August 4, 2020
by Sarah Beale, Staff Writer, MasterControl
Companies that were prepared with good quality management have fared better during the pandemic. ISO 9001 in particular has proved inadvertently helpful in adapting to disruption. To see how ISO connects to COVID-19, we spoke to Debby Newslow of D.L. Newslow & Associates.
December 31, 2019
by Christine Park, Founder and Owner, Christine Park and Associates
Life sciences companies that implement an integrated management system (IMS) can provide both improved compliance with ISO 9001:2015 while also better aligning your organization’s quality system and business model. Learn how to harmonize your systems.
March 5, 2019
by Mike Rigert, Staff Writer, MasterControl
ISO 9001:2015 is currently a key focus for transition for many life science and other regulated industry organizations. The high level structure (HLS) format within the standard has explicit requirements and when implemented with a robust quality management system (QMS), can help companies improve their document control processes and compliance levels.
September 11, 2018
by Christine Park, Founder and Owner, Christine Park and Associates
Rather than viewing ISO as a burden, think of it as a standard upon which you can build a foundation for the sustainability and growth of your business. Learn how to use ISO as a catalyst to align a quality management system (QMS) with the strategic direction of your company.
May 8, 2018
by David Manalan, Principal, INQC Consulting
Root cause analysis and corrective actions plans work well for solving quality problems, but how do you prevent quality incidences altogether? You have to dig deeper and investigate what David Manalan dubs the "real root cause."
March 27, 2018
by Colin Gray, Management System Consultant, Cavendish Scott
Transition to the new version of ISO 9001:2015 is upon us. Many have put it off for a whole host of reasons, and we are now at a point where we all need to act. Differing opinions exist about how easy or how hard the changes will be, but many factors determine that degree of difficulty.
September 1, 2017
B. Christine Park, Consultant, Christine Park & Associates
As we near the end of the first quarter of the new year, it’s time for everyone to get really serious with transition plans to the new ISO quality management systems standards and other regulatory requirement changes. Here are a few of the recent changes:
March 21, 2017
by Christine Park, Consultant, Christine Park & Associates
Most organizations are well under way with the transition to the new ISO 9001:2015. As such you should be very familiar with the emphasis on two four-letter words found throughout the document ….
