ISO 9000 and Regulatory

What is ISO 9000-9001 certification? If you are involved in product development, sooner or later ISO 9000 certification will affect your organization. Your vendors or your customers may demand it, or you may conclude that your organization will gain a competitive advantage from operating under a quality plan. What is the certification process? How long does it take and how much does it cost? How will it affect your organization and the way you manage projects? Does it guarantee high quality and successful projects? Where do you get more information, help and advice, both from the standards bodies that administer ISO 9000 and organizations that have been through the process? And what is CE Mark certification for Europe -- is it the same thing? A separate effort? What is different about managing the development of products under regulatory control? What is safety-significant software and how do I manage its development? What tools and techniques are available to help me?

• If you're interested in IT Audit processes, procedures, and templates, check out the IT Audit Checklist Programme at AuditNet, which provides a very detailed 25-page IT audit checklist; and TDAN.com, which provides a list of IT audit-related resources, including links to various other checklists.
• To get some fundamental information about ISO 9000, visit the International Standards Organization's web site. Click on the "ISO 9000 and ISO 14000" and you'll be taken to an information page. Be sure to check out the "Magical Demystifying Tour of ISO 9000 and ISO 14000" for a good "big picture" overview discussion. Brochures on ISO 9000 can be downloaded. And there is information on how to obtain copies of the actual standards.
• The DocumentCenter web site has an extensive library of industry, government, and regulatory standards, many of which can be downloaded online. They also offer automatic update services for organizations that must keep their standards libraries current as part of their quality system compliance.
• Completion criteria are explicit goals that must be attained to call an element of a project, or the entire project, "complete." Completion criteria are really a communication tool and an important aspect of "quality management" on your project. They ensure the team agrees on when a particular activity or phase will be "done" and plans work, testing, and reviews accordingly.
• See our book recommendations for ISO 9000 and Regulatory.