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Magazines and Journals search. Standards About ISO ISO Resources. Our Standards. ISO Related Topics. ISO Vs. ISO history and revisions: ISO , , and ISO was first published in by the International Organization for Standardization ISO , a specialized international agency for standardization composed of the national standards bodies of more than countries.
The ISO revision had five goals: Meet stakeholder needs Be usable by all sizes of organizations Be usable by all sectors Be simple and clearly understood Connect quality management system to business processes ISO was again updated in and ISO is the most current version. Quality system reviews should be:.
Carried out on a regular basis. Documented and records should be maintained. Quality system reviews should ensure that your: Quality system requirements are being met. Quality objectives are being achieved. Quality policy is being applied. Develop a quality system and a manual that describes it. Your quality system should ensure that your products conform to all specified requirements. Your quality manual should: State your quality policy. List your quality objectives. Provide an overview of your quality system.
Describe the structure of your organization. Discuss your quality system procedures. Introduce your quality documents and records. Teach people about your quality system.
Control quality system work practices. Guide the implementation of your quality system. Explain how your quality system will be audited.
Develop your procedures for all areas of your quality system. Document your procedures, and keep them up to date. Each procedure should: Specify its purpose and scope. Describe how an activity should be carried out. Describe who should carry out the activity. Explain why the activity is important to quality. Describe when and where it should be carried out. Explain what tools and equipment should be used. Explain what supplies and materials should be used.
Explain what documents and records should be kept. Procedures may also refer to detailed work instructions that explain exactly how the work should be done. You are expected to develop quality plans for products, processes, projects, and customer contracts. Your quality plans should list the quality objectives you intend to achieve, and the steps you intend to take to achieve these objectives. When you construct your quality plan, consider the following questions: Do you need to purchase any new equipment or instruments, or any new inspection and test tools?
Do you need to carry out any special training in order to fulfill all quality system requirements? Do you need to improve design, production, testing, inspection, installation, or servicing procedures? Do you need to improve your quality measurement and verification procedures? Do you need to develop any new measurement methods or instruments? Do you need to clarify your organization's standards of acceptability?
Do you need to develop any new documents, forms, reports, records, or manuals? Do you need to allocate more resources in order to achieve the required levels of quality? Quality planning for software Develop quality plans to control your software development projects.
Your quality plans should control:. Project implementation. Project schedules. Project resources. Project approvals. Project phases. When a phase can begin. When a phase has been completed. Your quality plans should define:. Quality requirements. Life cycle model. Review methods. Testing methods. Verification methods. Validation methods. Develop detailed quality plans and procedures, and define specific responsibilities and authorities to control:.
Configuration management. Product verification. Verification of your developed products. Verification of your purchased products. Verification of your customer-supplied products. Product validation. Validation of your developed products. Validation of your purchased products. Nonconforming products. Corrective actions. Your quality plans may include or refer to: Generic project, product, or contract procedures. Special project, product, or contract procedures.
Your quality plan can be a separate document or it can be part of another larger document. Or, it can be made up of several specific documents. Your quality plan should be updated and refined as your software development plan is implemented.
Make sure that all participating groups and organizations get a chance to review and approve the quality plan before it is implemented. Develop and document procedures to coordinate the review of sales orders and customer contracts. Make sure you include the customer in the process of review.
Develop and document procedures to coordinate the review of software development contracts. Develop procedures to coordinate the review of contracts that affect:. Software that will be developed for a customer. Software that will be developed for a market sector. Software that will be embedded in a hardware product. Software that will be developed for your internal use. Your contract review procedures should ensure that all contractual requirements are acceptable before you agree to provide products to your customers.
Specifically, your procedures should make sure that:. Your customer's order is clearly and completely defined. When verbal orders are received, make sure that you and your customer agree on what is required. You have resolved all differences between the original tender or proposal and the final contract or sales order. Your organization is capable of supplying the products ordered by the customer.
Customer contract review questions Have you and your customer agreed on terminology? Have you and your customer agreed on the criteria that will be used to accept or reject your product? Have you and your customer agreed on the data and facilities that will be provided by the customer? Have you and your customer agreed on how joint progress reviews will be carried out? Have you and your customer agreed on how joint product development will be carried out?
