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    ISO 13485:2016 helps manufacturers create QMS’s that ensures the quality and safety of medical devices

    From stethoscopes to MRI Scanners all medical devices need to be made to the highest quality standards, lives could literally depend on it.

    A medical device is defined as any product, such as an instrument, machine, or implant that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions. In the medical industry the quality and safety of devices is not negotiable which is why in 2003 The International Standards Organisation (ISO) published ISO 13485, Medical devices – Quality Management Systems – requirements for regulatory purposes. This standard has recently been revised.

    ISO 13485 is an internationally recognised standard aimed at organisations involved in the medical device industry. Its main objective is to help manufacturers create a Quality Management System that ensures the quality and safety of the finished product. The standard provides a step-by-step infrastructure for creating a Quality Management System and/or evaluating gaps in your current system in terms of monitoring and controlling processes.

    According to the
    ISO, ISO 13485:2016 specifies the requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

     Who can use it?

    ISO 13485:2016 is applicable to organisations regardless of their size and type. Where medical equipment is involved. Businesses of this nature can be involved in any number of the life-cycle stages including the design and development, production, storage and distribution, installation, or servicing of a medical equipment. ISO 13485:2016 is considered the best internationally accepted model a medical device organisation can implement to help demonstrate compliance to laws and regulations of the medical device industry.

    ISO 13485 vs ISO 9001

    Taking into account the main goal, ISO 13485 and ISO 9001 are essentially the same. Aside from helping companies create safe, high-quality products, other similarities include the fact that both standards use the plan-do-check-act process approach, both are customer-centred, and in order to comply with either standard, organisations will require effective processes and tools for Document Control, Employee Training, Audits and Corrective Action.

    Despite the above-mentioned similarities, it is important to note that there are significant differences between the two standards as well:

    • While ISO 9001 requirements focus heavily on consumer satisfaction, ISO 13485:2016 emphasises the safety of medical devices.
    • While ISO 9001 requires manufacturers to show ongoing improvement, ISO 13485:2016 merely asks that certified organisations effectively demonstrate the implementation and maintenance of the quality system.

    ISO 13485:2012 vs 2016

    The latest version of ISO 13485 which was published in 2016, replaces its 2012 version but is revised from its 2003 version. This is considered an evolution of its previous versions, rather than a revolution. The main differences between ISO 13485:2012 and ISO 13485:2016 are:

    • Processes for sterile barrier systems and sterilisation need to be authenticated.
    • Top management’s responsibility is more strictly defined
    • Computer software needs to be authorised when used in the quality management system
    • All medical device technical files and design and development files need to be established and maintained

    The Benefits

    Being ISO 13485:2016 certified, can help to improve an organisation’s overall performance, eliminate any uncertainty, and demonstrate a commitment to quality to both customers and regulators.  ISO 13485 can help organisations involved in any part of a medical device’s life cycle:

    • Reach new clients from all over the world.
    • Improve operational efficiency
    • Manage risks effectively
    • Improve business processes, and
    • Gain a competitive advantage

    In closing, the main benefit to being ISO 13485:2016 certified is that the health and safety of consumers is protected. While ISO 14969, ISO 14971 and ISO 9001 are similar, ISO 13485:2016 is specific to the medical device industry and is well-known and trusted by authorities, suppliers and manufacturers in the industry.

    How WWISE can help

    WWISE develops systems, repairs, maintains and improves them to ensure optimal competitiveness and efficiency for the client companies. To speak to a consultant on how we can assist your business to prepare for an initial ISO 13485:2016 certification or assist in transitioning from ISO 13485:2012, send us an email at or call us on
    08610 99473. You can also visit our website at for more information on other ISO standards we can assist with as well as other services we provide.

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