ISO 13485:2016 Active
Guest
·
Role
v1.0
PUR-001
Purchasing Control 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
7.4
Category
Purchasing

Procedure for controlling the procurement of products and services that affect product quality, including supplier evaluation, risk-based classification, and approved supplier list management.

#purchasing#supplier#vendor#asl#iso-13485
Regulatory Standards
ISO 13485:201621 CFR Part 820EU MDR 2017/745

Revision History

VersionDateAuthorDescription
v1.0May 8, 2026Management RepresentativeInitial release — created in response to internal audit finding F-2026-Q1-003