee the health and safety of the consumer.

Quality Assurance Standards

ISO17025:2005 quality assurance standards which specify the general requirements and the competence to carry out tests and calibrations which include sampling and testing using the standard methods, laboratory developed methods and other non-standards methods (Tawfik, & Fatah 2011).

This certification can be conferred to any organization performing calibrations and tests, thus it is applicable to an organization without taking into account the number of the staff. ISO17025:2005 quality assurance standard certification is for laboratories which show quality and competence particularly in the medical laboratory.

It is conferred to laboratories which have shown quality management system in place and their competence (Langley et al 2009). The standard contains five elements of Management requirements, scope, References, Terms and definitions and the Technical requirements.

The main aspects of this quality assurance standard are Management requirements and Technical requirements which relate directly to operation and effectiveness of the management system. Laboratories use this quality assurance standard to implement quality system that is aimed at improving the ability of the laboratory to achieve consistently good results.

GMP or The Good manufacturing practice is a practice required to be embraced by the manufacturing companies in the pharmaceutical industry, this shows systems of quality control covering the manufacture of drugs, their testing, their active ingredients and diagnosis (Australian Competition and Consumer Commission 2011). GMPs are the guidelines which impact on quality of the product.

The main aim of GMP is to safeguard the health and safety of the consumer and produce products of good quality that are effective at the same time. The GMP guidelines are not supposed to give the instruction on how to manufacture products, but rather the principles that should be observed during the manufacturing process.

Different countries have legislated GMP guidelines that companies must follow if they want to establish a pharmaceutical manufacturing entity in the country (Hoyle 2009).

GMP guidelines have been incorporated into different legislations in different countries, so they are to be followed strictly whereas the ISO17025:2005 and ISO15189:2007 are not mandatory, but it is for organizations that have shown to maintain quality management systems and strict quality controls.

Both ISO15189:2007 and ISO17025:2005 are certifications for companies involved in the laboratories whereas GMPs are for companies involved in the manufacturing of pharmaceuticals products.

All the three quality assurance standards imply that the company produces high quality products that are safe to use and can be trusted therefore ensuring good health for the consumer. It also implies that the organization has quality management systems in place and their products meet the highest standards in the market.

For an ISO1725:2005 certification, the company has to show that in its operations, it takes into account environment issues like degradation, pollution among others. The ISO15189:2007 certification have the same requirements, and in addition, the aspects of clinical tests are taken into account.

The ISO17025:2005 places emphasis on the selection of the tests and calibrations methods employed whereas the ISO15189:2007 emphasizes much on the patient’s outcome. The ISO 17025:2005 sets all the requirements that a calibration and a testing laboratory have to meet to show that their quality system is in place, they have competence and can generate valid results (Hoyle 2009).

The ISO15189:2007 is recognition of testing competence and calibration of medical laboratories and other medical laboratory services like the needs of the patients and the clinical personnel.

It emphasizes more on the care of the patients. Both ISO15189:2007 and ISO17025:2005 are almost similar with some very few differences whereas the GMP is totally different compared to the two quality assurance standard certifications. Business Excellence Models

Business excellence models are said to be frameworks used in an organization that drives actions in a more systematic manner which eventually leads to increased productivity and performance (Juran & Defeo 2010). These models are more holistic in approach and focus virtually on all the aspects of the organization.

Nowadays, there are numerous business excellence models used all over the world; these models are almost the same in nature with some slight variations. The Malcolm Baldrige award model or simply the Baldrige model was started in the United States of America by the congress to promote awareness on quality and recognize achievements of various organizations in the US (Leonard & McGuire, 2007).

These annual awards are presented by the President of the US to organizations who have shown outstanding performance and excellence in innovation and other business activities. Although it started in the US in 1987, it is used by different countries across the world with some slight modifications in the structure now (Porter & Tanner, 2004).

The awards are given to organizations in the manufacturing sector education, health, service and not for profit organizations. Before the recipients receive the awards. they have to show their achievement and their improvements in some of the seven key areas of strategic planning, customer and market focus, analysis, knowledge management, leadership, process management and results.

