ISO 9001 Bundle | All templates for ISO 9001:2015

This bundle pack of documents provides all required document templates to demonstrate conformity to ISO 9001:2015 This template bundle is the best option for companies starting a Quality Management System (QMS) from scratch and require all documents and forms. Within this bundle are all the templates relating to ISO 9001:2015 and include:

Procedures:

• Complaints Procedure
• Control of Measuring and Monitoring Equipment Procedure
• Control of creating and updating Records Procedure
• Control of Documented Information Procedure
• Control of Product and Service Provision Procedure
• Corrective and Preventative Action Procedure
• Customer Related Processes Procedure
• Design and Development Procedure
• Feedback Procedure
• Internal Audit Procedure 
• Leadership and Commitment Procedure
• Management Review Procedure
• Measurement Traceability Procedure (Servicing Requirements)
• Non-Conformance Procedure
• Product Identification & Traceability Procedure
• Product Realisation Planning Procedure
• Quality Management System Planning Procedure
• Quality Objectives & Planning to Achieve them Procedure
• Goods in and Goods out Inspection Procedure
• Resource Management Procedure
• Supplier Evaluation & Monitoring Procedure
• Training and Qualification Procedure

Records:

• Approved Supplier List
• Change Control Log
• Complaint Investigation Form
• Complaint and Feedback monitoring spreadsheet
• Continual Improvement Tracker
• Corrective and Preventative Action Form
• Corrective and Preventative Action log
• Employee Induction Form
• Internal Audit Plan
• Internal Audit Report Form
• Internal Audit Schedule 
• Job Description Template
• Management Review meeting agenda
• Management Review minutes template
• Master Document List
• Non-conformance report
• Non-conformance report log
• Quality Manual
• Quality Policy
• Supplier Evaluation Form
  
• Training Matrix
• Training Record

In addition you will also receive:

• ISO 9001:2015 compliance checklist 

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.