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  • Major vs Minor nonconformity

    In effect, if a minor nonconformity, raised during the previous audit, has not been resolved within the deadline – such a small nonconformity automatically becomes a major one.

    You can find more information in the following links:

  • ISO 45001 changes and challenges

    The main changes in Iso 45001 are the removal of the management representative and preventive action, and the addition of the requirements for context of the organization, top level risks and opportunities and format of the documented information requirements.

    The main challenges in the change to ISO 45001 for your OHSMS is in the identification of context of the organization, which includes interested parties, as well as how you may want to record this context. Along with the challenge of re-thinking risk for the OHSMS beyond just the risks posed by hazards.

    We had a webinar on the changes form OHSAS 18001 to ISO 45001, you can see a previous recording here: ISO 45001 vs OHSAS 18001 the main changes, https://advisera.com/45001academy/webinar/iso-45001-2017-vs-ohsas-18001-2007-the-main-changes-on-demand/ or you have questions on the changes you can sign up for the next webinar presentation on this topic which is occurring on July 15th, 2020, here: https://advisera.com/45001academy/webinar/iso-45001-2017-vs-ohsas-18001-2007-the-main-changes/

  • Validation requirements for 13485

    According to the ISO 13485:2016, requirement 7.5.6 Validation of processes for production and service provision, processes that need to be validated are processes where the resulting output can not be verified by subsequent monitoring and measurement. As far as I understand your process, if you measure your device after the molding (eg. weight, height, shape, volume or similar) and during assembly, you can clearly see that medical device is properly assembled, that there is no need to validate that part of the process. However, you need to validate the start of the molding process, when temperature and pressure have to be adjusted so that the medical device of proper characteristics can be achieved. If your machine for molding has some software and if you get a new version of the software for that machine, that for the new version you need to be sure that it did not change the final product. 

    For more information on validation, you can see the following articles:

    On the following links you can see how certain templates look like in our ISO 13485:2016 Documentation toolkit:

    • Record of Software Validation - https://advisera.com/13485academy/documentation/record-of-software-validation-iso-13485-2016/
    • Validation Report - https://advisera.com/13485academy/documentation/validation-report-iso-13485-2016/

    • Sterile Instruments Packaging

      There isn't anything in the ISO 13485:2016 about Sterile packaging changing color. It is rather specific because each manufacturer of sterile packaging has its own method of detection. However, in ISO 13485:2016 in requirement 7.5.7 Particular requirements for validation of a process for sterilization and sterile barrier system is stated that process for sterilization and sterile barrier system must be validated and that records of that validation must be maintained. It means that you need to define which is the criterion for sterilization to be declared successful. Therefore, you need to contact the manufacturer of sterile packaging to see how sterile barrier has to behave when the sterilization process is properly conducted.

      For more information on this topic, please see the following links:

      • How to manage the medical device sterilization process according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/06/28/how-to-manage-the-medical-device-sterilization-process-according-to-iso-13485/
      • Using ISO 13485 to manage process validation in the medical device manufacturing industry https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/

      • Annex 12-4

        Great explaination. Thank you

      • Environmental sustainability in the transport sector

        One of the cornerstones of an Environmental Management system is to determine its environmental aspects. Then, it is important to identify the activities with a better environmental return, those relevant for the environment but also with a payback that can motivate top management to invest in environmental sustainability.

        You can find more information in the following links:

      • Clause 4 vs Clause 9

        1. How can we be sure we have identified all the internal and external issues?

        Answer:

        ISO 9001:2015 does not use the word “identify” but the word “determine” and that makes a difference. “Determine” means that it is the organization that decides what is an issue. The purpose is not to make the longest list of issues but the most relevant list of issues. The purpose is not to keep a list of issues but to look for risks and opportunities.

        For example, this week, working with a client they considered:

        • negative internal issue - Low negotiation capacity
        • negative external issues - (Economic crisis x Increased competition in the sector x Falling public / private investment)

        I ask them to see if they could match any risk from mixing those issues. They said what was clear:

        – More competition, tighter margins

        - Is that relevant for any interest party?

        - Yes, it is for the shareholders - they answered.

        - What can the company do about it?

        And they pick a positive internal issue – Experience of working abroad

        Decision – invest much more in commercial contacts in order to win projects abroad

        Arriving at sound decisions to grab opportunities or minimize risks is what is important.

        2.How can we be sure we are monitoring and measuring them effectively?

        Answer:

        This is not about monitoring and measuring (clause 9.1) this is still about clause 4 and perhaps clause 9.3. “monitor and review information” this is more about keeping a radar checking for relevant issues and being able to make decisions about them. Organizations are effective when they avoid or minimize risks and when they are able to grab opportunities. That can be done during management review, for example. An evaluation on the ability to:

        • determine relevant issues
        • evaluate them
        • decide upon them (minimize or avoid risks, take advantage of opportunities)

        You can find more information in the following links:

      • Determining product safety characteristics

        Product safety characteristics affect product design and/or production process design.

        The issue of product safety is related to special characteristics and product safety characteristics are very important for the design and production of products. These important requirements are determined during the product and production design process. For example, material hardness and tensile stress are very important safety characteristics for the durability of brake parts. These characteristics come from product design specifications, product drawing, and design FMEA.

        In addition, the hardness of the material is also affected by the heat treatment conditions in production, production parameters such as temperature and time. Thus, production parameters such as temperature and time of heat treatment are the subject of product safety and they are also special characteristics related to safety for brake parts. Another example is the tightening torque amount for seat manufacturing and seat assembly process. Screw tightening torque is also safety characteristics and can be affected by the wrong set up of production or not calibration of torque meter, both of the causes may come from the production process.

        Critical characteristics of the product and production process; it is defined by legal regulations, security, and significant important critical characteristics.  All these characteristics have different symbols according to customer-specific requirements as (R/S, CC, SC)

        All these characteristics, come from legal regulations, product drawings, product specifications, and production parameters that affect the health of production operators and the durability of the product. 

        According to the IATF 16949 standard, Product Safety is relating to the design and manufacturing of products to ensure they do not represent harm or hazard to customers. As you know customers are regulations, end-users (driver and passenger), OEM plants, the other manufacturing plants, and production operators.  The customer should not be at risk of affecting the safety of the product. These special characteristics related to product safety is determined by regulation, product drawing, and which have to be monitored and controlled at the production point affecting the safety of the product.

        All these requirements must be transferred via product drawing, material specification, DFMEA, PFMEA, Control Plan, etc to the entire supply chain, and the entire supply chain must comply with the product and production-specific characteristics for product safety.

        For more information, please read the following article:

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