ISO 9001:2015 Manufacturing Supplier Audit Checklist

Creating a comprehensive ISO 9001:2015 Manufacturing Supplier Audit checklist involves several key components.

Below is a general ISO 9001:2015 Manufacturing Supplier Audit outline you can  customize according to your specific needs and requirements:

1. General Information:
   • Supplier Name:
   • Supplier Location:
   • Date of Audit:
   • Auditor Name(s):
   • Audit Scope:
2. Documentation Review:
   • Quality Manual:
   • Procedures and Work Instructions:
   • Records of Training and Competence:
   • Document Control Procedures:
   • Quality Policy and Objectives:
   • Corrective and Preventive Action Records:
   • Control of Non-Conforming Products:
   • Internal Audit Reports:
3. Management System:
   • Organizational Structure and Responsibilities:
   • Management Commitment to Quality:
   • Risk Management Processes:
   • Quality Planning and Objectives:
   • Customer Focus and Satisfaction:
   • Continual Improvement Processes:
   • Change Management Procedures:
4. Resource Management:
   • Competence, Awareness, and Training:
   • Infrastructure and Work Environment:
   • Availability of Resources:
   • Personnel Facilities and Welfare:
   • Equipment Maintenance and Calibration:
5. Product Realization:
   • Planning of Product Realization:
   • Customer Requirements Review:
   • Design and Development Processes (if applicable):
   • Purchasing Process and Supplier Evaluation:
   • Control of Production and Service Provision:
   • Validation of Processes for Production:
   • Identification and Traceability of Products:
   • Customer Property Protection:
6. Measurement, Analysis, and Improvement:
   • Monitoring and Measurement of Processes:
   • Product Conformity and Acceptance Criteria:
   • Control of Monitoring and Measuring Equipment:
   • Analysis of Data for Performance:
   • Internal Audit Process and Results:
   • Corrective and Preventive Action Processes:
   • Management Review Meeting Records:
7. Observations and Recommendations:
   • Compliance with ISO 9001:2015 Requirements:
   • Strengths of the Supplier’s Quality Management System:
   • Areas for Improvement or Corrective Action:
   • Recommendations for Enhancing Performance:
8. Conclusion:
   • Overall Assessment of Supplier’s Compliance:
   • Identified Risks and Opportunities:
   • Summary of Audit Findings:
   • Follow-up Actions and Timelines:

Ensure that each item in the ISO 9001:2015 Manufacturing Supplier Audit Checklist is clear, measurable, and specific. During the audit, verify compliance with ISO 9001:2015 requirements and identify areas where the supplier can improve their quality management system.

Performing an ISO 9001:2015 supplier audit using  eAuditor Audits & Inspections checklist can streamline the process and improve efficiency. Here’s how you can structure your audit using  eAuditor Audits & Inspections checklist:

1. Select  eAuditor Audits & Inspections App 
   • Choose  eAuditor Audits & Inspections that allows customization of checklists or develop your own app tailored to ISO 9001:2015 requirements from Android or Apple app store.
2. Pre-Audit Preparation:
   • Input basic audit information such as supplier name, location, and audit date into the eAuditor Audits & Inspections.
   • Verify that the eAuditor Audits & Inspections is updated with the latest checklist version and any specific requirements for the supplier being audited.
3. Conducting the Audit:
   • Start the audit process using the eAuditor Audits & Inspections ISO 9001:2015 manufacturing supplier audit checklist.
   • Go through each section of the checklist systematically, recording observations, evidence, and comments directly in the app.
   • Utilize the eAuditor Audits & Inspections‘s features such as attaching photos or videos as evidence during the audit.
   • Rate each checklist item according to compliance level or severity of non-conformity.
4. Document Review:
   • Use the app to review documentation such as quality manuals, procedures, and records.
   • Record findings and evidence directly in the eAuditor Audits & Inspections checklist.
5. On-site Inspection:
   • Use the eAuditor Audits & Inspections  to conduct on-site inspections of facilities, equipment, and processes.
   • Capture photos or videos of any non-conformities or areas of concern.
6. Communication and Collaboration:
   • Assign corrective actions directly within the app and track their status.
7. Generate Audit Report:
   • Once the audit is complete, generate an audit report directly from the  eAuditor Audits & Inspections.
   • The report includes a summary of findings, areas of non-conformity, recommendations, and any follow-up actions required.
8. Follow-up and Monitoring:
   • Use  eAuditor Audits & Inspections to track and monitor corrective actions and follow-up audits.
   • Schedule reminders for follow-up activities and deadlines.
9. Continuous Improvement:
   • Use insights gathered from audits to continuously improve the audit process and the supplier’s quality management system.

By utilizing  eAuditor Audits & Inspections  checklist for ISO 9001:2015 audits, you can improve the efficiency, accuracy, and effectiveness of the audit process while ensuring compliance with quality standards.