As most of you know, ISO 13485–Quality Management Systems—Requirements for Regulatory Purposes is being revised. ISO 13485:201X, as the final revision is being referred to, is expected to be available in late 2015 or early 2016. Understandably, this is causing anxiety for medical device manufacturers, many of whom are still struggling to conform to the current version of the standard. With this in mind, let’s review the basics of the ISO: 13485. In future posts, we’ll examine why the standard is being updated, and the most significant changes you can expect to see. Continue reading
Category Archives: Pharma@Risk™
#93 – CAPA SHOULD NOT BE A DREADED FOUR LETTER WORD – CINDY FAZZI
#65 – RISK MANAGEMENT: A PRIMER FOR LEAN QUALITY ASSURANCE – GINA GUIDO-REDDEN
In this month’s installment of the Quality System series, we will take a closer look at what is becoming perhaps the most useful tool in the belt of today’s Quality professionals: Risk Management.
This blog has been designed for readers whose organizations haven’t yet formally adopted this practice. The installment includes an overview of the terminology, objectives and processes involved in strengthening the existing Quality Systems with those designed to manage the risks inherent to product development and routine manufacturing and monitoring.
#60 – WHY RISK IS CRITICAL TO QUALITY MANAGEMENT – PAUL LEAVOY
When an operational risk management framework is embedded into quality management systems, the two begin to feed each other information that mutually improves both of these functions internally and in the supply chain.
Like many things in life, enterprise quality management approaches are not static. Certainly there are timeless elements of quality management strategies that have been applied for decades and will continue to be applied. But advances in computers and Web-based systems have brought specific quality management tactics to the next level. We are now witnessing an unprecedented level of access and visibility into quality management metrics and performance, in real time in some cases. Continue reading
#57 – CREATING, STAFFING, AND MANAGING AN INSPECTION WAR ROOM – WALT MURRAY
When I served in the military there was a term used that is still pretty familiar today: “sound general quarters!” When this order was issued, everyone instinctively stopped what they were doing and manned whatever station was theirs during that time. All commands during general quarters came from the war room behind the bridge of the vessel. Continue reading