Management Responsibility

One of the main requirements in ISO 9001 is to have a demonstrated commitment from upper management to support the quality management system (QMS) that is in place, along with working to continually improve the effectiveness of the QMS.  In this case, “upper management” refers to the individual at the top of the organization (such…

What is ISO 9001?

ISO 9001 is an internationally recognized standard that provides guidance in creating, and maintaining, a Quality Management System (QMS) within your company.  This standard can be applied to any size company, across all industry sectors.  It requires an organization to meet its own requirements, along with those of its customers and regulators.  A QMS should…

Statistical Techniques

There is a requirement in both the 21 CFR 820 and ISO 9001 to utilize statistical techniques.  According to the FDA, “Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics.  Sampling plans, when used, shall be…

Complaint Files

A requirement of ISO 9001, ISO 13485 and the FDA’s 21 CFR 820 is in regards to complaint files.  According to 21 CFR 820, a complaint is defined as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is…

Quality System Record

While similar in content to a Quality Manual, the Quality System Record is a requirement for the FDA’s 21 CFR 820.  This document must “include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s)…”  Specifically, the FDA is…

Handling, Storage, Distribution

Once product has been manufactured and packaged, there are requirements for how you handle, store and distribute the finished product.  21 CFR 820 breaks down the requirements for each of these processes.  A manufacturing company should establish procedures that will deter mix-ups, damage, deterioration or contamination from happening during handling and storage of product.  These…

Device Packaging

Usually one of the last items you think of when designing a new product, the packaging actually provides a critical function.  It is the barrier between the world and your medical device – meant to keep your product intact and functioning as designed.  Medical device packaging must be tested for stability.  This will provide assurance…

Device Labeling

Manufacturers are required to have labels for product and product labeling.  According to the FDA in section 201, a label is a “display of written, printed, or graphic matter upon the immediate container of any article” whereas “labeling includes equipment labels, control labels, package labels, directions for use, maintenance manuals, etc.” 21 CFR 820 specifically…

Document Control

Both FDA’s 21 CFR 820 and ISO 9001 have requirements for document control.  The goal with this section of the standards is to demonstrate that your quality system is compliant, that you design and manufacture products to meet design controls, and that your company is addressing risk management concerns.  The FDA typically takes the approach…

The Importance of Record Keeping

Record keeping is a critical component of any sterilization monitoring protocol. The Centers for Disease Control and Prevention (CDC), the American Dental Association (ADA), and the Organization for Safety and Asepsis Procedures (OSAP), all recommend keeping a log for the purpose of recording daily sterilization records. With each sterilization cycle, it is advised to document…