Introduction to AS9100 Quality Management System
AS9100 is a globally recognized quality management system standard designed for the aerospace industry. It builds upon the ISO 9001 standard and includes additional requirements and best practices tailored to the unique and stringent demands of the aerospace and defense sectors. AS9100 encompasses a comprehensive set of guidelines and principles that aerospace organizations must follow to ensure the safety, reliability, and quality of their products and services.
This standard emphasizes a strong focus on risk management, configuration management, and regulatory compliance. Organizations must establish and maintain a robust AS 9100 quality management system that promotes continuous improvement and helps prevent defects, errors, and safety issues. AS 9100 quality management system also significantly emphasizes traceability, accountability, and documentation to ensure that aerospace products are produced and delivered with the highest levels of precision and safety.
Certification to AS9100 is often a prerequisite for aerospace manufacturers and suppliers to do business in the industry. Compliance with AS9100 is essential to demonstrate an organization's commitment to quality, safety, and customer satisfaction, ultimately contributing to the overall reliability and performance of aerospace products and services.
What is the AS9100 Quality Management System?
AS9100 is a stringent quality management system standard developed for the aerospace industry. It extends upon ISO 9001, adding specific requirements tailored to aerospace's unique challenges and regulations. The primary goal of AS 9100 quality management system is to ensure the highest safety, reliability, and quality levels in aerospace products and services.
This standard mandates a comprehensive quality management framework focusing on areas like risk management, configuration control, and compliance with aerospace regulations. Organizations that seek AS9100 certification must establish and maintain robust AS 9100 quality management systems that foster continuous improvement, error prevention, and safety. The standard demands meticulous documentation, traceability, and accountability to ensure the production and delivery of aerospace products meet the industry's rigorous standards.
AS9100 certification is often a prerequisite for aerospace manufacturers and suppliers to participate in the industry. Complying with AS9100 using an AS 9100 quality management system showcases an organization's commitment to quality, safety, and customer satisfaction, contributing to aerospace offerings' overall dependability and performance.
Requirements for AS9100 Quality Management System
AS 9100 quality management system has several key requirements that organizations must meet to achieve certification:
- Quality Management System (QMS): Establish and maintain a documented QMS that complies with AS9100 requirements and aligns with the organization's goals and processes.
- Leadership Commitment: Demonstrate leadership commitment to the AS 9100 quality management system by ensuring its integration into the organization's strategic direction.
- Risk Management: Identify and manage risks related to product quality, safety, and compliance with aerospace regulations.
- Configuration Management: Maintain control over product design and development, ensuring proper documentation and change management.
- Resource Management: Allocate necessary resources, including personnel, infrastructure, and training, to support the AS 9100 quality management system effectively.
- Product Realization: Define processes for product design, development, production, and service to ensure compliance with customer and regulatory requirements.
- Measurement and Analysis: Establish procedures for monitoring and measuring processes, products, and customer satisfaction.
- Continual Improvement: Implement processes for identifying and correcting nonconformities and continuously improving the QMS.
- Supplier Management: Assess and monitor supplier performance to ensure product and service quality.
- Document Control: Maintain comprehensive document and record control to support effective QMS implementation.
Step-by-step Guide for AS9100 Quality Management System Certification
Obtaining AS9100 certification for your organization involves a structured process. Here's a step-by-step guide:
Step 1: Understand AS9100 Requirements
The initial step in pursuing AS9100 certification is thoroughly understanding the standard and its requirements. Begin by obtaining a copy of the AS9100 standard and any relevant supporting documents like AS9101, which outlines audit preparation and execution requirements. It can also be beneficial to acquire a copy of ISO 9001. Take the time to study these documents to become familiar with the AS9100 requirements and how your organization aligns with them.
Step 2: Conduct a Gap Analysis
A gap analysis, a pre-audit, involves comparing your current organizational practices with the standards outlined in the AS9100 requirements. It helps identify gaps or discrepancies between your existing processes and the standards. The findings from this analysis guide your implementation plan. The extent of the implementation process will depend on the number and size of gaps identified.
