Pursuing Excellence with ISO 9001

April 16, 2019 by Todd McBride Leave a Comment

ISO 9001 Certification Audit

It’s celebration time! You completed all the work to implement your ISO 9001 management system, successfully navigate the ISO 9001 certification audit, and now your ISO 9001 certificate has arrived. You’ve certainly earned a break and a party to celebrate this great accomplishment with everyone in the organization. Sooner or later though, life returns to normal and work must be done to manage, support, and improve the management system. Consider how you will continue pursuing excellence with ISO 9001 and other operational excellence tools. [Read more…]

Addressing ISO 9001 Audit Findings

April 1, 2019 by Todd McBride Leave a Comment

Before beginning our main article topic, I want acknowledge that the EBS Quality Solutions blog was recently selected by Feedspot as one of the Top 25 ISO Blogs! You can access the ISO Blogs list here. We greatly appreciate the recognition from Feedspot and continuing support from all of our readers! Now on to our normal programming.

What Happens After Your ISO Audit?

Now that you have completed your audit, what’s next? If you received less than a perfect score, meaning that the auditor found a couple things and issued some ISO 9001 audit findings (nonconformances), you will need to address these deficiencies before receiving your ISO 9001 certificate. A perfect score (no findings) will result in immediate issuance of your ISO 9001 certificate, usually within a couple of weeks. [Read more…]

What to Expect During Your ISO 9001 Certification Audit

March 21, 2019 by Todd McBride 2 Comments

ISO 9001 Certification Audit

Wow, you’ve finally arrived at your ISO 9001 certification audit. While there will be some nerves and anxiety, if you have done all the work to development and implement your management system in a manner that best suits your organization and have not taken any shortcuts, then your assessment should be fairly uneventful. Be sure to complete any needed preparation and training activities prior to the audit to further ensure success. [Read more…]

Preparing for Your ISO 9001 Certification Audit

March 11, 2019 by Todd McBride Leave a Comment

Preparing for Your ISO 9001 Certification Audit

Prior to your ISO 9001 certification audit, it would probably be a good idea to ensure that your management system and people are prepared and ready for the assessment. At this time, we will assume that you have fully implemented your management system and scheduled your stage one assessment. [Read more…]

ISO 9001 Certification Process

February 14, 2019 by Todd McBride Leave a Comment

ISO 9001 Certification Process

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…]

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…]

ISO 9001 System Release

January 29, 2019 by Todd McBride Leave a Comment

ISO 9001 System Release

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…]

ISO 9001 System Review

January 17, 2019 by Todd McBride Leave a Comment

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 Quality Manual

January 2, 2019 by Todd McBride Leave a Comment

ISO 9001 Quality Manual

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…]

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…]