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ISO 13485

ISO 13485:2016 lists the prerequisites for a quality management system for an organisation that provides medical devices and related services and constantly demonstrates its eligibility to meet customer and applicable regulatory requirement. The companies that are ISO 13485:2016 certified are involved in one or more of the stages like design and development, production, storage, distribution, installation, servicing of medical design. This International Standard aims to allow global alignment of suitable regulatory requirements for quality management systems applicable to enterprises involved in one or more phases of a medical device's life cycle. Suppliers or external parties who provide product, which includes QMS and related services can also get ISO 13485:2016 certified. This global standard is mandatory in some countries. The ISO 13485 is a process approach of quality management system. A process can be defined as any action that accepts input and transforms it to output Frequently, the output of one operation becomes the input to the next. The "process approach" refers to the implementation of a system of processes within an organisation, as well as the identification and interactions of these processes, and their management to create the intended outcome. When used as part of a quality management system, this method emphasises the importance of: a) comprehending and fulfilling requirements; b) looking at processes from the standpoint of added value; c) getting process performance results The latest version ISO 13485 for ISO medical devices was developed on March 2016.Except when otherwise stated, the requirements of ISO 13485:2016 apply to all companies, regardless of their size or kind. Audits can be carried out in three ways: 1. On-site audits take a full day to complete. The number of days required for an audit is determined by various factors, including the organization's size, complexity, risk, and nature. For registrars to calculate audit time, the International Accreditation Forum (IAF) has established standards. 2. Web meetings, teleconferencing, and electronic process verification can all be used to conduct remote audits. Remote audits are less prevalent and, in most cases, ineffective compared to on-site audits. 3. Internal audits are not usually synonymous with self-audits. You can ask your customer to perform a self-audit to eliminate the need for them to use their resources while still providing some assurance that you are following criteria. What changes did the current revision of ISO 13485 bring to auditing? Several additional clauses have been added to the ISO 13485:2003 and 2016 standards. The auditor will be expected to check that the company fulfil these standards and all of the other requirements. This is why, as the company begins their road towards ISO 13485:2016 certification, the company should do a gap analysis to identify any potential nonconformities that might be present in these areas so that you may resolve them prior to your certification assessment.

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ISO 28000

ISO 28000 defines the standards for a security management system, including those aspects that are crucial to supply chain security assurance. ISO 28000 certification is relevant to businesses of all sizes, from small to large, in manufacturing, service, storage, and transportation at any point in the production or supply chain. It was created in such a way that enterprises may use it to manage supply chains in a variety of difficult situations. By obtaining ISO 28000 certification, your company can ensure that hazards posed by logistical operations and supply chain partners are managed and regulated safely.The ISO 28000:2007 standard was created to standardize security activities as part of a larger supply chain management system. The creation of an international standard for security risk management enhances the overall interface with existing business risk management in a single integrated platform. The ISO 28000 standard establishes a best-practice framework for reducing supply-chain hazards to persons and cargo. It aids in the management and mitigation of potential security concerns in the logistics sector, such as terrorism, fraud, and piracy. ISO 28000 can assist any organisation in limiting the effects of security incidents by increasing supply chain visibility and reducing supply chain disruption. ISO 28000 certification (also known as "registration") is a third-party audit conducted by a certifying authority that issues an ISO 28000 certificate after verifying that a business complies with the standards. This accreditation is then maintained by the registrar's annual surveillance audits, with triennial re-certification. Benefits of ISO 28000 certification to your organization: 1. Facilitates cross-border trade and expedites the transport of commodities. 2. Monitors and handles security risks across your whole company and supply chain. 3. Enables the company to gain a competitive edge as well as new business opportunities 4. Encourages businesses to secure their own supply chain processes. 5. Assures stakeholders of your company's commitment to person safety and the security of goods and services. 6. Allows management to concentrate finite resources on the most pressing issues. 7. Compares the company's security management methods to best practices from around the world. 8. Risks to your organization and supply chain will be monitored and managed. 9. Reduces the number of security incidents to save money. 10. Facilitates cross-border trade and speed the transit of products 11. Compares the company's security management methods to best practices from around the world. 12. Allows for easy adoption and connection with your existing ISO management systems, as well as increased efficiency in system maintenance and audits. 13. Helps builds a security management system. 14. Ensures internal compliance with security management policy objectives Benefits of ISO 28000 certification to your customers: 1. It boosts the credibility and trustworthiness of the company by working with reliable vendors. 2. Production of final goods/ services which are satisfactorily 3. There are fewer returns and complaints with respect to goods and services. 4. Assurance of product/service quality to the customers 5. The company is able to provide evidence of safety

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ISO9004

In 1947, the International Organization for Standards was established to coordinate the development of standards and specifications for products, services, and business procedures around the world. Because of language issues, ISO was used as a worldwide acronym. It includes over 19,000 standards covering practically every aspect of technology and business.

