Catastrophe Prevention

Creating a Risk Management Plan

ISO 14971 breaks down all aspects of risk management.  One of the first steps to take in creating your risk management program is to create a Risk Management Plan.  For each medical device manufactured, “the manufacturer shall establish and document a risk management plan in accordance with the risk management process.” (ISO 14971:2007)  The Risk…

Determine Needs and Opportunities

Continual Improvement

ISO 9001 has put an emphasis on the concept of continual improvement.  In the most recent version, Clause 10.3 states “The organization shall continually improve the suitability, adequacy, and effectiveness of the quality management system.”  The organization must consider the results of evaluations and the outputs from management review to determine if there are needs…

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…

CVS site

Mesa Labs Compliance and Validation Services

Mesa Labs announces Compliance and Validation Services by launching a redesigned website to better highlight the areas where Mesa services can offer the most benefit. Having been a manufacturer of monitoring and validation equipment for decades, Mesa is uniquely suited to offer calibration and validation services as well as being ideally positioned to help its customers maintain compliance.