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ISO 9000 Frequently Asked Questions
ISO 9000 is an international family of generic quality standards, originally published by ISO (International Organization for Standardization) in 1987, updated in 1994, and again in 2000. It has currently been adopted by over 100 nations. It has been embraced by the European Union and by the U.S. as ANSI/ASQC Q9000, has been accepted by the U.S. Department of Defense and NASA, and has been incorporated into FDA and NATO standards. It is also the foundation for many industry-specific standards, such as QS-9000 for the automotive industry. This international standard specifies elements necessary for the foundation of a quality management system, but does not specify how the requirements are to be implemented. It does not replace product safety or regulatory standards and requirements. What are the significant changes in ISO 9001? The ISO 9001 changes include: focus on a process approach, including a process model; more consistent terminology; enhanced compatibility with ISO 14000; continual improvement of the quality management system; and significant emphasis on achieving customer satisfaction by meeting customer requirements. How do I get started implementing ISO 9001? Successful companies start an ISO 9001 implementation process with management commitment. A typical schedule for implementation ranges from 12 to 15 months. Learn more about the STAT-A-MATRIX 14-Step Implementation Process. What are the benefits of ISO 9001 registration? ISO 9001 helps meet customer requirements, enhances company image, reduces multiple audits, and provides a basis for quality improvement. If you export to Europe, registration will help you comply with European Union directives. What's the role of the registrar? A registrar is an impartial independent auditing body who evaluates your company against a given quality standard, for example, ISO 9001. Registrars are the only accredited body capable of providing a company with ISO 9001 registration. A list of registrars is available from ASQ by calling 1-800-248-1946. What's the difference between a lead and an internal auditor? Lead auditors and auditors are trained to audit both suppliers and facilities outside their own organizations (also known as second- and third-party audits) as well as elements within their own organization. Internal auditors are trained to audit their company's internal systems only (first-party audits). How does ISO 9000 compare with the FDA's Medical Device Quality System Regulation? FDA's Medical Device Quality System Regulation includes elements from ISO 9000 as well as other international standards. The Medical Device Quality System Regulation is mandatory as stated by the FDA, while ISO 9001 is a voluntary quality management system. Click here for more information on training programs for FDA-regulated industries. How does ISO 9000 compare with QS-9000, AS9100, and TL 9000? All of the elements of ISO 9001 are contained
in QS-9000, AS9100, and TL 9000; however, QS-9000
also contains additional elements specific to
the automotive industry, AS9100 has specific
aerospace requirements, and TL 9000 is customized
for the telecommunications industry. Also, QS-9000
is built around ISO 9001:1994, and there are
no plans to update it, since eventually it will
be replaced by ISO/TS 16949, which incorporates
several European automotive standards. What's the difference between CQA (certified quality auditor) and registered lead auditor status? If you have completed CQA training and passed ASQ's CQA exam, you will be certified by the ASQ as a quality auditor. To be a registered lead auditor, you must first take a five-day approved training program, pass the necessary exam, and then apply to the RABQSA or IRCA for certification as a registered lead auditor. Note: To attain registration as a lead auditor, you must pass the written final exam, earn a passing grade in the course's continuous assessments, and meet prescribed professional requirements, which include conducting a number of actual audits. To become an auditor for an automotive registrar, additional training is required. What's the difference between ISO 9000 and business process improvement? Business process improvement deals with the overall business systems of an organization, and can include an ISO 9001 quality management system. Business process improvement, such as Six Sigma, is a natural next step after ISO 9001 implementation. What's the difference between STAT-A-MATRIX ISO 9000 programs and others? Being one of the first U.S. companies to offer courses registered and certified by RABQSA and IRCA, we have trained more auditors than any organization in the world. In addition, our consultants average over 25 years of industry experience, giving them the ability to provide practical solutions to real-world issues. What training courses do you offer for ISO 9000? STAT-A-MATRIX offers a complete line of ISO 9000 programs, including RABQSA-certified lead auditor training and internal auditor training, as well as documentation, implementation, and other specialized programs.
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