Quality standards are defined as documents that provide requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for their purpose. Standards provide organizations with the shared vision, understanding, procedures, and vocabulary needed to meet the expectations of their stakeholders. Because standards present precise descriptions and terminology, they offer an objective and authoritative basis for organizations and consumers around the world to communicate and conduct business.
Organizations turn to standards for guidelines, definitions, and procedures that help them achieve objectives such as:
- Satisfying their customers’ quality requirements
- Ensuring their products and services are safe
- Complying with regulations
- Meeting environmental objectives
- Protecting products against climatic or other adverse conditions
- Ensuring that internal processes are defined and controlled
ASQ QUALITY STANDARDS
ASQ plays a vital role in the development of international standards. ASQ’s role is to administer the U.S. Technical Advisory Groups (TAGs) that develop the most popular standards—ISO 9001, ISO 19011, ISO 26000, and ISO 14001. Additionally, ASQ produces books, articles, case studies, webcasts, training, and other supporting materials for individuals and organizations looking to improve their use of and compliance to quality standards.
AS9100 is an aerospace standard (AS) designed to achieve high quality in the Aviation, Space, and Defense Industry. Released by IAQG (International Aerospace Quality Group), the AS9100 standard is based on ISO 9001 Quality Management System that is highly practiced and recognized in all the industries across the globe.
AS9100 is the internationally recognised Aerospace QMS Standard, that focuses on the systems necessary, to consistently provide quality products, processes and services
A Quality Management System is a collection of the company’s policies, processes, documented procedures, and records that define how the company will operate in order to provide products and services to customers. The QMS is much more than just quality assurance. You need to tailor the QMS to the needs of your company, and the AS9100 standard gives you a set of guidelines to help make sure that you don’t miss any important elements so that your aerospace QMS can be successful.
The aerospace industry has unique requirements for quality management, which is why many companies that deliver products and services within the aviation, space and defense spheres work to earn AS9100 certification. EN9100:2018 — also called AS9100D or AS9100 — is the most recent standard for organizations that design, develop or provide aviation, space and defense products and services, including parts, components and assemblies. Based on the systematic approach and requirements, AS9100 is designed to ensure high levels of quality with continual improvement in the manufacturing, production and management in the aviation, space and defence industry.
The AS9100 standard follows the clauses in the ISO 9001 standard exactly. The content of the standard is identical to that of ISO 9001 with no deletions; however, additional requirements have been added that relate to the needs of stakeholders in the aerospace industry. It added industry-specific guidelines for the safe development, production, and distribution of quality aerospace parts and products. In order to make the additions easy to recognize, they are in bold and italics in the document.
Aviation, space and defence industries, are among the highest risk and most regulated business sectors in the world. Supplier qualification for these sectors, mandates suppliers meet the compliance requirements of a quality management systems, such as AS9100, AS9110 and or AS9120. The standard specifically addresses aerospace regulatory, safety and reliability requirements for any aerospace organisation; from design and manufacturing to maintenance and stockist distributors.
AS9100 provides an operational framework for you to produce reliable products and services. These standards outline ways to improve quality and risk management processes, saving the time and cost of inefficiency and the potential for fatal errors in business operations. AS9100 can help you achieve better performance, products, and services through safer and more efficient ways of working.
AS9100 certification can be achieved by all levels of the supply chain by organizations around the world to improve quality, cost and delivery performance. This is accomplished through the reduction or elimination of organization-unique requirements, effective implementation of the quality management system and wider application of good business practices.
Benefits of AS9100
For businesses: AS9100 is designed to help companies provide more consistent quality to their customers while making continuous improvements to their processes.
- Standardization leads to lower costs by reducing redundancy, minimizing errors or recalls, and reducing time to market.
- The IAQG also enters all certified companies into its Online Aerospace Supplier Information System (OASIS) database, increasing their visibility across the industry.
- Certification to AS9100 and independent verification that you meet the requirements of the standard tell potential customers and partners all over the world that your company is reliable.
