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Thursday, June 17, 2010

International Standard Organization ISO 9001:2000 Clause 7 Part I

Clause 7: Product Realization

Clause 7.1: Planning of Product Realization
Quality manual gives the overall processes to be followed in the organization. A separate project plan is developed. The project plan gives the details of the quality objectives to be met, processes to be followed etc.

Clause 7.2: Customer Related Processes

Clause 7.2.1: Determination of requirements related to the product
A SRS document is maintained from the requirements that are to be obtained by the customer. This is done by the project team.
Clause 7.2.2: Review of requirements related to the product
The project team has to ensure that the requirements of the customer are well defined, documented and can be implemented. A written agreement should be there between the customer and the development organization on the requirements specifications.
Clause 7.2.3: Customer Communication A procedure for communication with the customer should be formalized by the project team.

Clause 7.3: Design and Development

Clause 7.3.1: Design and development planning
Interfaces should be defined, identify inputs and outputs, review process, verification and validation of design and controlling the design changes.
Clause 7.3.2: Design and development inputs Inputs that are required for design and development of the product should be identified.
Clause 7.3.3: Design and development outputs
The outputs of the design and development phase should include the product that meets the requirements, product acceptance criteria and user manuals.
Clause 7.3.4: Design and development review
To ensure that the work is progressing in the right direction and the end product is meeting all requirements as specified in SRS, the design and development has to be periodically reviewed.
Clause 7.3.5: Design and development verification
The project manager has to carry out the necessary verification of the design and development so that each and every requirement of the SRS is met.
Clause 7.3.6: Design and development validation
To ensure that the project is implemented as per plan, validation is done.
Clause 7.3.7: Control of design and development changes
During design and development, a number of changes are likely in SRS document are already prepared. Whenever a change is made, that change has to be estimated and conscious decision has to be taken.

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