Performance Excellence for Small Business
The final few articles in the EBS DIY ISO 9001 series will provide guidance through the ISO 9001 certification process. We’ll start with an overview of the entire process in this post, then delve deeper into the topic in future articles. [Read more…]
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…]
Now that you have all your processes defined and documentation approved, it is time for you ISO 9001 system release and “go live”. Rather than just pushing the button and hoping everything works, you might want to turn this new system on in a planned and controlled manner. Consider a “soft-launch” approach that allows you to test parts of the system while making changes and improvements where needed. [Read more…]
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…]
It is hard to believe that it’s been a full year since we started out current article series (DIY ISO 9001 Implementation). While we initially thought we could present all the needed information in twelve months, it looks like this series will continue a little longer. Our goal is to complete this body of work by the end of March.
Today we wrap up the actual ISO 9001 system development work with this article and then shift our focus for the remainder of the series to system implementation and certification activities. The final development piece is creation of a formal “ISO 9001 Quality Manual”. While optional, this document can still provide value as a key part of the management system by providing a repository for high-level management system information or processes that don’t warrant a separate procedure. [Read more…]
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 Context of the organizationAs our ISO 9001 DIY series continues, we will use the next three articles to explore “strategic” activities within the organization. Every business needs to execute and complete some level of planning to succeed and grow. Those organizations that don’t plan usually don’t succeed, or least struggle to grow or even stay solvent and viable. Because of this, ISO 9001 has added some new clauses which challenge organizations to take the first steps towards strategic management activities. This article explores the processes required to satisfy the following ISO 9001 context of the organization requirements:
The purpose of ISO 9001 management review (clause 9.3) is to provide a forum or platform for executive management (leadership) to review and understand the current performance of the management system and organization, and where needed, make changes and improvements. [Read more…]
What gets measured gets done, and in this case, improved. There is no way to know what aspect of your company that needs to be fixed or improved if you don’t first measure it. This means measuring the right things in the right way and reporting the results to those who can drive changes. As we continue with the EBS DIY ISO 9001 implementation series of articles, let’s dig in and take a look at the following ISO 9001 improvement clauses:
Improvement is generally accomplished through the application of several other clauses starting at the highest-level business and quality objectives (ISO 9001-6.2), management system changes (ISO 9001-6.3), management review (ISO 9001-9.3), and corrective action (ISO 9001-10.2). [Read more…]
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…]