GxP Lifeline

 

  • 3 Keys to Implement an Integrated Management System With ISO 9001

    31 December, 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.

    Full story

  • 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.

    Full story

  • 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.

    Full story

  • 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.

    Full story

  • ISO, Regulatory Requirement Changes Loom

    1 September, 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:

    Full story

  • How Training Personnel on Your Quality System Can Produce Positive ROI. Don’t Stop at the Quality Manager.

    18 July, 2017 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.

    Full story

  • 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 ….

    Full story