Quality Assurance Agreement

Free Quality Assurance Agreement Template

Use this free template as a starting point for a quality assurance agreement (sometimes called a "QAA" or "Quality Agreement") between a buyer and a supplier of goods, components, or services. QAAs sit alongside the main supply contract and define quality standards, inspection rights, and corrective-action processes. Copy and customise it to suit your products, regulatory regime, and supply chain risk.

QUALITY ASSURANCE AGREEMENT

Date: [Date of agreement]

Parties:

(1) Buyer: [Full legal name], a company incorporated in [Jurisdiction] with registered address at [Address] (the "Buyer")

(2) Supplier: [Full legal name], a company incorporated in [Jurisdiction] with registered address at [Address] (the "Supplier")

Background

A. The Parties have entered into, or intend to enter into, a supply arrangement under which the Supplier will supply [description of goods, components, or services] (the "Products") to the Buyer.

B. The Parties wish to record the quality standards, inspection rights, and corrective-action procedures applicable to that supply.

C. This Agreement supplements (and is to be read alongside) the underlying supply contract dated [Date] (the "Supply Contract"). In the event of conflict between this Agreement and the Supply Contract, this Agreement prevails on matters of quality and the Supply Contract prevails on commercial matters.

1. Quality Standards

The Supplier shall ensure that the Products:

• Conform to the specifications set out in Schedule [1] (the "Specifications")
• Comply with all applicable laws and regulations in the country of manufacture and the country of intended destination
• Where applicable, hold and maintain the certifications listed in Schedule [2] (e.g. ISO 9001, IATF 16949, ISO 13485, GMP, organic / Fair Trade)
• Are produced using only the materials, components, and processes approved by the Buyer

The Specifications may be updated by mutual written agreement; any material change to Specifications follows the change-control process in clause 6.

2. Supplier's Quality System

The Supplier shall:

• Maintain a documented quality management system appropriate to the Products
• Train its personnel on the quality requirements applicable to the Products
• Maintain accurate batch records (or production records, for non-batch products) for each lot of Products supplied
• Retain quality records for at least [7 years] from the date of supply, or longer where required by regulation
• Permit the Buyer to inspect the Supplier's facilities and quality records on reasonable notice during normal business hours

3. Inspection and Testing

• The Supplier shall inspect and test each batch of Products in accordance with the test plan in Schedule [3] before despatch
• Each shipment shall be accompanied by a certificate of conformity / certificate of analysis ("CoC" or "CoA") signed by the Supplier's authorised quality representative
• The Buyer is entitled to perform incoming inspection and testing on its own behalf. Inspection by the Buyer does not relieve the Supplier of responsibility for non-conforming Products
• The Buyer shall notify the Supplier in writing of any non-conformity discovered within [10 working days] of incoming inspection for visible non-conformity, or within [30 days] of discovery for latent non-conformity, and in any event within [12 months] of delivery

4. Non-Conforming Products

If the Buyer notifies the Supplier of non-conforming Products:

• The Supplier shall acknowledge receipt within [2 working days] and propose an initial response within [5 working days]
• The Supplier shall, at the Buyer's option and the Supplier's cost, replace the non-conforming Products, refund the price paid, or repair them where repair is practicable
• The Supplier shall reimburse the Buyer for reasonable costs incurred as a result of the non-conformity, including return shipping, handling, rework, and segregation, subject to the liability limits agreed in the Supply Contract
• For safety-critical non-conformity, the Supplier shall cooperate immediately in any recall, retrieval, or quarantine action and bear the Buyer's reasonable costs

5. Root Cause Analysis and Corrective Action (CAPA)

For each material non-conformity, the Supplier shall provide:

• An 8D / RCA report within [15 working days] of notification
• Details of the root cause and corrective and preventive actions implemented
• Evidence of effectiveness verification at the next batch, and again at [60 days] after implementation

The Buyer may require additional corrective measures if the proposed actions are insufficient.

6. Change Control

The Supplier shall not, without the Buyer's prior written consent:

• Change the manufacturing site, manufacturing process, or sub-supplier of key materials
• Change the formulation, components, or critical specifications of the Products
• Change the testing or inspection plan
• Discontinue or substitute any qualified material or component

Proposed changes shall be notified at least [60 days] before implementation, with sufficient information for the Buyer to assess impact (samples, validation reports, regulatory impact assessment).

7. Traceability

The Supplier shall maintain traceability from raw materials and components through to finished Product, sufficient to identify which batch of components is present in which batch of Products. The traceability records shall be available to the Buyer on request and shall be maintained for the period stated in clause 2.

8. Audit Rights

The Buyer (or its nominated representative) may audit the Supplier's facilities, processes, and records relevant to the Products:

• Routine audit: up to [once per calendar year], on at least [30 days'] notice
• For-cause audit: at any time on [5 working days'] notice following a material non-conformity or material quality incident
• Audits shall be conducted during normal business hours and shall not unreasonably interrupt the Supplier's operations

The Supplier shall make available the personnel, records, and facilities reasonably necessary to conduct the audit.

9. Sub-Suppliers

The Supplier remains responsible for the quality of Products notwithstanding any subcontracting. The Supplier shall flow down equivalent quality requirements to its sub-suppliers and shall qualify and re-qualify them in accordance with its quality management system.

10. Regulatory Reporting and Recalls

• The Supplier shall notify the Buyer in writing within [24 hours] of becoming aware of any regulatory enforcement action, product safety issue, or recall risk affecting the Products
• The Parties shall cooperate in any product recall or regulatory action, with costs allocated according to root cause

11. Confidentiality

Each Party shall keep confidential all non-public quality, technical, and process information of the other Party received under this Agreement, save for disclosure required by law, regulator, or with prior written consent. This obligation continues for [5] years after termination.

12. Term and Termination

• This Agreement runs concurrently with the Supply Contract and terminates automatically on its termination
• Either Party may terminate for material breach of the quality obligations not remedied within [30 days] of written notice
• On termination, the Supplier shall return or destroy confidential materials and continue to honour outstanding warranty and recall obligations

13. Governing Law

This Agreement is governed by the laws of [Jurisdiction] and the Parties submit to the exclusive jurisdiction of the courts of [Jurisdiction].

Signatures:

For and on behalf of the Buyer:

_ Date: _ [Name], [Position]

For and on behalf of the Supplier:

_ Date: _ [Name], [Position]

This is a basic template provided for informational purposes. For a professionally generated and legally tailored document, use Bind's contract automation platform.