Podcast
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?
- To assign responsibilities for the development of installation instructions and device servicing (correct)
- To provide a system for distributing medical products
- To document all complaints related to device servicing
- To ensure compliance with ISO 13485:2016 standards only
Which document number corresponds to the SOP for Control of Records?
Which document number corresponds to the SOP for Control of Records?
- QMS-SOP-0021
- QMS-SOP-0003 (correct)
- QMS-SOP-0026
- QMS-SOP-0031
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?
- It applies only to products manufactured directly by Compass Health.
- It includes installation and service support for all Compass Health products/devices. (correct)
- It excludes products sold indirectly by distributors.
- It applies only to devices that have been recalled.
What is the version number of the initial release of the SOP?
What is the version number of the initial release of the SOP?
Which standard is specifically referenced for installation activities in the procedure?
Which standard is specifically referenced for installation activities in the procedure?
What does the acronym RMA stand for?
What does the acronym RMA stand for?
What is the meaning of 'Correction' in the context of product management?
What is the meaning of 'Correction' in the context of product management?
Who qualifies as a 'Consignee'?
Who qualifies as a 'Consignee'?
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?
What purpose does a Customer Notification serve?
What purpose does a Customer Notification serve?
Flashcards
Purpose of SOP: Installation
Purpose of SOP: Installation
This document outlines the system and instructions for developing and documenting installation instructions and device servicing at Compass Health.
Scope of SOP: Installation
Scope of SOP: Installation
This procedure applies to all Compass Health products and devices that need installation and servicing. It includes installation and service support for devices sold directly and indirectly.
ISO 13485:2016 Section 7.5.3
ISO 13485:2016 Section 7.5.3
A standard that outlines the requirements for installation activities in medical device manufacturing.
Reference Documents
Reference Documents
Signup and view all the flashcards
Referenced SOPs (QMS-SOP-0003, 0026, 0024, 0028, 0029, 0031)
Referenced SOPs (QMS-SOP-0003, 0026, 0024, 0028, 0029, 0031)
Signup and view all the flashcards
RMA (Return Merchandise Authorization)
RMA (Return Merchandise Authorization)
Signup and view all the flashcards
CCB (Change Control Board)
CCB (Change Control Board)
Signup and view all the flashcards
PNR (Product Non-conformity)
PNR (Product Non-conformity)
Signup and view all the flashcards
Correction
Correction
Signup and view all the flashcards
Consignee
Consignee
Signup and view all the flashcards
Study Notes
Compass Health SOP: Installation
-
Purpose: To provide a system and instructions, assign responsibilities for the development and documentation of installation instructions and device servicing at Compass Health.
-
Scope: Applies to all Compass Health products requiring installation and servicing, including those sold by distributors.
-
Applicable Standards: ISO 13485:2016 Section 7.5.3 Installation activities.
-
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
-
Quality Assurance Manager: Reviews and approves procedures in this SOP.
-
Customer Support: Initiates complaint handling procedure if a returned device is associated with a serious injury or death and manages all service processes.
-
Operations: Establishes, manages and maintains documents to support service processes.
-
Service Team: Assigned installation responsibilities are updated with installation date and verification test outcomes on the Customer Distribution List.
-
Suppliers (if applicable): Kept informed of service instructions, especially key suppliers.
Procedure
-
General: Installation processes, specifications and instructions are developed, subject to all applicable controls in SOP: Software Development and SOP: Product Development.
-
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
-
Advisory Notices: Copies of advisory notices and a list of customers to whom they've been sent.
-
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.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Related Documents
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.
