The most recent update to the ISO 9001 Quality Management System was to the 2015 version which companies had to be re-certified to by September of 2017. Replex was no exception, and our 4th quarter 2016 was focused on updating and revising our QMS to comply with this update.

There were two key differences identified in the 9001:2015 update versus the 2008 version. The first concept is the idea of Plan-Do-Check-Act as a main part of the Quality Management System. Plan-Do-Check-Act is intended to continuously improve the processes of a company with the end results of improving production efficiency and quality to the customers.

PDCA is an iterative four-step management method used in business for the control and continual improvement of processes and products. The 4 steps of PDCA are as follows:

During the plan phase, establish the objectives and processes necessary to deliver results in accordance with the expected output. By establishing output expectations, the completeness and accuracy of the specification is also a part of the targeted improvement. When possible start on a small scale to test possible effects.

During the do phase, implement the plan, execute the process, make the product. Collect data for charting and analysis in the following check and act steps.

In the check phase, study the actual results and compare against the expected results to ascertain any differences. Look for deviation in implementation from the plan and also look for the appropriateness and completeness of the plan to enable the execution, i.e., the doing. Charting data can make this much easier to see trends over several PDCA cycles and in order to convert the collected data into information. Information is what you need for the next step: act.

If the check phase shows that the plan phase which was implemented in do phase is an improvement to the prior standard, then that becomes the new standard for how the organization should act going forward. Instead, if the check phase shows that the plan phase which was implemented in do phase is not an improvement, then the existing standard will remain in place. In either case, if the check phase showed something different than expected, then there is some more learning to be done, and that will suggest potential future PDCA cycles.

For more information checkout the full article in Wikipedia –

The second major change in the 2015 version is assessing risks and opportunities of the company. Risk is defined as “The possibility of events or activities impeding the achievement of an organization’s strategic and operational objectives.”

This included identifying risks and opportunities, planning actions to address risks and opportunities, integrate in the Quality Management System a process for handling risks and opportunities and how to evaluate the effectiveness of the actions put in place to address risks and opportunities.

The Replex management team held many meetings to properly identify, address, evaluate and measure the effectiveness of our actions to handle risks should they arise.

In addition to the rigorous auditing and high quality, working systems, becoming ISO 9001 certified means a manufacturer familiarizes itself with the common international language used between suppliers and vendors with respect to processes, specifications, revision-level control, nonconformance, and corrective actions. International customers or suppliers may not even speak the same language, but they will be able to communicate clearly through this standard. Suppliers and customers considering working with an international partner should insist on one that is ISO 9001 certified, to ensure that when it comes to these crucial issues, both parties are “on the same page”.

A manufacturer that has invested the significant time, energy, and resources required to achieve ISO 9001:2015 update certification has met exhaustive standards for a proven quality-management system and demonstrated to an independent third party that they’re working to improve it every day. The end result is both a better product and a better service to the customers.