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…]
ISO 9001 System Review
Now that the management system processes have been defined and associated documentation has been drafted, it is time to finish implementing the system including approval and release of all system documentation, along with completion of quality system training activities. [Read more…]
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…]
ISO 9001 Quality Objectives
Every ISO certified organization is required to define and establish their ISO 9001 quality objectives along with plans to achieve these objectives. Objectives should be aligned and focused on driving overall performance improvement throughout the organization.
Behind each major objective should be planned initiatives associated with continuous improvement activities. This serves as the “A” or “Act” part of the PDCA (Plan-Do-Check-Act) cycle. Remember that it is only those things that you measure and report that will get attention and improvement! [Read more…]
Leadership in ISO 9001
The ISO standard Leadership section (Clause 5.0) is all about the specific ISO 9001 leadership principles and requirements that your organization’s top management or leadership must fulfill. Some of the requirements spell out very tangible tasks and activities while others are a little more intangible. These include:
- General Leadership and Commitment,
- Customer Focus,
- Establishing and Communicating the Quality Policy,
- Organizational Roles, Responsibilities, and Authorities.
While some of the Leadership requirements are satisfied through other ISO 9001 requirements and processes, top management must still be knowledgeable about these requirements and the actions they must take to satisfy them. Every member of the leadership team should be able to intimately discuss each clause and demonstrate how they influence, impact, and satisfy each requirement and the associated management system processes and results. [Read more…]