Bison Stainless Tube LLC. is proud to announce it has successfully upgraded from ISO 9001:2008 to the new ISO 9001:2015 for the sales and distribution of stainless steel tubing. The first part of the process was to have an external Gap Analysis Audit to determine what additional processes and documents were required to meet the… Read Article →
Posts Tagged: ISO 45001
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 →
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 →