AS9100:2016
AS9100D (also known as AS9100:2016) is a quality management system (QMS) standard for organizations in the aerospace, aviation, and defense industries. It is based on ISO 9001:2015 but includes additional aviation, space, and defense-specific requirements to address the unique needs of these sectors. AS9100D includes 10 clauses, with clauses 4 through 10 focusing on specific QMS requirements.
Here’s a detailed breakdown of the clauses in AS9100D:
Clause 1: Scope
The standard applies to any organization involved in design, production, assembly, or services related to aerospace and defense. It specifies the requirements for a QMS that helps ensure products and services meet customer, statutory, and regulatory requirements.
Clause 2: Normative References
AS9100D relies on ISO 9001:2015 as the baseline and incorporates additional aerospace-specific requirements. There are no separate normative references outside of the ISO 9000 family.
Clause 3: Terms and Definitions
This clause references terms from ISO 9000:2015 and introduces key aerospace-specific terms such as "counterfeit part," "critical items," and "key characteristics."
Clause 4: Context of the Organization
This clause emphasizes understanding the organization’s internal and external issues that affect its ability to achieve the intended outcomes of its QMS.
Key sub-clauses:
- 4.1 Understanding the organization and its context: Identify internal and external factors that influence strategic direction and ability to deliver products.
- 4.2 Understanding the needs and expectations of interested parties: Understand stakeholder needs (e.g., customers, regulators, suppliers, employees).
- 4.3 Determining the scope of the QMS: Define the scope of the QMS based on the organization's context and products/services.
- 4.4 QMS and its processes: Organizations must establish, implement, and continuously improve the processes required for the QMS.
Aerospace-specific requirements:
- Emphasis on understanding and mitigating risks related to product safety, counterfeit parts, and regulatory requirements.
Clause 5: Leadership
Leadership is critical for the successful implementation of the QMS. Top management must demonstrate a commitment to customer satisfaction, regulatory compliance, and continuous improvement.
Key sub-clauses:
- 5.1 Leadership and commitment: Top management must demonstrate leadership and commitment to the QMS, customer focus, and safety.
- 5.2 Quality policy: Establish a quality policy that aligns with organizational strategy and focuses on quality and safety.
- 5.3 Organizational roles, responsibilities, and authorities: Roles and responsibilities must be clearly defined, communicated, and understood at all levels of the organization.
Aerospace-specific requirements:
- Product safety: Leadership must ensure the QMS incorporates processes to manage product safety risks.
- Ethical behavior: Organizations must promote ethical behavior and adhere to applicable codes of conduct in aerospace.
Clause 6: Planning
This clause focuses on addressing risks and opportunities while ensuring that quality objectives are met.
Key sub-clauses:
- 6.1 Actions to address risks and opportunities: Organizations must implement risk management strategies to prevent or minimize the impact of risks (including those related to counterfeit parts and product safety).
- 6.2 Quality objectives and planning to achieve them: Quality objectives must be measurable, consistent with the quality policy, and focus on product safety and customer satisfaction.
- 6.3 Planning of changes: Organizations must systematically plan changes to ensure continued compliance with QMS requirements.
Aerospace-specific requirements:
- Risk management: The aerospace industry mandates robust risk assessment and risk-based thinking to mitigate the impact of product failures.
- Configuration management: Organizations must manage product configurations to ensure product integrity throughout its lifecycle.
Clause 7: Support
This clause covers the resources, competence, communication, and documentation necessary for the effective operation of the QMS.
Key sub-clauses:
- 7.1 Resources: Provide resources (human, infrastructure, and environment) necessary for QMS processes, including testing and calibration resources.
- 7.2 Competence: Ensure that personnel are competent through education, training, and experience, especially in product safety and regulatory compliance.
- 7.3 Awareness: Employees must be aware of the quality policy, safety issues, and their role in achieving quality objectives.
- 7.4 Communication: Organizations must establish internal and external communication processes, including communication with customers and regulatory bodies.
- 7.5 Documented information: Control documentation (procedures, manuals, records) essential for the QMS, ensuring the availability, protection, and integrity of information.
Aerospace-specific requirements:
- Awareness of product safety and ethical behavior: Personnel must be aware of product safety issues and the importance of ethical behavior in aerospace manufacturing.
- Control of documented information: Additional controls are required for documentation related to product conformity and traceability, including configuration management.
Clause 8: Operation
This clause is the heart of AS9100D and covers how organizations manage product realization, including design, production, and delivery.
Key sub-clauses:
- 8.1 Operational planning and control: Plan and control operational processes to ensure conformity to product requirements, including those for special characteristics, customer property, and regulatory requirements.
- 8.2 Requirements for products and services: Define and review customer requirements, ensuring effective communication with customers about product requirements and issues like safety.
- 8.3 Design and development of products and services: Design and development processes must ensure the consideration of customer requirements, safety, reliability, and verification/validation processes.
