Maps to
FDA QMSR (Part 820): §820.186
ISO 13485: ISO 13485 §4.2.1 / 4.2.2
Requirement text
A quality manual must be established and maintained, covering the QMS scope with any justified exclusions, documenting or referencing required procedures, and describing the interaction between QMS processes.
Atomic constraints
- •A quality manual must be established and maintained.
- •The quality manual must define the QMS scope including any justified exclusions.
- •The quality manual must include or reference all required documented procedures.
- •The quality manual must describe the interaction between QMS processes.
- •The quality manual must be a controlled document subject to document control procedures.
Evidence signals
- •
FILE_EXISTS
(Quality.*Manual|QMS.*Manual|Quality.*System.*Manual)
- •
CONTENT_MATCH
Does this document describe the organization's quality management system scope, applicable exclusions, and references to quality procedures?
Audit defense
Our Quality Manual ([your document ID]) defines the scope of our QMS, identifies any justified exclusions from ISO 13485 or QMSR requirements, and references all required documented procedures. The process interaction map within the manual demonstrates how our QMS processes interconnect to ensure product conformity.