Have you and your customer agreed on which life cycle processes will be imposed by the customer? Have you and your customer agreed on how your software product be deployed? Have you and your customer agreed on how software users will be trained? Have you and your customer agreed on how you will handle changes in customer requirements? Have you agreed on how changes will be handled during software development? Have you agreed on how changes will be handled during software maintenance?
Have you and your customers agreed on how software upgrades will be handled? Have you and your customers agreed on how historical software versions will be handled? Have you and your customers agreed on how problems will be handled after product acceptance? Have you agreed on how complaints will be handled? Have you agreed on how claims will be handled? Have you agreed on who will be responsible for nonconformities after the warranty runs out? Are you satisfied that your customer will be able to meet all of his contractual obligations?
Technical contract review questions Have you established that the project is feasible and that all requirements can be met? Have you identified all the software development standards that will be referred to during the project? Have you defined all the software development procedures that will be used during the project? Have you defined all the facilities, tools, data, and other items that must be provided by the customer?
Have you developed and documented methods for determining whether customer supplied facilities, tools, data, and items are suitable? Have you clarified which operating system and which hardware platform will be used?
Have you agreed on how interfaces with the software product will be controlled? Have you defined all software replication and distribution requirements? Management contract review questions Have you identified significant risks and contingencies? Have you evaluated the impact these could have? Have you clarified the extent of your responsibility for subcontracted work? Have you established a project schedule? Does it say when progress reviews will be done? Does it say when technical reviews will be done?
Does it say when deliverables are due? Have you clarified and documented all installation, maintenance, and support requirements? Have you confirmed that all resources will be available when you need them? Will all technical resources be available?
Will all human resources be available? Will all financial resources be available? Legal contract review questions Have you taken steps to respect the rights of others? Will you respect all intellectual property rights? Will you respect all licensing agreements? Will you respect all confidentiality requirements?
Have you clarified the rules governing the guardianship of the master software copy? Have you clarified the conditions under which the customer may access or verify the master copy? Have you clarified exactly what kinds of information wil or will not be disclosed to the customer? Have you defined all product warranty terms? Have you defined all contractual liabilities and penalties?
Develop and document procedures to control the product design and development process. These procedures must ensure that all requirements are being met. Software development Control your software development project and make sure that it is executed in a disciplined manner.
Use one or more life cycle models to help organize your software development project. Develop and document your software development procedures. These procedures should ensure that:. Software products meet all requirements.
Software development follows your: Quality plan. Development plan. Software design Control your software design process and make sure that it is performed in a systematic way. Use a suitable software design method.
Study previous software design projects to avoid repeating old mistakes. Design software that is:. Easy to test, install, use, and maintain. Safe and reliable when failure could cause:. Human injury. Property damage. Environmental harm. Develop and document rules to control:. Coding activities. Naming conventions. Commentary practices. Programming languages. Apply configuration management techniques to document and control the use and review of all: Analysis tools.
Design techniques. Compilers and assemblers. Train personnel in the use of such tools and techniques. Your product planning procedures should ensure that:. Plans are prepared for each design activity or phase. Responsibility for implementing each plan, activity, or phase is properly defined. Qualified personnel are assigned to the product design and development process.
Adequate resources are allocated to the product design and development process. Plans are updated, and circulated to the appropriate participants, as designs change. Software design and development planning Prepare a software development plan. Your plan should be documented and approved before it is implemented. Your plan should control:.
Technical activities. Requirements analyses. Design processes. Integration methods. Testing techniques. Installation work. Acceptance testing. Management activities. Project supervision.
Progress reviews. Reporting requirements. Your software development plan should:. Define your project. Identify related plans and projects. List your project objectives. Define project inputs and outputs. Define inputs for each project activity. Define outputs for each project activity. Explain how your project will be organized. Explain how your teams will be structured. Explain who will be responsible for what. Explain how subcontractors will be used.
Explain how project participants will interact. Explain how all resources will be managed. Discuss project risks and potential problems. Identify important project assumptions. Present your project schedule. Define project phases and dependencies. Specify project time lines and milestones. Introduce your project budget.
