What is ISO 13485:2016?
ISO 13485:2016 is a quality management system standard. It’s similar to ISO 9001, but has a few more stipulations to help companies meet more specialized demands that come with making medical components and healthcare related products. This standard is often referred to when medical and related products are submitted for approval to government bodies that regulate healthcare, such as the Food and Drug Administration (FDA) in United States or the European Medicines Agency (EMA). Although ISO 13485 in itself is not a specific license to make a medical product, it is a clear demonstration of a supplier’s accountability and conformance to industry’s best practices when making components that are essential for safeguarding human health.
Here we take a more detailed look at the provisions of ISO 13485:2016. When a manufacturer applies these management tools correctly it benefits them in improving the quality and reliability of every product they make.
1. Risk Management
The management team has to conduct a comprehensive analysis of all relevant production and processing operations involved in making and delivering the finished product. More emphasis is given to steps that are critical to quality while analyzing. If required, additional support is taken from consultants who are experts in the field. Not only the risk is analyzed but also the possible mitigation plans are framed to eliminate the defects. The next step is to implement procedures to eliminate the source of those risks. And this means not just on a case-by-case basis but always, as a function of continuous improvement.
2. Clarification of Management Responsibilities
Breakdown of communication between individuals, supervisors and work teams is one of the primary causes of preventable errors. Therefore, the roles and responsibilities of every team member must be clear and unambiguous to reduce mistakes and achieve optimal performance. In order to clarify these channels of communication and to delegate authority and responsibility effectively, a rigorous audit of management structure is performed. This audit often reveals previously unknown weaknesses or inefficiencies whose mediation serves to enhance the quality and reliability of the supplier’s output.
3. Enhanced Training
Training systems for all personnel are essential for staying up to date with the increasingly sophisticated material and manufacturing technology used in the medical field and elsewhere. This training should be focused on the core skills that directly affect product quality. To achieve that, initial skills assessment of all personnel should be made and then dedicated programs should be implemented to immediately address any skills gaps. And this system should be well-regulated, recorded and upgraded regularly.
4. Facility Improvements
Having a well-organized factory is a core component for many quality management systems like Lean / Kaizen and ISO 9001. Not just for cosmetic benefits but a focus on upgrading the facilities goes far beyond. Cleanliness and orderliness help to quickly identify problems or non-conformances because it’s easier to spot when something is out of place. If there is a place to put all needed items and all machinery and equipment can be laid out in the most sensible and efficient way, tools don’t go missing. This also helps achieve worker safety and comfort. Beyond this, there may be some needed facility upgrades that leverage new technologies like robotics, digital product tracking or advanced metrology equipment. All of this improves the ability of the supplier to conform to the needed quality specifications of the customer, which is essential for medical device approvals.
5. Design and Development
As medical products in particular are becoming more sophisticated and complex, ISO 13485 is renewed with new standards for design and development guidelines for some product categories. This places an additional role on the manufacturer to ensure what is designed on paper actually works on the real world in a more reliable and repeatable way. This becomes more feasible when the supplier and the customer work together as partners to perfect a design long before it reaches the factory floor.
6. Control of the Supply Chain
Supply chains in the modern manufacturing world can be highly diffusing and depending on the materials involved it becomes difficult to both track and control what is incoming and what is outgoing. It is essential that all materials used to make life-saving medical components must comply with both engineering specifications and ethically responsible business practices. This can be done only when the manufacturer devises a robust system of inspection and verification for all incoming materials using scientific analytic equipment and backed up with a labeling and tracking system which guarantees that no non-conforming materials can get into the supply stream or contaminate products during processing.