{"id":591,"date":"2018-09-13T17:44:07","date_gmt":"2018-09-13T17:44:07","guid":{"rendered":"http:\/\/iso.thatwebdev1.co.uk\/?page_id=591"},"modified":"2024-04-30T15:47:54","modified_gmt":"2024-04-30T15:47:54","slug":"iso-13485-2","status":"publish","type":"page","link":"https:\/\/www.episodeltd.com\/iso-13485-2\/","title":{"rendered":"ISO 13485"},"content":{"rendered":"\n

ISO 13485<\/h1>\n\t

ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes,<\/em> is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. <\/h4>\n\t

How do I get ISO 13485?<\/h2>\n\t

There are the following stages to becoming and staying certified to ISO 13485:<\/p>\n

    \n
  1. Establish a system that complies with the standard<\/li>\n
  2. Understand how the Medical Device Regulations [MDR] affect you.<\/li>\n
  3. Complete a technical file for each product<\/li>\n
  4. Brief staff<\/li>\n
  5. Operate the system to slot gacor<\/a> make sure it is working correctly<\/li>\n
  6. Carry out internal audits and management reviews<\/li>\n
  7. Appoint a “notified body” to audit you against the standard and the MDR<\/li>\n
  8. Keep using the system once it has been certified (to keep the certificate)<\/li>\n<\/ol>\n

    There is more detailed information below about the various stages you need to go through.<\/p>\n\t\t\t\t\"\"\n\t

    Your ISO 13485 certification journey<\/h2>\n\t\t\t\t\"Group\n\t

    Getting Started<\/h3>\n\t
      \n
    1. Provide a comprehensive briefing of what the standard asks you to do in simple to understand terms<\/li>\n
    2. Begin to understand in detail how you operate<\/li>\n
    3. Set a timetable and stick to it<\/li>\n
    4. Decide what you want covered by the certificate – which sites, products and services.<\/li>\n
    5. Put the right resources in place<\/li>\n
    6. Collect all existing documentation<\/li>\n
    7. Establish a dedicated client portal on our collaboration and document sharing platform<\/li>\n
    8. Work with you to understand how the MDR regulations apply to you<\/li>\n<\/ol>\n\t\t\t\t\"Group\n\t

      Implementing<\/h3>\n\t
        \n
      1. Establish a detailed project plan in our online project management platform (and stick to it)<\/li>\n
      2. Decide with you what you need operationally<\/em><\/strong><\/li>\n
      3. Map out your business processes<\/li>\n
      4. Complete a gap analysis between what the standard and MDR requires and what you have\/do already<\/li>\n
      5. Implement the system<\/li>\n
      6. Submit the system to Episode Head Office for final QC checks<\/li>\n
      7. We return it to you for your final approval<\/li>\n
      8. Ensure all records, especially technical files are complete and up to date<\/li>\n
      9. Separate consultant Internally audits the system<\/li>\n
      10. Carry out a management review<\/li>\n<\/ol>\n\t\t\t\t\"Group\n\t

        Certification<\/h3>\n\t
          \n
        1. Work with you to select and appoint a UKAS accredited certification body.<\/li>\n
        2. Be onsite throughout the certification process<\/li>\n
        3. Address any issues that arise during the audit<\/li>\n
        4. Brief you on post-certification activity
          \na. 3 year cycle of annual surveillance audits and
          \nb. what you need to do throughout the year to maintain the system<\/li>\n
        5. Agree where the finished, certified system should be housed (in our free online platform or local in your own IT infrastructure)<\/li>\n<\/ol>\n\n

          Episode guarantees certification<\/strong><\/h4>\n\t

          FAQ’s<\/h3>\n\t