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Learn what is Quality Management System in Industries and in Aviation
WHAT IS Quality? QMS?
History of QMS
Principles of QMS (ISO 9001:2015)
QMS in Aviation
Takeaways
What is Quality?
What is Quality Management System (QMS)?
1) the characteristics of a product or service that bear on its ability to satisfy stated or implied needs;
2) a product or service free of deficiencies. According to Joseph Juran, quality means “fitness for use”; according to Philip Crosby, it means “conformance to requirements.”
Quality,” as defined by the International Organization for Standardization (ISO) standard 9000:2015,
is “the degree to which a set of inherent characteristics fulfils requirements.
A quality management system (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
Until the early 19th century, manufacturing in the industrialized world tended to follow this craftsmanship model.
The factory system, with its emphasis on product inspection, started in Great Britain in the mid-1750s and grew into the Industrial Revolution in the early 1800s.
In the early 20th century, manufacturers began to include quality processes in quality practices.
The birth of total quality in the United States came as a direct response to the quality revolution in Japan following World War II.
The Japanese welcomed the input of Americans Joseph M. Juran and W. Edwards Deming and rather than concentrating on inspection, focused on improving all organizational processes through the people who used them.
By the 1970s, U.S. industrial sectors such as automobiles and electronics had been broadsided by Japan’s high-quality competition. The U.S. response, emphasizing not only statistics but approaches that embraced the entire organization, became known as total quality management (TQM).
By the last decade of the 20th century, TQM was considered a fad by many business leaders. But while the use of the term TQM has faded somewhat, particularly in the United States, its practices continue.
In the few years since the turn of the century, the quality movement seems to have matured beyond Total Quality. New quality systems have evolved from the foundations of Deming, Juran and the early Japanese practitioners of quality, and quality has moved beyond manufacturing into service, healthcare, education and government sectors.
Quality management systems serve many purposes, including:
Two overarching benefits to the design and implementation of documented quality management systems include:
Meeting the customer’s requirements, which helps to instill confidence in the organization, in turn leading to more customers, more sales, and more repeat business
Meeting the organization's requirements, which ensures compliance with regulations and provision of products and services in the most cost- and resource-efficient manner, creating room for expansion, growth, and profit
Within these overarching benefits are advantages like helping to communicate a readiness to produce consistent results, preventing mistakes, reducing costs, ensuring that processes are defined and controlled, and continually improving the organization's offerings.
In short, it drives home the point that companies generally achieve increased sales and profitability by implementing QMS.
First published in March 1987, ISO 9001: Quality management systems - Requirements has become the most successful standard in the history of the International Organization for Standardization.
The ISO 9000:2000 revision had five goals:
ISO 9000:2000 was again updated in 2008 and 2015. ISO 9000:2015 is the most current version. The revised version is expected to be published in September 2026.
ISO 9001 is the only standard within the ISO 9000 family to which organizations can certify.
ISO 9001 is designed for any company (in fact, for any organization) of any size and in any industry. This broad application results in ISO 9001 Standard being rather broad, and its requirements rather difficult to read and understand.
The ISO 9000 family contains these standards:
ISO 9001:2015: Quality Management Systems - Requirements
ISO 9000:2015: Quality Management Systems - Fundamentals and Vocabulary (definitions)
ISO 9004:2018: Quality Management - Quality of an Organization - Guidance to Achieve Sustained Success (continuous improvement)
ISO 19011:2018: Guidelines for Auditing Management Systems
The popularity of the ISO 9000 series paved the way for other management system standards, including:
ISO 14000: Environmental management systems
ISO 26000: Guidance on social responsibility
ISO 31000: Risk Management Principles and Guidelines
OHSAS 18001: Occupational Health and Safety Assessment
Combine into an Integrated Management System (IMS)
The ISO 9000:2015 and ISO 9001:2015 standards are based on seven quality management principles that senior management can apply to promote organizational improvement.
The following is a summary of the ISO 9001:2015 requirements in lay man's terms.
0. Introduction
1. Scope of ISO 9001
2. Normative references
3. Terms and definitions
The introduction includes information on the quality management principles and the process approach, both of which form the basis of ISO 9001:2015. There is also some information on how ISO 9001:2015 relates to other ISO standards.
This section sets the requirements for the foundation of the ISO 9001 Quality Management System. The "context of the organization" is the business environment in which the company operates.
