Clearly Documented SOPs: A Key Strategy in Medical Device Quality Management

Clearly Documented SOPs: A Key Strategy in Medical Device Quality Management

At ComplianceQuest, we’ve worked with 100+ customers in the medical device ecosystem, helping them adopt a next-generation EQMS for their quality management workflow.
Thanks to this experience, we believe the following 7-step approach will be really helpful for quality leaders at medical device companies, who’re just embarking on the digital transformation journey of their quality processes:

  • Step 1: Understand the regulatory landscape
  • Step 2: Design your Quality & Compliance Process
  • Step 3: Benchmark against industry best practices
  • Step 4: Design standard operating procedures
  • Step 5: Create a Master Quality & Regulatory checklist
  • Step 6: Quality Analytics to derive insights from Quality Data
  • Step 7: Continuous Improvement

In this blog, we focus on how medical device quality leaders are building Standard Operating Procedures (SOPs).

The Role of Well Established Standard Operating Procedures (SOPs) in Medical Device QMS

A documented Standard Operating Procedure (SOP) lays down the rules for how tasks must be completed in your organization. Also, the subject matter experts along with the resources responsible to carry out the activities identified in SOPs must work collaboratively to create robust SOPs. By following this will;

  1. Give a structure to your quality systems and processes,
  2. Ensure the delivery of services and products consistently every time,
  3. Demonstrate compliance by ensuring strong document management, internal audits, and effective CAPA processes, and
  4. An EQMS like ComplianceQuest can aid the automation and digital transformation efforts of a medical device firm, by delivered a flexible, customizable and scalable EQMS platform. Based on your specific business needs for quality and compliance, the tool can be customized and designed for your process.

The Quality Leader & Team’s Role

The responsibilities of the quality leader are not restricted to motivating his team to implement quality assurance but bring about an enterprise wide change in the attitude of all employees across functions. By establishing a quality policy, laying out standard operating procedures and providing training, he ensures that all employees are:

  • Equipped with information on safety, health, environmental and operational information that can help them discharge their role effectively, aligning their actions to the quality goals,
  • Diligently following quality control in their respective functional areas consistently
  • Completing their tasks as scheduled, with minimum downtimes,
  • Ensuring socially and environmentally responsible manufacturing practices to protect the surroundings and contribute to community development,
  • Complying with the company and government regulations, and
  • Following the checklist

Rest of the Organization

Quality is not the responsibility of the quality leader or his team alone. While they provide an overall direction to the quality efforts of the organization, it has to become part of the DNA of business that the existing employees and newcomers also imbibe this culture and implement it without fail. The senior manager of the functional area must lead from the front, ensuring documentation and process control. With the cost of quality what it is, taking ownership of their processes and ensuring quality at every step of the way is critical to reducing errors, time to market and improve customer satisfaction.
Quality is the best business plan.John Lasseter, former chief creative officer of Walt Disney Animation Studios Pixar

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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