Quality Agreement
Quick facts
| Category | Formal quality roles and responsibilities agreement between parties |
|---|---|
| Used by | Medical devices, pharmaceuticals and other regulated manufacturing industries |
| Also called | None widely standardized |
| Related standards | ISO 13485, EU MDR |
| Related processes | Supplier evaluation, SCAR, change control, notified body |
| Semantic match | quality agreement, technical quality agreement, supplier quality roles responsibilities, outsourced process control |
What is Quality Agreement?
A quality agreement formally documents how quality responsibilities are divided between a manufacturer and an outsourced partner, whether a supplier of materials, a contract manufacturer, or another party performing an activity that affects product conformity.
Typical content includes which party is responsible for specific quality activities, such as testing, inspection or complaint handling; how changes affecting the product or process will be communicated and approved between the parties; how nonconformances and corrective actions will be handled; and how records will be maintained and shared.
ISO 13485 specifically expects a risk-based approach to controlling outsourced processes that affect product conformity, and written technical quality agreements are a common mechanism manufacturers use to formalize these controls with suppliers and other economic operators along the supply chain.
Why is Quality Agreement important?
Without a formal quality agreement, expectations around quality responsibilities between a manufacturer and its supplier can remain ambiguous, increasing the risk of miscommunication when a quality issue or proposed change arises.
Quality agreements are particularly important for regulated products, since a manufacturer often remains ultimately accountable to regulators for the product's quality and safety even when specific activities are outsourced.
Clear, documented quality agreements support faster, more effective resolution of nonconformances and changes, since both parties already understand their respective roles and required response timelines before an issue occurs.
How does Quality Agreement work?
A typical quality agreement development process includes:
- Risk assessment. Evaluate the risk associated with the outsourced activity to scope the agreement appropriately.
- Roles and responsibilities. Define which party is responsible for specific quality activities.
- Change notification. Establish requirements for communicating and approving changes.
- Nonconformance handling. Define how quality issues and corrective actions will be managed.
- Recordkeeping. Specify how records will be maintained and shared between parties.
- Periodic review. Revisit and update the agreement as the relationship or regulatory requirements evolve.
Quality Agreement vs. Commercial Contract
| Comparison | Quality Agreement | Commercial Contract |
|---|---|---|
| Focus | Quality roles, responsibilities and controls | Pricing, delivery and commercial terms |
| Typical owner | Quality department | Procurement or legal department |
Real-world examples of Quality Agreement
A medical device manufacturer establishes a quality agreement with a component supplier, specifying that the supplier must notify the manufacturer of any proposed material or process changes before implementation.
A pharmaceutical company formalizes a quality agreement with its contract manufacturer, defining which party is responsible for batch release testing and how deviations will be communicated.
A device manufacturer updates its quality agreement with a long-standing supplier after a regulatory change affects documentation requirements, ensuring both parties remain aligned on updated expectations.
Regulations and standards related to Quality Agreement
ISO 13485 requires manufacturers to apply a risk-based approach to controlling outsourced processes affecting product conformity, with technical quality agreements serving as a common way to formalize these controls with suppliers and other supply chain partners.
EU MDR similarly expects manufacturers to maintain appropriate oversight of outsourced activities, reinforcing the practical value of documented quality agreements in demonstrating this control during regulatory review.
Required by
How QT9 helps with Quality Agreement
QT9 QMS capabilities supporting quality agreements
- Maintain quality agreements as controlled, version-tracked documents.
- Link quality agreement terms to supplier evaluation and SCAR processes.
- Track change notification and approval requirements between parties.
- Support supplier portal access for streamlined communication.
- Maintain complete audit trails for quality agreement history and revisions.
- Connect quality agreement terms to broader supplier performance data.
See QT9 Software in Action
Discover how QT9 Software helps manufacturers improve efficiency, strengthen compliance and connect quality management and ERP processes within one integrated platform.
Common mistakes with Quality Agreement
Common mistakes include treating the quality agreement as a static document signed once and never revisited, even as the supplier relationship, regulatory requirements or product risk profile change over time.
Other problems include applying the same level of detail to every quality agreement regardless of risk, when a risk-based approach would scale the agreement's depth to the significance of the outsourced activity.
Frequently asked questions
Related quality management terms
Related content
Ready to Transform Your Business?
See how QT9 Software helps manufacturers simplify operations, improve traceability and drive continuous improvement with integrated quality management and ERP software.