ISO 9001:2015 Quality Management System Certification: Basic Steps to Certification

Getting certified to ISO 9001:2015 is relatively straight forward for most organizations. Obviously, organizations vary tremendously by size and complexity but the ISO 9001 standard is designed to accommodate companies of all shapes and sizes.

Here at Wilkshire Consulting we work mostly with small to medium business and specialize in helping organizations get certified quickly and efficiently.

During the initial consultation with our clients we collect some key information to determine the project scope such as the organizations size, structure and its core processes.

Outlining the organizations processes and activities are one of the first steps in determining scope of certification. Determining what to include in the scope is critical as it will be listed on the ISO 9001:2015 certificate. Some processes may not be relevant to the organizations customers and may be intentionally left out of the organization scope of certification.

An example scope statement could be: Providing Design, Machining, Fabrication, Assembly and providing manufacturing services to Various Industries.

From the scope we can then begin to perform process analysis on each process to determine how the organization controls any quality risks. This will include looking at the process step by step to determine where issues and quality defect can arise.

The next steps will be to establish the quality management system (QMS) documentation if there is not already a documented system in place. Quality related documentation such as policies, manuals, standard operating process, and work instruction will be reviewed and put in place as needed.

Keeping it simple is important. We do not want to create extra work that is unnecessary to maintain the quality management system. We focus on keeping the system small and lean. A solid QMS should help the organization and not hinder its forward progress.

After establishing the QMS documentation it’s time to implement the system. Training individuals on any new or revised documentation is key. We need to ensure everyone is on the same page and that quality risks have been address effectively.

The last stage of the certification project is to ensure that all of the documentation and implementation is actually in place and working. During this period, we check the system with compliance evaluations (as applicable), internal audits and perform a management review to ensure that top management is informed and understanding the performance of the QMS.

At this point, the organization is prepared for the 3rd party certification audit. The certification audit consists of two separate audits. The stage 1 or document review audit and the stage 2 implementation audit.

These audits are typically scheduled roughly 3-5 months out from the project start date. This gives us adequate time to ensure that the organization is ready and prepared for the audit.

If you are interested in learning morning about ISO 9001:2015 Certification please reach out to use at info@wilkshireconsulting.com