SOP-1901 for Managing Demonstration and Evaluation Products
10 Questions
8 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

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?

  • 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?

  • 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?

    <p>Health Care Compliance analyses</p> Signup and view all the answers

    What activities does SOP-1901 involve for demonstration/evaluation products?

    <p>Planning, monitoring, maintaining, inspecting, and reviewing inventory</p> Signup and view all the answers

    What is required whenever an evaluation product or demonstration product is handed over to a customer?

    <p>Legal documents to determine the scope and duration of the offer</p> Signup and view all the answers

    When a demonstration/evaluation product is returned to the warehouse, what is necessary before it can be transferred to another location?

    <p>Creation of necessary inspections and legal documents as per SOP</p> Signup and view all the answers

    What is advisable before sending out or transferring a product used for demonstration or evaluation purposes to another customer?

    <p>Preventive maintenance by a certified technician</p> Signup and view all the answers

    What action is necessary if a product used in demonstration or evaluation purposes is incomplete, damaged, or not cleaned?

    <p>Quarantine of the product until necessary actions are taken</p> Signup and view all the answers

    What is required every time a demonstration/evaluation product returns to the warehouse or needs to be transferred to another location?

    <p>Quality inspections for labelling requirements</p> Signup and view all the answers

    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.

    Studying That Suits You

    Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

    Quiz Team

    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.

    Use Quizgecko on...
    Browser
    Browser