Selecting the right medical device contract manufacturing (CM) outsourcing partner can seem like a daunting task for many OEMs. Often exploring a new partner begins with an examination of their quality system. The strength of the outsourcing partner’s quality system is paramount in predicting the strength and success of the manufacturing relationship, as well as the amount of risk within the outsourcing equation for the OEM.
So what criteria is most important to the OEM during initial quality system conversations with the contract manufacturing (CM) partner?
- Does the CM follow ISO 13485 standards? Are they certified?
This is often the very first question an OEM asks of a potential CM partner. By identifying the answer to this question, the OEM can establish the level at which the CM operates. - Is the CM registered with the FDA?
FDA registration is another level of accountability for the CM. It enhances their overall quality system and allows for auditing from an outside agency. - Is the CM practicing what their quality manual states?
By verifying internal auditing, annual ISO audits and external audits are taking place, an OEM can better ensure that the CM is following their manual, and addressing documentation, traceability, training and continuous improvement needs. - Is there a focus on customer’s needs and a willingness to work directly with OEMs to meet goals?
A willingness to work together to address needs and solve problems is a core value of a good CM partner. Establishing a healthy relationship from the front end will only assist in the overall long-term relationship success. - What is their response time?
Proactive response times and an open flow of communication from the start can help predict how the CM will respond if an issue or complaint arises at a later date.
These are just a handful of the initial questions that come up between an OEM and a CM partner. Once the answers to these important questions are established, the next step is often a full onsite quality audit by the OEM’s supply chain management and quality assurance team.
For even more tips on how to best conduct your search for a CM partner that will meet your company’s needs, download our free ebook, Contract Manufacturing: A Roadmap for OEMs, which features additional tools to help you evaluate and compare potential CMs.