- 8.4 Control of externally provided processes, products, and services: Ensure that suppliers meet all customer and regulatory requirements (supplier management), and control outsourced processes.
- 8.5 Production and service provision: Ensure that production processes meet requirements, including product identification, traceability, and preservation.
- 8.6 Release of products and services: Ensure that products are inspected and meet customer requirements before release.
- 8.7 Control of nonconforming outputs: Establish processes to control nonconforming products, including corrective action and product recall if necessary.
Aerospace-specific requirements:
- Product safety: This section adds specific provisions to ensure that product safety is managed throughout the entire production and service provision process.
- Prevention of counterfeit parts: Processes must be implemented to prevent the use of counterfeit or suspect parts in aerospace products.
- Control of critical items: Ensure that critical items (e.g., safety-related or mission-critical parts) are identified and controlled.
- Work transfers: When production is transferred between sites, organizations must plan and manage the transfer to ensure that quality is maintained.
Clause 9: Performance Evaluation
This clause emphasizes monitoring and measurement to assess QMS effectiveness and customer satisfaction.
Key sub-clauses:
- 9.1 Monitoring, measurement, analysis, and evaluation: Define what needs to be monitored and measured, including customer satisfaction, product conformity, and QMS performance.
- 9.2 Internal audit: Conduct regular internal audits to assess QMS compliance with AS9100D requirements and ensure continual improvement.
- 9.3 Management review: Top management must regularly review the performance of the QMS, including feedback on product safety, customer satisfaction, and process performance.
Aerospace-specific requirements:
- Customer satisfaction: Requires specific monitoring and measuring of customer satisfaction metrics, focusing on product performance, delivery, and safety.
- Quality performance indicators: Aerospace organizations must monitor and measure quality performance indicators, including defect rates, process yields, and corrective actions.
Clause 10: Improvement
The goal of this clause is to drive continuous improvement in the QMS to enhance customer satisfaction and meet aerospace industry standards.
Key sub-clauses:
- 10.1 General: Identify opportunities for improvement, focusing on customer satisfaction, safety, and process efficiency.
- 10.2 Nonconformity and corrective action: Address nonconformities by identifying their root causes, taking corrective action, and preventing recurrence.
- 10.3 Continual improvement: Organizations must continually improve the effectiveness of the QMS, considering product safety, regulatory compliance, and customer feedback.
Aerospace-specific requirements:
- Corrective actions for safety concerns: Ensure that corrective actions address product safety and the risk of future occurrences.
- Preventive actions for counterfeit parts: Organizations must take proactive measures to prevent the introduction of counterfeit parts into the supply chain.
AS9100D
Clause 1: Scope
The standard applies to any organization involved in design, production, assembly, or services related to aerospace and defense. It specifies the requirements for a QMS that helps ensure products and services meet customer, statutory, and regulatory requirements.
Clause 2: Normative References
AS9100D relies on ISO 9001:2015 as the baseline and incorporates additional aerospace-specific requirements. There are no separate normative references outside of the ISO 9000 family.
Clause 3: Terms and Definitions
This clause references terms from ISO 9000:2015 and introduces key aerospace-specific terms such as "counterfeit part," "critical items," and "key characteristics."
Clause 4: Context of the Organization
This clause emphasizes understanding the organization’s internal and external issues that affect its ability to achieve the intended outcomes of its QMS.
Key sub-clauses:
- 4.1 Understanding the organization and its context: Identify internal and external factors that influence strategic direction and ability to deliver products.
- 4.2 Understanding the needs and expectations of interested parties: Understand stakeholder needs (e.g., customers, regulators, suppliers, employees).
- 4.3 Determining the scope of the QMS: Define the scope of the QMS based on the organization's context and products/services.
- 4.4 QMS and its processes: Organizations must establish, implement, and continuously improve the processes required for the QMS.
Aerospace-specific requirements:
- Emphasis on understanding and mitigating risks related to product safety, counterfeit parts, and regulatory requirements.
Clause 5: Leadership
Leadership is critical for the successful implementation of the QMS. Top management must demonstrate a commitment to customer satisfaction, regulatory compliance, and continuous improvement.
Key sub-clauses:
- 5.1 Leadership and commitment: Top management must demonstrate leadership and commitment to the QMS, customer focus, and safety.
- 5.2 Quality policy: Establish a quality policy that aligns with organizational strategy and focuses on quality and safety.
- 5.3 Organizational roles, responsibilities, and authorities: Roles and responsibilities must be clearly defined, communicated, and understood at all levels of the organization.
Aerospace-specific requirements:
- Product safety: Leadership must ensure the QMS incorporates processes to manage product safety risks.
- Ethical behavior: Organizations must promote ethical behavior and adhere to applicable codes of conduct in aerospace.
Clause 6: Planning
This clause focuses on addressing risks and opportunities while ensuring that quality objectives are met.
