Medical Device Quality Management: Designing the QMS Workflow is Critical

Medical Device Quality Management: Designing the QMS Workflow is Critical

In one of our earlier blogs, we wrote about the first step that is needed to build a robust QMS workflow for your medical device company. Even before we get started, the key is to understand the regulatory landscape. This includes understanding the finer nuances of the requirements of ISO 13485, FDA Software Validation, European Union’s MDR and IVDR, etc.

Once that is done, we need to design a robust, data-driven workflow for quality and compliance. In today’s day and age, it is a no-brainer to use quality as a key parameter to drive competitive advantage and not just try to meet compliance requirements.

In this blog, we share some best practices to design a quality and compliance workflow in the medical device industry.

Designing a QMS Workflow for a Medical Device Manufacturing Company

An enterprise-wide quality management system like the cloud-based solution from ComplianceQuest can facilitate meeting the quality goals of the medical device manufacturing company. But, before choosing one, an organization must identify its quality goals based on the maturity level of the company. Based on that, it will have to establish a process that meets a few prerequisites.

Also, there should be an assessment of the status of the current quality practices and areas that need improvement. This will facilitate the development of the quality goal and designing an efficient but end-to-end quality process. The goals should be delineated as a quality policy and detailed in a quality manual elaborating the scope, procedures, guidelines and checklists for implementation and measures for continuous improvement.

The policy will delineate the procedures as required by the compliance standard, enabling effective planning, operations, monitoring and control.

Some of the metrics to measure success would be:

  1. Financial Performance,
  2. Product Quality,
  3. Process Improvement,
  4. Customer Satisfaction,
  5. Market Share, and
  6. Employee Satisfaction

In order for your EQMS journey to be successful, there are two prerequisites:

  1. There has to be a serious commitment from the top management to drive the digital transformation of the QMS workflow for the medical device manufacturing process.
  2. This vision and passion for quality must be spread across the enterprise.
  3. Every stakeholder in the medical device manufacturing lifecycle including suppliers, manufacturing personnel and customer teams must be committed to a world-class quality culture.

Maintaining documents and records of every process and every revision is essential even for compliance needs. While it may seem like additional work, it is beneficial for the organization in the long run and so needs to be part of the process being designed.

Training to be able to follow the quality process at every level is essential for the organization to meet its quality goals. It is not only about having the requisite skills for the task at hand, but also for following the processes as laid down in the policy. A good EQMS will have a robust document management and training solution, one that will ensure a culture of quality spreads far and wide across the enterprise.
Here’s a short checklist to make sure your EQMS journey starts off on the right note:

  1. Define a quality policy
  2. List down all key metrics that must be measured and tracked
  3. List out key owners and stakeholders for each and every quality process
  4. Map and integrate your QMS workflows across all activities of the enterprise
  5. Last but not the least, define quality objectives and drive continuous improvement

In this whitepaper, we share “A 7-Step Guide to Quality & Compliance for Medical Devices Companies” based on ComplianceQuest’s experience of serving 100+ customer customers in the medical device space.

Read it here:

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