What are the best quality control systems for small-scale manufacturing businesses?

ISO is the fundamental tool to help you to run the company without missing something important, if this case is like a startup company, ISO is absolutely a good start point to use as quality system.

ISO is great for small scale but it needs resources and cost and it also means recurring costs. Small scale organizations can design processes and systems to build quality into the processes and with error proofing they can consistently meet their customer requirements and expectations. Hire a knowledgeable person who can achieve this within your budget and you can grow faster and them you can go for better quality management systems.

As an auditor and RA SME I always try to set companies up for the future. If I’m writing a Quality System it doesn’t take a whole lot more to make sure 820 and 13485 are in there. Now some of my clients are very happy about that even if they were only marketing in the US for now. Always try to plan for the future. I’ve worked with 10 person companies that were able to be compliant with US and EU requirements. Remember the regs tell you what you have to do but not how. The trick is writing a QMS in a way that a 10 person company can manage it. As for other ISO, ASTM, AAMI standards. They provide assurance of good quality…who doesn’t benefit from that?

A quality management system based on the ISO 9001 international standard requirements forms an excellent foundation for any startup organisation. Once the QMS is created and the organisation progresses, one can easily add to the QMS specific procedures and processes to comply with ANY other standards or regulatory requirements, whether GxP requirements or legal obligations such as the human tissue authority or EU cells and Tissue regulations and legislation or FDA, medical device standards etc.q

As mentioned and a continuation on the topic, I would recommend a lean management system with more emphasis on the quality ( as one of the waste elements). The Standard work ( once connected to visual controls and documented) can serve as the most useful quality management element while your “true” simplified lean journey can help your business to minimize costs and build a brand name!

I love the methodology that is Six Sigma. Almost daily, we use the problem solving techniques that you learn in Six Sigma courses. From my prospective, its a modular system. You do not have to have in depth knowledge of all the segments to be able to use the tools with in Six Sigma. Level 1 troubleshooting, 5Y's and PDCA's are the three most used in my line of work.

Statistical data is so important to businesses. Using the correct tools you can predict when to change a part, or see when corrective measures are required before you go out of control in your processes. Speak with data!!

Based on the target product and available finances, companies can opt for full ISO certification or utilize open-source FDA cGLP/cGMP regulations for QC management. Regardless, prioritizing documentation control, data recording, and integrity alongside implementing tracking systems and timeline reviews are essential for operational success. When executed effectively, these practices yield substantial benefits for the company.