Quality Management System Competencies Your Reagent Supplier Should Possess

The ability of a clinical laboratory to provide consistent and reliable results to their customers depends on the consistent supply of high-quality reagents over time. Evaluating a potential reagent supply partner’s manufacturing capability requires an understanding of how that partner manages and controls their manufacturing operations to ensure your product is delivered on time and to your specifications every time. Described here are quality system competencies to look for and the benefits of partnering with a supplier who has an established quality system.

What is a quality management system?

A quality management system (QMS) is a formal system with documented processes and procedures that describe organizational responsibilities for achieving quality objectives. A well-implemented QMS helps to coordinate a manufacturer’s activities to effectively and efficiently meet customer and regulatory requirements continuously.

What key competencies define a well-implemented system?

A clinical reagent supply partner who has implemented a quality management system will generally have the following procedures in place:

1. Detailed manufacturing and QC protocols
2. Production and process controls
3. Product certificate of analysis
4. Traceable product batch records
5. Product stability programs
6. Product change control and notification processes
7. Supplier evaluation and qualification program
8. Equipment maintenance and calibration program
9. Non-conforming product processes and procedures
10. Qualified and trained product manufacturing personnel

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

11. Analytical (QC) method validation
12. Process validation
13. Intended use (assay-specific) QC testing
14. Product design according to design controls

What should I look for when evaluating a potential manufacturing partner?

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

1. Summarize their quality management system, which should minimally include reference to the list of attributes (a-j) above.
2. Provide certification, performed by an independent third party, to an international standard, such as ISO9001, ISO13485, and ISO18385.
3. Facilitate an on-site audit of their quality management system, as applicable.

An ideal manufacturing partner should also be willing to spend time consulting with you to ensure appropriate quality controls are in place to meet your intended use and regulatory requirements.

What are the benefits to partnering with a supplier that has implemented a quality system?

One of the largest benefits to partnering with a supplier who regularly operates under a quality management system is the predictability of high product quality. Utilizing documented processes and procedures with qualified and trained personnel to manufacture product provides for 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. Additionally, your partner’s quality management system can provide you documentation readily compliant with your own quality system. You will save both time and money by not having to build all of these controls yourself.