Iso Trg Module2

ISO 9001 and ISO 9000-3 Standards

Cybermate Infotek Limited

ISO 9001 Quality system  Model

for quality assurance in design, development, production, installation and servicing

ISO 9000-3 Quality management and quality assurance standards

 Part

3 Guidelines for the application of ISO 9001 : 1994 to the development, supply, installation and maintenance of computer software.

Quality system requirements  Management

responsibility  Quality system  Contract review  Design control  Document and data control  Purchasing  Control of customer supplied product

Quality system requirements (contd)  Product

identification and traceability  Process control  Inspection and testing  Control of inspection, measuring and test equipment  Inspection and test status  Control of non conforming product  Corrective and preventive action

Quality system requirements (contd)  Handling,

storage, packaging, preservation and delivery  Control of quality records  Internal quality records  Training  Servicing  Statistical techniques

4.1 Management responsibility  Quality

policy  Organisation - Responsibility and authority  Resources  Management representative  Management review

4.2 Quality system  Quality

manual  Quality procedures  Work Instructions or Guidelines  Quality record formats

4.2 Quality system (contd) Quality planning consists  Quality requirements  Life cycle model to be used  Criteria for start and end of phase  Verification and validation activities reviews, tests etc.,

4.3 Contract review  Before

submission of tender or acceptance of order, reviews are done to ensure that  Requirements are defined and documented  Any differences between contract and tender are resolved  Supplier has the capability to meet contractual requirements  Contract review records

4.3 Contract review (contd) Contract review issues  Customer related  Technical  Managerial  Legal, security and confidentiality

4.4 Design control  Development

consists of - Requirements analysis, architectural design, detailed design and coding.  Development to be done as per project plans  Development to be organised as per life cycle model.

4.4 Design control (contd) Design and development planning  Definition of project  Resource requirements  Project schedules  Review methods  Related plans - quality plan, test plan, configuration management plan, installation and maintenance plan.

4.4 Design control (contd) Organisational and technical interfaces  Define the interfaces between different groups which input into the design process  Customer  Testing, installation, maintenance, training depts.  Subcontractors, regulatory bodies, associated development projects, help desk

4.4 Design control (contd) Design input  Software Requirements Specification may be provided by the customer or prepared by the supplier.  SRS to cover functionality, reliability, usability, efficiency, maintainability, portability etc.,  Hardware and software aspects.

4.4 Design control (contd) Design output  Shall meet design input requirements  Refer to the acceptance criteria  Consist of architectural design, detailed design, source code, user manual etc.,

4.4 Design control (contd)  Design

review  Design verification  Design validation  Design changes

4.5 Document and data control  Documents

- Quality system documents, Project documents (SRS, SDD, Test plan etc.,)  Document preparation, review and approval  Right documents at the right place.  Document change control

4.6 Purchasing  Evaluation

of subcontractors  Purchasing data - Specs, inspection instructions etc.,  Verification of purchased product - Supplier verification at subcontractor’s premises and customer verification of subcontracted product

4.7 Control of customer supplied product  Verification,

storage and maintenance of customer supplied products like software, tools, test data, design documents etc.,

4.8 Product identification and traceability  Identification

of software items during development phases  Configuration management plan for each project  Version control  Build status and Baseline  Change control

4.9 Process control  Replication  Backups

and disaster recovery plans  Network control  Hardware maintenance  Virus control

4.10 Inspection and testing  Test

plans for unit, integration, system and acceptance tests.  Receiving inspection and testing  Unit testing  Module testing  Integration testing  System testing

4.10 Inspection and testing (contd)  Tests

to be performed - functional, boundary, performance, usability etc.,  Acceptance testing as per acceptance criteria  Inspection and tests records

4.11Control of inspection, measuring and test equipment  Environment

used for testing software  Validation of test tools used in testing

4.12 Inspection and test status  Untested,

tested with error, tested successfully or approved for release  Movement of software between development and testing.

4.13 Control of nonconforming product  Transfer

non conforming product to a separate environment  Review and disposition of non conforming product

4.14 Corrective and preventive action Corrective action  Handling of customer complaints  Investigate causes of non conformities relating to product, process and quality system.  Corrective action to eliminate cause of actual non conformities.

4.14 Corrective and preventive action (contd) Preventive action  Analyse test, review, audit, service reports to identify and eliminate potential causes of non conformities.  Root cause analysis

4.15 Handling, storage, packaging, preservation and delivery  Avoid damage to media  Virus control  Storage in protected environment  Delivery by physical media or electronic transfer.

4.16 Control of quality records  Identification,

collection, indexing, access, filing, storage, maintenance and disposition of quality records.  Quality records demonstrate conformance to specified requirements and effective operation of quality system.

4.17 Internal quality audits  Plan

and implement internal quality audits  Auditors are independent of the area being audited.  Results of audits are recorded and brought to the notice of the auditee.  Corrective action taken to close deficiencies.  Follow up audits

4.18 Training  Training

to enhance skills and knowledge  Training needs are identified  Training provided as per plans

4.19 Servicing  Maintenance

and customer support  Problem resolution  Interface modifications  Functional expansion  Performance improvement

4.20 Statistical techniques  Establishing,

controlling and verifying process capability and product characteristics  Product characteristics - testability, usability, reliability, maintainability, availability

4.20 Statistical techniques (contd)  Process

capability - process maturity, defect density, defect removal efficiency, milestone slippage  Metric reporting and actions for improvement.