AMT 654

AVIATION QUALITY
MANAGEMENT SYSTEM
ISO 9001:2008 & ISO 9001:2009 REVISED 2015
BY 3-A GROUP C
ISO 9001:2008

ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently
provide products that meet customer and applicable statutory and regulatory requirements; in addition to enhancing customer satisfaction
through the effective application of the system, including processes for continual improvement of the system and assurance of conformity to
customer and applicable statutory and regulatory requirements.
All requirements of ISO 9001 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Quality standardization evolves with ISO 9001 by adding:
• Greater emphasis on setting the objectives, monitoring performance and metrics;
• Clearer expectations on management; and
• More careful planning for and preparing the resources needed for ensuring quality.
What is Quality Management System?
Quality management system is defined as a set of interrelated or interacting elements to establish policy and objectives for an organization
and to achieve those objectives with regard to quality.
0.1 GENERAL

The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management
system is influenced by
• a) its organizational environment, changes in that environment, and the risks associated with that environment,
• b) its varying needs,
• c) its particular objectives,
• d) the products it provides,
• e) the processes it employs,
• f) its size and organizational structure.
It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for
guidance in understanding or clarifying the associated requirement.
This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, statutory and
regulatory requirements applicable to the product, and the organization's own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.
0.2 PROCESS APPROACH

This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer
requirements.

For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be
considered as a process. Often the output from one process directly forms the input to the next.

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.

When used within a quality management system, such an approach emphasizes the importance of

• a) understanding and meeting requirements,

• b) the need to consider processes in terms of added value,

• c) obtaining results of process performance and effectiveness, and

• d) continual improvement of processes based on objective measurement.

The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs.
Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in  Figure 1 covers all the requirements of
this International Standard, but does not show processes at a detailed level.

NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows.

Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies.

Do: implement the processes.

Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.

Act: take actions to continually improve process performance.

FIGURE 1 — MODEL OF A PROCESS-BASED
QUALITY MANAGEMENT SYSTEM
0.3 RELATIONSHIP WITH ISO 9004

ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each
other, but can also be used independently.
ISO 9001 specifies requirements for a quality management system that can be used for internal application by
organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality
management system in meeting customer requirements.
At the time of publication of this International Standard, ISO 9004 is under revision. The revised edition of ISO 9004
will provide guidance to management for achieving sustained success for any organization in a complex, demanding,
and ever changing, environment. ISO 9004 provides a wider focus on quality management than ISO 9001; it addresses
the needs and expectations of all interested parties and their satisfaction, by the systematic and continual improvement
of the organization's performance. However, it is not intended for certification, regulatory or contractual use.
0.4 QUALITY MANAGEMENT SYSTEM

The organization shall establish, document, implement and maintain a QMS and continually improve   its effectiveness in accordance
with the requirements of ISO 9001 by:
• Determining the processes needed for the QMS and their application throughout the organization;
• Determining the sequence and interaction of these processes;
• Determining criteria and methods needed to ensure that both the operation and control of these processes are effective;
• Providing resources and information necessary to support the operation and monitoring of these processes;
• Monitoring, measuring and analyzing these processes; and
• Implementing actions necessary to achieve planned results and continual improvement of these processes.
This clause also includes requirements related to the QMS documentation that includes: the quality policy and objectives, the quality
manual, procedures, records, documents to ensure effective planning, operation and control of processes and other documentation
specified by national or regional regulations. It also provides requirements on how to control these documents and records.
0.5 MANAGEMENT RESPONSIBILITY

Top management shall demonstrate an ongoing commitment to the development and

implementation of the QMS and continually improving its effectiveness by:
• Communicating to the organization the importance of meeting customer as well as statutory
and regulatory requirements;
• Establishing the quality policy;
• Ensuring that quality objectives are established;
• Conducting management reviews; and
• Ensuring the availability of resources.
0.6 RESOUCE MANAGEMENT

