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  • Measurment uncentriy

    The Expert Advice responses to the following will provide some suitable information.

    ISO 17025 queries (question 2. I do not understand the concept of measurement uncertainty. Can you help me with it?) at https://community.advisera.com/topic/iso-17025-queries/
    Measurement uncertainty at https://community.advisera.com/topic/measurement-uncertainity/
     Also have a look at the ISO 17025 toolkit document template: Evaluation of Measurement Uncertainty Procedure at https://advisera.com/17025academy/documentation/evaluation-of-measurement-uncertainty-procedure/ This  covers the basic principles and steps to plan, measure and calculate the data required for an evaluation of measurement uncertainty. The two appendices related to the document, Measurement Uncertainty Checklist and Measurement Uncertainty Record support the process. I recommend you also look to your sector and suppliers for commonly used approaches.

  • Contamination/requirements for sterile medical device contamination intro vitro diagnostic device (IVD) (i.e. IVD)?

    1. What would you suggest on measures that could be taken to implement contamination control and work instruction/procedure with a checklist maybe?

    To answer this question, I need to know what kind of medical device you have. Contamination control is definitively depending on the type of medical devices.

    2. Also, Is there a Quality Manual checklist anywhere that actually provides me with the requirements that the Quality Manual must include?

    Following article can help you to prepare the Quality manual for ISO 13485:2016:

    Also, you can see on this link how we have prepared the Quality Manual in our ISO 13485:2016 documentation toolkit:

    • Quality Manual https://advisera.com/13485academy/documentation/quality-manual-iso-13485-2016/
    • ISO 13485:2016 Documentation Toolkithttps://advisera.com/13485academy/iso-13485-documentation-toolkit/

    • What in ISO 14534: 2015 should be applied to contact lens care products?

      Standard ISO 14534:2011 is a technical standard that specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses. So, it is necessary to have this standard and see what are specific requirements regarding the contact lens care products. 

      MDD 93/42/EEC specifies what needs to be done to show that every medical device is safe for performance. MDD asks the manufacturer to prepare the technical file which has in general following elements: description of the medical device (for example characteristics, content, type of the raw material, technical drawings, manufacturing process, clean room characteristics), clinical evaluation, post-market surveillance system, essential requirement checklist, declaration of conformity, stability testing, biocompatibility testing. To fulfill all of these requirements for contact lens care products you need to know what are the specific requirements for those products that are described in the ISO 14534:2011.  

    • Coaching

      1) Can ISO 27001 be implemented by a person who is not an expert on the subject of IT system, (I will be the only one and I am Chemist) but who has previously implemented ISO 22000.

      First is important to note that IT controls are only part of the implementation of ISO 27001 (the number of non-related IT controls are greater).
       
      Considering that, your experience in ISO 22000 will help (these standards share many common requirements, like document control, internal audit, management review, etc.), with the proper support.
       
      Our ISO 27001 Documentation toolkit is made for beginners, with little to no knowledge of ISO 27001 (many companies with no experience in ISO 27001 have successfully implemented this standard with our toolkit).
       
      To see how the toolkit looks like, please access this link: https://advisera.com/27001academy/iso-27001-documentation-toolkit/

      For more information, see:

      These materials will also help you regarding ISO 27001:

      2) According to the fact that I am not an expert in information technology, which package is recommended to buy: 797, 1200 or 2000?

      Considering your previous experience with ISO 22000, the toolkit with extended support (our second level toolkit) is a suitable solution, considering the 5 hours of one-on-one support with an ISO 27001 expert (against 1 hour from the toolkit with expert support), the expert review of 5 completed documents (against 1 document review from the toolkit with expert support), and the pre-audit check. In case you identify later that you need more support, you can ask for an upgrade in your toolkit.  

    • Risk and control self assessment

      For risk assessment you can consult these materials:

      To see how documents for risk assessment compliant with ISO 7001 looks like, see: ISO 27001/ISO 22301 Risk Assessment Toolkit https://advisera.com/27001academy/iso-27001-22301-risk-assessment-toolkit/

      For controls self-assessment, see:

    • Finding ISO 27017/18 content

      The documents you are looking for which cover the mentioned clauses can be found in the following folders:

      • Clauses on Service Agreements with cloud providers is covered by the Appendix – Security Clauses for Clients, Suppliers and Partners, located on folder 08 Annex A >> A.15 Supplier relationships
      • User Data Privacy Protection Agreement Guidelines is covered by the Appendix – Security Clauses for Clients, Suppliers and Partners, located on folder 08 Annex A >> A.15 Supplier relationships and Policy for Data Privacy in the Cloud, located on folder 04 Information Security Policy
      • Security Requirements Specification is covered by the Appendix – Security Requirements Specification, located on folder 08 Annex A >> A.14 System acquisition development and maintenance

      By the way, included in your toolkit there is a List of Documents file which points out which document covers which clauses and controls from these standards.

    • Corrective action timeline

      Attention, you are using correction and corrective action interchangeably. That is not right. First, you develop a correction to eliminate the nonconformity and its consequences. Then, if your organization decides to develop a corrective action, after determining the reason for the problem, the root cause(s), you have to implement a corrective action and, according to ISO 9001:2015 clause 10.2.1 d), you should review the effectiveness of the corrective action. So, you should state both criteria and a timeline to evaluate the effectiveness of the action.

      Please check the following information:

    • Performing validation of process/activity

      According to requirement 7.5.6 Validation of processes for production and service provision, validation must be done for processes in which the resulting output cannot be verified by subsequent monitoring or measurement. It means that, for example, validation is not necessary when the mass of the medical device is in question, because you can weigh each product and check is the mass according to the specification. However, if you have a sterile product, it is not easy to check the sterility of the product. In that case, you need to dexterous the product and make an analysis of sterility. This is not convenient because you will destroy all your products and have a lot of costs. For such processes, validation must be performed. 

      Therefore, validation is documented evidence that declares a process or system will consistently meet a predetermined specification. It is a series of documented tests and gathered information that proves a system will produce a product that meets all specifications and standards. 

      Very often, there are standards that guide you on what has to be done to validate certain processes. Some of the most used standards for validations for medical devices are the following:

      • ISO 11737-2:2019(en) - Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process
      • ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation, and routine control of a sterilization process for medical devices
      • ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing, and assembly processes
      • ISO 14644-2:2015(en)
      • Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

      For more information about this topic, please see the following articles:

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