April 29, 2018

ISO 9001

In today’s global market, low operation or production cost alone are no longer sufficient to survive in the future. Whether you are a small business owner or a multinational corporation, a manufacturing or service company, consistent quality product or service as a result of reliable and quality processes is a must to meet the challenges ahead. Today’s successful companies are those that have a strong commitment in quality, from back office operation to the service and products delivery.

ISO 9001 which represents an international consensus on good management practices is a powerful tool that can be used by any organizations, regardless of the size or type of business, in developing a solid management system. ISO 9001 provides a framework for taking a systematic approach in managing your business processes in order to consistently produce a conforming products which lead to customer satisfaction.

ISO 9001 is not a legal requirement in cooperating with foreign market, however international business perceive ISO 9001 standard as a key in doing business worldwide and improving the standard of the company itself. In addition, nowadays customers often use the standard as a way to differentiate the cooperated companies, particularly when products and services are similar.  Finally, quality management system developed using ISO 9001 is an excellent foundation for continual improvement.

ISO 9001 IWA 1

The additional guidance was provided by the ISO International Workshop Agreement (IWA) 1, Guidelines for process improvements in health service organizations. ISO has published a new version of IWA 1. The new version has been made even more “user friendly” for organizations in the sector by incorporating improvements based on developments in the fields and comments by health care providers since the original was published in 2001.

The guidelines include much of the text of ISO 9004, Quality management systems – Guidelines for performance improvements, supplemented by text specifically aimed at assisting health services organizations to implement a QMS, regardless of whether they decide to pursue certification to ISO 9001.

The objective is the systematic pursuit of process improvement in order to attain continual improvement, the prevention of error and other adverse outcomes, and the reduction of variation and organizational “waste” – such as non-value added activities.

The principal improvements to the new version of IWA 1 include the following :

  • The “translation” of quality-related terminology into language and situations readily understood by health care professionals
  • The addition after many of the ISO 9004:2000 requirements of paragraphs of related advice on “what to look for” and “Guidance/examples”.

The expert who developed IWA 1 stated, “Implementing this guidance and maintaining the system with discipline and rigour through the organization should produce effectiveness and efficiencies with a cost benefit of up 17:1 based on experience of other sectors.”

One of the authors, Mickey Christensen, who was Chair of the committee that developed the original proposal for IWA 1, cites the case of Southern Pharmaceutical Corporation as an example of the benefits of ISO 9001:2000 implementation, supplemented by guidance from IWA 1. The company delivers medicines and medical equipment such as oxygen breathing apparatus (as well as setting it up) to patients at their homes.

ISO 9001 IWA 2

ISO 9001 IWA 2 provides guidance for a quality management system in educational organizations. The guidelines contained within IWA 2:2007 do not add to, change or otherwise modify the requirements of ISO 9001:2000, and are not intended for use in contracts for conformity assessment or for certification.

This International Workshop Agreement provides guidance to educational organizations for implementing an effective quality management system in conjunction with and based on ISO 9001.

The objective is to assure the overall effectiveness of the education organization’s quality management system and the delivery and continual improvement of its educational service to the learner.

The educational organization should define the scope of the quality management system and the areas included for its application. Examples include departments within a larder educational organization, an entire educational organization, or all educational organizations in a given government. The educational organization should define and manage the processes for the quality management system.

Process related to the aim of the organization should be included during and following the provision of the educational service :

  • Education design
  • Curriculum development
  • Education delivery
  • Assessment of learning.

International Workshop Agreement IWA 2 was approved at a workshop held in Acapulco, Mexico, in October 2002, which was hosted by the Mexican General Bureau of Standards (DGN).

ISO 9001 IWA 4

The ISO 9001 IWA 4 provides local governments with guidelines for the voluntary application of ISO 9001:2008 on an integral basis. These guidelines do not, however, add, change or modify the requirements of ISO 9001:2008.

The present general guidelines aim to help local government organizations relate the concepts of quality management as described in the ISO 9000 family of standards with the practice and terminology commonly employed in the local government context. It is expected that a development plan or work programme in the short or medium term is received, understood, and applied by the employees, officers and representatives of the local government.

However, the plan or programme itself does not ensure that the needs and expectations of the local community will be covered if the processes needed for the effective implementation of such plans or programmes are deficient or nonexistent. The need to avoid these deficiencies has motivated the elaboration of this guide to help local governments in the implementation of an effective quality management system.

Certification of the quality management system by external parties is not a requirement of this guide, though local governments may choose to seek certification to ISO 9001:2008 if they wish. Internal quality audits can provide the verification of compliance with the requirements, in conjunction with the control of complaints or claims from customers, users, citizens and the local community in general.

Any quality management system will be influenced by the different policies, objectives, diverse work methods, resource availability and administrative practices that are specific for each local government. Therefore, it may be expected that the details of each quality management systems will vary in each local government. It is not the detailed method of implementation of the quality management system that is important; what matters is that it yields effective, consistent and reliable results. The quality management system should be as simple as possible in order to function properly. It needs to be understandable enough to meet the policies and quality objectives of the local government.

ISO 9000:2005 (Quality management systems – Fundamentals and vocabulary) states that, in order for an organization to be successful, it needs to be guided and controlled in a systematic and transparent way. This is particularly true for local government, where transparency and accountability to its citizens are vital in order to gain their trust and confidence. Sustainable success will only result from the implementation of an integral quality management system that addresses the needs and expectations of all interested parties. The quality management system of a reliable and successful local government should therefore cover all activities and processes that can affect its ability to satisfy the requirements of its “customers”/citizens as well as those of other interested parties, such as regional or national governments.

ISO 9001 IWA 9

ISO 9001 IWA 9 is a framework for managing sustainable development in business districts, which provides a framework for managing sustainable development in a business district, including the evaluation, comparison and improvement of its performance. It also identifies and describes factors to be considered when developing and evaluating the economic, environmental and social performance of new and existing business districts.

This international standard can also be used to compare or to assess the performance of business districts regarding the provisions described within it and does not set benchmarks or expected levels of performance regarding the impacts of business districts.

It is intended to be used in conjunction with, and in accordance with the principles set out in, ISO 15392, ISO 26000 and the standards on environmental management prepared by ISO/TC 207.

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