1. Vendor Background and Overview

Confirm vendor's history and experience in the industry

Review the organizational structure and key personnel

Assess vendor's mission, vision, and values alignment with your organization

2. ISO Certification Status

Verify current ISO certifications and their expiration dates

Review the scope of ISO certifications held by the vendor

Assess the vendor's commitment to maintaining ISO standards

3. Document Control

Evaluate the vendor’s document control processes

Review how vendor maintains and updates ISO-related documentation

Confirm access control for sensitive documents and records

4. Management Responsibility

Assess the vendor’s management commitment to ISO compliance

Review management review meeting minutes and actions taken

Evaluate the vendor’s communication of ISO policies and objectives

5. Resource Management

Review the vendor's resource allocation for ISO initiatives

Evaluate staff training and competency related to ISO standards

Assess the adequacy of facilities and equipment used by the vendor

6. Risk Assessment and Management

Review the vendor's risk assessment methodologies

Evaluate the effectiveness of risk management strategies in place

Assess how the vendor identifies and addresses potential non-conformities

7. Process Management

Review key processes related to ISO standards

Evaluate process mapping and documentation practices

Assess the effectiveness of process monitoring and measurement

8. Non-Conformance Management

Review the vendor's procedures for handling non-conformities

Assess corrective action and preventive action (CAPA) processes

Evaluate the effectiveness of past CAPA implementations

9. Internal Audits

Review the schedule and scope of internal audits conducted by the vendor

Assess the effectiveness of internal audit findings and follow-ups

Evaluate the training of internal auditors and their competencies

10. Continuous Improvement

Review the vendor's approach to continuous improvement initiatives

Assess the use of performance metrics and KPIs for improvement

Evaluate initiatives taken to enhance customer satisfaction and service delivery

11. Customer Feedback and Complaints

Review the process for collecting and analyzing customer feedback

Assess how the vendor addresses and resolves customer complaints

Evaluate the effectiveness of feedback loops for process improvement

12. Supplier Management

Review the vendor's criteria for selecting and evaluating subcontractors

Assess the monitoring of subcontractor compliance with ISO standards

Evaluate communication and collaboration with key suppliers

13. Training and Awareness

Review training programs related to ISO compliance for staff

Assess effectiveness of training in promoting ISO awareness

Evaluate records of training attendance and competency assessments

14. Performance Evaluation

Analyze vendor performance data against ISO standards

Review trends and patterns in performance metrics

Gather insights from stakeholders regarding vendor performance

15. Final Evaluation and Recommendations

Summarize audit findings and highlight strengths and weaknesses

Provide actionable recommendations for compliance and improvement

Outline a plan for follow-up audits or ongoing monitoring activities