Guest Speaker: Edgar Fernandez, P.Eng, CRSP, CSP, SAFEFICCIENT LIMITED
Currently, the ISO 9001:2015 has changed to a risk based approach.
We at SAFEFFICIENT created The Common Knowledge Approach™. This approach helps to increase safety and performance by tapping into the common knowledge of your team.
We have the expertise in process safety management (PSM), and have used that knowledge to implement the ICH-Q9 " Risk Management" and ICH-Q10 " Quality Management System for the Pharmaceutical Industry." Both are a risk-based approach standards.
We have helped companies to identify hazards that can impact the quality of the process and product, and have facilitated quality hazard assessments, implementation of management of change, process mapping to help establish the requirements of both standards from the research and development stage to the commercial production.
We do not lead the process of the ISO implementation but instead help the auditors, QA managers, CEO's, and president of small and big companies to (i) understand the new approach that has many elements of process safety, and (ii) how to transfer the expertise of PSM to the new ISO 9001:2015.
London, Ontario N5Y 5R6