Quality Management Systems: Key Considerations in Choosing a Manufacturing Partner

Choosing the right manufacturing partner means understanding how they manage and control their processes—so you get your product on time and exactly to your specifications, every time.  

What to Look for When Seeking a Manufacturing Partner

When seeking a manufacturing partner in the life science, clinical and applied science industries, key considerations to bear in mind are:  

• Scientific expertise that matches your product requirements  
• Consultation and technical support to help make the design decisions you need  
• Manufacturing capabilities that meet your current and future production needs  
• Ability to meet quality standards and comply with regulatory requirements  
• Logistical support and delivery capabilities  

When you evaluate a manufacturing partner, understanding these five key areas helps you make informed decisions—so you can be confident in choosing a partner who meets your needs today and as you grow. 

What Makes a Quality Management System Work? 

A quality management system (QMS) is a formal system with documented processes and procedures that describe organizational responsibilities for achieving quality objectives. A strong QMS helps manufacturers stay efficient and consistent while meeting customer and regulatory expectations. A manufacturing partner who has implemented a quality management system will generally have the following procedures already in place:  

• Detailed manufacturing and QC protocols  
• Production and process controls  
• Product certificate of analysis  
• Traceable product batch records  
• Product stability programs  
• Product change control and notification processes  
• Supplier evaluation and qualification program  
• Equipment maintenance and calibration program  
• Non-conforming product processes and procedures  
• Qualified and trained product manufacturing personnel  

Depending on your product’s intended use, these manufacturing controls may be enough to ensure consistent manufacture of your product over time. In some cases, the intended use of your product may require additional manufacturing controls. Some additional controls that may be required could be:  

• Analytical (QC) method validation  
• Process validation  
• Intended use (assay-specific) QC testing  
• Product design according to design controls 

 Because these additional controls may be specific to the product, they may add time or cost to implement.

What to Look for When Evaluating a Potential Manufacturing Partner

When you are evaluating potential manufacturing partners who have implemented a robust quality management system, your potential partner should be able to:  

• Summarize their quality management system that minimally includes references to the list of procedures outlined above
• Provide certification, performed by an independent third party, to an international standard, such as ISO9001, ISO13485 and ISO18385 
• Facilitate an on-site audit of their quality management system, as applicable

Look for a manufacturing partner who actively consults with you to ensure quality controls align with your needs. If you're seeking a partner with deep expertise, let’s talk about how Promega’s QMS can support your success. 

What Are the Benefits of Partnering with a Manufacturer with a Quality System?

Partnering with a manufacturer who operates under a robust QMS ensures predictable, high-quality product manufacturing—giving you reliability and confidence in every order. Manufacturing product using documented processes and procedures with qualified and trained personnel provides for the supply of a consistently-performing product on time, every time. If there is an infrequent occurrence of non-conforming product, your partner already has systems in place to facilitate any necessary product investigations. You may choose to lean on a manufacturer with a mature quality system, which can save time and money by not having to build all these controls yourself. 

Choosing the right manufacturer is a critical decision that can greatly impact the success of your product, whether it’s in life sciences, clinical diagnostics, or applied sciences. A partner with a robust QMS can ensure that your product is consistently manufactured to the highest standards, meeting both regulatory and customer expectations. By evaluating key factors such as scientific expertise, quality standards, production capabilities, and logistical support, you can make an informed decision that aligns with your current needs and future goals. 

Put Our Quality System to Work for You

At Promega, our commitment to quality isn’t new—we’ve been setting the standard since 1988. With certifications across 15 global facilities, we ensure consistency, reliability, and compliance, so you can focus on your goals, and that commitment exemplifies our commitment to our clients, our business and all those who rely on and benefit from the use of our products. Each of our multiple ISO certifications has demonstrated to a third party that the organization meets all requirements of the standards and has implemented a quality system capable of developing, manufacturing, testing and delivering high-quality products around the world. 

 The Promega Madison, USA, facility maintains certification to ISO9001 and ISO13485, the standard for the manufacture of medical devices. We also maintain certification in ISO18385, which focuses on minimizing the risks of human DNA contamination in products. Currently, 15 Promega facilities around the world have certified to ISO standards. 

 You can have confidence in our ability to manufacture products and assay components reproducibly and to provide the required quality.

 Looking to qualify Promega as a new supplier? Please reach out to use at: qualitysurvey@promega.com

 Learn More about Quality at Promega

 Put Promega's QMS to Work for You

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