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Blog 2018-03-19T20:22:12+00:00

Part 4: Quality Management Process Design

Quality Management Process Design - Do You Need a Swiss Army Knife or a Scalpel? As a new quality system is born it receives the DNA from the current company processes and the DNA of the quality system standard selected. As the quality system is used and deficiencies are found through audits or just day to day [...]

By | March 16th, 2018|Categories: Quality Management|Tags: , |0 Comments

Part 3: Alignment of KPIs in Quality Management

Alignment of KPIs in Quality Management After the goals are defined, the next major tasks will require the management team’s full engagement. Key performance indicators (KPIs) have been used for a long time to measure the performance of the company, departments, processes, and individuals. Creating a KPI is not difficult. If you want to measure something there is typically [...]

By | March 15th, 2018|Categories: Quality Management|Tags: , |0 Comments

Part 2: Align your Quality System with Your Organization’s Goals

Align Your Quality System with Your Organization's Goals When starting your quality system improvement journey you need to know where you want to go. Since the endpoint or goal might not be clear to start with, determine at least the direction you need to go and then evolve the goal over time. Finding the right goal is not easy. Should [...]

By | March 14th, 2018|Categories: Quality Management|Tags: , , |0 Comments

Serán BioScience customized their QMS with Novunex

Serán BioScience Serán BioScience, Inc., located in Bend, Oregon, USA, provides optimized drug development and manufacturing services. The laboratory supports the development of pharmaceuticals in early stages with analytical methods, assisting in performance evaluation and creating the foundation for clinical manufacturing testing. Mandy Cameron is Quality Manager at Serán BioScience Q: What did you find as [...]

By | March 14th, 2018|Categories: Success Stories|Tags: , , |0 Comments

Part 1: Quality Management System Stuck in Average

Quality Management System Implemented, Yet Stuck in Average? Most of the companies I have seen throughout my career grew their quality management systems organically. An organic inception and growth of a quality system typically happen when a company starts to map the ISO structures to their internal processes. Since the ISO quality system standards have been developed around operating and [...]

By | March 13th, 2018|Categories: Quality Management|Tags: , , |0 Comments

ISO 13485:2016 – What’s New

ISO 13485:2016 - What's New? Short innovation cycles and a high level of regulation are typical for the medical device industry. In order to bring medical products to market, a variety of regulatory and statutory requirements have to be met. As a result of an ongoing tightening of these requirements, the newest ISO 13485 Standard has been released in 2016. [...]

By | March 13th, 2018|Categories: Quality Management|Tags: , , |0 Comments