organizations or private-sector organizations of any size, it can also
be applied to any field, from manufacturing to services and software. It is possible
to incorporate actively what seems necessary for its business activities.
 Features of ISO9000 family of standards
The main features of the ISO9000 family of standards are as follows.
1. The ISO9000 family of standards constitute a quality management system and form an effective management tool.
2. It is a top-down management system that defines responsibility and activates the organization.
3. WHAT is a requirement, but HOW is a decision taken by the organization. It respects the autonomy of the organization and is a tool that allows the organization to individual expression.
Outline of ISO9000 family of standards
The ISO9000 family of standards was created to assist organizations in all fields and of all types and sizes to implement and operate effective quality management systems. The 2000 version of ISO9000 family consists of 12 standards - the four core standards of ISO9000, ISO9001, ISO9004 (these three standards issued as of Dec. 15,2000) and ISO19011 and eight related standards.
| ISO9000:2000 |
Fundamentals of quality management systems and specification of the terms and definitions used in quality management systems |
| ISO9001:2000 |
Requirements for a quality management system. Based on this standards, organization can use in case of needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements and to enhance customer satisfaction. ( This standard replaces ISO9001;1994, ISO9002: 2000 and ISO9003:1994) |
| ISO9004:2000 |
Guideline for both effectiveness and efficiency in quality management system, giving a wider range of objectives of quality management system than does ISO9001:2000, particularly for the continual improvement of an organization's overall performance and efficiency as well as effectiveness. This standard is not intended for certification or contractual Purposes. ( this standard replaces ISO9004-1;1994.) |
| ISO19011:2002 |
Guidance on environmental and Quality management system audits. (This is to replace ISO10011-1:1990, ISO1011-2:1991, ISO10011-3:1991, ISO14010:1996, ISO14011:1996 and ISO14012:1996.) |
Quality management system
[Innovation of eight principles]
ISO9000s:2000 represents a shift from the approach of quality assurance to an approach of quality management systems. The revisions in the 2000 version are informed by numerous opinions received from countries throughout the world, resulting in a set of eight principles of quality management systems. An awareness of these eight principles is therefore essential to an understanding of the standards.
Quality management principles (Extract from ISO9000:2000 Fundamentals and vocabulary 0.2)
To lead and operate an organization successfully, it is necessary to direct and control it in a systematic and transparent manner. Success can result from implementing and maintaining a management system that is designed to continually improve performance while addressing the needs of all interested parties. Managing an organization encompasses quality management amongst other management disciplines.
.......Eight quality management principles have been identified that can be used by top management in order to lead the organization towards improved performance.
Eight quality management principles (Extract from ISO9000:2000 Fundamentals and vocabulary 0.2)
a. Customer focus
Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations. (Run the organization so that it's attention is turned always to its customers.)
b. Leadership
Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives. (Top management must demonstrate leadership and pull the organization.)
c. Involvement of people
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit. (All people in the organization must fulfill the missions assigned them.)
d. Process approach
A desired result is achieved more efficiently when activities and related resources are managed as a process. (Improve process/output by managing individual processes.)
e. System approach to management
Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives. (Top management must control the arrangement of processes and connections in the system overall and make innovative improvement.)
f. Continual improvement
Continual improvement of the organization's overall performance should be a permanent objective of the organization. (Do not be satisfied with the way things are. Always work to improve them.)
g. Factual approach to decision making
Effective decisions are based on the analysis of data and information. (Decide what to do next on the basis of an accurate understanding of past performance.)
h. Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. (Don't think of your suppliers as subcontractors, treat them as partners.) |
Six main features of ISO9001:2000
I. Top management commitment
The role of top management receives greater emphasis in ISO9001:2000. This includes the management commitment to the development and improvement of a quality management system through such means as customer focus, consideration of statutory and regulatory requirements and the establishment of measurable quality objectives for relevant functions and levels.
II. Process and process approach
1. Process
An activity using resource management, and managed in order to enable the transformation of inputs into outputs (Extract from ISO9000:2000 Fundamentals and vocabulary 0.2)
2. The distinctive characteristics of processes
- A process makes it possible to define what activities and operations are to be performed, to what extent, with what objectives and with what results (output).
- A process makes it possible to perform activities and operations not a single time, but repeatedly.
- A process makes it possible to measure (evaluate) the output (value added) of activities and operations.
- A process makes it possible to predict what results activities and processes will have.
- "Plan-Do-Check-Act" (PDCA*) can be applied to all processes. |
PDCA
PDCA(Plan-Do-Check-Act) can be briefly described as follows.(see Figure 1)
Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies.
Do: implement the processes.
Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.
Act: take actions to continually improve process performance.
3. Process approach (see Figure 2)
- The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the "process approach".
- An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction. Using the process approach also allows management of the activities in the system overall as a consistent, practical flow. |
The requirements of the process approach are as follows.
