Calibration System Procedure | ISO 13485 | FDA QSR Compliant
- The ISO 13485 Calibration System Procedure establishes the process and methodology used to ensure medical device manufacturing and test equipment is calibrated to defined specifications. ISO 13485:2016 Compliant
- FDA QSR Compliant
- Includes Related Forms
- MS Word Format
- Digital Content - Instant Download
Calbration System ProcedureThe Calibration System Procedure establishes the process and methodology used to ensure medical device manufacturing and test equipment is calibrated to defined specifications.
Calibration System Procedure - OverviewThe Calibration System Procedure defines the process of entering equipment into the calibration system and establishing a calibration procedure for all calibrated equipment used in the manufacture or testing of medical devices. The Calibration System Procedure defines the process of establishing the calibration frequency and the requirements for re-calibration.
The Calibration System Procedure includes detailed form used to log equipment into the calibration system and for documenting calibration information in files established for all calibrated equipment. Calibration System Procedure - ComplianceThe Calibration System Procedure is FDA QSR and ISO 13485:2016 compliant.
To learn more about our Calibration System Procedure contact us at [email protected]
RELATED LINKS |
Calibration System Procedure
|
Customer's also viewed
Installation Qualification IQ Procedure | ISO 13485 | FDA QSR Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- Includes Related Forms
- MS Word Format
- Digital Content - Instant Download
Medical Device Quality Management System | DESIGN PLUS
The DESIGN PLUS Quality Management System (QMS) is configured for companies engaged in research and development of medical devices but perform no manufacturing (Specification Developers). The Design Plus QMS system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 46 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download
Medical Device Quality Management System | MANUFACTURING
The Medical Device Quality Management System | MANUFACTURING product is designed for companies engaged in both product development and the manufacture of medical devices. The system is rich in content and provides detailed instruction governing research and development, manufacturing and post commercialization activities. The system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 60 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download
Medical Device Quality Management System | MANUFACTURING PLUS
The Medical Device Quality Management System | MANUFACTURING PLUS System is our "top line" QMS product configured for companies engaged in the design and manufacture of medical devices seeking ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 72 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download