ISO 9004, is a tool for quality management that was initially published in 1987 and was most recently updated in 2009. ISO 9004 is a magnanimous term for standards established and published by the International Organization for Standardization (ISO). The current version of this standard is ISO 9004:2009 , which is titled as "Managing for the sustained success of an organization-A quality management approach” This standard is not intended to certify a company, but rather to act as a guide to help a quality management strategy achieve long-term success. This standard is applicable to all businesses, regardless of their industry. The standard can be used in conjunction with ISO 9001 or as a stand-alone guide to assist enterprises in achieving and maintaining long-term goals.

ISO 9004 has a broader focus on quality management than ISO 9001; it covers the needs and expectations of all relevant interested parties and gives guidelines for the organization's entire performance to be improved in a systematic and continuous manner. It advocates self-assessment as a valuable tool for evaluating an organization's maturity level, including leadership, strategy, management system, resources, and procedures, in order to discover areas of strength and weakness, as well as chances for improvement or innovation, or both. The ISO 9004 document contains clauses that are similar to those found in the ISO 9001 requirements standard. The purpose is to provide assistance on how to implement and upgrade procedures developed in accordance with ISO 9001 regulations in order to ensure the quality management system's long-term success. PURPOSE ISO 9001 establishes a framework for a systematic approach for managing an organization's processes in order to ensure that its products and services are consistent and fulfil customer expectations. ISO 9004 is designed to assist enterprises in extending the benefits of their quality management system (QMS) to all stakeholders, resulting in long-term success. CERTIFICATION ISO 9001 is a set of requirements that can be used to certify an organization's compliance with those requirements. ISO 9004 is not a certification standard. It's a guide for ensuring achievement of continual improvement. Focus ISO 9001 is largely a customer requirement standard, guaranteeing that, established customer requirements are met and that effective customer feedback is addressed. To achieve long-term success, ISO 9004 focuses on addressing the needs of consumers and other interested parties. Continual Improvement Continuous improvement of the QMS is primarily accomplished in ISO 9001 by conducting management reviews, internal/external audits, and corrective/preventive actions. ISO 9004 encourages enterprises to conduct self-assessments in order to identify areas of strength and weakness, as well as potential for improvement or innovation, or both.

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ISO 14001

Working in an environment where risks to heath and safety are properly controlled should be a priority. Everyone deserves to work in an environment as such. An organization’s occupational health and safety management system should help to create a healthy and safe environment for workers to prevent serious injuries and to maintain compliance. Identifying issues regarding health and safety is of utmost importance in preventing accidents and putting worker safety first. A certification in ISO 14001 can benefit your organization when it comes to these concerns. ISO 14001 is a standard that maps out the framework that a company can follow to set up an effective environmental management system. An effective management system is an essential system put in place for businesses to behave in an environmentally friendly way. The “eco-friendly” trend has influenced many organizations. Not along does being environmentally aware has it perks, but it can also be cost effective.

Efficiency can be improved when it comes to creating an image that customers can relate to. An organization can’t claim to be conscious about the environment if they can’t back it up. Proof of environmental intake needs be provided. This is where the need for a certification comes into place. Obtaining a certification from an ISO training allows an organization to fully implement an effective management system to its full potential. ISO training can help you identify the proper training needs, and it can make a significance in a person’s career. An ISO 14001 certification with QMII with benefit you in many ways and provide you with a better understanding of the standard. In our lead auditor course, participants will learn how management systems prevent pollution and assure sustainability. This course will also teach you how to audit systems and processes for conformity and effectiveness. Throughout this course, you will be given an opportunity to use your insights and expertise to reduce the cost of meeting environmental obligations and goals. There are other options for obtaining this certification that is affordable, but it comes with a disadvantage. Due to ISO 14001 being an international and the most widely used EMS in the world, it is more expensive. An organization can risk losing a potential customer if they don’t recognize the certification that is provided. An organization could lose out on money in the long run if they choose the wrong system. It’s important to choose wisely when it comes to the budget, needs, and expectations when seeking a certification. If your organization is seeking to reduce their environmental impact, then an ISO 14001 certification is highly recommended. At QMII, our ISO 14001 lead auditor training is structured to provide end to end audit support inside and outside of the classroom. By taking the ISO 14001 training with QMII, we can ensure proper audit management and how to relate the requirements of the standard to your business management system. Throughout the training you will also gain the tools necessary to conduct and lead process and system audits to determine the conformity of ISO 14001.

