How ISO 13485 Helps Medical Device Manufacturers with Quality Products

The medical device industry is one of the fundamental sectors of every economy that directly caters to the health and welfare needs of people. Manufacturing every type of medical products is highly regulated. Each must adhere to certain quality regulations to ascertain customers that their treatment or care are never be compromised with substandard products or devices. In such a backdrop, achieving the ISO 13485 certification is considered a benchmark step for any medical device manufacturer. The ISO 13485 standard specifies a set of requirements for establishing a Quality Management System (QMS) for the manufacturers which helps them to produce quality and reliable devices.

Any manufacturer who intends to produce and sell medical devices or any intermediate parts is going to benefit from the ISO 13485 certification. It is also equally beneficial for the service providers who offer medical-related services.  Seeking the certification helps them to adhere to quality production besides aligning their products with customers’ needs.

Being a top-quality assurance certification, ISO 13485 aids medical manufacturers in rewarding ways. Let’s find out how.

Streamlines Production Processes

A QMS is established based on ISO 13485 requirements and quickly compels the manufacturers to standardize their product development processes. The processes include everything from start to end, i.e., procurement of raw materials and product designing, prototyping and product development, product validation, packaging and distribution, installation, and maintenance services. When all production processes are executed with a definite approach with proper documentation, there is better efficiency which results in better quality outputs.  Moreover, the streamlining of processes ensure more timely delivery of the products, which is a prerequisite for medical device manufacturers to sustain in the industry.

Calls for Uniform Responsibility by the Management

Implementation of a formalized QMS requires the constant and unfailing commitment of the management of organization. The management leaders should be involved in structuring, developing, and implementing the QMS, aligning with the patient needs and regulatory requirements of the ISO 13485 standard. They can seek assistance from trained ISO consultants who know every aspect of the standard and can best help you understand how to develop your QMS meeting its requirements. When top leaders or managers are involved in the planning and functioning of a QMS, it works efficiently ensuring quality in the products. 

Helps Avoid Product Recalls

One of the top benefits of having an effective QMS is prevention of faulty devices and hence, their recalls.  Nearly, half of the device recalls are related to flaw and inefficiencies in the product development processes. A QMS not only supports the production processes but also evaluates the inputs and customer requirements. It also implements certain regulations on the supplier processes to ensure that all inputs are of great quality too. A QMS also helps in ensuring that all customer requirements are met by the end products by regulating the production as well as inputs. Hence, any flaws and inadequacies are avoided in the products with the QMS and so a manufacturer can significantly reduce its product recalls.

Leads to Continuous Improvement

Measurement and analysis of the performance of medical products over time is essential for a manufacturing organization to make sure their QMS is effective. It is also a necessary condition for maintaining the compliance of QMS with the ISO 13485 requirements. Performance evaluation is completed with post-production feedback from customers (i.e., complaints from patients and healthcare organizations). Apart from post-production feedback, there are other ways to evaluate the quality performance such as internal audit reports, analysis of sales figures, surveys, monitoring processes, and measuring consistency in products. Using various methods of performance evaluation helps in the continual improvement of QMS with application of corrective and preventive actions. No doubt, an improving QMS also results in better quality devices with time.

Quality must be always the priority of medical device manufacturers as their products are meant to fulfill the health emergency needs of the people! Achieving the ISO 13485 certification helps the manufacturers to streamline their production procedures and ensure minimal defects in their products via a strong QMS. Compromising on the quality of medical products comes with heavy costs i.e., life and safety of humans along with reputation damage. Fortunately, with this ISO certification, manufacturers can assure the quality of their products and survive well in the market.