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  • Some Information regarding ISO 13485 and ISO 9001

    I am working in a manufacturing company of surgical masks in Dubai I want to know does Manufacturing of Surgical Masks lie under the ISO 13485 scope? and If We implement ISO 9001 in our company, does we require to implement ISO 13485 in the company or is it same..

  • Is ISO 13485 for medical devices only?

    ISO 13485 is for medical devices only or for products as well like hand sanitizers and chemicals used on masks?

  • ISO 13485 for Class 1 FDA medical device

    What are the requirements if any for FDA class 1 medical device to comply with ISO 13485

  • ISO 13485:2016 clause 4.1.1 - documenting roles

    So far the templates have been helpful but have a question about ISO 13485:2016 clause 4.1.1 "The organization shall document the role(s) undertaken by the organization under the applicable regulatory requirement: My company manufactures and distributes...so exactly what am I documenting and how do I present it in good form?

  • Reducing number of documents for review

    How can we reduce the number of documents to be reviewed?

  • Integrated approach of ISO 13485 and ISO 9001

    1.An Integrated approach of ISO 13485 and ISO9001 What should be focused on considering these 2 standards (These will be audited separately). For integrated approach, I am following Anenxure B of ISO 13485

    2. How to pass ISO 9001 stage 1 and stage 2 audit?

    3. A Regulatory procedure and form is required that will meet both the standards requirements

  • Steps for obtaining CE certification or CE Mark

    WE are a manufacturer of Medical Device Face mask and PPE. We are recently certified ISO 13485 and would like to get CE certification or CE Mark
    What're the steps shall we follow?
     

  • Requirement for ISO 13485 of procedure of Human resources and another procedure of Infrastructure and working environment

    1. Hi, if we have few employees (8) with many outsourced freelancers, and we don't own the working place, is it required for ISO13485 a procedure of Human resources and another procedure of Infrastructure and working environment?

    2. If it is, why?

  • Difference between list of internal documents and list of type of records

    Looking at the first folder “00”, what is the difference between list of internal documents and list of type of records?

  • Are flowcharts mandatory for every process?

    Is it a must to have flowcharts for every single process?
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