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Benefits of Continual Improvement

What is quality management? Quality management can be described as what ensures that an organization, product, or service is consistent. The four main components in quality management are quality assurance, quality planning, quality control and quality improvement. Quality Management is not only focused on product or service quality, but how to achieve it. Overall, there are eight quality management principles. Although they are not prioritized the importance of each principle varies from organization to organization and could possibly change over time. The fifth principle is continuous improvement. What is continuous improvement? Some may call it continual improvement, but they have the same meaning. Continuous improvement is the ongoing processes, services, or processes through gradual and breakthrough improvements. Gradual improvement can be sought over time while breakthrough improvements are all at once. The continual improvement model that is widely used is the PDCA (Plan- Do-Check-Act). This cycle is often used by ISO 9001 to provide an effective way to approach problem solving, manage change, and test improvement measures before updating procedures. In ISO 9001: 2015, clause 10.3 discusses continual improvement. When using the PDCA cycle, this clause is part of the “act.” This class is identified with act because it is aimed at generating actions. As a company it is your responsibility to demonstrate improvement rather than an auditing looking for it. Why is continual improvement important? Improvement is necessary for an organization to maintain current levels of performance, to react to changes in its internal and external conditions and to create new opportunities. Continuous improvement can bring many benefits. The size of your organization and degree to which it’s implemented depends on what results you may see. By implementing a continuous improvement culture this means your business is always getting better. Continuous improvement increases efficiency, engagement, customer satisfactions, and creates more effective systems. Here at QMII, we teach how to use auditing to improve your organization. In our ISO 9001:2015 Lead Auditor training we ensure that you gain the necessary skills to conduct and lead 1 st , 2 nd , and 3 rd party audits. Participants will also learn how about process and system audits, including audits of undocumented systems to determine conformity to ISO 9001:2015. To learn more about ISO 9001 and the training services we provide, please visit our website at https://www.qmii.com/iso-9001-2015-lead- auditor-training/.

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ISO 14001

Working in an environment where risks to heath and safety are properly controlled should be a priority. Everyone deserves to work in an environment as such. An organization’s occupational health and safety management system should help to create a healthy and safe environment for workers to prevent serious injuries and to maintain compliance. Identifying issues regarding health and safety is of utmost importance in preventing accidents and putting worker safety first. A certification in ISO 14001 can benefit your organization when it comes to these concerns. ISO 14001 is a standard that maps out the framework that a company can follow to set up an effective environmental management system. An effective management system is an essential system put in place for businesses to behave in an environmentally friendly way. The “eco-friendly” trend has influenced many organizations. Not along does being environmentally aware has it perks, but it can also be cost effective.

Efficiency can be improved when it comes to creating an image that customers can relate to. An organization can’t claim to be conscious about the environment if they can’t back it up. Proof of environmental intake needs be provided. This is where the need for a certification comes into place. Obtaining a certification from an ISO training allows an organization to fully implement an effective management system to its full potential. ISO training can help you identify the proper training needs, and it can make a significance in a person’s career. An ISO 14001 certification with QMII with benefit you in many ways and provide you with a better understanding of the standard. In our lead auditor course, participants will learn how management systems prevent pollution and assure sustainability. This course will also teach you how to audit systems and processes for conformity and effectiveness. Throughout this course, you will be given an opportunity to use your insights and expertise to reduce the cost of meeting environmental obligations and goals. There are other options for obtaining this certification that is affordable, but it comes with a disadvantage. Due to ISO 14001 being an international and the most widely used EMS in the world, it is more expensive. An organization can risk losing a potential customer if they don’t recognize the certification that is provided. An organization could lose out on money in the long run if they choose the wrong system. It’s important to choose wisely when it comes to the budget, needs, and expectations when seeking a certification. If your organization is seeking to reduce their environmental impact, then an ISO 14001 certification is highly recommended. At QMII, our ISO 14001 lead auditor training is structured to provide end to end audit support inside and outside of the classroom. By taking the ISO 14001 training with QMII, we can ensure proper audit management and how to relate the requirements of the standard to your business management system. Throughout the training you will also gain the tools necessary to conduct and lead process and system audits to determine the conformity of ISO 14001.

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Quality Management Systems Internal Auditor Training

Keyword -

Internal Quality Management System auditing is a method that evaluates the level of implementation of  quality

standards in any organisation and has thus become a valuable instrument for improvisation. The internal auditor

training of Quality Management System consists of a fusion of training sessions, activities,  and group

discussions.

This course is recommended for learners who wish to perform internal audits by becoming an external  

auditor of Quality management systems.

Outcomes of the Course

The Internal Auditor Training will enable you to  

• Gain an in-depth understanding of an internal auditor's roles and accountabilities during auditing  process.

• Strategize the whole auditing process, by carefully planning, conducting and reporting the audit in  

accordance with ISO 19011

• Understand the whole process of quality management system with respect to ISO 9001 standards.  

• Gain a basic understanding of auditing principles and procedures.

• Understand the role of an internal auditor in ensuring the maintenance and improvisation of quality  

management system  

• Learn the application of effective audit skills and personal behaviours which is important for an  effective

and efficient conduct in a management system audit.

