The Implementation of International Standards - Essay Example

? Standards and Standardization of Standards and Standardization Introduction Standards are an important and positive aspect of every person’s daily lives as they contribute to the three dimensions of sustainable developments, that is the economic, social and environmental dimensions. The standards in the present world ensure that products are of the most desirable characteristics, efficiency and interchangeability at the most affordable economic costs. Given the upsurge in standards-based certification methods and schemes to structure the content and quality of products, there has been intensification in standards and standardization. The international method and schemes that are used are applied to the methods and processes used for the creation and maintenance of content, the specific tools used for content creation and maintenance and the interoperability of the contents. The implementation of international standards and other standardization procedures has the effect of reducing the risks that may be met as well as improving the quality of goods and services that may be offered consequently improving an economy as well as the welfare of the society as a whole. Economists propose a mode of categorization of standards that can be based on the economic effects that come across that is useful in the analysis of both the economic forces that determine standardization as well as the impacts of the standardization. Therefore, it can be authoritatively argued that any standard enhances trade as they reduce asymmetries in information, show the consumers that there is quality and create a common basis of discussion for the partners involved in trade that has an effect in the reduction of costs incurred in transaction (Estevadeordal, Suominen and Teh 2009, p.251). International standards can be used to facilitate trade in terms of imports while national standards are essential in protecting domestic suppliers from competition from foreign markets and through this; consumers are protected as well as reduced costs for companies. In addition, due to the fact that industries rely more on a network of suppliers and differentiated value chains, international standards are an important element in the assessing the quality of products and the reduction of risks to both consumers and the suppliers. Swann (2010) states that there is a positive relationship between international standards and standardization of exports or imports whereby for national standards, the results are inconclusive while internationally it affects trade and the economies depending on their design and mode of implementation (Swann 2010, p.6). Standardization is a voluntary, consensus-driven activity carried out by all interested parties and along with the code of mutually recognizing others, it plays a noteworthy role in the in the proper running of both the internal and international markets. Harmonization of standards helps ensure that there is a free movement of merchandises within the national and international markets thus making the businesses or enterprises to be more competitive in the market (Chrisdoulaki 2010, p.5). The standards set up by different criteria of standardization has got the beneficial effect of protecting the health and the safety of consumers of the products offered in the market place whether locally or internationally as well as the protection of the environment in which we live in. National/international Product Certification schemes Canadian Standards Association (CSA) The Standards Council of Canada whose main task is to improve and promote efficient as well as effective standardization procedures for products and services used within Canada and internationally has accredits the Canadian Standards Association (CSA). It conducts both standardization and certification after which it awards the CSA certification mark when products meet the required safety and performance levels in its fifty-seven areas of operation. Within the arm bit of CSA group is the CSA International that tests and certifies products globally and OnSpex that evaluates products meant for consumption by consumers through consulting, product specifications, evaluations, analysis of data about the product (CSA Group, 2012). The Canadian Standards Association (CSA) is tasked with the development and maintenance of standards in healthcare in order to protect patients and healthcare providers in the healthcare system. This is achieved through the setting of minimum requirements for enhancing the safety of medical equipment and devices, buildings used to provide healthcare, systems in place and the management of professional services and practices. The net effect of this is that there is increased efficiency in the provision of healthcare and the facilities involved and the systems in place that has the effect of not putting the life of patients at risk or compromising it (CSA Group, 2012). CSA works in conjunction with healthcare sector stakeholders in Canada and internationally to develop technological solutions to healthcare systems and relevant infrastructure, which are meant to provide safe and reliable healthcare. It is involved in Blood and Transplantation, Healthcare Facilities, health Informatics, labels and packaging, Medical devices, medical laboratories and sterilization as part of the standardization procedure that must be used to in ensuring that the correct standards are adhered to in the healthcare sector. Through the CSA standardization in healthcare, it is able to raise awareness about the integral role that standards play in the lives of both Canadians and international consumers of the healthcare products used or produced in Canada (CSA Group, 2012). TUV SUD TUV SUD is an independent organization that has a long-standing experience