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  • Client tolerances much wider than standards

    Hello everyone,
    A calibration laboratory states that in its calibration certificates it indicates conformity or non-conformity based on a tolerance specified by the customer. The tolerance values given by the customer are significantly wider than those implied by the relevant standard or industry norms. When questioned about 7.2.1.1 (“the laboratory shall use appropriate methods”), the argument is that the decision rule based on the customer’s tolerance is allowed by ISO/IEC 17025, referring to the note in 7.8.6.1: “Where the decision rule is prescribed by the customer, regulations or normative documents, a further consideration of the level of risk is not necessary.”
    My concern is that using a much wider customer-specified tolerance may conflict with the requirement to use “appropriate methods”, since the conformity statement could be misleading when compared to the normative expectations.
    In your interpretation, is relying solely on customer-specified tolerances (even if they are much wider than normative ones) acceptable under ISO/IEC 17025? Or should the laboratory ensure that the method and decision rule remain technically appropriate beyond simply following the customer’s prescription? Thanks in advance for your insights.

  • Clarification on Laboratory Evaluation Requirements (IATF 16949)

    In the context of IATF 16949 requirements, is a formal evaluation of external calibration and testing laboratories required in addition to verifying ISO/IEC 17025 accreditation? If yes, then the applicable evaluation criteria for labs may differ from those used for raw material suppliers and may impact the supplier’s overall performance rating.

  • Use of a Single Quality Manual for a Group with Multiple Subsidiaries

    Can a corporate group composed of three subsidiaries, each with its own name and legal information, use a single Quality Manual for all entities?

  • What is the main difference between ISO/IEC 27701:2019 and ISO/IEC 27701:2025 ?

    The main difference is that ISO/IEC 27701:2025 is a stand-alone standard, whereas the 2019 version was an extension of ISO/IEC 27001. This means organizations can now be certified for their Privacy Information Management System (PIMS) without requiring an existing ISO/IEC 27001 certification. 

  • record about Phisical and Electronic correspondance

    Hi In the first "Procedure for document and record control" we have one paragarpahe related to phisical and electronic records and when i choose for both Excel file the sentece become wired Each external document that is necessary for the planning and operation of the ISMS must be recorded in the Register of external correspondence in Excel or in the Register of external correspondence in Excel, according to their form. The Register of external correspondence in Excel and the Register of external correspondence in Excel must contain the following information: sender, document name, and date of receipt. The person who receives such external documents in paper or other physical forms (e.g., through regular mail or as courier parcels) must make a record in the Register of external correspondence in Excel. The person who receives external documents in electronic form (e.g., through email) must record them in the Register of external correspondence in Excel. hiw can we modify that paragraphe ? Also when we subscribe and get a quick workshop on getting started with confirmi, the person who present the tool told me that an update will be available wher we can modifiy the documents in a more flexibale way with teh possibility to ad headers and footers like in world can you tell me when it will be available ?   thanks Ed    

  • Risk level = 4, how to bring the residual risk at zero

    Hi, In Conformio, I’m currently in the Risk Register phase, Treatment step. When both Impact and Likelihood of my risk are set to 2-High (Level set to 4 – Not acceptable), I’m not able to bring the residual risk at zero. It remains at one, even when selecting all suggested risk treatment controls (safeguards). What should I do to bring the residual risk at zero? Or should I rather accept this residual risk of one?

  • Distributor traceability

    When it comes to traceability, the AS9100 standard does not give detailed requirements on how to do this, but only says that you need to control the unique identity if that is a requirement, and retain documents necessary to ensure this traceability.

    So, as per the standard, your question goes back to what your customer's requirements are. If your customer allows waivers on traceability, then that is acceptable, but if not, then it is not acceptable. As the standard is used by any organization within aerospace, the requirements only describe what needs to be done but need to be supplemented with the customer and legal requirements.

     

    For a bit more on the traceability requirements in AS9100, see the article: How to meet traceability requirements in an AS9100D-based QMS, https://advisera.com/9100academy/blog/2019/06/05/as9100-traceability-requirements-how-to-meet-them/

  • Reviewing incidents in Conformio Management Review

    We have the same problem here

  • UPDATE ADDRESS

    If you plan to move the department of the system to another address then have to update what records? Note: Only use the network of the new address, the rest is managed according to the old system. Thanks!

  • Secure Development policy

    There is a paragraph in the Secure development policy which states: In addition to the risk assessment performed according to the Risk Assessment and Risk Treatment Methodology, Head of RD must perform the annual assessment of the following: the risks related to unauthorized access to the development environment the risks related to unauthorized changes to the development environment technical vulnerabilities of the IT systems used in the organization the risks a new technology might bring if used in the organization the risk a new development methodology and/or programming language might bring if used in the organization the risks related to licensing requirements The question is, is this assessment to be done in the Risk Register or is it an additional document that needs to be drafted by the Head of R&D? Thanks
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