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  • Determining risks and opportunities

    I recommend starting with determining the context. For the internal issues, think about that kind of issues systematically arise in the reports and internal meetings (complaints, successes, costs, customer satisfaction, performance indicators, ...). Classify the positive internal issues as strengths and the negative internal issues as weaknesses.

    I use the PESTLE analysis framework in order to support the discipline of questioning the mind around various areas that may affect an organization (politics, economics, social, technology, legislation and environment) to determine external issues. After the PESTLE analysis I recommend collecting positive external issues as opportunities and negative external issues as threats and organize the information in a SWOT matrix.

    Then you can combine strengths with opportunities or with threats, or combine weaknesses with opportunities or with threats, and from those combinations see if you can determine risks or opportunities.

    Below you can see some examples of application of this methodology:

    https://www.screencast.com/users/ccruz5284/folders/Default/media/ac230d7e-88bb-470b-bf17-547a7736c774

    I describe this methodology in more detail in this free webinar on demand - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-free-webinar-on-demand/

    You can find more information in the following links:

  • Reducing number of documents for review

    If I understand your question correctly, you asked how to reduce the number of documents from the ISO 13485:2016 that you need to prepare for your Quality management system.

    There are certain points from requirements 6, 7, and 8 that can are not applicable for each manufacturer. 

    For example, if your medical device is not sterile, then requirements (and all applicable documentation) 7.5.5 Particular requirements for sterile medical devices and 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems are not applicable for you.   

    If your medical device does not require installation and service, then requirements 7.5.3 Installation activities and 7.5.4 Servicing activities and all applicable documentation is not applicable for your Quality management system, so you do not need to prepare it.

    List of mandatory documents for ISO 13485:2016 you can find in the following link:

    • List of mandatory documents required by ISO 13485:2016 https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/

       

    • Detailed chain of custody from a lab accredited ISO17025

      I will address your question generally in terms of a basic contract agreement and specifically in terms of the requirements an ISO 17025 laboratory should meet for their accreditation. At this point, both parties should clearly define the problem – what you are asking and for what reason and why and for what reason they are saying they cannot assist?

      The scope and requirements of the service should have been very clear before testing commenced. If it was not requested by  yourself upfront and not advertised by the laboratory as part of their normal service, the laboratory may not be able to provide evidence of the specific chain of custody of your receipt sample. This may be due to confidentiality and basic operational (batching) limitations. What the laboratory is responsible for is to manage the risks and requirements for handling of your sample, ensure unique identification and have a system in place to ensure traceability of that sample from testing through to reporting, They need to ensure that your interests are protected through their management system; ensure the technical validity of your results and data integrity.

      This brings me to the addrressing your concern. The laboratory is required to have a documented process to handle complaints and make a description available to you. I suggest you state the exact problem. If for example results deviated from other laboratories, you could perhaps request a retest. I suggest you ask both laboratories what the measurement uncertainty is for their method and to explain the reason for the deviation to you.  If you are concerned there was a gross mix-up and the result is not that of your sample, start by checking if the number or name you identified your sample appears on the issued report. If correct, you can at least request a photograph of your retained sample, to verify the lab identification number. Alternatively, you could request access to relevant areas to check the receipt label on your retained sample. Ask them to provide the details and verify in writing that there is traceability of your sample from receipt to reporting, for example registration verified, what the batch number was, analysis date.  Furthermore you can ask the laboratory to provide some evidence to verify the quality assurance requirements were met for the batch that your sample was part of. You can also request return your retained sample.

      In summary the laboratory must meet specified contractual obligations, handle your sample suitably, deal with your complaint as per procedure and cooperate with “reasonable” requests (that do not put any management system activities at risk). If the laboratory blatantly refuses to cooperate, your recourse is to report them to their ISO 17025 accreditation body. You can find the details on their ISO 17025 accreditation certificate.I trust however, that the issue will be resolved, once the purpose and reasons are understood by both parties.

      You may be interested, for reference, to have a look at the following articles:

    • Can aflatoxin be accredited using ELISA?

      I gather from your question that your laboratory is already accredited?  Adding any test method to a scope of accreditation involves ensuring that all the ISO 17025 resource requirements (clauses 6.1 to 6.6) and process (clauses 7.1 to 7.11) are met for the particular test.

      The laboratory should perform a full risk and opportunities analysis related to introducing any new test. For ELISA Assay Kits, you need to ensure that the most suitable technique (e.g. Sandwich versus Competitive ELISA) and applicable kit is used for the type of aflatoxins of interest. The laboratory must ensure that the method performance required for the purpose of the test is met. For example the test will only provide a total aflatoxin result for the aflatoxin antibodies used in a competitive ELISA test.

      It crucial to use a suitable kit produced by a reputable company, with published validation an performance criteria. Then the laboratory will need, as with all tests, to validate the method inhouse before use. Remember that depending on the matrices, interferences must be addressed as ELISA test methods are not suitable for certain matrices, for example strong colour and flavours in concentrated additives.

      The reply to a similar topic in the 17025 Expert Advice Community may provide some more support.
      Have a look at Methods verification at https://community.advisera.com/topic/methods-verification/


      The ISO 17025 toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/ can assist further. It includes the procedure for validation and verification of methods, named Test and Calibration Method Procedure, along a Test Method Development, Verification and Validation Register and Test Method Development, Verification and Validation Record. The techniques for method validation are listed as well as the required records.

      It is the responsibility of the laboratory to choose the suitable technique, plan experiments, reference sector specific guidelines and meet specific regulatory and accreditation body requirements. The procedure is also available separately at https://advisera.com/17025academy/documentation/test-and-calibration-method-procedure/

    • IATF 16949:2016 Training

      As stated in IATF 16949: 2016 standard 7.2.3 f) ‘’Maintenance of and improvement in internal auditor competence shall be demonstrated through f) executing a minimum number of audits per year, as defined by the organization ''.

      The minimum number of internal audits to be performed should be determined by the organization. Performing 1 audit annually may be a risk for the knowledge and practice of internal auditors.

      If such a situation is present, my advice is that you can develop the relevant internal auditor with internal training and can conduct its first audit with an experienced auditor. If you indicate these points that I recommend in your internal audit procedure, it will be effective for the system.

      For more information, please read the following article:

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