• Learn the demonstration of activities involved in the preparation of an audit like the principles,  

processes and methods of auditing.  

• Gain an understanding about the process of evaluation of documented information required by  

ISO9001: 2015.

• Gain an in-depth knowledge about the interrelationships between the quality processes, policies,  quality

planning and objectives.

• Demonstrate the adherence to the quality management systems.

• Identify the Quality Management Terms with respect to ISO 9001

• Describe the requirements and the intents of the quality management system. • Comprehend the concept

of process-based quality management system for ISO 9001 • Apply PDCA approach, that is

Plan – Do – Check – Act of the process approach. • Understand the principles and benefits of quality

management system.

• Ensures that there is a correct application of accepted and authorised Audit protocols • Facilitate value

adding auditing and reporting to support improve in system performance. • Learn the skills necessary to plan

and execute internal audits.

• Generate reports related to audit findings, enabling  

Prerequisites for training  

The candidates opting for this training must justify the given prerequisites  

• Must have the basic knowledge of Quality Management System - ISO 9001:2015

• Should know the Quality management terms and definitions from ISO 9000.

• Should have the basic understanding of the fundamental requirements for ISO 9001 • Should have

an in-depth knowledge of the seven quality management principles of ISO 9001 • Must know about

the responsibilities of top management and the PDCA ( Plan- Do – Check – Act) cycle

Accreditation

This Quality Management Systems Internal Auditor Training is certified by the International Register of  

Certified Auditors (IRCA A17993).

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ISO 9001 & PDCA

For any organization, it is vital that you have a quality management system (QMS) in place. If your

QMS

is in place this helps your organization’s reputation. Your customers will return if they know they can trust you, as well as the products or services you offer. The ISO 9001 standard is an international standard that defines the framework for a quality management system. Organizations that seek to deliver a quality product or service can use the framework to build a management system that would help attain this goal.

ISO 9001 is not meant for the customer, but for the organization implementing it. Although, it is centered around the customer requirements, which primarily focuses on the customer; the benefit is to the organization implementing it.

The ISO 9001 requires continual improvement of your products and / or services and the effectiveness of the quality management system. What is continual improvement? Continuous improvement (sometimes called continual improvement) can be defined as the ongoing improvement of products, services, or processes through incremental and breakthrough improvements. The most widely used tool for the continuous improvement model is a four-step quality assurance method known as – the plan, do, check, act (PDCA) cycle.

This cycle is used by ISO 9001 to provide an effective way to approach problem solving, manage change, and test improvement measures before updating procedures. The entire concept of continuous improvement relies on the PDCA cycle. Within the ISO 9001:2015 standard there is seven quality management principles. Within the seven principles the philosophy of the process approach is utilized. The PDCA cycle is used as a guide to improve performance within the management system. The seven quality principles are customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management.

Obtaining a certification in ISO 9001 is the start of a quality management system, but to keep your management system working effectively you need to value each PDCA element equally. The PDCA cycle is importance because it prevents the work process from recurring mistakes. It allows your team to test possible solutions on a small scale as well as in a controlled environment. The goal of a quality management system is to work towards improvement for your organization. By utilizing the PDCA cycle you will help focus the processes and objectives of the QMS toward the desire improvement.

At QMII, we provide knowledgeable and experienced instructors that will teach ISO 9001 lead auditor training in a unique format. Participants will learn the main concept of ISO 9001 as well as being able to gain the skills needed to conduct and process audits accordingly. An organization may not need an ISO certification, they can still benefit from ISO 9001 and ISO training.

