What Is Iso 9001? Iso 9001 Is An International Standard

Risk management is the process where individual and overall risks are understood and managed, thus optimizing success by minimizing the threats and to maximize opportunities [APM Body of Knowledge, p. 179]. All projects are inherently risky, because it performed by people and subject to the external influences or environment. Risk is something that it cannot be predicted. That is why into the company’s organization, risk management has an essential and vital part in any project whether that is in the planning procedure or to project implementation. Risks are always exists and can be translated as an opportunity to gain benefits. In addition a risk may incur serious monetary losses. The first step of risk management begins when identifies risk. These are identified through several techniques that risk management can select and use. One of the most effective techniques is brainstorming where members are attending meetings in order to gain ideas of either to identify a risk or how to overcome the arising risk. However a document review technique is also applied which is also very helpful, in this technique, documents are reviewed from prior projects which leads to a better understanding of the risks that may do occur. If a company seeks risk management capabilities, is to gaining competitive advantage, riskier businesses seek potential and higher profits.

ISO 9001:2008 sets the requirements on the quality procedures and their content in sections 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2, and 8.5.3.

To create, launch, and sustain an effective quality management program it is crucial that a ground work of fundamental policies be established and adhered to. Policies direct everyone within the hospital in order to accomplish the organization’s goals and mission.

2. ISO 14001 is a set of standards that govern how a company designs service processes.

A critical part of the management of quality is the strategic and systematic approach to

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).

For the third and fourth tools, Yell used and achieved standard regulation from ISO 9000 and ISO 14000. Description of ISO 9000 is an internationally recognized quality standard to create and maintain quality assurance system in design, development, production, installation, and servicing for all types of organization, in many industries. In addition, it contains rules and regulations about practicing in good management, where it can recognize the basic discipline and give criteria to make sure that services and products meet customer needs and requirements. As a conclusion, it can help the company to deal with customer orders, stock control, purchasing, service provision and service delivery. Whether ISO 14000 is an internationally recognized act for create and maintain environmental management system which is suitable for all types of organization as well. The purpose of the standard is to reduce the pollution and waste of production from the company. As a conclusion, it can avoid the company being sued in the future because of negatively effect to the environment.

Alternatively, the organization might introduce ISO 9000. By doing so “X” may gauge fulfillment of its customer’s quality requirements and applicable regulatory requirements while aiming to enhance customer satisfaction and achieve continual improvement of its performance.

ISO 13485:2003 is an International Organizational for Standardization published in 2003. This international standard requires specifications for a quality management system where an organization needs to provide for designing or manufacturing medical devices. These requirements are essential for any organization that provides services that are related to medical devices disregarding the type or the size of the organization.

ISO 9000 and ISO 14000 are among the most widely known international standards. The standards have been implemented by some 610,000 organizations in 160 countries. ISO 9000 is an international reference for quality management requirements while ISO 14000 is an international reference enabling organizations to meet their environmental challenges (Praxiom Research Group, 2004).

The most important standard within the ISO 14000 series is the ISO 14001 standard. ISO 14001 specifies the requirements of an environmental management system (EMS) for small to large organizations. The ISO 14001 is based on the Plan-Check-DO-Review Improve cycle shown in figure 1.

the need for our company to adopt quality management principles and how they will benefit our business

The newest standards are ISO 26000, which standardizes social responsibility, and ISO/IEC 27001, which is a developed management system to standardize information security (ISO, n.d.). The most well-known and best-selling standard of the ISO governing body is ISO 9000, which was developed in 1987 (ISO, n.d.). ISO 9000 is for quality management standards. Quality management includes standards that help the organization identify processes that can be developed and employ constant performance improvement. ISO 9000 has been utilized by many national and international companies to constantly improve performance and processes, but ISO 9000 usually involves a manufacturing company.

Risk based thinking – The current “preventive action process” is replaced with “risk based thinking”. We are expected to identify the risks and opportunities that may effect our company as service providers and define actions to tackle them. They must be included in our QMS processes. Going forward, management must be involved from the start in the development of the QMS and will, as a result, be aware of the risk factors. Management meetings should include time for disscussions on recognising risks and be made aware of concerns from lower level employee regarding risk. When all employees are involved in the “risk based thinking process” it is expected that this will provide valuable information re potential threaths to the business.