Podcast
Questions and Answers
What is the purpose of SOP-1901?
What is the purpose of SOP-1901?
- To control inventory of clinical use products
- To provide customer support for clinical use products
- To manage demonstration and evaluation products in the organization (correct)
- To analyze health care compliance
How does a demonstration product differ from an evaluation product?
How does a demonstration product differ from an evaluation product?
- There is no difference between demonstration and evaluation products
- Demonstration products are not intended for clinical use, while evaluation products are intended for clinical use during a specified period (correct)
- Demonstration products are intended for clinical use, while evaluation products are not
- Demonstration products have no time limit for use, while evaluation products have a specified duration of use
What standards does SOP-1901 comply with?
What standards does SOP-1901 comply with?
- ISO 13485:2016 and ISO 22000
- ISO 9001:2015 and ISO 22000
- ISO 13485:2016 and ISO9001:2015 (correct)
- ISO 13485:2016, ISO9001:2015, and ISO 14001
What does SOP-1901 NOT include?
What does SOP-1901 NOT include?
What activities does SOP-1901 involve for demonstration/evaluation products?
What activities does SOP-1901 involve for demonstration/evaluation products?
What is required whenever an evaluation product or demonstration product is handed over to a customer?
What is required whenever an evaluation product or demonstration product is handed over to a customer?
When a demonstration/evaluation product is returned to the warehouse, what is necessary before it can be transferred to another location?
When a demonstration/evaluation product is returned to the warehouse, what is necessary before it can be transferred to another location?
What is advisable before sending out or transferring a product used for demonstration or evaluation purposes to another customer?
What is advisable before sending out or transferring a product used for demonstration or evaluation purposes to another customer?
What action is necessary if a product used in demonstration or evaluation purposes is incomplete, damaged, or not cleaned?
What action is necessary if a product used in demonstration or evaluation purposes is incomplete, damaged, or not cleaned?
What is required every time a demonstration/evaluation product returns to the warehouse or needs to be transferred to another location?
What is required every time a demonstration/evaluation product returns to the warehouse or needs to be transferred to another location?
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.
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Description
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.
