ISO 13485:2016 Active
Guest
·
Role
v1.0
DocumentsManagement ReviewMR-001
MR-001
Management Review Procedure
Approved
Version
v1.0
Effective Date
May 8, 2026
Classification
CONTROLLED DOCUMENT
Tier Level
Tier 2 — SOP/Plan
Author
Management Representative
Owner
Management Representative
ISO Clause
5.6
Category
Management Review

Procedure for planning, conducting, documenting, and following up on QMS management reviews per ISO 13485:2016 Clause 5.6. Addresses sole proprietor operation adaptations.

#management-review#sop#iso-13485#clause-5.6
Regulatory Standards
ISO 13485:201621 CFR Part 820

Revision History

VersionDateAuthorDescription
v1.0May 8, 2026Management RepresentativeInitial release — created in response to internal audit finding F-2026-Q1-001