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QMS 101: Quality Management System Guide

Dot Compliance

Quality Management System Examples. Quality Management Systems, ISO 9001:2015. An international standard for Quality Management systems is ISO 9001:2015. (or One of the worldwide quality standards in the ISO 9000 family, ISO 9001:2015, is regarded as the most extensively used method for quality management systems.

FDA 52
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SQA Regulatory Surveillance Summary for January and February 2024

SQA

Additional findings included concerns with respect to document control, records management, and lack of compliance with Standard Operating Procedures (SOPs). In addition, SOPs did not align with specified requirements and did not have a standardized format.

FDA 40