As we had previously discussed, it is important and beneficial to set up a Quality Management System (QMS) while still early in product development stage. Many companies recognise this, but still find it a challenge to decide when to put in place a QMS. Most often, a good gauge would be when business operations have moved from Research & Development (R&D) stage to Design & Development (D&D).
R&D vs D&D
A frequently asked question is the difference between R&D and D&D. Understanding this difference has enabled many companies to make timely preparation to begin the proper implementation of their QMS.
Research is the systematic investigation into and study of materials and sources, in order to establish facts and reach new conclusions. Conducting R&D indicates that testing is being done on the viability of a potential product, that is usually created with an entirely new science or methodology. When your company first starts up, you are likely at the R&D stage, where most work revolves around such tests and checks of the innovative proposal. At this stage of business growth, products and ideas often undergo multiple iterations (or might even be scrapped), with many components yet to be finalised, and numerous changes expected to be made. As such, it is usually impractical to begin rigorous documentation.
When should I set up my QMS?
At the point where you are taking your discovered science and pushing it towards a design prototype, you can consider it to be past the stage of R&D. Although this is still at the early stages of your company’s growth, work done at this point is considered to be D&D of your product. This would be an ideal time to implement your QMS and set up proper documentation processes.
Product development is the turning of a discovered science into a product that a company can market and sell. It involves the entire product life-cycle, from designing and creating to marketing and selling the product. Documentation should cover all stages of the product life-cycle, as evidence of the proper considerations and work done to ensure patient safety.
Why the emphasis on documentation?
In the context of medical device companies, documentation is required as part of a proper QMS that is often in line with the ISO 13485 and the US FDA 21 CFR 820 requirements. The objective is to build a strong culture of quality within the company, with a focus on traceability of processes to ensure patient safety and consistently good product/service performance. Documentation refers to the establishing of documents, references, reports, records and more, to show the procedures and processes that your company has in place. It serves as evidence that you are actually putting in action the Standard Operating Procedures (SOPs) that were drawn out at the beginning of your QMS setup. This evidence is what auditors require during their assessments.
The extensiveness for documentation often grows together with the complexity of your product life-cycle and business processes. To ensure that proper documents are prepared and kept as supporting evidence, one needs to be clear about the activity being performed and the relevant documentation requirements. As such, it is important to be clear about the definition of your various business activities. Individual teams need to know what is to be performed and what must be recorded accordingly.
A QMS is best established and developed early. This would help your team maintain clarity as D&D continues, given the comprehensive records kept. While documentation and record-keeping might sound overwhelmingly voluminous, our Stendard Solution™ will help you streamline and enhance your document control processes. In the coming weeks, we will give you a sneak peek of this new solution, so stay tuned!
In the meantime, you can read more about the ISO 13485:2016 here: