• ISO 13485 QUALITY SYSTEMS
• ISO 13485 PROCEDURE BUNDLES
• ISO 13485 QUALITY SYSTEM PROCEDURES
  • ISO 13485 DOCUMENTATION REQUIREMENTS PROCEDURES
  • ISO 13485 MANAGEMENT RESPONSIBILITY PROCEDURES
  • ISO 13485 RESOURCE MANAGEMENT PROCEDURES
  • ISO 13485 PRODUCT REALIZATION PROCEDURES
    • ISO 13485 DESIGN DEVELOPMENT PROCEDURES
    • ISO 13485 PURCHASING PROCEDURES
    • ISO 13485 PRODUCTION SERVICE PROVISION PROCEDURES
    • ISO 13485 CONTROL MONITORING MEASUREMENT DEVICES PROCEDURES
  • ISO 13485 MEASUREMENT ANALYSIS IMPROVEMENT PROCEDURES
• VALIDATION PROTOCOLS
• CONTRACTS - AGREEMENTS

ISO 13485 Quality Management Systems | Section 7.5 | Production and Service Provision

ISO 13485 PRODUCTION SERVICE PROVISION PROCEDURES

Supplier Management Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Identification Procedure | ISO 13485 | FDA QSR Compliant

$99.00

$99.00

Lot Inspection Procedure | ISO 13485 | FDA QSR Compliant

$119.00

$119.00

Environmental Controls Procedure | ISO 13485 | FDA QSR Compliant

$119.00

$119.00

Installation Qualification IQ Procedure | ISO 13485 | FDA QSR Compliant

$119.00

$119.00

Validation Protocol and Report Procedure | ISO 13485 | FDA QSR Compliant

$99.00

$99.00

Controlled Environment Cleaning Procedure | ISO 13485 | FDA QSR Compliant

$49.00

$49.00

Sterile Load Preparation - Release Procedure | ISO 13485 | FDA QSR Compliant

$199.00

$199.00

Software Validation Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Ethylene Oxide EO Sterilization Validation Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Gamma Irradiation Sterilization Validation Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

First Article Inspection Procedure

$49.00

$49.00

Injection Mold Validation Procedure

$149.00

$149.00

Respiratory Protection Procedure

$149.00

$149.00

Biohazard Procedure

$149.00

$149.00

Lockout - Tagout Procedure

$149.00

$149.00

Line Clearance Procedure

$49.00

$49.00

Ethylene Oxide (EO) Product Adoption Protocol

$149.00

$149.00

Cleanroom Design and Validation Procedure

$149.00

$149.00

Device History Record Procedure

$149.00

$149.00

ISO 13485 Process Validation Procedure Bundle

$399.00

$399.00

Medical Device Process Validation Procedure

$149.00

$149.00