Compass Health SOP: Contract Review Process

Compass Health SOP: Contract Review and Order Management

• Purpose: To establish a standardized procedure for contract approvals from Legal, Regulatory, Engineering, Product, and Sales departments, ensuring compliance and alignment with company policies.

• Scope: Applies to all customer contracts for Compass Health products and services.

• Applicable Standards: Includes ISO 13485:2016 sections on product requirements, review of requirements, customer communication, documentation requirements, and design safety principles.

Process Roles

• Contract Manager: Responsible for adhering to the SOP, coordinating approvals, and maintaining contract records.

• Sales Department: Drafts initial contract terms based on customer needs.

• Legal Department: Reviews contracts for legal compliance, potential risks and adherence to company policies.

• Regulatory Department: Ensures regulatory compliance and suggests amendments to address regulatory concerns.

• Engineering Department: Reviews for technical feasibility and alignment with product specifications and resource availability.

• Product Department: Ensures contract terms align with product offerings and suggests amendments for accuracy.

Procedure

• Contract Initiation: Sales identifies customer needs and drafts initial terms (product details, delivery, payment). Internal review for policy compliance and customer requirements. Submits draft to the Contract Manager.

• Preliminary Review: Contract Manager reviews for completeness, consistency, company policy compliance, and inclusion of all required details like customer information, scope of work, deliverables, timelines, and pricing. Forwards to Legal.

• Legal Review: Legal Department reviews for compliance with laws, potential risks, and policy adherence. Suggests amendments to mitigate risks and forwards the amended draft to Regulatory.

• Regulatory Review: Regulatory Department reviews for compliance with industry regulations and standards. Provides regulatory approval and forwards to Engineering.

• Engineering Review: Engineering reviews for technical feasibility, alignment with specs, and resource availability and makes necessary modifications. Provides engineering approval and forwards to Product.

• Product Review: Product Department reviews for alignment with product offerings, capabilities and strategic goals and suggests amendments to optimize delivery. Provides product approval and forwards to Sales.

• Final Review and Approval: Sales conducts final review, incorporating customer-specific requirements and obtains final customer approval. Submits the finalized contract to the Contract Manager for execution.

• Execution and Record Keeping: Contract Manager executes the contract, ensures all parties sign, distributes copies to relevant departments, and maintains records in the company's document management system.

• Document Control: SOP is reviewed annually and updated as necessary. Changes must be documented and approved by the respective department heads.

Flowchart Summary

• The flowchart illustrates the sequential steps in the contract review and order management process, involving Sales, Legal, Regulatory, Engineering, and Product. The process culminates with the final contract execution and records management with the relevant document.

This quiz explores the standard operating procedures for contract review and order management at Compass Health. It covers roles involved, applicable standards, and compliance requirements to ensure aligned workflows within departments like Legal, Regulatory, and Sales.