Frequently, when I interview either potential clients or candidates—depending on my employment situation at the time, I ask them to tell me what the term quality management system (QMS) means to them. The typical response I get is “well, you know, the SOP’s…and ah…the test results…and um…the documents?” I continue to be truly surprised as to how little top management as well as functional areas outside of quality and compliance understand about such an important part of the business.
Medical device companies (pharmaceutical and biotechnology as well) operate within a regulated world. They must abide by the requirements of the national regions where they desire to commercialize their products. For example:
- United States – Code of Federal Regulations (CFR)
- Europe – Medical Device Directives (MDD)
- Canada – Canadian Medical Devices Regulations (CMDR)
- Japan – Pharmaceutical Affairs Law (PAL)
- Australia – Therapeutic Goods (Medical Devices) Regulations
Compliance to these requirements is not optional, and one common theme among all the various national regions for decades is that medical device manufacturers establish, implement, and maintain a quality management system (QMS).
So, just what is a quality management system (QMS)? Perhaps it is best to start by describing what a QMS is not. It is not a “one-size-fits-all” solution—shame on you if you try to purchase a QMS from the internet. It is not a “create it and forget it” activity. It is not a “do it when you feel like it” constraint. A QMS does not include company financial information. It does not encompass securities information. It does not incorporate company payroll information. It does not contain pricing and sales information.
A quality management system (QMS) is a business model, in other words, a proscribed way of doing business. It is all things a company uses to establish, document, implement, and maintain the quality of its products. It includes all the people, facilities, raw materials, manufacturing equipment, operating procedures, work instructions, records, used to design, develop, manufacture, and distribute company products. A QMS begins at the supplier and extends throughout the company to the end user/customer.
I’m thinking maybe it’s a bit like when you were a kid and thought you just knew how to drive a car because mom and dad made it look so easy. The important thing to acknowledge is that a quality management system (QMS) is more than just a company’s operating procedures and work instructions and records. A QMS is a way of life!