Creating a comprehensive AS9100D checklist involves outlining key requirements from the AS9100D standard, which is a widely recognized Quality Management System (QMS) standard for the aerospace industry. The checklist can be used by organizations to ensure that they are compliant with the standard and to identify areas that need improvement before undergoing an audit.
Below is a checklist based on the main clauses and sub-clauses of the AS9100D standard. Each item should be reviewed to ensure compliance:
Context of the Organization (Clause 4)
4.1 Understanding the Organization and its Context: Has the organization determined external and internal issues relevant to its purpose and strategic direction?
4.2 Understanding the Needs and Expectations of Interested Parties: Has the organization determined the needs and expectations of interested parties that are relevant to the QMS?
4.3 Determining the Scope of the QMS: Is the scope of the QMS documented and does it consider all external and internal issues, as well as requirements of relevant interested parties?
4.4 QMS and its Processes: Has the organization established, implemented, maintained, and continually improved the QMS, including necessary processes and their interactions?
Leadership (Clause 5)
5.1 Leadership and Commitment: Are top management demonstrating leadership and commitment to the QMS?
5.2 Quality Policy: Has a quality policy been established, is it appropriate to the context of the organization, and is it communicated within the organization?
5.3 Organizational Roles, Responsibilities, and Authorities: Are roles, responsibilities, and authorities within the QMS clearly defined, documented, and communicated?
Planning (Clause 6)
6.1 Actions to Address Risks and Opportunities: Has the organization determined risks and opportunities that need to be addressed to ensure the QMS can achieve its intended outcomes?
6.2 Quality Objectives and Planning to Achieve Them: Are quality objectives established at relevant functions, levels, and processes? Are these objectives measurable and consistent with the quality policy?
6.3 Planning of Changes: Are changes to the QMS carried out in a planned manner?
Support (Clause 7)
7.1 Resources: Are necessary resources for establishing, implementing, maintaining, and improving the QMS determined and provided?
7.1.5 Monitoring and Measuring Resources: Are resources for monitoring and measuring provided, and are measuring equipment calibrated or verified?
7.2 Competence: Are personnel performing work under the organization’s control competent, based on education, training, or experience?
7.3 Awareness: Are employees aware of the quality policy, their contributions to the QMS, and the implications of not conforming to QMS requirements?
7.4 Communication: Are internal and external communications relevant to the QMS determined and implemented?
7.5 Documented Information: Is documented information required by the QMS controlled, updated, and retained appropriately?
Operation (Clause 8)
8.1 Operational Planning and Control: Are processes needed to meet requirements for the provision of products and services planned and controlled?
8.2 Requirements for Products and Services: Are requirements for products and services defined, including applicable statutory and regulatory requirements?
8.3 Design and Development of Products and Services: Are design and development processes established, implemented, and maintained?
8.4 Control of Externally Provided Processes, Products, and Services: Are controls in place to ensure that externally provided processes, products, and services conform to requirements?
8.5 Production and Service Provision: Are production and service provision processes controlled, and are there provisions for property belonging to customers or external providers?
8.6 Release of Products and Services: Are products and services released to the customer with appropriate documented information?
8.7 Control of Nonconforming Outputs: Are nonconforming outputs identified, controlled, and actions taken to prevent their unintended use or delivery?
Performance Evaluation (Clause 9)
9.1 Monitoring, Measurement, Analysis, and Evaluation: Are processes established for monitoring, measurement, analysis, and evaluation of the QMS?
9.2 Internal Audit: Is an internal audit program established, implemented, and maintained?
9.3 Management Review: Are management reviews conducted at planned intervals, and do they address the performance and effectiveness of the QMS?
Improvement (Clause 10)
10.1 General: Are opportunities for improvement determined and acted upon to enhance customer satisfaction?
10.2 Nonconformity and Corrective Action: Are nonconformities addressed, and corrective actions taken to control and correct them, and to prevent recurrence?
10.3 Continual Improvement: Is there an ongoing effort to improve the suitability, adequacy, and effectiveness of the QMS?
Additional Considerations for Aerospace (AS9100D-Specific)
Product Safety: Are processes in place to ensure product safety throughout the product lifecycle?
Counterfeit Part Prevention: Are measures established to prevent the use of counterfeit or suspect counterfeit parts?
Awareness: Are personnel aware of their contribution to product and service conformity, product safety, and the importance of ethical behavior?
Risk Management: Is there a documented process for managing risks to the achievement of applicable requirements, including processes for risk identification, assessment, mitigation, and acceptance?
Using the Checklist
This checklist can be used as a self-assessment tool during internal audits or as a preparatory step before undergoing third-party certification audits. Ensure that each item is reviewed thoroughly, evidence of compliance is collected, and any gaps are addressed with appropriate corrective actions.
If you need a more detailed checklist tailored to specific processes or operations, feel free to contact us!
