EZ Quality System

Image displaying three categories with numbers: 'Quality Manual' with 1, 'FDA Systems' with 6, and 'Key Elements' with 59.
A donut chart showing six categories: Quality System, Facilities & Equipment, Materials System, Production System, Packaging & Labeling, Laboratory Control, with varying segment sizes.
A four-tiered pyramid diagram showing levels of a quality management system: Level 1 - Quality Manual, Level 2 - Policies, Level 3 - SOPs (Rep. + Sub), Level 4 - Specs, Protocols, Plans, & Forms.

The 4-Layer Architectural Hierarchy

Just as a skyscraper requires a solid foundation, a quality system needs a logical structure. We organize 59 key elements into 4 robust layers, creating a "Granular Control Matrix".

Level 1: Quality Manual

The 'Constitution' of the system. It defines the overall scope and management responsibility. This is the Single Source of Truth governing the entire ecosystem.

Level 2: Policies

Strategic declarations defining 'What we do' to ensure compliance. There are 59 policy documents, one for each key element.

Level 3: SOPs (Rep.+Sub)

Standard Operating Procedures. Includes Representative SOPs (Process Flows) and detailed Sub-SOPs.

Level 4: Records & Evidence

The concrete evidence of execution. Includes Specifications, Validation Protocols, Plans, and Recording Forms.