Quality Agreement Template - Ombu Enterprises LLC

Contents
1 Administrative Elements.......................................................................................................4
1.1 Scope.............................................................................................................................4
1.2 Parties to the Agreement...............................................................................................4
1.3 Definitions, Abbreviations, and Acronyms ..................................................................4
1.4 Referenced Documents .................................................................................................5
1.5 Products and Services Covered By This Agreement ....................................................5
1.6 Site(s) Involved.............................................................................................................6
1.7 Quality Management Systems ......................................................................................6
1.7.1 ISO 9001:2008 Quality Management System ......................................................6
1.7.2 Other Required Standards.....................................................................................7
1.8 Use of Third Parties ......................................................................................................7
1.8.1 Directed Procurement ...........................................................................................7
1.8.2 Supplier Selected ..................................................................................................7
1.9 Term of Agreement.......................................................................................................8
1.10 Assignment ...................................................................................................................8
2 Compliance ...........................................................................................................................8
2.1 Specifications................................................................................................................8
2.2 Specification Changes...................................................................................................8
2.3 Activity by Regulators, Notified Bodies, or Certification Bodies................................8
2.4 Third Party Quality Agreements...................................................................................9
3 Providing Product or Service................................................................................................9
3.1 Work Environment........................................................................................................9
3.2 Personnel.......................................................................................................................9
3.3 Equipment.....................................................................................................................9
3.4 Automated Processes ....................................................................................................9
3.5 Monitoring and Measuring Equipment.......................................................................10
3.6 Process Validation ......................................................................................................10
3.7 Packaging Operations .................................................................................................10
4 Documentation and Records...............................................................................................11
4.1 Record Retention ........................................................................................................11
5 Storage and Shipment .........................................................................................................11
5.1 Storage ........................................................................................................................11
5.2 Shipment .....................................................................................................................11
6 Change Control ...................................................................................................................11
6.1 Change Requests.........................................................................................................11
6.2 Deviations ...................................................................................................................12
6.3 Other Changes.............................................................................................................12
7 Non-Conformance, CAPA, and Complaints.......................................................................12
7.1 Disposition of Non-conforming Material ...................................................................12
7.2 Corrective Action........................................................................................................12
7.2.1 Supplier Initiated Corrective Action...................................................................12
7.2.2 Customer Initiated Corrective Action.................................................................12
7.3 Complaints ..................................................................................................................13
Quality Agreement Template Page 2 of 15
Prepared by Ombu Enterprises, LLC
www.OmbuEnterprises.com