This toolkit is an invaluable resource for industries and professionals seeking to implement the ISO 9001:2015 standard. It provides every component necessary to establish, manage, and maintain a Quality Management System (QMS) in full compliance with ISO 9001:2015.


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This toolkit is an invaluable resource for industries and professionals seeking to implement the ISO 9001:2015 standard. It provides every component necessary to establish, manage, and maintain a Quality Management System (QMS) in full compliance with ISO 9001:2015.

The toolkit includes a comprehensive set of audit templates, manuals, guides, and other essential resources required to develop and sustain a compliant QMS. Developed by ISO experts and certified internal and lead auditors with extensive hands-on experience in management system implementation, every document in this kit is 100% compliant and practical. You simply need to edit and customize these “ready-to-use” materials to align with your company's specific processes and terminology.

By using this toolkit, you save substantial time in developing compliant documentation and avoid the high costs associated with contracting a consultant to produce these documents. All resources are provided in accessible formats such as Word, PDF, Excel, and PowerPoint.

Key customizable resources in the toolkit include:

Among the editable resources, which can be customized and/or modified to meet a specific need contained in this toolkit includes:

  • Sets of Audit Checklist Formats
  • Quality Plan
  • Quality Meeting Template
  • Auditing Cycle Flowchart
  • Instrument Calibration Documents
  • Standard Operating Procedures (SOP) for
    • Change Management
    • Communication Plan 
    • Control of Documented Information 
    • Incident Management & Crisis Resolution Procedure
    • Internal Audit
    • Laboratory Work Instructions for Equipment & Processes
    • Monitoring & Measuring 
    • Planning Quality Objective
    • Raw & Packaging Material Handling
    • Handling of Trade Mark
    • SOP Templates of Different Designs
    • Traceability SOP
    • Raw Materials Inspection SOP
    • In-process Inspection SOP
    • Finished Products Inspection SOP
    • Handling of Internal Non-conformities
    • Customer Complaints SOP
    • Customer Complaint Resolution SOP
    • Corrective Action & Preventive Action (CAPA) SOP
    • Fumigation SOP
    • Rework SOP
    • Recall SOP
    • Procedure for use of Sharps
  • Document Control Master List
  • · Forms & Records
    • Change Management Form
    • Concession Form
    • Customer Complaint Register
    • Fumigation & Pest Control Log
    • Inprocess Control Chart
    • Inprocess Quality Log
    • Internal Nonconfomance Report
    • Line Clearance Checklist
    • Material Inspection Request Form
    • Product Concession Form
    • Product Deviation Form
    • Product Inspection Report
    • Raw Materials Inspection Report
    • Product Recall Form
    • Product Traceability
    • QA Inspection Plan
    • QC Hold and Rework Log
    • QC Job Release Record
    • QC Rejects
    • QC Release Records
    • Recall Log Activities
    • Stock Cards
    • Validation Certificate
  • Internal Audit, Nonconformity & Resolution Report 
  • ·Nonconforming Products and Process Control Form
  • Water Quality Monitoring Plan
  • Traceability Plan
  • Risk Management/Process Hazard Analysis
  • Product Development Checklist
  • Cleaning Validation Checklist
  • Action Plan Template
  • Communication Plan Formats
  • Monthly Review Meeting Presentation Example.
  • QMS Manual - Documented Information Example.
  • Quality Process Manual
  • ISO 9001 Standard
  • Complete Study Guide on Quality Management System (QMS) - eBook
  • Raw & Packaging Material Handling Procedure
  • Cleaning Plan
  • Staff Performance Appraisal
  • Waste Handling & Management Procedures and Checklist
  • Employee Skills Matrix
  • Employee Training & Competence Records
  • Corrective Action Plan
  • Personnel Training Record
  • Training Plan
  • Attendance Record

This toolkit is ideally suited for consultants, auditors (both seasoned and beginners), and anyone involved in or interested in assisting organizations to achieve ISO 9001:2015 compliance.