Compass Health SOP: Management Review Process

Compass Health SOP: Management Review

• Purpose: This procedure 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 at Compass Health.

• Scope: This procedure applies to the quality management system, quality policy, and quality objectives at Compass Health.

Applicable Standards and Regulations

• 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

Revision History

• Version 1.0: Initial Release dated 03-Jan-2024

Management Review Process

• Schedule: Management reviews are conducted at least annually, but more frequently as needed based on business changes (facilities, key management, product changes).

• Agenda: The agenda includes follow-up actions, quality policy and objectives review, proposed changes, feedback, complaint handling, reporting to regulatory authorities, and audits (internal, external, and supplier).

• Outputs: Management Review outputs include a statement regarding the suitability, adequacy, and effectiveness of the quality management system and its processes, or actions needed for improvement, and a record of decisions, action items to maintain the suitability, adequacy, and effectiveness and improvement needed for product/service and customer requirements reflecting changes to regulatory requirements.

Process Roles

• Management Representative: A member appointed by top management responsible for ensuring quality management system processes are established, implemented, maintained, reporting on performance to top management, and identifying areas needing improvement. This includes liaison with external parties, such as third-party auditors and regulatory authorities.

• QA/RA (Head of QA/RA): Attends all Management Reviews, reviews presented data to assess the continued adequacy and effectiveness of the quality system, and identifies opportunities for improvement in the Quality Management System.

• Top Management: Includes Head of Product, COO, Engineering Lead, and CEO, and is responsible for ensuring the promotion and awareness of regulatory and customer requirements within Compass Health.

Acronyms and Definitions

• FDA: Food and Drug Administration
• CMDR: Canadian Medical Device Regulations
• TG(MD)R: Therapeutic Goods (Medical Devices) Regulations

Quality Objectives and Policy

• Quality Policy: Changes to Compass' Quality Policy proposed during the Management Review Meeting.
• Quality Objectives: New or modified quality objectives outlining for the meeting.

Management Review Meeting Materials and Formats

• Management Review Meeting Agenda: A presentation outlining agenda points as per ISO standard (Section 5.2).
• Management Review Meeting Minutes: Includes attendance list, decision/action items, and effectiveness statements, following the established guidelines/checklist for the meeting (QMS-TMP-0655).

Quality Records

• Record types and descriptions: The document includes a table for record types and their descriptions, necessary for quality control and maintenance of the organization's quality management system.

Explore the management review process at Compass Health, focusing on the responsibilities and procedures for effective quality management system evaluations. Understand the applicable standards such as ISO 13485:2016 and FDA regulations that guide the management review agenda and schedule.