Scribd Logo
Upload

Welcome to Scribd!

  • 160 views

    ISO 13485-2016 - DR - Pack - Control of Non Conforming Products

    Uploaded by

    kmasan
    The document discusses ISO 13485 quality management system standards for medical device design and development. It outlines requirements for establishing objectives and processes, implementing processes, monitoring processes and products, and taking actions to improve. When making design or development changes, manufacturers must consider whether the changes will still allow the product to meet requirements and specifications, not adversely affect intended use or risk assessments, impact other product components or interfaces, or create manufacturing or use problems.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd

    ISO 13485-2016 - DR - Pack - Control of Non Conforming Products

    Uploaded by

    kmasan
    160 views4 pages
    The document discusses ISO 13485 quality management system standards for medical device design and development. It outlines requirements for establishing objectives and processes, implementing processes, monitoring processes and products, and taking actions to improve. When making design or development changes, manufacturers must consider whether the changes will still allow the product to meet requirements and specifications, not adversely affect intended use or risk assessments, impact other product components or interfaces, or create manufacturing or use problems.

    Original Description:

    iso certificates

    Original Title

    ISO 13485-2016_Dr_Pack_Control of Non Conforming Products

    Copyright

    © © All Rights Reserved

    Available Formats

    PPTX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    The document discusses ISO 13485 quality management system standards for medical device design and development. It outlines requirements for establishing objectives and processes, implementing processes, monitoring processes and products, and taking actions to improve. When making design or development changes, manufacturers must consider whether the changes will still allow the product to meet requirements and specifications, not adversely affect intended use or risk assessments, impact other product components or interfaces, or create manufacturing or use problems.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    160 views4 pages

    ISO 13485-2016 - DR - Pack - Control of Non Conforming Products

    Uploaded by

    kmasan
    The document discusses ISO 13485 quality management system standards for medical device design and development. It outlines requirements for establishing objectives and processes, implementing processes, monitoring processes and products, and taking actions to improve. When making design or development changes, manufacturers must consider whether the changes will still allow the product to meet requirements and specifications, not adversely affect intended use or risk assessments, impact other product components or interfaces, or create manufacturing or use problems.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 4

    ISO 13485 : 2016

    PRESENTATION OF

    7.3 Design & Development


    As per
    ISO / TR 14969
    Medical devices Quality management systems
    Guidance on the application of ISO 13485:2003
    CONTINUAL IMPROVEMENT

    Customer + Regulatory Requirements


    Customer + Regulatory Requirements

    Management
    Responsibility

    Resource Measurement,
    Management analysis,
    improvement

    Product
    input Product output
    Realization
    Process
    Process
    4. Quality Management System

    Plan:- Establish the objectives and


    processes necessary to delivery results
    in accordance with customer
    requirements and the organization
    policies

    Do:- Implement the process

    Check:- Monitor and measure


    processes and product against policies,
    objectives and requirements for the
    product and report the results

    Act:- Take actions to improve process


    performance
    7.3 Design and Development

    7.3.9 Design and Development Changes

    Improving one characteristic might have an unforeseen adverse influence on


    another. For example, the following should be considered in order to help in
    avoiding this situation

    a) Will the product still conform to the product requirements?


    b) Will the product still conform to the product specifications?
    c) Will the intended use be affected?
    d) Will the existing risk assessment be adversely affected?
    e) Will different components of the product or system be affected?
    f) Will there be a need for further interface design (e.g., physical contact with
    other components in a product or system)?
    g) Will the change create problems in manufacture, installation or use?
    h) Will the design still be verifiable?
    i) Will the change affect the regulatory status of the product?

    You might also like