The day-to-day management of an effective quality management system relies on using

the appropriate resources for each task. These include competent staff with relevant (and
demonstrable) training and supporting services, awareness and communication.
To achieve conformity to product requirements it is important to provide and maintain
an appropriate infrastructure.
This clause also includes the managing of the work environment, which must be
managed by the organization in order to achieve conformity to product requirements.
0.7 PRODUCT REALIZATION

This clause describes all processes related to product realization, starting from planning of product realization, customer related processes, design
and development to the end product and after sales services. In detail this clause includes:
• Planning of product realization: During this stage the organization must plan and develop all processes necessary for product realization;
• Customer-related processes: It is important to manage processes related to customers in order to make sure the organization is determining and
meeting their requirements;
• Design and development: The design and development process must include design and development planning,     inputs, outputs, review,
verification, validation and control of design and development changes;
• Purchasing: It is important to establish documented procedures to ensure that purchased product conforms to specified purchase requirements;
• Production and service provision: This sub-clause includes the control and validation of production and service provision. The identification and
traceability, customer property and preservation of product are also part of this sub-clause.
• Control of monitoring and measuring devices: The requirements for what needs to be measured and the acceptance criteria may come from the
customer, regulatory, industry or the organization itself. Monitoring and measurement must be carried out in consistency with the requirements.
0.8 MEASUREMENT, ANALYSIS AND
IMPROVEMENT
Once the quality management system is implemented, permanent monitoring, measurement, analysis and
improvement is required, to:
• Demonstrate conformity to the product;
• Ensure conformity of the QMS; and
• Continually improve the effectiveness of the QMS.
An organization can continually improve the effectiveness of its management system through the use of the quality
policy, objectives, audit results, analysis of data, corrective and preventive actions.
Continual improvement can be defined as all the actions taken throughout the organization to increase effectiveness
(reaching objectives) and efficiency (an optimal cost/benefit ration) of quality processes to bring increased benefits
to the organization and its stakeholders.
ISO 9001: 2009 REVISED 2015
CLAUSES 1 OF 8
Process approach
The process approach is the key to an effective Quality Management System. It basically means that every operation of the company must be observed
as a process, meaning you should identify all inputs, necessary resources, documents, activities, and outputs from each operation. Once you set up your
system based on the processes, you will be able to monitor and measure your processes, their effectiveness, and efficiency and improve them, which is
the reason why it is emphasized at the beginning of the implementation, before going into any other details regarding the standard requirements.
In simple terms, the process approach represents the concept of observing all operations in the company as processes. This includes breaking the
company down into its processes, and determining their sequence, interaction, inputs, and outputs; as well as identifying the processes in the company,
which processes can start before other processes are finished, resources and information needed to start the process, and what results we expect from the
process.
The best way to start implementing the process approach is to create a process map that will include all processes in your company and their
interconnections. For example, the delivery process cannot be done before the production and sales process, and the production cannot be done before
the purchasing of raw materials. Once you create this global process map and identify all the processes and their interrelations, you can start defining
your processes in terms of what are necessary inputs, what controls need to be applied, and what are the outputs of the process. But this will be done
throughout the implementation; it doesn’t have to be done at once.
ISO 9001: 2009 REVISED 2015
CLAUSES 2 OF 8

