Home » ISO 13485 Procedures Package
ISO 13485 Procedures Package
 Our set of ISO 13485 procedures is designed for you to use with your ISO 13485 Quality Management System. They are in Microsoft Word format and are ready to customize for your organization.
The procedures are available individually or as part of our Quality Manual and Procedure Package. These procedures have been designed to be integrated with our Quality Manual and Procedures.
Procedures Available Individually or in a package :
ISO 13485 Procedure & Forms Packages
Individual Procedure Packs - We give you more!
These individual Procedures Packs also include any forms referenced in the procedures. To see which forms are
included with specific procedures, please view the procedures-forms matrix:
Product Description |
Price |
AP-423
Document Control Procedure
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AP-424
Control of Quality Records Procedure
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AP-500
Management Responsibility Procedure  (sample)
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AP-622
Competence, Awareness and Training Procedure |
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AP-740
Purchasing Procedure
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AP-821
Monitoring, Measuring and Analysis of
Customer Satisfaction
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EP-630
Infrastructure Procedure
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EP-640
Work Environment Procedure
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EP-722
Risk Management Procedure
Read about Risk Management for Medical Devices
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EP-730
Design & Development Procedure
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MP-710
Planning of Product Realization Procedure
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MP-750
Control of Production & Service Provision Procedure
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MP-752
Validation of Processes for Product Procedure
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MP-753
Identification and Traceability Procedure
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MP-754
Customer Property Procedure
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MP-755
Preservation of Product Procedure
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MP-760
Control of Measuring & Monitoring Devices Procedure
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MP-824
Monitoring & Measuring of Product & Realization
Processes Procedure
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QP-821
Post Production Feedback Procedure
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QP-822
Internal Audit Procedure
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QP-830
Control of Nonconforming Product Procedure
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QP-840
Statistical Techniques Procedure
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QP-841
Root Cause Analysis Procedure
Root Cause Analysis Training
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QP-852
Corrective Action Procedure
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QP-853
Preventive Action Procedure
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QP-854
Product Recall and Advisory Notice Procedure
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SP-720
Customer Related Processes Procedure
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070-PROC
Procedure Package
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