Approved Supplier List (ASL)

What is an approved supplier list (ASL)?

An approved supplier list (ASL) is a repository of all the suppliers approved by the company and the parts or materials they are approved to supply. It is a critical component of medical device supplier management.

The FDA’s Quality System Regulation (QSR) requires that all medical device companies establish procedures for ensuring purchased products or services meet their requirements. Thus, medical device companies should have these procedures in place before creating their ASL.

Some factors that may dictate if a supplier will be added to the ASL include:

  • Whether the organization has supplier management procedures in place for their supplies
  • The product or service specifications
  • Whether the company has a documented quality system
  • The volume they can produce
  • The standards they are certified to

What are the benefits of an approved supplier list?

An ASL offers a single list containing all suppliers from which a company sources products and services. Any supplier included on the list has met the company’s quality requirements, saving time in the future when looking to purchase a product or service.

Additionally, when completing an audit, the ASL shows that time was spent choosing a supplier that met certain requirements. By meeting these requirements, they also provide higher-quality products and services.