Software Development in an ISO 9000 company

ISO 9001:2008 standard defines requirements for a process-oriented Quality Management System. This means that desired results are achieved more efficiently when the related resources and activities, together with encompassing customer needs and satisfaction, are managed as a process. Quality Management System is specified in a Quality Manual document featuring a three-tier structure, which consists of Quality Processes (including Quality Policies), Quality Procedures and Work Instructions.

The problem is that Work Instructions are sometimes too bureaucratic. A good example of that approach is Tricker’s book on ISO 9000. According to it, a Work Instruction takes about 16 pages. Half of them contains purely administrative data (document data sheet, distribution list, amendments, list of annexes etc.). That makes the whole Quality Management System documentation superfluously thick.

Another drawback of Tricker’s approach is form-orientation: Work Instructions focus on how to fill-in the forms used by the Quality Procedures. What we propose is to make Work Instructions shorter (some elements can be omitted, some, e.g. terminology, can be put together and placed in one section). Moreover, Work Instructions should describe practices specific for a given methodology of

software development.

In our opinion, quality organization needs two things: general Quality Management System operating on a high abstraction level and a Thesaurus (knowledge database), which should materialize company’s knowledge. In the thesaurus templates of e.g. Quality Plans, historical data concerning past projects etc can be deposited. This information will be indispensable during planning and improving software processes.

The clauses of ISO 9001:2008 can be split into two parts. One part describes the general Quality Management System (chapters 4, 5, and 6) while the other part specifies requirements for a methodology to be adopted by an ISO-9000 company (chapters 7 and 8 of ISO 9001:2008). In the remaining part of the paper we will focus on requirements imposed by chapters 7 and 8 of the ISO 9001:2008.

ISO 9001:2008 standard defines requirements for a process-oriented Quality Management System. This means that desired results are achieved more efficiently when the related resources and activities, together with encompassing customer needs and satisfaction, are managed as a process. Quality Management System isspecified in a Quality Manual document featuring a three-tier structure, which consists of Quality Processes (including Quality Policies), Quality Proceduresand Work Instructions. The problem is that Work Instructions are sometimes too bureaucratic. A good example of that approach is Tricker’s book on ISO 9000. According to it, a Work Instruction takes about 16 pages. Half of them contains purelyadministrative data (document data sheet, distribution list, amendments, list of annexes etc.). That makes the whole Quality Management System documentation superfluously thick.

Another drawback of Tricker’s approach is form-orientation: Work Instructions focus on how to fill-in the forms used by the Quality Procedures. What we propose is to make Work Instructions shorter (some elements can be omitted,some, e.g. terminology, can be put together and placed in one section). Moreover,Work Instructions should describe practices specific for a given methodology ofsoftware development.In our opinion, quality organization needs two things: general Quality Management System operating on a high abstraction level and a Thesaurus (knowledgedatabase), which should materialize company’s knowledge. In the thesaurustemplates of e.g. Quality Plans, historical data concerning past projects etc can be deposited. This information will be indispensable during planning and improving software processes. The clauses of ISO 9001:2008 can be split into two parts. One part describes the general Quality Management System (chapters 4, 5, and 6) while the other part specifies requirements for a methodology to be adopted by an ISO-9000 company (chapters 7 and 8 of ISO 9001:2008). In the remaining part of the paper we will focus on requirements imposed by chapters 7 and 8 of the ISO9001:2008.

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ISO 9001:2008 Documentation Requirements

ISO 9001:2008 Documentation Requirements
ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”
Clause 4.2.1 General explains that the quality management system documentation shall include:
documented statements of a quality policy and quality objectives;
a quality manual documented procedures required by this International Standard documents needed by the organization to ensure the effective planning, operation and control of its processes, and records required by this International Standard;
The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:
the size of organization and type of activities;
the complexity of processes and their interactions, and
the competence of personnel.
All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.