Key sub-clauses:
- 6.1 Actions to address risks and opportunities: Organizations must implement risk management strategies to prevent or minimize the impact of risks (including those related to counterfeit parts and product safety).
- 6.2 Quality objectives and planning to achieve them: Quality objectives must be measurable, consistent with the quality policy, and focus on product safety and customer satisfaction.
- 6.3 Planning of changes: Organizations must systematically plan changes to ensure continued compliance with QMS requirements.
Aerospace-specific requirements:
- Risk management: The aerospace industry mandates robust risk assessment and risk-based thinking to mitigate the impact of product failures.
- Configuration management: Organizations must manage product configurations to ensure product integrity throughout its lifecycle.
Clause 7: Support
This clause covers the resources, competence, communication, and documentation necessary for the effective operation of the QMS.
Key sub-clauses:
- 7.1 Resources: Provide resources (human, infrastructure, and environment) necessary for QMS processes, including testing and calibration resources.
- 7.2 Competence: Ensure that personnel are competent through education, training, and experience, especially in product safety and regulatory compliance.
- 7.3 Awareness: Employees must be aware of the quality policy, safety issues, and their role in achieving quality objectives.
- 7.4 Communication: Organizations must establish internal and external communication processes, including communication with customers and regulatory bodies.
- 7.5 Documented information: Control documentation (procedures, manuals, records) essential for the QMS, ensuring the availability, protection, and integrity of information.
Aerospace-specific requirements:
- Awareness of product safety and ethical behavior: Personnel must be aware of product safety issues and the importance of ethical behavior in aerospace manufacturing.
- Control of documented information: Additional controls are required for documentation related to product conformity and traceability, including configuration management.
Clause 8: Operation
This clause is the heart of AS9100D and covers how organizations manage product realization, including design, production, and delivery.
Key sub-clauses:
- 8.1 Operational planning and control: Plan and control operational processes to ensure conformity to product requirements, including those for special characteristics, customer property, and regulatory requirements.
- 8.2 Requirements for products and services: Define and review customer requirements, ensuring effective communication with customers about product requirements and issues like safety.
- 8.3 Design and development of products and services: Design and development processes must ensure the consideration of customer requirements, safety, reliability, and verification/validation processes.
- 8.4 Control of externally provided processes, products, and services: Ensure that suppliers meet all customer and regulatory requirements (supplier management), and control outsourced processes.
- 8.5 Production and service provision: Ensure that production processes meet requirements, including product identification, traceability, and preservation.
- 8.6 Release of products and services: Ensure that products are inspected and meet customer requirements before release.
- 8.7 Control of nonconforming outputs: Establish processes to control nonconforming products, including corrective action and product recall if necessary.
Aerospace-specific requirements:
- Product safety: This section adds specific provisions to ensure that product safety is managed throughout the entire production and service provision process.
- Prevention of counterfeit parts: Processes must be implemented to prevent the use of counterfeit or suspect parts in aerospace products.
- Control of critical items: Ensure that critical items (e.g., safety-related or mission-critical parts) are identified and controlled.
- Work transfers: When production is transferred between sites, organizations must plan and manage the transfer to ensure that quality is maintained.
Clause 9: Performance Evaluation
This clause emphasizes monitoring and measurement to assess QMS effectiveness and customer satisfaction.
Key sub-clauses:
- 9.1 Monitoring, measurement, analysis, and evaluation: Define what needs to be monitored and measured, including customer satisfaction, product conformity, and QMS performance.
- 9.2 Internal audit: Conduct regular internal audits to assess QMS compliance with AS9100D requirements and ensure continual improvement.
- 9.3 Management review: Top management must regularly review the performance of the QMS, including feedback on product safety, customer satisfaction, and process performance.
Aerospace-specific requirements:
- Customer satisfaction: Requires specific monitoring and measuring of customer satisfaction metrics, focusing on product performance, delivery, and safety.
- Quality performance indicators: Aerospace organizations must monitor and measure quality performance indicators, including defect rates, process yields, and corrective actions.
Clause 10: Improvement
The goal of this clause is to drive continuous improvement in the QMS to enhance customer satisfaction and meet aerospace industry standards.
Key sub-clauses:
- 10.1 General: Identify opportunities for improvement, focusing on customer satisfaction, safety, and process efficiency.
- 10.2 Nonconformity and corrective action: Address nonconformities by identifying their root causes, taking corrective action, and preventing recurrence.
- 10.3 Continual improvement: Organizations must continually improve the effectiveness of the QMS, considering product safety, regulatory compliance, and customer feedback.
Aerospace-specific requirements:
- Corrective actions for safety concerns: Ensure that corrective actions address product safety and the risk of future occurrences.
- Preventive actions for counterfeit parts: Organizations must take proactive measures to prevent the introduction of counterfeit parts into the supply chain.