A Quality Roadmap for Therapeutics Developers, Medical Device Companies and Contract Manufacturers
The 9000 series of standards from the International Organization for Standards (ISO) is intended to define processes, goals and requirements so products and services companies will be accountable and validated for quality among all stakeholders. In the life sciences, where regulatory adherence is so critical, standards can support efforts to impart a culture of quality and manage quality as an essential element of company operations.
ISO 9001, in particular, is one of the most important quality management standards because it provides a framework for quality across all aspects of an organization, but for companies with repeatable processes, and especially for those where the processes need to statutory and regulatory requirements, they create consistency and needed conformity.
Implementing a standards-based way of developing products doesn't directly correlate to ROI, but quality managers can make the case internally for why ISO 9001 positively impacts product success and the creates a methodology for product development and delivery. Using ISO 9001 standards requires an ongoing discipline of managing all aspects of implementation, adherence, testing, documentation and auditing. Those tasked with these things can only do it with the use of an effective quality management solution (QMS).
Within the family of 9000 standards are variants that are particularly relevant. ISO 13485, for example, is a medical devices variant of ISO 9001 and is a precursor to getting market approval for companies that want to sell in Canada and Europe. ISO 14971 pertains to medical devices also and is to do with risk management.
All of these standards are based on eight main management principles that provide the foundation for the 9000 series. In our work with life sciences companies, we know that within those principles are a few essential items that will help internal champions evangelize when trying to communicate the need for implementing a QMS. They include:
Places customer needs first: Ultimately, customers are the most important stakeholders, and we know that they place quality above almost any other buying factor, including price. We see this both with our direct stakeholders(pharma, medical device and contract manufacturing customers), and the customers those companies serve. These are potentially life-saving drugs and products, and the ability to bring them to market faster and with more reliability is why we have such a loyal customer base. ISO 9001 and its principles are integrated into how we develop and deliver Qualio; customers recognize the benefits and will be motivated to become repeat and loyal users.
Establishes consistency: Once you can do something the right way, it's worth repeating. To make this point, ISO 9001 gives guidelines for process automation and repeatability. Over the long-term, this reduces costs because it instills a certain way of doing things. As this becomes baked into the company culture, there is less re-tooling or starting over. Consistency is intertwined with repeatability, and Qualio has been able to move ahead of others in the industry by providing leading-edge business process management capabilities with our QMS. This ensures that actions that can be repeated are done so through automation, while retaining flexibility to address changing issues.
Provides framework for decision making: ISO 9001 lays out a specific set of decision-making guidelines that rely on relevant data. Because it automates the process of collecting and presenting information, the organization can make effective decisions that can have the most effective impact. Qualio’s QMS is built to provide both a flexible and authoritative structure that removes "gut" feelings from the equation and therefore creates a more sound set of decision points.
Crowdsources the best intellectual property: It would be nearly impossible to have a single person who understands every aspect of product development, market factors, and sales optimization. Especially for life sciences products, where the goal is to improve the lives of individuals, it is important that the product incorporate the best thinking from those who have expertise in their respective domains. ISO 9001 seeks "...engaged people at all levels throughout the organization...to enhance its capability to create and deliver value." Collecting and using the best intellectual property within your organization translates into a product that is informed with the best science, the most effective treatment, and an understanding of how to make it successful in the market.
Encourages continuous innovation: While immediate goals call for delivery of a marketable product, ISO 9001 also encourages a mindset of continuous improvement and innovation which can lead to repeatability of best practices throughout the organization as a way of doing business. As we’ve discovered, when product planning and development activity can be tracked and retained, it provides a better foundation to implement new and better ways of building solutions.
Qualio's QMS provides a QMS that helps organizations manage all aspects of ISO 9001 to enable them to serve all stakeholders more effectively. We invite you to try it out with a free 14-day trial.