Compass Health AI SOP: Management Review PDF

Compass Health AI SOP: Management Review Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver 02-Jan-2024 Baskin...

Compass Health AI SOP: Management Review Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver 02-Jan-2024 Baskin COO Document# QMS-SOP-0004 Revision History Version Date Description 1.0 03-Jan- Initial Release 2024 Document# QMS-SOP-0004 1 Introduction 1.1 Purpose This procedure establishes the process and responsibilities for conducting Management Reviews at Compass Health in order to ensure the continued suitability, adequacy and effectiveness of the quality management system, quality policy and quality objectives. 1.2 Scope This procedure applies to the quality management system, quality policy and quality objectives at Compass Health. 2 Applicable and Reference Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure: ISO 13485:2016 Section 5.6 Management Review FDA QSR § 820.20 Management Responsibilities TG (MD)R Sch3 P1 1.4 2.2 Reference Documents Document Title Document # Quality Manual QMS-MAN-0001 Document# QMS-SOP-0004 Quality Objectives form QMS-FRM-0065 Compass’ Quality Policy QMS-QP-0001 Management Review Meeting Minute QMS-TMP-0655 Template 3 Acronyms and Definitions Acronym Description FDA Food and Drug Administration CMDR Canadian Medical Device Regulations TG(MD)R Therapeutic Goods (Medical Devices) Regulations 4 Process Roles Role Description of Responsibilities A member of management who is appointed by top management to have the responsibility and authority to: Management Representative ensure that processes needed for the QMS are established, implemented and maintained; report to top management on the performance of the QMS and any need for improvement; Document# QMS-SOP-0004  ensure the promotion and awareness of regulatory and customer requirements throughout the organization. At Compass Health, the Management Representative is the Regulatory Affairs Lead. Liaise with external parties on matters related to the QMS (i.e. QA/RA third-party auditors and regulatory authorities). Required to attend all Management Reviews, review data presented to determine the continued adequacy an Top effectiveness of the quality system and assess opportunities for Management improvement and need for changes. Top Management minimally includes the Head of Product, COO, Engineering Lead and the CEO. 5 Management Review Process 5.1 Schedule Management Reviews will be conducted at least once a year. The meetings may be held more frequently based on the needs of the business or significant changes to the business such as facility changes, key management changes or product line changes. 5.2 Agenda At a minimum the following areas shall be included in the agenda of every management review: Follow up action items from previous management review Review Quality Policy and Objectives and any proposed changes Feedback Complaint Handling Reporting to regulatory authorities Audits (internal, external and supplier audits) Document# QMS-SOP-0004  Monitoring and Measurement of Processes Monitoring and Measurement of Products Corrective and Preventive Action Training (status and effectiveness of training) Changes that could affect the Quality Management System Resource needs Recommendations for Improvement Applicable new or revised regulatory requirements An agenda is compiled by QA/RA Lead and distributed to all attendees at least one week prior to the meeting. 5.3 Outputs Management Review outputs shall minimally include and be recorded within the Management Review Meeting Minute: A statement regarding the suitability, adequacy and effectiveness of the Quality Management System and its processes (recorded in the minutes) and/or reference to actions required in order to improve suitability, adequacy and effectiveness. For any new or modified quality objectives, a project leader shall be assigned and the Quality Objectives Form (QMS- FRM-0065) shall be completed by Quality Assurance A record of decisions or action items related to: o Improvement needed to maintain the suitability, adequacy, and effectiveness of the quality Management system and its processes. o Improvement of products and/or services related to customer requirements o Changes needed to respond to applicable new or revised regulatory requirements o Resource needs 6 Quality Records Record type Description Document# QMS-SOP-0004  A presentation deck outlining the agenda for the management Management Review review meeting as prescribed by the ISO 13485:2016 standard Meeting Agenda (see Section 5.2 above) Contains attendance list, decision/action items and the effectiveness statement-distributed to all attendees of the Management Review meeting. QMS-TMP-0655 provides a guideline/checklist for the Meeting Minutes meeting. It lists the input and output of the meeting that are required. Compass’ Quality Any implemented changes to Compass’s Quality Policy Policy proposed during the Management Review Meeting. Quality Objectives Outlining new or modified quality objectives Document# QMS-SOP-0004