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…

Preventive Maintenance

Preventive maintenance is a concept that includes care and servicing of equipment for the purpose of keeping equipment in a satisfactory operating condition.  It is designed to improve equipment life and avoid any unplanned maintenance activities.  This is accomplished through a systematic inspection, detection and correction of any developing failures before they occur.  Preventive maintenance…

Methods for Supplier Evaluation

There are a number of ways to conduct an evaluation of your suppliers.  To begin with, many organizations create a survey in which they outline various questions pertaining to quality systems.  Some companies consider ISO 9001 certification to be the best representation of control over production and quality, and therefore will evaluate the supplier based…

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…