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AS9100 Vs AS9110

What is AS9100 The standards developed for the Airspace industry are mutually exclusive in nature. AS9100 and AS9110 both are the quality management systems that assures those certain foundations of quality management principles are laid on. It gives a direction to the organisation’s activities for meeting customer and regulatory requirements in an efficient and an effective way. The only difference lies is in the criteria that they work on. 1. AS9100 – These deals with the Designing, Developing and Manufacturing activities in the Airspace Industry. AS9100 is an extension of the already existing standards (ISO 9001), which is defined as the international standard for Aviation, Space and defense (AS&D) industry. AS9100 has additional information to that of ISO 9001, to meet the ongoing needs of the Aerospace Industry. The major changes that have been introduced in ISO 9001 in the form of AS9100, is in areas like primary sections of “Product Realization” and “Measurement, Analysis and Improvement.”, Additional emphasis is placed on product safety, management of counterfeit parts, ethical behavior and human factors. This aerospace standard (AS), is developed by the International Aerospace Quality Group. (IAQG) taking into consideration the perspective of representatives from all over the world. Purpose of AS9100 The purpose of this standard is to build the confidence of customers of aviation, space and defence industry. This is done by closely establishing requirements and industry accepted practices. Benefits of having AS9100 • Provides assurance to all external and internal stakeholders about the quality standards of the Business. • Developsstrategic communication, which eventually builds on the company reputation and the confidence of stakeholders. • The overall impact will be on the profitability, which will eventually increase. This will be merely because of productivity which will improve and the rework cost that will be reduced. • Customer satisfaction increases exponentially. • It ensures Early identification of defects and ensures its correction at a lower cost to the business. • Develops competitive advantage over the competitors. What is AS9110 • This is developed for organisations that are into provision of maintenance, repair, and overhaul services for military aviation products. It is intended to be used by the companies that mainly operate autonomously. • It is suitable for both certified and non-certified organisations. It is tailored for organizations with National Airworthiness Authority (NAA) repair station certification. It includesthose that provide maintenance, repair, and overhaul services for military aviation products. There are several versions of AS9110 that has been developed over the years. a) AS9110 (2003) • The AS9110 standard includes ISO 9001:2000 quality management system requirements and specifies additional requirements • This standard includes ISO 9001:2008 quality management system requirements. b) AS9110 Rev B (2012) • AS9100B includes ISO 9001:2008 quality management system requirements and specifies additional aviation maintenance industry requirements, definitions, and notes as shown in bold, italic text. c) AS9110 Rev C (2016) • AS9110 Rev C (2016) includes the ISO 9001:2015 requirements and supplements them with additional quality system requirements Over the years, different versions of both the standards has been released to withstand the customer requirements in the industry as well as to comply with the regulatory requirements.

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Benefits of AS9100 & AS9110

The AS 9100 series of QMS (Quality Management System) standards were created by the International  Aerospace Quality Group (IAQG) to establish a global standard for the aerospace sector. The aerospace  supply chain, including design, manufacture, replacement, and maintenance, is covered under AS 9100. The  insufficiency of prior standards that had been applied to the aerospace sector led to the development of  this standard.  

The benefits of AS9100

1. Increase in customer satisfaction - AS9100 emphasizes on the idea of a clear understanding of the  customer requirements. This is done so that the organization meets the need of the customer more  effectively and efficiently. This increases the customer satisfaction, thereby resulting in repeat business and increase in sales.  

2. Improved Company Image

AS9100 has become the default expectations of the customers, since it is an internationally recognized  standard for Quality Management System in the Airspace Industry. Hence any company following this  standard, will definitely build a good company image.

3. Better decision making: - AS9100 promotes making decisions based on facts and figures rather than gut  feelings. By making judgments based on data, the organizations are able to optimize their resources.  4. Increased efficiency: AS9100 emphasizes on a process approach to understand the supply of products and  services. All kind of inefficiencies are uncovered and eliminated from the system resulting in improved  delivery of the products and services.

5. Engaging your employees: The organizations will not only witness the smooth running of all processes, but  the workforce also gets engaged towards the goals of process improvement and customer satisfaction by  identifying and mapping the processes and involving the employees involved in those processes in the  activity.

6. Habitual Improvements - The process of continual improvement gets engrained in the AS9100 criteria, thus  ensuring gradual betterment. The organization can leverage the power of your engaged staff and focus  them on finding methods to make the processes they are involved in better, faster, and cheaper to run by  making improvement a part of the daily business.  

The benefits of AS9110

Organizations have earned profits from a well-designed and implemented Quality Management System  based on AS9110

1. The consistency of output is improved by well-defined and documented procedures This results from the initial process evaluation and improvement that occurs during the implementation  process, as well as increased personnel training and qualification. Better process documentation or control  leads to more consistency in performance, as well as fewer scrap and rework. Employees have more  information to troubleshoot problems on their own, while managers receive fewer late-night  troubleshooting calls.

2. Quality is monitored at all times, hence the adherence to quality standards is ensured every time. 3. Procedures ensure that remedial action is taken whenever defects occur, lowering defect rates and  allowing for earlier detection and correction at a reduced cost.

4. Since all the process is structured and systemized, new staff finds it easier to follow the documented  procedures.

5. As a result of the systemized structure, the product reliability increases thereby resulting in cost reductions.

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Why is AS9100 important?