Describe the work that will be done. Describe each task. Describe the inputs for each task. Describe the outputs for each task. Identify all relevant control strategies. Identify all relevant standards and conventions. Identify all relevant rules and regulations.
Identify all relevant practices and procedures. Identify configuration management practices. Identify backup and recovery procedures. Identify archiving procedures. Identify all relevant methods and approaches.
Identify methods used to control nonconforming products. Identify methods used to control software development software. Identify methods used to control virus protection activities. Identify all relevant tools and techniques. Identify methods used to qualify all tools and techniques. Identify methods used to control all tools and techniques.
Make sure that your software development plan or your subcontractors' plans:. Define how the responsibility for software development will be distributed between all participants. Define how technical information will be shared and transmitted between all participants. Explain how all project participants will provide input. Explain how subcontractors will provide input during design, installation, maintenance, and training.
Explain how regulatory authorities will provide input during design, installation, maintenance, and training. Explain how help desk staff will provide input during design, installation, maintenance, and training. Explain how other related projects will provide input during design, installation, maintenance, and training. Explain how end users will provide input during design, installation, maintenance, and training. Make sure that your customer has accepted the responsibility to:.
Cooperate and support your project. Provide the information you need when you need it. Resolve outstanding issues in a timely manner. Make sure that your customer representative has been given the responsibility and authority to:. Clarify requirements and expectations.
Answer questions and solve problems. Make and implement agreements. Approve plans and proposals. Establish acceptance criteria. Provide appropriate customer-supplied products. Define and distribute authorities and responsibilities. Schedule joint progress reviews. You and your customer together should review:. Your developmental activities. Your customer's activities. Your users' activities. Training activities. Conversion activities. Results of verification activities. Results of acceptance tests.
Results of conformance evaluations. Design input requirements can be classified as follows:. Customer expectations. Contractual conditions. Statutory imperatives. Regulatory requirements. Environmental constraints. Safety considerations. Performance standards. Functional specifications. Descriptive prescriptions. Aesthetic preferences. Software design input Design input requirements should be specified by the customer. However, sometimes the customer will expect you to develop the design input specification.
In this case, you should:. Prepare procedures that you can use to develop the design input specification. These procedures should be documented and should explain:. How interviews, surveys, studies, prototypes, and demonstrations will be used to develop your design input specification. How you and your customer will formally agree: To accept the official specification.
To accept changes to the official specification. How changes to specifications will be controlled. How prototypes and product demonstrations are evaluated.
How input requirements will be met through the use of hardware, software, and interface technologies. How reviews, evaluations, and other discussions between you and your customer will be recorded. Work closely with your customer in order to avoid misunderstandings and to ensure that the specification meets the customers needs. Express your specification using terms that will make it easy to validate during product acceptance.
Ask your customer to formally approve the resulting design input specification. Your design input specification may address the following kinds of characteristics or requirements: Functional requirements.
Reliability requirements. Usability requirements. Efficiency requirements. Maintainability requirements. Portability requirements. Interface requirements. Hardware interface requirements. Software interface requirements. Operational requirements. Safety requirements. Security requirements.
Statutory requirements. Design outputs are usually documents. They include drawings, parts lists, process specifications, servicing procedures, and storage instructions. These types of documents are used for purchasing, production, installation, inspection, testing, and servicing. Design outputs must be expressed in terms that allow them to be compared with design input requirements. Design output documents must identify those aspects of the product that are crucial to its safe and effective operation.
These aspects can include operating, storage, handling, maintenance, and disposal requirements. Design output documents must be reviewed and approved before they are distributed. Design outputs must be accepted only if they meet official acceptance criteria.
Software design output Prepare design output documents using standardized methods and make sure that your documents are correct and complete. Software design outputs can include design specifications, source code, user guides, etc.
Design review procedures should:. Be formally documented. Ensure that reviews are recorded. Ensure that representatives from all relevant areas are involved in the process of review. Software design review Plan and perform design reviews for software development projects. Your reviews should ensure that all:. Design activities and results are reviewed.
Product nonconformities are identified and addressed. Process deficiencies are identified and addressed. Review conclusions and observations are recorded. Software design review procedures Develop and document design review procedures. Your procedures should make sure that you:. Clarify exactly what is being reviewed. Distinguish between different types of reviews.
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