21 CFR 820.20 - Management Responsibility (QMSR)

What it says

Management with executive responsibility must establish and communicate a quality policy and objectives, define organisational structure and authority relationships, provide adequate resources, and conduct periodic management reviews of the quality system's continuing suitability and effectiveness.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This provision parallels EU GMP Chapter 1's placement of ultimate quality system responsibility on senior management, reflecting a shared underlying principle now more explicitly aligned across drug, device and EU frameworks following QMSR's adoption of ISO 13485:2016.
• Management review is a defined, required activity under this provision specifically, not simply implied by general management oversight, requiring documented evidence that executive management genuinely engaged with quality system performance.
• Adequate resourcing of the quality function is named explicitly as an executive management responsibility, meaning chronic under-resourcing can itself become a citable management responsibility gap, not just a downstream symptom of other problems.

What FDA inspectors look for

• Whether management review meetings occur on schedule and show genuine engagement with quality data, rather than functioning as a reporting formality.
• Whether the quality function is resourced adequately relative to the organisation's actual scale and complexity.
• Whether the documented quality policy and objectives are genuinely understood and referenced by personnel throughout the organisation, not just published without practical integration.

Related regulations