In the realm of medical devices, ensuring safety and efficacy is not just a priority—it is imperative. One of the key tools in achieving this goal is the implementation of the ISO 13485:2016 standard.

In today's world, where environmental concerns are at the forefront of global discussions, organizations are increasingly recognizing the importance of adopting sustainable practices. Among the various frameworks available, ISO 14001:2015 stands out as a comprehensive standard for environmental management systems (EMS). This blog aims to provide an overview of the requirements outlined in ISO 14001:2015 and how organizations can leverage it to enhance their environmental performance.

As Illinois manufacturers settle back into a “new normal” there is no shortage of responsibilities weighing on our minds. One area that can easily get overlooked as we move through this uncertain time is your Quality Management Systems (QMS). With our focus elsewhere, new procedures or training can get implemented without proper documentation. We can get behind on our internal auditing schedule. Or we lose sight of action items from prior meetings and audits.

This is an original article by Robin Friestad of Quality Time Consulting.

I’ve recently taken the plunge into starting my own business. Part of what I’m learning to do is to “sell” what I love best. Twenty years ago, I would have been dumbfounded to predict that I would want to make a living out of ISO 9001 implementations and Internal Audits. I mean – I had been through a major implementation, several surveillance audits, and a couple re-registration audits at a Fortune 500 company. They were never pleasant. Oh, it wasn’t the external registrar, it was my upper management fretting about whether we would “pass” or not. I even came into work during my maternity leave to lend some confidence to my General Manager that it was going to be ok.

This is a guest blog, written by Alec Alessandra, M.B.A, former John Deer Executive, former IMEC Board Member, and Senior Strategist of Strategic Impact Partners, and Robert Pojasek, Ph.D, Senior Strategist of Strategic Impact Partners.

Many small and medium-sized supplier organizations are receiving notices from their larger sourcing customers to implement a variety of different international standards at their facilities. These standards could include:

• ISO 9001: 2015 (for quality)
• ISO 14001: 2015 (for the environment)
• ISO 31000: 2018 (regarding risk management)
• ISO 45001: 2018 (covering health and safety)
• ISO 50001:2018 (covering energy management)
• The Ethical Trading Initiative Program

Did you know that 2.78 million fatalities occur in workplaces around the world each year? Keep your company from becoming part of a statistic and reduce your work related fatalities and injuries; learn about the new ISO 45001, released in March 2018.

By embarking on the adoption of ISO 45001, an occupational health and safety management system, you can begin to transform workplace processes that can often lead to work-related tragedies and injuries. This new standard builds on the OHSAS 18001 framework, while integrating health and safety responsibilities into the management of an organization. The new standard also focuses on risk management, which will help organizations become more proactive in ensuring safe work environments and earn the reputation as a “safe place to work”, leading to reduced injuries and increased productivity.

CIM TECH Plastics is a precision customer injection molder with extensive experience with production of small to medium sized precision components utilizing engineering and commercial grade thermoplastic materials. As a division of Tramec Plastics & Composites, CIM TECH leveraged an internal and external network of expertise to achieve their recent ISO registration success.

Written by Jim Dunbar, IMEC Marketing Coordinator

IMEC is very pleased to announce that Doran Scales, Inc. of Batavia, IL has completed the ISO 9001:2015 registration, demonstrating their on-going commitment to total customer satisfaction and quality improvement. The single most instrumental factor which has established Doran’s strong position in the market is a straight forward desire to “Provide the best customer service in the industry."

Written by Gretchen Clifton, IMEC Technical Specialist

The new ISO 9001:2015 standard places more emphasis on understanding our processes; how they impact our business from an individual process standpoint as well as how they integrate with other processes. The key to success is creating processes that are efficient and effective, integrate well with others for a cohesive flow from start to finish, and ultimately, provide the results we need.

Many companies have a high level process map that fulfills the requirements of ISO or TS, or perhaps as an outcome of a value stream mapping activity. They created it, but has it really been used for anything?

IMEC is happy to announce United Group, Inc. has successfully implemented a quality management system and become certified to the ISO 9001:2008 standard.  Achieving ISO 9001:2008 registration is an important milestone for United Group as it illustrates a strong commitment to quality at all levels of the organization including the commitment to their customers, and truly, all stakeholders. It is an on-going effort that demonstrates the dedication of all members of the team.