Is Risk Reduction Necessary?

Performing a Risk Evaluation

After completing your Risk Analysis, the next step is to perform a Risk Evaluation.  According to ISO 14971, “For each identified hazardous situation, the manufacturer shall decide, using the criteria defined in the risk management plan, if risk reduction is required…The results of this risk evaluation shall be recorded in the Risk Management File.” Risk…

Friday Facts - Customer Satisfaction

Customer Satisfaction

ISO 9001 has identified the evaluation of customer satisfaction as one of the key measurements regarding the performance of a company’s quality management system.  There are many organizations that consider this a key indicator of corporate health. The goal of this requirement is to establish if the customer perceives that the company has met their…

Friday Facts - Production & Service Control

Production & Service Control

ISO 9001 and ISO 13485 address the concept of Control of Production and Service.  In ISO 9001, it states “The organization shall plan and carry out production and service provision under controlled conditions.”  ISO 13485 expands on this by saying “The control must be performed and achieved according to the planning requirements specified…”.  Essentially, a…

complaint box (web)

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…