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Questions and Answers
What is the main purpose of the procedure outlined in the document?
What is the main purpose of the procedure outlined in the document?
Which document number corresponds to the SOP for Control of Records?
Which document number corresponds to the SOP for Control of Records?
Which of the following statements is true regarding the scope of the procedure?
Which of the following statements is true regarding the scope of the procedure?
What is the version number of the initial release of the SOP?
What is the version number of the initial release of the SOP?
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Which standard is specifically referenced for installation activities in the procedure?
Which standard is specifically referenced for installation activities in the procedure?
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What does the acronym RMA stand for?
What does the acronym RMA stand for?
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What is the meaning of 'Correction' in the context of product management?
What is the meaning of 'Correction' in the context of product management?
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Who qualifies as a 'Consignee'?
Who qualifies as a 'Consignee'?
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What information is included in the Customer Distribution List maintained by Compass Health?
What information is included in the Customer Distribution List maintained by Compass Health?
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What purpose does a Customer Notification serve?
What purpose does a Customer Notification serve?
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Study Notes
Compass Health SOP: Installation
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Purpose: To provide a system and instructions, assign responsibilities for the development and documentation of installation instructions and device servicing at Compass Health.
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Scope: Applies to all Compass Health products requiring installation and servicing, including those sold by distributors.
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Applicable Standards: ISO 13485:2016 Section 7.5.3 Installation activities.
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Reference Documents: Includes SOPs for Control of Records, Complaint Handling, Control of Nonconforming Product and Device Recall and Advisory Notices (QMS-SOP-0003, QMS-SOP-0026, QMS-SOP-0024, and QMS-SOP-0028 respectively).
Process Roles
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Quality Assurance Manager: Reviews and approves procedures in this SOP.
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Customer Support: Initiates complaint handling procedure if a returned device is associated with a serious injury or death and manages all service processes.
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Operations: Establishes, manages and maintains documents to support service processes.
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Service Team: Assigned installation responsibilities are updated with installation date and verification test outcomes on the Customer Distribution List.
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Suppliers (if applicable): Kept informed of service instructions, especially key suppliers.
Procedure
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General: Installation processes, specifications and instructions are developed, subject to all applicable controls in SOP: Software Development and SOP: Product Development.
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Installation: Detailed installation procedures are documented and validated before use. The procedures include a verification test following installation. The Service Team updates the Customer Distribution List with the installation date, if the verification test passes.
Quality Records
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Advisory Notices: Copies of advisory notices and a list of customers to whom they've been sent.
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Customer Distribution List: List of Compass Health customers for a specific product line and for all products shipped. Includes traceability of products by contact name, organization name, email address, postal address, serial number of the product, installation date. The list is kept current when products are installed.
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Description
This quiz evaluates your understanding of the installation procedures and responsibilities outlined in the Compass Health SOP. Topics include relevant standards, roles in the process, and the necessary documentation associated with device servicing. Test your knowledge of installation activities required for compliance with ISO 13485:2016.
