FDA QMSR Production and Service Provision Control Policy, SOP & Forms | qmsdoc.com

Production and Service Provision Control templates for FDA QMSR compliance.

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Aligned to ISO 13485:2016 §7.5.1 Control of Production and Service Provision.

What’s Included

Policy & SOP (Phase 3)

📄 MD-QMS-K7 Policy of Production and Service Provision Control
📄 MD-QMS-S701 SOP of Production and Service Provision Control
📄 MD-QMS-S704 Contamination Control Procedure

Production Forms (F701-01 to 21)

📄 F701-01 Manufacturing Work Order
📄 F701-02 Process Transfer Checklist
📄 F701-03 Product Document Checklist
📄 F701-04 Deviation Record
📄 F701-06/07 Initial Production Mgmt Plan/Review
📄 F701-08 Special Process Work Record
📄 F701-11 Manufacturing Material Removal Record
📄 F701-12 Improvement Activity Record
📄 F701-21 Lot Release Record
📊 F701 Production Control Forms (Excel)

Table of Contents (Policy Document)

Purpose / Scope / Normative References / Definitions
Control of Production
Control of Service Provision
Special Processes (Sterilization, Welding, etc.)
Process Validation Linkage
Contamination Control
Records & Lot Release
References / Supplementary Provisions

Aligned to 21 CFR Part 820 (QMSR) and ISO 13485:2016.

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Table of Contents — FDA QMSR Production and Service Provision Control Policy, SOP & Forms

Purpose
Scope
Definitions
Roles and Responsibilities
Procedure
References
Supplementary Provisions

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What’s Included

Policy & SOP (Phase 3)

Production Forms (F701-01 to 21)

Table of Contents (Policy Document)

📄 Preview the Document Before You Buy

Table of Contents — FDA QMSR Production and Service Provision Control Policy, SOP & Forms

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