The first requirement is to identify external and internal strengths and weaknesses that are relevant to the company and the ISO 9001 Quality Management System.
Next, the needs and expectations of not only the customers but a wide range of "interested parties" (or stakeholders) need to be determined, and how they are relevant to the ISO 9001 Quality Management System.
Here you also need to decide on the scope of the ISO 9001 Quality Management System (and the ISO 9001 certification). While it is possible to exclude functions and certain products or services, the scope will in most cases be the entire company.
Finally you will need to use the process approach to determine the processes of the ISO 9001 Quality Management System. The Quality Management System will need to be implemented, maintained and continually improved upon.
The documentation of the Quality Management System must include procedures and work instructions to ensure the effective operation and control of all processes. This documentation must be controlled to ensure the correct people have access to current revisions.
Records are established and controlled to provide evidence of a properly maintained ISO 9001 Quality Management System.
Remember that "Quality Management System" refers to integrated management processes throughout the entire company.
TIP:
There is a common misconception that ISO 9001:2015 requires less documentation than previous revisions of the standard because there is no longer an explicit requirement for a quality manual. However, ISO 9001:2015 contains numerous implicit documentation requirements. Since most companies consider the documentation the most difficult part of the ISO 9001 implementation, the use of good ISO 9001 templates can be beneficial
In 2024, ISO passed a resolution in support of the ISO London Declaration to combat climate change, which affected ISO management system standards (MSS)—including ISO 9001. The amendment added two new statements to ISO MSSs that require organizations to consider the effects of climate change on the organization’s ability to achieve the intended results of its management system.
4.1 Understanding the organization and its context
The organization shall determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended result(s) of its quality management system.
The organization shall determine whether climate change is a relevant issue.
4.2 Understanding the needs and expectations of interested parties.
The organization shall determine:
The interested parties that are relevant to the quality management system.
The relevant requirements of these interested parties.
Which of these requirements will be addressed through the quality management system.
NOTE: Relevant interested parties can have requirements related to climate change.
This section of ISO 9001:2015 is all about the involvement of top management in the ISO 9001 Quality Management System.
The first part of this clause summarizes the various responsibilities of top management with regards to the ISO 9001 Quality Management System. Among those is the requirement that top management integrate the ISO 9001 Quality Management System into the operational processes of the company, and aligns policy and objectives with the strategy of the company.
Importantly, top management must take leadership when it comes to customer focus, including determining customer requirements, determining related risks and addressing them, and maintaining a focus on customer satisfaction.
Top management establishes its quality policy. Particular attention is given to a commitment to meeting requirements and to continual improvement, and a framework for establishing and reviewing quality objectives.
Top management ensures that responsibilities and authorities within the company are clearly established. A task or job can only be accomplished if it is clear who is responsible for it.
Top management is ultimately responsible for the ISO 9001 Quality Management System but they may appoint an ISO 9001 Management Representative who takes on various responsibilities and authorities of the ISO 9001 Quality Management System.
TIP:
Use good standard forms to simplify compliance. For example responsibilities and authorities are best established using job descriptions; a good standard format will save much time when creating new job descriptions, when advertising positions, when performing employee evaluations, etc. .
This section focuses on planning and the concept of risk-based thinking.
The first part addresses how the company needs to engage in risk and opportunity management. ISO 9001 doesn't dictate action to address all risks and opportunities but requires to set up a system of evaluating risks and opportunities in order to make an informed decision as to what (if any) action is needed.
Secondly, senior management needs to establish measurable quality objectives and plan how to achieve them. Those quality objectives are basically strategic objectives of the company that are relevant to product and service requirements, as well as customer satisfaction.
Lastly, clause 6 addresses the planning of changes, which has to be done in a systematic manner.
TIP:
Risk management does not require the establishment of a new department or the hiring of a risk manager. Small to mid-size companies may choose to use a risk management matrix and calculate a priority number - it's a simple yet effective system.
This section of ISO 9001:2015 is all about support functions: various resources, competence and training, communication and documentation.
The first part of this clause clarifies the requirement for a company to determine and provide, in a timely manner, resources needed to implement and improve the processes of the Quality Management System.
Resources include people (human resources) and their competence, as well as training necessary to achieve the required competencies.
Further, the company must identify, provide and maintain the infrastructure needed to achieve the conformity of its products or services. Infrastructure includes buildings, equipment, transportation and communications technology.
