Regulatory agencies and notified bodies provide guidance on how companies should implement and maintain supplier controls. Their goal is to ensure that the supplied parts and services contribute to the overall quality and safety of the product.
Supplier regulations and their importance
The FDA has defined guidelines in CFR 820.50 which apply to all suppliers, contractors, and consultants that contribute to a company’s product or ongoing quality management activities.
Supplier Standard Operating Procedures
In order to assess suppliers, it is important to follow the FDA guidelines and establish standard operating procedures for your company.