what is the difference between iso 13485 and 21 cfr 820?

In the case of Section 820.72, Solumina’s Tool and Gauge Management system allows for the establishment of procedures to calibrate, inspect, check, and otherwise maintain tools and measuring equipment.

Solumina is an integrated, configurable, and easy-to-use Quality Management System (QMS) and a Manufacturing Execution System (MES) software solution that is designed to facilitate compliance with 21 CFR Part 820 and other FDA regulations, including 21 CFR Part 11 electronic signature requirements within a single integrated software suite.

Manufacturing Operation Management (MOM) as a Solution for Enforcing FDA Regulations in Medical Device ManufacturingĪ better solution is to use a Manufacturing Operation Management System (MOM) system, such as iBASEt’s Solumina, to enforce the FDA regulations. This lack of enforcement introduces risk into the process and puts satisfaction of 21 CFR 820 requirements into question, while introducing a potentially time consuming rework to correct the problem. When someone on the plant floor grabs a tool to use, they know it must be a certified tool, but nothing in the QMS stops the employee from using a tool that is not certified. This section covers inspection, maintenance, and testing equipment to provide certification that the proper tooling is being used in the medical manufacturing process.Ī QMS will tell the manufacturer that it must always use certified equipment, and indicate the tests and procedures needed for certification, but the reality of the shop floor is that there are often multiple tools at hand, some of which are certified, and some of which are not. Section 820.72 of the regulation is a good example of the problem. Although 21 CFR Part 820 and 21 CFR Part 11 spell out the rules and regulations for quality that a medical manufacturer must meet, will a Quality Management System (QMS) alone really satisfy these critical requirements? Documentation Versus Enforcement: Why QMS Alone is Not EnoughĪ QMS will document everything the FDA stipulates in its quality regulations, but falls short, because it cannot enforce them on the plant floor. These regulations outline the practices that govern all methods used in the design, manufacturing, packaging, labeling, storage, installation, and servicing of all medical devices.

These regulations are similar to ISO 13485 standards for Quality Management Systems (QMS), but are not the same. The FDA requires medical device manufacturers to implement quality systems that meet the regulations found in 21 CFR Part 820 and 21 CFR Part 11.

Food and Drug Administration (FDA) regulations. Manufacturing Operations Management (MOM) is a key solution for medical device manufacturers striving to satisfy complicated U.S.

What is the difference between iso 13485 and 21 cfr 820?