The company must identify and manage those human and physical factors of the work environment needed to achieve conformity of its products or services.
Maintenance activities of equipment, machinery as well as the work environment are part of this section.
The company must take special care of all measuring devices and properly calibrate them.
Organizational knowledge is another resource that must be determined, maintained and, importantly, shared so that the company can fully utilize it. Organizational knowledge is a wide-ranging term, which includes best practices.
When addressing the needed competence of its people, the company must not only consider training but also hiring and reassignment of people.
Awareness is another part of clause 7. Management and staff must be aware of the quality policy and relevant objectives, as well as their part in the ISO 9001 Quality Management System.
Further, the company needs to have established internal and external communications channels.
Last but not least, clause 7 addresses documents and records. Essentially, the company must control its documents to ensure that the right people have the current version of the right document available. Records must be kept for numerous activities.
TIP:
Integrate your company's HR function well into your ISO 9001 quality system, and make them take on a leading role during the ISO 9001 implementation
In this section, the ISO 9001:2015 standard sets the requirements for the processes needed to achieve the product or service. This is how your product or service is designed, produced, tested, handled, shipped, etc.
Emphasis is placed on how the company understands, communicates and meets customer requirements, and what it does if customer requirements change. Design and development reviews, verification, and validation must be planned for at the very beginning of the design and development process. This clause also addresses the purchasing of products and services and outsourcing. Controls include supplier evaluations, selection, disqualification and receiving inspections.
The clause specifies several controls for the actual production and service provision, ranging from work instructions to QC inspections. There are also requirements for the identification of components and the ability of tracing a product or service back, as well as for handling products that belong to customers or suppliers.
Then the standard addresses how the final product or service can eventually be released to the customer.
Lastly this clause addresses cases in which output is found as not conforming to requirements, including cases in which such a nonconformance is only detected after the product has been delivered or the service provided.
TIP:
Most companies write work instructions and flowcharts to define and standardize their work processes. You will save yourself much time if you follow the ISO 9001 requirements for document control from the beginning when writing these documents.
This section is all about measuring and evaluating.
Measurement and monitoring activities needed to assure conformity and achieve improvement must be defined, planned and implemented. Measuring and monitoring allows the company to manage by fact, not by guess. The company must monitor information relating to customer perception as to whether the company has fulfilled customer requirements.
Further, this section focuses on the analysis of data arising from monitoring and measurement activities. There are several methods to analyze data, including statistical techniques, but the outcome of the analysis is designed to gain the necessary information to make fact-based decisions.
Internal auditing of the company must be done at planned intervals to understand if the ISO 9001 Quality Management System is working as planned. Audits are checks on the system, not on individuals.
Finally, management reviews will need to be carried out. The management reviews cover a wide range of topics related to the ISO 9001 Quality Management System, ranging from customer satisfaction to the performance of suppliers. The result of management reviews are decisions and actions regarding improvements, changes and resource needs.
TIP:
Start your internal audit program early during the implementation phase - your initial audits can double as training opportunities.
The last section of ISO 9001:2015 requires companies to determine and identify opportunities for improvement.
There is a requirement for the improvement of products and services with an eye to current and future market needs. This clause also includes requirements regarding the correction of nonconformities. First, companies must react to the nonconformity. Secondly, companies must engage in corrective action to correct the underlying causes of existing problems, as well as engage in preventive action to correct situations that could lead to potential problems.
Last but not least, the company must plan and manage the processes for the continual improvement of the ISO 9001 Quality Management System. The company must use the quality policy, objectives, internal audit results, analysis of data, corrective and preventive action and management review to facilitate continual improvement.
TIP:
This is a very important section of the ISO 9001 Standard. Depending on how it is implemented, it can add tremendous value or create bureaucracy and waste. We highly recommend placing emphasis on this crucial section.
PDCA is an improvement cycle based on the scientific method of proposing a change in a process, implementing the change, measuring the results, and taking appropriate action.
It also is known as the Deming Cycle or Deming Wheel after W. Edwards Deming, who introduced the concept in Japan in the 1950s. It is also known as PDSA, where the “S” stands for “study”.
The PDCA cycle has four stages:
Plan — determine goals for a process and needed changes to achieve them.
Do — implement the changes.
Check — evaluate the results in terms of performance
Act — standardize and stabilize the change or begin the cycle again, depending on the results
QMS
The European Joint Aviation Authorities (JAA), through its Joint Aviation Requirements, first promoted the compulsory introduction of quality management in airline operations in the European Union.