In assessing the recipients, the board examines the report on organization opportunities and strength in every detail. Since its inception, the Baldrige award has become the most converted and has helped many organizations to improve their performance by improving value to customers.

Most of the awards across the world have been modeled like the Baldrige. The core values of Baldrige include visionary leadership, customer driven excellence, valuing employed and partners. The benefits in participating on such awards are that these enable the organizations to align their processes, resources, people and their customer’s needs. They also help the organization on their daily operations to think strategically.

The Australian Business Awards is another business excellence model, this award is national in nature and used to honor organizations that have shown and demonstrated excellence in their business and product development and have shown a commitment, sustainability and commercial success in their operations.

These awards were started in 2006, and it was a way of recognizing organization that have shown progress in environmental and social contributions. The award is given to all the organizations from private and public companies, government departments to no-governmental organizations.

The award falls into ten categories that is enterprise, innovation, service excellence, public service, E-Business, project management, recommended employer, community contribution and environmental sustainability.

Business excellence models are developed by the national bodies in their respective countries, and the winners of the awards are recognized as leaders in their industry and always branded as the elite in their industry (Cobb 2003). These awards enable organizations to benchmark with other organization in the same industry and help the organizations to assess their performance and identify their strengths as well.

Conclusion

Both the quality assurance standards like the ISO certification and the Business excellence models have a lot in common because the organizations are subjected to independent rigorous assessment and meet the stringent requirements which are awarded or certified. Both the business excellence model and the quality assurance standards focus on the management system in areas, such as leadership, strategic planning among others.

No organization with weak management system ever gets either the award or the certification. All the business excellence models and the quality assurance standards are geared towards the final consumer of the goods or the services. The awards and the certifications will always give the consumer the confidence that the goods and services are safe and of high quality.

It also gives the customer the assurance that the products are consistent in quality and taste. Both the quality assurance standards and business excellence models are the sources of pride for the organization which has received them because this shows that the goods and services are of world class and can effectively compete with others in the industry.

In both instances, the organizations are assessed by a team of independent evaluators who are not biased and cannot be influenced. Both are indications that the company is ethically managed organization and involved in sustainable environmental activities like conserving the environment and limiting pollution and solid wastes.

Currently, environmental issues have become very critical to all and these awards and standards always have an element of environmental dimension. Good business practices are another main focus of both these business excellence awards and the quantity assurance standard if the organization engages in exploitative practices and slavery like conditions.

For instance, poor wages of its staff cannot gain any of this awards or the standard recognition. All these quality assurance standards recognition and the business excellence awards ensure a win-win situation for the organization, their employees, the consumers, the environment and the community at large.

Reference List

Australian Business Awards, 2011. 2011 Categories: Business Awards. Australian Business Awards. Web.

Australian Competition and Consumer Commission, 2011. New legal protections for Australian consumers. Australian Competition and Consumer Commission. Web.

Cobb, C., G., 2003. From quality to business excellence: a systems approach to management. New York: ASQ Quality Press.

Hoyle, D., 2009. ISO 9000 Quality Systems Handbook. 6^th ed. New York: Taylor & Francis.

International Organization for Standardization, n. d. International Standards for Businesses, Government and Society. International Organization for Standardization. Web.

Juran, J. M., & Defeo, J. A., 2010. Juran’s Quality Handbook:The Complete Guide to Performance Excellence. Washington, D C.: McGraw-Hill.

Langley, G. J., Moen, R., Nolan, K. M., Nolan,T. W., & Norman, C. L., 2009. The Improvement Guide: A Practical Approach to Enhancing Organizational Performance. New York, NY: John Wiley and Sons.

Leonard, D., & McGuire, M., 2007. The executive guide to understanding and implementing the Baldrige criteria. Boston: ASQ Quality Press.

Porter, L. J., & Tanner, S. J., 2004. Assessing Business Excellence: A Guide to Business Excellence And Self-Assessment. New York, NY: Elsevier.

Tawfik. H. M., & Fatah, A., 2011. ISO/IEC 17025 Accreditation: Between the Desired Gains and the Reality. The Quality Assurance Journal. Web.

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