Maps to
QMSR / ISO 13485: §820.186
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.
What changed
This is one of the most significant new requirements for companies transitioning from Part 820 to the QMSR. Part 820 had no requirement for a quality manual. Companies were required to have a quality system, documented procedures, and various records, but there was no mandate to produce a single overarching document describing the QMS scope, structure, and process interactions. Many Part 820-only companies simply do not have a quality manual.
ISO 13485 section 4.2.2 requires the organization to establish and maintain a quality manual that includes: (a) the scope of the QMS, including details of and justification for any exclusions, (b) the documented procedures established for the QMS or reference to them, and (c) a description of the interaction between the processes of the QMS. The QMSR codifies this as 820.186, making it an explicit FDA requirement for the first time.
The quality manual serves a structural purpose that goes beyond documentation — it forces the organization to articulate how its QMS works as a system rather than a collection of independent procedures. The process interaction requirement (often implemented as a process map or turtle diagram) reveals gaps in process linkages that individual SOPs cannot show. For example, many companies have a CAPA SOP and a Management Review SOP but have never documented how CAPA trending feeds into management review inputs.
For Part 820-only companies, creating a quality manual from scratch is not trivial but is well-understood work. The document itself is typically 15-30 pages. The harder part is defining justified exclusions (e.g., if the company does not manufacture sterile devices, section 6.4.2 contamination control requirements can be excluded with justification) and documenting process interactions that may never have been explicitly mapped. Companies that are also ISO 13485 certified already have a quality manual and need only verify it references QMSR-specific requirements like UDI and the FDA-plus elements.
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.
- •The quality manual must describe the interaction between QMS processes using a process map, turtle diagram, or equivalent representation that shows how process outputs flow as inputs to other processes.
- •Any exclusions from ISO 13485 requirements must be justified in the quality manual with documented rationale, and exclusions may only be made from clauses that do not affect the organization's ability to meet applicable regulatory requirements.
- •The quality manual must identify the organizational structure and define authorities and responsibilities for quality management system functions.
- •The quality manual must be reviewed and updated whenever significant changes occur to the QMS, regulatory requirements, or organizational structure.
Common gaps
No Quality Manual Exists
majorThe organization has SOPs, work instructions, and quality records but has never produced a quality manual as a standalone controlled document. This is a binary gap — the document either exists or it does not.
QMS Scope and Exclusions Not Documented
moderateEven companies with a quality manual or quality policy document have not formally documented the scope of their QMS — which products, sites, and processes are covered — and have not justified any exclusions from ISO 13485 requirements.
Process Interaction Map Missing
moderateThe quality manual exists but does not describe how QMS processes interact with each other. Individual SOPs exist in isolation without documented linkages showing how outputs of one process (e.g., complaint data) feed as inputs to another (e.g., CAPA, management review, risk management updates).
Missing 'Interaction of Processes' map
moderateThe manual lists SOPs but doesn't have a visual or textual 'Process Map' showing how inputs from one (e.g., Design) become inputs for another (e.g., Production). ISO 13485 §4.2.2 requires this description.
Incomplete scope / exclusions
moderateThe manual fails to explicitly define the 'Scope' or justify 'Exclusions' (e.g., 'We don't do design'). ISO 13485 §4.2.2 requires documented scope and rationale for exclusions.
Evidence signals
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FILE_EXISTS
(Quality.*Manual|QMS.*Manual|Quality.*System.*Manual)
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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.