The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.
A company can maintain a relationship with customers, as well as get increased business through complying to the ISO 900 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.
The Introduction to ISO 9001:2008 DVD covers 3 major areas, which will help companies in the process of implementing ISO 9000 Standards. It consists of:
First, to describe some basic information on ISO 9000 Standards. It will specifically refer to ISO 9001:2008 Standards. The video will explained on topic like what is ISO 9000 Standards, The origin, history & evolution, Series of ISO 9000, version & certification in ISO 9000 Standards.
Then, the DVD will go into the introduction on quality management. It will explained on topics like what is quality, quality characteristic, quality management, Quality Management Principles, ISO 9000 vs. Quality, what is Quality Management System & etc.
Finally, the DVD will technically highlight the requirement of Quality Management System in ISO 9001:2008. It also going through in details the steps in implementing Quality Management System in ISO 9001:2008.
The story of ISO 9000 Standards is a story of standards, methods and regulation. The brief history that follows is in no way comprehensive but is intended to illustrate four things: 1. that ISO 9000 standards are an ancient concept that survived several millennia; that a means of verifying compliance often follows the setting of standards; 2. that the formalizing of working practices is centuries old and seen as a means to consistently meet standards; 3. that market regulation (relative to the standard of goods and services) has been around for centuries for the protection of both craftsmen and traders. 4. ISO 9000 is a symptom of practices that were around centuries before anyone coined the term quality management. It is in some respects a natural progression that will continue to evolve. The story is told from a British viewpoint.
ISO 9000 grew out of BS 5750, a standard published by the British Standards Institution (BSI) in 1979. Initially, it was used only in manufacturing industries. ISO 9000 is now employed across a variety of other types of businesses. It is a set of international standards of quality management systems. ISO 9000 has been accepted by more than 100 countries as their national quality assurance standard by the end of 1997. The history of ISO 9000 Standards dates back to Mil-Q-9858a, the first quality standard for military procurement established in 1959 by the US. By 1962, NASA (National Aeronautics and Space Administration) developed its quality system requirements for suppliers. In 1965, NATO (North Atlantic Treaty Organization) accepted the AQAP (allied quality assurance procedures) specifications for the procurement of equipments. During the 1970s, BSI published BS 9000 (the first UK standard for quality assurance) and BS 5179 (guidelines for quality assurance) norms. In 1979, it created BS 5750, a series of standards for use by manufacturing companies. They were enforced through assessments and audits. In 1988, ISO (International Standards Organization) adopted the BS 5750 standard without changes and published it globally under the name ISO 9000. The ISO adopted this standard with a view to create an international definition of the necessary characteristics of a quality system for all businesses, regardless of industry. In 1994, the ISO revised the ISO 9000 standard and published it globally. In the beginning, ISO 9000 was implemented exclusively by large companies. But by mid-1990s, small and mid-sized companies began to increasingly implement these standards. In the United States, the total number of registrations increased from a little more than 2,200 in 1993 to more than 17,000 in 1998. Of these 17,000 registrations, almost 60 percent were held by businesses with annual sales of $100 million or less.
ISO 9000 Standards – Quality Management Principles A quality management principle is defined by ISO/TC 176 as a comprehensive and fundamental rule or belief, for leading and operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other interested parties. Eight principles have emerged as fundamental to the management of quality.
