In the life sciences industry, maintaining a robust quality management system is crucial for sustained growth. As your company seeks to thrive in the years ahead, it's imperative to understand and address the signs of aging processes within your operations. A well-structured and future-proof quality management system not only ensures compliance with current standards but also positions your company to adapt seamlessly to emerging requirements.
Explore the insights in this blog to assess the coherence of your quality management system and learn about the impact of maintaining a consistently high standard. Adopting a proactive stance in developing your quality management system can be a game-changer for your company's performance in the industry.
What Is a Quality Management System?
First and foremost, it's crucial to review the definition of a Quality Management System (QMS).
According to ISO 9001, a quality management system is a collection of processes, policies, and procedures that empower a company to fulfill the needs and expectations of its customers while ensuring operational efficiency.
Following ISO 13485, a quality management system comprises documented processes, procedures, and policies specifically crafted to ensure the development, manufacturing, and distribution of medical devices in accordance with regulatory requirements and industry-specific quality standards. ISO 13485 emphasizes that the primary objective of a QMS is to secure the safety and performance of medical devices throughout their life cycle, from design to patient use.
What Do We Mean by Coherence?
The term "coherence" in this context denotes ensuring that each process is comprehensible to users, aligns with the business's requirements, and fulfills the criteria of regulatory agencies. Your QMS serves as your company's storefront for all "non-specialists," encompassing roughly 90% of individuals who will engage with or comprehend your operations. The intricacy of a quality management system can rapidly escalate, with different components often constructed to address immediate needs—sometimes belatedly and occasionally by individuals with roles spanning from manager to developer to maintenance technician.
The outcome? A system functioning on a small scale, within a highly specific context, where maintenance planning is integrated into an individual schedule, and management of corrective and preventive actions (CAPAs) are executed through dedicated development software. Meanwhile, document control is often managed at arms length by the quality team.
While this may be an extreme example, it unfortunately mirrors the reality faced by many. In commercialization, certification, and/or growth, upholding the coherence of your quality management system demands a substantial degree of precision.
How Can You Ensure Coherence in Your Quality Management System?
Regardless of the solution currently in place or chosen for the future, understanding the objectives of your quality management system is paramount. These objectives go beyond ensuring the safety and performance of your products; they also encompass effectively demonstrating these attributes. But how can you achieve this?
Every element of your system is intricately linked to a key process within your company. Controlling these processes demands clear, representative documentation. The more accurately your documentation mirrors your operations, the easier it becomes for those in charge to comprehend their responsibilities, fostering consistency and easing the integration of new team members.
It's a widely acknowledged fact that a company transitioning from product development to a marketable product must navigate several pivotal stages. Navigating these stages with a comprehensible system minimizes misunderstandings and frustrations. As controls intensify, questions become more precise, and challenges grow more complex, having well-documented processes ensures transparency. Processes that were previously known only to individuals involved in development must now be documented and comprehended by the entire team.
Key Takeaways
A coherent quality management system needs to be understandable, easy to explain, and fully compliant.
The implementation of a coherent and streamlined quality system demands strategic planning efforts that yield long-term benefits. Prioritizing coherence in quality management serves to decentralize information, making it more accessible and facilitating training, process updates, growth, audits, and system maintenance. Striking a balance between time invested and gains becomes more achievable when stakeholders understand and actively participate in your quality management system.
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