ISO9001:2015 Big Changes. Big Challenges. Bigger Questions
Big Changes. Big Challenges. Bigger Questions.
Nearly 15 years ago, the ISO9001 standard underwent a fundamental change. It shifted the focus of managing quality from a “shopping list” of 20 requirements to a systems approach. ISO9001:2000 centered on the closed loop principle of Plan, Do, Check, Act as its engine and Process Control as its transmission. In 2015, its mandate will grow, institutionalizing the use of process control techniques and performance monitoring and will encompass leadership, risks/opportunities and the interests of other interested parties (beyond the immediate customer). At the same time, the documentation training wheels will come off: no more manual, no more mandatory procedures and say goodbye to “preventive actions” which are replaced by risk based thinking.
Join us for a complimentary webinar, “ISO9001:2015 Big Changes. Big Challenges. Bigger Questions” We will highlight the changes, address the challenges and answer as many questions as we can.
About the Presenter
Charles J. Scalies is the founder and President of Source4Quality, Inc. Since 1991, Charles has been assisting and guiding MEA member firms in implementation and augmentation of quality systems to meet ISO9001, ISO13485, 21CFR820 and CMDCAS. He also trains internal auditors and conducts internal audits on behalf of Source4Quality customers.
He is also Managing Director of QECUS, facilitating ISO9001 certification audits in the USA by QEC Certification, a UKAS accredited certification body. Charles is also a lead auditor for QEC Certification.
MEA’s “Trending Topics” webinars are 30 minute online discussions with MEA Experts available to MEA Members only. If you are not a Member, learn more about an MEA Membership.