Standard Issues


Standards Outlook: Trust, but Verify

by Russell, J.P.

Grouping product, service and process audits together is somewhat natural, because a process audit may include a product or service audit. I’ve dubbed the combination a verification audit....

Standards Outlook: Remaining Relevant

by West, John E. "Jack"

Without changes, ISO 9001 risks becoming irrelevant on the world stage. So, what new ideas should be included in the next edition?...

Standards Outlook: The Right Approach

by Liebesman, Sandford

The process approach is at the heart of a quality management system (QMS) defined by ISO 9001. And, as everyone knows, it’s necessary to have the old ticker checked out from time to time....

World of Confusion

by Schnoll, Les

U.S. manufacturers of medical devices must comply with U.S. Food and Drug Administration (FDA) labeling requirements and also face the challenge of labeling in multiple languages if they want to sell their products in the global marketplace....

Standards Outlook: Revised AS&D Standards Take Flight

by Cressionnie, L.L. “Buddy”

The International Aerospace Quality Group has released the IAQG 9100:2009 aviation, space and defense standards in all three of its sectors....

Standards Outlook: Effective Audit Programs

by Russell, J.P.

Today's organizations need to be agile and responsive to the changing requirements in private and public business sectors. Properly directed, internal audit program resources can help an organization stay focused and uncover improvement opportunities....

Standards Outlook: Major Upgrades

by Reid, R. Dan

The new fourth edition of the Chrysler, Ford and General Motors (GM) Potential Failure Mode and Effects Analysis (FMEA) Reference Manual, which was released last year, is a significant upgrade from the third edition published in 2001....

Standards Outlook: Dynamic Duo

by Liebesman, Sandford

Lean and Six Sigma are two methods aimed at improving the quality of an organization’s operations and its financial results. Both concentrate on customer satisfaction and improved business performance....

Open Access

Standards Outlook: To Launch or Not to Launch

by Schnoll, Les

Having quality professionals on medical device product development teams eliminates last-minute conflicts....

Standards Outlook: Risk and Quality Management

by Gordon, Dale K.

The media has made all of us aware of the global financial crisis caused by the assumption of risk by banks and speculators in stocks and commodities....

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