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  • Cross-mapping ISO 13485, ISO 15189 and other accreditation and regulatory Canadian standards

    It is really hard work, but I think it is doable. Since both standards are similar to ISO 9001:2008, maybe that is the starting point.

    Following articles can be helpful:

    • Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
    • ISO 13485:2016 vs. ISO 13485:2003 matrix - https://info.advisera.com/13485academy/free-download/iso-13485-2016-vs-iso-13485-2003-matrix
    • ISO 17025 vs. ISO 9001 – Main differences and similarities - https://advisera.com/17025academy/blog/2019/07/11/iso-17025-vs-iso-9001-main-differences-and-similarities//

    • Best approach to comply with clause 4.4.1.2

      Since the product design belongs to the customer; you are exempt from the preparation of the product drawing and design FMEA, as specified in article 4.4.1.2 of the IATF 16949: 2016 standard. Except for those you are exempt from; You should take the subjects '' a '' to '' m '' specified in 4.4.1.2 of IATF 16949: 2016 standard into your quality system.

      For example, if I give an example of product safety and critical 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.Since the design is the responsibility of the customer, the customer should show the technical drawing. But 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 products.

       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. 

      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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