What is AS9100? AS9100 is known as the international Quality Management System standard for the Aviation, Space and Defense industry. The purpose of the standard is to provide suppliers with requirements for creating and maintaining a comprehensive quality system with safe and reliable products to these industries. Although the standard has gone through multiple revisions the latest one is AS9100 rev D, which was introduced in 2016. AS9100 and ISO 9001 AS9100 is based on ISO 9001. The two standards are similar, however the AS9100 has additional aerospace requirements that make the QMS requirements more relevant for the aerospace industry. Another similarity between the two standards include how they are both intended for organizations to show that they can provide products and services in compliance with customers’ requirements. What is the importance of AS9100? Within the aerospace industry, there are specific requirements, and the quality management systems need to incorporate these requirements. The AS9100 is for the aerospace suppliers and by implementing an AS9100 compliant quality management System you will be able to demonstrate to your customers that you are meeting the needs and improving the quality of your products and services while also increasing your customer satisfaction. The AS9100 is based on seven quality management principles that are necessary to make a quality management system work. Your customers will be more satisfied knowing that your QMS is based on these principles. Benefits of AS9100 AS9100 can bring many benefits to your organization. Changes in your Quality Management System will take instant additional energy, however the results of having an AS9100 quality management system will bring positive results. The following results will be in areas such as customer satisfaction and product safety. When implementing AS9100 the benefits may be easy to see, however you must remember that your quality management system will only return what you put into it. Organizations are told by the standard what needs to be implemented, but not how to implement it. All in all, an organization must alter your QMS to suit your needs. At QMII, we offer an AS9100 Lead Auditor training in a unique format. Our AS9100 course provides an in- depth look into what skills you need to manage first, second and third party As9100 audits. You will also learn how this relates to your aerospace quality management system. For more information on AS9100 and our learning approach, visit our website at https://www.qmii.com/.

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Benefits of AS9100 & AS9110

The AS 9100 series of QMS (Quality Management System) standards were created by the

International  Aerospace Quality Group (IAQG) to establish a global standard for the aerospace sector.

The aerospace  supply chain, including design, manufacture, replacement, and maintenance,

is covered under AS 9100. The  insufficiency of prior standards that had been applied to the aerospace sector

led to the development of  this standard.  

The benefits of AS9100

1. Increase in customer satisfaction - AS9100 emphasizes on the idea of a clear understanding of the  customer

requirements. This is done so that the organization meets the need of the customer more  effectively and

efficiently. This increases the customer satisfaction, thereby resulting in repeat business and increase in sales.  

2. Improved Company Image

AS9100 has become the default expectations of the customers, since it is an internationally recognized  

standard for Quality Management System in the Airspace Industry. Hence any company following this  

standard, will definitely build a good company image.

3. Better decision making: - AS9100 promotes making decisions based on facts and figures rather than gut  

feelings. By making judgments based on data, the organizations are able to optimize their resources.  

4. Increased efficiency: AS9100 emphasizes on a process approach to understand the supply of products and

services. All kind of inefficiencies are uncovered and eliminated from the system resulting in improved  

delivery of the products and services.

5. Engaging your employees: The organizations will not only witness the smooth running of all processes,

but  the workforce also gets engaged towards the goals of process improvement and customer satisfaction by

identifying and mapping the processes and involving the employees involved in those processes in the  activity.

6. Habitual Improvements - The process of continual improvement gets engrained in the AS9100 criteria,

thus  ensuring gradual betterment. The organization can leverage the power of your engaged staff and focus

them on finding methods to make the processes they are involved in better, faster, and cheaper to run by

making improvement a part of the daily business.  

The benefits of AS9110

Organizations have earned profits from a well-designed and implemented Quality Management System  

based on AS9110

1. The consistency of output is improved by well-defined and documented procedures This results from the

initial

process evaluation and improvement that occurs during the implementation  process, as well as increased

personnel training and qualification. Better process documentation or control  leads to more consistency in

performance, as well as fewer scrap and rework. Employees have more  information to troubleshoot

problems on their own, while managers receive fewer late-night  troubleshooting calls.

2. Quality is monitored at all times, hence the adherence to quality standards is ensured every time. 3.

Procedures ensure that remedial action is taken whenever defects occur, lowering defect rates and  allowing for

earlier detection and correction at a reduced cost.

4. Since all the process is structured and systemized, new staff finds it easier to follow the documented

procedures.

5. As a result of the systemized structure, the product reliability increases thereby resulting in cost reductions.

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ISO 13485

April 08, 2022

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What is AS9100?

What is AS9100?  

AS9100 is known as the international Quality Management System standard for the Aviation,

Space and Defense industry.

The purpose of the standard is to provide suppliers with  requirements for creating and maintaining a

comprehensive quality system with safe and reliable  products to these industries.

Although the standard has gone through multiple revisions the

latest one is AS9100 rev D, which was introduced in 2016.

AS9100 and ISO 9001

AS9100 is based on ISO 9001. The two standards are similar, however the AS9100 has additional

aerospace requirements that make the QMS requirements more relevant for the aerospace  industry.

Another similarity between the two standards include how they are both intended for  

organizations to show that they can provide products and services in compliance with customers’

requirements.  

What is the importance of AS9100?

