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  • Data retention

    Please note that ISO 27001 does not prescribe data retention requirements (for any type of information), only that these must be defined, based on results of risk assessment and applicable legal requirements (e.g., laws, regulations, and contracts).

    Considering that, you should consider hiring legal expert advice, to help you identify relevant legal requirements applicable to your organization.

    This article may provide you a starting point:

  • Checklist to see if we should become ISO 17025

    The starting point is to understand the purpose of the ISO 17025 Standard, the requirements and identify the benefit for your laboratory.

    To assist, begin with the article What is ISO 17025?, available at https://advisera.com/17025academy/what-is-iso-17025/

    Then have a look at the free Whitepapers available at https://advisera.com/17025academy/free-downloads/, particularly

    • Clause-by-clause explanation of ISO 17025:2017
    • Diagram of ISO 17025 Implementation Process
    • Project Plan for ISO/IEC 17025 implementation

    Then there are some useful articles at https://advisera.com/17025academy/blog/, particularly 

    • Six key benefits of ISO 17025 implementation
    • Checklist of ISO 17025 implementation steps

    The ISO 17025 Toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/ has previews, including an Internal Audit Process Checklist you would use to populate all the requirements in (as from above)  to determine the gaps and level of compliance for implementation and accreditation. You could also obtain the assessment checklist form the ISO 17025 accreditation body you would deal with.

  • Requirement for ISO 9001: 2015 certification in cargo and marine services

    Thanks for the information. Most appreciated 

  • MDR Technical Documentation

    According to the definitions in the ISO 13485:2016, a medical device family is a group of medical devices manufactured by or for the same organization and have the same basic design and performance characteristics related to safety, intended use, and function. You can have one Technical documentation for the group of the medical devices with a complete list of the various configurations/variants. 

    To see how to structure the Technical file according to MDR, see this Technical file template: https://advisera.com/13485academy/documentation/technical-file-template/

  • Archiving period for Documents in IATF 16949

    Regarding the retention of records, the legal regulations and the periods specified by the customer-specific requirements are important. The first issue to be examined is these 2 places. 

    In addition, the IATF 16949: 2016 standard defined in clause 7.5.3.2.1 as follows.

    "Production part approvals, tooling records including maintenance and ownership), product and process design records, purchase orders (if applicable), or contracts and amendments shall be retained for the length of time that the product is active for production and service requirements, plus one calendar year unless otherwise specified by the customer or regulatory agency."

  • Management representative in ISO 13485

    Yes, you can outsource a person as a management representative. A management representative should be someone who is knowledgeable, trained, and have experience in dealing with the Quality Management System according to ISO 13485 of the company as well as familiar. Also, it would be preferable that that person has experience with your type of medical devices and technologies. This person must be available upon your request.

    With an outsourced Management representative, you need to have a contract where mutual obligations will be defined.

    For more information, please see the following articles:

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