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    ISO 13485 & MDR Blog

    ISO 13485 structure and requirements

    Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 requirements and structure.

    The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.

    Clause 4 – Quality Management System (“Intersection”)

    Clause 4 targets two very specific aspects of a Quality Management System: General Requirements and Documentation Requirements.

    General Requirements. In evaluation of any ISO standard, there are a few systematic requirements that are the driving force for establishment and implementation of a Quality Management System. The requirements specific to ISO 13485 include the following:

    1. Adhere to the standard.
    2. Document what needs to be documented.
    3. Maintain what is required of you.
    4. Have written procedures in place and ensure the effectiveness of the system that you implement.
    5. Consider the risk factors in all activities.
    6. Introduce steps to minimize the risks identified and aim to not cause catastrophic events.
    7. Identify how things should be done to generate your medical device and stick to those processes.
    8. Determine ways to track your activities, correct any process failures or oversights, and generate records to show all the activities are being done.
    9. Determine the requirements that you are legally bound to, and follow them!
    10. Even when outsourcing work, ensure you maintain responsibility for that work.
    11. Any systems used in your manufacturing processes should be confirmed to ensure they work as intended and don’t negatively affect your processes.

    Documentation Requirements. Most quality systems require a key component, a Quality Manual. Beyond the Quality Manual, an organization should determine the promise that they will make to ensure an environment and culture that can be consistent with putting quality first in all activities. This commitment can be captured with a policy or objective statement. The standard includes very specific requirements for both procedures and records, each of which must be fulfilled:

    1. Medical device creation should be accompanied by a file that includes product specifics and guidance on intended use.
    2. Plan for controlling documents.
    3. Plan for controlling records.

    Clause 5 – Management Responsibility (“Highway”)

    Management must demonstrate their commitment by showing they can be held accountable for the operations within their organization. They have to ensure that their focus does not deter from the needs of the end user, and that all laws are followed in the manufacturing process. Management has an absolute responsibility to support the quality policy, confirm its alignment with the laws of the country of work, and communicate the mission to employees. They have a responsibility to plan, delegate authority, and communicate effectively. They are also responsible for a periodic review of operations and improvement within the organization, known as the Management Review.

    Clause 6 – Resource Management (“Roadway”)

    Top management has a responsibility to ensure that the Quality Management System is compliant with ISO 13485 and adheres to local regulatory requirements. As a requirement within ISO 13485, top management must ensure that adequate resources are available to perform the work promised by the organization. Providing resources can refer to personnel, infrastructure, consumables, equipment, succession planning, and risk aversion. This can be as specific as controlling the daily workflow to prevent contaminants or ensuring that operations are seamless in years to come with an awareness of looming retirements. This commitment from management, although it may seem minimal, is critical to the organization’s success in medical device manufacturing and is required according to Clause 6.

    ISO 13485:2016 requirements and structure

    Clause 7 – Product Realization (“Overpass”)

    An organization must plan for the journey from conceptualization to implementation. This can include developing a process for documenting how thoughts are initiated, concepts are verified, and products are designed and developed, as well as how to verify and validate to fulfill the requirements for ISO 13485, Clause 7. Communication is critical for the design and development of the device.

    The key is to follow the process from planning to inputs, outputs to review, onward to verification, followed by confirmation through validation. Transferring ideas, controlling the design, documenting any required changes, and retaining any and all files included in the process is critical in product realization. Defining and tracking supplies, retaining critical information associated with each product, and determining how to verify these products should be clearly documented within a procedure.

    Monitoring each part of the process involves ensuring cleanliness, monitoring installment, performing the necessary service, and fulfilling the requirements specific to medical devices. Effectively monitoring and maintaining equipment, as well as ensuring that identification requirements are met for the device itself, are also components of product realization. Lastly, monitoring the effectiveness of the product as it relates to traceability, managing customer property, and ensuring preservation of product will help achieve compliance with ISO 13485.

    Clause 8 – Measurement, Analysis and Improvement (“Bridge”)

    Now that your product has been manufactured and has been released for general use, you kind of have a responsibility to ensure that the people have what they want. So, how do you accomplish that? It’s simple: you seek feedback. According to Clause 8, development of a procedure for effectively monitoring and measuring product success must include:

    • handling complaints
    • reporting events to regulatory authorities
    • undergoing internal evaluations through auditing
    • continual process and product evaluation internally
    • identifying and controlling products that don’t meet the original design requirement (nonconforming product)
    • analyzing data generated and continually improving the process

    Concluding via “Thoroughfare”

    The “roadmap” outlined above gives you an opportunity to understand both the structure and the requirements for compliance with ISO 13485:2016. With an understanding of the five critical clauses, we encourage you to explore the path for implementation.

    To see an even more detailed explanation of each clause, download this free Clause-by-clause explanation of ISO 13485:2016.

    Advisera Chany Runnels
    Chany Runnels
    Chany Runnels has a BS in Biology and an MBA with a concentration in Organizational Management. She has consulted in healthcare, industry, and government, providing roadmaps for the implementation of Quality Management Systems. She has successfully led laboratories in the manufacturing verification of medical devices, which were distributed domestically and internationally. These devices were compliant with FDA cGMP and modeled in accordance with ISO 13485. Previously serving as a Forensic Biology SME, she has been qualified as an auditor for ISO 17025/Forensic Testing Agencies and FBI’s QAS.