The gap analysis should include the following steps:
- Compare your current quality management system with AS9100 requirements.
- Document where your system complies or does not comply with the standard.
- Collaborate with management to determine the project plan based on gap analysis results.
Upon completing the gap analysis, an assessment report is typically produced, which includes:
- Areas where your company conforms with AS9100 requirements.
- Areas where your company falls short of compliance.
- Recommendations that form the basis for your implementation plan.
Using the gap analysis results, you can develop a project plan to address the gaps.
Step 3: Create an Implementation Plan
The subsequent step involves crafting a detailed plan for implementing AS9100 within your organization, using insights from the gap analysis. This plan should outline the steps required to implement AS9100 and include specific, measurable objectives and realistic timelines.
When formulating the plan, you'll design and document your quality manual and procedures. This often involves reviewing and redesigning your current processes to ensure they align with AS9100 requirements. You must also establish methods to control these processes, including appropriate documentation.
Pay special attention to the key elements emphasized in AS9100, such as comprehensive planning, data requirements, review authorization, and process control. Your implementation plan should provide details for each task, including the relevant AS9100 section, necessary documentation, responsible personnel or teams, required approvals, needed training, essential resources, and estimated completion dates.
Additionally, your plan should encompass the costs associated with certification and implementation and the expected benefits. This information is instrumental for cost planning, justifying expenses, and securing support from management and employees.
Step 4: Develop Documentation
Effective documentation control is essential for AS9100 implementation. Once you've adjusted or established processes to comply with the standard, you must document them as quality system procedures. Your documentation serves as a guide for your processes and enables you to verify compliance. While you can design your documentation to suit your organization's specific needs, it must also meet AS9100 requirements.
To begin, consider the minimum documentation requirements. Include documentation in your implementation plan and generate additional documents as necessary.
Step 5: Provide Employee Training
Ensuring all employees are informed about the decision to implement AS9100, its impact on their roles, and the implementation process is crucial for a smooth transition. Employee awareness of the benefits of AS9100 certification can help gain their support.
All employees implementing and complying with the standard should receive appropriate training. Ensure employees have sufficient time to complete their training before the implementation begins.
Step 6: Execute Your Plan
The next phase is to put your implementation plan into action. The AS9100 implementation process can vary from company to company, depending on the gaps identified in the gap analysis and the tasks outlined in the plan. Run your quality management system as per your plan, monitoring the process closely. If issues arise during implementation or potential improvements are identified, make necessary adjustments. Document all changes thoroughly and ensure relevant employees are informed.
Conduct initial audits to identify areas of improvement and prepare for certification. Develop an initial AS9100 audit checklist to evaluate the effectiveness of your system and verify compliance. Ensure that your processes align with AS9100 standards and document the results. Make any required adjustments based on the audit findings.
Step 7: Select a Certification Body
Once your quality management system has been in operation and initial audits have been conducted, you can start researching third-party certification bodies (CB). Assess their accreditations, experience in AS9100 certification, and their approach to improving organizations through audits. Choosing a certification body with these attributes enhances the value of the audit and certification process.
Step 8: Audit and Certification
At this stage, you're ready to initiate the third-party audit and certification process, which verifies your compliance with AS9100 requirements. If your organization successfully passes these required audits, you will receive AS9100 certification.
After selecting the certification body, complete an application form to provide information about your company, the standard you seek certification for, and any additional requirements. This information helps define the scope of the assessment and generates a certification proposal.
The assessment phase consists of two mandatory visits from the certification body. It begins with a stage one assessment, which validates your readiness for a full assessment. The stage one assessment involves a review of documentation at your management system center, typically your head office.
The certification body will decide whether to grant certification if your organization successfully passes the stage two audit. Upon receiving a positive decision, you will be issued AS9100 certification, valid for three years. To maintain your certification, you must complete annual surveillance and recertification audits every three years.