International Standard For Quality Management Systems

Quality Management System Development and Implementation, where we identify necessary procedures based on client- and product-specific needs and develop and deploy customized standard operating procedures (SOPs)

Yes, I have extensive experience in interpreting and providing advice on operating procedures, policies, guidelines and legislation. As a Quality Assurance professional, I have involved significantly in authoring, revising, distributing, maintaining, and providing training Standard Operating Procedures as per applicable regulatory guidelines, policies and legislation; Health Canada, FDA, EMEA, OECD Series on Principles of Good Laboratory Practice, ISO 9001 etc; and preparing, preparing, distributing required documentation including production/study/validation forms, protocol, study/method validation plan, method validation and clinical and non-clinical study reports to adhere to regulatory and client expectations. For example, laboratory environment

(International Organization for Standardization) ISO 9000, Quality Management Systems is a series of standards which outline how an organization may create and sustain an effective quality assurance system. The standards offer direction to organizations that want to ensure their services and products consistently meet customer

Quality management is an act that monitor all activities that needed to maintain and sustain high quality output, continuous improvement of process and product to a desire level of excellence in order to create customer satisfaction (Flynn, Schroeder, & Sakakibara, 1994, p. 342). Nowadays, increase in globalization and international trade had led to the increase of competition in the global market. The increase of competition had forced companies to focus on the concept of quality in their business and discover that effective quality management can increase their competitive advantage in the global market (Anderson, Rungtusanatham, & Schroeder, 1994).

19.   Firms that wish to do business with the European Community can benefit from having a quality management system that needs ISO 9000 standards TRUE

“ISO is commonly known as ‘International Organization for Standardization’, the ISO 9001:2000 standard is used for quality systems audited by outside auditors. This standard is applicable for manufacturing companies not only for software. This standard is given based on the documentation, design, production, testing, servicing and other processes.” (Testing Excellence.com, 2009).

The Company has developed a Quality Management System (QMS) in order to achieve these objectives. The system defines the Company’s technical and administrative policies and procedures. The Company will implement the QMS through training of new Associates, regular refresher training and internal audits. The Company will continue to improve the Quality Management System over time. This will be done by annual review process and regular revisions as improvements and/or corrections are identified.

The ISO9000 roots date back to 1946, to a conference in London where a committee of nations were standardising the organisation of quality. A union between two previous standardisation organisations allowed the birth of the ISO (Latimer, 2012); the merger of the International Federation of the National Standardising Associations (ISA) and the United Nations Standards Coordinating Committee (UNSCC).

Quality management is a structured approach to organizational management that seeks to improve the quality of products and services through continual refinements in response to continuous feedback (Gharakhani, 2013). Thus, it necessitates the consistent application of the appropriate human and technical processes, tools and techniques. A strategic quality strategy will be effective only through long-term commitment and dedicated application by executive management and all employees (Gharakhani, 2013). The purpose of this paper is to converse on implementing successful quality improvement practices within organizations to help achieve viable quality management. Further, this paper also highlights the conditions that must be in place such as management commitment, employee involvement, communication, and continuous improvement for successful quality management to be aligned with ISO 9000.

All these reasons are related to TQM also. (Melivile, 1989)of GEC Plessey Telecommunication Ltd. state that their comp any chose ISO 9000 as a part of the Total Quality Improvement Programme because they want to move away from the traditional role of chasing failures, towards an attitude of prevention and for every individual to be responsible for producing good quality products and services. ISO 9000 (Nair) is seen as a route to TOM since they are complementary to one another.It shows total integration between ISO 9000 and TQM. There are three major reasons why organizations should implement ISO 9000 –

Global competitiveness had increased the need to invest more into the efficiency of management and importance of having and understanding globalized standards (Aba and Badar 42). The ISO 9000 was created in 1987 and is a series of quality management standards. The ISO 9000 standards is so malleable that they are updated and changed roughly every three years since their endorsement (Aba and Badar 42). Because the ISO is versatile, certified companies are guaranteed exemplar standards being implemented regularly. Quazi and Padibjo (1998) stated that certified companies saw an improvement in their quality and an increase in their sales and market share (as cited in Aba and Badar 45). A benefit of ISO 9000 is that it highlights an effective system of quality that is an abetment in eliminating errors which in turn saves money (Aba and Badar 43-44). On reviews of a financial and scale efficiency, it was revealed that ISO certified businesses are more efficient than businesses that are not certified (Aba and Badar 45). The ISO set the foundation for company standards and established fundamental properties for further research in developing prosperous quality assurance programs.

It provides the requirements for the implementation of a quality management system for organizations wishing to continuously improve their customer satisfaction and provide compliant products and services. It is a generic and process focused set of standards, meaning it can be applied to any organization operating in any sector or industry; it targets the processes within the organization rather than the resulting product/output.

Companies ' utilize the quality control process along with following policies and procedures to monitor the quality of goods and services. They measure the quality through statistics and corporations are committed to produce products without defect. The manufacturing industry needs specific regulations and quality control measures should be required to protect consumers, corporations, and the environment. Stronger companies, leaders, and employees are created when quality control is implemented and used properly. By educating employees through training, setting goals, expectations and creating quality control standards new business relationships with vendors are formed and relationships with existing suppliers are stronger. Regulations from city and state are also required in order for corporations to distribute goods. Without a quality control process, companies ' run the risk of delivering defective or contaminated goods.

The Company has developed a Quality Management System (QMS) in order to achieve these objectives. The system defines the Company’s technical and administrative policies and procedures. The Company will implement the QMS through training of new Associates, regular refresher training and internal audits. The Company will continue to improve the Quality Management System over time. This will be done by annual review process and regular revisions as improvements and/or corrections are identified.

ISO 9000 certification is one of the most widespread recognize and awarded quality certification in the world. To be certified ISO 9000 a company must show that they have a quality system and procedures that are being followed. Having such a quality certification give the company advertising benefits and their purchaser save money and time as there is no need to quality tests them. For example Hotel chain Ritz- Carlton it was more meaningful for them to have a perfect individual service, proving such by obtaining the Malcolm Baldridge Quality Award than the quality of food they offer. However quality is not achieved for a life time, it has to be maintain and is not only the responsibility of the managers but of the whole company. Therefore Empowerment is crucial. Empowerment is the giving of more power, leading to more autonomy. Everybody in the company need to be empowered to know, describe, measure, improve the process and make it reliable. Salegna and Fazel (2000) identified the lack of real employee empowerment as being an obstacle to TQM systems. Processes are own by the worker, who is working by following these processes, not knowing them and understand them it would be difficult for them to deliver quality. The Japanese companies, from which the TQM system was made, has turn out to be successful as their companies are build with a culture of quality. Approximately 40 years back products from