Tatiana HürlimannHow to run your ISO 9001 audit1. Familiarize Yourself with ISO 9001 Standards: Understand the requirements of ISO 9001 and how they apply to your organization.Jul 21, 2023Jul 21, 2023
Tatiana HürlimannBusiness processes and their managementProcess Management is a very exciting and fulfilling task. But what kind of processes are there? Here are some common examples:Jul 21, 2023Jul 21, 2023
Tatiana HürlimannRisk scores in a hazard matrixThe GAMP5 methodology is used for assessing hazards including hazard matrixes for the risk score and risk class. Here are few examples of…Jul 21, 2023Jul 21, 2023
Tatiana HürlimannControl the impact of changeChange Management is an important part of the daily operations. Here are some examples of Changes Control:Jul 21, 2023Jul 21, 2023
Tatiana Hürlimann20 tips for an efficient Document ControlEffective document control is essential for maintaining quality management processes. Here are 20 detailed tips to improve document control…Jul 21, 2023Jul 21, 2023
Tatiana HürlimannNon-Conformities, Deviations, and Non-ConformanciesNon-conformities, deviations, and non-conformancies are terms used in various contexts to describe instances where something does not meet…Jul 21, 2023Jul 21, 2023
Tatiana HürlimannExamples of CAPAs: Corrective and Preventive Actions1. Conducting an internal investigation to identify the root cause of a product failure and implementing corrective measures to address the…Jul 21, 2023Jul 21, 2023
Tatiana HürlimannMedical Quality and ComplianceMedical devices play a critical role in the healthcare industry, ranging from simple tools like thermometers to advanced equipment like MRI…Jul 21, 2023Jul 21, 2023
Tatiana Hürlimann50 features of a professional Quality Management Software1. Document Control: A professional Quality Management System (QMS) ensures effective document control, including version control, approval…Jul 21, 2023Jul 21, 2023