Within the aerospace industry, there are specific requirements, and the quality management  

systems need to incorporate these requirements. The AS9100 is for the aerospace suppliers

and  by implementing an AS9100 compliant quality management System you will be able to  

demonstrate to your customers that you are meeting the needs and improving the quality of your  

products and services while also increasing your customer satisfaction. The AS9100 is based on

seven quality management principles that are necessary to make a quality management system  work.

Your customers will be more satisfied knowing that your QMS is based on these principles.  

Benefits of AS9100

AS9100 can bring many benefits to your organization. Changes in your Quality Management  

System will take instant additional energy, however the results of having an AS9100 quality  

management system will bring positive results. The following results will be in areas such as

 customer satisfaction and product safety. When implementing AS9100 the benefits may be easy  

to see, however you must remember that your quality management system will only return what

you put into it. Organizations are told by the standard what needs to be implemented,

but not  how to implement it. All in all, an organization must alter your QMS to suit your needs.

At QMII,  we offer an AS9100 Lead Auditor training in a unique format. Our AS9100 course

provides an in depth look into what skills you need to manage first, second and third party  

As9100 audits. You

will also learn how this relates to your aerospace quality management system.

For more  information on AS9100 and our learning approach, visit our

website at https://www.qmii.com/.

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How an ISO 14001 Certification Can Be Beneficial

Everyone deserves to work in an environment where risks to health and  safety are properly controlled. An organization’s occupational health  and safety management system should help to create a healthy and safe  environment for workers to prevent serious injuries and to maintain  compliance. Identifying health and safety issues is of utmost importance  in preventing accidents and putting worker safety first.

Obtaining an ISO 14001 certification can be beneficial  to you and your organization.  This standard maps out a framework that  an organization can follow to set up an effective environmental  management system. An effective management system is an essential system  put in place for businesses to behave in an environmentally friendly  fashion. Not only does being an ecofriendly has its perks such as being  cost effective, but it can also improve efficiency when it comes to  creating an image that customers can relate to. An organization can’t  claim to be environmentally friendly if they can’t back it up. This is  where a need for a certification comes into place.

Nowadays as global warming becomes more of a threat, more  organizations are becoming environmentally conscious. As a result of  this many are turning to and adopting practices that can reduce their  carbon footprint. By taking a training course in ISO 14001, you can  assure your business partners and clientele that you are committed to  the environment. Overall, the initial benefit of becoming certified in  ISO 14001 is demonstrating good environmental performance. However, one  of the key benefits to being ISO 14001 certified is gaining more  protection over your business reputation. When an organization can show  minimal negative effects on the environment this makes the corporation  image better. A better reputation can increase the number of clients as  well as brand equity.

At QMII, we offer an ISO 14001 certification which will ensure that  you learn the requirements of the standard and how to relate these  requirements to your business management system.  In our lead auditor  course, you will learn how management systems prevent pollution and  assure sustainability. Not only this, but you will also learn how to  audit systems and processes for conformity and effectiveness. Throughout  the training process, you will be given the opportunity to use your  insights and expertise to reduce the cost of meeting environmental  obligations and goals. For more information on ISO 14001 and how it can  benefit you, please visit our website at https://www.qmii.com/iso-14001-2015-lead-auditor-training-course/.

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How an ISO 14001 Certification Can Be Beneficial

Everyone deserves to work in an environment where risks to health and safety are properly controlled. An organization’s occupational health and safety management system should help to create a healthy and safe environment for workers to prevent serious injuries and to maintain compliance. Identifying health and safety issues is of utmost importance in preventing accidents and putting worker safety first.

Obtaining an ISO 14001 certification can be beneficial to you and your organization.  This standard maps out a framework that an organization can follow to set up an effective environmental management system. An effective management system is an essential system put in place for businesses to behave in an environmentally friendly fashion. Not only does being an ecofriendly has its perks such as being cost effective, but it can also improve efficiency when it comes to creating an image that customers can relate to. An organization can’t claim to be environmentally friendly if they can’t back it up. This is where a need for a certification comes into place. 

Nowadays as global warming becomes more of a threat, more organizations are becoming environmentally conscious. As a result of this many are turning to and adopting practices that can reduce their carbon footprint. By taking a training course in ISO 14001, you can assure your business partners and clientele that you are committed to the environment. Overall, the initial benefit of becoming certified in ISO 14001 is demonstrating good environmental performance. However, one of the key benefits to being ISO 14001 certified is gaining more protection over your business reputation. When an organization can show minimal negative effects on the environment this makes the corporation image better. A better reputation can increase the number of clients as well as brand equity. 

At QMII, we offer an ISO 14001 certification which will ensure that you learn the requirements of the standard and how to relate these requirements to your business management system.  In our lead auditor course, you will learn how management systems prevent pollution and assure sustainability. Not only this, but you will also learn how to audit systems and processes for conformity and effectiveness. Throughout the training process, you will be given the opportunity to use your insights and expertise to reduce the cost of meeting environmental obligations and goals. For more information on ISO 14001 and how it can benefit you, please visit our website at https://www.qmii.com/iso-14001-2015-lead-auditor-training-course/.

