March 13, 2023

Quality Agreements – Ownership and Format

The Quality and/or Regulatory departments need to be the primary authors of the Quality Agreement.  Yet the Quality Agreement nonetheless still needs to be corporately/legally executed between the parties.  Thus, the signatories should be executive officers in order to assure the Agreement has the necessary weight.

If you are working on your Quality Agreements, then kudos to you.  Those are international, including U.S. FDA, staples of proper supplier control.  While it may be tempting to conclude that Quality Agreements are just a figment of ex-U.S. ISO 13485 scenarios, U.S. FDA investigators will in fact (I’ve had it happen) ask to see your “Quality Agreements” also.  Not only is FDA already using that language in practice, the agency is only 12-24 months (my estimate) from formally putting it into its revised Quality Management System Regulation (QMSR); so don’t get caught off guard or pick a semantical fight that you won’t win with FDA.

Indeed, while FDA’s current QS Regulation doesn’t actually use the words “Quality Agreement” (instead using “quality requirements”, “purchasing data”, and “purchasing documents”), the fundamental intent and requirements are generally the same.  Remember that FDA’s current QS Regulation’s supplier control requirements were fashioned after ISO’s “subCONTRACTor” requirements.  And FDA and other international agencies can be preferential to the GHTF’s (Global Harmonization Task Force’s) and NBOG approach, which also push this into contractual terms.  So we are in fact talking about quality contracts (“Agreements”) here.

In general, Quality Agreements need to cover a number of key things such as, but not necessarily limited to:

• Corrective action and preventive action, Process Validation

• Acceptance and verification activities

• Complaint investigational support

• Supplier training/competence

• Design process

• Change control

• Handling of non-conformities

• Access for audits

• and others.

I would recommend against getting too creative or cute when achieving the parties’ contractual agreement on these topics, especially since the world has already adopted, with FDA soon to officially follow, the “Quality Agreement” vernacular.