Supplier Quality Management has become increasingly important in any regulated industry. The Medical Device industry is no exception. FDA has had requirements to Purchasing Controls for a long time, and the EU has made an increased focus by introducing Economical Operator with the new Medical Device Regulation (MSR). However modern supplier management is not only related to the regulatory requirements, but also the general relationship to and partnership to the supplier.
This requires robust systems for choosing, evaluating and managing suppliers. The requirements going into these systems depend heavily on the companies involved and the general needs of the business. Part of this is doing effective supplier audits and feedback.
Supplier audit
A key component in working with suppliers in a regulated business is to perform supplier audits. The objectives of the supplier audits are both to document that regulatory requirements are followed as well as show that contractual requirements are fulfilled, but also to give feedback to both parties, where different understandings of requirements and contract exists.
Madsen Quality Consulting can be your extra resource for carrying out supplier audits. This can be both if you are a smaller organization, that doesn’t want to have this resource in-house or if you just need this resource for a limited period. Likewise, we can be the objective auditor, if you want an outside evaluation of the quality situation at your supplier.
Supplier Quality Management
Supplier Quality Management is today an integral part of both the supply chain and the quality management in any medical device company. This both secures regulatory compliance, but also enhances the corporation between the companies. Effective Supplier Quality Management will reduce cost and lead time, and at the same time reduce the risk of product failure and the likelihood of reporting to the authorities and recalls.
At Madsen Quality Consulting we can assist you in identifying effective parameters for identifying suppliers from a quality perspective. Likewise, we can assist you in setting up systems for the on-going evaluation of suppliers. If you need assistance on setting up the quality agreement, we can support you on this as well.