ISO 9001 System Launch

February 5, 2019 by Todd McBride Leave a Comment

ISO 9001 System Launch and Confirmation

As you are launching and implementing your ISO 9001 management system, it might be a good idea to review, confirm, and if needed, update some key activities and artifacts that were created along the way. Take some time to consider the full extent of the management system that has now been implemented along with the results of your internal audit and management review as you complete this exercise. Once your reviews and updates are complete, but sure to update any needed documentation. [Read more…]

Application of ISO 9001 Risks and Opportunities

December 17, 2018 by Todd McBride Leave a Comment

ISO 9001 Risks and Opportunities

Risk management has been prevalent in many different industries (banking, insurance, etc.) for decades but has gained significant visibility and traction in other industries as a fundamental business practice over the past ten to fifteen years. Industries such as pharmaceuticals, medical device, and aerospace adopted a risk-approach within their management system requirements back in the early 2000’s and emphasis on risk continues to increase within these and other industries. [Read more…]

ISO 9001 Corrective Action

October 29, 2018 by Todd McBride Leave a Comment

ISO 9001 Corrective Action (Nonconformity and Corrective Action)

Things go wrong within any organization and a formal corrective action process provides a systematic way to capture, assess, and correct issues when they arise. The requirements defined by ISO 9001:2015 (clause 10.2) allow for correction of the immediate problem (containment & correction) and then provide a method for discovering the actual cause of the issue (root cause investigation) and implementing changes to ensure the problem doesn’t happen again (corrective action). The process then asks us to revisit the solution at some point in the future to verify that the solution worked and didn’t create some new unforeseen issues (effectiveness verification). The data and outputs of the process are fed back into the organization’s planning and improvement processes (risk management and performance evaluation). [Read more…]