GxP Lifeline

Apply ISO 9001:2015’s HLS for Improved Document Control and Compliance

5 March, 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.
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Leveraging the Value of Quality in Your Business Through ISO

11 September, 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.
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Quality Problems: Beyond Root Causes to 'Real Causes'

8 May, 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."
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Five Tricks and One Philosophy for ISO 9001:2015 Transition

27 March, 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.
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ISO, Regulatory Requirement Changes Loom

1 September, 2017 by 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:
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The Most Important Four-Letter Words in ISO 9001:2015

21 March, 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 ….
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How Training Personnel on Your Quality System Can Produce Positive ROI. Don’t Stop at the Quality Manager.

18 July, 2017 By Greg Peckford, Founder, Quality Career Advancement

Is the quality manager the only individual within an organization that requires training on quality and improvement methods? Absolutely not! In order for an organization to get the most value out of their quality program, and to ensure it is effective, is to train as many people as possible or even all employees, depending on the size of the company, on the concepts and strategies that its quality management system is based on.
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