It is recommended to keep the Quality Agreement separate from the Supply Agreement and other commercial or business agreements, so that it’s independent from pricing, terms of payment, scopes of work and other elements of these documents and therefore may be modified or severed independently.

The Quality Agreement should contain the following five core elements:

1. Purpose and scope
2. Terms, including the effective and termination dates
3. Provisions for dispute resolution
4. Responsibilities of the product owner versus the Contracted Facility – this should be detailed enough to cover all the responsibilities defined in ISO 13485.
5. Management of change and revisions

In addition to the five core elements listed, there are a few key components, which should be addressed in the agreement as well.

The key components are:

1. A plan for handling corrective and preventative action investigations.
2. A clause for the “right to audit” ensuring the organization has the right to audit the supplier.
3. A requirement for notification of any major regulatory audit findings.
4. And A requirement ensuring the organization is notified of any product or process changes.

The quality agreement is an extremely important part of the supplier management system and ensuring these items are addressed will provide a robust foundation of incoming product quality.