$247 — Standard Tier

Manufacturing Process Control Toolkit: FDA 820.70 + ISO 13485 Templates

Manufacturing Process Control Toolkit — process control procedure, batch record (DHR), in-process inspection checksheets, SPC control charts, equipment qualification, and environment monitoring.

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What's Included

Manufacturing Process Control Procedure (21 CFR 820.70 + ISO 13485 Section 7.5)
Production Batch Record Template (Device History Record)
In-Process Inspection Procedure and Checksheet Template
Statistical Process Control (SPC) Implementation Guide and Control Chart Templates
Equipment Qualification and Calibration Control Procedure
Production Environment Monitoring and Control Procedure

Benefits

Process control procedure covers all 21 CFR 820.70 and ISO 13485 Section 7.5 requirements
DHR batch record template includes all required 21 CFR 820.184 fields
SPC guide covers control chart selection, control limit calculation, and special cause detection rules
Equipment qualification procedure covers IQ/OQ/PQ with calibration interval and OOC response

Is This For You?

This toolkit is designed for teams facing these challenges:

FDA 483 observation for inadequate manufacturing process controls documentation
Device History Records missing required fields for 21 CFR 820.184 compliance
No statistical process control program to detect manufacturing process signals
Equipment calibration program missing out-of-calibration impact assessment procedure

Who This Is For

Manufacturing engineers building production control documentationQA managers implementing ISO 13485 Section 7.5 production controlsOperations directors establishing DHR and batch record systemsQuality engineers implementing SPC in medical device manufacturing

Frequently Asked Questions

What is a Device History Record (DHR)?

The DHR is the collection of records containing the production history of a finished device. FDA 21 CFR 820.184 requires DHR procedures and records including manufacture date, quantity, acceptance records, labels, and device identification.

Is SPC required for medical device manufacturing?

Not explicitly required, but ISO 13485 Section 8.4 requires analysis of process performance data. SPC is widely expected as evidence of a controlled manufacturing process during audits.

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Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $247

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