{"id":583,"date":"2018-09-13T17:43:17","date_gmt":"2018-09-13T17:43:17","guid":{"rendered":"http:\/\/iso.thatwebdev1.co.uk\/?page_id=583"},"modified":"2024-04-30T16:28:07","modified_gmt":"2024-04-30T16:28:07","slug":"iso-13485-2","status":"publish","type":"page","link":"https:\/\/www.episodeltd.com\/standard-list\/quality\/iso-13485-2\/","title":{"rendered":"ISO 13485"},"content":{"rendered":"\n\t

ISO 13485<\/h1>\n\t

ISO 13485:2016, Medical devices \u2013 Quality management systems \u2013 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

Here are the following stages to becoming and staying certified to ISO 13485:<\/p>\n1. Establish a system that complies with the standard
\n2. Understand how the Medical Device Regulations<\/a> [MDR] affect you.
\n3. Complete a technical file for each product
\n4. Brief staff
\n5. Operate the system to make sure it is working correctly
\n6. Carry out internal audits and management reviews
\n7. Appoint a \u201cnotified body\u201d to audit you against the standard and the MDR
\n8. Keep using the system once it has been certified (to keep the certificate)\nThere is more detailed information below about the various stages you need to go through.
\n\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 \u2013 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. Submit it to you for your approval<\/li>\n
    8. Ensure all records, especially technical files are complete and up to date<\/li>\n
    9. Separate consultant Internally audit 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. \u00a0Agree where the finished, certified system should be housed (in our free online platform or local in your own IT infrastructure)<\/li>\n<\/ol>\n

        <\/h4>\n

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

        FAQ\u2019s<\/h3>\n\t