ISO 13485 – Quality Management System for Medical Devices


    ISO 13485 is an international standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016.

    Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. More and more, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.

    While it remains a stand-alone document, ISO 13485 is based on ISO 9001. There are some key differences and additional requirements, in addition to product-specific demands and more stringent documentation requirements. ISO 13485 calls for risk management to be in place for all stages of product realization, training and supervision of staff, project site specs, and prevention of contamination. A clinical evaluation must be carried out as part of design and development evaluation in line with regulatory requirements. The cleanliness of products and contamination control must be considered, as must the status of the product with respect to monitoring and measurement.

    A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.

    Other specific differences include:

    • the promotion and awareness of regulatory requirements as a management responsibility. Examples of market-specific regulatory requirements include 21 CFR 820, the Quality System Regulation for medical devices sold in the United States, enforced by the U.S. Food and Drug Administration (FDA), or the Medical Devices Directive 93/42/EEC, required for doing business in the European Union
    • controls in the work environment to ensure product safety
    • focus on risk management activities and design control activities during product development
    • specific requirements for inspection and traceability for implantable devices
    • specific requirements for documentation and validation of processes for sterile medical devices
    • specific requirements for verification of the effectiveness of corrective and preventive actions

    Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements.

    What is a medical device?
    A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.


    Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

    • Increase access to more markets worldwide with certification
    • Outline how to review and improve processes across your organization
    • Increase efficiency, cut costs and monitor supply chain performance
    • Demonstrate that you produce safer and more effective medical devices
    • Meet regulatory requirements and customer expectations
    • ISO 13485 is the quality management system standard accepted as the basis for CE marking of medical devices under European Directives.


    ISOLOGIC has developed a streamlined method to keep ISO implementation minimally invasive.

    How? We implement the environmental system for you, we write all the necessary manuals and then we train all relevant staff (Managers/Supervisors) how to use it. We provide your company with all the necessary forms and help files.

    While Top Management is needed in some of the sessions the majority of the Implementation work is done with the person you have appointed as your Management System Coordinator – MSC. Employing extra staff is not required – an existing, responsible staff member can easily handle the MSC’s tasks.

    We will help you to identify the right person.

    For information on the Implementation process, duration and cost please here Click Hereand complete the Quick Response Form.