Monthly Archives: April 2017

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 →

According to the ASQ Global State of Quality 2 Research ( www.globalstateofquality.org ) study of nearly 1,700 companies in 20 countries, quality process-oriented companies are three times as likely to be identified as successful and half as likely to have customer service/quality disasters. So it is no surprise then that the worldas most popular quality… 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 →

To answer these questions, we must first and foremost understand that not all risk is equal. Additional wording was added to AS9100D and to the annex to highlight and acknowledge that the usage of risk within the standard varies depending on the stated requirements. While the risks are inherently related, their treatment can be significantly… Read Article →

In order to achieve ISO 9001:2015 certification, companies must demonstrate that they have implemented effective quality management systems, including strong customer focus and a process of continuous improvement across all areas of the business, including facilities, people, training, services and equipment. Felling Trailers certification process was carried out in partnership with Transpacific Certification LTD and… Read Article →

So it is no surprise then that the worldas most popular quality management standard, ISO 9001, has recently been updated as ISO 9001:2015 and this will be especially beneficial to government entities looking to increase their security. Today, as management system standards are updated, they are done so against Annex SL, also known as the… Read Article →

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