Maps to
FDA QMSR (Part 820): §820.70
ISO 13485: ISO 13485 §7.5.1
Requirement text
Production and service provision shall be carried out under controlled conditions, including availability of documented information defining product characteristics, work instructions where necessary, use of suitable equipment, implementation of monitoring and measurement activities, and implementation of product release and delivery activities.
Atomic constraints
- •Work instructions must be documented and available at the point of use for all production operations.
- •Production procedures must define the sequence of operations, materials, equipment, and acceptance criteria.
- •Product release procedures must define the authorized release activities before distribution.
- •Production records must be maintained demonstrating process execution per defined procedures.
- •Production monitoring and measurement activities must be implemented per the quality plan.
Evidence signals
- •
FILE_EXISTS
(Work.*Instruction|WI-|Production.*SOP|Manufacturing.*Procedure|Release.*Procedure|Batch.*Record)
- •
CONTENT_MATCH
Does this document describe production work instructions, manufacturing steps, production monitoring activities, or product release authorization procedures?
Audit defense
Production of [your product] is controlled through documented work instructions and procedures in [your document ID]. Each production operation has documented work instructions available at the point of use, and product release is authorized only after review of all required acceptance records per QMSR 820.70.