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Software Management and Organisation

This document outlines organizational roles and responsibilities, personnel competence requirements, and documentation requirements for software development according to EN 50128:2011. It specifies that roles like requirements manager, designer, implementer, tester, integrator, verifier and validator must be defined and personnel must have the proper training and experience for their roles. It also requires the development of key lifecycle documents like a software quality assurance plan, verification plan and validation plan at the start of a project and maintenance throughout the software development lifecycle. Documentation must be properly structured, versioned and validated.

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Aulia Laila Fithri
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61 views

Software Management and Organisation

This document outlines organizational roles and responsibilities, personnel competence requirements, and documentation requirements for software development according to EN 50128:2011. It specifies that roles like requirements manager, designer, implementer, tester, integrator, verifier and validator must be defined and personnel must have the proper training and experience for their roles. It also requires the development of key lifecycle documents like a software quality assurance plan, verification plan and validation plan at the start of a project and maintenance throughout the software development lifecycle. Documentation must be properly structured, versioned and validated.

Uploaded by

Aulia Laila Fithri
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
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Reference

Document Name Terms Clause Subclause


EN 50128 : 2011 Organisation, roles and responsibilities 5.1 5.1.2.1

EN 50128 : 2011 5.1.2.2


EN 50128 : 2011 5.1.2.3

EN 50128 : 2011 5.1.2.4


EN 50128 : 2011 5.1.2.5

EN 50128 : 2011 5.1.2.6


EN 50128 : 2011 5.1.2.7
EN 50128 : 2011 5.1.2.8
EN 50128 : 2011 5.1.2.9

EN 50128 : 2011 5.1.2.10


EN 50128 : 2011 5.1.2.11

EN 50128 : 2011 5.1.2.12

EN 50128 : 2011 5.1.2.13

EN 50128 : 2011 5.1.2.14

EN 50128 : 2011 Personnel competence 5.2 5.2.2.1

EN 50128 : 2011 5.2.2.2

EN 50128 : 2011 5.2.2.3


EN 50128 : 2011 5.2.2.4

EN 50128 : 2011 Lifecycle issues and documentation 5.3 5.3.2.1

EN 50128 : 2011 5.3.2.2


EN 50128 : 2011 5.3.2.3

EN 50128 : 2011 5.3.2.4

EN 50128 : 2011 5.3.2.5

EN 50128 : 2011 5.3.2.6

EN 50128 : 2011 5.3.2.7

EN 50128 : 2011 5.3.2.8

EN 50128 : 2011 5.3.2.9

EN 50128 : 2011 5.3.2.10


EN 50128 : 2011 5.3.2.11

EN 50128 : 2011 5.3.2.12

EN 50128 : 2011 5.3.2.13

EN 50128 : 2011 5.3.2.14


Detail Requirement Description

As a minimum, the supplier shall implement the parts of EN ISO 9001 dealing with the organisation and
management of the personnel and responsibilities.

Responsibilities shall be compliant with the requirements defined in Annex B.


The personnel assigned to the roles involved in the development or maintenance of the software shall be
named and recorded.
An Assessor shall be appointed by the supplier, the customer or the Safety Authority
The Assessor shall be independent from the supplier or, at the discretion of the Safety Authority, be part
of the supplier’s organisation or of the customer’s organisation
The Assessor shall be independent from the project.
The Assessor shall be given authority to perform the assessment of the software
The Validator shall give agreement/disagreement for the software release
Throughout the Software Lifecycle, the assignment of roles to persons shall be in accordance with
5.1.2.10 to 5.1.2.14, to the extent required by software SIL.
The roles Requirements Manager, Designer and Implementer for one component can perform the
roles Tester and Integrator for a different component.
The roles of the Verifier and the Validator shall be defined at the project level and shall remain
unchanged throughout the development project
The key competencies required for each role in the software development are defined in Annex B. If
additional experience, capabilities or qualifications are required for a role in the software life cycle, these
shall be defined in the Software Quality Assurance Plan.
Documented evidence of personnel competence, including technical knowledge, qualifications,
relevant experience and appropriate training, shall be maintained by the supplier’s organisation in order
to demonstrate appropriate safety organisation
The organisation shall maintain procedures to manage the competence of personnel to suit
appropriate roles in accordance to existing quality standards.
Once it has been proved to the satisfaction of an assessor or by a certification that competence has
been demonstrated for all personnel appointed in various roles, each individual will need to show
continuous maintenance and development of competence. This could be demonstrated by keeping a
logbook showing the activity is being regularly carried out correctly, and that additional training is being
undertaken in accordance with EN ISO 9001 and ISO/IEC 90003:2004, 6.2.2 “Competence, awareness and
training".

A lifecycle model for the development of software shall be selected. It shall be detailed in the
Software Quality Assurance Plan in accordance with 6.5.
The lifecycle model shall take into account the possibility of iterations in and between phases.
Quality Assurance procedures shall run in parallel with lifecycle activities and use the same
terminology.
The Software Quality Assurance Plan, Software Verification Plan, Software Validation Plan and
Software Configuration Management Plan shall be drawn up at the start of the project and maintained
throughout the software development life cycle

All activities to be performed during a phase shall be defined and planned prior to the
commencement of the phase.
All documents shall be structured to allow continued expansion in parallel with the development
process.
For each document, traceability shall be provided in terms of a unique reference number and a
defined and documented relationship with other documents
Each term, acronym or abbreviation shall have the same meaning in every document. If, for historical
reasons, this is not possible, the different meanings shall be listed and the references given

Except for documents relating to pre-existing software (see 7.3.4.7), each document shall be written
according to the following rules:
– it shall contain or implement all applicable conditions and requirements of the preceding document
with which it has a hierarchical relationship;
– it shall not contradict the preceding document.

Each item or concept shall be referred to by the same name or description in every document.
The contents of all documents shall be recorded in a form appropriate for manipulation, processing
and storage.
When documents which are produced by independent roles are combined into a single document,
the relation to the parts produced by any independent role shall be traced within the document
Documents may be combined or divided in accordance with 5.3.2.12. Some development steps
may be combined, divided or, when justified, eliminated, at the discretion of the Project Manager and
with the agreement of the Validator
Where any alternative lifecycle or documentation structure is adopted it shall be established that it
meets all the objectives and requirements of this European Standard.
Documentation
Category
Input
Documentation Impementation Reference
Output Document Name
pementation Reference V&V
Remark/ Status
Tagging V&V Method used V&V Reference
V&V
V&V Result V&V Result Reference

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