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    ISO 13485:2016
    Medical Devices – Quality
    Management Systems

    ISO 13485:2016 Medical Devices – Quality Management Systems

    The ISO 13485:2016 Standard specifies requirements for a Medical Devices Quality Management System, through which organisations will demonstrate their ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

    Key requirements that distinguish ISO 13485:2016 from ISO 9001:2015 include a specific Medical Device File. This file contains documents that include descriptions of design records, manufacturing processes, product specifications, device usage guides, quality measurement criteria, levels of compliance with Regulatory Bodies and Quality Standards, and, if required, servicing and installation records.

    What is ISO 13485:2016?

    Why does an Organisation need ISO 13485:2016?

    What are the Benefits of Implementing ISO 13485:2016?

    How do I implement ISO 13485:2016 in an organisation?

    Why Choose WWISE to assist your organisation?

    Guideline Conformance Process:

    What is ISO 13485:2016?

    This international standard is based on a process approach to develop, implement and maintain medical devices – quality management system. A process can be defined as any activity that receives an input and converts it to an output. The output from one process often forms part of the input to the next process.

    Below is an illustration of the ISO 13485:2016 Process Model:

    Why does an organisation need ISO 13485:2016?

    • Organisations that are involved in one or more stages of product design, development, production, storage, distribution, installation, or servicing of a medical device, as well as the design, development, or provisioning of associated activities (e.g. technical support) are required to conform to an International Standard that regulates medical devices.
    • This global Standard is mandatory in some countries.
    • Certification verifies your organisations ability to provide medical devices and related services that meet customer and applicable regulatory requirements consistently.
    • The Standard assists organisations to ensure maintained customer satisfaction and continuous improvement.
    • The Standard allows you to align seamlessly with Unites States Food and Drug Administration (FDA) and South African Health Products Regulatory Authority (SAPHRA).

    What are the benefits of implementing ISO 13485:2016?

    • Improved customer satisfaction. The ISO 13485:2016 Standard is founded on a set of quality management principles. Customer satisfaction can be achieved by assessing customer needs and expectations and striving to achieve them.
    • Improve your processes. Using the process approach as defined in the Standard highlight’s opportunities for improvement. Confidently identify and eliminate waste within and between processes , reduce errors, and avoid rework—facilitating greater efficiency and savings.
    • Create a culture of continual improvement. With the support of an embedded culture, management and employees are motivated to improve current activities.
    • Increased employee engagement. Through this process, employees will identify improvements in their own processes/activities, resulting in increased investment in the growth and success of the organisation.
    • Global recognition. Many countries and customers require manufacturers that medical products to be certified.
    • Reduced costs of sales. This certification improves the organisations credibility, earning prospective customer’s trust and confidence.
    • Statutory, regulatory, and marketing requirements are met.

    How do I implement ISO 13485:2016 in an organisation?

    ISO Consulting & Implementation:

    We have a range of professional consultants, engineers, and registered auditors to assist in implementing and maintaining any ISO management system. Our industry expertise includes services, telecommunication, manufacturing, construction, engineering services, fast-moving consumer goods, mining, power generation, state owned companies, and government-run organisations. A good consultant takes the time to truly understand the processes of your company.

    Therefore, they can approach the implementation of ISO requirements accordingly. The cost of hiring a consultant and the time spent to implement your ISO management system will definitely pay off in the long run.

    WWISE has a 4-Phase Approach:

    • Phase 1: Gap Analysis Audit and Information Gathering
    • Phase 2: ISO Documentation, Risk Assessment, and Process Mapping
    • Phase 3: Implementation and Coaching
    • Phase 4: Certification

    WWISE provides a turnkey solution which includes templates, 1-on-1 coaching, on-the-job training, and mentorship. As a consulting firm, we do not provide certification services. However, we will guide you through the certification process and ensure that your business becomes certified.

    Why Choose WWISE to assist your organisation?

    An Organisation cannot certify to a guideline standard; you can implement the standard and receive a letter of conformity.

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