ISO.2.2 ISO 9001 Conformity on the Basis of the V-Model

  ISO.2.2 ISO 9001-Konformität auf der Basis des V-Modells

Contents		ISO.2.2 ISO 9001 Conformity on the Basis of the V-Model Links to the V-Model Mailinglist

ISO.2.2 ISO 9001 Conformity on the Basis of the V-Model

In order to obtain an ISO 9001 certificate, all processes in the certification range have to be regulated by process rules. The V-Model is such a process rule according to ISO 9001 (interpreted by ISO 9000, part 3) for the process "Software Development". Contrary to other process regulations, the V-Model contains very substantial process regulations integrating many subprocesses. Therefore, in the QA manual of the contractor, the V-Model must be embedded bindingly as process regulations (at least for orders from the defense area). The necessity of the project-specific operationalization of the V-Model in the form of a Project Manual corresponds with this and remains valid.

The V-Model meets the requirements of the ISO 9001 for the technical process of the software development. The organizational requirements of the ISO 9001 go beyond this and must be met by the contractor in addition to this. Thus the V-Model is a building block helping to meet the ISO 9001 standard that essentially simplifies the procedure to get a certificate; however, it must be supplemented by organizational, contractor-specific regulations and embedded in the contractor context (cf. allocation of roles, etc.).

Since its objective is the functional description of the procedure, the V-Model does not contain any information about the appropriate corporate or departmental problems. Everything in connection with the embedding in the corporation or with a project-specific context has been left out on purpose.

Based on the structural items of the ISO 9000, part 3 (instruction for the use of the ISO 9001), the following table includes the allocation of V-Model regulations (activities and products) for the ISO requirements. The table is to

• illustrate how the individual ISO requirements are met in the V-Model and
• to simplify the realization of the ISO requirements by means of references to the contents of the V-Model.

The following explains which organizational requirements have to be additionally met in order to get an ISO 9001 certification:

1.	The management of the contractor has to specify and to document its business strategies and goals as well as its commitment with regard to quality. It must be guaranteed that these strategies are understood, realized and observed on all levels of the organization (ISO 9000, part 3, chapter 4.1.1.1).
2.	The responsibilities, authorizations and relationships between staff members holding management posts, executive posts, and controlling posts, that might possibly have an impact on quality, have to be specified and documented (ISO 9000, part 3, chapter 4.1.1.2.1).
3.	The contractor has to specify the requirements for the internal verification, to make available appropriate resources, and to hire qualified staff for the tasks of verification (ISO 9000, part 3, chapter 4.1.1.2.2).
4.	The contractor has to appoint a representative agent from management who must have the authority and responsibility to guarantee that the requirements of the ISO 9001 will be met and observed at all times (ISO 9000, part 3, chapter 4.1.1.2.3).
5.	The QA system must be evaluated by top management at appropriate intervals, in order to guarantee that the system is always up to date and effective. Any documents about such reviews have to be safely stored and maintained (ISO 9000, part 3, chapter 4.1.1.3).
6.	All elements, requirements and preparations for the QA system have to be systematically and orderly documented in a QA manual (ISO 9000, part 3, chap 4.2.2).
7.	In order to verify that all activities relevant for quality correspond with the planned steps, the contractor has to introduce a planned, comprehensive, and documented internal quality audit system and also to guarantee the efficiency of the QA system (ISO 9000, part 3, chapter 4.3).
8.	The contractor has to introduce, document and maintain procedures for a general improvement that goes beyond the improvement of the project itself (correction measures) (ISO 9000, part 3, chapter 4.4).
9.	The contractor should introduce and maintain procedures for the audit of contracts and for the coordination of these activities (ISO 9000, part 3, chapter 5.2).
10.	The contractor should introduce and maintain procedures for the realization of maintenance tasks (ISO 9000, part 3, chapter 5.10).
11.	The contractor should apply quantitative measurement methods for the quality of the development and delivery process (ISO 9000, part 3, chapter 6.4.2).
12.	The contractor should introduce and maintain procedures for the investigation of the training requirements for staff members and personnel in charge of quality-relevant activities (ISO 9000, part 3, chapter 6.9). If the customer demands a QA system according to ISO 9001, the contractor can prove this with the appropriate certificate of an accredited certification agent.