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Audits VS. Inspections

There is often confusion about the difference between audaudits its and inspections. The purpose of each may seem the same, but they are slightly different. Audits focus on why, while inspections focus on what.The purpose of an audit is to get the confidence that processes are working well. An audit involves various layers to answer a “why” question. It involves exploratory reviews involving documentation, risk assessments, and nonconformities etc. While an audit may need more effort in finding an answer, an inspection is less complicated. The answer to an inspection question will involve a straightforward yes or no answer.Inspections focus more on action, while audits are about the process. Inspections review a single point in time, but an audit follows a process from start to finish. An inspection simply looks at the product or service. The process of an inspection is quite simple, it either clears the project if it meets the requirements specification or rejects it. If it is rejected, its loss can be reworked at an extra cost.Inspections must be conducted at every step to minimize the chances of product failure.Why are audits and inspections important to an organization? Inspections deal with things that cause immediate accidents or other issues. Inspections protect the customer, so the customer is not harmed by a non-conforming product yet from an organization’s point of view that they are too late. The audit is to cover the root cause of these problems. The audits provide the input and ensure continuous improvement and it is where we take on nonconformities.Here at QMII, we provide valuable information when it comes to our auditing services. We can give insight on where your system is working well as well as the risks and suggest opportunities for improvement. QMII’s audit services reduce the fear of an audit. Some individuals fear being blamed for non-conformities and often dread the idea of an audit. Our services are to ensure auditees are put at ease while QMII auditors look to find effectiveness of controls in the system.Although there is often confusion when differentiating audits and inspections, it can be easier to think of it as the Plan-Do-Check-Act cycle. Inspections are a “do” while audits are a “check.” Inspections are required to do, and the audits are the process of checking and making sure inspections have been done.

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The Flight Delight – AS 9100 and AS 9110 By Anjalika Singh Vice President, QMII

When I think of something sweet to eat, I think of Turkish Delight. It has dates, pistachios, hazelnuts, walnuts, and what makes it tasty are starch and sugar. When I think of flying, I assume that it would desire it’s two main delights – AS 9100 and AS 9110. Somehow, these two get sidelined and somewhere it’s ignored, and something goes amiss leading to an airplane’s malfunction, failure and worse, crash.

I oversee admin and sales at QMII. We sell lots of courses and have to be confident in knowing what we are selling and what training we are coordinating for with the students who have enrolled. Most of them are for AS 9100 Rev D and AS 9110 Rev C. The most common question that I am asked about is “what is the difference between AS 9100 and AS 9110?” Also, “if I do one of them like AS 9100 or AS 9110, is the other one taken care of on it’s?

The answer to the first question – There’s a difference between AS 9100 and AS 9110.

The answer to the second question is – No the other course is not automatically taken care of if you do either AS 9100 or AS 9110.

The similarity between AS 9100 Rev D and AS 9110 Rev C is that they both provide Quality Management System (QMS) for the aerospace industry. They were developed by the International Aerospace Quality Group (IAQG) through SAE International. Both standards are based on ISO 9001 as the foundation. AS9100 adds specific requirements for the aerospace manufacturing industry. AS9110 adds specific requirements that are preeminent and fundamental for the maintenance and repair of commercial, private, and military aircrafts.

When I try to explain this to these students, they get a better understanding of the concept and differences between AS 9100 and AS 9110. One time, I sat in the class, just to get a clearer perspective of the subject, and I drifted away a little thinking about Denzel Washington’s movie called Flight. Excellent movie made by the guy who directed Forest Gump. Flight is a movie about a pilot who miraculously crash-lands his plane after a mechanical failure, saving nearly everyone on board. He is hailed as the hero, but only for a brief amount of time. Once the investigation begins, the judgement comes to him being a drug abuser and an alcoholic pilot, and that puts him in a different light altogether, completely opposite to being a hero.

Out of curiosity, I glanced through Wikipedia to read more about what inspired the writing of this movie, and I see that it was loosely inspired from the plane crash of Alaska Airlines Flight 261. So I started reading more about the actual crash and the emphasis of mechanical failure that led to the crash and zero survivors. The crash happened due to loss of control caused by jackscrew failure because of improper maintenance. During the NTSB’s investigation, it was also discovered that there were significant deficiencies that "the FAA should have uncovered earlier", and the corrective actions to these deficiencies were not effectively done.

However, the main bummer was the aircraft design and the certification issues, which made me realize the importance of AS 9100 and AS 9110. It is so good to see the students take interest in AS 9100 and AS 9110 just to be able to add value to it, and I am glad I am able to convey the subject better and add further more value to it for their own benefit in learning AS 9100 and AS 9110.

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