Supplier Management
What is Supplier Management?
The processes for managing supplier relationships, performance, contracts, and risks throughout the lifecycle of supplier engagements.
Terms that appear alongside supplier management
Each of these is named in at least one of the same controls as supplier management. The number is how many controls name both.
- audit 9 shared controls
- compliance 8 shared controls
- risk assessment 6 shared controls
- vulnerability 4 shared controls
- change control 3 shared controls
- software bill of materials 3 shared controls
- software bill of materials sbom 3 shared controls
- remediation 3 shared controls
Frameworks that govern supplier management
What the standards actually require on supplier management
Requirements naming supplier management across 6 standards, quoted from the control text.
Section 2.7 Management of Outsourced Activities + Section 2.8 Change in Product Ownership address external party arrangements which retain PQS responsibility with the marketing authorisation holder (MAH).
ICH-Q10-Section2-Outsourced-Ownership-Vendor-Supplier-CMO-CRO · ICH Q10 Section 2 - Outsourced Activities + Management of Materials + Change of Ownership + CMO + CRO + Supplier Management →ISO 13485:2016 Section 7.4 (Purchasing) - the supplier-management framework. (7.4.1) PURCHASING PROCESS - documented procedures for evaluation + selection + monitoring + re-evaluation of suppliers based on supplier's ability to supply product meeting requireme...
QMSR-ISO13485-Sec7_Purchasing · Purchasing controls + supplier management (ISO 13485:2016 Section 7.4) →Cybersecurity activities distributed between OEM, Tier 1, and lower-tier suppliers are managed through cybersecurity interface agreements (CIA) and joint assessments.
21434-Annex-E · Distributed Cybersecurity Activities and Supplier Management →Ensure that the organisation's suppliers and their performances are managed appropriately to support the seamless provision of quality products and services aligned with strategy.
GM-SUP-1 · Supplier Management →Per PIC/S GMP Chapter 7: outsourced activities. Requirements include (a) implement Outsourced Activities controls including written agreement + Quality Agreement + (b) qualify contract acceptors including initial + ongoing assessment + audits + (c) maintain co...
PICSGMP-7 · Chapter 7: Outsourced Activities and Supplier Management →Per MSA + best practice: Contractual Cascade to Suppliers + flow-down + supplier audits + remediation.
UKMSA-3 · Contractual Cascade and Supplier Management →Questions people ask about supplier management
What is Supplier Management?
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See how Supplier Management applies across compliance frameworks
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