What is Quality System Regulation (QSR)?

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Quality System Regulation Definition

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. Quality systems for FDA-regulated products are known as current good manufacturing practices (CGMPs).

FAQs

What is QSR in manufacturing?

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.

Source: https://www.complianceonline.com

What does QSR stand for in medical devices?

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

What is a QSR FDA?

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.

What does QSR apply to?

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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