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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