1. It is necessary to identify which of multiple processes are critical to achieving the organization's business goals, its quality policy and its quality targets, and to meeting the demands and expectations of the market and the organization's customers.
2. It is necessary to specify what measurements shall be made and the criteria for those measurements in order to evaluate whether core processes are functioning in line with objectives.
3. It is necessary to evaluate core processes on the basis of the results of evaluation and measurement, and to improve processes to enhance further customer satisfaction.
III. Continual improvement
Continual improvement is the ongoing, continual improvement of the effectiveness and/or efficacy of the organization's quality management system with the objective of achieving the organization's policy and objectives. The aim of continually improving the quality management system is to enhance its ability to improve the satisfaction of customers and other interested parties.
Continual improvement means making gradual improvements.
IV. Emphasizing customer requirements and customer satisfaction (Customer focus)
ISO9001:2000 prescribes a focus on the customer throughout. The relevant sections are 5.2 Customer focus, 5.5.2 Management representative -c) ensuring the promotion of awareness of customer requirements throughout the organization, 5.6.2 Review input -b) Customer feedback, 5.6.3 Review output -b) improvement of product related to customer requirements, 7.2 Customer-related processes, 8.2.1 Customer satisfaction, and 8.4 Analysis of data -a) customer satisfaction and b) conformance to product requirements.
V. Documentation
ISO9001:2000 provides flexibility with respect to documentation of the organization's quality management system. This makes it possible to minimize the documentation needed for demonstration of effective process planning, operation and control, and of implementation and continual improvement of the quality management system.
There are six sections, listed below, in ISO9001:2000 that mandate obligatory documentation of procedures. Where the standard explicitly requires documented procedures, those procedures must be established, documented, implemented and maintained.
[Requirements for Obligatory Documented Procedures] |
| 4.2.3 Control of documents |
4.2.4 Control of records |
| 8.2.2 Internal audit |
8.3 Control of nonconforming product |
| 8.5.2 Corrective action |
8.5.3 Preventive action |
VI.This means that other procedures that need to be documented in order to implement an effective quality management system should be documented by the organization. The extent of the quality management system documentation can differ from one organization to another.
o The size of organization and type of activities
o The complexity of processes and their interactions
o The competence of personnel
VII. ISO9001:2000 1.2 Application
According to ISO9001:2000 1.2 Application, an organization may be permitted to exclude requirements prescribed in ISO9001. Permissible exclusions are outlined below.
1. Permissible exclusions are limited to those requirements within clause 7 of ISO9001:2000.
2. Exclusions of requirements that affect the organization's ability or responsibility to provide product that meets customer and applicable regulatory requirements are not permitted. (Certification for ISO9001:2000 may not be granted.)
3. Where a requirement is excluded, the quality manual must contain justification for the exclusion.
Other Features of the 2000 Version
1. ISO9001:2000 is coordinated with ISO14001:1996 to enhance their compatibility.
ISO9001:2000 does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements.
2. The structure of ISO9001:2000 follows the PDCA process classification.
Grouping requirements in line with the PDCA process -- Management responsibility (5), Resource management (6), Product realization (7) and Measurement, analysis and improvement (8)-- makes it easy to use for all organizations offering products and services.
3. ISO9001:2000 emphasizes quality objectives.
The 2000 version requires that an organization establishes quality objectives for each relevant function and level. These objectives are necessary not only to satisfy product requirements, but must also be measurable and conform with quality policy, including the commitment to continual improvement.
4. ISO9001:2000 clarifies quality planning.
Overall quality management system planning is described in 5.4.2 Quality management system planning, and planning for individual products in 7.1 Planning of product realization.
5. ISO9001:2000 places requirements on the work environment.
It requires the organization shall determine and manage the work environment needed to achieve conformity to product requirements.
6. ISO9001:2000 includes requirements for communications.
The standard includes requirements regarding internal communications within the relevant various levels and functions (5.5.3 Internal communication) and requires, with respect to product information, enquiries, contracts, and customer feedback, including customer complaints, that communications with customers be performed reliably (7.2.3 Customer communication).
7. ISO9001:2000 includes requirements for data analysis.
The standard requires that the organization collect and analyze data regarding customer satisfaction, conformance to product requirement, characteristics and trends of processes and products, and suppliers.
Validity Term of ISO9001:1994 and ISO9002:1994
• The certification of organizations already certified for ISO9001:1994, ISO9002:1994 and ISO9003:1994 will remain valid until 14 December 2003.
• Organizations seeking certification under the terms of the 1994 version will submit their applications by the end of December 2001. (Audits under the terms of the 1994 version will be performed by the end of December 2002, and any certification thus granted will remain valid until14 December 2003.)
|
Home
Contact us
Webboard 