and expertise in the medical sector and compliance with regulations that re set by the authorities concerned. Through its framework for functional safety in the medical industry, TUV SUD has in place the IEC 60601-1: 2005 3rd edition that harmonizes standards for medical equipment and is usually recognized by most nations of the world and healthcare providers. Through the IEC 60601-1: 2005 3rd edition concerning the safety of medical equipment, there is a requirement for essential performance that obliges the manufacturers of medical equipment to display to the risk control measures they have incorporated in the equipment for them to remain operationally safe. This is to ensure that the manufacturers adhere to the functional safety requirements to protect themselves from prosecution and protect consumers from the disastrous effects in medical equipment (TUV SUD n.d). TUV SUD plays an important role in the medical sector through compliance through support of comprehensive assessment of the functioning of medical equipment, testing their workability, certifying and training of those tasked with their operations. In the area of testing, TUV SUD conducts electrical safety testing, EMC testing and environmental testing as well as Independent Safety Assessment that does conformity assessment against the relevant medical devices and assessment of safety related issues. It also assesses the functionality and safety of active medical devices, the usability of active medical devices and risk management files (TUV SUD, n.d). As part of the standardization procedure, TUV SUD also conducts consulting by certifying products to the relevant standards to show its commitment to safety and reliability of its products. It also trains medical equipment manufacturers and users of either the functional safety of the equipment both for basic use and experts and the analysis and management of risks for medical devices in line with ISO 14971. TUV SUD conducts CE-certification for medical software and implements IEC 62304 standards for manufacturers of medical devices (TUV SUD, n.d). Comparison Both the CSA and TUV SUD are an integral part in the provision of quality assurance standards to consumers as they provide the relevant development and regulation of the products that are put in the market. While the CSA standardizes all products, the TUV SUD focuses mainly on electrical and mechanical appliances by certifying them before they are distributed in the market. Quality Assurance Standards Hazard Analysis Critical Control Point (HACCP) This is a methodical way of identifying, evaluating, and controlling the safety hazards associated with food whereby the hazards are identified beforehand, appraised, and measures to control the same are created to prevent, reduce or eliminate the hazard altogether (Jahnke and Ku?hn 2003, p. 32). It entails seven fundamental principles that include the conducting of hazard analysis, determination of the critical control points and establishment of critical limits and procedures used to monitor. It also requires that corrective action and record keeping and documentation procedures as well as the procedure for documenting in ensuring that hazards are prevented, reduced or eliminated. Hazard Analysis Critical Control Point (HACCP) ensures that procedures important in controlling the often meticulous practices for documenting processes are followed as well as the thorough assessment of risks through proper reporting and communication channels. HACCP is well suited for applications such as the identification of microbiological hazards and their controls in processes as well as evaluating the impact of actions of operators that may have an effect on the quality and safety of a product. It is also important as an input in the definition of Critical Process parameters and the associated alert limits for the set parameters and as a structure to assess, supports and communicate the important role of sanitization and cleaning process in food production. Once the team to carry out the HACCP has been assembled according to the criteria set, they should describe the product, its intended use and the processes involved done through physical, biological or chemical means. Thereafter, the team reviews the process of the process of production of the product by challenging, refining and confirming the process flow before conducting a hazard analysis. The team then determines the Critical Control Points using the Codex Critical Point Decision tree before the establishment of the Critical Limits to separate acceptability and unacceptability in order to support the implementation of suitable monitoring and control systems. In a HACCP, the company then establishes a system to monitor the Control of CCP that basically gives the parameters of control with an associated limit before establishing a Corrective Action Plan by defining the necessary corrections aimed at bringing CCP into control in cases of deviation. The HACCP team is also required to create measures that confirm that the HACCP System adopted is ready and working in addressing or mitigating the risks and later establish and keep documentation concerning all the procedures and records for all stakeholders. Good Manufacturing Practice (GMP) Good Manufacturing Practice (GMP) is a criterion for testing and production that ensures that manufacturers come up with products that is of the desired quality mostly practiced in pharmaceutical and medical device companies to ensure that the health of consumers is safeguarded. Pharmaceutical companies are required by most legislations to comply with the GMPs set by the relevant legislations in respective countries and other regulatory bodies and must follow certain basic principles. The Good Manufacturing Practice (GMP) principles include ensuring that the manufacturing processes