QUALITY AGREEMENT BETWEEN MANUFACTURERS AND SUPPLIERS

The simple, easy to edit Quality Agreement is officially available! Buy it now!

$75.00

QUALITY AGREEMENT BETWEEN MANUFACTURERS AND SUPPLIERS – TEMPLATE

A Quality Agreement is necessary for all medical device manufacturers to ensure all products, raw materials, services and related components are provided within relevant compliance related guidelines. It is also mandatory for Critical Suppliers. Notified Bodies will request a copy of your Quality Agreement with Critical Suppliers during audits. The Quality Agreement includes requirements of ISO 13485 and related regulations such as EU MDR 2017/745 and 21 CFR 820. After purchasing, you will receive a word document that is ready to edit. You will receive a copy of the Quality Agreement within 24 hours of payment.

$75.00


Included in your Quality Agreement are requirements for:

  • Managing changes to product / service specifications
  • Handling non-conformances and dispositioning of non-conforming material
  • Responsibilities when implementing corrective and prevention actions
  • Requirements for change control
  • Requirements when deviating from processes
  • Operational requirements
  • Record keeping requirements
  • Process validation requirements
  • Inspection, Measuring and Test Equipment requirements
  • Collaborations in the event of an audit
  • Adverse event reporting requirements and responsibilities
  • Controls to be implemented when utilising third parties
  • Much more!


Purchase your simple easy to edit template of a Medical Device Quality Agreement between Manufacturers and Suppliers today!

QUALITY AGREEMENT BETWEEN MANUFACTURERS AND SUPPLIERS – TEMPLATE

After purchasing, you will receive a word document that is ready to edit. You will receive a copy of the Quality Agreement within 24 hours of payment.

$75.00