Standard Issues

2020

Standard Issues: Auditing the Virtual Environment

by Lopez, Herick

Virtual environments are here to stay, therefore auditing activities should recognize the challenges that such environments pose to audit objectives. ISO 19011:2018—Guidelines for auditing management systems introduces the concept of virtual auditing....


Standard Issues: An Essential Ingredient

by Cressionnie, L.L. “Buddy”

Quality management system (QMS) effectiveness is directly tied to an organization’s culture. Some readers will vigorously disagree and search for the word “culture” in ISO 9001. It appears in clause 4.1, note 3....


Standard Issues: The Future of Management Systems

by Reid, R. Dan

ISO has published about 23,000 documents covering almost every industry. As the organization says, “ISO international standards impact everyone, everywhere.” ISO now has published more than 70 management system standards....


Standard Issues: Context Is Key

by Cianfrani, Charles A.; Sheps, Isaac; West, John E. “Jack”

To enable sustained success, an organization must determine the external and internal issues, and its interested parties that are relevant to its purpose and strategic direction, and that affect its ability to achieve its intended results....


Standard Issues: Fundamental to Success

by Cressionnie, L.L. “Buddy”

ISO 9001:2000 was transformational with its introduction of the process approach. Now, almost 20 years later, some organizations still have not embraced the process approach, and some auditors aren’t auditing according to the process approach....


Standard Issues: Going Through Changes

by Mehta, Bob

When working in a highly-regulated environment such as the medical technology (med-tech) industry, there is one basic concept all quality and regulatory professionals can take to the proverbial bank: regulations will change....



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