Overview
Product Testing
Customer Service



Overview
In order to achieve the above dynamic, Microflex Corporation has implemented an internal quality system that is compliant with ISO 13485:2003. Via the process of implementing and maintaining a Certified Quality system we have introduced three “C’s” as main elements into the Microflex business process; Control, Consistency, and Continuous improvement of both our Product and Customer Service Quality Processes. The ISO 13485 model that we base our Quality System on is a standard that is specific to Medical Devices, and is used when an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices. Additional requirements include; more stringent detail regarding technical files, complaint handling, work environment, risk analysis, identification/traceability and record retention to name a few.

Product Testing
The Quality Process begins when a batch/lot of product is tested in manufacturing for compliance to applicable ASTM standards. Results of product testing including physical measurements of weight, length, palm width, cuff width, cuff thickness, palm thickness, fingertip thickness, ultimate elongation, tensile strength, powder content, protein content and leak, are recorded by the Microflex Quality Department for compliance to Product Specifications. Product specifications set by Microflex are, in many cases, more stringent than the industry accepted standards set by Regulatory bodies.

Our attention and analysis of product quality is a necessary component in our efforts to continually advance customer satisfaction and the technology of thin film hand protection.

Customer Service
All of our Quality System Processes that touch our customers are trended and analyzed to ensure that our Customers are receiving the best and most consistent service possible. We measure our order taking processes to ensure that we are getting the order right the first time and that all of our customers are treated with the respect that they deserve. We also measure the incidents in our warehouses and shipping methods to identify activities that cause problems for our customers. We use this information to correct our systems to eliminate these errors and problems. One of our most important programs is Complaint Management.

The Microflex Complaint Management System is defined as:

A formal documented system for the handling and processing of customer information inquiries and complaints. This system is based on two major activities: providing customer satisfaction and investigation into product complaints.

The first measure of successful complaint management is to ensure that the immediate problem reported by the customer is resolved to their satisfaction. The Quality Assurance (QA) Department ensures that the customer issue is resolved within a 10-day time frame and all complaint calls are answered with messages returned within 12 hours of the initial customer contact.

• All Sales Service Representatives are trained to address customer complaints. The first action taken is to assess the problem and make recommendations to reduce customer discomfort.
• Adverse Reaction Calls are taken and resolved by two full time Quality Assurance team members who are trained and dedicated to ensure that customers’ health issues are taken seriously and handled in a timely manner.

We notify our Manufacturing team of every complaint received in an effort to promote stringent attention to product quality by our manufacturers. If warranted, documented processes exist for forwarding results of in-depth investigations to manufacturing and requesting corrective and preventive actions based on identified product non-conformances.

Trending of complaint issues are generated and reviewed on a monthly basis in order to identify unfavorable complaint trends. QA documents complaint trends and reports this information to senior management frequently. One of the greatest benefits of our Complaint Management System comes from trending and analyzing our customer concerns. This allows us to ensure that our Sales personnel are informed about customer issues in a timely manner and can provide the best possible feedback to our customers. In addition, this information is used by our R&D team to continually improve our product line.