- STORE
- >
- ISO 13485 QUALITY SYSTEM PROCEDURES
- >
- ISO 13485 MANAGEMENT RESPONSIBILITY PROCEDURES
- >
- Management Review Procedure | ISO 13485 | FDA QSR Compliant
Management Review Procedure | ISO 13485 | FDA QSR Compliant
$119.00
$119.00
Unavailable
per item
The ISO 13485 Management Review Procedure governs the management review process, management responsibilities, review inputs and outputs, review schedule and includes standardized forms to support all management review activity.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- Management Review Forms
- MS Word Format
- Digital Content - Instant Download
SKU:
SOP 5-001
Management Review ProcedureThe Management Review Procedure governs the management review process, management responsibilities, review inputs and outputs, review schedule and includes standardized forms to support all management review activity.
Management Review Procedure - OverviewThe Management Review Procedure covers the review of the suitability, adequacy and effectiveness of the quality system at defined intervals to ensure the quality system satisfies the requirements of 21 CFR Part 820, ISO 13485:2016 and MDR 2017/745. The Management Review Procedure includes multiple forms that address each element to be reviewed.
Management Review Procedure - ComplianceThe Management Review Procedure is ISO 13485:2016, MDR 2017/745 and FDA 21 CFR Part 820 complaint.
To learn more about our ISO 13485 Management Review Procedure contact us at [email protected]
RELATED LINKSMedical Device Quality Management System BASE
Medical Device Quality Management System BASE PLUS Medical Device Quality Management System DESIGN Medical Device Quality Management System DESIGN PLUS Medical Device Quality Management System MANUFACTURING Medical Device Quality Management System MANUFACTURING PLUS |
|
Customer's also viewed
Internal Audit Procedure | ISO 13485 | FDA QSR Compliant
$99.00
The ISO 13485 Internal Audit Procedure defines the process, methods and cycle for conducting internal audits.
- ISO 13485:2016
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
Complaint Handling Procedure | ISO 13485 | FDA QSR Compliant
$149.00
The ISO 13485 Complaint Handling Procedure governs the process for receiving, reporting, investigating, documenting and closing medical device complaints.
- Comprehensive Complaint Data Capture Form
- Includes Decision Trees (FDA MDR, Canadian, European)
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- MS Word Format
- Digital Content - Instant Download
Complaint Trending Procedure | ISO 13485 | FDA QSR Compliant
$99.00
The Complaint Trending Procedure defines the process utilized to analyze trends in complaint data, describes statistical techniques that can be used during data analysis, and provides instruction on the establishment of alert and action limits to the complaint handling process.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- MS Word Format
- Digital Content - Instant Download