ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
ISO 9001 provides a generic yet comprehensive structure on which organisations can establish processes to help achieve business objectives. It has received widespread global recognition with around one million certificates issued.
ISO 9001 compliant business management systems have been adopted across all industry types, from manufacturing through to professional service organisations.
ISO 22716 Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices
These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do they cover aspects of protection of the environment.
During this course, you will learn from the beginning the concepts that every employee from the pharmaceutical industry must know and comply with, since the compliance with GMP standards is the decisive aspect for the production of high quality products. Moreover, I will present the most important elements of a pharmaceutical system and the appropriate behaviors that must be followed.
The quality management standard EN 15224 was specifically developed for the healthcare system. For the first time since the publication in December 2012, there is a single European and sector-specific standard for the healthcare system.
It is aimed at medical practitioners, hospitals, and any institutions engaged in nursing or other health care.