ISO 9000, Part 3	V-Model
	direct		indirect
	Rule/Activity	Product	Rule/Activity	Product
4 Quality Assurance System-Scope
4.1 Responsibilities of Management
4.1.1 Responsibilities of Management of the Supplier
4.1.1.1 Quality Strategy				QA Plan
4.1.1.2 Organization			Roles/Activities Allocations	Project Manual 7.1, 7.2
4.1.1.3 Review of Quality Assurance System by Management
4.1.2 Responsibility of Management of the Customer
4.1.3 Joint Reviews	PM6	Report Documents		Project Plan 3.1.5
4.2 Quality Assurance System
4.2.1 General Information
4.2.2 Documentation of the Quality Assurance System				V-Model as one of the Process Instructions
4.2.3 Quality Assurance Plan	QA1	QA Plan, Assessment Plan
4.3 Internal Quality Audits			QA5
4.4 Correction Measures	PM6
a) Investigation of the Cause	PM7	Report Documents	CM4.7	Project History
b) Analysis of Processes		QA Plan	QA3
c) Error Prevention Measures	CM3
d) Control Measures	CM3, V-Model Change Procedures
e) Procedural Changes	V-Model Change Procedures
ISO 9000, Part 3	V-Model
	direct		indirect
	Rule/Activity	Product	Rule/Activity	Product
5 Quality Assurance System - Lifecycle Activities
5.1 General Information	V-Model
5.2 Contract Review
5.2.1 General Information	PM2		PM1	Project Manual, included in Contract
5.2.2 Contract Items relevant for Quality	CM3	Project Manual
5.3 Specification of Contractor
5.3.1 General Information	SD1.2 SD1.3 SD1.4 SD1.5 SD1.6	User Requirements	QA1.1	QA Plan
5.3.2 Cooperation	SD1.7	Protocol		Project Manual 7.4
5.4 Development Plan
5.4.1 General Information	PM1.1, PM1.2, PM1.3, PM1.5	Project Manual, Project Plan
5.4.2 Development Plan
5.4.2.1 Phases	SD, QA	Project Manual
5.4.2.2 Management	PM	Project Manual, Project Plan
5.4.2.3 Development Methods and Tools	PM1.4	Project Manual 6
5.4.3 Direction of Development	PM6, PM8, QA1.2	Assessment Plan
5.4.4 Specification for Development Phases	PM4	Project Manual
5.4.5 Results of Development Phases	QA2, QA4	Project Manual, Assessment Specification (Verification)
5.4.6 Verification of Each Phase	PM6	Project Plan (for Time Schedule)
ISO 9000, Part 3	V-Model
	direct		indirect
	Rule/Activity	Product	Rule/Activity	Product
5.5 Planning of Quality Assurance
5.5.1 General Information	QA1.1, QA1.2	QA Plan, Assessment Plan
5.5.2 Content of Quality Assurance Plan
a) Quality Goals	QA1.1	QA Plan
b) Criteria	QA2.1, QA2.2	QA Plan
c) Types	QA1.1	QA Plan
d) Planning	QA2	Assessment Plan
e) Responsibilities	QA1.1	QA Plan
5.6 Design and Implementation
5.6.1 General Information
5.6.2 Design
a) Design Aspects	PM1.3, SD1 to SD5-SW	Project Manual
b) Design Methods	PM1.4, SD1 to SD5-SW	Project Manual 6
c) Design Experience	CM4.5
d) Following Processes		Technical Requirements
5.6.3 Implementation
a) Rules	SD6-SW	Project Manual 8
b) Implementation Methods		Project Manual 6
5.6.4 Reviews	QA4, PM6, Product Flow according to V-Model	Assessment Protocol -> CM
ISO 9000, Part 3	V-Model
	direct		indirect
	Rule/Activity	Product	Rule/Activity	Product
5.7 Testing and Validation
5.7.1 General Information
5.7.2 Test Planning
a) Test Plans	QA2	Assessment Plan
