ISO 9001 > FAQ

ISO 9000 is an international family of generic quality standards, originally published by the International Organization for Standardization (ISO) in 1987, updated in 1994, and again throughout the years (up to 2009). It has currently been adopted by more than 175 nations. It has been embraced by the European Union and by the United States as ANSI/ASQC Q9000 and has been recognized by the U.S. Department of Defense and NASA.

It also is the foundation for many industry-specific standards, such as ISO/TS 16949 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.

Successful companies start an ISO 9001 implementation process with management commitment. A typical schedule for implementation ranges from 6 to 12 months.

ISO 9001 helps meet customer requirements, enhances company image, reduces multiple external audits, and provides a basis for quality improvement. If you export to Europe, registration will help you comply with European Union directives.

A registrar, or certification body, is an impartial independent auditing body that evaluates your organization’s management system against a given quality standard (e.g., ISO 9001 or ISO 14001). Certification bodies provide successfully assessed organizations with a certificate of registration to the applicable standard. A list of accredited certification bodies is available from the American National Accreditation Body (ANAB) at www.anab.org.

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).

The U.S. Food and Drug Administration’s Medical Device Quality System Regulation includes elements from ISO 9001 as well as from other international standards. The Medical Device Quality System Regulation is mandatory as stated by the FDA, whereas ISO 9001 is a voluntary quality management system. Click here for more information on training programs for FDA-regulated industries.

All elements of ISO 9001 are contained in AS9100 and TL 9000; however, AS9100 has specific aerospace requirements, and TL 9000 is customized for the telecommunications industry.
Click here for more information on TL 9000.
Click here for more information on AS9100.

If you have completed CQA training and have passed ASQ's CQA examination, you will be certified by the ASQ as a quality auditor. To be a registered lead auditor, you must first take a 5-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 several actual audits. For those wishing to achieve lead auditor certification within the automotive or aerospace industry, additional requirements apply.

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.

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 more than 25 years of industry experience, giving them the ability to provide practical solutions to real-world issues.