10 Questions
What is the purpose of SOP-1901?
To manage demonstration and evaluation products in the organization
How does a demonstration product differ from an evaluation product?
Demonstration products are not intended for clinical use, while evaluation products are intended for clinical use during a specified period
What standards does SOP-1901 comply with?
ISO 13485:2016 and ISO9001:2015
What does SOP-1901 NOT include?
Health Care Compliance analyses
What activities does SOP-1901 involve for demonstration/evaluation products?
Planning, monitoring, maintaining, inspecting, and reviewing inventory
What is required whenever an evaluation product or demonstration product is handed over to a customer?
Legal documents to determine the scope and duration of the offer
When a demonstration/evaluation product is returned to the warehouse, what is necessary before it can be transferred to another location?
Creation of necessary inspections and legal documents as per SOP
What is advisable before sending out or transferring a product used for demonstration or evaluation purposes to another customer?
Preventive maintenance by a certified technician
What action is necessary if a product used in demonstration or evaluation purposes is incomplete, damaged, or not cleaned?
Quarantine of the product until necessary actions are taken
What is required every time a demonstration/evaluation product returns to the warehouse or needs to be transferred to another location?
Quality inspections for labelling requirements
Study Notes
Purpose of SOP-1901
- The purpose of SOP-1901 is to outline the process for handling demonstration and evaluation products.
Demonstration vs Evaluation Products
- A demonstration product is used to showcase the product's features and capabilities to customers.
- An evaluation product is used by customers to assess the product's suitability for their needs.
Compliance with Standards
- SOP-1901 complies with relevant standards and regulations.
Exclusions
- SOP-1901 does not include products used for internal testing or training.
Activities Involved
- SOP-1901 involves the following activities for demonstration/evaluation products:
- Handling and storage
- Tracking and record-keeping
- Cleaning and maintenance
- Quality control
Handover Requirements
- Whenever an evaluation product or demonstration product is handed over to a customer, a formal handover process is required, including documentation and signature.
Product Return Process
- When a demonstration/evaluation product is returned to the warehouse, it must be inspected and cleaned before it can be transferred to another location.
Pre-Transfer Precautions
- Before sending out or transferring a product used for demonstration or evaluation purposes to another customer, it is advisable to inspect the product for damage or defects.
Incomplete or Damaged Products
- If a product used in demonstration or evaluation purposes is incomplete, damaged, or not cleaned, it must be reported and repaired or replaced before it can be reused.
Warehouse Return Requirements
- Every time a demonstration/evaluation product returns to the warehouse or needs to be transferred to another location, it must be inspected, cleaned, and documented.
Learn about the standard operating procedure (SOP) SOP-1901, which provides a standardized workflow for managing demonstration and evaluation products to meet customers' expectations. The SOP covers instructions and requirements for control from Quality, Regulatory, Compliance, and Finance perspectives.
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