All the requirements of ISO 9001:2008 are related to one or more of these principles. These principles provide the reasons for the requirements and are thus very important. The quality management principles can be listed as below:
1. Customer focus Organizations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations. The customer focus principle is reflected in ISO 9000 Standards through the requirements addressing: a. Communication with the customer b. Care for customer property c. The determination of customer needs and expectations d. Appointment of a management representative e. Management commitment
2. Leadership Leaders establish unity of purpose and direction for the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives. The leadership principle is reflected in ISO 9000 Standards through the requirements addressing: a. The setting of objectives and policies b. Planning c. Internal communication d. Creating an effective work environment
3. 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. The involvement of people principle is reflected in ISO 9000 Standards through the requirements addressing: a. Participation in design reviews b. Defining objectives, responsibilities and authority c. Creating an environment in which people are motivated d. Internal communication e. Identifying competence needs
4. Process approach A desired result is achieved more efficiently when related resources and activities are managed as a process. The process approach principle is reflected in ISO 9000 Standards through the requirements addressing: a. The identity of processes b. Defining process inputs and outputs c. Providing the infrastructure, information and resources for processes to function
5. System approach to management This principle is expressed as follows: Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives. The system approach principle is reflected in ISO 9001 through the requirements addressing: a. Establishing, implementing and maintaining the management system b. Interconnection, interrelation and sequence of processes c. The links between processes d. Establishing measurement processes
6. Continual improvement This principle is expressed as follows: Continual improvement of the organization’s overall performance should be a permanent objective of the organization. The continual improvement principle is reflected in ISO 9000 Standards through the requirements addressing: a. Improvement processes b. Identifying improvements c. Reviewing documents and processes for opportunities for improvement
7. Factual approach to decision making This principle is expressed as follows: Effective decisions are based on the analysis of data and information. The factual approach principle is reflected in ISO 9000 Standards through the requirements addressing: a. Reviews, measurements and monitoring to obtain facts b. Control of measuring devices c. Analysis to obtain facts from information d. Records for documenting the facts e. Approvals based on facts
8. Mutually beneficial supplier relationships This principle is expressed as follows: An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. The mutually beneficial supplier relationships principle is reflected in ISO 9000 Standardsthrough the requirements addressing: a. Control of suppliers b. Evaluation of suppliers c. Analysis and review of supplier data
ISO 9000 Standards – Document control procedures The ISO 9000 Standards requires that a documented procedure be established to define the controls needed.
This requirement means that the methods for performing the various activities required to control different types of documents should be defined and documented.
Although the ISO 9000 standards implies that a single procedure is required, should you choose to produce several different procedures for handling the different types of documents it is doubtful that any auditor would deem this noncompliant. Where this might be questionable is in cases where there is no logical reason for such differences and where merging the procedures and settling on a best practice would improve efficiency and effectiveness.
Documents are recorded information and the purpose of the document control process is to firstly ensure the appropriate information is available where needed and secondly to prevent the inadvertent use of invalid information. At each stage of the process are activities to be performed that may require documented procedures in order to ensure consistency and predictability. Procedures may not be necessary for each stage in the process.
Every process is likely to require the use of documents or generate documents and it is in the process descriptions that you define the documents that need to be controlled. Any document not referred to in your process descriptions is therefore, by definition, not essential to the achievement of quality and not required to be under control. It is not necessary to identify uncontrolled documents in such cases. If you had no way of tracing documents to a governing process, a means of separating controlled from uncontrolled may well be necessary.
The procedures that require the use or preparation of documents should also specify or invoke the procedures for their control. If the controls are unique to the document, they should be specified in the procedure that requires the document. You can produce one or more common procedures that deal with the controls that apply to all documents. The stages in the process may differ depending on the type of document and organizations involved in its preparation, approval, publication and use. One procedure may cater for all the processes but several may be needed. The aspects you should cover in your document control procedures, (some of which are addressed further in this chapter) are as follows Planning new documents, funding, prior authorization, establishing need etc.
- Preparation of documents, who prepares them, how they are drafted, conventions for text, diagrams, forms etc. - Standards for the format and content of documents, forms and diagrams. - Document identification conventions. - Issue notation, draft issues, post approval issues. - Dating conventions, date of issue, date of approval or date of distribution. - Document review, who reviews them and what evidence is retained. - Document approval, who approves them and how approval is denoted. - Document proving prior to use. - Printing and publication, who does it and who checks it. - Distribution of documents, who decides, who does it, who checks it. - Use of documents, limitations, unauthorized copying and marking. - Revision of issued documents, requests for revision, who approves the request, who implements the change. - Denoting changes, revision marks, reissues, sidelining, underlining. Amending copies of issued documents, amendment instructions, and amendment status. - Indexing documents, listing documents by issue status. - Document maintenance, keeping them current, periodic review. - Document accessibility inside and outside normal working hours. - Document security, unauthorized changes, copying, disposal, computer viruses, fire and theft. - Document filing, masters, copies, drafts, and custom binders. - Document storage, libraries and archive, who controls location, loan arrangements. - Document retention and obsolescence.
