Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.
Source: https://www.complianceonline.com
Quality System Regulation (QSR), also known as FDA 21 CFR Part 820, is a system that ensures that medical devices meet quality and safety requirements. These requirements are called current good manufacturing practices (CGMP).
Source: https://www.regdesk.co
The FDA’s quality system regulation (QSR) as defined in 21 CFR Part 820 states that manufacturers should establish and follow a quality system to help ensure that their products consistently meet applicable requirements and specifications.
The QSR applies to manufacturers in the United States and is created and managed by the FDA, while the ISO 13485 is a standard in the GMS which is used internationally. ISO 13485 is a voluntary standard, while the QSR is a mandatory regulation.
Source: https://www.regdesk.co
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