Focused on the Design and Manufacturing

What is ISO 13485?

ISO 13485 is a stand-alone document that is similar in subject to ISO 9001, but with a direct focus regarding the manufacture and design of medical devices. There are a few key differences between the two standards, though. ISO 9001 has requirements for continual improvement of a company’s QMS while ISO 13485 just requires the…

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…

Quality Policy

Another item that is required by both 21 CFR 820 and ISO 9001 is the Quality Policy.  Though it is jointly written by management and quality experts, the process of writing a Quality Process is a beneficial exercise for management as it has them focus on systems and how the company operates.   This document…

cGMP

A frequent term thrown around most manufacturing companies is GMP (also called cGMP).  While most people seem to have a vague understanding of what Good Manufacturing Practices (GMP) are, many do not have a clear grasp of what the requirements are.  To start with, GMP is a system that provides assurance to customers that products…

Customer Requirements

As customers are the driving force behind any business, it makes sense to make sure they are taken care of.  Does your company have processes and/or procedures in place to identify your customer’s requirements?  For medical device companies, there are regulations in place from the FDA and ISO to make sure there are practices in…

Why Calibration Matters

The concept of equipment calibration is an important one throughout FDA and ISO requirements.  ISO 9001, section 7.6 discusses it in a broad sense, while ISO 17025, “General Requirements for the Competence of Testing and Calibration Laboratories”, is specifically about calibration.  In 21 CFR 820.72, it’s stated that “Calibration procedures shall include specific directions and…

Identification & Traceability

While identification and traceability are a requirement of 21 CFR 820, ISO 9001 and ISO 13485, it also makes good business sense to take this approach.  Each of the standards have a requirement for manufacturers to have product identified at all stages of its lifecycle (receipt, production, distribution, etc.).  The goal of this requirement is…

Quality Plan

In 21 CFR 820 Subpart B, the FDA states “Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured.  The manufacturer shall establish how the requirements for quality will be met.” A quality plan states the goals your company has to improve…

FDA Inspections

If your company holds a 510(k) on a device, the FDA may perform an inspection of your facility for any number of reasons including routinely scheduled investigations or response to a reported problem.  These inspections are supposed to happen at least once every two years.  There is no requirement, though, for the FDA to give…

Device History Record

The FDA requires manufacturers to maintain Device History Records (DHR).  Within ISO 13485, there isn’t a specific requirement for a DHR, but it does require the manufacturer to create all of the individual records the FDA requires the DHR to contain.  The Device History Record is meant to be a collection of records containing all…