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Questions and Answers
What is the primary purpose of the Management Review procedure at Compass Health?
What is the primary purpose of the Management Review procedure at Compass Health?
Which document outlines the responsibilities of the Management Representative?
Which document outlines the responsibilities of the Management Representative?
Which of the following standards is NOT referenced in the Management Review SOP for Compass Health?
Which of the following standards is NOT referenced in the Management Review SOP for Compass Health?
What role does the Management Representative play in the quality management system?
What role does the Management Representative play in the quality management system?
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What is included in the scope of the Management Review procedure?
What is included in the scope of the Management Review procedure?
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What is the minimum frequency of Management Reviews at Compass Health?
What is the minimum frequency of Management Reviews at Compass Health?
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Who is minimally included in the Top Management at Compass Health?
Who is minimally included in the Top Management at Compass Health?
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Which element is NOT included in the agenda of a Management Review?
Which element is NOT included in the agenda of a Management Review?
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Who is responsible for compiling the agenda for Management Reviews?
Who is responsible for compiling the agenda for Management Reviews?
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Which statement correctly captures the outputs of the Management Review?
Which statement correctly captures the outputs of the Management Review?
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Study Notes
Compass Health SOP: Management Review
- This SOP outlines the process and responsibilities for conducting Management Reviews to ensure the continued suitability, adequacy, and effectiveness of the quality management system, quality policy, and quality objectives.
Scope
- This procedure applies to the quality management system, quality policy, and quality objectives at Compass Health.
Applicable Standards
- ISO 13485:2016 Section 5.6 Management Review
- FDA QSR § 820.20 Management Responsibilities
- TG (MD)R Sch3 P1 1.4
Reference Documents
- Quality Manual (QMS-MAN-0001)
Management Review Process
- Schedule: Reviews are conducted at least annually, more frequently if business needs or changes require it.
- Agenda: The agenda includes follow-up action items from previous reviews, review of quality policy and objectives (and proposed changes), feedback, complaint handling, reporting to regulatory authorities, and audits (internal, external, and supplier).
- Outputs: The review outputs are recorded in the meeting minutes, including a statement on the suitability, adequacy, and effectiveness of the Quality Management System. The record also includes decisions and action items related to improving the system.
Process Roles
- Management Representative: This member of management is appointed to ensure processes are established and maintained, and reports on QMS performance and areas needing improvement.
Acronyms and Definitions
- FDA: Food and Drug Administration
- CMDR: Canadian Medical Device Regulations
- TG(MD)R: Therapeutic Goods (Medical Devices) Regulations
Quality Objectives Form, Quality Policy, and Management Review Templates
- Compass quality policy document (QMS-QP-0001)
- Quality Objectives Form (QMS-FRM-0065)
- Management Review Meeting Minute Template (QMS-TMP-0655)
Revision History
- Version 1.0 was released on 03-Jan-2024.
Approvals
- Tenzin Yangzom (Head of QA/RA), Author, 02-Jan-2024
- James Baskin (COO), Approver, 02-Jan-2024
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Description
Test your knowledge on the Management Review procedures at Compass Health, including the roles of management representatives and the standards referenced in their SOP. This quiz covers the responsibilities and scope of management reviews, ensuring you understand the quality management system in practice.