Several other countries (for example, in the Gulf regions) have followed the JAA’s regulatory efforts with regard to quality management, in many cases adopting the same regulations by simply changing their names.
This is a path, however, that many important aviation markets, most notably the United States, have not followed.
The European regulation that currently establishes a mandatory QMS is EU Regulation on Air Operations (EU OPS) 1.035, but it prescribes only basic quality requirements, “to monitor compliance with, and adequacy of, procedures required to ensure safe operational practices and airworthy aeroplanes.”
In airline operations, QMSs are mandatory with only safety in mind and with no consideration for other, more strategic, business areas.
Air Operator Certificate
9.2.2.3 QUALITY SYSTEM
(a) Each operator shall establish a quality system and designate a quality manager to
monitor compliance with, and adequacy of, procedures required to ensure safe
operational practices and airworthy aircraft. Compliance monitoring shall include a
feedback system to the accountable manager to ensure corrective action as
necessary.
Approved Maintenance Organization
6.5.1.2 MAINTENANCE PROCEDURES AND INDEPENDENT QUALITY ASSURANCE SYSTEM
(a) The AMO shall establish procedures acceptable to the Authority to insure good
maintenance practices and compliance with all relevant requirements in these
regulations such that aircraft and aeronautical products may be properly returned to
service.
(b) The AMO shall establish an independent quality assurance system, acceptable to the
Authority, to monitor compliance with and adequacy of the procedures and by
providing a system of inspection to ensure that all maintenance is properly
performed.
Approved Training Organization
3.1.2.2 APPLICATION FOR ISSUANCE OR AMENDMENT OF AN ATO CERTIFICATE
(c)The ATO shall establish procedures acceptable to the Licensing Authority to ensure
compliance with all relevant requirements of this Part. The procedures shall include a
quality system which meets the procedures in IS: 3.1.2.2 (Quality System)
Product Audit: Assessing the final product to ensure it meets specifications.
Process Audit: Evaluating the processes to verify they are performing as intended.
System Audit: Checking the overall system for compliance with standards.
Surveillance Audit: Ongoing monitoring to ensure continued compliance.
Causes
Impact
Consequence Event
Preceding Events
Top Event
(Loss of Control)
IOSA
IS-BAO
DOC Series
Doc 7300 - Doc 10208
https://www.icao.int/publications/Pages/doc-series.aspx
Annex 1 - Personnel Licensing
Annex 2 - Rules of the Air
Annex 3 - Meteorological Services
Annex 4 - Aeronautical Charts
Annex 5 - Units of Measurement
Annex 6 - Operation of Aircraft
Annex 7 - Aircraft Nationality and Registration Marks
Annex 8 - Airworthiness of Aircraft
Annex 9 - Facilitation
Annex 10 - Aeronautical Telecommunications
Annex 11 - Air Traffic Services
Annex 12 - Search and Rescue
Annex 13 - Aircraft Accident and Incident Investigation
Annex 14 - Aerodromes
Annex 15 - Aeronautical Information Services
Annex 16 - Environmental Protection
Annex 17 - Security
Annex 18 - The Safe Transportation of Dangerous Goods by Air
Annex 19 - Safety Management
PART 01 – General Policies, Procedures and Definitions
PART 02 – Personnel Licensing
PART 03 – Approved Training Organizations
PART 04 – Aircraft Registration and Marking
PART 05 – Airworthiness
PART 06 – Approved Maintenance Organization
PART 07 – Instrument and Equipment
PART 08 – Operations
PART 09 – Air Operator Certification and Administration
PART 10 – Commercial Air Transport by Foreign Air Carriers within Republic of the Philippines
PART 11 – Aerial Work and Operating Limitations for Non-Type Certificated Aircraft
PART 13 – Accident & Incident Reporting and Investigation
PART 18 – Transportation of Dangerous Goods by Air
In real aviation safety programs, quality assurance and safety management are handled differently.
In safety programs:
Separate departments/company divisions handle quality assurance and safety management; or
The main point here is that:
Safety management and quality assurance both inherit from the same underlying management process of
In smaller safety programs, it makes sense for safety managers to handle both safety and quality assurance. In larger organizations, it may make sense for a separate entity in the company to management quality assurance operations, but only so long as both are following the same underlying management process.