Is your Supply Chain Quality Focused?
When you are looking to become an ISO 13485:2016 certified organization, ensuring that your supply chain is quality focused should be a top priority. As an original equipment manufacturer (OEM) of medical devices, your organization is responsible to ensure that any parts supplied to you are compliant with ISO requirements. This can be a tedious and difficult task and therefore it is ideal to work with suppliers that are strong enough to identify risks, prevent defects and to catch a defect quickly if one does occur.
Understanding the best approach to evaluate the QMS of your medical device supplier can be confusing. An effective quality program includes four critical elements that you need to look for:
- certification to ISO 13485
- risk management for product realization
- a strong CAPA (corrective and preventive actions) program
- a culture where quality is a top priority
In addition to the above elements, OEMs also need to be confident that their medical device suppliers have met the deadline for the upgraded ISO standards. How can you have confidence that your suppliers have been certified on time and not leave you with the crisis of an uncertified supplier?
Did your supplier meet the ISO Deadline?
Both ISO 9001 and ISO 13485 have been upgraded and both standards are past their transition deadlines. OEMs will want to know whether their suppliers met the September 2018 deadline for ISO 9001:2015 or the March 2019 deadline for ISO 13485:2016. One objective of the new standards is to upgrade supplier risk management with more focus on controls throughout the supplier’s processes. The standards emphasize being preventive rather than reactive. This approach helps reduce the probability of a defective part reaching the patient.