Compass Health AI Contract Review and Order Management SOP PDF

Compass Health AI SOP: Contract Review and Order Management 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: Contract Review and Order Management 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-0006 Revision History Version Date Description 1.0 03 January 2024 Initial Release Document #: QMS-SOP-0006 1. Purpose To establish a standardized procedure for obtaining necessary approvals from the Legal, Regulatory, Engineering, Product, and Sales departments for customer contracts, ensuring that all contracts are compliant, feasible, and aligned with company policies and regulations. 2. Scope This SOP applies to all customer contracts for products and services offered by Compass Health. 3 Applicable Standards The following standards and regulations are intended to be met by this procedure: ISO 13485:2016 Section 7.2.1 Determination of requirements related to the product ISO 13485:2016 Section 7.2.2 Review of requirements related to the product ISO 13485:2016 Section 7.2.3 Customer communication TG(MD)R Sch3 P1 Cl 1.4(4) & (5) – Documentation of requirements TG(MD)R Sch 1 P1 2 – Design to meet safety principles 4 Process Roles Role Description Contract Ensures adherence to this SOP, coordinates the approval process, Manager and maintains contract records. Sales Drafts initial contract terms based on customer needs. Department Document #: QMS-SOP-0006  Legal Reviews contracts for legal compliance and risk management. Department Regulatory Ensures contracts comply with industry regulations. Department Engineering Department Confirms technical feasibility and alignment with product specifications Product Ensures contract terms align with product offerings and capabilities. Department Department Responsible for reviewing and providing approvals. Heads 4. Procedure 4.1 Contract Initiation Sales Department: Identify customer needs and draft initial contract terms, including product specifications, delivery schedules, pricing, and payment terms. Conduct an internal review to ensure the draft meets basic company policies and customer requirements. Submit the draft contract to the Contract Manager. 4.2 Preliminary Review Contract Manager: Review the draft contract for completeness, consistency, and initial compliance with company policies. Ensure all necessary details are included, such as customer information, scope of work, deliverables, timelines, and pricing. Forward the draft contract to the Legal Department. Document #: QMS-SOP-0006 4.3 Legal Review Legal Department: Review the draft contract for legal compliance, potential risks, and adherence to company policies and applicable laws. Suggest amendments to mitigate legal risks and ensure enforceability. Provide legal approval and forward the amended draft to the Regulatory Department. 4.4 Regulatory Review Regulatory Department: Review the draft contract to ensure compliance with relevant industry regulations and standards. Suggest amendments to address regulatory concerns and ensure adherence to industry guidelines. Provide regulatory approval and forward the approved draft to the Engineering Department. 4.5 Engineering Review Engineering Department: Review the draft contract for technical feasibility, alignment with product specifications, and resource availability. Suggest amendments to ensure technical requirements and capabilities are accurately reflected. Provide engineering approval and forward the approved draft to the Product Department. 4.6 Product Review Product Department: Document #: QMS-SOP-0006 Review the draft contract to ensure alignment with product offerings, capabilities, and strategic goals. Suggest amendments to optimize product delivery and customer satisfaction. Provide product approval and forward the approved draft to the Sales Department. 4.7 Final Review and Approval Sales Department: Conduct a final review of the fully approved draft contract, incorporating any additional customer-specific requirements or adjustments. Obtain final approval from the customer. Submit the final contract to the Contract Manager for execution. 4.8 Execution and Record Keeping Contract Manager: Execute the final contract with the customer, ensuring all parties sign the agreement. Distribute copies of the executed contract to all relevant departments. Maintain records of the contract and all associated approvals in the company’s document management system. 5. Document Control This SOP shall be reviewed annually and updated as necessary. All changes to this SOP must be documented and approved by the respective department heads. Document #: QMS-SOP-0006 This SOP ensures that customer contracts undergo thorough scrutiny and alignment with all relevant departments, minimizing risks and ensuring compliance and feasibility. Document #: QMS-SOP-0006