- In addition to the increased visibility and improved reputation AS9100 certification, many aerospace organizations will only work with companies that are certified. This means that certification opens new doors for growing your business
- An AS9100-certified quality management system helps you to consistently provide high-quality products and services to your customers, leading to increased customer satisfaction.
For the global economy: Businesses and organizations complying to quality standards helps products, services, and personnel cross borders and also ensures that products manufactured in one country can be sold and used in another.
For consumers: A product or service based on an international standard will be compatible with more products or services worldwide, which increases the number of choices available across the globe.
What are the requirements in AS9100?
The organization shall establish, implement, maintain, and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard. The organization’s quality management system shall also address customer and applicable statutory and regulatory quality management system requirements.
The organization shall establish and maintain documented information that includes:
- a general description of relevant interested parties;
- the scope of the quality management system, including boundaries and applicability;
- a description of the processes needed for the quality management system and their application throughout the organization;
- the sequence and interaction of these processes;
- assignment of the responsibilities and authorities for these processes.
The organization shall
- Identify the processes of the organization and interaction of the processes.
- Determine operational controls to ensure processes are effective.
- Ensure the availability of adequate resources and information.
- Monitor, measure and analyse processes.
- Implement necessary actions to achieve planned objectives and targets.
Implementing an AS9100 standard
- Get commitment and support from senior management.
- Engage the whole business with good internal communication.
- Get customer and supplier feedback on current quality management.
- Perform a Gap analysis: Compare existing quality management with AS9100 requirements. Document where your system complies and does not comply with the standard’s requirements. Discuss with management what to include in the project plan based on the results of the gap analysis
- Create An Implementation Plan: When creating your plan, you will design and document your quality manual and procedures. A significant portion of completing this is looking at your current processes and redesigning them as needed so that they meet the requirements of AS9100. You will need to establish methods for controlling these processes, including documentation. Your plan should also cover the costs of certification and implementation, as well as the benefits. This information will help you to plan for the costs, justify expenses and earn buy-in from management and employees.
- Map out and share roles, responsibilities and timescales.
- Adapt the basic principles of the AS9100 standard to your business.
- Design Documentation: Once you have developed or modified your processes to comply with the standard, you will need to document them as quality system procedures. Your documentation will help guide your processes and enable you to verify compliance.
- Establish an implementation team to get the best results
- Motivate staff involvement with training and incentives. All employees who will be involved with the implementation and enabling compliance with the standard should receive the training they need to fulfill their duties. Be sure that employees have adequate time to complete training before beginning the implementation process.
- Implement Your Plan: The next step is to carry out the plan you created. Run your quality management system according to your plan for several months, making sure to monitor the process carefully. If issues arise during implementation or you identify potential improvements, make adjustments as necessary. Thoroughly document all changes made and ensure that all relevant employees are informed of them.
- Share AS9100 knowledge and encourage staff to train as internal auditors.
- Choose A Certification Body: Once you have run your quality management system for some time and have conducted initial audits, you can start looking into third-party certification bodies (CB).
- Audit And Certify: This part of the process verifies that you meet the requirements of the standard. If you pass the required audits, you will receive certification to AS9100. The purpose of the stage one assessment of the initial certification audit is to verify that your company is prepared for a full assessment. During the stage two audit, the CB will check whether your quality management system fully meets the requirements of AS9100. This audit will cover all locations that are within the scope of your certification and will also include any site work your company is undertaking.
- Regularly review your AS9100 system to make sure you are continually improving it
- Maintain Your Certification: To maintain your certification, you must complete a surveillance audit every year and a recertification audit every three years. Surveillance audits are partial audits and ensure that your organization stays compliant with the requirements of your chosen standards during the three-year certification cycle. During surveillance audits, you must show that you have been making continual improvements to your system. The duration of your surveillance audits will depend on the size and structure of your organization, the risk and complexity involved in your activities, the number of standards included in your certification and the number of sites that fall under the scope of the certification.
