IEEE ISO IEC 90003-2018 pdf free download – Software engineering — Guidelines for the application of ISO 9001:2015 to computer software.
4.3 Determining the scope of the quality management system
ISO 9001:2015, Quality management systems — Requirements
4.3 Determining the scope of the quality management system
The organization shall determine the boundaries and applicability of the quality management system to establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.
The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered,and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.
Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.
The application of this document is appropriate to software that is:
— acquired from another organisation (e.g., part of a commercial contract or other form of agreement);
— a product available for a market sector;
— used to support the processes of an organization;
— embedded in a hardware product;
— related to software services.
Some organizations may be involved in all of the above activities; others may specialize in one area.
Whatever the situation, the determined scope of the organization’s quality management system should cover all aspects (software related and non-software related) of the business, apart from any justification for requirements determined as not being applicable.
4.4 Quality management system and its processes
4.4.1 Quality management system processes
ISO 9001:2015, Quality management systems — Requirements
4.4.1 The organization shall establish, implement, maintain and continually improve a quality
management system, including the processes needed and their interactions, in accordance with the
requirements of this International Standard.
The organization shall determine the processes needed for the quality management system and their
application throughout the organization, and shall:
a) determine the inputs required and the outputs expected from these processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring, measurements and related
performance indicators) needed to ensure the effective operation and control of these processes;
d) determine the resources needed for these processes and ensure their availability;
e) assign the responsibilities and authorities for these processes;
f) address the risks and opportunities as determined in accordance with the requirements of 6.1;
g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
h) improve the processes and the quality management system.
NOTE Guidance is provided for items a) and b) of ISO 9001:2015, 4.4.1 in relation to the organizational processes as follows.
4.4.1.1 Process identification and application
The organization should also identify the processes for software development, testing, operation or maintenance, as applicable.
4.4.1.2 Process sequence and interaction
The organization should also define the sequence and interaction of the processes in:
1) life cycle models for software development, e.g. incremental, spiral, iterative and evolutionary (adaptive);
2) quality and development planning, which should be based upon a life cycle model;
3) the software quality system, data, documentation, procedures and processes and controls should be integrated into the overall quality system based on ISO 9001; all areas of management should take responsibility for all software processes, software development and end products that may contain software.
4.4.1.3 Evidence of effective operation
Examples of evidence of effective operation of the quality management system may include:
a) changes (and the reasoning) to resources (people, software and equipment);
b) estimates, e.g. project size and effort (people, cost, schedule);IEEE ISO IEC 90003 pdf download.