Quality System Extension.png
Quality System Extension.png

Quality System Extension

$6,000.00

An extension to complete the Quality System Starter Package. This documentation package provides the remaining Standard Operating Procedures and accompanying forms and templates to complete an ISO 13485-compliant Quality Management System (see the full list below).

An extension to complete the Quality System Starter Package. This documentation package provides the remaining Standard Operating Procedures and accompanying forms and templates to complete an ISO 13485-compliant Quality Management System (see the full list below).

Recommended Add Ons:
Complete Quality System
Complete Quality System
$8,000.00
Regulatory Support or Submission
Regulatory Support or Submission
$0.00
Quality System Starter
Quality System Starter
$3,000.00
Complete Development Package
Complete Development Package
$0.00

Standard Operating Procedures and supporting documents are included:

  • Control of Inspection, Measurement, Manufacturing, and Test Equipment

  • Supplier Management

  • Material Receiving and Verification of Purchased Products

  • Receiving and First Article Inspection

  • Purchasing Controls

  • Identification and Traceability

  • Material Transfer, Storage, and Control

  • Shipping and Distribution

  • Sterilization

  • Lot Release

  • Corrective and Preventive Action

  • Returned Goods Authorization

  • Complaint Handling

  • Quality Audits

  • Production and Process Controls

  • Process Validation

  • Statistical Techniques

  • Control of Nonconforming Materials

  • Customer Order Fulfillment

  • Clinical Adverse Events Management

  • Clinical Operations Procedure

  • Postmarket Surveillance