Plan-Do-Check-Act cycle
The core of this standard, and many other management system standards, is the so-called Plan-Do-Check- Act (PDCA) cycle,
which says that, in order to have an effective management system. The first step in the cycle is planning, which includes
defining objectives, policies, procedures, and processes, including measuring aimed to show whether the processes are
delivering the expected results. The next step is the Do phase, which represents the realization of the planned arrangements,
applying policies and procedures, performing processes, and producing records. After the Do phase comes the Check phase,
where the results of the Do phase are analyzed to determine performance and effectiveness of the activities and actions that
were taken during the Do phase, which includes analyzing, monitoring, and measuring results, audits, and management
reviews. As the final stage of the cycle, the Act phase is where the organization needs to take actions according to the results
of the Act phase in order to achieve continual improvement. The PDCA cycle should be an ongoing cycle that drives the
organization towards continual improvement.
ISO 9001: 2009 REVISED 2015
CLAUSES 3 OF 4
All terms and definitions related to ISO 9001:2015 can be found in the standard. Unfortunately, ISO Procedure – A defined way to execute an activity or a process. Procedures can be
9001:2015 does not provide any definitions for the terms used, and it is very important to get an
documented or not.
understanding of the terms before the company starts implementing the requirements of the standard.
Here are some of the most important terms and definitions. Quality – Quality is the difference between a customer’s expectations and the
Top management – An individual or group of individuals who coordinate and control an organization at the customer’s perception of the product or service that he received – the higher the
highest level. In cases when the scope of the management system covers just part of an organization, then top difference, the better perceived quality.
management refers to the individuals who direct and control that part of the organization.
Nonconformity – The failure to meet a requirement.
Organization – A person or group of people who has their own functions with responsibilities, authorities,
and relationships to achieve the objectives. Risk – Risk is the “effect of uncertainty on objectives,” and an effect is a positive or
Context of the organization – A combination of internal and external factors that can have an effect on negative deviation from what is expected. For example, the company plans to deliver
purpose, objectives, performance, and sustainability of the organization. Internal factors include values, its products to the customers, but there is a risk of product nonconformity due to a
culture, knowledge, and performance of the organization. External factors include legal, technological,
poorly controlled production process.
competitive, market, cultural, social, and economic environment.
Interested party (stakeholder) – A person or organization that is involved in or perceives itself to be Effectiveness – The level of success in achieving or producing a desired result. For
affected by activities and actions taken by the organization. Interested parties can be customers, suppliers, example, the production process is effective if it is able to produce the products.
contractors, local community, government, etc.
Documented information – Information required to be controlled and maintained by
Process – A sequence of activities that use inputs to deliver an intended result. For example, the production
process has several steps that must be conducted in the appropriate sequence; inputs in this process are raw
an organization, and the medium on which it is contained. For example, the
materials, product specifications, and work instructions, while the outputs are the product, quality check documented policies, procedures, work instructions, and records represent documented
report, etc. information.
ISO 9001: 2009 REVISED 2015
CLAUSES 4 OF 8
Context of the organization
4.1 Understanding organization and its context
This clause brings new requirements compared to the 2008 version of the standard, and requires the organization
to determine all internal and external issues that may be relevant to the achievement of the objectives of the QMS
itself. This includes all elements that are, and may be capable of, affecting these objectives and outcomes in the
future.
4.2 Understanding needs and expectations of interested parties
Due to the effect that interested parties may have on the organization in terms of quality of products and services,
customer satisfaction, and statutory and regulatory requirements, the standard requires the organization to
determine interested parties relevant to the QMS and their needs and expectations.
ISO 9001: 2009 REVISED 2015
CLAUSES 4 OF 8
4.3. Determining the scope of Quality Management System
Determining the scope of the QMS is one of the main milestones in the implementation. The scope must be examined and defined considering
the internal and external issues, interested parties and their needs and expectations, as well as legal and regulatory compliance obligations.
Additional required considerations for the QMS scope are products, services, and organizational size, nature and complexity. The scope and
justified exclusions must be kept as documented information.
4.4. Quality Management System and its processes
The organization needs to establish, implement, maintain, and continually improve its QMS, including the processes needed and their
interactions, in accordance with the requirements of the standard.
This is where the process approach comes into action. The organization will need to determine inputs and outputs of the processes, sequence
and interaction of the processes, resources needed, and responsibilities, and ensure the effectiveness of the processes.
In addition, the organization will have to maintain necessary documented information to support the operation of the processes and keep
records to evidence that the processes were carried out as planned.