Compass Health AI SOP: Installation PDF

Compass Health AI SOP: Installation 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: Installation 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-0021 Revision History Version Date Description 1.0 Initial Release Document# QMS-SOP-0021  1. Introduction Purpose The purpose of this procedure is to provide for a system and instructions—and to assign responsibilities for—the development and documentation of installation instructions and performance of device servicing at Compass Health. Scope This procedure applies to all Compass Health products/devices requiring installation and servicing. This includes installation and service support for Compass Health manufactured product sold indirectly by distributors and directly by Compass Health. 2. Applicable Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure: ISO 13485:2016 Section 7.5.3 Installation activities 2.2 Reference Documents Document Title Document # SOP: Control of Records QMS-SOP-0003 SOP: Complaint Handling QMS-SOP-0026 SOP: Control of Nonconforming product QMS-SOP-0024 SOP: Device Recall and Advisory Notices QMS-SOP-0028 Document# QMS-SOP-0021 SOP: Medical Device Reporting and Mandatory QMS-SOP-0029 Problem Reporting SOP: Corrective and Preventive Action QMS-SOP-0031 3. Acronyms and Definitions Table 1: Acronyms Acronym Meaning RMA Return Merchandise Authorization PNR Product Non-conformity CCB Change Control Board Table 2: Definitions Term Meaning Correction Repair, modification, adjustment, relabeling, or inspection (including patient monitoring) of a product without its physical removal to some other location Consignee Anyone who received, purchased, or used the product being recalled Customer An advisory notice is sent to clients issued to provide information and/or Notification advice on what actions should be taken by the customer in the use, modification, disposal, or return of a medical device for the purpose of corrective action. Customer A list maintained by Compass Health per product line, which includes: Distribution List contact name, organization name, email address (if known), postal address, Serial number of the product, shipment date, and if appropriate, installation date, Service Team member performing installation, and confirmation of installation verification test. This list is generated for each product line and constantly updated whenever a product is being shipped to or installed at a customer site and provides traceability of each individual product shipped out of Compass Health. Document# QMS-SOP-0021  The customer list is stored electronically such that a complete customer list can be retrieved within 1 business day. 4. Process Roles Role Responsibilities Quality Assurance Review and approve procedures in this SOP Manager Customer Support Responsible for initiating proper complaint handling procedure if customer reports that the problem with returned device is associated with a serious injury or death, or such an allegation is communicated by anyone else Operations Establish, manage and maintain this document and supporting documents to support all service processes. Conduct escalation, as appropriate, to the Management Team and or QA of specific activities. Service Team Assigned installation responsibilities for each product line Update the Customer List indicating the date of installation and the verification test outcome once installation is completed and verification test passes. Suppliers (if If included as key supplier, Suppliers will be kept informed applicable) and shall receive instructions based on the nature of the service request. 5. Procedure General Installation processes, specifications and instructions are developed for a new or upgrade to a product as part of the design phase, subject to all applicable controls specified in SOP: Software Development and SOP: Product Development Process. Work instructions will be established as required and as specified in the Product Development Plan. Qualification, training and awareness requirements for service engineers are the same as for engineers responsible for verification of new product. Document# QMS-SOP-0021  5.1 Installation The installation procedure for a product is defined as part of the Product Development Process (see SOP: Product Development Process). Detailed installation steps are documented and validated prior to use. All installation procedures shall include a verification test to verify proper installation of the product, and any specific qualification requirements for the person installing the product. When installation is completed and the verification test passes, the Service Team shall update the Customer Distribution List indicating the date of installation and that the verification test passed. A Customer Distribution list is maintained at Compass Health which includes: Contact name Organization name email address (if known) Postal address Serial number of the product installation date. The Customer Distribution list is generated for each product line and constantly updated whenever a product is installed at a customer site and provides traceability of each individual product installation. 6. Quality Records Records/ Notices Description Advisory notices Copies of advisory notices and list of customers to whom the notices were sent Customer Distribution List List of Compass Health customers for a specific product line and for all products shipped - provides traceability of Compass Health product. - includes: contact name, organization name, email address (if known), postal address, Serial number of the product, installation date Document# QMS-SOP-0021