With electronically stored documentation, the document database may provide many of the above features and may not need to be separately prescribed in your procedures. Only the tasks carried out by personnel need to be defined in your procedures. A help file associated with a document database is as much a documented procedure as a conventional paper based procedure.
Documents That Ensure Effective Planning, Operation And Control
The ISO 9000 standard requires management system documentation to include documents required by the organization to ensure the effective planning, operation and control of its processes. The documents required for effective planning, operation and control of the processes would include several different types of documents. Some will be product and process specific and others will be common to all processes. Rather than stipulate the documents that are needed, ISO 9000 Standards now provides for the organization to decide what it needs for the effective operation and control of its processes. This phrase is the key to determining the documents that are needed. There are three types of controlled documents, namely: - Policies and practices (these include process descriptions, control procedures, guides, operating procedures and internal standards) - Documents derived from these policies and practices, such as drawings, specifications, plans, work instructions, technical procedures and reports - External documents referenced in either of the above There will always be exceptions to this model but in general the majority of documents used in a management system can be classified in this way. Derived documents are those that are derived by executing processes; for example, audit reports result from using the audit process, drawings result from using the design process, procurement specifications result from using the procurement process. There are, however, two types of derived document: prescriptive and descriptive documents. Prescriptive documents are those that prescribe requirements, instructions, guidance etc. and may be subject to change. They have issue status and approval status, and are implemented in doing work. Descriptive documents result from doing work and are not implemented. They may have issue and approval status. Specifications, plans, purchase orders, drawings are all prescriptive whereas audit reports, test reports, inspection records are all descriptive. This distinction is only necessary because the controls required will be different for each class of documents.
The ISO is a federation of non-governmental organizations established in 1947 to develop international standards, improve international communication and collaboration, and facilitate the exchange of goods and services. The federation is currently comprised of close to 100 national standards bodies (member bodies) from countries representing approximately 95 percent of the world’s industrial production.
The headquarters of the ISO secretariat is in Geneva, Switzerland.2 The ISO’s involvement in establishing environmental standardsbegan in 1991 after organizers for the UN Conference on Environment and Development (held in Rio de Janeiro in 1992) asked whether or not ISO would be attending the conference and whether it was involved in any environmental activities. As a result, the ISO established a Strategic Advisory Group on the Environment (SAGE) in 1991 to assess the need for international environmental management standards.3 SAGE recommended that ISO proceed with an environmental standard by 1992 and that a technical committee be established to carry it through. On June 1, 1993, ISO’s Technical Committee 207 (TC 207) held its first plenary meeting.
TC 207 was directed to establish environmental standards in five areas of environmental management: - environmental management systems; environmental auditing and related - environmental investigation; environmental labeling; environmental performance evaluation; and life-cycle assessment.
Consequently, TC 207 was divided into five subcommittees (SCs) for each category of standard and one SC to cover the terms and definitions of the standards. In addition, a working group, which reports directly to TC 207, was formed to deal with the environmental aspects in product standards. The five SCs have two or more working groups (WGs) that report to them (unlike the WG on product standards previously mentioned which reports directly to TC 207).
The key factor that has propelled the ISO 14000 series of standards forward throughout the early 1990s is the increase in national environmental standards. Examples of these standards include some two dozen eco-labeling schemes worldwide (see Annex 1), the British Standards Institute’s BS 7750 (Specification for Environmental Management Systems), the Canadian Standards Association’s Z750 (A Guide for a Voluntary Environmental Management System), and the EU EMAS (Eco-Management and Audit Scheme). Other similar environmental management standards have been developed by the French Standards Association, the South African Bureau of Standards and the Spanish Standards Association.
With the proliferation of environmental standards, concerns have been expressed that these standards would fragment international markets and unduly favor the companies of the countries or of the regions where these standards were developed, unless they were developed by authoritative and broadly based international bodies. The ISO was to serve this role.
