Posts Tagged: ISO 9001 accreditation

2 Several elements of ISO 9001:2015 are already present in robust pharma quality systems included from regulations (domestic and international), regulatory guidance, best practices and industry expectations. Therefore, the focus of this article will not be how to incorporate ISO 9001:2015 into a pharmaceutical organizations quality system, but rather on supplier quality where ISO 9001:2015… Read Article →

The ISO/TC 176 quality management and quality assurance committee presented the 2015 revision as having neutral impact to organizations with quality management systems (QMS) using the 2008 version of the standard. The assumption here is that risk assessment of the QMS processes were intuitive, and the requirement is now more overt than covert in https://www.iso.org/higher-education-teaching-materi.html… Read Article →

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