Saturday, January 19, 2008

Waht is ISO?

ISO or the International Organization for Standardization is a non-governmental organization that was established in 1947. ISO includes a network of 157 national standards bodies (as of 9/12/06) from the world’s leading industrial nations. One of the main goals of ISO is to develop worldwide standardization by promoting adoption of international quality standards. By doing so, barriers of trade are eliminated.


ISO has created 15,000 standards as of 8/16/05 in a variety of industries. Examples of standards ISO has created include the standardized codes for country names, currencies and languages, standardized format of worldwide telephone and banking cards, as well as sizes and colors of road signs, and automobile bumper heights.


ISO includes 3,000 technical working bodies (as of 9/12/06), in which some 50,000 experts from industry, labor, government, and standardization bodies in all parts of the world develop and revise standards. ISO has created standards for the automotive, manufacturing, mechanics, packaging, and health care fields amongst many others.


Standards can be broadly sub-divided into three categories, namely product, process, and management standards. The first refers to characteristics related to quality and safety for example. Process standards refer to the conditions under which products and services are to be produced, packaged or refined. Management system standards assist organization to manage their operations. They are often used to help create a framework that then allows the organization to consistently achieve the requirements that are set out in product and process standards.



What is ISO 9000?
What is the difference between ISO 9000, ISO 9001, and ISO 9001:2000? And what are ISO 9002 and ISO 9003?

The quick answer is “none”. These terms are all used to describe the ISO 9001 standard. Prior to December 2000, there used to be an ISO 9001, an ISO 9002 and an ISO 9003 standard; without focusing on the technical differences between them, people would just simply refer to each as ISO 9000. In December 2000, the International Organization for Standardization (ISO) merged ISO 9001, ISO 9002, and ISO 9003 into a revised ISO 9001 standard. In order to distinguish between the previous ISO 9001 version, the current standard is often referred to as ISO 9001:2000 or ISO 9000:2000.

► Tip: More detailed information can be found on http://www.iso.ch/.



Summary of the ISO 9001 Standard
The ISO 9000 standard contains requirements affecting virtually all aspects of any company. Because ISO 9000 is designed for any company of any size and in any industry, the requirements are rather broad and hard to read. The ISO 9001:2000 requirements fall into the following sections:



Section 1: Quality Management System
This section of the ISO 9001:2000 standard outlines the necessary steps to implement the ISO 9001 quality management system:

  1. Identify the process (or activities) needed for the quality management system,
  2. Determine the sequence and interaction of these processes,
  3. Determine how these processes are effectively operated and controlled,
  4. Ensure that all information is available to support the operation and monitoring of these processes,
  5. Measure, monitor and analyze these processes, and implement action necessary to correct the processes and achieve continual improvement.

The ISO 9000 quality management system requires documentation that includes a quality manual, certain procedures, as well as work instructions. All documentation (including quality records) must be controlled according to a document control procedure. Also in this section, ISO 9001 emphasizes the need for continuous improvement.

► Tip: Most companies find the documentation requirements daunting. The use of templates can be of tremendous benefits. See our Product Collection section for your consideration.

Section 2: Management Responsibility
ISO 9001:2000 places great emphasis on top management’s commitment to quality. This section requires a quality policy and quality objectives, and it reinforces the involvement of top management with customer requirements.

This ISO 9001 section also requires top management to establish responsibilities and authorities within the company, including the establishment of an ISO 9000 management representative.

► Tip: Use a good standard format for all job descriptions – this will save much time when creating new job descriptions, when advertising positions, when performing employee evaluations, etc.

Section 3: Resource Management
This section of ISO 9001:2000 clarifies the requirement for a company to determine and provide, in a timely manner, resources (for example, equipment, facilities, etc) needed to implement and improve the processes of the ISO 9001 quality management system and to address customer satisfaction. This section also includes requirements for employee training, as well as for the physical facilities and the work environment.

► Tip: Integrate your company’s HR function well into your ISO 9001 quality system, and make them take on a leading role during the ISO 9001 implementation.

Section 4: Product Realization
The ISO 9001:2000 standard defines Product Realization as “that sequence of processes and sub processes required to achieve the product.” This is how your product is designed, produced, tested, handled, shipped, etc. This section also applies to service providers. Emphasis is placed on how the company understands, communicates and actually meets customer requirements. This section also contains various requirements for the design of products and for the planning of processes, projects and services.

► Tip: Most companies write work instructions and flowcharts to define and standardize their work processes. You will save yourself much time if you follow the ISO 9001 requirements for document control from the outset when writing these documents.

Section 5: Measurement, Analysis and Improvement
The last section of the ISO 9001:2000 standard closes the loop by providing requirements for measurement and monitoring activities, so that the company can immediately identify when not on track. Measurement and monitoring activities also include internal audits and the monitoring of customer perception as to whether the company has fulfilled customer requirements. All of these activities must be defined, planned and implemented. Measuring and monitoring allows the company to manage by fact, not by guess.

► Tip: This is a very important section of the ISO 9001 standard. Depending on how it is implemented, it can add tremendous value or create bureaucracy and waste. We highly recommend placing emphasis on this crucial ISO 9001 section.

To be continued...

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