At R&Q, we are seeing firsthand how heavily impacted companies of all sizes are by the volatile global markets brought on by the COVID-19 pandemic. To assist our country’s more vulnerable businesses, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed in March, thereby permitting the U.S. Small Business Administration’s (SBA) to initiate the Paycheck Protection Program (PPP). What better use of this program than to spend this time having employees “Sharpening the Saw” while simultaneously gaining a competitive advantage by focusing manpower on improvements and working toward ISO 9001:2015 Quality Management Systems implementation.

For some companies, production levels are at a record-breaking high, where others have come to complete halt due to a lack of demand and help is needed now to provide employees with security during the next few months. You should be looking for ways to embrace Stephen Covey’s principle of “Sharpen the Saw”! Companies looking to capitalize on the program can utilize the economic downtime to conduct some “self-care” upon the internal structure of your business. This approach allows your company to maintain a level of employee engagement, while also driving initiatives that will build a competitive advantage within your industry.

Now is the time for your company to improve your business processes and bottom-line long term. We recommend strongly considering the immense benefits of implementing the internationally recognized ISO 9001:2015 Quality Management Systems (QMS) program. This program will provide a structured approach to help your team identify critical business processes, document, improve, apply metrics and enable management measurements. The best benefit of implementing this system is, above all, efficiency. Eliminate the areas of your process that cause mistakes, delays, and inefficiencies by training your team on the globally accepted ISO 9001:2015 approach.

Do not overlook the opportunity to reengage the workforce on these initiatives – who better to utilize than the small army that you have amassed and trained to understand, build, deliver and/or maintain your product or service? Take the time to reflect, understand and improve your business’ processes and procedures and how they interact throughout the company, in turn leading to increased productivity and improving your bottom line. When the quarantine orders are lifted and your customer orders are piling, you will be steps above the competition with your ISO 9001:2015 Quality Management Systems training in place and ready to make your customers thrilled!

Some focal process improvement areas that can be capitalized on are:
• Understanding where processing bottlenecks restrict maximizing throughput
• Identifying the hidden “rework loops” that are costing extra time and materials
• Looking for misaligned or out of control processes that waste raw materials
• Conducting past due maintenance to prevent unnecessary downtime

Some successful quality methodologies to train upon to maintain positive results:
• Value Stream and Process Control Mapping
• Design and Process Risk Management
• Lean / Six Sigma / 5S Philosophies

If you aren’t quite sure where to start or currently do not have the expertise on hand to drive such initiatives in a short time – then do not hesitate to contact R&Q today. We are experts at remote Quality Management and Process Improvement and would love to answer your questions!

We can partner with you in excelling your business through:
• Customizing a business-balanced approach to full ISO 9001:2015 Quality Management Systems implementation. Any QMS initiative should remain flexible to drive a strategic vision while retaining a positive culture, continual improvement, and factual decision making.
• Customizing the facilitation of process enhancements to achieve consistency of a product or service provided and reducing the “decoupling effect” where the established process no longer adequately supports real-time operations. Process gap analysis and data analytics can assist with reengineering procedural concepts and documentation to compliantly realign expectations to real life.
• Customized quality initiative training either to support a full ISO 9001:2015 Quality Management Systems implementation or select quality management concepts to assist in driving a quality-minded culture.

You can learn more about our Quality Systems services here.

Stay safe and productive everyone!

We have many free virtual events in the works for this week and beyond! Check them out here and be sure to join us on Friday, April 17 for our first ever RQM+ Live! A new weekly and interactive live show featuring expert panelists discussing hot topics, challenges, and solutions in the medical device industry. This episode will focus on moving medical device manufacturing out of China. Click the button below to learn more and register for free! 

Join us! >>As always, R&Q experts are here to help you navigate the difficult road ahead with ample virtual content and remote experts on hand so don't hesitate to reach out to your R&Q representative and contact us today.

[1] U.S. Small Business Administration. Paycheck Protection Program. Accessed 15 April 2020. 
[2] U.S. Department of the Treasury. The CARES Act Provides Assistance to Small Businesses. Accessed 15 April 2020.
[3] British Assessment Bureau. Benefits of ISO 9001:2008/ISO 9001:2015 to your business. Accessed 13 April 2020.

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About Regulatory & Quality Solutions (R&Q):


R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blogview our service offeringswatch free webinars, and more at The and means more.

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