9001 Web-based Seminars

ISO 13485 as a Quality Management System for Medical Devices - Webinar GlobalCompliancePanel This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. Thursday, February 16, 2012 10: 00 AM PST | 01: 00 PM EST  more...

ISO 13485 as a Quality Management System for Medical Devices by GlobalCompliancePanel This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...ors understand how the system works? * Will your ISO 9001 registrar ask for justification of these statistical methods? * Should you start to use these c=0 plans you have heard about? * Can you improve the process? Areas Covered in the Session: * Sampling concepts o With or without replacement o Simple or stratified sampling * The binomial  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ...successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. Why should you attend: International interest in certified quality systems is increasing. A Many foreign countries are now requesting medical device firm's supply them proof of certification to ISO 13485: 2003. To apply a CE mark under the Medical Device Directive, 93/ 42/ EEC, certification  more...

The Process Approach to Auditing - Webinar By GlobalCompliancepanel ...9001: 2000 provides a focus on the processes that comprise the quality management system (QMS). Also, the general requirements laid out in Clause 4. 1, the foundation for auditing a process-based system, are taken up for discussion at this webinar. There are eight basic processes that an organization must have to function effectively. These are: * Management of the Quality System  more...

ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel Overview: This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device  more...

Outsourced processes and ISO 90012008 - Webinar by GlobalCompliancePanel ...9001 went into effect. The literature says the new version doesn't introduce any new requirements but only clarifications to the existing requirements. One of the clarifications involves the use of Outsourced Processes in the Quality Management System. The changes clarify the organization's responsibility for conformity to all customer, regulatory, and statutory requirements. The changes  more...

Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel ... requirements in the FDAa ™s QSR, ISO 13485, and ISO 9001. After analysis of these requirements, the presentation examines available guidance documents. The FDA issued the Medical Device Quality Systems Manual to help companies implement the Quality system Regulation. Chapter 7 discusses the role of calibration systems in the QMS and helps define the regulatory expectations. ISO 10012:  more...

Auditing a Process-based System - Compliance Training Seminar by GlobalCompliancePanel There are a number of reasons for someone to attend this webinar. First and foremost they will gain an understanding of the process approach. The process approach requires management to identify all processes of the QMS, their sequence and interaction. They must ensure the effectiveness of all processes and the availability of needed resources, and monitor, measure, analyze and improve them. They  more...