International Organization for Standards (ISO) was created so that companies would have a consistent way to ensure products and services were created to be safe, reliable and of a good quality. These standards provide a way to help organizations continuously meet and exceed their customers’ needs. They also provide a stepping stone to meeting regulatory requirements by identifying the processes necessary to implement a Quality Management System within any type of company, no matter how many people are currently employed.
ISO has over 19,500 standards, which touch on almost all aspects of daily life. According to the ISO website, “They help to harmonize technical specifications of products and services making industry more efficient and breaking down barriers to international trade. Conformity to International Standards helps reassure consumers that products are safe, efficient and good for the environment”.
An ISO certified company is able to access new markets, facilitate free trade, and level the playing field for developing countries. By implementing, and adhering to, ISO a company is better able to:
- Meet customer requirements
- Generate more revenue and business
- Improve company and product quality
- Increase customer satisfaction with manufactured products
- Describe, understand and communicate your company processes
- Develop a professional culture and better employee morale
- Improve the consistency of operations
- Provide focus for management and employees
- Improve efficiency, reduce waste, and save money
- Achieve international quality recognition
Mesa Labs’ BI Division is certified to the following Standard:
- ISO 13485: Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes (Bozeman and Omaha are both certified to this standard)
Mesa Labs’ BI Division claims to manufacture BIs according to the following Standard:
- ISO 11138-1: Sterilization of Health Care Products—Biological Indicators—Part 1: General Requirements
Mesa Labs’ BI Division references the following Standards in some of our procedures (meaning we claim compliance with them within the scope of the procedure):
- ISO 14971: Medical Devices—Application of Risk Management to Medical Devices
Let’s talk biological indicators!
Talk with one of our experts to get your questions answered and see how we can help you solve your BI pain points.