The ISO 13485 medical device guidelines were put into place to standardize the production industry and satisfy the customer. ISO 13485 is a quality management standard that is used as a guiding principle for businesses all over the world. In addition to representing a stamp of approval that customers use to qualify their business, this standard is fundamental in the pursuit of innovation. The system is not designed to drag a company down in policy changes. Rather, it trims the excess and makes the company leaner and more accountable. Here are 5 facts that show the ISO 13485 to be a beneficial addition to medical device production.

Fact 1: Ridiculous jump in memberships puts ISO on the map

The ISO 13485 standard for medical devise manufacturing cannot be ignored. The number of participants speaks for the popularity of the name and public respect for what they do. ISO registrations increased a whopping 61% from 2005-2006! While these numbers are global, they are steadily building momentum and ISO guidelines stand poised to become the international standard in product quality management.

Fact 2: The woman in the red dress

Nothing makes a component manufacturer look more attractive than the stamp of approval of ISO 13485 compliance. Companies that are buying components to build their final product want to know that their vendors are in adherence to regulatory guidelines. Imagine your client getting audited. When, not if, the auditors follow their supply chain for discrepancies, everything must be in order. This endorsement means the company checks out, so to speak.

Fact 3: Not out of the woods yet

Registering for the ISO 13485 medical device standard and getting the company ship-shape is a very important step, but there is still more to do. The legal side represents a very important aspect of operations and must be fulfilled separate from ISO. The FDA is the biggest watchdog on the block, submitting to their Alpha status is wise.

Fact 4: The younger brother is more free-spirited

ISO 9001 is the elder, but still widely accepted, installment of quality management protocols from the International Organization for Standardization. These guidelines called for a company to demonstrate continuous improvements over time. This was well-meant but ineffective evidently, as the newer version permits the achievement of excellence followed by the consistent maintenance of the processes. Once the manufacturer has accomplished an effective and high-quality product, they need simply maintain it.

Fact 5: A lean, mean, manufacturing machine

As a determining factor for approval by the ISO, manufacturers must look within to meet strict process efficiency standards. This works in a domino effect of positive effects to cut the company’s waste and streamline labor, keep the costs of production low, and allow for competitive pricing.

The ISO 13485 is an improvement in quality management standards that benefits everyone in the chain from the medical devise and component manufacturers to the consumers at retail stores. These five facts shed light on the standards that are responsible for helping the industry improve the quality of medical devices.

To learn more about ISO 13485 and how it impacts your projects, live chat with one of our qualified staff at