are clearly defined and controlled to ensure that they are consistent and comply with the set specifications. The processes must also be controlled and any subsequent changes must be assessed especially when they have an impact on the quality of drugs. GMPs ensure that instructions and procedures are written clearly in a clear language and that operators have adequate training to carry out the procedures as well as documenting them. It also requires that records are made and kept of the processes taken in the production of drugs and other pharmaceutical products is recorded including the quality and the quantity of the drug expected and that any deviations were investigated and documented. Good Manufacturing Practice therefore requires that records of the manufacture or productions of the pharmaceutical products plus the distribution channels and path are kept in a manner that can easily be traced and understood. For drugs, there must be a system of recalling any batch that may be in supply or sale but is defective and that any complaints or failures of drugs that are in the market are investigated and the appropriate measures taken to remedy the situation (O'Donnell et al 2012, pp. 243-261). It is important to note that the guidelines set by GMP are not prescriptive in nature in the manner goods should be manufactured but are a series of principles that guide manufacturers in the manufacturing process and manufacturers are only called upon to ensure that their processes are efficient and effective. Comparison The GMP involves the guidelines for quality assurance of production workflows and the environment that is used for the production of pharmaceutical products, medical products and other foods as well as the modes of packaging them. The HACCP is different as it is a preventive system for food and those who consume them and encompasses concepts such as an analysis of the hazards that may be there in the production of food, controlling the production of food, establishment of corrective actions and the documentation process. Business Excellence Models Australian Business Excellence Framework This framework is system that integrates leadership and management describing the important elements that sustain business organizations and enterprises to higher levels of performance (Sai Global 2013). It is essential as it can be used to evaluate and improve all the facets of the business organization that may include leadership, business strategy and planning, knowledge and information, human resources, delivery of products and services. ABEF provides business organizations of the sustainability of the performance of their businesses and brings about integral changes in organizational performance and culture. It is based on principles of business excellence based on a unified management theory and can be used to improve any part of the business organization through effective prioritization of what should be done in the business to improve on its performance. ABEF is aimed at processing efficiency and effectiveness through reduction of wasteful activities, empowering and motivating the workforce as well as increasing the productivity of the business. It also focuses on the superior customer service delivery of products and services as well as sustainable performance through an increase in stakeholder values (Sai Global 2013). The ABEF is expressed in nine principles of business excellence aimed at creating an environment that is sustainable and encourages the perpetuity of businesses. The nine principles which are considered to be the laws that are used for reasoning and prediction of how business organizations run are further divided into seven categories and sixteen subcategories that can be monitored or improved and they include leadership, customer and stakeholders, strategy and planning, people, information and knowledge, process management, improvement and innovation, results and sustainable performance. Through a proper coordination of these nine principles divided into seven categories and sixteen subcategories, ABEF provides ample foundation on which business organizations can be sustainable in terms of performance. It also offers businesses strong structures for decision-making and the integration of initiatives aimed at improving the business thus help in the achievement of organizational goals to deliver customer and stakeholder perception value as well as the provision of performance benchmarking for the business organization (Sai Global 2013). Canadian Framework for Business Excellence The Canadian Framework for Business Excellence is implemented by several organizations as a model for the management of organizational excellence and is based on the basic principles of excellence geared towards the achievement of positive results for businesses as well as enhancing their performances. This framework include leadership, people-focus, planning, management of processes, focus on the customer and supplier or partner focus as a means of achieving overall performance of the business (Excellence Canada 2013). Under the Canadian Framework for Business Excellence, there are seven principles that drive the excellence to be achieved by business organizations. Leadership is a key factor is important as one of the key drivers as it determines how an organization is managed towards excellence. The Canadian model emphasizes planning in that it addresses the structure and the operations of the business by establishing short-term and long-term priorities that meets the needs of the clients or the customers of the business organization. In addition, customer/client/citizen focus is one of the most important facet of Canadian business excellence model as it forms an integral path through which organizations improve towards organizational excellence (Excellence Canada 2013). People