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WELCOME: We specialize in helping our clients develop, implement and maintain effective quality management systems. We have particular expertise in the ISO 9000 registration process.Our philosophy is that an effective quality management system should be based upon an existing management structure, and should not be a source of bureaucracy, excessive paperwork or lack of flexibility.Our "hands-on" approach goes well beyond the awarding of a registration certificate, to developing a simple and manageable quality system, which will provide the maximum benefit for the organization.WHAT IS: ISO 9000 is a series of international quality standards and guidelines, issued by the International Organization for Standardization in Geneva, Switzerland. The standards were designed with the aim of ensuring that any organization, regardless of size, can consistently deliver the product or service that meets their customer's quality expectations.ISO 9000 is a practical tool to assist users in assuring the quality of their product or service. Like all ISO standards, its use is voluntary - unless a business sector makes it a market requirement, or unless a government issues regulations making its use obligatory. Therefore, organizations that implement ISO 9000 voluntarily are only doing so because they expect the standard to help them to do things better - and to provide real benefits.The requirements of ISO 9000 are simply good business management practices, which when implemented provide a framework for taking a systematic approach to managing your organization's activities. The requirements are completely generic. Since most of us like to think that our business is unique, it is essential that an international quality standard allow for the diversity of all types of organization, large or small, product or service, public or private. ISO 9000 lays out what the requirements are for developing a quality management system, but it does not dictate how those requirements must be met.9001, 9002, 9003 - The Numbers Explained!Within the ISO 9000 series, there are three different "models" against which organizations can be certified. The difference is simply one of scope:-ISO 9001 sets out the requirements for an organization whose business processes range all the way from design and development, to production, installation and servicing; - or an organization which does not carry out design and development, ISO 9002 is the appropriate standard, since it does not include the design control requirements of ISO 9001 - otherwise, its requirements are identical; - ISO 9003 is the appropriate standard for an organization whose business processes do not include design control, process control, purchasing or servicing, and which basically uses inspection and testing to ensure that final products and services meet specified requirements. ISO 9003 includes approximately 80% of the requirements of ISO 9001WHY: Every organization has a quality system, many without realizing it. Organizations exist to provide a product or service, and each has its own method of satisfying customers. The term "Quality" in ISO 9000 refers to all of the features of the product, or service, which are required by the customer. Any organization which has dissatisfied customers, runs the risk of losing the very reason for its existence! To keep customers - and keep them satisfied - the organization's product or service needs to meet their requirements.Although the majority of organizations initially consider registration for external reasons, i.e. customer demands, our experience continues to show that the internal benefits far outweigh the external benefits.Internal benefits include:-Clearly defined responsibilities and authorities -Documented policies and procedures -Heightened awareness of company objectives -Improved internal communications -Improved trace ability to "root causes" of quality problems -Documented system is invaluable training tool -Improved control during periods of growth or change -Continuous quality assessment by experienced professionals -Improved records in case of litigation -External benefits include:-Formalized systems resulting in consistent quality of service-Enriched relationships with customers and suppliers -Enhanced organizational quality image -Access to new markets both domestic and internationalPROCESS: It has often been said that, in order to achieve ISO 9000 registration, an organization must:Say what you do Do what you say Prove it! To "say what you do," an organization must formally document its quality system policies and procedures. To "do what you say," the organization should carry out its internal processes as laid out in its policies and procedures. Finally, to "prove it," the organization must successfully demonstrate that it operates to these policies and procedures to an independent audit team, or "registrar".From the time the decision is made to proceed with registration, the organization could be ready for the registrar audit within a timeframe of eight months to two or more years. Our clients typically achieve registration in less than one year. (A registrar is an independent organization that has been accredited to perform ISO 9000 quality system audits and issue registration certificates.)The majority of work in preparing for registration involves documenting the quality management system. Approximately 60-70% of the documentation will relate to existing internal processes. The balance of the documentation will relate to additional requirements under ISO 9000, such as the process for conducting internal audits, taking corrective and preventative action, and controlling quality system documentation. Once the documentation is complete, the organization should conduct internal audits, the results of which must be reviewed by management who should respond by making corrections and improvements to the system.Approximately six weeks prior to the registrar audit, the registrar's auditors will perform a "desk audit" of the organization's quality system documentation, by comparing it to the requirements of the ISO 9000 standard. Any deficiencies will be noted and must be corrected. During the registration audit, the audit team will come on site to interview the organization's personnel and review records, to determine if the documented quality system is properly implemented. A successful audit results in the issuance of a registration certificate.An experienced consultant can apply years of knowledge to help in the development and implementation of an effective quality system, deriving maximum benefit for the organization.APPROACH:The Eden approach to developing a quality management system is very much "hands-on", and involves working closely with the client to develop comprehensive flowcharts and procedures to document internal processes. The benefits of this approach are many:Documenting procedures can be time-consuming and frustrating, and there are many questions to be answered. What exactly needs to be documented? How detailed should the procedures be? How can existing documentation be incorporated into the system? These questions can be difficult to answer without expert knowledge. Our "hands-on" approach results in a professionally documented quality system, which clearly reflects the day-to-day processes of the organization Our clients typically achieve successful registration sooner than they would if the documentation was produced internally. We manage the project in its entirety, which substantially reduces the workload and resulting frustration that can occur when working on such a project internally. Many of our clients achieve registration with a "flawless" initial audit, without the need for the extra expense of a pre-assessment with the registration. Our support during the development of an ISO 9000 quality management can be tailored to meet the needs of any service-related organization. Our experienced associates can:Provide overview training Conduct Gap Analysis to establish level of compliance to appropriate standard Develop approach based on a process/element matrix Develop detailed implementation plan with Gantt chart and defined goals Facilitate Registrar Selection Compile flowcharts of existing processes
Develop Level II Procedure Identify necessary Level III Instructions & Forms Assist in implementation of quality systems documentation Provide ongoing support throughout the process Develop the Level I Quality Manual Conduct training of Internal Audit Team Coordinate internal audit, analyze results and provide feedback Establish guidelines for Management Review and facilitate meeting Support client on-site during registration audioSUPPORT: Achieving ISO 9000 registration should not be seen as the end of a process, but rather, the beginning. A successful registration audit confirms that the organization has in place a fundamentally sound quality management system. As the system matures, the organization should begin to reap the benefits of implementing the system.Many of our clients take advantage of our ongoing support services, which include:Coordination and support of the Internal Audit Process Periodic Training needs assessments Input into Management Review meeting Customer Satisfaction surveys Employee feedback surveys Documentation updates
CONTACT US: Eden Associates96 Townsend AvenueBurlington, OntarioCanadaL7T 1Y7Telephone: (905) 632-0002Toll-free: 1 888 263-EDEN(1 888 263-3336)Fax: (905) 632-3425e-mail: mail@edenassociates.com
<a href="welcome.htm">Welcome</a>
<a href="iso.htm">What is ISO</a>
<a href="why.htm">Why Get Registered</a>
<a href="the.htm">The Process</a>
<a href="approach.htm">The Eden Approach</a>
<a href="success.htm">Success Stories</a>
<a href="faq.htm">F.A.Q.'s</a>
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