International Standard Organization ISO 9001:2000 Clause 7 Part II

Clause 7.4: Purchasing

Clause 7.4.1: Purchasing Processes
There should be some defined procedures for the selection of suppliers and verification of purchased products.
Clause 7.4.2: Purchasing Information
When you purchase a product, the manager has to specify the product specifications, the quality management system requirements and many other requirements such as installation, warranty, maintenance etc.
Clause 7.4.3: Verification of Purchased Product
The project manager has to specify the acceptance criteria for the proposed product and when the supplier gives the product, the verification has to be done as per procedure.

Clause 7.5: Production and Service Operations

Clause 7.5.1: Control of production and service provision
Proper planning has to be done to make multiple copies, installation, and later maintenance of the product when delivered to the customers.
Clause 7.5.2: Validation of processes for production and service provision
Process has to be established to obtain the feedback on the performance of the product from the customer in cases where the verification is not possible.
Clause 7.5.3: Identification and traceability
The product should be identified and traceable during all stages of production, delivery, and installation.
Clause 7.5.4: Customer Property
The customer may give some of its property to the developer. In such cases, the development organization has to take proper care of the customer's property.
Clause 7.5.5: Preservation of the product
A process has to be defined for identification of the product, packaging, storage, and protection.

Clause 7.6: Control of monitoring and measuring devices

It is necessary to ensure that the test and measuring instruments such as oscilloscopes, protocol analyzers etc uses to ensure that the product meets the requirements are working well.

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.

International Standard Organization ISO 9001:2000 Clause 6

Clause 6: Resource Management

Clause 6.1: Provision of resources The resources that are necessary to implement the quality management system should be in place. This should be ensured by the management.

Clause 6.2: Human Resources

Clause 6.2.1: General By selecting the right people and by imparting the necessary training, the management has to ensure that the people have the necessary competence.
Clause 6.2.2: Competence, awareness and training:
The management has to ensure that each and every employee has the necessary understanding of the quality, development processes and the products.

Clause 6.3: Infrastructure

The management has to provide the necessary hardware , software, testing tools and also supporting services such as communication facilities, Internet access etc. so that the employees can carry out their responsibility to meet the quality requirements.

Clause 6.4: Work environment

A friendly work environment is a must to deliver quality products and the management has to provide such a work environment.

International Standard Organization ISO 9001:2000 Clause 5

Clause 5: Management Responsibility

Clause 5.1: management Commitment
The measurable quality objectives that are meant to meet customer requirements should be defined and communicated the quality objectives to employees.
Clause 5.2: Customer Focus
The management has to ensure that the customer's requirements are well understood and the customer is well satisfied with the product.
Clause 5.3: Quality Policy
The quality policy reflects the commitment of the management. The quality of the policy has to be signed by the Chief Executive Officer of the organization.

Clause 5.4: Planning

Clause 5.4.1: Quality Objectives
Quality objectives such as increasing productivity, reducing defects etc. has to be defined by the management based on the quality policy of the management.
Clause 5.4.2: Quality management system planning
A quality management system has to be planned by the management to meet the quality objectives. The details of the processes are to be defined.

Clause 5.5: Responsibility, Authority and Communication

Clause 5.5.1: Responsibility and Authority
The quality management system makes it compulsory that a proper and a clear organization chart is drawn, indicating the reporting structure and the responsibilities and authorities of each individual.
Clause 5.5.2: Management Representative
The management representative should be appointed who has the responsibility and authority to implement the quality management system.
Clause 5.5.3: Internal Communication
To avoid lack of communication among team members, a proper procedure for internal communication should be established so that all the employees are in unison.

Clause 5.6: Management Review

Clause 5.6.1: General
Quality policy, quality objectives and quality manual should be periodically reviewed to discuss the effectiveness and possible improvements.
Clause 5.6.2: Review Inputs
The inputs have to be obtained from customers, external auditors, and internal auditors.
Clause 5.6.3: Review output
The outputs will be the action points needed for effective quality management system implementation. This is done after the management review.

International Standard Organization ISO 9001:2000 Clauses 1-4

ISO 9001:2000 standard gives the requirements to develop a quality management system. The standard has eight clauses.

Clause 1: Scope
The first clause specifies the scope of the document which defines the quality management system to deliver a quality product.
Clause 2: Normative Reference
All the references to the document are specified in this clause.
Clause 3: Terms and Definitions
All the terms and conditions that are specified in ISO 9000:2000 are specified in this clause.
Clause 4.1: General Requirements
To deliver a quality product, the management should have a well-defined and documented quality management system that defines the processes to be followed. The processes should include both technical and managerial processes.
Clause 4.2: Documentation Requirements
Quality policy, Quality manual, Detailed definition of procedures mentioned in quality manual, Quality records are included in the documentation of quality management.
Clause 4.2.2: Quality Manual
All the processes that are to be followed for the entire software development life cycle should be described in quality manual. The quality manual can refer to other documents that gives details of the process definition.
Clause 4.2.3: Control of documents
A procedure should be established for controlling the documents as the documents related to the processes and projects will change time to time.
Clause 4.2.4: Control of records
It is necessary to maintain records to give evidence to the external auditing agencies that the quality system is being effectively operational.