AS9100 Requirements in addition to ISO 9001 requirements
Planning for Product Realization
- Control of work transfers between facilities, to suppliers or between suppliers
- Risk identification & Management with respect to quality and delivery of the product
- Procedure for configuration management
- regulatory requirements/authority approvals/recognitions
- Documented procedure to be established for production equipment, tools and programs
- Validation, qualification of Special processes
- Control of changes to equipment and processes
- Product preservation and shelf-life control
- assembly components traceability to be made evident.
- identification of special requirements & key characteristics
- First Article Inspection (FAI) requirements
- Foreign Object Debris/Damage (FOD) programs
- Criteria for workmanship (written standard, master sample)
Design and Development
- Verification and validation
Purchasing and Purchased Product
- Flow down of purchase requirement to suppliers
- Product purchased for use in a controlled or limited way
- Product monitoring and measurement
- Criteria for rejection and special measurement instructions
- Corrective action, including flow down of corrective action to suppliers
The quality management system documentation shall include
- Quality policy and quality objectives
- Quality manual
- Documented procedures and work instructions
- Documents and records needed for effective implementation of processes
- Quality requirements by the applicable regulatory authorities
What are the major benefits of AS9100?
The internal benefits at the organizational management level are
- Conformance to Legal and Regulatory Requirements
- Controlled consistency of manufactured products
- Improved customer perception of the organization’s image, culture and performance.
- Improved internal and external Communications
- A better understanding of the organizational processes
- Clear responsibilities and authorities agreed for all staff
- Greater involvement of the top management in the QMS
- Risk-based thinking in the QMS
- Higher emphasis on performance monitoring
The external benefits are
- Reduce risks, failures as well as waste
- Ensure consistency and traceability of products and services
- Demonstrate effective and proven quality management
- Continually improve the quality throughout the supply chain
- Managed productivity and efficiency and control costs
- Improve time and resource management
- The desired level of assurance in the quality
- Increased organizational Profitability
The AS9100 helps you stand out in the market
- Gain customer trust and international recognition
- Become preferred supplier
- Gain a competitive advantage and increased marketing and sales opportunities.
- Enhance organizational credibility and Reputation
- Gain better access to OEMs
Aerospace management standards: AS9110 and AS9120
In addition to AS9100, which is a general aerospace industry standard, the IAQG has also created two more specific aerospace management standards: AS9110 and AS9120. The former, Aerospace Management Systems for Maintenance, Repair and Overhaul (MRO) Stations, adds additional requirements to AS9100 relating to the maintenance of commercial, private and military aircraft. The latter, Aerospace Management Systems for Stockist Distributors, adds requirements for the sourcing and production of aerospace components and materials. NQA can assess compliance with AS9100, AS9110 and AS9120.
Because AS9100 certification helps ensure an organization has adequate quality management systems in place, many aerospace manufacturers and suppliers will work only with certified partners. As a result, AS9100 certification is important for any aerospace-related company to consider.
Terms & Definitions section of the standard it gives very clear information:
3.1 Counterfeit Part – An unauthorized copy, imitation, substitute, or modified part (e.g., material, part, component), which is knowingly misrepresented as a specified genuine part of an original or authorized manufacturer
3.2 Critical Items – Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the provision and use of the products and services; including safety, performance, form, fit, function, producibility, service life, etc.; that require specific actions to ensure they are adequately managed. Examples of critical items include safety critical items, fracture critical items, mission critical items, key characteristics, etc.
3.3 Key Characteristic – An attribute or feature whose variation has a significant effect on product fit, form, function, performance, service life, or producibility, that requires specific actions for the purpose of controlling variation.
3.4 Product Safety – The state in which a product is able to perform to its designed or intended purpose without causing unacceptable risk of harm to persons or damage to property.
3.5 Special Requirements – Those requirements identified by the customer, or determined by the organization, which have high risks of not being met, thus requiring their inclusion in the operational risk management process. Factors used in the determination of special requirements include product or process complexity, past experience, and product or process maturity. Examples of special requirements include performance requirements imposed by the customer that are at the limit of the industry’s capability, or requirements determined by the organization to be at the limit of its technical or process capabilities.
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