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Internal Audit Quality Assurance Iso 9001

Leadership and Commitment

1.1* - Are top management committed to quality and ISO 9001 compliance?

Criteria: Evidence of top management's commitment to quality and ISO 9001 compliance through documented policies, objectives, and resource allocation.

Requirements: Top management's commitment to quality, establishment of quality policy and objectives, adequate resource allocation.

Planning and Risk Management

2.1* - Is there a documented process for planning and managing risks?

Criteria: Evidence of a documented process for identifying, assessing, and managing risks related to the QMS and product realization.

Requirements: Risk management process, risk identification and assessment, risk mitigation plans.

Resource Management

3.1* - Are resources adequately allocated for implementing and maintaining the QMS?

Criteria: Evidence of adequate allocation of resources (personnel, infrastructure, equipment) for implementing and maintaining the QMS.

Requirements: Resource allocation plan, availability of necessary resources.

Process Management

4.1* - Are processes defined and documented?

Criteria: Evidence of documented processes for all key activities related to product realization and QMS.

Requirements: Process documentation, process flowcharts, work instructions.

Performance Evaluation

5.1* - Is there a process for measuring and monitoring customer satisfaction?

Criteria: Evidence of a process for collecting and analyzing customer feedback to measure customer satisfaction.

Requirements: Customer satisfaction measurement process, customer feedback analysis.

Improvement

6.1* - Are there processes in place for addressing nonconformities and implementing corrective actions?

Criteria: Evidence of documented processes for identifying, documenting, and addressing nonconformities and implementing corrective actions.

Requirements: Nonconformity identification process, corrective action implementation.

Internal Audit

7.1* - Is there an internal audit process in place to assess QMS compliance?

Criteria: Evidence of a documented internal audit process to assess QMS compliance against ISO 9001 requirements.

Requirements: Internal audit plan, audit schedule, audit reports.

Management Review

8.1* - Is there a management review process to evaluate the effectiveness of the QMS?

Criteria: Evidence of a documented management review process to evaluate the performance and effectiveness of the QMS.

Requirements: Management review meetings, review of QMS performance, review of improvement opportunities.

Note: This checklist is a starting point and should be customized to align with the specific requirements of the engineering organization and ISO 9001 standard. The criteria, requirements, and evidence can be modified and expanded based on the organization's needs.

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