focus is another important principle of the Canadian Framework for Business Excellence is it integrates the power of the people in the achievement of organizational excellence which is attained by the optimization of the internal human resources available. In achieving excellence, Canadian businesses focus on process management by choosing which activities within the organization have the effect of satisfying or meeting the needs of the customers or the clients of the business organization (Excellence Canada 2013). This is evaluated by how the tasks in the organization are organized to achieve the strategic goals of the organization with emphasis on process management. Further, this excellence model has supplier/partner focus as one of its pillars as external connections with other institutions makes organizations excel in whatever they undertake. Finally, organizational performance under the Canadian Framework for Business Excellence determines the potential of the business enterprise or the organization to improve and achieve its strategic goals or objectives (Excellence Canada 2013). Comparison The Canadian Framework for Business Excellence has got seven categories that are aimed at improving the excellence in business practices that is leadership, planning, customer focus, people focus, process management, supplier partner focus and business performance. While the Australian model which is administered by SAI Global focuses on three categories of leadership, customer focus, strategy and planning, people, information and knowledge, process management, improvement and innovation as well as success and sustainability. While the Canadian framework focuses on leading through involvement while the Australian framework focuses on leadership by example. Conclusion In the increasingly competitive business environments, the business excellence models play an integral role in the realization of the motives of businesses. To monitor the process towards the excellence in business, very many businesses use the excellence models to achieve their objectives. The quality systems are used by organizations to self-assess themselves on how they perform among the markets or between their fellow competitors thus enabling organizations to achieve their goals as well as satisfy the needs of the consumers. Standardized products and services are important to consumers in the sense that they build confidence as the products or services, which have passed through standardization offered to the consumers, are always assumed safe, healthy, secure, of high quality and flexible in nature making them to be widely accepted. Therefore, among businesses and enterprises standardization provides a solid foundation upon which there can be growth and development and the opportunity to share and improve existing practices and products. In addition, standards have a great beneficial impact on the public as a whole as it often reflects the needs and expectations of the public in terms of quality, safety, efficacy and sustainability in the economic sense and in social and environmental dimensions. Standards also play an integral role in the regulation of products and services as the involvement of all stakeholders in the standardization helps in the building of consensus through all inclusive participation and the fact that companies that adopt standardization are afforded lighter regulatory regimes. Thus, international standards and standardization can help in enabling and the improvement of collaboration between nations especially where there is no regulatory framework in the international market. The standards facilitate better cooperation of companies that are involved in supplying products, services, and the whole value chain as it emphasizes collaboration and of partners with complementary expertise and functions in the global market. Through international standards, there is increased global research and development in the product market. Trade theory dictates that the removal of barriers is beneficial to all businesses shown in terms of higher output at low costs. Companies and businesses therefore follow excellent strategies that help them to achieve recognition as well as assure their customers of the quality of their products. References Chrisdoulaki, S. 2010. Mutual Recognition of Product Standards Regulations After 2008. [Online] Available at: [Accessed June 24 2013]. CSA Group. 2012. Health Care. [Online] Available at: [Accessed June 24 2013]. EstevadeordaL, A., Suominen, K., & Teh, R. R. (2009). Regional rules in the global trading system. Cambridge, UK; New York, Cambridge University Press. Excellence Canada. 2013. Introduction to the Framework for Excellence - Online Learning. Available at: [Accessed June 25 2013] Jahnke M, & Ku?hn K.D. 2003. Use of the hazard analysis and critical control points (HACCP) risk assessment on a medical device for parenteral application. PDA Journal of Pharmaceutical Science and Technology / PDA. 57. O'Donnell K, Greene A, Zwitkovits M, & Calnan N. 2012. Quality Risk Management: Putting GMP Controls First. PDA Journal of Pharmaceutical Science and Technology / PDA. 66. SAI GLOBAL. 2013. Australian Business Excellence Framework. [Online] Available at: http://www.saiglobal.com/Improve/ExcellenceModels/BusinessExcellenceFramework/ [Accessed June 25 2013]. Sharp, J. R. (2000). Quality in the manufacture of medicines and other healthcare products. London, Pharmaceutical Press. TUV SUD. n.d. Functional Safety in the Medical Industry. Keeping you safe. [Online]. Available at: http://www.tuv-sud.com/activity/focus-topics/functional-safety/functional-safety-in-the-medical-industry [Accessed June 25 2013]. Swann, G. M. 2010.“International Standards and Trade: A Review of the Empirical Literature.” OECD Trade Policy Working Papers, No. 97. OECD Publishing Read More