Compliancehelp Consulting, LLC

 Product quality is a key priority which manufacturing businesses always strive to achieve. It certainly becomes an essential attribute if you’re in the medical device manufacturing industry. Even a minor defect or flaw in the products can become extremely fatal for patients or even healthcare professionals using them. As a medical device manufacturer, it is your responsibility to ensure that all your products are quality-oriented and will deliver superior performance. Though you might often face difficulty in understanding or identifying the key parameters of quality estimation of your products, following the guidelines as stated in the process of the ISO 13485 certification can be of great help for you. Want to find out how? Let’s dive deeper into what this certification/standard is all about.   The ISO 13485 standard: What is it ISO 13485 is a quality management standard specifically designed to help the medical device manufacturing industry for delivering superior quality ...

 The ISO 9001 standard defines the requirements and guidelines for implementing the Quality Management System (QMS). Investing in it has become a necessary strategy for organizations today in the competitive business environment because it helps them to exhibit their firm commitment to the best quality practices and deliver high-quality products or services. Implementing the ISO 9001 quality management system is quite an intricate procedure for your organization which needs the involvement and proactive participation of top management. The role of management is also specifically outlined in the requirements of the standard. This blog is going to define them in simple terms. If you own a business, this blog will be very helpful for you. You will learn here about the specific roles and responsibilities you have as a business manager in getting the ISO 9001 compliant QMS.  Roles of the Business Managers in Implementation of the ISO 9001 QMS Examining Processes While the QMS need...