Items Tagged with 'ISO standards'

The 2012 edition acknowledged electronic records. The 2026 edition regulates them.

Organizations should begin discussions with their registrar now to better understand transition expectations, audit timing, and any additional documentation or review requirements that may be introduced during the transition process.

Overproduction ties up materials, time, and energy in inventory for which there is no immediate use.

Amtivo, a leading global provider of certification and assurance services, announced the appointment of Randy Daugharthy as President of Amtivo’s operations in the United States, effective immediately.

Traditionally, quality management focused on ensuring consistency, minimizing errors, and satisfying customer requirements. 

British Assessment Bureau, a leading UK-based certification body and part of Amtivo Group, announced plans to rebrand as Amtivo before the end of 2026.

Information about the updates to ISO 9001, ISO 14001, and ISO 45001 is becoming more accessible. Unlike past practices where drafts were kept secret until the FDIS, details are now emerging. Here’s what we know about the new Management System Standards so far.

The upcoming revision of ISO 10017: 2017 focuses on "Quality management — Guidelines for configuration management," aimed at maintaining consistency in a product’s functionality and characteristics throughout its lifecycle. The configuration management process includes five steps.

Sai Ranjith Ramakrishnan Kumar (Sai) is a medical device quality engineering expert, Six Sigma Green Belt Certified, and programs chair of ASQ Granite State Section. Quality talked with him about his contributions to advancing quality practices in industry and beyond, focusing on enhancing patient safety, ensuring regulatory compliance, and driving innovation in the profession.

This paper presents Method 5, which controls the Probability of False Acceptance using Specific Risk, and Method 6, the Managed Guard-Band Strategy by Michael Dobbert, using Global Risk. Choosing the right rule is essential for managing risk and improving measurement accuracy, with examples illustrating how these rules can reduce costs.