How to Build the Best Quality Assurance Plan for Distributed Medical Manufacturers


    What does it take to deliver maximum quality assurance?

    The most effective medical device manufacturers commit to quality-driven processes and procedures to deliver maximum quality assurance during every step of the product development process. When paired with a quality management system, medical device manufacturers have the framework needed to guide continuous improvement efforts and orchestrate evidence-based decision making.

    Unfortunately, the distributed environment can add additional complexity to medical manufacturing quality assurance. As an industry-leading quality management software provider, we've seen how the best distributed medical manufacturers build the very best quality assurance plan.

    And we're here to share those expert insights with you.

    5 Components of a Great Quality Assurance Plan

    What is a quality assurance plan exactly? A quality assurance plan is the documented processes and procedures to ensure that products are of the utmost quality. The document outlines the exact activities that your team must follow to produce a product that both adheres to regulatory requirements and satisfies customers.

    Here are the steps to create a great quality assurance plan.

    1. Get Teams Engaged

    When discussing company culture, it's a good idea to emphasize that a shift in mindset needs to occur. Unfortunately, some medical manufacturers overlook the real value that shifting from a compliance-driven culture to a quality-driven culture brings. With this approach, buy-in across the distributed ecosystem is required.

    In this scenario, executives begin to understand that investing in the right quality management plan is important and begin to devote the resources to employee training and engagement in quality.

    2. Follow a Template

    When building a quality assurance plan, adhering to regulatory requirements should be your first priority. With the right medical device quality management system template, you can build a quality-driven culture and align with regulations.

    The fact is, templates can give your organization a fast-start baseline for a quality management system. However, while a template-based quality management system is one option for medical device startups and scale-ups, it's not necessarily the best option. We recommend investing in a cloud-based quality management system to access the structure that you need and scale as you go.

    If you're not ready for a QMS, here are some good template alternatives:

    3. Create a Timeline

    As a best practice, include a project timetable that outlines beginning and ending dates for the entire quality assurance plan. Be sure to include dates for specific activities inside the project as well. By creating a project timeline, team members can better align with key dates and deliverables.

    4. Create Roles and Responsibilities

    More than just creating a project timeline, you need to identify the tasks and activities of quality assurance and assign those tasks to specific team members. In theory, the project review authority and project manager will work together to determine the schedule for quality assurance reviews and audits.

    5. Select the Right eQMS

    Selecting the best eQMS for your life sciences company is critical to your success. Whether you're a new company getting started and need an eQMS, scaling and need to be effective and leave your homegrown system, or are a more mature organization that wants efficiency and effectiveness, your eQMS will determine the effectiveness of your processes and products.

    Qualio Powers Distributed Medical Manufacturers

    Qualio is a cloud-based quality management system designed specifically for the needs of startups and small to mid-sized businesses in highly regulated life sciences industries. Our platform offers an intuitive user experience and simple implementations with a design that's built to scale with fast company growth.

    Qualio is the world’s leading enterprise quality management system (eQMS) for medical device companies with up to 500 employees and goals of growing quickly. We can recommend several specialized medical device risk management consulting firms that work with Qualio and have an excellent track record. Start a conversation with us today, and we’ll be happy to help you find the best consultant for your needs.