b) Test Cases	QA2.3	Assessment Specification
c) Test Types	QA1.1, QA2.1	QA Plan 5
d) Test Environment	QA2.2	Assessment Plan 5.1
e) Criteria		Assessment Specification
f) User Documentation
g) Staff/Personnel	PM1.1, QA1.2	Project Manual 7, Assessment Plan 3
5.7.3 Testing
a) Test Results		Assessment Report
b) Problems	QA5
c) Based on Changes in Participating Dpmts.	CM3
d) Adequacy	QA4	Assessment Plan 2
e) HW and SW Config.	CM2	CID
5.7.4 Validation	QA4 (for the System)
5.7.5 Field Test	QA4 (with special Assmt. Criteria)
5.8 Acceptance
5.8.1 General Information	QA4			Project Manual
5.8.2 Planning of Acceptance Tests	QA2			Contract
5.9 Reproduction, Delivery and Installation
5.9.1 Reproduction			Contract
a) Copies		Project Manual
b) Type of Data Volume		Project Manual
c) Documentation		Project Manual
d) Copyright
e) Storage	CM4.4
f) Obligation to Deliver
5.9.2 Delivery	SD8.3	QA Plan 5.3
5.9.3 Installation	SD9.2		Contract
ISO 9000, Part 3	V-Model
	direct		indirect
	Rule/Activity	Product	Rule/Activity	Product
5.10 Maintenance
5.10.1 General Information	CM3
5.10.2 Maintenance Plan	SD1.8	SWMM Concept
5.10.3 Identification of Initial State of Product	CM4.4
5.10.4 Supporting Organization	SD1.8	SWMM Concept	Contract
5.10.5 Different Maintenance Activities		CM Plan
5.10.6 Maintenance Notes and Reports	CM3
5.10.7 Release Procedure	acc. to Product Flow V-Model	CM Plan
a) Release			Part 1, Chapter 2.3
b) Release Types
c) Future Changes			CM
d) Change Procedures
e) Change Notes	CM3
6 Quality Assurance System-Supporting Activities (not phase-dependent)
6.1 Configuration Management
6.1.1 General Information	CM
6.1.2 Configuration Management Plan	CM1, PM1	CM Plan
a) Organization		Project Plan
b) Activities		Project Manual 5
c) Tools		Project Manual 6
d) State of Elements		CM Plan 3
6.1.3 Configuration Management Activities
6.1.3.1 Identification and Traceability of Configuration	CM2	CM Plan, CID
6.1.3.2 Management of Changes	CM3
6.1.3.3 Configuration Status Report	CM2	CID
ISO 9000, Part 3	V-Model
	direct		indirect
	Rule/Activity	Product	Rule/Activity	Product
6.2 Document Management
6.2.1 General Information	Product Flows acc. to V-Model
a) Documents
b) Approval	V-Model Change Procedure
c) Change Procedures	PM1 (Tailoring)
6.2.2 Document Types
a) Procedural Instructions
b) Planning Documents	Product Flows acc. to V-Model
c) Product Documents	Product Flows acc. to V-Model
6.2.3 Approval and Release of Documents
a) Availability			CM
b) Updated Documents			V-Model Release
6.2.4 Document Change		CM Plan	CM2	Project Manual 4.3
6.3 Quality Protocol		QA Plan 5.2	V-Model (CM)
6.4 Measurements
6.4.1 Measurements at Product	QA5
6.4.2 Process Measurement			QA3, PM8, CM4.7
6.5 Rules, Practices and Agreements
6.6 Tools and Techniques			Project Manual 6
6.7 Procurement
6.7.1 General Information	PM2; SD1, SD2	Assessment Specification
6.7.2 Assessment of Subsuppliers				QA Plan 5.2
6.7.3 Validation of Procured Products	QA2, QA4	Assessment Specification
6.8 Added Software Product	PM2, QA2, QA4	Assessment Specification
6.9 Training	PM10

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